MPEP § 2131 — MPEP § 2131
Current through: 2022-07-01

2131-Anticipation — Application of 35 U.S.C. 102 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2100 

 Section 2131 
 

 
 
 
 
 
 2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017]

 A claimed invention may be rejected under 35 U.S.C.
 102 when the invention is anticipated (or is “not novel”) over a
 disclosure that is available as prior art. To reject a claim as anticipated by a reference,
 the disclosure must teach every element required by the claim under its broadest reasonable
 interpretation. See, e.g., MPEP § 2114 , subsections II and IV.
 

 “A claim is anticipated only if each and every element as set forth in the
 claim is found, either expressly or inherently described, in a single prior art reference.”
 Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2
 USPQ2d 1051, 1053 (Fed. Cir. 1987). “When a claim covers several structures or
 compositions, either generically or as alternatives, the claim is deemed anticipated if any
 of the structures or compositions within the scope of the claim is known in the prior art.”
 Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir.
 2001) (claim to a system for setting a computer clock to an offset time to address the Year
 2000 (Y2K) problem, applicable to records with year date data in “at least one of
 two-digit, three-digit, or four-digit” representations, was held anticipated by a system
 that offsets year dates in only two-digit formats). See also MPEP § 2131.02 . “The
 identical invention must be shown in as complete detail as is contained in the ... claim.”
 Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913,
 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is
 not an ipsissimis verbis test, i.e., identity of terminology is not
 required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
 Note that, in some circumstances, it is permissible to use multiple references in a
 35 U.S.C.
 102 rejection. See MPEP § 2131.01 .
 

 
 2131.01 Multiple Reference 35 U.S.C. 102 Rejections [R-01.2024]

 Normally, only one reference should be used in making a rejection under
 35 U.S.C.
 102 . However, a 35 U.S.C. 102 rejection over
 multiple references has been held to be proper when the extra references are cited
 to:
 

 
 (A) Prove the primary reference contains an “enabled disclosure;”
 
 

 (B) Explain the meaning of a term used in the primary reference; or
 
 

 (C) Show that a characteristic not disclosed in the reference is
 inherent. 
 

 
 See subsections I-III below for more explanation of each
 circumstance.
 

 I. TO PROVE REFERENCE CONTAINS AN “ENABLED DISCLOSURE” Extra References and Extrinsic Evidence Can Be Used To Show the
 Primary Reference Contains an “Enabled Disclosure” When the claimed composition or machine is disclosed identically
 by the reference, an additional reference may be relied on to show that the
 primary reference has an “enabled disclosure.” In re Samour,
 571 F.2d 559, 197 USPQ 1 (CCPA 1978) and In re
 Donohue, 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985) (Compound claims
 were rejected under pre-AIA 35 U.S.C. 102(b) over
 a publication in view of two patents. The publication disclosed the claimed
 compound structure while the patents taught methods of making compounds of that
 general class. The applicant argued that there was no motivation to combine the
 references because no utility was previously known for the compound and that the
 35 U.S.C.
 102 rejection over multiple references was improper. The
 court held that the publication taught all the elements of the claim and thus
 motivation to combine was not required. The patents were only submitted as
 evidence of what was in the public's possession before the invention.). 
 

 II. TO EXPLAIN THE MEANING OF A TERM USED IN THE PRIMARY REFERENCE Extra References or Other Evidence Can Be Used to Show Meaning of a
 Term Used in the Primary Reference Extrinsic evidence may be used to explain but not expand the
 meaning of terms and phrases used in the reference relied upon as anticipatory of
 the claimed subject matter. In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991) (Baxter
 Travenol Labs. invention was directed to a blood bag system incorporating a bag
 containing DEHP, an additive to the plastic which improved the bag’s red blood
 cell storage capability. The examiner rejected the claims over a technical
 progress report by Becker which taught the same blood bag system but did not
 expressly disclose the presence of DEHP. The report, however, did disclose using
 commercial blood bags. It also disclosed the blood bag system as “very similar to
 [Baxter] Travenol’s commercial two bag blood container.” Extrinsic evidence
 (depositions, declarations and Baxter Travenol’s own admissions) showed that
 commercial blood bags, at the time Becker’s report was written, contained DEHP.
 Therefore, one of ordinary skill in the art would have known that “commercial
 blood bags” meant bags containing DEHP. The claims were thus held to be
 anticipated.).
 

 In Actelion Pharmaceuticals Ltd v. Mylan
 Pharmaceuticals Inc., 85 F.4th 1167, 1171-74, 2023 USPQ2d 1314 (Fed.
 Cir. 2023), the court reviewed the intrinsic evidence including the claims,
 specification, and prosecution history and held that the meaning of the claim term
 “a pH of 13 or higher” could not be determined without turning to extrinsic
 evidence. It was unclear from the claims whether “a pH of 13 or higher” “carries
 any meaning to a person of ordinary skill in the art as regards precision of
 measurement, significant digits, or rounding.” Id. at
 1171-1172. The specification also was unclear about any desired level of precision
 for the term, inconsistently describing the level of specificity for a pH of 13.
 Id. at 1172-1173. Finally, the prosecution history also did
 not illuminate a level of precision and whether “pH of 13” encompassed values that
 round to 13, such as 12.5. Id. at 1173. The court therefore found that in this
 case extrinsic evidence should be consulted to understand “the meaning of a term
 in the relevant art during the relevant time
 period”. Actelion, 85 F.4th at 1174 (quoting Teva
 Pharmaceuticals USA, Inc v. Sandoz, Inc., 574 U.S. 318, 331,135 S.
 Ct. 831, 841, 113 USPQ2d 1269, 1276 (2015)).
 

 III. TO SHOW THAT A CHARACTERISTIC NOT DISCLOSED IN THE REFERENCE IS INHERENT
 Extra Reference or Evidence Can Be Used To Show an Inherent
 Characteristic of the Thing Taught by the Primary Reference “To serve as an anticipation when the reference is silent about
 the asserted inherent characteristic, such gap in the reference may be filled with
 recourse to extrinsic evidence. Such evidence must make clear that the missing
 descriptive matter is necessarily present in the thing described in the reference,
 and that it would be so recognized by persons of ordinary skill.”
 Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264,
 1268, 20 USPQ2d 1746, 1749-50 (Fed. Cir. 1991) (The court went on to explain that
 “this modest flexibility in the rule that ‘anticipation’ requires that every
 element of the claims appear in a single reference accommodates situations in
 which the common knowledge of technologists is not recorded in the reference; that
 is, where technological facts are known to those in the field of the invention,
 albeit not known to judges.” 948 F.2d at 1268, 20 USPQ at 1749-50.). Note that as
 long as there is evidence of record establishing inherency, failure of those
 skilled in the art to contemporaneously recognize an inherent property, function
 or ingredient of a prior art reference does not preclude a finding of
 anticipation. Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342,
 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Two prior art references disclosed
 blasting compositions containing water-in-oil emulsions with identical ingredients
 to those claimed, in overlapping ranges with the claimed composition. The only
 element of the claims arguably not present in the prior art compositions was
 “sufficient aeration . . . entrapped to enhance sensitivity to a substantial
 degree.” The Federal Circuit found that the emulsions described in both references
 would inevitably and inherently have “sufficient aeration” to sensitize the
 compound in the claimed ranges based on the evidence of record (including test
 data and expert testimony). This finding of inherency was not defeated by the fact
 that one of the references taught away from air entrapment or purposeful
 aeration.). See also In re King, 801 F.2d 1324, 1327, 231 USPQ
 136, 139 (Fed. Cir. 1986); Titanium Metals Corp. v. Banner, 778
 F.2d 775, 782, 227 USPQ 773, 778 (Fed. Cir. 1985). See MPEP § 2112 -
 §
 2112.02 for case law on inherency. Also note that the
 critical date of extrinsic evidence showing a universal fact need not antedate the
 filing date. See MPEP § 2124 . 
 

 

 
 2131.02 Genus-Species Situations [R-07.2022]
 I. A SPECIES WILL ANTICIPATE A CLAIM TO A GENUS “A generic claim cannot be allowed to an applicant if the prior art
 discloses a species falling within the claimed genus.” The species in that case will
 anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ
 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614
 (Fed. Cir. 1989) (Gosteli claimed a genus of 21 specific chemical species of bicyclic
 thia-aza compounds in Markush claims. The prior art reference applied against the
 claims disclosed two of the chemical species. The parties agreed that the prior art
 species would anticipate the claims unless applicant was entitled to his foreign
 priority date.).
 

 II. A REFERENCE THAT CLEARLY NAMES THE CLAIMED SPECIES ANTICIPATES THE CLAIM NO
 MATTER HOW MANY OTHER SPECIES ARE NAMED A genus does not always anticipate a claim to a species within the
 genus. However, when the species is clearly named, the species claim is anticipated
 no matter how many other species are additionally named. See Ex
 parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed
 compound was named in a reference which also disclosed 45 other compounds. The Board
 held that the comprehensiveness of the listing did not negate the fact that the
 compound claimed was specifically taught. The Board compared the facts to the
 situation in which the compound was found in the Merck Index, 
 saying that “the tenth edition of the Merck Index lists ten
 thousand compounds. In our view, each and every one of those compounds is ‘described’
 as that term is used in [pre-AIA] 35 U.S.C. 102(a) , in
 that publication.”). Id. at 1718. See also In re
 Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982) (The claims
 were directed to polycarbonate containing cadmium laurate as an additive. The court
 upheld the Board’s finding that a reference specifically naming cadmium laurate as an
 additive amongst a list of many suitable salts in polycarbonate resin anticipated the
 claims. The applicant had argued that cadmium laurate was only disclosed as
 representative of the salts and was expected to have the same properties as the other
 salts listed while, as shown in the application, cadmium laurate had unexpected
 properties. The court held that it did not matter that the salt was not disclosed as
 being preferred, the reference still anticipated the claims and because the claim was
 anticipated, the unexpected properties were immaterial.).
 

 III. A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT
 DISCLOSURE WHEN THE SPECIES CAN BE “AT ONCE ENVISAGED” FROM THE DISCLOSURE “[W]hether a generic disclosure necessarily
 anticipates everything within the genus … depends on the factual aspects of the
 specific disclosure and the particular products at issue.” Sanofi-Synthelabo
 v. Apotex, Inc., 550 F.3d 1075, 1083, 89 USPQ2d 1370, 1375 (Fed. Cir.
 2008). See also Osram Sylvania Inc. v. American Induction Tech.
 Inc., 701 F.3d 698, 706, 105 USPQ2d 1368, 1374 (Fed. Cir. 2012) (“how
 one of ordinary skill in the art would understand the relative size of a genus or
 species in a particular technology is of critical importance”).
 

 A reference disclosure can anticipate a claim when the
 reference describes the limitations but "'d[oes] not expressly spell out' the
 limitations as arranged or combined as in the claim, if a person of skill in the art,
 reading the reference, would ‘at once envisage’ the claimed arrangement or
 combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780
 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re
 Petering, 301 F.2d 676, 681(CCPA 1962)). In
 Kennametal, the challenged claim was to a cutting tool
 requiring a ruthenium binding agent with a physical vapor deposition (PVD) coating.
 The reference described all the elements of the claimed coated cutting tool but did
 not explicitly disclose the specific combination of ruthenium binding agent with a
 PVD coating. However, the reference disclosed that ruthenium was one of five
 specified binding agents and PVD was one of three suitable coating techniques. The
 Federal Circuit stated that the reference’s “express ‘contemplat[ion]’ of PVD
 coatings provided sufficient evidence that a reasonable mind could find that a person
 of skill in the art… would immediately envisage applying a PVD coating. Thus,
 substantial evidence supports the Board's conclusion that [the reference] effectively
 teaches 15 combinations, of which one anticipates pending claim 1. Though it is true
 that there is no evidence in [the reference] of ‘actual performance’ of combining the
 ruthenium binder and PVD coatings, this is not required.”
 Kennametal, 780 F.3d at 1383, 114 USPQ2d at 1255 (citations
 omitted). See also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor
 Co., 851 F.3d 1270, 1274, 122 USPQ2d 1116, 1120 (Fed. Cir. 2017)
 (“ Kennametal does not stand for the proposition that a
 reference missing a limitation can anticipate a claim if a skilled artisan viewing
 the reference would “at once envisage” the missing limitation. Rather,
 Kennametal addresses whether the disclosure of a limited number
 of combination possibilities discloses one of the possible combinations.”).
 

 When a claimed compound is not specifically named in a reference,
 but instead it is necessary to select portions of teachings within the reference and
 combine them, e.g., select various substituents from a list of alternatives given for
 placement at specific sites on a generic chemical formula to arrive at a specific
 composition, anticipation can only be found if the classes of substituents are
 sufficiently limited or well delineated. Ex parte A, 17 USPQ2d
 1716 (Bd. Pat. App. & Inter. 1990). If one of ordinary skill in the art is able
 to “at once envisage” the specific compound within the generic chemical formula, the
 compound is anticipated. One of ordinary skill in the art must be able to draw the
 structural formula or write the name of each of the compounds included in the generic
 formula before any of the compounds can be “at once envisaged.” One may look to the
 preferred embodiments to determine which compounds can be anticipated. In re
 Petering, 301 F.2d 676, 133 USPQ 275 (CCPA 1962).
 

 In In re Petering, the prior art disclosed a
 generic chemical formula “wherein X, Y, Z, P, and R ' -
 represent either hydrogen or alkyl radicals, R a side chain containing an OH group.”
 The court held that this formula, without more, could not anticipate a claim to
 7-methyl-9-[d, l ' -ribityl]-isoalloxazine because the
 generic formula encompassed a vast number and perhaps even an infinite number of
 compounds. However, the reference also disclosed preferred substituents for X, Y, Z,
 P, R, and R ' as follows: where X, P, and
 R ' are hydrogen, where Y and Z may be hydrogen or
 methyl, and where R is one of eight specific isoalloxazines. The court determined
 that this more limited generic class consisted of about 20 compounds. The limited
 number of compounds covered by the preferred formula in combination with the fact
 that the number of substituents was low at each site, the ring positions were
 limited, and there was a large unchanging structural nucleus, resulted in a finding
 that the reference sufficiently described “each of the various permutations here
 involved as fully as if he had drawn each structural formula or had written each
 name.” The claimed compound was 1 of these 20 compounds. Therefore, the reference
 “described” the claimed compound and the reference anticipated the claims.
 

 In In re Schauman, 572 F.2d 312, 197 USPQ 5 (CCPA
 1978), claims to a specific compound were anticipated because the prior art taught a
 generic formula embracing a limited number of compounds closely related to each other
 in structure and the properties possessed by the compound class of the prior art was
 that disclosed for the claimed compound. The broad generic formula seemed to describe
 an infinite number of compounds but claim 1 was limited to a structure with only one
 variable substituent R. This substituent was limited to low alkyl radicals. One of
 ordinary skill in the art would at once envisage the subject matter within claim 1 of
 the reference. 
 

 Compare In re Meyer, 599 F.2d 1026, 202 USPQ 175
 (CCPA 1979) (A reference disclosing “alkaline chlorine or bromine solution” embraces
 a large number of species and cannot be said to anticipate claims to “alkali metal
 hypochlorite.”); Akzo N.V. v. International Trade Comm’n, 808 F.2d 1471, 1 USPQ2d 1241 (Fed.
 Cir. 1986) (Claims to a process for making aramid fibers using a 98% solution of
 sulfuric acid were not anticipated by a reference which disclosed using sulfuric acid
 solution but which did not disclose using a 98% concentrated sulfuric acid
 solution.). See MPEP §
 2144.08 for a discussion of obviousness in genus-species
 situations.
 

 

 
 2131.03 Anticipation of Ranges [R-01.2024]
 I. A SPECIFIC EXAMPLE IN THE PRIOR ART WHICH IS WITHIN A CLAIMED RANGE
 ANTICIPATES THE RANGE “[W]hen, as by a recitation of ranges or otherwise, a claim covers
 several compositions, the claim is ‘anticipated’ if one of them is
 in the prior art.” Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing
 In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962))
 (emphasis in original) (Claims to titanium (Ti) alloy with 0.6-0.9% nickel (Ni) and
 0.2-0.4% molybdenum (Mo) were held anticipated by a graph in a Russian article on
 Ti-Mo-Ni alloys because the graph contained an actual data point corresponding to a
 Ti alloy containing 0.25% Mo and 0.75% Ni and this composition was within the claimed
 range of compositions.). “If the prior art discloses a point within the claimed
 range, the prior art anticipates the claim.” UCB, Inc. v. Actavis Labs. UT,
 Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
 

 II. PRIOR ART WHICH TEACHES A RANGE OVERLAPPING OR TOUCHING THE CLAIMED RANGE
 ANTICIPATES IF THE PRIOR ART RANGE DISCLOSES THE CLAIMED RANGE WITH “SUFFICIENT
 SPECIFICITY” When the prior art discloses a range which touches or overlaps the
 claimed range, but no specific examples falling within the claimed range are
 disclosed, a case by case determination must be made as to anticipation. In order to
 anticipate the claims, the claimed subject matter must be disclosed in the reference
 with “sufficient specificity to constitute an anticipation under the statute.” What
 constitutes a “sufficient specificity” is fact dependent. If the claims are directed
 to a narrow range, and the reference teaches a broader range, other facts of the
 case, must be considered when determining whether the narrow range is disclosed with
 “sufficient specificity” to constitute an anticipation of the claims. Compare
 ClearValue Inc. v. Pearl River Polymers Inc., 668 F.3d 1340,
 101 USPQ2d 1773 (Fed. Cir. 2012) with Atofina v. Great Lakes Chem.
 Corp, 441 F.3d 991, 999, 78 USPQ2d 1417, 1423 (Fed. Cir. 2006).
 

 In ClearValue, the claim at issue
 was directed to a process of clarifying water with alkalinity below 50 ppm, whereas
 the prior art taught that the same process works for systems with alkalinity of 150
 ppm or less. In holding the claim anticipated, the court observed that “there is no
 allegation of criticality or any evidence demonstrating any difference across the
 range.” Id. at 1345, 101 USPQ2d at 1777. In
 Atofina, the court held that a reference temperature range of
 100-500 degrees C did not describe the claimed range of 330-450 degrees C with
 sufficient specificity to be anticipatory, even though there was a slight overlap
 between the reference’s preferred range (150-350 degrees C) and the claimed range.
 “[T]he disclosure of a range is no more a disclosure of the end points of the range
 than it is each of the intermediate points.” Id. at 1000, 78
 USPQ2d at 1424. Patentee described claimed temperature range as “critical” to enable
 the process to operate effectively, and showed that one of ordinary skill would have
 expected the synthesis process to operate differently outside the claimed range. 
 

 If the prior art disclosure does not disclose a
 claimed range with “sufficient specificity” to anticipate a claimed invention, any
 evidence of unexpected results within the narrow range may render the claims
 nonobvious. See MPEP §
 716.02 et seq. The question of “sufficient specificity” is similar to
 that of “clearly envisaging” a species from a generic teaching. See
 MPEP
 § 2131.02 . 
 

 A 35 U.S.C. 102 and
 103 combination rejection is permitted if it is unclear if the
 reference teaches the range with “sufficient specificity.” The examiner must, in this
 case, provide reasons for anticipation as well as a reasoned statement regarding
 obviousness. Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. &
 Inter. 1993) (expanded Board). For a discussion of the obviousness of ranges see
 MPEP
 § 2144.05 .
 

 III. PRIOR ART WHICH TEACHES A VALUE OR RANGE THAT IS VERY CLOSE TO, BUT DOES NOT
 OVERLAP OR TOUCH, THE CLAIMED RANGE DOES NOT ANTICIPATE THE CLAIMED RANGE “[A]nticipation under § 102 can be found only when the
 reference discloses exactly what is claimed and that where there are differences
 between the reference disclosure and the claim, the rejection must be based on
 §
 103 which takes differences into account.” Titanium
 Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)
 (Claims to titanium (Ti) alloy with 0.8% nickel (Ni) and 0.3% molybdenum (Mo) were
 not anticipated by, although they were held obvious over, a graph in a Russian
 article on Ti-Mo-Ni alloys in which the graph contained an actual data point
 corresponding to a Ti alloy containing 0.25% Mo and 0.75% Ni.).
 

 

 
 2131.04 Secondary Considerations [R-08.2012]

 Evidence of secondary considerations, such as unexpected results or
 commercial success, is irrelevant to 35 U.S.C. 102 rejections and thus
 cannot overcome a rejection so based. In re Wiggins, 488 F.2d 538,
 543, 179 USPQ 421, 425 (CCPA 1973).
 

 

 
 2131.05 Nonanalogous or Disparaging Prior Art [R-08.2012]

 “Arguments that the alleged anticipatory prior art is ‘nonanalogous
 art’ or ‘teaches away from the invention’ or is not recognized as solving the problem
 solved by the claimed invention, [are] not ‘germane’ to a rejection under
 section
 102 .” Twin Disc, Inc. v. United States, 231 USPQ 417, 424 (Cl. Ct. 1986) (quoting
 In re Self, 671 F.2d 1344, 213 USPQ 1, 7 (CCPA 1982)). See also
 State Contracting & Eng’ g Corp. v. Condotte America, Inc., 
 346 F.3d 1057, 1068, 68 USPQ2d 1481, 1488 (Fed. Cir. 2003) (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.).
 

 A reference is no less anticipatory if, after disclosing the invention,
 the reference then disparages it. The question whether a reference “teaches away” from
 the invention is inapplicable to an anticipation analysis. Celeritas
 Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47
 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The prior art was held to anticipate the claims
 even though it taught away from the claimed invention. “The fact that a modem with a
 single carrier data signal is shown to be less than optimal does not vitiate the fact
 that it is disclosed.”). See Upsher-Smith Labs. v. Pamlab, LLC, 412
 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(claimed composition that
 expressly excluded an ingredient held anticipated by reference composition that
 optionally included that same ingredient); see also Atlas Powder Co. v. IRECO,
 Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999) (Claimed
 composition was anticipated by prior art reference that inherently met claim limitation
 of “sufficient aeration” even though reference taught away from air entrapment or
 purposeful aeration.).
 

 

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 2101-2102-[Reserved] 

 2103-Patent Examination Process 

 2104-Requirements of 35 U.S.C. 101 
 2104.01-Barred by Atomic Energy Act 

 
 

 2105-Patent Eligible Subject Matter — Living Subject Matter 

 2106-Patent Subject Matter Eligibility 
 2106.01-[Reserved] 

 2106.02-[Reserved] 

 2106.03-Eligibility Step 1: The Four Categories of Statutory Subject Matter 

 2106.04-Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception 
 2106.04(a)-Abstract Ideas 
 2106.04(a)(1)-Examples of Claims That Do Not Recite Abstract Ideas 

 2106.04(a)(2)-Abstract Idea Groupings 

 2106.04(a)(3)-Tentative Abstract Ideas 

 
 

 2106.04(b)-Laws of Nature, Natural Phenomena & Products of Nature 

 2106.04(c)-The Markedly Different Characteristics Analysis 

 2106.04(d)-Integration of a Judicial Exception Into A Practical Application 
 2106.04(d)(1)-Evaluating Improvements in the Functioning of a Computer, or an Improvement to Any Other Technology or Technical Field in
 Step 2A Prong Two 

 2106.04(d)(2)-Particular Treatment and Prophylaxis in Step 2A Prong Two 

 
 

 
 

 2106.05-Eligibility Step 2B: Whether a Claim Amounts to Significantly More 
 2106.05(a)-Improvements to the Functioning of a Computer or To Any Other Technology or Technical Field 

 2106.05(b)-Particular Machine 

 2106.05(c)-Particular Transformation 

 2106.05(d)-Well-Understood, Routine, Conventional Activity 

 2106.05(e)-Other Meaningful Limitations 

 2106.05(f)-Mere Instructions To Apply An Exception 

 2106.05(g)-Insignificant Extra-Solution Activity 

 2106.05(h)-Field of Use and Technological Environment 

 
 

 2106.06-Streamlined Analysis 
 2106.06(a)-Eligibility is Self Evident 

 2106.06(b)-Clear Improvement to a Technology or to Computer Functionality 

 
 

 2106.07-Formulating and Supporting Rejections For Lack Of Subject Matter Eligibility 
 2106.07(a)-Formulating a Rejection For Lack of Subject Matter Eligibility 
 2106.07(a)(1)-Form Paragraphs for use in Lack of Subject Matter Eligibility Rejections 

 
 

 2106.07(b)-Evaluating Applicant’s Response 

 2106.07(c)-Clarifying the Record 

 
 

 
 

 2107-Guidelines for Examination of Applications for Compliance with the Utility Requirement 
 2107.01-General Principles Governing Utility Rejections 

 2107.02-Procedural Considerations Related to Rejections for Lack of Utility 

 2107.03-Special Considerations for Asserted Therapeutic or Pharmacological Utilities 

 
 

 2108-[Reserved] 

 2109-Inventorship 

 2109.01-Joint Inventorship 

 2110-[Reserved] 

 2111-Claim Interpretation; Broadest Reasonable Interpretation 
 2111.01-Plain Meaning 

 2111.02-Effect of Preamble 

 2111.03-Transitional Phrases 

 2111.04-“Adapted to,” “Adapted for,” “Wherein,” “Whereby,” and Contingent Clauses 

 2111.05-Functional and Nonfunctional Descriptive Material 

 
 

 2112-Requirements of Rejection Based on Inherency; Burden of Proof 
 2112.01-Composition, Product, and Apparatus Claims 

 2112.02-Process Claims 

 
 

 2113-Product-by-Process Claims 

 2114-Apparatus and Article Claims — Functional Language 

 2115-Material or Article Worked Upon by Apparatus 

 2116-Novel, Nonobvious Starting Material or End Product 
 2116.01-Novel, Nonobvious Starting Material or End Product 

 
 

 2117-Markush Claims 

 2118-2119-[Reserved] 

 2120-Rejection on Prior Art 
 2120.01-Rejections Under 35 U.S.C. 102(a)(1) and (a)(2) and Pre-AIA 35 U.S.C. 102(a), (b), or (e): Printed Publication or Patent 

 2120.02-Rejections Under 35 U.S.C. 102(a)(1) or Pre-AIA 35 U.S.C. 102(a) or (b): Knowledge by Others, or Public Use, or On Sale 

 
 

 2121-Prior Art; General Level of Operability Required to Make a Prima Facie Case 
 2121.01-Use of Prior Art in Rejections Where Operability is in Question 

 2121.02-Compounds and Compositions — What Constitutes Enabling Prior Art 

 2121.03-Plant Genetics — What Constitutes Enabling Prior Art 

 2121.04-Apparatus and Articles — What Constitutes Enabling Prior Art 

 
 

 2122-Discussion of Utility in the Prior Art 

 2123-Rejection Over Prior Art’s Broad Disclosure Instead of Preferred Embodiments 

 2124-Exception to the Rule That the Reference Must be Prior Art 
 2124.01-Tax Strategies Deemed Within the Prior Art 

 
 

 2125-Drawings as Prior Art 

 2126-Availability of a Document as a “Patent” for Purposes of Rejection Under 35 U.S.C. 102(a) or Pre-AIA 35 U.S.C. 102(a), (b),
 and (d) 
 2126.01-Date of Availability of a Patent as a Reference 

 2126.02-Scope of Reference’s Disclosure Which Can Be Used to Reject Claims When the Reference Is a “Patent” but Not a “Publication” 

 
 

 2127-Domestic and Foreign Patent Applications as Prior Art 

 2128-“Printed Publications” as Prior Art 
 2128.01-Level of Public Accessibility Required 

 2128.02-Date Publication Is Available as a Reference 

 
 

 2129-Admissions as Prior Art 

 2130-[Reserved] 

 2131-Anticipation — Application of 35 U.S.C. 102 
 2131.01-Multiple Reference 35 U.S.C. 102 Rejections 

 2131.02-Genus-Species Situations 

 2131.03-Anticipation of Ranges 

 2131.04-Secondary Considerations 

 2131.05-Nonanalogous or Disparaging Prior Art 

 
 

 2132-Pre-AIA 35 U.S.C. 102(a) 
 2132.01-Overcoming a Pre-AIA 35 U.S.C. 102(a) Rejection based on a Printed Publication or Patent 

 
 

 2133-Pre-AIA 35 U.S.C. 102(b) 
 2133.01-Rejections of Continuation-In-Part (CIP) Applications 

 2133.02-Rejections Based on Publications and Patents 
 2133.02(a)-Overcoming a Pre-AIA 35 U.S.C. 102(b) Rejection Based on a Printed Publication or Patent 

 
 

 2133.03-Rejections Based on “Public Use” or “On Sale” 
 2133.03(a)-“Public Use” 

 2133.03(b)-“On Sale” 

 2133.03(c)-The “Invention” 

 2133.03(d)-“In This Country” 

 2133.03(e)-Permitted Activity; Experimental Use 
 2133.03(e)(1)-Commercial Exploitation 

 2133.03(e)(2)-Intent 

 2133.03(e)(3)-“Completeness” of the Invention 

 2133.03(e)(4)-Factors Indicative of an Experimental Purpose 

 2133.03(e)(5)-Experimentation and Degree of Supervision and Control 

 2133.03(e)(6)-Permitted Experimental Activity and Testing 

 2133.03(e)(7)-Activity of an Independent Third Party Inventor 

 
 

 
 

 
 

 2134-Pre-AIA 35 U.S.C. 102(c) 

 2135-Pre-AIA 35 U.S.C. 102(d) 
 2135.01-The Four Requirements of Pre-AIA 35 U.S.C. 102(d) 

 
 

 2136-Pre-AIA 35 U.S.C. 102(e) 
 2136.01-Status of Unpublished or Published as Redacted U.S. Application as a Reference Under Pre-AIA 35 U.S.C. 102(e) 

 2136.02-Content of the Prior Art Available Against the Claims 

 2136.03-Critical Reference Date 

 2136.04-Different Inventive Entity; Meaning of “By Another” 

 2136.05-Overcoming a Rejection Under Pre-AIA 35 U.S.C. 102(e) 
 2136.05(a)-Antedating a Pre-AIA 35 U.S.C. 102(e) Reference 

 2136.05(b)-Showing The Reference Is Describing An Inventor's Or At Least One Joint Inventor's Own Work 

 
 

 
 

 2137-Pre-AIA 35 U.S.C. 102(f) 
 2137.01-[Reserved] 

 2137.02-[Reserved] 

 
 

 2138-Pre-AIA 35 U.S.C. 102(g) 
 2138.01-Interference Practice 

 2138.02-“The Invention Was Made in This Country” 

 2138.03-“By Another Who Has Not Abandoned, Suppressed, or Concealed It” 

 2138.04-“Conception” 

 2138.05-“Reduction to Practice” 

 2138.06-“Reasonable Diligence” 

 
 

 2139-Rejections Under Pre-AIA 35 U.S.C. 102 
 2139.01-Effective Filing Date of a Claimed Invention Under Pre-AIA 35 U.S.C. 102 

 2139.02-Determining Whether To Apply Pre-AIA 35 U.S.C. 102(a), (b), or (e) 

 2139.03-Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 102 

 
 

 2140-[Reserved] 

 2141-Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 
 2141.01-Scope and Content of the Prior Art 
 2141.01(a)-Analogous and Nonanalogous Art 

 
 

 2141.02-Differences Between Prior Art and Claimed Invention 

 2141.03-Level of Ordinary Skill in the Art 

 
 

 2142-Legal Concept of Prima Facie Obviousness 

 2143-Examples of Basic Requirements of a Prima Facie Case of Obviousness 
 2143.01-Suggestion or Motivation To Modify the References 

 2143.02-Reasonable Expectation of Success Is Required 

 2143.03-All Claim Limitations Must Be Considered 

 
 

 2144-Supporting a Rejection Under 35 U.S.C. 103 
 2144.01-Implicit Disclosure 

 2144.02-Reliance on Scientific Theory 

 2144.03-Reliance on Common Knowledge in the Art or “Well Known” Prior Art 

 2144.04-Legal Precedent as Source of Supporting Rationale 

 2144.05-Obviousness of Similar and Overlapping Ranges, Amounts, and Proportions 

 2144.06-Art Recognized Equivalence for the Same Purpose 

 2144.07-Art Recognized Suitability for an Intended Purpose 

 2144.08-Obviousness of Species When Prior Art Teaches Genus 

 2144.09-Close Structural Similarity Between Chemical Compounds (Homologs, Analogues, Isomers) 

 
 

 2145-Consideration of Applicant’s Rebuttal Arguments and Evidence 

 2146-Pre-AIA 35 U.S.C. 103(c) 
 2146.01-Prior Art Disqualification Under Pre-AIA 35 U.S.C. 103(c) 

 2146.02-Establishing Common Ownership or Joint Research Agreement Under Pre-AIA 35 U.S.C. 103(c) 

 2146.03-Examination Procedure With Respect to Pre-AIA 35 U.S.C. 103(c) 
 2146.03(a)-Provisional Rejection (Obviousness) Under 35 U.S.C. 103(a) Using Provisional Prior Art Under Pre-AIA 35 U.S.C. 102(e) 

 
 

 
 

 2147-Biotechnology Process Applications; Pre-AIA 35 U.S.C. 103(b) 

 2148-Form Paragraphs for Use in Rejections Under Pre-AIA 35 U.S.C. 103 

 2149-[Reserved] 

 2150-Examination Guidelines for 35 U.S.C. 102 and 103 as Amended by the First Inventor To File Provisions of the Leahy-Smith America
 Invents Act 

 2151-Overview of the Changes to 35 U.S.C. 102 and 103 in the AIA 

 2152-Detailed Discussion of AIA 35 U.S.C. 102(a) and (b) 
 2152.01-Effective Filing Date of the Claimed Invention 

 2152.02-Prior Art Under AIA 35 U.S.C. 102(a)(1) (Patented, Described in a Printed Publication, or in Public Use, on Sale, or Otherwise
 Available to the Public) 
 2152.02(a)-Patented 

 2152.02(b)-Described in a Printed Publication 

 2152.02(c)-In Public Use 

 2152.02(d)-On Sale 

 2152.02(e)-Otherwise Available to the Public 

 2152.02(f)-No Requirement of “By Others” 

 
 

 2152.03-Admissions 

 2152.04-The Meaning of “Disclosure” 

 2152.05-Determining Whether To Apply 35 U.S.C. 102(a)(1) or 102(a)(2) 

 2152.06-Overcoming a 35 U.S.C. 102(a)(1) or 102(a)(2) Rejection 

 2152.07-Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 102 

 
 

 2153-Prior Art Exceptions Under 35 U.S.C. 102(b)(1) to AIA 35 U.S.C. 102(a)(1) 
 2153.01-Prior Art Exception Under AIA 35 U.S.C. 102(b)(1)(A) To AIA 35 U.S.C. 102(a)(1) (Grace Period Inventor-Originated Disclosure
 Exception) 
 2153.01(a)-Grace Period Inventor-Originated Disclosure Exception 

 2153.01(b)-[Reserved] 

 
 

 2153.02-Prior Art Exception Under AIA 35 U.S.C. 102(b)(1)(B) to AIA 35 U.S.C. 102(a)(1) (Inventor-Originated Prior Public Disclosure
 Exception) 

 
 

 2154-Provisions Pertaining to Subject Matter in a U.S. Patent or Application Effectively Filed Before the Effective Filing Date
 of the Claimed Invention 
 2154.01-Prior Art Under AIA 35 U.S.C. 102(a)(2) “U.S. Patent Documents” 
 2154.01(a)-WIPO Published Applications 

 2154.01(b)-Determining When Subject Matter Was Effectively Filed Under AIA 35 U.S.C. 102(d) 

 2154.01(c)-Requirement Of “Names Another Inventor” 

 2154.01(d)-Provisional Rejections Under 35 U.S.C. 102(a)(2); Reference Is a Copending U.S. Patent Application 

 
 

 2154.02-Prior Art Exceptions Under 35 U.S.C. 102(b)(2) to AIA 35 U.S.C. 102(a)(2) 
 2154.02(a)-Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(A) to AIA 35 U.S.C. 102(a)(2) (Inventor-Originated Disclosure Exception) 

 2154.02(b)-Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(B) to AIA 35 U.S.C. 102(a)(2) (Inventor-Originated Prior Public Disclosure
 Exception) 

 2154.02(c)-Prior Art Exception Under AIA 35 U.S.C. 102(b)(2)(C) to AIA 35 U.S.C. 102(a)(2) (Common Ownership or Obligation of Assignment) 

 
 

 
 

 2155-Use of Affidavits or Declarations Under 37 CFR 1.130 To Overcome Prior Art Rejections 
 2155.01-Showing That the Disclosure Was Made by the Inventor or a Joint Inventor 

 2155.02-Showing That the Subject Matter Disclosed Had Been Previously Publicly Disclosed by the Inventor or a Joint Inventor 

 2155.03-Showing That the Disclosure was Made, or That Subject Matter had Been Previously Publicly Disclosed, by Another Who Obtained
 the Subject Matter Disclosed Directly or Indirectly From the Inventor or a Joint Inventor 

 2155.04-Enablement 

 2155.05-Who May File an Affidavit or Declaration Under 37 CFR 1.130 

 2155.06-Situations in Which an Affidavit or Declaration Is Not Available 

 
 

 2156-Joint Research Agreements 

 2157-Improper Naming of Inventors 

 2158-AIA 35 U.S.C. 103 
 2158.01-Form Paragraphs for Use in Rejections Under AIA 35 U.S.C. 103 

 
 

 2159-Applicability Date Provisions and Determining Whether an Application Is Subject to the First Inventor To File Provisions of
 the AIA 
 2159.01-Applications Filed Before March 16, 2013 

 2159.02-Applications Filed on or After March 16, 2013 

 2159.03-Applications Subject to the AIA but Also Containing a Claimed Invention Having an Effective Filing Date Before March 16, 2013 

 2159.04-Applicant Statement in Transition Applications Containing a Claimed Invention Having an Effective Filing Date on or After
 March 16, 2013 

 
 

 2160-[Reserved] 

 2161-Three Separate Requirements for Specification Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 
 2161.01-Computer Programming, Computer Implemented Inventions, and 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 

 
 

 2162-Policy Underlying 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 

 2163-Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph,
 “Written Description” Requirement 
 2163.01-Support for the Claimed Subject Matter in Disclosure 

 2163.02-Standard for Determining Compliance With the Written Description Requirement 

 2163.03-Typical Circumstances Where Adequate Written Description Issue Arises 

 2163.04-Burden on the Examiner with Regard to the Written Description Requirement 

 2163.05-Changes to the Scope of Claims 

 2163.06-Relationship of Written Description Requirement to New Matter 

 2163.07-Amendments to Application Which Are Supported in the Original Description 
 2163.07(a)-Inherent Function, Theory, or Advantage 

 2163.07(b)-Incorporation by Reference 

 
 

 
 

 2164-The Enablement Requirement 
 2164.01-Test of Enablement 
 2164.01(a)-Undue Experimentation Factors 

 2164.01(b)-How to Make the Claimed Invention 

 2164.01(c)-How to Use the Claimed Invention 

 
 

 2164.02-Working and Prophetic Examples 

 2164.03-Relationship of Predictability of the Art and the Enablement Requirement 

 2164.04-Burden on the Examiner Under the Enablement Requirement 

 2164.05-Determination of Enablement Based on Evidence as a Whole 
 2164.05(a)-Specification Must Be Enabling as of the Filing Date 

 2164.05(b)-Specification Must Be Enabling to Persons Skilled in the Art 

 
 

 2164.06-Quantity of Experimentation 
 2164.06(a)-Examples of Enablement Issues-Missing Information 

 2164.06(b)-Examples of Enablement Issues — Biological and Chemical Cases 

 2164.06(c)-Examples of Enablement Issues – Computer Programming Cases 

 
 

 2164.07-Relationship of Enablement Requirement to Utility Requirement of 35 U.S.C. 101 

 2164.08-Enablement Commensurate in Scope With the Claims 
 2164.08(a)-Single Means Claim 

 2164.08(b)-Inoperative Subject Matter 

 2164.08(c)-Critical Feature Not Claimed 

 
 

 
 

 2165-The Best Mode Requirement 
 2165.01-Considerations Relevant to Best Mode 

 2165.02-Best Mode Requirement Compared to Enablement Requirement 

 2165.03-Requirements for Rejection for Lack of Best Mode 

 2165.04-Examples of Evidence of Concealment 

 
 

 2166-Rejections Under 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, First Paragraph 

 2167-2170-[Reserved] 

 2171-Two Separate Requirements for Claims Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 

 2172-Subject Matter Which the Inventor or a Joint Inventor Regards as The Invention 
 2172.01-Unclaimed Essential Subject Matter 

 
 

 2173-Claims Must Particularly Point Out and Distinctly Claim the Invention 
 2173.01-Interpreting the Claims 

 2173.02-Determining Whether Claim Language is Definite 

 2173.03-Correspondence Between Specification and Claims 

 2173.04-Breadth Is Not Indefiniteness 

 2173.05-Specific Topics Related to Issues Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 
 2173.05(a)-New Terminology 

 2173.05(b)-Relative Terminology 

 2173.05(c)-Numerical Ranges and Amounts Limitations 

 2173.05(d)-Exemplary Claim Language (“for example,” “such as”) 

 2173.05(e)-Lack of Antecedent Basis 

 2173.05(f)-Reference to Limitations in Another Claim 

 2173.05(g)-Functional Limitations 

 2173.05(h)-Alternative Limitations 

 2173.05(i)-Negative Limitations 

 2173.05(j)-Old Combination 

 2173.05(k)-Aggregation 

 2173.05(l)-[Reserved] 

 2173.05(m)-Prolix 

 2173.05(n)-Multiplicity 

 2173.05(o)-Double Inclusion 

 2173.05(p)-Claim Directed to Product-By- Process or Product and Process 

 2173.05(q)-“Use” Claims 

 2173.05(r)-Omnibus Claim 

 2173.05(s)-Reference to Figures or Tables 

 2173.05(t)-Chemical Formula 

 2173.05(u)-Trademarks or Trade Names in a Claim 

 2173.05(v)-Mere Function of Machine 

 
 

 2173.06-Practice Compact Prosecution 

 
 

 2174-Relationship Between the Requirements of 35 U.S.C. 112(a) and (b) or Pre-AIA 35 U.S.C. 112, First and Second Paragraphs 

 2175-Form Paragraphs for Use in Rejections Under 35 U.S.C. 112(b) or Pre-AIA 35 U.S.C. 112, Second Paragraph 

 2176-2180-[Reserved] 

 2181-Identifying and Interpreting a 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph Limitation 

 2182-Search and Identification of the Prior Art 

 2183-Making a Prima Facie Case of Equivalence 

 2184-Determining Whether an Applicant Has Met the Burden of Proving Nonequivalence After a Prima Facie Case Is Made 

 2185-Related Issues Under 35 U.S.C. 112(a) or (b) and Pre-AIA 35 U.S.C. 112, First or Second Paragraphs 

 2186-Relationship to the Doctrine of Equivalents 

 2187-Form Paragraphs for Use Relating to 35 U.S.C. 112(f) or Pre-AIA 35 U.S.C. 112, Sixth Paragraph 

 2188-2189-[Reserved] 

 2190-Prosecution Laches and Res Judicata 

 

 

 
 

 
 
 

 
 

 

 
 
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