MPEP § 2112 — MPEP § 2112
Current through: 2022-07-01

2112-Requirements of Rejection Based on Inherency; Burden of Proof 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2100 

 Section 2112 
 

 
 
 
 
 
 2112 Requirements of Rejection Based on Inherency; Burden of Proof [R-01.2024]

 [Editor Note: This MPEP section is applicable regardless of whether an application
 is examined under the AIA or under pre-AIA law. For applications subject to the first
 inventor to file (FITF) provisions of the AIA, the relevant time is "before the
 effective filing date of the claimed invention". For applications subject to
 pre-AIA 35 U.S.C.
 102 , the relevant time is "at the time of the invention". See
 MPEP §
 2150 et seq. Many of the court decisions discussed in this
 section involved applications or patents subject to pre-AIA 35 U.S.C. 102 . These court
 decisions may be applicable to applications and patents subject to AIA 35 U.S.C.
 102 but the relevant time is before the effective filing date of
 the claimed invention and not at the time of the invention.] 

 The express, implicit, and inherent disclosures of a prior art reference
 may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103 . “The inherent
 teaching of a prior art reference, a question of fact, arises both in the context of
 anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d
 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part
 on inherent disclosure in one of the references). See also In re
 Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983).
 

 I. SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DISCOVERY OF A NEW
 PROPERTY “[T]he discovery of a previously unappreciated property of a prior art
 composition, or of a scientific explanation for the prior art’s functioning, does not
 render the old composition patentably new to the discoverer.” Atlas Powder Co.
 v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
 Thus the claiming of a new use, new function or unknown property which is inherently
 present in the prior art does not necessarily make the claim patentable. In re
 Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re
 Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the
 court held that the claimed promoter sequence obtained by sequencing a prior art plasmid
 that was not previously sequenced was anticipated by the prior art plasmid which
 necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court
 stated that “just as the discovery of properties of a known material does not make it
 novel, the identification and characterization of a prior art material also does not
 make it novel.” Id. See also MPEP § 2112.01 with regard to inherency
 and product-by-process claims and MPEP § 2141.02 with regard to inherency
 and rejections under 35 U.S.C. 103 .
 

 II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE RELEVANT TIME There is no requirement that a person of ordinary skill in the art
 would have recognized the inherent disclosure at the relevant time, 
 but only that the subject matter is in fact inherent in the prior art reference.
 Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67
 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation
 requires recognition by a person of ordinary skill in the art before the critical date
 and allowing expert testimony with respect to post-critical date clinical trials to show
 inherency); see also Toro Co. v. Deere & Co., 355 F.3d 1313,
 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) (“[T]he fact that a characteristic is a
 necessary feature or result of a prior-art embodiment (that is itself sufficiently
 described and enabled) is enough for inherent anticipation, even if that fact was
 unknown at the time of the prior invention.”); Abbott Labs v. Geneva Pharms.,
 Inc., 182 F.3d 1315, 1319, 51 USPQ2d 1307, 1310 (Fed. Cir. 1999) (“If a
 product that is offered for sale inherently possesses each of the limitations of the
 claims, then the invention is on sale, whether or not the parties to the transaction
 recognize that the product possesses the claimed characteristics.”); Atlas
 Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1348-49, 51 USPQ2d 1943, 1947
 (Fed. Cir. 1999) (“Because ‘sufficient aeration’ was inherent in the prior art, it is
 irrelevant that the prior art did not recognize the key aspect of [the] invention.... An
 inherent structure, composition, or function is not necessarily known.”);
 SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343-44,
 74 USPQ2d 1398, 1406-07 (Fed. Cir. 2005) (holding that a prior art patent to an
 anhydrous form of a compound “inherently” anticipated the claimed hemihydrate form of
 the compound because practicing the process in the prior art to manufacture the
 anhydrous compound “inherently results in at least trace amounts of” the claimed
 hemihydrate even if the prior art did not discuss or recognize the hemihydrate);
 In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d
 1643, 1650 (Fed. Cir. 2007) (The court noted that although the inventors may not have
 recognized that a characteristic of the ingredients in the prior art method resulted in
 an in situ formation of a separating layer, the in
 situ formation was nevertheless inherent. “The record shows formation of
 the in situ separating layer in the prior art even though that
 process was not recognized at the time. The new realization alone does not render that
 necessary [sic] prior art patentable.”).
 

 III. A REJECTION UNDER 35 U.S.C. 102 AND 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 Where applicant claims a composition in terms of a function, property
 or characteristic and the composition of the prior art is the same as that of the claim
 but the function is not explicitly disclosed by the reference, the examiner may make a
 rejection under both 35 U.S.C. 102 and 103 . “There is nothing inconsistent
 in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation
 under 35 U.S.C.
 102 .” In re Best, 562 F.2d 1252, 1255 n.4, 195
 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product,
 apparatus, and process claims claimed in terms of function, property or characteristic.
 Therefore, a 35 U.S.C.
 102 and 103 rejection is appropriate for
 these types of claims as well as for composition claims. 
 

 IV. EXAMINER MUST PROVIDE RATIONALE OR EVIDENCE TO SHOW INHERENCY The fact that a certain result or characteristic
 may occur or be present in the prior art is not sufficient to
 establish the inherency of that result or characteristic. In re
 Rijckaert, 9 F.3d 1531, 1534, 28 USPQ2d 1955, 1957 (Fed. Cir. 1993)
 (reversed rejection because inherency was based on what would result due to optimization
 of conditions, not what was necessarily present in the prior art); In re
 Oelrich, 666 F.2d 578, 581-82, 212 USPQ 323, 326 (CCPA 1981). Also, “[a]n
 invitation to investigate is not an inherent disclosure” where a prior art reference
 “discloses no more than a broad genus of potential applications of its discoveries.”
 Metabolite Labs., Inc. v. Lab. Corp. of Am. Holdings, 370 F.3d 1354, 1367, 71 USPQ2d 1081,
 1091 (Fed. Cir. 2004) (explaining that “[a] prior art reference that discloses a genus
 still does not inherently disclose all species within that broad category” but must be
 examined to see if a disclosure of the claimed species has been made or whether the
 prior art reference merely invites further experimentation to find the species).
 

 “In relying upon the theory of inherency, the examiner must provide a
 basis in fact and/or technical reasoning to reasonably support the determination that
 the allegedly inherent characteristic necessarily flows from the
 teachings of the applied prior art.” Ex parte Levy , 17 USPQ2d 1461,
 1464 (Bd. Pat. App. & Inter. 1990) (emphasis in original). In PAR
 Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 112
 USPQ2d 1945 (Fed. Cir. 2014), the Federal Circuit remanded a decision to the district
 court because the record did not present sufficient evidence to prove inherency in the
 context of obviousness. The district court concluded the pharmacokinetic parameters of a
 claim are inherent properties of the obvious formulation. The Federal Circuit stated
 that while “inherency may support a missing claim limitation in an obviousness
 analysis”, “the use of inherency, a doctrine originally rooted in anticipation, must be
 carefully circumscribed in the context of obviousness.” Id. at
 1194-95, 112 USPQ2d at 1952. “[I]n order to rely on inherency to establish the existence
 of a claim limitation in the prior art in an obviousness analysis – the limitation at
 issue necessarily must be present, or the natural result of the combination of elements
 explicitly disclosed by the prior art.” Id. at 1195-96, 112 USPQ2d at
 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 
 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a
 proper finding of inherency does not require that all limitations are taught in a single
 reference, and that inherency may meet a missing claim limitation when the limitation is
 “the natural result of the combination of prior art elements .”
 (emphasis in original). The court found that pharmacokinetic limitations of the asserted
 claims were inherently met by combining prior art references because the limitations
 were necessarily present in the prior art combination. Id. See also
 Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329-32,
 2020 USPQ2d 6227 (Fed. Cir. 2020). 
 

 In In re Schreiber, 128 F.3d 1473, 44 USPQ2d 1429
 (Fed. Cir. 1997), the court affirmed a finding that a prior patent to a conical spout
 used primarily to dispense oil from an oil can inherently performed the functions
 recited in applicant’s claim to a conical container top for dispensing popped popcorn.
 The examiner had asserted inherency based on the structural similarity between the
 patented spout and applicant’s disclosed top, i.e., both structures had the same general
 shape. The court stated:
 

 
 [N]othing in Schreiber’s [applicant’s] claim suggests that
 Schreiber’s container is 'of a different shape’ than Harz’s [patent]. In fact, [ ] an
 embodiment according to Harz (Fig. 5) and the embodiment depicted in figure 1 of
 Schreiber’s application have the same general shape. For that reason, the examiner
 was justified in concluding that the opening of a conically shaped top as disclosed
 by Harz is inherently of a size sufficient to ‘allow [ ] several kernels of popped
 popcorn to pass through at the same time’ and that the taper of Harz’s conically
 shaped top is inherently of such a shape ‘as to by itself jam up the popped popcorn
 before the end of the cone and permit the dispensing of only a few kernels at a shake
 of a package when the top is mounted to the container.’ The examiner therefore
 correctly found that Harz established a prima facie case of anticipation.
 

 
 Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432.
 

 V. ONCE A REFERENCE TEACHING PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS MADE
 THE BASIS OF A REJECTION, AND THE EXAMINER PRESENTS EVIDENCE OR REASONING TO SHOW
 INHERENCY, THE BURDEN OF PRODUCTION SHIFTS TO THE APPLICANT “[T]he PTO can require an applicant to prove that the prior art
 products do not necessarily or inherently possess the characteristics of his [or her]
 claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102 , on
 ‘ prima facie obviousness’ under 35 U.S.C. 103 ,
 jointly or alternatively, the burden of proof is the same.” In re Best,
 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation
 omitted). The burden of proof is similar to that required with respect to
 product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205
 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255).
 

 In Fitzgerald, the claims were directed to a
 self-locking screw-threaded fastener comprising a metallic threaded fastener having
 patches of crystallizable thermoplastic bonded thereto. The claim further specified that
 the thermoplastic had a reduced degree of crystallization shrinkage. The specification
 disclosed that the locking fastener was made by heating the metal fastener to melt a
 thermoplastic blank which is pressed against the metal. After the thermoplastic adheres
 to the metal fastener, the end product is cooled by quenching in water. The examiner
 made a rejection based on a U.S. patent to Barnes. Barnes taught a self-locking fastener
 in which the patch of thermoplastic was made by depositing thermoplastic powder on a
 metallic fastener which was then heated. The end product was cooled in ambient air, by
 cooling air or by contacting the fastener with a water trough. The court first noted
 that the two fasteners were identical or only slightly different from each other. “Both
 fasteners possess the same utility, employ the same crystallizable polymer (nylon 11),
 and have an adherent plastic patch formed by melting and then cooling the polymer.”
 Id. at 596 n.1, 619 F.2d at 70 n.1. The court then noted that the
 Board had found that Barnes’ cooling rate could reasonably be expected to result in a
 polymer possessing the claimed crystallization shrinkage rate. Applicants had not
 rebutted this finding with evidence that the shrinkage rate was indeed different. They
 had only argued that the crystallization shrinkage rate was dependent on the cool down
 rate and that the cool down rate of Barnes was much slower than theirs. Because a
 difference in the cool down rate does not necessarily result in a difference in
 shrinkage, objective evidence was required to rebut the 35 U.S.C.
 102 / 103 prima facie case.
 

 In Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429,
 1432 (Fed.Cir.1997), the court held that applicant’s declaration failed to overcome a
 prima facie case of anticipation because the declaration did not
 specify the dimensions of either the dispensing top that was tested or the popcorn that
 was used. Applicant’s declaration merely asserted that a conical dispensing top built
 according to a figure in the prior art patent was too small to jam and dispense popcorn
 and thus could not inherently perform the functions recited in applicant’s claims. The
 court pointed out the disclosure of the prior art patent was not limited to use as an
 oil can dispenser, but rather was broader than the precise configuration shown in the
 patent’s figure. The court also noted that the Board found as a factual matter that a
 scaled-up version of the top disclosed in the patent would be capable of performing the
 functions recited in applicant’s claim.
 

 See MPEP
 § 2113 for more information on the analogous burden of proof
 applied to product-by-process claims.
 

 
 2112.01 Composition, Product, and Apparatus Claims [R-10.2019]
 I. PRODUCT AND APPARATUS CLAIMS — WHEN THE STRUCTURE RECITED IN THE REFERENCE IS
 SUBSTANTIALLY IDENTICAL TO THAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS ARE
 PRESUMED TO BE INHERENT Where the claimed and prior art products are identical or
 substantially identical in structure or composition, or are produced by identical or
 substantially identical processes, a prima facie case of either
 anticipation or obviousness has been established. In re Best, 562
 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for
 believing that the products of the applicant and the prior art are the same, the
 applicant has the burden of showing that they are not.” In re
 Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
 Therefore, the prima facie case can be rebutted by evidence
 showing that the prior art products do not necessarily possess
 the characteristics of the claimed product. In re Best, 562 F.2d
 at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims
 were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having
 corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25%
 Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held
 that the claim was anticipated because the percentages of Mo and Ni were squarely
 within the claimed ranges. The court went on to say that it was immaterial what
 properties the alloys had or who discovered the properties because the composition is
 the same and thus must necessarily exhibit the properties.).
 

 See also In re Ludtke, 441 F.2d 660, 169 USPQ 563
 (CCPA 1971) (Claim 1 was directed to a parachute canopy having concentric
 circumferential panels radially separated from each other by radially extending tie
 lines. The panels were separated “such that the critical velocity of each
 successively larger panel will be less than the critical velocity of the previous
 panel, whereby said parachute will sequentially open and thus gradually decelerate.”
 The court found that the claim was anticipated by Menget. Menget taught a parachute
 having three circumferential panels separated by tie lines. The court upheld the
 rejection finding that applicant had failed to show that Menget did not possess the
 functional characteristics of the claims.); Northam Warren Corp. v. D. F. Newfield Co., 7 F.Supp. 773, 22 USPQ 313 (E.D.N.Y. 1934) (A
 patent to a pencil for cleaning fingernails was held invalid because a pencil of the
 same structure for writing was found in the prior art.).
 

 II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE
 THE SAME PROPERTIES “Products of identical chemical composition can not have mutually
 exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d
 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are
 inseparable. Therefore, if the prior art teaches the identical chemical structure,
 the properties applicant discloses and/or claims are necessarily present.
 Id. (Applicant argued that the claimed composition was a
 pressure sensitive adhesive containing a tacky polymer while the product of the
 reference was hard and abrasion resistant. “The Board correctly found that the
 virtual identity of monomers and procedures sufficed to support a prima
 facie case of unpatentability of Spada’s polymer latexes for lack of
 novelty.”).
 

 III. PRODUCT CLAIMS – NONFUNCTIONAL PRINTED MATTER DOES NOT DISTINGUISH CLAIMED
 PRODUCT FROM OTHERWISE IDENTICAL PRIOR ART PRODUCT Where the only difference between a prior art product and a claimed
 product is printed matter that is not functionally related to the product, the
 content of the printed matter will not distinguish the claimed product from the prior
 art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed.
 Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The
 Federal Circuit held that the claim was anticipated by a prior art reference that
 taught a kit that included instructions and a buffer agent, even though the content
 of the instructions differed, explaining “[i]f we were to adopt [applicant’s]
 position, anyone could continue patenting a product indefinitely provided that they
 add a new instruction sheet to the product.”). See also In re
 Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983)
 (
 "Where the printed matter is not functionally
 related to the substrate, the printed matter will not distinguish the invention
 from the prior art in terms of patentability….[T]he critical question is whether
 there exists any new and unobvious functional relationship between the printed
 matter and the substrate."
 
 
 ); In re Miller, 
 418 F.2d 1392, 1396 (CCPA 1969) (finding a new and nonobvious relationship between a
 measuring cup and writing showing how to “half” a recipe); In re
 Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (matters relating to
 ornamentation only which have no mechanical function cannot be relied upon to
 patentably distinguish the claimed invention from the prior art); In re
 Xiao, 462 Fed. App'x 947, 950-51 (Fed. Cir. 2011) (non-precedential)
 (affirming an obviousness rejection of claims directed to a tumbler lock that used
 letters instead of numbers and had a wild-card label instead of one of the letters);
 In re Bryan, 323 Fed. App'x 898, 901 (Fed. Cir. 2009)
 (non-precedential) (printed matter on game cards bears no new and nonobvious
 functional relationship to game board). 
 

 The court has extended the rationale in the printed
 matter cases, in which, for example, written instructions are added to a known
 product, to method claims in which "an instruction limitation" (i.e., a limitation
 “informing” someone about the existence of an inherent property of that method) is
 added to a method known in the art. King Pharmaceuticals, Inc. v. Eon
 Labs, Inc., 616 F.3d 1267, 1279, 95 USPQ2d 1833, 1842 (2010). Similar to
 the inquiry for products with printed matter thereon, for such method cases the
 relevant inquiry is whether a new and nonobvious functional relationship with the
 known method exists. In King Pharma, the court found that the
 relevant determination is whether the "instruction limitation" has a "new and
 unobvious functional relationship" with the known method of administering the drug
 with food. Id. The court held that the relationship was
 non-functional because "[i]nforming a patient about the benefits of a drug in no way
 transforms the process of taking the drug with food." Id. That is,
 the actual method of taking a drug with food is the same regardless of whether the
 patient is informed of the benefits. Id. “In other words, the
 ‘informing’ limitation ‘in no way depends on the method, and the method does not
 depend on the ‘informing’ limitation.’" Id. (citing In re
 Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004)); see also In re
 Kao, 639 F.3d 1057, 1072-73, 98 USPQ2d 1799, 1811-12 (Fed. Cir.
 2011).
 

 

 
 2112.02 Process Claims [R-01.2024]
 I. PROCESS CLAIMS — PRIOR ART DEVICE ANTICIPATES A CLAIMED PROCESS IF THE DEVICE
 CARRIES OUT THE PROCESS DURING NORMAL OPERATION Under the principles of inherency, if a prior art device, in its
 normal and usual operation, would necessarily perform the method claimed, then the
 method claimed will be considered to be anticipated by the prior art device. When the
 prior art device is the same as a device described in the specification for carrying
 out the claimed method, it can be assumed the device will inherently perform the
 claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed.
 Cir. 1986) (The claims were directed to a method of enhancing color effects produced
 by ambient light through a process of absorption and reflection of the light off a
 coated substrate. A prior art reference to Donley disclosed a
 glass substrate coated with silver and metal oxide 200-800 angstroms thick. While
 Donley disclosed using the coated substrate to produce architectural colors, the
 absorption and reflection mechanisms of the claimed process were not disclosed.
 However, King’s specification disclosed using a coated substrate of Donley’s
 structure for use in his process. The Federal Circuit upheld the Board’s finding that
 “Donley inherently performs the function disclosed in the method claims on appeal
 when that device is used in ‘normal and usual operation’” and found that a
 prima facie case of anticipation was made out.
 Id. at 138, 801 F.2d at 1326. It was up to applicant to prove
 that Donley’s structure would not perform the claimed method when placed in ambient
 light.). See also In re Best, 562 F.2d 1252, 1255, 195 USPQ 430,
 433 (CCPA 1977) (Applicant claimed a process for preparing a hydrolytically-stable
 zeolitic aluminosilicate which included a step of “cooling the steam zeolite ... at a
 rate sufficiently rapid that the cooled zeolite exhibits an X-ray diffraction pattern
 ....” All the process limitations were expressly disclosed by a U.S. patent to
 Hansford except the cooling step. The court stated that any sample of Hansford’s
 zeolite would necessarily be cooled to facilitate subsequent handling. Therefore,
 rejections under 35
 U.S.C. 102 and 103 were properly made. Applicant
 had failed to introduce any evidence comparing X-ray diffraction patterns showing a
 difference in cooling rate between the claimed process and that of Hansford or any
 data showing that the process of Hansford would result in a product with a different
 X-ray diffraction. Either type of evidence would have rebutted the rejections under
 35 U.S.C.
 102 . A further analysis would be necessary to determine if the
 process was nonobvious under 35 U.S.C. 103 .); Ex
 parte Novitski, 26 USPQ2d 1389 (Bd. Pat. App. & Inter. 1993) (The
 Board rejected a claim directed to a method for protecting a plant from plant
 pathogenic nematodes by inoculating the plant with a nematode inhibiting strain of
 P. cepacia. A U.S. patent to Dart disclosed
 inoculation using P. cepacia type Wisconsin 526 bacteria for
 protecting the plant from fungal disease. Dart was silent as to nematode inhibition
 but the Board concluded that nematode inhibition was an inherent property of the
 bacteria. The Board noted that applicant had stated in the specification that
 Wisconsin 526 possesses an 18% nematode inhibition rating.). 
 

 II. PROCESS OF USE CLAIMS — NEW AND NONOBVIOUS USES OF OLD STRUCTURES AND
 COMPOSITIONS MAY BE PATENTABLE The discovery of a new use for an old structure based on unknown
 properties of the structure might be patentable to the discoverer as a process of
 using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA
 1957). However, when the claim recites using an old composition or structure and the
 “use” is directed to a result or property of that composition or structure, then the
 claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1
 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in
 animals, were found to be anticipated by the applied prior art which disclosed the
 same compounds, as well as a method of using them for effecting analgesia but which
 was silent as to addiction. The court upheld the rejection and stated that the
 inventors had merely found a new property of the compound and such a discovery did
 not constitute a new use. The court went on to reverse the obviousness rejection of
 claims 2-5 and 7-10 which recited a process of using a new compound. The court relied
 on evidence showing that the nonaddictive property of the new compound was
 unexpected.). See also In re Tomlinson, 363 F.2d 928, 150 USPQ
 623 (CCPA 1966) (The claim was directed to a process of inhibiting light degradation
 of polypropylene by mixing it with one of a genus of compounds, including nickel
 dithiocarbamate. A reference taught mixing polypropylene with nickel dithiocarbamate
 to lower heat degradation. The court held that the claims read on the obvious process
 of mixing polypropylene with the nickel dithiocarbamate and that the preamble of the
 claim was merely directed to the result of mixing the two materials. “While the
 references do not show a specific recognition of that result, its discovery by
 appellants is tantamount only to finding a property in the old
 composition .” 363 F.2d at 934, 150 USPQ at 628 (emphasis in
 original)). 
 

 

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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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