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MPEP 2100 (Patentability)

AIA began on March 16, 2019

A skim of the headings of 2100 takes you through the entirety of the law — i.e., from what is patentable
to why it is patentable, to novelty, obviousness and, lastly, to proper forms for claims. All of 35 USC §101,
§102, §103 and §112 are covered here.

1. 101: Patentable Subject Matter

1. Patent Eligibility Analysis
1. Is the claim directed to one of the four patent-eligible subject matter categories:
process, machine, manufacture, or composition of matter?
1. Process: a method, an act, or a series of acts or steps.
2. Machine: a concrete thing, consisting of parts, or of certain devices and
combination of devices.
3. Manufacture: an article produced from raw or prepared materials by giving
to these materials new forms, qualities, properties, or combinations,
whether by hand labor or by machinery
1. E.g., ceramics, cast metal articles, hammers, crowbars, chairs,
shovels, gloves, shoes, envelopes and mouse-pads.
4. Composition of matter: an instrument formed by the intermixture of two or
more ingredients, and possessing properties which belong to none of these
ingredients in their separate state. Chemical compositions?
2. Four requirements
1. First, whoever invents or discovers an eligible invention may obtain only ONE patent
2. Second, the inventor(s) must be the applicant(s) in an application
3. Third, a claimed invention must fall within one of the four eligible categories of
invention, i.e., process, machine, manufacture, or composition of matter, as these
categories have been interpreted by the courts.
4. a claimed invention must be useful or have a utility that is specific, substantial, and
credible.
3. Living Subject Matter
1. Patentable
1. Human-made inventions
2. Not Patentable
1. Products of nature
2. Inventions encompassing a human being (embryos, fetuses, etc)
3. Dolly the Sheep (identical clones): breakthrough methods of producing a
live-born clone of a pre-existing, nonembryonic, donor mammal because it
is an exact genetic replica and doesn’t possess markedly different
characteristics from animals found in nature.
4. Computer-Related Inventions
1. Bilski: A process claim, to be patentable under 35 U.S.C. 101, must be limited to a
particular practical application.
2. Factors To Be Considered in Deciding Whether a Claim Is an Unpatentable Abstract
Idea

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1. Whether the Method Involves or Is Executed by a Particular Machine or

Apparatus
1. Must be sufficiently particular: the claim must clearly convey that
the computer is programmed to perform the steps of the method
because such programming, in effect, creates a special purpose
computer limited to the use of the particularly claimed combination
of elements (i.e., the programmed instructions) performing the
particularly claimed combination of functions.
2. Whether the Machine or Apparatus Implements the Steps of the Method
1. Integral use of a machine or apparatus to achieve performance of
the method weighs toward eligibility
3. Use of a machine or apparatus that contributes only nominally or
insignificantly to the execution of the claimed method (e.g., in a data
gathering step or in a field-of-use limitation) would weigh against eligibility
4. Whether Performance of the Claimed Method Results in or Otherwise
Involves a Transformation
1. Purely mental processes in which thoughts or human-based actions
are "changed" are not considered an eligible transformation.
2. However, transformation of electronic data has been found when
the nature of the data has been changed such that it has a different
function or is suitable for a different use
5. Utility
1. Utility: Must have utility and produce the results claimed by the application.
1. The claimed invention is generally the focus of the utility requirement,
unless the utility for a dependent claim is different from the claim it is
dependent on. If other dependents don’t have utility, the independent
should be rejected.
2. 112(a) and (b) issues
1. Claim Interpretation
1. Claims are given their broadest interpretation in light of the supporting disclosure.
Disclosure may be express, implicit or inherent.
2. Finally, when evaluating the scope of a claim, every limitation in the claim must be
considered. The claim as a whole must be considered.
2. Utility/Useful
1. Must have any reasonable use identified. Not de minimis. Real world value
required!
3. Inoperative inventions = no utility
1. “inoperative” inventions lack utility because they don’t produce the useful results
claimed by the patent applicant. Doesn’t have to be perfect. Very rare to be rejected
for this.
4. Deficiency under 101 = deficiency under 112(a). If a recited invention is useless, then how
can the spec teach how to use them.
5. The claimed invention is the focus of the utility requirement
6. An asserted utility must be specific, not general

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3. Claim Interpretation; Broadest Reasonable Interpretation 35 U.S.C §112 consistent with the spec.
4. Plain Meaning
1. The words of a claim must be given their "plain meaning" unless they are defined in the
specification. Plain meaning means the meaning given to the term by phositas. Applicant
can be their own lexicographer as long as the meaning assigned to the term is not repugnant
to the term’s well-known usage.
5. Weight of Preamble
1. The preamble is not given the effect of a limitation unless it breathes life and meaning into
the claim. In order to limit the claim, the preamble must be "essential to point out the
invention defined by the claim." Be careful. The preamble in a Jepson claim can be given the
effect of a limitation.
6. Transitional Phrases
1. define the scope of a claim with respect to what unrecited additional components or steps,
if any, are excluded from the scope of the claim.
2. “Comprising”
1. synonymous with "including," "containing," or "characterized by," is inclusive or
open-ended and does not exclude additional, unrecited elements or method steps.
3. “consisting of”
1. excludes any element, step, or ingredient not specified in the claim.
4. consisting essentially of
1. limits the scope of a claim to the specified materials or steps "and those that do not
materially affect the basic and novel characteristic(s)" of the claimed invention.
7. New Uses of Known Compounds aren’t patentable
1. A rejection under 35 U.S.C. §102/103 can be made when the prior art product seems to be
identical except that the prior art is silent as to an inherent characteristic.
2. Composition Claims -if the composition is physically the same, it must have the same
properties.
3. Process Of Use Claims - new and unobvious uses of old structures and compositions may be
patentable.
8. Product-by-Process Claims
1. Are only limited by the structure implied by the steps.
2. If the product in the product-by-process claim is the same as or obvious from a product of
the prior art, the claim is unpatentable even though the prior product was made by a
different process.
3. The medium of an enabling disclosure makes no difference.
9. §103 Rejections and Use of Inoperative Prior Art
1. Even if a reference discloses an inoperative device, it is prior art for all that it teaches.
10. In Some Circumstances, a Factual Reference Need Not Antedate the Filing Date
1. References that postdate may still be relied upon to show the level of ordinary skill in the art
at around the time the invention was made.
11. Abandoned Applications, Including Provisional Applications disclosed to the public can be used as
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1. An abandoned patent application may become evidence of prior art only when it has been
appropriately disclosed, as, for example, when the abandoned patent [application] is
reference[d] in the disclosure of another patent, in a publication, or by voluntary disclosure
12. Printed publications are prior art when there’s a satisfactory showing that the document has been
disseminated or otherwise made available to the extent that persons interested and are phositas
can locate it with reasonable diligence.
1. Level of public accessibility: sufficiently accessible, even if restricted.
2. Internal documents intended to be confidential aren’t “printed publications”
3. When? On the date it is received by a member of the public.
13. Admissions as Prior Art
1. When applicant states that something is prior art, it is taken as being available as prior art
against the claims. Admitted prior art can be used in obviousness rejections.
2. A Jepson claim results in an implied admission that the preamble is prior art.
14. Genus-Species Situations
1. A disclosed reference of a species will anticipate a generic claim to a genus.
15. Anticipation of Ranges
1. A specific example in the prior art which is within a claimed range anticipates the range.
2. Prior art which teaches a range within, overlapping, or touching the claimed range
anticipates if the prior art range discloses the claimed range with "sufficient specificity."
16. Non-analogous Art
1. The question of whether a reference is analogous art is not relevant to whether that
reference anticipates. A reference may be directed to an entirely different problem than the
one addressed by the inventor, or may be from an entirely different field of endeavor than
that of the claimed invention, yet the reference is still anticipatory if it explicitly or
inherently discloses every limitation recited in the claims.
17. Factors Indicative of "Commercial Exploitation"
1. USC 102(a)’s “on sale” status, aka premature “commercial exploitation” of a “completed”
invention depends on Subjective intent through objective evidence, such as the preparation
of price lists, the display of samples to prospective customers, etc. Examples are advertising,
use of an invention where an admission fee is charged, preparation of price lists, etc. No
actual sales need to occur. private offers/sales do not trigger the post-AIA bar.
18. Inventorship
1. Unless a person contributes to the conception of the invention, she is not an inventor.
2. As long as the inventor maintains intellectual domination over making the invention - ideas,
suggestions, and materials may be adopted from others.
3. The inventor is not required to reduce the invention to practice.
4. Requirements for joint inventorship
1. Inventors are join inventors based on some contribution to at least one of the claims
made by each of the named inventors. They qualify even though:
1. They did not physically work together or at the same time;
2. Each did not make the same type or amount of contribution; or
3. Each did not make a contribution to the subject matter of every claim of the
patent. [F]or persons to be joint inventors..., there must be some element
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5. Conception
1. Conception has been defined as "the complete performance of the mental part of
the inventive act" and it is "the formation in the mind of the inventor of a definite
and permanent idea of the complete and operative invention as it is thereafter to be
applied in practice.
19. Reduction to practice
1. Reduction to practice may be an actual reduction or a constructive reduction to practice,
e.g., filing of a patent application. For an actual reduction to practice, the invention must
have been sufficiently tested to demonstrate that it will work for its intended purpose, but it
need not be in a commercially satisfactory stage of development.
20. 35 U.S.C. §103 - "Obviousness" — the "Graham” Factual Inquiries
1. Graham Factual Inquiries - Steps to a determination of obviousness:
1. Determine the scope and contents of the prior art;
2. Ascertain the differences between the prior art and the claims in issue;
3. Resolve the level of ordinary skill in the pertinent art; and
4. Evaluate the evidence of secondary considerations (discussed below).
2. When applying §103:
1. The claimed invention must be considered as a whole;
2. The references must be considered as a whole and must suggest the desirability and
thus the obviousness of making the combination;
3. The references must be viewed without hindsight vision afforded by the claimed
invention; and
4. Reasonable expectation of success is the standard with which obviousness is
determined.
3. Objective evidence of "secondary considerations"
1. such as unexpected results, commercial success, long-felt need, failure of others,
copying by others, licensing, and skepticism of experts are relevant to the issues of
obviousness and must be considered in every case in which they are present.
4. Legal conclusions of obviousness must be supported by an explicit articulation of the
reasons. KSR.
5. 7 obviousness rationales of KSR
1. Combining prior art elements according to known methods to yield predictable
results;
1. Combining prior art elements + known methods = predictable results
1. Non-obvious: when the flaws of the combined prior art (a flawed
drug) were not known to phositas, when the combined prior art
elements resulted in non-predictable results (Crocs), when the
reference teached away from the proposed combination of prior art
elemetns.
2. Obvious: the combined prior art elements retained their original
respective properties or functions after being combined,
2. Simple substitution of one known element for another to obtain predictable
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1. Substitution of one phosita-known element for another phosita-known

element + phositas had the ability to substitute = predictable results
1. Obvious: The substitution in a method having the same ends
(substituting a different technique to decaffeinate), a reasonable
expectation of success from a known substituted component,
2. Non-obvious: modifying a prior art in a way that would destroy an
advantageous property,
3. Analogous art? Art from a different field can be analogous art (the
folding bed as applied to the folding treadmill). The focus is on the
problem to be solved.
4. Lead compounds:
1. Obviousness based on structural similarity can be proved by
identification of some motivation that would have led one
of ordinary skill in the art to select and then modify a known
compound (i.e. a lead compound) in a particular way to
achieve the claimed compound. It is sufficient to show that
the claimed and prior art compounds possess a
'sufficiently close relationship ... to create an expectation,'
in light of the totality of the prior art, that the new
compound will have 'similar properties' to the old
2. From the perspective of the law of obviousness, any known
compound might possibly serve as a lead compound.
However, there must be some reason for starting with
that lead compound other than the mere fact that the
"lead compound" merely exist
3. it may be proper to reject a claimed chemical compound as
obvious even without identifying a single lead compound.
3. Use of known technique to improve similar devices (methods or products) in the
same way;
1. Base device that claim invention improved + comparable device with the
same technique of improvement as claimed device + phosita could have
applied the known technique to the base device = predictable results
4. Applying a known technique to a known device (method or product) ready for
improvement to yield predictable results;
1. Ref. base system + applicable ref. known technique = predictably improved
claimed system
5. "Obvious to try" - choosing from a finite number of identified, predictable
solutions, with a reasonable expectation of success;
1. Recognized need + identified, predictable, finite potential solutions (53
anions is good enough) + reasonable expectation of success for phosita =
reasonably expected results
2. Philosophy: this isn’t an improvement or legit innovation… it’s common
sense and ordinary skill. Unpredictability doesn’t really matter.

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3. Not obvious: the prior art gave either no indication of which parameters
were critical or no direction as to which of many possible choices is likely to
be successful; the prior art gave only general guidance; even when only a
small number of possible choices exist, the "obvious to try" line of reasoning
is not appropriate when, upon consideration of all of the evidence, the
outcome would not have been reasonably predictable and the inventor
would not have had a reasonable expectation of success;
4. Obvious: the prior art teachings lead a phosita to a narrower set of options
that would be obvious to try.
5. identification of a "specific hint or suggestion in a particular reference" does
not require a “reasoned explanation.”
6. Known work in one field of endeavor may prompt variations of it for use in either
the same field or a different one based on design incentives or other market forces
if the variations are predictable to one of ordinary skill in the art;
1. Similar device + design incentives or market forces to prompt adaptation of
the similar device = predictable variation
2. Obvious: applying modern electronics to older mechanical devices; whether
a phosita, facing the wide range of needs created by developments in the
field of endeavor, would have seen a benefit to upgrading an existing device
with a variation.
7. Some teaching, suggestion, or motivation in the prior art that would have led one
of ordinary skill to modify the prior art reference or to combine prior art reference
teachings to arrive at the claimed invention.
1. Whether a phosita would have been motivated to combine the prior art
to achieve the claimed invention and that there would have been a
reasonable expectation of success
2. Explicit suggestion to combine the prior art is not necessary. Motivation to
combine may be implicit.
3. whether the ordinary artisan possesses knowledge and skills rendering him
capable of combining the prior art references.
6. Determining the level of ordinary skill
1. the educational level of the inventor;
2. type of problems encountered in the art;
3. prior art solutions to those problems;
4. rapidity with which innovations are made;
5. sophistication of the technology; and
6. educational level of active workers in the field.

21. Three Separate Requirements for Specification under §112(a)

1. The specification must include (1) a written description of the invention, (2) enablement,
and (3) best mode of carrying out the claimed invention.
1. The three requirements are separate and distinct from each other.
2. a written description of the invention

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1. An applicant's specification must convey with reasonable clarity to those skilled in

the art that, as of the filing date sought, she was in possession of the invention, i.e.,
whatever is now claimed.
2. The claimed subject matter must be supported by the specification.
3. Typical cases where inadequate written description issue arises
1. An amendment affecting a claim: An amendment to the claims or the
addition of a new claim must be supported by the description of the
invention in the application as filed. An amendment to the specification
(e.g., a change in the definition of a term used both in the specification and
claim) may indirectly affect a claim.
2. Reliance on Priority Filing Date (parent app, provisional app, foreign app):
the claims in a U.S. application are entitled to the benefit of the priority
filing date of an earlier filed application if the subject matter of the claim is
disclosed in the manner provided by 35 U.S.C. §112(a) in the earlier-filed
application.
3. Range limitations: With respect to changing numerical range limitations, the
analysis must take into account which ranges one skilled in the art would
consider inherently supported by the discussion in the original disclosure.
E.g., in re a range of "25% - 60%" and specific examples of "36%" and "50%."
“At least 35%" does not meet the description requirement because the
phrase "at least" has no upper limit.
4. Claimed subject matter not disclosed in remainder of specification: The
claims as filed in the original specification are part of the disclosure; the
applicant may amend the specification to include the claimed subject
matter.
3. Enablement
1. No undue experimentation: the specification’s description must enable a phosita on
how to make and how to use the invention without undue experimentation. The
fact that experimentation may be complex does not necessarily make it undue, if
the art typically engages in such experimentation.
2. Specification must be enabling as of the filing date.
1. In general, the examiner should not use post-filing date references to
demonstrate that the patent is non-enabling. Exceptions to this rule could
occur if a later-dated reference provides evidence of what one skilled in the
art would have known.
3. Everything within the scope of the claim must be within the scope of enablement
provided by the disclosure to a phosita.
1. If a reasonable interpretation of the claim is broader than the description in
the specification, it is necessary for the examiner to make sure the full scope
of the claim is enabled.
4. How to make: Must disclose at least one method for making/using the claim
invention that bears a reasonable correlation to the entire scope of the claim.

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5. How to use: statement of utility in the specification contains within it a connotation

of how to use, and/or the art recognizes that standard modes of administration are
known and contemplated.
6. No working example is necessary. No need for actual reduction to practice.
7. Unpredictability in the art: The more unpredictable the art is and the lower the
amount of knowledge in the state of art, the higher the standard of enablement
(more guidance or direction necessary), and the more embodiments that should be
described to ensure enablement.
8. Inoperative subject matter: The presence of inoperative embodiments within the
scope of a claim does not necessarily render a claim non-enabled.
9. Critical features must be claimed
1. A feature which is taught as “critical” in a specification and is not recited in
the claims should result in a rejection. In determining whether an unclaimed
feature is critical, the entire disclosure must be considered. Features which
are merely preferred are not considered critical.
4. best mode of carrying out the claimed invention
1. The requirement does not permit inventors to disclose only what they know to be
their second-best embodiment, while retaining the best for themselves.
2. Considerations in re “best mode”.
1. the invention is defined in the claims. The specification need not set forth
details not related to the essence of the invention.
2. A Specific Example of the “Best Mode” Is Not Required
1. Best mode may be represented by a preferred range of conditions
or group of reactants.
3. Designation of the Best Mode Is Not Required
4. Updating Best Mode Is Not Required for applications with an earlier
effective filing date (e.g., continuing apps, foreign priority apps, etc)
22. Two Separate Requirements for Specification under §112(b)
1. Two Separate Requirements
1. the claims must set forth the subject matter that applicants regard as their invention
(subjective); and
2. the claims must objectively and definitely define scope of the subject matter that
will be protected by the patent grant (objective to phositas).
2. Claims must particularly point out and distinctly claim the invention
3. New terminology: The meaning of every term should be apparent from the prior art or from
the disclosure (spec and drawings) at the time of filing.
4. Claim terminology can be defined in essentially whatever terms applicants choose, so long
as the terms are not used in ways that are contrary to accepted meanings in the art.
5. Clarity and precision: Definiteness of the scope of the claims is analyzed in light of
1. The content of the disclosure;
2. The teachings of the prior art; and
3. The claim interpretation that would be given by a phosita at the time of filing.
6. The use of relative terminology in patent claim language will not automatically render the
claim indefinite. The acceptability of the claim language depends on whether one of

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ordinary skill in the art most closely pertaining to the invention would understand what is
claimed in light of the specification.
1. Definite enough:
1. “approximately”
2. “essentially” (with guidelines in spec)
3. “Substantially”
2. Indefinite - when the specification lacks some standard for measuring the degree
intended.
1. “like”
2. “Similar”
3. Adding “type” to a definite expression
4. “relatively shallow”, “of the order of”, “the order of about 5 mm”,
“substantial portion”.
7. Shifts in claims are permitted.
8. Inconsistency between the claim and the specification + prior art can cause a definite claim
to take on an unreasonable degree of uncertainty.
9. Reciting numerical ranges in a claim generally isn’t indefinite, unless there are narrow and
broader ranges in the same claim which make it indefinite.
1. Indefinite examples: (A) "a temperature of between 45 and 78 degrees Celsius,
preferably between 50 and 60 degrees Celsius"; and (B) "a predetermined quantity,
for example, the maximum capacity."
10. Absolutely indefinite claim language
1. “for example”
1. "R is halogen, for example, chlorine";
2. “such as”
1. "material such as rock wool or asbestos";
2. "normal operating conditions such as while in the container of a
proportioner."
11. Lack of Antecedent basis
1. There is no requirement that the words in the claim must match those used in the
specification disclosure. But. A claim is indefinite when it contains words or phrases
whose meaning is unclear.
2. Lack of clarity:
1. When a claim refers to “said widget” or “the widget” when the claim
contains no earlier recitation or limitation of a widget.
2. When two widgets are referenced earlier in a claim and it’s unclear which
one is being referenced later.
12. Referencing limitations from other claims is okay as long as there’s no confusion.
13. Functional limitations (defining something by what it does instead of what it is) are fine.
14. Acceptable alternative limitations: Alternative expressions are permitted if they present
no uncertainty or ambiguity about the scope or clarity of the claims
1. Markush Groups
1. “an alkali metal selected from the group consisting of lithium, sodium, and
potassium” or

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2. “an alkali metal is lithium, sodium, or potassium”

3. Markush groups are closed.
4. is a type of claim most often used to conserve writing additional claims,
which can be financially important because the standard filing fees in a non-
provisional patent application only include twenty total claims, three of
which may be independent.
2. “Or” terminology
1. Alternative expressions using "or" are acceptable, such as
1. "wherein R is A, B, C, or D,"
2. "made entirely or in part of"
3. "iron, steel or any other magnetic material."
3. “optionally” terminology
1. It /can/ be okay, but not always. There should be no ambiguity in the way it
is used for it to be proper.
2. Proper: "containing A, B, and optionally C"
15. Negative limitations
1. there is nothing inherently ambiguous or uncertain about a negative limitation, as
long as there is a basis in the original disclosure.
16. “prolix” rejection
1. Examiners should reject claims as "prolix" (unnecessarily wordy) only when they
contain such long recitations or unimportant details that the scope of the claimed
invention is rendered indefinite
17. "Multiplicity" rejection
1. An unreasonable number of claims -- that is, unreasonable in view of the nature and
scope of applicant's invention and the state of the art -- may afford a basis for a
rejection on the ground of multiplicity.
18. Product-By-Process claims
1. A product-by-process claim, which is a product claim that defines the claimed
product in terms of the process by which it is made, is proper.
1. “The product of the process of Claim 1.”
2. “A widget prepared by a process comprising the steps of: . . .”
19. Claims directed to both Product and Process are invalid
1. A single claim which claims both an apparatus and the method steps of using the
apparatus is indefinite
2. it is unclear “whether infringement … occurs when one creates a system that allows
the user use the apparatus, or whether infringement occurs when the user actually
uses the apparatus.
20. Mere “use” claims are invalid
1. Attempts to claim a process without setting forth any steps involved in the process
generally raises an issue of indefiniteness under 35 U.S.C. §112(b). For example, a
claim which read: "A process for using monoclonal antibodies of claim 4 to isolate
and purify human fibroblast interferon" was held to be indefinite because it merely
recites a use without any active, positive steps delimiting how this use is actually
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21. Omnibus claims are invalid

1. An omnibus claim -- e.g., a claim for "A device substantially as shown and described"
without specifics -- should be rejected under 35 U.S.C. §112(b) because it is
indefinite in that it fails to point out what is included or excluded by the claim
language.
22. Trademarks or trade names in a claim can be valid
1. However, if the trademark or trade name is used in a claim as a limitation to identify
or describe a particular material or product, the claim is invalid.
23. Means-plus-function language to invoke 112(f)
1. Must:
1. Use the phrase “means for” or “step for”… or be equivalently a function to
be performed that does not provide any structure, material, or acts which
could preclude application of 112(f)
2. The “means for” or “step for” must be modified by functional language
3. The phrase “means for" or "step for" must not be modified by structure,
material or acts for achieving the specified function.
2. A means plus function claim limitation satisfies 112(f) if:
1. The written description links or associates particular structure, materials, or
acts to the function recited in a means-(or step-)plus-function claim
limitation; or
2. It is clear based on the facts of the application that one skilled in the art
would have know what structure, materials, or acts perform the function
recited in a means-(or step-)plus-function limitation.
3. "the terms and phrases used in the claims must find clear support or antecedent
basis in the description so that the meaning of the terms in the claims may be
ascertainable by reference to the description." In the situation in which the written
description only implicitly or inherently sets forth the structure, materials, or acts
corresponding to a means-(or step-) plus-function, and the examiner concludes that
one skilled in the art would not recognize what structure, materials, or acts perform
the function recited in a means (or step-) plus-function, the examiner should either:
1. Have the applicant clarify the record by amending the written description
such that it expressly recites what structure, materials, or acts perform the
function recited in the claim element; or
2. State on the record what structure, materials, or acts perform the function
recited in the means-(or step-) plus-function limitation.

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