Meissner Filtration v. Sani-Tech - Complaint

Case 2:22-cv-01194 Document 1 Filed 02/22/22 Page 1 of 14 Page ID #:1
1 CONSTANTINE MARANTIDIS, CA Bar No. 173318

cmarantidis@lewisroca.com
2 G. WARREN BLEEKER, CA Bar No. 210834
wbleeker@lewisroca.com
3 KYLE W. KELLAR, CA Bar No. 294253
kkellar@lewisroca.com
4 LEWIS ROCA ROTHGERBER CHRISTIE LLP
655 N. Central Avenue, Suite 2300
5 Glendale, CA 91203-1445
Telephone: (626) 795-9900
6 Facsimile: (626) 577-8800
7 Attorneys for Plaintiff
8 Meissner Filtration Products, Inc.
9
10 UNITED STATES DISTRICT COURT
11 CENTRAL DISTRICT OF CALIFORNIA

655 North Central Avenue
Glendale, CA 91203-1445
12
MEISSNER FILTRATION Case No. 2:22-cv-01194
13 PRODUCTS, INC.,
14 Plaintiff, COMPLAINT FOR PATENT
Suite 2300
INFRINGEMENT
15 vs.
16 SANI-TECH WEST, INC. d/b/a
SANISURE, DEMAND FOR JURY TRIAL
17
Defendant.
18
19
20 Plaintiff Meissner Filtration Products, Inc. (“Meissner” or “Plaintiff”)
21 through its undersigned counsel, brings this action against Defendant Sani-Tech
22 West, Inc. d/b/a SaniSure (“SaniSure” or “Defendant”). In support of the
23 Complaint, Plaintiff alleges as follows:
24 JURISDICTION AND VENUE
25 1. This is an action for patent infringement pursuant to 35 U.S.C. § 271
26 et seq. This Court has exclusive subject matter jurisdiction over this action under
27 28 U.S.C. §§ 1331 and 1338(a).
28
-1-
116804645.3
1 2. This Court has personal jurisdiction over SaniSure because, on

2 information and belief, SaniSure has done substantial business in this judicial
3 district. Further, SaniSure is a California corporation with a regular and established
4 place of business in this judicial district at 1020 Flynn Road, Camarillo, California
5 93012.
6 3. Venue is proper in this Court under 28 U.S.C. §§ 1391(b)(2),
7 1391(c)(2), and 1400(b) based on the foregoing facts and because, on information
8 and belief, a substantial part of the acts or omissions giving rise to the claim,
9 including SaniSure’s acts of infringement, have occurred in this judicial district.
10 THE PARTIES
11 4. Meissner is a corporation organized and existing under the laws of the
12 State of California having a principal place of business at 1001 Flynn Road,

13 Camarillo, California 93012.
14 5. On information and belief, Defendant Sani-Tech West, Inc. d/b/a
Suite 2300
15 SaniSure 1 is a California corporation having a business and agent address of 1020

16 Flynn Road, Camarillo, California 93012.
17 THE ASSERTED PATENT
18 6. United States Patent No. 7,373,825 (“the ’825 Patent”), titled
19 “GAUGE TEE DEVICE,” was duly issued by the United States Patent and
20 Trademark Office (“USPTO”) on May 20, 2008. A true and correct copy of the
21 ’825 Patent is attached hereto as Exhibit B.
22 7. Meissner owns by assignment the entire right, title, and interest in and
23 to the ’825 Patent. As the owner of the entire right, title, and interest in and to the
24 ’825 Patent, Meissner possesses the right to sue and to recover for infringement of
25 the ’825 Patent.
26
1
27 Attached hereto as Exhibit A is a true and correct copy of Sani-Tech West, Inc.’s
Fictitious Business Name Statement listing SaniSure as one of its registered
28 fictitious business names.
-2-
116804645.3
1 8. The ’825 Patent is directed to a disposable sanitary gauge tee. Figure

2 8 of the ’825 Patent, which illustrates non-limiting aspects of some of the claimed
3 embodiments, illustrates a gauge tee device 10” having a pressure fluid passageway
4 24”, the pressure fluid passageway 24” having a diameter at its proximal end 22”
5 that is substantially the same as the diameter at its distal end 30”.
6
7
8
9
10
11
12
13
14
Suite 2300
15
16
17
18 9. Meissner sells products embodying the invention of the ’825 Patent,
19 called Single-Use Gauge Tees. Since at least December 2016, Meissner has
20 identified the ’825 Patent on its Single-Use Gauge Tees that are covered by this
21 patent.
22 10. The only independent claim of the ’825 Patent, claim 1, recites:
23 1. A disposable sanitary gauge tee with no dead zone for use
24 in pressure measurement of fluid in disposable tubing comprising:
a body including a main fluid passageway in fluid connection
25
with a proximal end of a pressure fluid passageway;
26 said main fluid passageway including a fluid port and a second
27 fluid port, wherein a hose barb is operatively attached to said body at
said fluid port and said second fluid port, wherein said disposable
28 tubing can be removably attached to said hose barbs;
-3-
116804645.3
1 said pressure fluid passageway including a distal end for

2 removable attachment of a sanitary pressure gauge and a biocompatible
gauge protector for isolation of said fluid from said sanitary pressure
3 gauge; and
4 said proximal end of said pressure fluid passageway being
5 substantially the same diameter as said distal end of said pressure fluid
passageway, therein providing a total transfer of fluid within said
6 pressure fluid passageway during fluid flow.
7
THE DEFENDANT AND ACCUSED PRODUCTS
8
11. SaniSure is currently making, using, offering for sale, and/or selling
9
disposable sanitary gauge tees, which it markets as aSURE® Instrument Fittings,
10
that infringe the ’825 Patent, including at least those identified by product numbers
11
23-181010 and 23-181012 (collectively, the “Accused Products”).
12
12. On information and belief, TBL Performance Plastics LLC (“TBL
13
Plastics”), formerly a Delaware limited liability company, originally manufactured,
14 used, offered for sale, and/or sold the Accused Products. TBL Plastics hosts, on its
Suite 2300
15 webpage, a brochure showing and describing the Accused Products (the “TBL
16 aSURE Brochure”). A true and correct copy of the TBL aSURE Brochure,
17 available at https://www.tblplastics.com/wp-content/uploads/2018/07/Single-Use-
18 Pressure-Sensor-Fitting-aSURE.pdf, is attached hereto as Exhibit C. Page 3 of the
19 TBL aSURE Brochure is of particular relevance.
20 13. On information and belief, on August 16, 2021, TBL Plastics merged
21 with SaniSure, with SaniSure as the surviving entity and TBL Plastics as the
22 disappearing entity. A document titled Agreement and Plan of Merger between
23 SaniSure and TBL Plastics, as filed with the California Secretary of State, and
24 retrieved from the California Secretary of State official website, is attached hereto
25 as Exhibit D.
26 14. On or about January 17, 2022, SaniSure published a webpage and
27 article at https://sanisure.com/news/sanisure-has-been-granted-a-broad-patent-
28 claim-for-its-novel-asure-fitting-program/ and https://sanisure.com/wp-
-4-
116804645.3
1 content/uploads/2022/01/SaniSure-patent-for-aSURE-fitting-program-3.pdf,
2 respectively. True and correct copies of a screenshot of the webpage and the article
3 are attached hereto as Exhibits E and F, respectively. The SaniSure webpage states
4 that “SaniSure has been granted a broad-use patent for its novel aSURE™ fitting
5 program” and further states that “[t]he aSURE™ program incorporates a built in
6 hermetically fused elastomeric sanitary gasket or diaphragm (Cellgyn®) to a
7 standard, rigid polypropylene sanitary fitting (sub straight).” (Exhibit E). The
8 SaniSure article includes substantially similar assertions. (Exhibit F).
9 15. A comparison between SaniSure’s “novel” aSURE instrument fitting
10 and one of the Accused Products as shown in the TBL aSURE Brochure is provided
11 below.
12
13
14
Suite 2300
15
16
17
18
19
20
21 SaniSure’s Fitting TBL Plastic’s Fitting
22 (Exhibit E) (Exhibit C, page 3)
23
24 16. On information and belief, SaniSure’s webpage and article (Exhibits
25 E and F) refer to U.S. Patent No. 11,143,336 (the “’336 Patent”), which issued on
26 October 21, 2021. A true and correct copy of the ’336 Patent is attached hereto as
27 Exhibit G. The ’336 Patent was assigned from TBL Plastics to SaniSure on
28
-5-
116804645.3
1 August 16, 2021, which is recorded at reel/frame 057443/0598 of the USPTO’s

2 assignment records. 2
3 17. On information and belief, the ’336 Patent describes the “standard,
4 rigid polypropylene sanitary fitting (sub straight)” described in SaniSure’s
5 webpage and article at column 9, lines 49–55, where it states that the “[f]itting
6 member 104 is a T fitting defining a linear flow-through pathway or lumen segment
7 108 extending between two openings 110 and 112 at opposite ends. The fitting
8 member includes a third opening 114 at an end 116 of a lateral branch or stem 118
9 of the T fitting, which defines an ancillary lumen or tributary liquid channel lateral
10 to the flow-through pathway 108.” Figures 30 and 31 of the ’336 Patent, both of
11 which show the “fitting member 104,” are provided below. On information and
12 belief, the “standard, rigid polypropylene sanitary fitting (sub straight)” referenced
13 by SaniSure on its webpage and in its article is consistent with the illustrated fitting
14 member 104 in Figures 30 and 31 of the ’336 Patent
Suite 2300
15
16
17
18
19
20
21
22
23
24 2
Although TBL Plastics was aware of the ’825 Patent as late as February 5, 2020,
25 and SaniSure was aware of the ’825 Patent as late as March 19, 2021, the ’825
Patent was not disclosed to the USPTO during prosecution of the ’336 Patent. See
26 infra, paragraphs 28–29. And on September 29, 2021, a continuation application
27 of the ’336 Patent was filed with the USPTO and assigned U.S. Application No.
17/489,340. To date, the ’825 Patent has not been disclosed to the USPTO during
28 prosecution of the continuation application of the ’336 Patent.
-6-
116804645.3
1 18. A comparison between Figure 30 of the ’336 Patent and Figure 8 of

2 the ’825 Patent is provided below. .
3
4
5
6
7
8
9
19. The ’336 Patent, at column 10, lines 6–8, goes on to explain that the
10
“[g]asket 106 is heat fused to fitting member 104 so as to form a fluid-tight seal
11
between material of the gasket and material of the fitting member.” Thus, on
12
information and belief and consistent with the disclosure of the ’336 Patent,
13
SaniSure manufactures its aSURE Instrument Fittings by first manufacturing a
14
Suite 2300
fitting member and separately and independently affixing a gasket to one end of
15
the fitting member.
16
20. SaniSure’s disposable sanitary gauge tees, including at least those
17
identified by product numbers 23-181010 and 23-181012, referred to above and
18
below as the Accused Products, each have, either literally or under the doctrine of
19
equivalents, all the elements of at least claim 1 of the ’825 Patent as described in
20
the chart attached hereto as Exhibit H and as follows:
21
(i) SaniSure describes the Accused Products on its website
22 as the “aSURE™ Instrument fitting[s]” and the “aSURE instrument
tee[s].” (Exhibit C, page 3; Exhibit F). The Accused Products do not
23
have a dead zone and may be used to measure pressure in disposable
24 tubing;
25 (ii) The Accused Products have a body including a main fluid
passageway in fluid connection with a proximal end of a pressure
26
fluid passageway;
27 (iii) The main fluid passageway of the Accused Products
28 includes a fluid port and a second fluid port, and a hose barb is
-7-
116804645.3
1 operatively attached to the body at the fluid port and the second fluid
2 port. Disposable tubing can be removably attached to said hose barbs;
3 (iv) During manufacture, the pressure fluid passageway of the

Accused Products includes a distal end for removable attachment of a
4 sanitary pressure gauge and a biocompatible gauge protector for
5 isolation of the fluid from the sanitary pressure gauge. Additionally, in
their final configuration, the pressure fluid passageway of the Accused
6 Products includes a distal end for removable attachment of a sanitary
7 pressure gauge and a biocompatible gauge protector for isolation of the
fluid from the sanitary pressure gauge; and
8
(v) The proximal end of the pressure fluid passageway of the
9 Accused Products has substantially the same diameter as the distal end
of the pressure fluid passageway such that a total transfer of fluid is
10
provided within the pressure fluid passageway during fluid flow.
11
12 21. As would be understood by one of ordinary skill in the art,

13 “substantially the same diameter” as recited in claim 1 of the ’825 Patent does not
14 require exactly the same diameter at the proximal and distal ends of the pressure
Suite 2300
15 fluid passageway but covers variations between the diameter at the proximal and
16 distal ends of the pressure fluid passageway. As can be seen at least in Figure 8 of
17 the ’825 Patent, which is reproduced again below, such variations in diameters of
18 the proximal end 22” and the distal end 30” of the pressure fluid passageway 24”
19 were shown in at least one illustrated embodiment:
20 ///
21 ///
22 ///
23 ///
24 ///
25 ///
26 ///
27 ///
28 ///
-8-
116804645.3
1
2
3
4
5
6
7
8
9
10
11
12 22. For example, as described at column 6, lines 48–50 of the ’825 Patent,
13 “[t]he proximal end 22” is almost or substantially the same diameter as the distal
14 end 30” of the pressure fluid passageway 20”.”
Suite 2300
15 23. SaniSure markets and sells the Accused Products with a

16 biocompatible gauge protector affixed to the pressure fluid passageway. However,
17 on information and belief, and as described at least in the ’336 Patent, SaniSure
18 first manufactures a sanitary gauge tee without the biocompatible gauge protector
19 affixed to the pressure fluid passageway. The Accused Products, at least at this
20 stage of manufacture before the biocompatible gauge protector is affixed to the
21 pressure fluid passageway, have, either literally or under the doctrine of
22 equivalents, all of the elements of at least claim 1 of the ’825 Patent. On
23 information and belief and consistent with SaniSure’s website and article, SaniSure
24 refers to its Accused Products at this stage of manufacture as the “standard, rigid
25 polypropylene sanitary fitting (sub straight)” and describes it as the “fitting member
26 104” in the ’336 Patent. Thus, on information and belief, SaniSure, makes, either
27 literally or under the doctrine of equivalents, a disposable sanitary gauge tee that
28 has all the elements of at least claim 1 of the ’825 Patent.
-9-
116804645.3
1 24. Additionally and alternatively, on information and belief, the pressure

2 fluid passageway of the Accused Products in the as-sold configuration remains
3 capable of removable attachment of a sanitary pressure gauge and a biocompatible
4 gauge protector. For example, even with the presence of the biocompatible gauge
5 protector affixed over the pressure fluid passage way, the pressure fluid
6 passageway of the Accused Product remains capable of removable attachment of a
7 sanitary pressure gauge and a biocompatible gauge protector for isolation of fluid
8 from the sanitary pressure gauge.
9 25. Additionally and alternatively, the biocompatible gauge protector sold
10 with the Accused Products can be removed from the disposable sanitary gauge tee
11 without destroying the disposable sanitary gauge tee, separately and additionally
12 rendering the distal end of the pressure fluid passageway of the Accused Products
13 “for removable attachment of a sanitary pressure gauge and a biocompatible gauge
14 protector for isolation of the fluid from the sanitary pressure gauge.”
Suite 2300
15 26. In addition, because the pressure fluid passageway in the Accused

16 Products performs substantially the same function in substantially the same manner
17 as in the claimed embodiment to obtain the same result, any difference between the
18 Accused Products and claim 1 of the ’825 Patent is insubstantial and does not avoid
19 infringement.
20 27. Accordingly, SaniSure has infringed, and continues to infringe, at
21 least claim 1 of the ’825 Patent by making, using, offering for sale, and/or selling
22 the Accused Products, which embody all of the features of at least claim 1 of the
23 ’825 Patent both during manufacture and as marketed and sold.
24 THE PARTIES’ HISTORY
25 28. Meissner contacted TBL Plastics as early as January 3, 2020, prior to
26 TBL Plastic’s merger with SaniSure, informing it of Meissner’s patent rights in the
27 ’825 Patent. A true and correct copy of the January 3, 2020, letter is attached hereto
28 as Exhibit I. Counsel for TBL Plastics responded on February 5, 2020. A true and
-10-
116804645.3
1 correct copy of the February 5, 2020, letter from TBL Plastic’s counsel to
2 Meissner’s counsel is attached hereto as Exhibit J.
3 29. On March 19, 2021, Meissner filed suit against SaniSure and TBL
4 Plastics in this court for infringement of the ’825 patent based on the same Accused
5 Products. That suit was assigned Case No. 2:21-cv-02446 (the “first suit”). Based
6 on representations made by counsel for SaniSure and TBL Plastics, Meissner filed
7 a Notice of Voluntarily Dismissal Without Prejudice on June 17, 2021. [Case No.
8 2:21-cv-02446, Dkt. 9]. The first suit was dismissed without prejudice on June 21,
9 2021 so that the parties could attempt to settle the matter. [Case No. 2:21-cv-
10 02446, Dkt. 10].
11 30. The parties were unable to resolve the dispute. Accordingly, the
12 instant suit is being filed.

13 31. Since being put on notice of the ’825 Patent, SaniSure has not ceased
14 manufacturing, offering for sale, or selling the Accused Products and has, in fact,
Suite 2300
15 doubled down on the Accused Products.

16 CLAIM FOR RELIEF
17 (Patent Infringement of U.S. Patent No. 7,373,825)
18 32. Meissner incorporates and re-alleges Paragraphs 1 through 31 of this
19 Complaint as if fully set forth herein.
20 33. The USPTO duly issued the ’825 Patent on May 20, 2008.
21 34. The ’825 Patent is valid and enforceable.
22 35. Meissner has, since at least December 2016, marked its products
23 covered by the ’825 Patent pursuant to 35 U.S.C. § 287.
24 36. SaniSure has infringed at least claim 1 of the ’825 Patent, either
25 literally or under the doctrine of equivalents, by making, using, offering to sell,
26 and/or selling in the United States its aSURE Instrument Fittings, including at least
27 those identified by product numbers 23-181010 and 23-181012 (referred to above
28 and below as the “Accused Products”).
-11-
116804645.3
1 37. SaniSure’s infringement of the ’825 Patent has injured Meissner, and
2 Meissner is entitled to recover damages adequate to compensate it for SaniSure’s
3 infringement, which in no event can be less than a reasonable royalty.
4 38. Upon information and belief, SaniSure’s infringement was willful
5 because SaniSure made, used, offered for sale, and/or sold, and continue to do the
6 same, the Accused Products despite an objectively high likelihood that their actions
7 constituted infringement of a valid patent, and SaniSure, and TBL Plastics prior to
8 its merger with SaniSure, knew or should have known of such risk when they
9 infringed the ’825 Patent.
10 39. TBL Plastics, and by implication SaniSure, was put on actual notice
11 of the ’825 Patent as early as February 5, 2020, but continued to make, use, offer
12 for sale, and sell the Accused Products. At the latest, SaniSure was put on actual
13 notice by the filing of the first suit on March 19, 2021. Accordingly,
14 SaniSure’s infringement is willful.
Suite 2300
15 40. Pursuant to 35 U.S.C. § 284, the Court should award Meissner treble
16 damages as a result of SaniSure’s willful infringement.
17 41. SaniSure’s infringement of the ’825 Patent is exceptional.
18 Accordingly, pursuant to 35 U.S.C. § 285, Meissner is entitled to recover from
19 SaniSure its reasonable attorneys’ fees and costs incurred in prosecuting this action.
20
21 PRAYER FOR RELIEF
22 WHEREFORE, Plaintiff respectfully requests that this Court enter judgment
23 as follows:
24 1. That SaniSure has infringed the ’825 Patent;
25 2. That SaniSure’s infringement of the ’825 Patent has been willful;
26 3. Entry of a permanent injunction against further infringement of
27 the ’825 Patent by SaniSure;
28
-12-
116804645.3
1 4. An award of damages adequate to compensate Meissner for

2 SaniSure’s infringement of the ’825 Patent, including pre-judgment interest and
3 costs;
4 5. An Order requiring SaniSure to account for and pay to Meissner any
5 and all profits made by SaniSure from its sales of the Accused Products pursuant
6 to 35 U.S.C. § 289;
7 6. An award of all other damages permitted by 35 U.S.C. § 284;
8 7. A determination that this is an exceptional case within the meaning of
9 35 U.S.C. § 285 and an award to Meissner of its costs and reasonable attorneys’
10 fees incurred in this action; and
11 8. Such other relief as this Court deems just and proper.
12
13 Dated: February 22, 2022 Respectfully submitted,
14 LEWIS ROCA ROTHGERBER
Suite 2300
CHRISTIE LLP
15
16 By /s/Kyle W. Kellar
Constantine Marantidis
17 G. Warren Bleeker
18 Kyle W. Kellar
21
22
23
24
25
26
27
28
-13-
116804645.3
1 JURY DEMAND
2 Plaintiff requests a jury trial of all issues in this action so triable.
3
4 Dated: February 22, 2022 Respectfully submitted,
5 LEWIS ROCA ROTHGERBER
CHRISTIE LLP
6
7 By /s/Kyle W. Kellar
8 G. Warren Bleeker
9 Kyle W. Kellar
12
13
14
Suite 2300
15
16
17
18
19
20
21
22
23
24
25
26
27
28
-14-
116804645.3
Case 2:22-cv-01194 Document 1-1 Filed 02/22/22 Page 1 of 62 Page ID #:15
Exhibit A
Print Results https://clerkrecorderselfservice.ventura.org/web/search/DOCSEARCH184S2
Search Results
Showing selected 1 of 1 Total Results Printed Feb 11, 2022 11:44:05 AM
Search Fictitious Business Names where Business Name contains SANISURE
FBN STATEMENT • 20181217100227220

Filing Date Business Name(s) (3) Registrant(s) Expiration Date
12/17/2018 09:36 AM SANISURE SANI-TECH WEST, INC. 12/17/2023
SANI-TECH WEST
SURETECH TOOL & MOLD
Related Documents (1)
Document Number Document Type Recording Date Book/Page

20190131100018200 AFFIDAVIT OF PUBLICATION - 01/31/2019
FBN
Exhibit A
-15-
1 of 1 2/11/2022, 11:44 AM
Exhibit B
Exhibit B
-16-
Exhibit B
-17-
Exhibit B
-18-
Exhibit B
-19-
Exhibit B
-20-
Exhibit B
-21-
Exhibit B
-22-
Exhibit B
-23-
Exhibit B
-24-
Exhibit B
-25-
Exhibit B
-26-
Exhibit B
-27-
Exhibit B
-28-
Exhibit B
-29-
Exhibit C
aSURE
™
Fittings
Superior Alignment Ensures
Seal Integrity
Exclusive
Fused Gasket The Only Sanitary Fitting Available with
Design Patent Pending
Patent Pending
a One-Piece Composite Gasket Design.
Materials
of Construction
Adapter Body; Polypropylene
Gasket; Cellgyn™ TPE
TM
Performance Plastics
Exhibit C
-30-
TM
aSURE Fittings
™
The New Concept in Functional Design!

The aSURE™ utilizes a unique approach that incorporates an elastomeric
TPE (Cellgyn™) gasket fused into a singular sanitary fitting, forming a
one-piece composite design. The result is a gendered fitting that can be
used in conjunction with any standard sanitary connection. It provides
superior ergonomics and less risk of contamination.
aSURE™ fittings have been developed for single-use connectivity

applications where the most stringent practices are required. They are
manufactured from medical-grade materials and are animal derived
component free (ADCF).
Features Benefits
One Piece Design Ensures Proper Alignment
Medical Grade Materials/ ADCF Lowers Risk of Contamination
No Solvents or Cements Gendered Connection Aids in Proper Work Instruction
Gamma Stable 25 kGy to 40 kGy / Autoclavable Superior Economics
Gendered Connection Eliminates Lost or Misused Gaskets
Single Use Technology Excellent Compatibility with Most Acids and Bases
Mini Sanitary X Hose Barb

F-AS-14MPHR075-125 Mini Tri-Clamp x 1/8" Mono Barb Adapter Biocompatibility:
F-AS-14MPHR075-187 Mini Tri-Clamp x 3/16" Mono Barb Adapter All materials in contact with fluid path meet USP Class VI
<88> requirements, FDA Title 21 CFR 177.1520 , are Animal
F-AS-14MPHR075-250 Mini Tri-Clamp x 1/4" Mono Barb Adapter
Derived Component Free (ADCF) , and REACH Compliant
F-AS-14MPHR075-375 Mini Tri-Clamp x 3/8" Mono Barb Adapter
F-AS-14MPHR075-500 Mini Tri-Clamp x 1/2" Mono Barb Adapter Manufacturing:
F-AS-14MPHR075-750 Mini Tri-Clamp x 3/4" Mono Barb Adapter Manufactured and Packaged in an ISO Class 7
1-1/2” Sanitary X Hose Barb (Class 10,000) Environment
F-AS-14MPHR150-250 1-1/2” Tri-Clamp x 1/4" Mono Barb Adapter
F-AS-14MPHR150-1000 1-1/2” Tri-Clamp x 1" Mono Barb Adapter
aSURE™ Fittings Patented one-piece, composite design.

Exhibit C
-31-
™ Cellgyn (TPE) ™
Diaphragm
aSURE
™
Instrument Fitting
Provides a Protective Barrier for
Aseptic Applications
The aSURE™ instrument fitting was developed as a
means to maintain a sterile barrier where disposable
manifolds are used on hybrid single-use process equip-
ment. Fixed or tethered pressure-monitoring devices
provide extremely high accuracy and are often hard
wired into a central control panel. The aSURE™ instru-
ment fitting provides a practical means of maintaining
a sterile barrier on a complex manifold set, and provides
a barrier without the need to have a gauge present
during the sterilization process.
Features Benefits Available Sizes

One Piece Design Maintains a Sterile Barrier PN: 23-181010
Medical Grade Materials/ ADCF Works with Any 1-1/2” Sanitary Pressure Instrument Sanitary Fitting Instrument Tee
1-1/2” TC X 1/2" Hose Barb (600 Series)
No Solvents or Cements Safe Disposal (no electronics or metals) Material: ADCF Polyethylene/ Cellgyn™ TPE
Gamma Stable from 25 kGy to 40 kGy Re-use of Instrument Means Better Economics
PN: 23-181012
Gendered Connection Non-Restrictive Flow Path Sanitary Fitting Instrument Tee
1-1/2” TC X 1" Hose Barb (600 Series)
Single Use Technology No Dead Leg
Material: ADCF Polyethylene/ Cellgyn™ TPE
*Accuracy:
0 to 15 psi (0 to 1.0 bar): + 0.0% / - 6.5%
15 to 60 psi (1.0 to 4.1 bar): + 0.0% /- 0.6%
Leak Testing:
Pressure-Decay Testing is performed on each unit before
packaging
Biocompatibility:
All materials in contact with fluid path meet USP Class VI <88>
requirements, FDA Title 21 CFR 177.1520 , are Animal Derived Component
Free (ADCF) , and REACH Compliant
Manufacturing:
Manufactured and packaged in an ISO Class 7 (Class 10,000) environment
Superior alignment ensures seal integrity. TM
Exhibit C
-32-
Related Products
aSURE WFI Sampler

Visit us on-line at
™
™ www.tblplastics.com
to learn more.
aSURE™ WFI Samplers are a simple solution for achieving a contaminant-free sample
from a WFI use point. The assemblies come double bagged in an easy peel, low
permeability, medical-grade pouch and are gamma irradiated to ensure microbial
control. All assembly is conducted in a state-of-the-art ISO Class 7 cleanroom.
Demand the one-piece aSURE™ design for the cleanest hassle-free connection.
aSURE™ WFI samplers are manufactured from medical-grade polypropylene and

Cellgyn™ (TPE) materials.
Note: Pictured with Bio-Ease clamp (Optional)
Biocompatibility:
All materials in contact with fluid path meet USP Class VI <88> requirements, FDA Title 21 CFR
177.1520 , are Animal Derived Component Free (ADCF) , and REACH Compliant
AS-CGN04.3.1299-18 aSURE™ WFI Sampler Hose Mini (TC) Connection

¼” ID X 7/16” OD Cellgyn (TPE) Tube X 18" Length, Double Bagged/ Gamma Treated
AS-CGN04.3.1299-36 aSURE™ WFI Sampler Hose Mini (TC) Connection
AS-CGN04.3.2499-18 aSURE™ WFI Sampler Hose 1-1/2" (TC) Connection
¼” ID X 7/16 OD Cellgyn (TPE) Tube X 18" Length, Double Bagged/ Gamma Treated
AS-CGN04.3.2499-36 aSURE™ WFI Sampler Hose 1-1/2" (TC) Connection
Made in the USA
TBL Performance Plastics

18 White Lake Road, Sparta, NJ 07871 TM
Tel 973.383.2834 Fax 973.383.4161 sales@tblplastics.com www.tblplastics.com Performance Plastics

Exhibit C
-33-
Exhibit D
Exhibit D
-34-
Exhibit D
-35-
Exhibit D
-36-
Exhibit D
-37-
Exhibit D
-38-
Exhibit D
-39-
Exhibit D
-40-
Exhibit E
Exhibit E
-41-
Exhibit F
SaniSure has been granted a broad-use patent for its novel aSURE
fitting program.
Camarillo, CA, 17 January 2022 - SaniSure has been granted a broad-use patent for its novel
aSURE fitting program. The aSURE fitting program incorporates a built in hermetically
fused elastomeric sanitary gasket or diaphragm (Cellgyn®) to a standard rigid,
polypropylene sanitary fitting (sub straight). With this patent claims, granted for both open
flow path gaskets and barrier style diaphragms, the program addresses two distinctly
different applications.
As a diaphragm, the aSURE acts as a sterile barrier. The aSURE instrument tee is ideal
for use in SUT manifolds that are gamma sterilized. The use of the aSURE instrument tee,
enables more control options, with incredible accuracy and superior to proprietary single
use pressure sensors. With a diaphragm affixed to the branch of a tee fitting, users can
sterilize a manifold set without installing a mechanical connection to maintain sterility. A
sanitary pressure instrument of choice can be installed post sterilization without
compromising sterility. The electronic waist is eliminated because standard stainless steel
pressure instruments are retained and reused as they do not contact the critical fluid path.
Our standard fitting program is offered in sanitary fitting X hose barb configurations.
They incorporate built-in gaskets with polypropylene hose barb adapters, made for single
use systems, built to transport fluidic pharmaceutical and medicaments materials safely
and securely. It provides a better method for connecting lengths of tubing in a fluid flow
system. Integrating this gasket with a fitting member and forming a gasket-fitting
composite, substantially reduces risk of contamination in handling and of leakage in use.
With no handling of a separate gasket, installation is simplified, and the risk of
contamination from operator interface or connections missing gaskets is eliminated. With a
fitting member, it can also minimize build cost, build time, cleaning cost, system defects
and environmental impact
The aSURE adaptors are ideal for WFI water sampling. They can be supplied gamma
sterilized individually or fitted for a facility’s specific need. The iatrical gasket on the fitting
in a pre-sterilized pouch eliminates operator handling that can contaminate a sample site.
If you would like to know more about this broad patent or our aSURE use case paper and
aSURE brochure, contact us here.
Exhibit F
-42-
1020 Flynn Road | Camarillo, CA | +1.805.465.5600 | SaniSure.com

Exhibit G
US011143336B1
( 12) United States Patent ( 10 ) Patent No .: US 11,143,336 B1

DuPont , Jr. et al . (45 ) Date of Patent : Oct. 12 , 2021
( 54 ) CONNECTOR, METHOD OF MAKING USPC 285/3 , 4 , 367 , 21.2 ; 137 / 68.12 , 76
2
CONNECTOR AND TUBING ASSEMBLY See application file for complete search history.
METHOD
( 71 ) Applicant: TBL PERFORMANCE PLASTICS , ( 56 ) References Cited
LLC , Sparta , NJ (US ) U.S. PATENT DOCUMENTS
( 72 ) Inventors : Paul Robert DuPont, Jr., Sparta , NJ 3,806,386 A * 4/1974 Burke et al . B29C 65/08
( US ) ; Christopher R. Ray , Newton, NJ 156 /73.1
(US ) ; John A. Capra , Chester, NJ (US ) 4,019,512 A * 4/1977 Tenczar A61M 39/14
604/411
( * ) Notice: Subject to any disclaimer, the term of this 4,030,494 A * 6/1977 Tenczar A61M 39/14
patent is extended or adjusted under 35 604/411
U.S.C. 154 ( b ) by 386 days . 4,157,723 A * 6/1979 Granzow B29C 66/857
141/1
( 21 ) Appl. No .: 16 /189,351 4,187,846 A * 2/1980 Lolachi A61M 39/18
604/411
4,265,280 A * 5/1981 Ammann B29C 66/52298
(22 ) Filed : Nov. 13 , 2018 141/98
4,325,417 A * 4/1982 Boggs A61L 2/08
Related U.S. Application Data 141/98
5,117,875 A * 6/1992 Marrucchi B01F 15/0205
( 60 ) Provisional application No. 62/ 585,154 , filed on Nov. 141/1
13 , 2017 5,605,360 A * 2/1997 Kurisaki GOIL 19/0007
285/93
( 51 ) Int . Ci . 5,643,227 A * 7/1997 Stevens A61M 39/0606
F16L 47/02 ( 2006.01 ) 604/ 167.02
6,874,522 B2 * 4/2005 Anderson A61J 1/10
F16L 13/02 ( 2006.01 ) 137 /68.3
F16L 41/02 ( 2006.01 )
B29C 65/02 ( 2006.01 ) ( Continued )
F16L 21/00 ( 2006.01 )
B29L 31/24 ( 2006.01 ) Primary Examiner — David Bochna
B29K 623/00 ( 2006.01 ) (74 ) Attorney, Agent , or Firm — R. Neil Sudol
( 52 ) U.S. Ci .
CPC F16L 13/02 (2013.01 ) ; B29C 65/02 ( 57 ) ABSTRACT
( 2013.01 ) ; F16L 21/00 (2013.01 ) ; F16L
41/021 (2013.01 ) ; F16L 47/02 ( 2013.01 ) ; A fitting or connector for use in constructing a tubing
B29K 2623/12 ( 2013.01 ) ; B29L 2031/24 assembly is made by bonding an olefin gasket to an end face
( 2013.01 ) of a polypropylene fitting member. The gasket is bonded to
( 58 ) Field of Classification Search the fitting member via a heat fusion technique that causes
CPC . F16L 47/02 ; F16L 47/03 ; F16L 23/22 ; F16L localized melting together of the gasket and the fitting and
23/04 ; F16L 23/08 ; F16L 23/10 ; F16L generates a composite fitting or connector.
23/12 ; F16L 23/162 ; F16L 23/165 ; B29C
65/02 ; B29C 66/53241 ; B29C 66/53423 ;
B29C 66/53425 10 Claims , 8 Drawing Sheets
120 al Map
102 "
132
Exhibit G
-43-
US 11,143,336 B1
Page 2
( 56 ) References Cited
U.S. PATENT DOCUMENTS
7,097,209 B2 * 8/2006 Sparrman A61M 39/14
285/3
7,578,530 B2 * 8/2009 Eriksson F16L 23/10
285/367
8,196,971 B2 * 6/2012 Hansen F16L 23/10
285/367
8,448,992 B2 * 5/2013 Min A61M 39/143
285/3
10,794,524 B2 * 10/2020 Bunn , Sr. F16L 47/14
2001/0022448 A1 * 9/2001 Matsuzawa F16L 23/08
285/367
2007/0045968 A1 * 3/2007 Long B29C 45/14344
277/608
2007/0106264 A1 * 5/2007 Proulx A61M 39/16
604/533
2008/0245154 A1 * 10/2008 Sekine GO1L 9/0073
73/724
2008/0265561 A1 * 10/2008 Buchanan B29C 65/7473
285 /21.1
2009/0068032 A1 * 3/2009 Furey F04B 43/025
417/395
2009/0119886 A1 * 5/2009 Werth F16L 47/14
24/193
2011/0148096 A1 * 6/2011 Engle GO1K 1/14
285/93
2016/0053925 A1 * 2/2016 Dohi F16L 21/03
285/337
2019/0009479 A1 * 1/2019 DuPont, Jr. B29C 66/52241
* cited by examiner
Exhibit G
-44-
U.S. Patent Oct. 12. 2021 Sheet 1 of 88 US 11,143,336 B1
3
?
22
FIG 30
3
?
24
23
22 ? 22
FIG2
4 F
23
? 22
FG3 20
2
FIGI 32
FE4
?
a3
*,
?
?? 27
Exhibit G
-45-
140
(
29
)
46
FIGA F14.35
154Fig.36
WW
%
-4
Flag FIG
34
.
36
f 36 152 148
C FG7
38
FG.
10
Farm
36
mm
134
Exhibit G
-46-
ZO 32
27
K4410 44Fig.15
45
AFG12
FIG.13 44 32
38
F16.1 24
36 445 FIG.lt
FIG16 ?? 34
*
.
24
Exhibit G
-47-
56 -22
FIG.21
5032
22
Q
FiG18 Fiala 52
ooh
.
22 34
28
52
. 56
34 FIG17 5432
54 56
32
IFG20
27
kr FIG.2
Exhibit G
-48-
22
0
26
Fig
.
3432
.
WVI XV
T FIG.24
I ? 27
-
FG 2
. 30
25
FIG
32
. 50 32
ce
ZE 54
D
C BO
F I G . 2 3 32
66
?
ZZ
CD
Exhibit G
-49-
LIG
28
. Fig.29
AL
Oy
ww 201
72 22
Exhibit G
-50-
TITEL home112
Fig . 30
FG 32 Allah
FIG . 31
108
?? 118
MV 144
YA ALANLAR
FIG . 33
Exhibit G
-51-
250 254
1
226
228
222
.224 Fig. 37
2522
2064
206mg
222 228 Fig.38
Exhibit G
-52-
US 11,143,336 B1
1 2
CONNECTOR , METHOD OF MAKING shapes by a multitude of manufacturing methods, including
CONNECTOR AND TUBING ASSEMBLY molding. In biopharmaceutical processing systems, plastics
METHOD are typically sterilized by means of Gamma or electron
beam irradiation , or Autoclave.
CROSS - REFERENCE TO RELATED 5
There is aa need in the industry for systems , components
APPLICATION and methods that help avoid system contamination while
minimizing build cost , build time, cleaning cost , system
This application claims the benefit of U.S. Provisional defects and environmental impact.
Patent Application No. 62 / 585,154 filed Nov. 13 , 2017 , the The typical end configuration used to join devices and
entire disclosure of which is hereby incorporated by refer- 10 tube ends is the “ sanitary , ” also known as the " tri - clamp , ”
ence . design , which uses a face - seal gasket between two mating
components. The gasket and fittings are separate compo
FIELD OF THE INVENTION nents . Until the installation is complete , the faces of the
fittings and gaskets are vulnerable to outside contamination .
The invention relates to tubing systems used to transport 15 Installation of the gasket requires handling that also
fluidic materials in the manufacture , for instance , of phar- increases risk of contamination.
maceuticals and medicaments. More particularly, this inven- In addition, low -profile , translucent gaskets can be diffi
tion relates to a fitting or connector used to couple tubing cult to see , particularly in a clean - room environment where
a
sections to form a fluid transport circuit. This invention also operators wear gowns , gloves and sometimes eye protection.
relates to a method for manufacturing the fitting or connec- 20 Missing gaskets can go unnoticed .
tor. This invention further relates to associated methods of Gaskets and fitting face designs have not been fully
constructing tubing systems. standardized in the industry. The degree of standardization
of plastic components lags behind that of stainless steel
BACKGROUND OF THE INVENTION products. For this reason users currently must take care in
25 selecting and testing combinations of system components ,
For as long as drug products have been manufactured, the fittings and gaskets . Sealing performance may vary depend
Biotech and Pharmaceutical industry used various methods ing on fitting manufacturer and gasket manufacturer. Small
to convey liquid products during the drug manufacturing changes in a component can lead to system problems or
process. In more recent years the industry's mindset has require re-validation .
been to move away from traditional processes which relied 30
on fixed capital intensive piping systems. Traditional sys OBJECTS OF THE INVENTION
tems are typically made from stainless steel or glass lined
piping . Because these systems were capital intensive, drug It is an object of the present invention to provide an
manufacturers would go to large expense to validate improved fitting for connecting lengths of tubing in aa fluid
cleanability and ensure no cross contamination from one 35 flow system used in the manufacture of pharmaceuticals and
batch to the next. Facility owners have had to invest in medicaments .
expensive large and sophisticated utility plants with chemi- It is a related object of the present invention to provide an
cal dosing systems and ultra -high purity steam systems improved method for connecting lengths of tubing in a fluid
necessary to sterilize the systems. flow system used in the manufacture of pharmaceuticals and
More recently manufacturing methods have trended to 40 medicaments .
faster drug development and faster regulatory clearance to An associated object of the present invention is to provide
market. This trend is in conjunction with , and partially due an improved method for manufacturing a fitting for con
to , world health authorities granting fast track approvals of necting lengths of tubing in a fluid flow system used in the
vaccines and therapies to combat the new strains of mutated manufacture of pharmaceuticals and medicaments .
diseases , which are arising more frequently. 45 Another object of the present invention is to provide such
Today, many of the new drug manufacturing processes a fitting and such methods that help avoid system contami
utilize “ Single Use Systems”. These are basically pre- nation while minimizing build cost , build time , cleaning
sterilized sub - systems manufactured from plastics . They are cost , system defects and environmental impact.
used once , or a limited number of times , and then discarded .
For example, instead of a stainless steel vessel and piping, 50 SUMMARY OF THE INVENTION
a typical single use system would consist of a number of
plastic bag ( s ) connected by a series of plastic tubing sets The present invention is directed in part to a method of
with mechanical connection means, including tubing mani- manufacturing a fitting or connector for use in constructing
folds, between bags , tubes and other system components. a tubing assembly. The method comprises providing a fitting
Concern over the seal integrity on tubing manifolds is of 55 member including a plurality of ends with respective open
paramount concern . Manifolds are constructed using fittings ings that communicate with one another via a lumen of the
to connect multiple incoming and outgoing tubing lengths in connector member, one of the ends being formed with an
various configurations. end face. The method further comprises providing a gasket,
Because of their high temperature rating, Stainless Steel disposing the gasket against the end face, and bonding the
Piping Systems are typically sanitized by methods of hot 60 gasket to the end face of the fitting member to form a
water or “ Steam in Place ” ( SIP ) . Plastic systems are typi- fluid -tight seal between the gasket and the end face of the
cally sterilized by different methods and components are fitting member.
replaced more frequently, thereby reducing potential con- Pursuant to aa feature of the present invention , the bonding
tamination from incomplete cleaning of the system between of the gasket to the end face of the fitting member includes
batches. 65 applying energy to at least one of the gasket and the fitting
Single use plastics offer many other advantages. Compo- member to sealingly fuse the gasket to the end face . In
nents may cost less and can be manufactured in desired particular, the applying of energy includes elevating a tem
Exhibit G
-53-
US 11,143,336 B1
9
3 4
perature of the gasket and / or the fitting member to heat fuse It is a preferred, but not required, feature of the present
the gasket to the end face of the fitting member. invention that the gasket includes a major surface on a side
Preferably, the gasket is made of a first polymeric material opposite the fitting, with that major surface including a
and the fitting member is made of a second polymeric projection . It is a more particular feature of the present
material different from the first polymeric material. The first 5 invention that the projection is an annular rib or bead which
polymeric material is typically more flexible and deformable member is receivable in an annular groove in an additional fitting
that the second polymeric material. The applying of energy in a hydraulic . The two fitting members cooperate to form a joint
to the gasket and / or the fitting member preferentially or fluid - conveyance circuit .
includes an applying of heat energy in an amount to induce 10 In accordancepreferably
The gasket is heat fused to the fitting member.
with another feature of the present inven
a microscopic or molecular - level mixing of the first poly tion , the fitting member
meric material with the second polymeric material at an end openings defining aorflowpreform -
is a T fitting having two
through pathway and a third
interface between the end face of the fitting and the gasket end opening laterally of said flow - through pathway . The
to produce a density or concentration gradient of the first gasket is attached at the end of the fitting member or preform
polymeric material and an oppositely directed density or 15 which has the third end opening . The
concentration gradient of the second polymeric material fluid -impermeable diaphragm at least coextensive with a
gasket includes a
between the gasket and the fitting member. In brief, the central opening of the gasket, whereby the gasket provides
gasket is bonded to the fitting member via a heat fusion a seal and impediment to fluid flow . The T composite fitting
technique that causes localized melting together of the or connector is preferably used for attachment of a gauge or
gasket and the fitting and generates a composite fitting or 20 measurement device to a tubing assembly.
connector. In the composite fitting or connector, the gasket In accordance with another feature of the present inven
face of the fitting member is soft and pliable and that tion , the gasket includes a web member at least coextensive
material gradually merges with the more rigid material of the with a central opening of the gasket , where the web member
fitting member .The fitting member becomes a unitary object is a diaphragm , a screen , or a perforated plate .
with different part of the unitary object having different 25 A method of constructing a connector and tubing assem
physical characteristics. bly comprises, in accordance with the present invention,
In a preferred embodiment of the present invention , providing a first fitting or connector member including a
wherein the end of the fitting member face is provided with plurality of ends with respective openings that communicate
a recess and the gasket includes a pair of major surfaces, one with one another through a lumen of the first fitting or
of the major surfaces including a projection, the disposing of 30 connector member, the first fitting or connector member
the gasket against the fitting end face includes disposing the being provided at one of the ends with a gasket bonded to the
projection in the recess . The mating projection and recess first fitting or connector member so as to form a fluid - tight
serve to facilitate alignment and registration of the gasket seal between material of the gasket and material of the fitting
with the end face of the fitting member prior to and during or connector member. The method further comprises pro
the bonding process . (The mating features may be dispensed 35 viding a second fitting or connector member including a
with where ancillary external support and fixation devices plurality of ends with respective openings that communicate
are used to ensure mutual alignment and registration of the with one another through a lumen of the second fitting or
gasket and the fitting member.) The mixing of polymeric connector member, the second fitting or connector member
material and concomitant gradient generation can effectuate having an end face . The method also comprises juxtaposing
an obliteration of the structural idiosyncrasies of the gasket 40 the first fitting or connector member and the second fitting
and the fitting member at the interface therebetween . In or connector member so that the end face ( of the second
particular, any projection on the gasket and an associated fitting or connector member) is in contact with the gasket
receptive recess on the fitting member end face may disap- (bonded to the first fitting or connector member ), and
pear. coupling the first fitting or connector member and the second
A fitting or connector for use in constructing a tubing 45 fitting or connector member to one another to form a fluid
assembly comprises, in accordance with the present inven- tight seal between the end face and the gasket.
tion, a fitting member including a plurality of ends with Where the gasket is made of a first polymeric material and
respective openings that communicate with one another via the first fitting or connector member is made of a second
a lumen of the connector member. The fitting member is polymeric material different from the first polymeric mate
provided at one of the ends with a gasket bonded to the 50 rial, the gasket is preferably heat fused to the first fitting or
fitting member so as to form a fluid - tight seal between connector member. In that case , the first polymeric material
material of the gasket and material of the fitting member. is mixed with the second polymeric material at an interface
Where the gasket is made of a first polymeric material and between the first fitting or connector member and the gasket
the fitting member is made of a second polymeric material to produce a density or concentration gradient of the first
different from the first polymeric material, the gasket is 55 polymeric material and an oppositely directed density or
preferably fused to the fitting member so that it is impossible concentration gradient of the second polymeric material
to detect where the fitting member ends and the gasket between the gasket and the first fitting or connector member.
begins . The first polymeric material is mixed with the Pursuant to a preferred feature of the present invention ,
second polymeric material at an interface between the fitting the coupling of the first fitting or connector member and the
member and the gasket to produce a density or concentration 60 second fitting or connector member to one another is imple
gradient of the first polymeric material and an oppositely mented by placing a clamp about juxtaposed ends of the first
directed density or concentration gradient of the second fitting or connector member and the second fitting or con
polymeric material between the gasket and the fitting mem- nector member and locking the clamping about the juxta
ber. posed ends of the first fitting or connector member and the
Pursuant to a preferred feature of the present invention , 65 second fitting or connector member.
the first polymeric material is olefin and the second poly- A preferred embodiment of the present invention is ,
meric material is polypropylene . accordingly, a polypropylene fitting and thermoplastic olefin
Exhibit G
-54-
US 11,143,336 B1
5 6
gasket with fitting end geometry and gasket geometry, A composite fitting or connector in accordance with the
before fusion , essentially matching , or very similar to , present invention is formed without the use or application of
common sanitary “ tri -clamp ” characteristics, such as ASME solvents , glues or adhesives. A composite fitting or connec
BPE standard configuration for steel fittings with gaskets. tor in accordance with the present invention may provide
A method for use in constructing a connector and tubing 5 gendered connection that works with any non -gendered
assembly comprises, in accordance with the present inven sanitary connection .
tion, providing a T - type fitting or connector member having The present invention fulfills a long -standing need in the
two end openings defining a flow - through pathway and a industry
third end opening lateral to the flow -through pathway. The invention . as evidenced by the problems solved by the
No manufacturer offers a sanitary fitting with an
fitting
openingorwith
connector
a gasketmember
bondedis toprovided at theor connector
the fitting third end 10 elastomeric gasket permanently affixed to its face. At least
one manufacturer offers plastic sanitary fittings with
member so as to form a fluid -tight seal between material of mechanically
the gasket and material of the fitting or connector member. such existing design affixed gaskets of dissimilar materials . One
The gasket includes a fluid - impermeable diaphragm at least comprises a gasket with special features
coextensive with a central opening of the gasket, whereby 15 that mechanically attach to special tabs on a fitting. This
design has the disadvantage that the gasket can separate
the gasket provides a seal and impediment to fluid flow . The from the fitting during shipping, handling or installation ,
method further comprises juxtaposing an access port of a
gauge or measurement device with the gasket bonded to the exposing the two mating faces to potential contamination .
fitting or connector member and removably coupling the This may lead to a false sense that the gasket will always be
gauge or measurement device to the fitting or connector 20 attached.
member to form a fluid tight seal between the gauge or
measurement device and the gasket. BRIEF DESCRIPTION OF THE DRAWINGS
A tubing assembly component, for use in assembling a
tubing circuit, comprises, in accordance with the present FIG . 1 is a front, left side and top perspective view of a
invention , a fitting member such as ( a ) a tubular member 25 fitting member used in constructing a fitting or connector in
with two or more ports or (b ) an end cap for use in closing accordance with the present invention .
off an unused port, where the fitting member is made of hard FIG . 2 is a rear, left side and top perspective view of the
polymeric material such as polypropylene and is provided fitting member of FIG . 1 .
with a gasket made of a different, soft and pliable polymeric FIG . 3 is aa side elevational view of the fitting member of
material such as olefin , with the gasket bonded to the fitting 30 FIGS . 1 and 2 .
member so as to form a fluid -tight seal between material of FIG . 4 is a front elevational view of the fitting member of
the gasket and material of the fitting member. FIGS . 1-3 .
In summary, the present invention is directed to an FIG . 5 is a rear elevational view of the fitting member of
elastomer gasket heat- fused to a rigid polymer fitting. Fus- FIGS . 1-4 .
ing the two components eliminates two exposed faces and 35 FIG . 6 is a longitudinal cross - sectional view of the fitting
the corresponding sealing interface. This integration of the member of FIGS . 1-5 , taken along line VI -VI in FIG . 5 .
gasket into the fitting member, forming a gasket - fitting FIG . 7 is a top perspective view of a gasket or sealing ring
composite substantially reduces risk of contamination in used in constructing a fitting or connector in accordance
handling and of leakage in use . There is no handling of a with the present invention .
separate gasket. Installation is simplified . Risk of connec- 40 FIG . 8 is a front elevational view of the gasket or sealing
tions missing gaskets is eliminated . Performance risks ring of FIG . 7 .
related to selection and variation of mating components are FIG . 9 is a side elevational view of the gasket or sealing
eliminated for that interface. Where the gasket has an ring of FIGS . 7 and 8 .
impermeable membrane or diaphragm and is used at a gauge FIG . 10 is aa cross -sectional view of the gasket or sealing
or device coupling point, the degree of cleanliness of the 45 ring of FIGS . 7-9 , taken along line X -X in FIG . 8 .
gauge is no longer crucial, as the gauge does not come into FIG . 11 is a front, left side and top perspective view of a
contact with the sterile interior surfaces of the tubing and fitting or connector in accordance with the present invention ,
fittings. assembled from the fitting member of FIGS . 1-6 and the
Because the gasket is fused , it cannot separate in shipping gasket or sealing ring of FIGS . 7-10 , that also represents a
or preparation. It is impossible to install a fitting with no 50 preliminary stage in manufacturing a connector or compos
gasket. ite fitting member in accordance with the invention .
An instrument fitting pursuant to the present invention FIG . 12 is a rear, left side and top perspective view of the
was developed as a means to maintain a sterile barrier where fitting member of FIG . 11 .
disposable manifolds are used on hybrid single -use process FIG . 13 is aa side elevational view of the fitting member of
equipment. Fixed or tethered pressure monitoring devices 55 FIGS
provide extremely high accuracy and are often hard wired
. 11 and 12 .
FIG . 14 is aa front elevational view of the fitting member
into a central control panel . The present instrument fitting of FIGS . 11-13 .
provides a practical means of maintaining a sterile barrier on FIG . 15 is a rear elevational view of the fitting member of
a complex manifold set, and ensures a barrier without the FIGS . 11-14 .
need to have a gauge present during the sterilization process . 60 FIG . 16 is a longitudinal cross - sectional view of the fitting
A fitting in accordance with the present invention incor- member of FIGS . 11-15 , taken along line XVI - XVI in FIG .
porates an elastomeric, e.g. , TPE ( CellgynTM ), gasket fused 15 .
into a singular sanitary fitting, forming a one -piece compos- FIG . 17 is a front, left side and top perspective view of a
ite design. The result is a gendered fitting that can be used fitting or connector in accordance with the present invention ,
in conjunction with any standard sanitary connection. It 65 a modification of the embodiment of FIGS . 11-16 .
provides superior ergonomics and less risk of contamina- FIG . 18 is a rear, left side and top perspective view of the
tion. fitting or connector of FIG . 17 .
Exhibit G
-55-
US 11,143,336 B1
7 8
FIG . 19 is a side elevational view of the fitting or although not exclusive , use in the manufacture of medica
connector of FIGS . 17 and 18 . ments consists of an injection molded body member of a
FIG . 20 is a front elevational view of the fitting or relatively stiff and form -maintaining polymeric material
connector of FIGS . 17-19 . such as polypropylene . Body member 20 is provided at one
FIG . 21 is a rear elevational view of the fitting or 5 end with a conical formation 22 and at an opposite end with
connector of FIGS . 17-20 .
FIG . 22 is a longitudinal cross - sectional view of the fitting asurface
circumferential flange 24. Flange 24 is formed on an outer
, facing in aa direction opposite conical formation 22 ,
or connector of FIGS . 17-21 , taken along line XXII -XXII in with an annular groove 26 and is integral on an opposite side
FIG . 20 .
FIG . 23 is aa front, left side and top perspective view of a with a conical portion 28 that in turn is integral with conical
pair of juxtaposed fittings or connectors including the fitting 10 formation 22 via a cylindrical segment 30. A second cir
cumferential flange 32 may be provided, for instance, at the
or connector of FIGS . 17-22 , aligned with one another for junction or intersection of conical portion 28 and cylindrical
forming a joint in a fluid - flow tubing system . segment 30. Flange 32 has a beveled or rounded circular
FIG . 24 is a rear, left side and top perspective view of the outer perimeter 34 .
juxtaposed fittings or connectors of FIG . 23 . Conical end formation 22 and flange 24 define respective
FIG . 25 is a side elevational view of the juxtaposed 15 openings 23 and 25 that communicate with one another via
fittings or connectors of FIGS . 23 and 24 .
FIG . 26 is a front elevational view of the juxtaposed a lumen 27 of the fitting member.
fittings or connectors of FIGS . 23-25 . As depicted in FIGS . 7-10 , a gasket or O - ring sealing
FIG . 27 is a longitudinal cross - sectional view of the element 36 , which is preferably made of a flexible or
juxtaposed fittings or connectors of FIGS . 23-26 , taken 20 planar
deformable polymeric material such as olefin , comprises a
base member 38 formed on opposing major faces ( not
along line XXVII - XXVII in FIG . 26 .
FIG . 28 is an elevational plan view of juxtaposed fittings designated ) with a pair of annular ribs or beads 40 and 42 .
or connectors in accordance with the present in ion , with Ribs or beads 40 and 42 are typically of the same size and
adjacent and aligned flanges disposed in a recess in an profile but may be provided with differing sizes and shapes ,
opened tubing clamp. 25 as well as locations relative to base member 38. Ribs or
FIG . 29 is a side elevational view of the juxtaposed beads are shown as centrally located . However either one or
fittings or connectors and open tubing clamp of FIG . 28 . the other may be of larger or smaller diameter and disposed
FIG . 30 is a longitudinal cross - sectional view of a T fitting exemplarily along a circular outer edge or circular inner
member or preform , similar to the views of FIGS . 6 , 16 , 22 , edge of base member 38 .
and 27 , for attachment or installation of a gauge or mea- 30 As shown in FIGS . 11-16 , a composite fitting or connector
surement device to a tubing assembly. 44 comprises gasket or O -ring 36 disposed along an outer
FIG . 31 is a perspective view of the T fitting member or annular surface or end face 46 of flange 24 , with one of the
preform of FIG . 30 . annular beads or ribs 40 and 42 seated inside groove 26 .
FIG . 32 is a transverse cross - sectional view, similar to Gasket or O -ring 36 is bonded to the end face 46 of fitting
FIG . 10 , of a gasket which is permanently attachable to the 35 member 20 to form a fluid - tight seal between the gasket and
fitting member of FIGS . 30 and 31 pursuant to the present the end face of the fitting member. The bonding of gasket or
invention , where the gasket includes a liquid - impermeable O -ring 36 to annular surface or end face 46 of fitting member
diaphragm . 20 may include applying energy to gasket 36 and / or fitting
FIG . 33 is an exploded view of a gauge or measurement member 20 to sealingly fuse the gasket to the fitting end
device and a composite fitting or connector manufactured 40 face. In particular, the applying of energy includes elevating
from the fitting member of FIGS . 30 and 31 and the gasket a temperature of at least one of the gasket and the fitting
of FIG . 32 . member to heat fuse the gasket 36 to the end face 46 .
FIG . 34 is a perspective view of a gasket provided in a FIGS . 17-22 show an embodiment of a composite fitting
central opening with a filter screen , which gasket may be or connector 50 having a main body 52 made of a hard or
incorporated into a composite fitting or connector in accor- 45 stiff polymeric material such as polypropylene and an annu
dance with the present invention . lar bead or rib 54 projecting from a flange 56 at one end of
FIG . 35 is a perspective view of a gasket provided in a the fitting or connector. Bead or rib 54 is made of aa flexible,
central opening with a thin perforated plate , which gasket resilient and deformable material such as olefin .
may be incorporated into a composite fitting or connector in Fitting or connector 50 is made by a process as described
accordance with the present invention . 50 hereinabove with reference to FIGS . 11-16 . More particu
FIG . 36 is cross - sectional views of a circular end cap that larly, in the process for manufacturing composite fitting or
may be attached over an unused port in a tubing system , the connector 50 heat is applied in such an amount or intensity
end cap including a fused and integral gasket pursuant to the that a reformation or fusing occurs between a gasket preform
present invention . ( not separately visible in FIGS . 17-22 owing to a heat
FIG . 37 is a transverse cross - sectional view, similar to 55 induced reformation of the component parts ) and a fitting
FIG . 32 , showing a modified gasket which is permanently preform , namely, main body 52. The applying of energy to
attachable to the fitting member of FIGS . 30 and 31 pursuant at least one of the gasket preform ( which similar to , but
to the present invention, where the gasket includes a liquid- includes some geometric modification of, gasket or O - ring
impermeable diaphragm . 36 ) and the main -body fitting member 52 preferentially
FIG . 38 is partial view of a composite fitting or connector 60 includes an applying of heat energy in an amount to induce
manufactured from the fitting member of FIGS . 30 and 31 a microscopic or molecular- level mixing of the olefin mate
and the gasket of FIG . 37 . rial of the gasket with the polypropylene material of the
main -body fitting member 52 at an interface between an end
DETAILED DESCRIPTION face ( see end face 46 ) of the main body 52 and the gasket to
65 produce a density or concentration gradient of the olefin
As illustrated in FIGS . 1-6 , a fitting member 20 for use in polymer and an oppositely directed density or concentration
formed or assembling fluid flow conduits for particular, gradient of the polypropylene between the gasket preform
Exhibit G
-56-
US 11,143,336 B1
9 10
and the main body 52. In an intermediate plane the densities filled with air. Air being compressible hinders or reduces
or concentrations of the olefin polymer and the polypropyl- gauge accuracy . In addition , a greater force is required to
ene are substantially equal on average. From a macroscopic move the diaphragm . At low pressures, a centered dia
observational point of view, the gasket loses its separate phragm would prevent the gauge from reading anything at
identity and merges with or becomes a feature of the main 5 all .
body 52 or fitting. The composite fitting or connector 50 is Gasket 106 is heat fused to fitting member 104 so as to
a hard or stiff member provided with a soft or deformable form a fluid - tight seal between material of the gasket and
bead or rib 54 , as well as resilient outwardly projecting material of the fitting member. In a tubing circuit assembled
annular flange 56 , which is soft and pliable on the end face to include composite fitting or connector 102 , one juxta
carrying the fused gasket. 10 poses an access port 130 of a gauge or measurement device
Main body 52 of fitting or connector 50 has the same 132 with the gasket 106 bonded to fitting member 104 and
structure as fitting member 20 described above with refer- removably couples the gauge or measurement device 132 to
ence to FIGS . 1-6 . Like reference numerals are used to composite fitting or connector 102 to form a fluid tight seal
designate like parts . between access port 130 of the gauge or measurement
FIGS . 23-27 depict composite fitting or connector 50 in 15 device and the gasket 106. It is not necessary to assiduously
juxtaposition to and linearly aligned with a second fitting sterilize or clean the gauge or measurement device prior to
member 60 , with annular bead or rib 54 seated in an annular attachment thereof to fitting or connector 102 as sterility of
groove 62 on an end face 64 of the second fitting member. the fluid flow system will be maintained by the integrated
This second fitting 60 is made of a stiff polymeric material diaphragm 128 .
( e.g. , polypropylene ) throughout. A liquid -tight seal is 20 FIG . 34 depicts a gasket 134 provided in aa central opening
formed between fittings or connectors 50 and 60 owing to 136 with a filter screen 138. FIG . 35 shows a gasket 140
the incorporation of a gasket or sealing ring, including bead provided in a central opening 142 with a thin plate 144
54 , into the structure of fitting or connector 50 . provided with one or more perforations 146. Gasket 134 or
Fitting or connector 60 has the same basic structure as 140 may be incorporated into a composite fitting or con
fitting member 20 described above with reference to FIGS . 25 nector by heat fusing as described hereinabove .
1-6 . Like reference numerals are used to designate like parts . FIG . 36 depicts a circular end cap 148 that may be
In their juxtaposition, fittings or connectors 50 and 60 form attached over an unused port in a tubing system . Endcap 149
a central flange 66 which is received in an annular recess of including a gasket portion 150 of soft polymeric material
a hinged clamp 68 shown in FIG . 28. Clamp 68 includes two (e.g. , olefin ) heat fused and integrated with a body member
generally C - shaped halves 70 and 72 each with a C - shaped 30 portion 152 of hard polymeric material ( e.g. , polypropylene)
recess 74 ( only one shown) in which the composite central as described above. A projection such as an annular rib or
flange 66 is seated . Upon a pivoting closure of clamp halves bead 154 may be included as an integral part of gasket
70 and 72 and a tightening of a locking wing nut 76 , clamp portion 150 and concomitantly of end cap 148. End cap 148
68 serving in part to press the two fittings or connectors 50 may be used to close off unused ports in an assembled tubing
and 60 together and induce the gasket end of fitting 50 to 35 system .
deform against the end face 64 of fitting 60 to create a better FIG . 37 illustrates a modified gasket preform member 206
seal . of a soft pliable polymeric material such as olefin that is
As illustrated in FIGS . 30-33 , a composite fitting or bondable to fitting member or preform 104 (FIGS . 30 and
connector 102 (FIG . 33 ) for use in assembling a fluid flow 31 ) in substitution for the gasket preform member 106 of
circuit exemplarily in the manufacture of medicaments and 40 FIG . 32. Gasket preform member 206 comprises an annular
pharmaceutical compositions comprising a fitting member body or ring 220 provided on opposing lateral faces 252 and
or preform 104 (FIGS . 30 and 31 ) of a hard polymeric 254 with annular beads or ribs 222 and 224. Disposed within
material such as polypropylene and a gasket preform mem- a center opening 226 of gasket 206 and coextensive with the
ber 106 (FIG . 32 ) of aa soft pliable polymeric material such opening is a diaphragm 228 in the form of a web of
as olefin , bonded and preferably heat fused to one another so 45 impermeable polymeric material, particularly olefin , heat
that the material of the gasket 106 mixes with the material bonded around its periphery to body or ring 220. Diaphragm
ofthe fitting member 104 along an interface between the two 228 is disposed to one side of gasket 206 , so that an outer
elements, as described hereinabove. surface 250 is substantially coplanar with lateral face or
Fitting member 104 is a T fitting defining a linear flow- major surface 252 of ring 220. This offset of diaphragm 228
through pathway or lumen segment 108 extending between 50 from a center plane of gasket 206 ensures a positive mar
two openings 110 and 112 at opposite ends . The fitting riage between the diaphragm and a sanitary gauge, e.g., 132
member includes a third opening 114 at an end 116 of a ( FIG . 33 ) , eliminating a gap or space that would otherwise
lateral branch or stem 118 of the T fitting, which defines an fill with air.
ancillary lumen or tributary liquid channel lateral to the Like gasket 106 , gasket 206 is heat fused to fitting
flow - through pathway 108 . 55 member 104 so as to form a fluid - tight seal between material
Gasket 106 comprises an annular body or ring 120 of the gasket and material of the fitting member, as shown
provided on opposing lateral faces (not designated ) with in FIG . 38. Gasket 206 may be provided with an annular
annular beads or ribs 122 and 124. Disposed within a center nipple 256 projecting from the apex of annular bead or rib
opening 126 of gasket 106 and coextensive with the opening 224. Nipple 256 melts quickly at the commencement of a
is a diaphragm 128 in the form of a web of impermeable 60 heat fusing procedure to form aa thin film between bead or rib
polymeric material bonded around its periphery to body or 224 and an annular groove 258 provided in end 116 of a
ring 120. Preferably, diaphragm 128 is disposed to one side lateral or stem 118 of the T fitting 104 ( see FIG . 30 ) . The film
of gasket 106 , substantially coplanar with one of the two enhances contact between gasket 206 and the fitting ( e.g. , T
opposing lateral faces or major surfaces . This offset of fitting 104 ) , particularly between bead or rib 224 and groove
diaphragm 128 from a center plane of the gasket ensures a 65 258. The film also promotes heat fusion of the two elements.
positive marriage between the diaphragm and a sanitary Care must be taken during the heat fusion process to
gauge. The offset eliminates a gap or space that becomes restrict the heat application to the ring bodies 120 , 220 so
Exhibit G
-57-
US 11,143,336 B1
11 12
that the diaphragms 128 , 228 are insulated from the heat the bonding of said gasket to said end face of said fitting
energy. Otherwise the diaphragms can warp and distort. An member including applying heat energy to both said
insulation shield (not shown) may be positioned around the gasket and said fitting member to cause localized
diaphragms 128 , 228 during the heat fusion procedure. melting together of said first polymeric material and
Although the invention has been described in terms of 5 said second polymeric material at said end face to heat
particular embodiments and applications, one of ordinary fuse said gasket to said end face,
skill in the art, in light of this teaching , can generate wherein the applying of heat energy to said gasket and
additional embodiments and modifications without depart- said fitting member includes applying heat energy to
ing from the spirit of or exceeding the scope of the claimed both said gasket and said fitting member in an amount
invention . For instance , the gasket preform (e.g. , 36 ) used to 10 to induce a mixing of said first polymeric material with
form a composite fitting or connector member pursuant to said second polymeric material at an interface between
the present invention may have any suitable configuration of said end face and said gasket to produce a density or
body, flange and projecting elements. The side of the gasket concentration gradient of said first polymeric material
that faces away from the fitting member may have a plurality and an oppositely directed density or concentration
of pegs or lugs . Likewise the fitting or connector may be 15 gradient of said second polymeric material between
provided with any suitable geometry . The fitting member or said gasket and said fitting member, and
preform and the gasket preform may be provided with any wherein said end face is provided with a recess , said
surface configuration at the surface or sides that are placed gasket including a first major surface and a second
into contact as that surface configuration is consumed or major surface opposed to one another, said first major
reshaped inside the fused joint. Projections may serve a 20 surface including a projection, the disposing of said
temporary function during manufacture of facilitating reg- gasket against said end face including disposing said
istration or alignment of the gasket preform and the fitting projection in said recess .
preform . Accordingly, it is to be understood that the draw- 3. A fitting or connector assembly for use in constructing
ings and descriptions herein are proffered by way of example a tubing assembly, comprising:
to facilitate comprehension of the invention and should not 25 a fitting member including a plurality of ends with respec
be construed to limit the scope thereof. tive openings that communicate with one another via a
lumen of said connector member,
What is claimed is : said fitting member being provided at one of said ends
1. A method of manufacturing a fitting or connector for with a gasket bonded to said fitting member so as to
use in constructing a tubing assembly, comprising: 30 form a fluid -tight seal between material of said gasket
providing a fitting member including a plurality of ends and material of said fitting member,
with respective openings that communicate with one said gasket including a fluid - impermeable diaphragm at
another via a lumen of said connector member, one of least coextensive with a central opening of said gasket,
said ends being formed with an end face ; whereby said gasket provides a seal and impediment to
providing a gasket, said gasket being made of a first 35 fluid flow through an opening at said one of said ends;
polymeric material and said fitting member being made and
of a second polymeric material different from said first a gauge or measurement device coupled to said fitting
polymeric material, said gasket including a first major member at said one of said ends so that said gasket and
surface and a second major surface opposed to one said diaphragm isolate said gauge or measurement
another, said gasket further including a diaphragm 40 device from fluid flow in said fitting member,
disposed to one side of said gasket and having a surface wherein said gasket is made of a first polymeric material
substantially coplanar with said second major surface ; and said fitting member is made of a second polymeric
disposing said first major surface of said gasket against material different from said first polymeric material,
said end face; and said gasket being heat fused to said fitting member, said
bonding said gasket to said end face of said fitting 45 first polymeric material being mixed with said second
member to form a fluid -tight seal between said gasket polymeric material at an interface between said fitting
and said end face of said fitting member, member and said gasket to produce a density or con
the bonding of said gasket to said end face of said fitting centration gradient of said first polymeric material and
member including applying heat energy to both said an oppositely directed density or concentration gradient
gasket and said fitting member to cause localized 50 of said second polymeric material between said gasket
melting together of said first polymeric material and and said fitting member.
said second polymeric material at said end face to heat 4. A fitting or connector assembly for use in constructing
fuse said gasket to said end face . a tubing assembly, comprising:
2. A method of manufacturing a fitting or connector for a fitting member including a plurality of ends with respec
use in constructing a tubing assembly, comprising: 55 tive openings that communicate with one another via a
providing a fitting member including a plurality of ends lumen of said connector member ,
with respective openings that communicate with one said fitting member being provided at one of said ends
another via a lumen of said connector member, one of with a gasket bonded to said fitting member so as to
said ends being formed with an end face ; form a fluid -tight seal between material of said gasket
providing a gasket , said gasket being made of a first 60 and material of said fitting member,
polymeric material and said fitting member being made said gasket including a fluid - impermeable diaphragm at
of a second polymeric material different from said first least coextensive with aa central opening of said gasket,
polymeric material; whereby said gasket provides a seal and impediment to
disposing said gasket against said end face ; and fluid flow through an opening at said one of said ends;
bonding said gasket to said end face of said fitting 65
and
member to form a fluid -tight seal between said gasket a gauge or measurement device coupled to said fitting
and said end face of said fitting member, member at said one of said ends so that said gasket and
Exhibit G
-58-
US 11,143,336 B1
13 14
said diaphragm isolate said gauge or measurement juxtaposing said fitting or connector member and said
device from fluid flow in said fitting member, gauge or measurement device so that an access port of
wherein said gasket includes a major surface on a side said gauge or measurement device is in contact with
opposite said fitting, said major surface including an said gasket ; and
annular rib or bead which is receivable in an annular 5 coupling said fitting or connector member and said gauge
groove in an additional fitting member. or measurement device to one another to form a fluid
5. A fitting or connector assembly for use in constructing tight seal between said access port and said gasket so
a tubing assembly, comprising: that said gasket and said liquid -impermeable dia
a fitting member including a plurality of ends with respec- 10 phragm isolate said gauge or measurement device from
tive openings that communicate with one another via a direct contact with fluid flowing in said fitting or
lumen of said connector member, connector member during use thereof and so that said
said fitting member being provided at one of said ends gauge or measurement device is operative to measure a
with a gasket bonded to said fitting member so as to physical parameter of the fluid ,
form a fluid -tight seal between material of said gasket 15 wherein said gasket is made of a first polymeric material
and material of said fitting member, and said fitting or connector member is made of a
said gasket including a fluid - impermeable diaphragm at second polymeric material different from said first
least coextensive with a central opening of said gasket , polymeric material, said gasket being heat fused to said
whereby said gasket provides a seal and impediment to fitting or connector member so that said first polymeric
fluid flow through an opening at said one of said ends ; 20 material is mixed with said second polymeric material
and at an interface between said fitting or connector mem
a gauge or measurement device coupled to said fitting ber and said gasket to produce a density or concentra
member at said ne of said ends so that said gasket and tion gradient of said first polymeric material and an
said diaphragm isolate said gauge or measurement oppositely directed density or concentration gradient of
device from fluid flow in said fitting member, 25 said second polymeric material between said gasket
wherein said gasket is heat fused to said fitting member and said fitting or connector member.
through localized heating of said gasket and said fitting 8. The method defined in claim 7 wherein the coupling of
member. said fitting or connector member and said gauge or mea
surement device is removable or releasable, thereby
6. A fitting or connector assembly for use in constructing 30 enabling
a tubing assembly, comprising: re - use of said gauge or measurement device with
a fitting member including a plurality of ends with respec out sterilization of said gauge or measurement device.
tive openings that communicate with one another via a 9. The method defined in claim 7 , further comprising:
lumen of said connector member , flowing fluid through a tubing circuit including said fitting
said fitting member being provided at one of said ends 35 or connector member, said gasket and said liquid
impermeable diaphragm remaining imperforate and
with a gasket bonded to said fitting member so as to intact during the flowing of fluid through said tubing
form a fluid - tight seal between material of said gasket circuit to isolate said gauge or measurement device
and material of said fitting member, from direct contact with the flowing fluid ; and
said gasket including a fluid - impermeable diaphragm at during the flowing of fluid in said tubing circuit including
least coextensive with a central opening of said gasket , 40 said fitting or connector member, operating said gauge
whereby said gasket provides a seal and impediment to or measurement device to measure a physical param
fluid flow through an opening at said one of said ends ; eter of the flowing fluid .
and 10. A method of constructing a connector and tubing
a gauge or measurement device coupled to said fitting assembly , comprising:
member at said one of said ends so that said gasket and 45 providing a fitting or connector member including a
said diaphragm isolate said gauge or measurement plurality of ends with respective openings that com
device from fluid flow in said fitting member, municate with one another through a lumen of said
wherein said fitting member is a T fitting having two end fitting or connector member, said fitting or connector
openings defining a flow -through pathway and aa third member being provided at one of said ends with a
end opening laterally of said flow - through pathway, 50 gasket bonded to said fitting or connector member so as
said one of said ends exhibiting said third end opening, to form a fluid - tight seal between material of said
said third end opening being closed off or sealed by said gasket and material of said fitting or connector member,
gasket including said diaphragm . said gasket being provided with a liquid - impermeable
7. A method of constructing a connector and tubing diaphragm preventing fluid flow through said one of
assembly, comprising: 55 said ends;
providing a fitting or connector member including a providing a gauge or measurement device;
plurality of ends with respective openings that com- juxtaposing said fitting or connector member and said
municate with one another through a lumen of said gauge or measurement device so that an access port of
fitting or connector member, said fitting or connector said gauge or measurement device is in contact with
member being provided at one of said ends with a 60 said gasket ; and
gasket bonded to said fitting or connector member so as coupling said fitting or connector member and said gauge
to form a fluid - tight seal between material of said or measurement device to one another to form aa fluid
gasket and material of said fitting or connector member, tight seal between said access port and said gasket so
said gasket being provided with a liquid - impermeable that said gasket and said liquid - impermeable dia
diaphragm preventing fluid flow through said one of 65 phragm isolate said gauge or measurement device from
said ends; direct contact with fluid flowing in said fitting or
providing a gauge or measurement device; connector member during use thereof and so that said
Exhibit G
-59-
US 11,143,336 B1
15 16
gauge or measurement device is operative to measure a
physical parameter of the fluid ,
wherein the coupling of said fitting or connector member
and said gauge or measurement device to one another
includes placing a clamp about juxtaposed ends of said 5
fitting or connector member and said gauge or mea
surement device and locking said clamping about said
juxtaposed ends of said fitting or connector member
and said gauge or measurement device .
10
Exhibit G
-60-
Exhibit H
US Patent No. 7,373,825 TBL Performance Plastics Tee
(As shown in FIG. 1 Below)
1. A disposable sanitary gauge tee with no 1. A disposable sanitary gauge tee 1 with no
dead zone for use in pressure measurement of dead zone for use in pressure measurement of
fluid in disposable tubing comprising: fluid in disposable tubing comprising:
a body including a main fluid passageway in a body 10 including a main fluid passageway
fluid connection with a proximal end of a 20 in fluid connection with a proximal end 22
pressure fluid passageway; of a pressure fluid passageway 12;
said main fluid passageway including a fluid said main fluid passageway including a fluid
port and a second fluid port, wherein a hose port 16 and a second fluid port 18, wherein a
barb is operatively attached to said body at hose barb 14 is operatively attached to said
said fluid port and said second fluid port, body at said fluid port and said second fluid
wherein said disposable tubing can be port, wherein said disposable tubing can be
removably attached to said hose barbs; removably attached to said hose barbs;
said pressure fluid passageway including a said pressure fluid passageway 12 including a
distal end for removable attachment of a distal end 30 for removable attachment of a
sanitary pressure gauge and a biocompatible sanitary pressure gauge and a biocompatible
113617274.1 Exhibit H
-61-
gauge protector for isolation of said fluid from gauge protector 26 for isolation of said fluid
said sanitary pressure gauge; from said sanitary pressure gauge;
and said proximal end of said pressure fluid and said proximal end 22 of said pressure fluid
passageway being substantially the same passageway 12 being substantially the same
diameter as said distal end of said pressure diameter 23 as said distal end of said pressure
fluid passageway, therein providing a total fluid passageway, therein providing a total
transfer of fluid within said pressure fluid transfer of fluid within said pressure fluid
passageway during fluid flow. passageway during fluid flow. (This
embodiment is described on column 6, lines
48-56 in reference to FIG. 8. In FIG. 8, the
diameter at the absolute distal end of the fluid
passage is greater than at the proximal end.
Thus, “substantially the same” allows for some
leeway in the difference between the
diameters at the proximal and distal ends of
the pressure fluid passage)
8. The disposable sanitary gauge tee of claim 8. The disposable sanitary gauge tee of claim
113617274.1 Exhibit H
-62-
1 for use in a process selected from the group 1 for use in a process selected from the group
consisting of aseptic filtration, upstream consisting of aseptic filtration, upstream
management of chromatography with management of chromatography with
disposable devices, capsule conditioning, disposable devices, capsule conditioning,
capsule flushing, viral clearance filtration or capsule flushing, viral clearance filtration or
processes, buffer filtration or flushes, processes, buffer filtration or flushes,
diafiltration, monitoring air blow-down of diafiltration, monitoring air blow-down of
process tubing or systems, aseptic process tubing or systems, aseptic
downstream pressure measurement of downstream pressure measurement of
filtration or validated processes, aseptic filtration or validated processes, aseptic
measurement of tangential flow filtration, measurement of tangential flow filtration,
disposable system production of disposable system production of
carcinogenic/oncological products, or any carcinogenic/oncological products, or any
other process with cleaning validation issues. other process with cleaning validation issues.
113617274.1 Exhibit H
-63-
FIG. 1 TBL Performance Plastics Tee
113617274.1 Exhibit H
-64-
Exhibit I
Lewis Roca Rothgerber Christie LLP 655 North Central Avenue 626.795.9900 main Partner
Post Office Box 29001 Suite 2300 626.577.8800 fax Admitted in California
Glendale, CA 91209-9001 Glendale, CA 91203-1445 lrrc.com CMarantidis@lrrc.com
January 3, 2020
Via Email With Confirmation By Mail

sales@tblplastics.com
Robert DuPont
TBL Performance Plastics
18 White Lake Road
Sparta, New Jersey 07871
Re: U.S. Patent No. 7,373,825 entitled Gauge Tee Device

LRRC Ref. 408325-00300
Dear Mr. DuPont:
We are intellectual property counsel for Meissner Filtration Products, Inc. ("Meissner"). We
recently became aware of your new single-use instrument tee fittings, from a brochure entitled
“aSURE Instrument Fitting”, a copy of which is enclosed herein for your reference. While we
have not evaluated your new tee fittings, we would like to make you aware of U.S. Patent No.
7,373,825 (a copy of which is enclosed herein), owned by Meissner, which may cover such tee
fittings.
Please revert back to us with any questions, comments, or concerns, or if you are interested in
purchasing such tee fittings directly from Meissner.
Very truly yours,
CM/rl
Enclosures
Exhibit I
-65-
109755661_1
Albuquerque / Colorado Springs / Denver / Irvine / Las Vegas / Los Angeles / Phoenix / Reno / Silicon Valley / Tucson
Exhibit J
Exhibit J
-66-

Meissner Filtration v. Sani-Tech - Complaint

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Meissner Filtration v. Sani-Tech - Complaint

Uploaded by

Copyright:

Available Formats

Case 2:22-cv-01194 Document 1 Filed 02/22/22 Page 1 of 14 Page ID #:1

1 CONSTANTINE MARANTIDIS, CA Bar No. 173318

11 CENTRAL DISTRICT OF CALIFORNIA

1 2. This Court has personal jurisdiction over SaniSure because, on

12 State of California having a principal place of business at 1001 Flynn Road,

15 SaniSure 1 is a California corporation having a business and agent address of 1020

1 8. The ’825 Patent is directed to a disposable sanitary gauge tee. Figure

1 said pressure fluid passageway including a distal end for

1 August 16, 2021, which is recorded at reel/frame 057443/0598 of the USPTO’s

1 18. A comparison between Figure 30 of the ’336 Patent and Figure 8 of

3 (iv) During manufacture, the pressure fluid passageway of the

12 21. As would be understood by one of ordinary skill in the art,

15 23. SaniSure markets and sells the Accused Products with a

1 24. Additionally and alternatively, on information and belief, the pressure

15 26. In addition, because the pressure fluid passageway in the Accused

12 instant suit is being filed.

15 doubled down on the Accused Products.

1 4. An award of damages adequate to compensate Meissner for

FBN STATEMENT • 20181217100227220

Related Documents (1)

Document Number Document Type Recording Date Book/Page

The New Concept in Functional Design!

aSURE™ fittings have been developed for single-use connectivity

Mini Sanitary X Hose Barb

aSURE™ Fittings Patented one-piece, composite design.

Features Benefits Available Sizes

Superior alignment ensures seal integrity. TM

aSURE WFI Sampler

aSURE™ WFI samplers are manufactured from medical-grade polypropylene and

Note: Pictured with Bio-Ease clamp (Optional)

AS-CGN04.3.1299-18 aSURE™ WFI Sampler Hose Mini (TC) Connection

Made in the USA

TBL Performance Plastics

Tel 973.383.2834 Fax 973.383.4161 sales@tblplastics.com www.tblplastics.com Performance Plastics

1020 Flynn Road | Camarillo, CA | +1.805.465.5600 | SaniSure.com

( 12) United States Patent ( 10 ) Patent No .: US 11,143,336 B1

U.S. Patent Oct. 12. 2021 Sheet 1 of 88 US 11,143,336 B1

U.S. Patent Oct. 12. 2021 Sheet 2 of 8 US 11,143,336 B1

U.S. Patent Oct. 12. 2021 Sheet 3 of 8 US 11,143,336 B1

U.S. Patent Oct. 12. 2021 Sheet 4 of 8 US 11,143,336 B1

U.S. Patent Oct. 12. 2021 Sheet 5 of 8 US 11,143,336 B1

U.S. Patent Oct. 12. 2021 Sheet 6 of 8 US 11,143,336 B1

U.S. Patent Oct. 12. 2021 Sheet 7 of 8 US 11,143,336 B1

U.S. Patent Oct. 12. 2021 Sheet 8 of 8 US 11,143,336 B1

US Patent No. 7,373,825 TBL Performance Plastics Tee

(As shown in FIG. 1 Below)

fluid in disposable tubing comprising: fluid in disposable tubing comprising:

pressure fluid passageway; of a pressure fluid passageway 12;

said sanitary pressure gauge; from said sanitary pressure gauge;

passageway during fluid flow. passageway during fluid flow. (This

embodiment is described on column 6, lines

48-56 in reference to FIG. 8. In FIG. 8, the

diameter at the absolute distal end of the fluid

passage is greater than at the proximal end.

Thus, “substantially the same” allows for some

leeway in the difference between the

diameters at the proximal and distal ends of

the pressure fluid passage)

consisting of aseptic filtration, upstream consisting of aseptic filtration, upstream

management of chromatography with management of chromatography with

disposable devices, capsule conditioning, disposable devices, capsule conditioning,

processes, buffer filtration or flushes, processes, buffer filtration or flushes,

diafiltration, monitoring air blow-down of diafiltration, monitoring air blow-down of

process tubing or systems, aseptic process tubing or systems, aseptic