MPEP § 2107 — MPEP § 2107
Current through: 2022-07-01

2107-Guidelines for Examination of Applications for Compliance with the Utility Requirement 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2100 

 Section 2107 
 

 
 
 
 
 
 2107 Guidelines for Examination of Applications for Compliance with the
 Utility Requirement [R-11.2013]
 
 I. INTRODUCTION The following Guidelines establish the policies and procedures to be
 followed by Office personnel in the evaluation of any patent application for compliance
 with the utility requirements of 35 U.S.C. 101 and 35 U.S.C.
 112(a) , or pre-AIA 35 U.S.C. 112 , first
 paragraph. These Guidelines have been promulgated to assist Office personnel in their
 review of applications for compliance with the utility requirement. The Guidelines do
 not alter the substantive requirements of 35 U.S.C. 101 and 35 U.S.C. 112 , nor
 are they designed to obviate the examiner’s review of applications for compliance with
 all other statutory requirements for patentability. The Guidelines do not constitute
 substantive rulemaking and hence do not have the force and effect of law. Rejections
 will be based upon the substantive law, and it is these rejections which are appealable.
 Consequently, any perceived failure by Office personnel to follow these Guidelines is
 neither appealable nor petitionable.
 

 II. EXAMINATION GUIDELINES FOR THE UTILITY REQUIREMENT Office personnel are to adhere to the following procedures when
 reviewing patent applications for compliance with the “useful invention” (“utility”)
 requirement of 35
 U.S.C. 101 and 35 U.S.C. 112(a) or
 pre-AIA 35 U.S.C.
 112 , first paragraph. 
 

 
 (A) Read the claims and the supporting written description.
 
 (1) Determine what the applicant has claimed, noting any
 specific embodiments of the invention.
 

 (2) Ensure that the claims define statutory subject matter
 (i.e., a process, machine, manufacture, composition of matter, or
 improvement thereof).
 

 (3) If at any time during the examination, it becomes readily
 apparent that the claimed invention has a well-established utility, do not
 impose a rejection based on lack of utility. An invention has a
 well-established utility if (i) a person of ordinary skill in the art would
 immediately appreciate why the invention is useful based on the
 characteristics of the invention (e.g., properties or applications of a
 product or process), and (ii) the utility is specific, substantial, and
 credible.
 

 
 

 (B) Review the claims and the supporting written description to
 determine if the applicant has asserted for the claimed invention any specific and
 substantial utility that is credible:
 
 (1) If the applicant has asserted that the claimed invention is
 useful for any particular practical purpose (i.e., it has a “specific and
 substantial utility”) and the assertion would be considered credible by a
 person of ordinary skill in the art, do not impose a rejection based on lack
 of utility.
 
 (i) A claimed invention must have a specific and
 substantial utility. This requirement excludes “throw-away,”
 “insubstantial,” or “nonspecific” utilities, such as the use of a
 complex invention as landfill, as a way of satisfying the utility
 requirement of 35 U.S.C. 101 .
 

 (ii) Credibility is assessed from the perspective of one
 of ordinary skill in the art in view of the disclosure and any other
 evidence of record (e.g., test data, affidavits or declarations from
 experts in the art, patents or printed publications) that is probative
 of the applicant’s assertions. An applicant need only provide one
 credible assertion of specific and substantial utility for each
 claimed invention to satisfy the utility requirement.
 

 
 

 (2) If no assertion of specific and substantial utility for the
 claimed invention made by the applicant is credible, and the claimed
 invention does not have a readily apparent well-established utility, reject
 the claim(s) under 35 U.S.C. 101 on the
 grounds that the invention as claimed lacks utility. Also reject the claims
 under 35 U.S.C. 112(a) or
 pre-AIA
 35 U.S.C. 112 , first paragraph, on the basis that the
 disclosure fails to teach how to use the invention as claimed. The
 35 U.S.C. 112(a) or
 
 pre-AIA 35 U.S.C. 112 , first paragraph, rejection
 imposed in conjunction with a 35 U.S.C. 101 rejection
 should incorporate by reference the grounds of the corresponding
 35
 U.S.C. 101 rejection.
 

 (3) If the applicant has not asserted any specific and
 substantial utility for the claimed invention and it does not have a readily
 apparent well-established utility, impose a rejection under
 35
 U.S.C. 101 , emphasizing that the applicant has not
 disclosed a specific and substantial utility for the invention. Also impose
 a separate rejection under 35 U.S.C. 112(a) or
 pre-AIA 35 U.S.C. 112 , first paragraph, on the basis
 that the applicant has not disclosed how to use the invention due to the
 lack of a specific and substantial utility. The 35 U.S.C.
 101 and 35 U.S.C. 112 rejections
 shift the burden of coming forward with evidence to the applicant to:
 
 (i) Explicitly identify a specific and substantial
 utility for the claimed invention; and
 

 (ii) Provide evidence that one of ordinary skill in the
 art would have recognized that the identified specific and substantial
 utility was well-established at the time of filing. The examiner
 should review any subsequently submitted evidence of utility using the
 criteria outlined above. The examiner should also ensure that there is
 an adequate nexus between the evidence and the properties of the now
 claimed subject matter as disclosed in the application as filed. That
 is, the applicant has the burden to establish a probative relation
 between the submitted evidence and the originally disclosed properties
 of the claimed invention.
 

 
 

 (C) Any rejection based on lack of utility should include a
 detailed explanation why the claimed invention has no specific and
 substantial credible utility. Whenever possible, the examiner should provide
 documentary evidence regardless of publication date (e.g., scientific or
 technical journals, excerpts from treatises or books, or U.S. or foreign
 patents) to support the factual basis for the prima facie 
 showing of no specific and substantial credible utility. If documentary
 evidence is not available, the examiner should specifically explain the
 scientific basis for his or her factual conclusions.
 
 (1) Where the asserted utility is not specific or
 substantial, a prima facie showing must establish
 that it is more likely than not that a person of ordinary skill in the
 art would not consider that any utility asserted by the applicant
 would be specific and substantial. The prima facie 
 showing must contain the following elements:
 
 (i) An explanation that clearly sets forth the
 reasoning used in concluding that the asserted utility for the
 claimed invention is not both specific and substantial nor
 well-established;
 

 (ii) Support for factual findings relied upon in
 reaching this conclusion; and
 

 (iii) An evaluation of all relevant evidence of
 record, including utilities taught in the closest prior art.
 

 
 

 (2) Where the asserted specific and substantial utility
 is not credible, a prima facie showing of no
 specific and substantial credible utility must establish that it is
 more likely than not that a person skilled in the art would not
 consider credible any specific and substantial utility asserted by the
 applicant for the claimed invention. The prima
 facie showing must contain the following elements:
 
 (i) An explanation that clearly sets forth the
 reasoning used in concluding that the asserted specific and
 substantial utility is not credible;
 

 (ii) Support for factual findings relied upon in
 reaching this conclusion; and
 

 (iii) An evaluation of all relevant evidence of
 record, including utilities taught in the closest prior art.
 

 
 

 (3) Where no specific and substantial utility is
 disclosed or is well-established, a prima facie
 showing of no specific and substantial utility need only
 establish that applicant has not asserted a utility and that, on the
 record before the examiner, there is no known well-established
 utility.
 

 
 

 (D) A rejection based on lack of utility should not be
 maintained if an asserted utility for the claimed invention would be
 considered specific, substantial, and credible by a person of ordinary skill
 in the art in view of all evidence of record.
 

 
 

 
 Office personnel are reminded that they must treat as true a statement
 of fact made by an applicant in relation to an asserted utility, unless countervailing
 evidence can be provided that shows that one of ordinary skill in the art would have a
 legitimate basis to doubt the credibility of such a statement. Similarly, Office
 personnel must accept an opinion from a qualified expert that is based upon relevant
 facts whose accuracy is not being questioned; it is improper to disregard the opinion
 solely because of a disagreement over the significance or meaning of the facts
 offered.
 

 Once a prima facie showing of no specific and
 substantial credible utility has been properly established, the applicant bears the
 burden of rebutting it. The applicant can do this by amending the claims, by providing
 reasoning or arguments, or by providing evidence in the form of a declaration under
 37 CFR
 1.132 or a patent or a printed publication that rebuts the basis
 or logic of the prima facie showing. If the applicant responds to the
 prima facie rejection, the Office personnel should review the
 original disclosure, any evidence relied upon in establishing the prima
 facie showing, any claim amendments, and any new reasoning or evidence
 provided by the applicant in support of an asserted specific and substantial credible
 utility. It is essential for Office personnel to recognize, fully consider and respond
 to each substantive element of any response to a rejection based on lack of utility.
 Only where the totality of the record continues to show that the asserted utility is not
 specific, substantial, and credible should a rejection based on lack of utility be
 maintained.
 

 If the applicant satisfactorily rebuts a prima facie 
 rejection based on lack of utility under 35 U.S.C. 101 , withdraw the
 35 U.S.C.
 101 rejection and the corresponding rejection imposed under
 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph.
 

 
 2107.01 General Principles Governing Utility Rejections [R-07.2022]

 
 35 U.S.C. 101 
 Inventions patentable. 

 Whoever invents or discovers any new and useful process, machine,
 manufacture, or composition of matter, or any new and useful improvement thereof, may
 obtain a patent therefor, subject to the conditions and requirements of this
 title.
 

 

 See MPEP
 § 2107 for guidelines for the examination of applications for
 compliance with the utility requirement of 35 U.S.C. 101 .
 

 The Office must examine each application to ensure compliance with the
 “useful invention” or utility requirement of 35 U.S.C. 101 . In discharging this
 obligation, however, Office personnel must keep in mind several general principles that
 control application of the utility requirement. 35 U.S.C. 101 has been interpreted
 as imposing four purposes. First, 35 U.S.C. 101 limits an inventor to
 ONE patent for a claimed invention. If more than one patent is sought, a patent
 applicant will receive a statutory double patenting rejection for claims included in
 more than one application that are directed to the same invention. See
 MPEP §
 804 . Second, the inventor(s) must be the applicant in an
 application filed before September 16, 2012, (except as otherwise provided in
 pre-AIA 37 CFR
 1.41(b) ) and the inventor or each joint inventor must be
 identified in an application filed on or after September 16, 2012. See
 MPEP §
 2109 for a detailed discussion of inventorship,
 MPEP §
 602.01(c) et seq. for details regarding correction of inventorship,
 MPEP §
 2157 for rejections under 35 U.S.C. 101 and 115 for failure
 to set forth the correct inventorship, and MPEP § 2137 for rejections under
 pre-AIA 35 U.S.C.
 102(f) (for applications subject to pre-AIA 35 U.S.C.
 102 ) for failure to set forth the correct inventorship. Third,
 35 U.S.C.
 101 defines which categories of inventions are eligible for patent
 protection. An invention that is not a machine, an article of manufacture, a composition
 or a process cannot be patented. See Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980);
 Diamond v. Diehr, 450 U.S. 175, 209 USPQ 1 (1981); In re
 Nuijten, 500 F.3d 1346, 1354, 84 USPQ2d 1495, 1500 (Fed. Cir. 2007).
 Fourth, 35 U.S.C.
 101 serves to ensure that patents are granted on only those
 inventions that are “useful.” This second purpose has a Constitutional footing — Article
 I, Section 8 of the Constitution authorizes Congress to provide exclusive rights to
 inventors to promote the “useful arts.” See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991). Thus,
 to satisfy the requirements of 35 U.S.C. 101 , an applicant must
 claim an invention that is statutory subject matter and must show that the claimed
 invention is “useful” for some purpose either explicitly or implicitly. Application of
 this latter element of 35 U.S.C. 101 is the focus of these guidelines.
 

 Deficiencies under the “useful invention” requirement of
 35 U.S.C.
 101 will arise in one of two forms. The first is where it is not
 apparent why the invention is “useful.” This can occur when an applicant fails to
 identify any specific and substantial utility for the invention or fails to disclose
 enough information about the invention to make its usefulness immediately apparent to
 those familiar with the technological field of the invention. Brenner v. Manson, 383 U.S. 519, 148 USPQ 689 (1966); In re
 Fisher, 421 F.3d 1365, 76 USPQ2d 1225 (Fed. Cir. 2005); In re
 Ziegler, 992 F.2d 1197, 26 USPQ2d 1600 (Fed. Cir. 1993). The second type of
 deficiency arises in the rare instance where an assertion of specific and substantial
 utility for the invention made by an applicant is not credible.
 

 I. SPECIFIC AND SUBSTANTIAL REQUIREMENTS To satisfy 35 U.S.C. 101 , an invention must
 be “useful.” Courts have recognized that the term “useful” used with reference to the
 utility requirement can be a difficult term to define. Brenner v. Manson, 383 U.S. 519, 529, 148 USPQ 689, 693 (1966) (simple
 everyday word like “useful” can be “pregnant with ambiguity when applied to the facts
 of life.”). Where an applicant has set forth a specific and substantial utility,
 courts have been reluctant to uphold a rejection under 35 U.S.C. 101 
 solely on the basis that the applicant’s opinion as to the nature of the specific and
 substantial utility was inaccurate. For example, in Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980), the court reversed
 a finding by the Office that the applicant had not set forth a “practical” utility
 under 35 U.S.C.
 101 . In this case the applicant asserted that the composition
 was “useful” in a particular pharmaceutical application and provided evidence to
 support that assertion. Courts have used the labels “practical utility,” “substantial
 utility,” or “specific utility” to refer to this aspect of the “useful invention”
 requirement of 35
 U.S.C. 101 . The Court of Customs and Patent Appeals has
 stated:
 

 
 Practical utility is a shorthand way of attributing “real-world”
 value to claimed subject matter. In other words, one skilled in the art can use a
 claimed discovery in a manner which provides some immediate benefit to the
 public.
 

 
 Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA
 1980).
 

 Practical considerations require the Office to rely on the
 inventor’s understanding of the invention in determining whether and in what regard
 an invention is believed to be “useful.” Because of this, Office personnel should
 focus on and be receptive to assertions made by the applicant that an invention is
 “useful” for a particular reason. 
 

 A. Specific Utility A “specific utility” is specific to the
 subject matter claimed and can “provide a well-defined and particular benefit to
 the public.” In re Fisher, 421 F.3d 1365, 1371, 76 USPQ2d 1225,
 1230 (Fed. Cir. 2005). This contrasts with a general utility
 that would be applicable to the broad class of the invention. Office personnel
 should distinguish between situations where an applicant has disclosed a specific
 use for or application of the invention and situations where the applicant merely
 indicates that the invention may prove useful without identifying with specificity
 why it is considered useful. For example, indicating that a
 compound may be useful in treating unspecified disorders, or that the compound has
 “useful biological” properties, would not be sufficient to define a specific
 utility for the compound. See, e.g., In re Kirk, 376 F.2d 936,
 153 USPQ 48 (CCPA 1967); In re Joly, 376 F.2d 906, 153 USPQ 45
 (CCPA 1967). Similarly, a claim to a polynucleotide whose use is disclosed simply
 as a “gene probe” or “chromosome marker” would not be considered to be
 specific in the absence of a disclosure of a specific DNA
 target. See In re Fisher, 421 F.3d at 1374, 76 USPQ2d at 1232
 (“Any EST [expressed sequence tag] transcribed from any gene in the maize genome
 has the potential to perform any one of the alleged uses…. Nothing about
 [applicant’s] seven alleged uses set the five claimed ESTs apart from the more
 than 32,000 ESTs disclosed in the [ ] application or indeed from any EST derived
 from any organism. Accordingly, we conclude that [applicant] has only disclosed
 general uses for its claimed ESTs, not specific ones that satisfy
 §
 101 .”). A general statement of diagnostic utility, such as
 diagnosing an unspecified disease, would ordinarily be insufficient absent a
 disclosure of what condition can be diagnosed. Contrast the situation where an
 applicant discloses a specific biological activity and reasonably correlates that
 activity to a disease condition. Assertions falling within the latter category are
 sufficient to identify a specific utility for the invention. Assertions that fall
 in the former category are insufficient to define a specific utility for the
 invention, especially if the assertion takes the form of a general statement that
 makes it clear that a “useful” invention may arise from
 what has been disclosed by the applicant. Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688 (CCPA 1973).
 

 B. Substantial Utility “[A]n application must show that an invention is useful to the
 public as disclosed in its current form, not that it may prove useful at some
 future date after further research. Simply put, to satisfy the ‘substantial’
 utility requirement, an asserted use must show that the claimed invention has a
 significant and presently available benefit to the public.”
 Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The claims at
 issue in Fisher were directed to expressed sequence tags
 (ESTs), which are short nucleotide sequences that can be used to discover what
 genes and downstream proteins are expressed in a cell. The court held that “the
 claimed ESTs can be used only to gain further information about the underlying
 genes and the proteins encoded for by those genes. The claimed ESTs themselves are
 not an end of [the inventor’s] research effort, but only tools to be used along
 the way in the search for a practical utility…. [Applicant] does not identify the
 function for the underlying protein-encoding genes. Absent such identification, we
 hold that the claimed ESTs have not been researched and understood to the point of
 providing an immediate, well-defined, real world benefit to the public meriting
 the grant of a patent.” Id. at 1376, 76 USPQ2d at 1233-34).
 Thus a “substantial utility” defines a “real world” use. Utilities that require or
 constitute carrying out further research to identify or reasonably confirm a “real
 world” context of use are not substantial utilities. For example, both a
 therapeutic method of treating a known or newly discovered disease and an assay
 method for identifying compounds that themselves have a “substantial utility”
 define a “real world” context of use. An assay that measures the presence of a
 material which has a stated correlation to a predisposition to the onset of a
 particular disease condition would also define a “real world” context of use in
 identifying potential candidates for preventive measures or further monitoring. On
 the other hand, the following are examples of situations that require or
 constitute carrying out further research to identify or reasonably confirm a “real
 world” context of use and, therefore, do not define “substantial utilities”:
 

 
 (A) Basic research such as studying the properties of the
 claimed product itself or the mechanisms in which the material is
 involved;
 

 (B) A method of treating an unspecified 
 disease or condition;
 

 (C) A method of assaying for or identifying a material that
 itself has no specific and/or substantial utility;
 

 (D) A method of making a material that itself has no specific,
 substantial, and credible utility; and
 

 (E) A claim to an intermediate product for use in making a
 final product that has no specific, substantial and credible utility. 
 

 
 Office personnel must be careful not to interpret the phrase
 “immediate benefit to the public” or similar formulations in other cases to mean
 that products or services based on the claimed invention must be “currently
 available” to the public in order to satisfy the utility requirement. See, e.g.,
 Brenner v. Manson, 383 U.S. 519, 534-35, 148 USPQ 689, 695
 (1966). Rather, any reasonable use that an applicant has identified for the
 invention that can be viewed as providing a public benefit should be accepted as
 sufficient, at least with regard to defining a “substantial” utility.
 

 C. Research Tools Some confusion can result when one attempts to label certain
 types of inventions as not being capable of having a specific and substantial
 utility based on the setting in which the invention is to be used. One example is
 inventions to be used in a research or laboratory setting. Many research tools
 such as gas chromatographs, screening assays, and nucleotide sequencing techniques
 have a clear, specific and unquestionable utility (e.g., they are useful in
 analyzing compounds). An assessment that focuses on whether an invention is useful
 only in a research setting thus does not address whether the invention is in fact
 “useful” in a patent sense. Instead, Office personnel must distinguish between
 inventions that have a specifically identified substantial utility and inventions
 whose asserted utility requires further research to identify or reasonably
 confirm. Labels such as “research tool,” “intermediate” or “for research purposes”
 are not helpful in determining if an applicant has identified a specific and
 substantial utility for the invention. 
 

 II. WHOLLY INOPERATIVE INVENTIONS; “INCREDIBLE” UTILITY An invention that is “inoperative” (i.e., it does not operate to
 produce the results claimed by the patent applicant) is not a “useful” invention in
 the meaning of the patent law. See, e.g., Newman v. Quigg, 877 F.2d 1575, 1581, 11 USPQ2d 1340, 1345 (Fed. Cir. 1989);
 In re Harwood, 390 F.2d 985, 989, 156 USPQ 673, 676 (CCPA 1968)
 (“An inoperative invention, of course, does not satisfy the requirement of
 35 U.S.C.
 101 that an invention be useful.”). However, as the Federal
 Circuit has stated, “[t]o violate [35 U.S.C.] 101 the claimed
 device must be totally incapable of achieving a useful
 result .” Brooktree Corp. v. Advanced Micro Devices, Inc., 977 F.2d 1555, 1571, 24 USPQ2d 1401,
 1412 (Fed. Cir. 1992) (emphasis added). See also E.I. du Pont De Nemours and
 Co. v. Berkley and Co., 620 F.2d 1247, 1260 n.17, 205 USPQ 1, 10 n.17
 (8th Cir. 1980) (“A small degree of utility is sufficient . . . The claimed invention
 must only be capable of performing some beneficial function . . . An invention does
 not lack utility merely because the particular embodiment disclosed in the patent
 lacks perfection or performs crudely . . . A commercially successful product is not
 required . . . Nor is it essential that the invention accomplish all its intended
 functions . . . or operate under all conditions . . . partial success being
 sufficient to demonstrate patentable utility . . . In short, the defense of
 non-utility cannot be sustained without proof of total incapacity.” If an invention
 is only partially successful in achieving a useful result, a
 rejection of the claimed invention as a whole based on a lack of utility is not
 appropriate. See In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed.
 Cir. 1995); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA),
 reh’g denied, 480 F.2d 879 (CCPA 1973); In re
 Marzocchi, 439 F.2d 220, 169 USPQ 367 (CCPA 1971).
 

 Situations where an invention is found to be “inoperative” and
 therefore lacking in utility are rare, and rejections maintained solely on this
 ground by a federal court even rarer. In many of these cases, the utility asserted by
 the applicant was thought to be “incredible in the light of the knowledge of the art,
 or factually misleading” when initially considered by the Office. In re
 Citron, 325 F.2d 248, 253, 139 USPQ 516, 520 (CCPA 1963). Other cases
 suggest that on initial evaluation, the Office considered the asserted utility to be
 inconsistent with known scientific principles or “speculative at best” as to whether
 attributes of the invention necessary to impart the asserted utility were actually
 present in the invention. In re Sichert, 566 F.2d 1154, 196 USPQ
 209 (CCPA 1977). However cast, the underlying finding by the court in these cases was
 that, based on the factual record of the case , it was clear
 that the invention could not and did not work as the inventor claimed it did. Indeed,
 the use of many labels to describe a single problem (e.g., a false assertion
 regarding utility) has led to some of the confusion that exists today with regard to
 a rejection based on the “utility” requirement. Examples of such cases include: an
 invention asserted to change the taste of food using a magnetic field
 (Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985)), a
 perpetual motion machine (Newman v. Quigg, 877 F.2d 1575, 11 USPQ2d 1340 (Fed. Cir. 1989)), a flying
 machine operating on “flapping or flutter function” (In re
 Houghton, 433 F.2d 820, 167 USPQ 687 (CCPA 1970)), a “cold fusion”
 process for producing energy (In re Swartz, 232 F.3d 862, 56
 USPQ2d 1703 (Fed. Cir. 2000)), a method for increasing the energy output of fossil
 fuels upon combustion through exposure to a magnetic field (In re
 Ruskin, 354 F.2d 395, 148 USPQ 221 (CCPA 1966)), uncharacterized
 compositions for curing a wide array of cancers (In re Citron, 325
 F.2d 248, 139 USPQ 516 (CCPA 1963)), and a method of controlling the aging process
 (In re Eltgroth, 419 F.2d 918, 164 USPQ 221 (CCPA 1970)). These
 examples are fact specific and should not be applied as a
 per se rule. Thus, in view of the rare nature of such cases,
 Office personnel should not label an asserted utility “incredible,” “speculative” or
 otherwise unless it is clear that a rejection based on “lack of utility” is
 proper.
 

 III. THERAPEUTIC OR PHARMACOLOGICAL UTILITY Inventions asserted to have utility in the treatment of human or
 animal disorders are subject to the same legal requirements for utility as inventions
 in any other field of technology. In re Chilowsky, 229 F.2d 457,
 461-2, 108 USPQ 321, 325 (CCPA 1956) (“There appears to be no basis in the statutes
 or decisions for requiring any more conclusive evidence of operativeness in one type
 of case than another. The character and amount of evidence needed may vary, depending
 on whether the alleged operation described in the application appears to accord with
 or to contravene established scientific principles or to depend upon principles
 alleged but not generally recognized, but the degree of certainty as to the ultimate
 fact of operativeness or inoperativeness should be the same in all cases”);
 In re Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967)
 (“Thus, in the usual case where the mode of operation alleged can be readily
 understood and conforms to the known laws of physics and chemistry, operativeness is
 not questioned, and no further evidence is required.”). As such, pharmacological or
 therapeutic inventions that provide any “immediate benefit to
 the public” satisfy 35 U.S.C. 101 . The utility being asserted in
 Nelson related to a compound with pharmacological utility.
 Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980). Office
 personnel should rely on Nelson and other cases as providing
 general guidance when evaluating the utility of an invention that is based on any
 therapeutic, prophylactic, or pharmacological activities of that invention. 
 

 Courts have repeatedly found that the mere
 identification of a pharmacological activity of a compound
 that is relevant to an asserted pharmacological use provides an “immediate benefit to
 the public” and thus satisfies the utility requirement. As the Court of Customs and
 Patent Appeals held in Nelson v. Bowler :
 

 
 Knowledge of the pharmacological activity of any compound is
 obviously beneficial to the public. It is inherently faster and easier to combat
 illnesses and alleviate symptoms when the medical profession is armed with an
 arsenal of chemicals having known pharmacological activities. Since it is crucial
 to provide researchers with an incentive to disclose pharmacological activities in
 as many compounds as possible, we conclude that adequate proof of any such
 activity constitutes a showing of practical utility.
 

 
 Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980).
 

 In Nelson v. Bowler, the court addressed the practical utility requirement in
 the context of an interference proceeding. Bowler challenged the patentability of the
 invention claimed by Nelson on the basis that Nelson had failed to sufficiently and
 persuasively disclose in his application a practical utility for the invention.
 Nelson had developed and claimed a class of synthetic prostaglandins modeled on
 naturally occurring prostaglandins. Naturally occurring prostaglandins are bioactive
 compounds that, at the time of Nelson’s application, had a recognized value in
 pharmacology (e.g., the stimulation of uterine smooth muscle which resulted in labor
 induction or abortion, the ability to raise or lower blood pressure, etc.). To
 support the utility he identified in his disclosure, Nelson included in his
 application the results of tests demonstrating the bioactivity of his new substituted
 prostaglandins relative to the bioactivity of naturally occurring prostaglandins. The
 court concluded that Nelson had satisfied the practical utility requirement in
 identifying the synthetic prostaglandins as pharmacologically active compounds. In
 reaching this conclusion, the court considered and rejected arguments advanced by
 Bowler that attacked the evidentiary basis for Nelson’s assertions that the compounds
 were pharmacologically active.
 

 In In re Jolles, 628 F.2d 1322, 206 USPQ 885
 (CCPA 1980), an inventor claimed protection for pharmaceutical compositions for
 treating leukemia. The active ingredient in the compositions was a structural analog
 to a known anticancer agent. The applicant provided evidence showing that the claimed
 analogs had the same general pharmaceutical activity as the known anticancer agents.
 The court reversed the Board’s finding that the asserted pharmaceutical utility was
 “incredible,” pointing to the evidence that showed the relevant pharmacological
 activity.
 

 In Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985), the Federal
 Circuit affirmed a finding by the Board of Patent Appeals and Interferences that a
 pharmacological utility had been disclosed in the application of one party to an
 interference proceeding. The invention that was the subject of the interference count
 was a chemical compound used for treating blood disorders. Cross had challenged the
 evidence in Iizuka’s specification that supported the claimed utility. However, the
 Federal Circuit relied extensively on Nelson v. Bowler in finding that Iizuka’s application had sufficiently
 disclosed a pharmacological utility for the compounds. It distinguished the case from
 cases where only a generalized “nebulous” expression, such as “biological
 properties,” had been disclosed in a specification. Such statements, the court held,
 “convey little explicit indication regarding the utility of a compound.”
 Cross, 753 F.2d at 1048, 224 USPQ at 745 (citing In re
 Kirk, 376 F.2d 936, 941, 153 USPQ 48, 52 (CCPA 1967)).
 

 Similarly, courts have found utility for therapeutic inventions
 despite the fact that an inventor is at a very early stage in the development of a
 pharmaceutical product or therapeutic regimen based on a claimed pharmacological or
 bioactive compound or composition. The Federal Circuit, in Cross v. Iizuka, 753 F.2d 1040, 1051, 224 USPQ 739, 747-48 (Fed. Cir.
 1985), commented on the significance of data from in vitro testing
 that showed pharmacological activity:
 

 
 We perceive no insurmountable difficulty, under appropriate
 circumstances, in finding that the first link in the screening chain, in
 vitro testing, may establish a practical utility for the compound in
 question. Successful in vitro testing will marshal resources
 and direct the expenditure of effort to further in vivo testing
 of the most potent compounds, thereby providing an immediate benefit to the
 public, analogous to the benefit provided by the showing of an in
 vivo utility.
 

 
 The Federal Circuit has reiterated that therapeutic utility
 sufficient under the patent laws is not to be confused with the requirements of the
 FDA with regard to safety and efficacy of drugs to marketed in the United States.
 

 
 FDA approval, however, is not a prerequisite for finding a
 compound useful within the meaning of the patent laws. Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 [(Fed.Cir.
 1994)]. Usefulness in patent law, and in particular in the context of
 pharmaceutical inventions, necessarily includes the expectation of further
 research and development. The stage at which an invention in this field becomes
 useful is well before it is ready to be administered to humans. Were we to require
 Phase II testing in order to prove utility, the associated costs would prevent
 many companies from obtaining patent protection on promising new inventions,
 thereby eliminating an incentive to pursue, through research and development,
 potential cures in many crucial areas such as the treatment of cancer.
 

 
 In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995).
 Accordingly, Office personnel should not construe 35 U.S.C. 101 , under the logic of
 “practical” utility or otherwise, to require that an applicant demonstrate that a
 therapeutic agent based on a claimed invention is a safe or fully effective drug for
 humans. See, e.g., In re Sichert, 566 F.2d 1154, 196 USPQ 209
 (CCPA 1977); In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA 1962);
 In re Anthony, 414 F.2d 1383, 162 USPQ 594 (CCPA 1969);
 In re Watson, 517 F.2d 465, 186 USPQ 11 (CCPA 1975).
 

 These general principles are equally applicable to situations where
 an applicant has claimed a process for treating a human or animal disorder. In such
 cases, the asserted utility is usually clear — the invention is asserted to be useful
 in treating the particular disorder. If the asserted utility is
 credible , there is no basis to challenge such a claim on
 the basis that it lacks utility under 35 U.S.C. 101 .
 

 See MPEP § 2107.03 for special considerations for asserted
 therapeutic or pharmacological utilities.
 

 IV. RELATIONSHIP BETWEEN 35 U.S.C. 112(a) or PRE-AIA 35 U.S.C. 112, FIRST
 PARAGRAPH, AND 35 U.S.C. 101 A deficiency under the utility prong of 35 U.S.C. 101 
 also creates a deficiency under 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph. See In re
 Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995); In re
 Jolles, 628 F.2d 1322, 1326 n.10, 206 USPQ 885, 889 n.11 (CCPA 1980);
 In re Fouche, 439 F.2d 1237, 1243, 169 USPQ 429, 434 (CCPA
 1971) (“If such compositions are in fact useless, appellant’s specification cannot
 have taught how to use them.”). Courts have also cast the 35 U.S.C.
 101 / 35 U.S.C. 112 relationship such
 that 35 U.S.C.
 112 presupposes compliance with 35 U.S.C. 101 .
 See In re Ziegler, 992 F.2d 1197, 1200-1201, 26 USPQ2d 1600, 1603
 (Fed. Cir. 1993) (“The how to use prong of section 112 incorporates as a
 matter of law the requirement of 35 U.S.C. 101 that the
 specification disclose as a matter of fact a practical utility for the invention. ...
 If the application fails as a matter of fact to satisfy 35 U.S.C. §
 101 , then the application also fails as a matter of law to enable
 one of ordinary skill in the art to use the invention under 35 U.S.C. §
 112 .”); In re Kirk, 376 F.2d 936, 942, 153 USPQ
 48, 53 (CCPA 1967) (“Necessarily, compliance with § 112 requires a description of
 how to use presently useful inventions, otherwise an applicant would anomalously be
 required to teach how to use a useless invention.”). For example, the Federal Circuit
 noted, “[o]bviously, if a claimed invention does not have utility, the specification
 cannot enable one to use it.” In re Brana, 51 F.3d 1560, 34 USPQ2d
 1436 (Fed. Cir. 1995). As such, a rejection properly imposed under 35 U.S.C. 101 
 for lack of utility should be accompanied with a rejection under 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph. It is equally clear that a rejection based on “lack of utility,” whether
 grounded upon 35
 U.S.C. 101 or 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph, rests on the same basis (i.e., the
 asserted utility is not credible). To avoid confusion, any lack of utility rejection
 that is imposed on the basis of 35 U.S.C. 101 should be
 accompanied by a rejection based on 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph. The 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, rejection should be set out as a separate rejection that incorporates by
 reference the factual basis and conclusions set forth in the 35 U.S.C. 101 
 rejection. The 35 U.S.C. 112(a) or
 pre-AIA
 35 U.S.C. 112 , first paragraph, rejection should indicate that
 because the invention as claimed does not have utility, a person skilled in the art
 would not be able to use the invention as claimed, and as such, the claim is
 defective under 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph. A 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, rejection based on lack of utility should not be imposed or maintained
 unless an appropriate basis exists for imposing a utility rejection under
 35 U.S.C.
 101 . In other words, Office personnel should not impose a
 35
 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, rejection grounded on a “lack of utility” basis unless a 35 U.S.C. 101 
 rejection is proper. In particular, the factual showing needed to impose a rejection
 under 35 U.S.C.
 101 must be provided if a rejection under 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, is to be imposed on “lack of utility” grounds.
 

 It is important to recognize that 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, addresses matters other than those related to the question of whether or
 not an invention lacks utility. These matters include whether the claims are fully
 supported by the disclosure (In re Vaeck, 947 F.2d 488, 495, 20
 USPQ2d 1438, 1444 (Fed. Cir. 1991)), whether the applicant has provided an enabling
 disclosure of the claimed subject matter (In re Wright, 999 F.2d
 1557, 1561-1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)), whether the applicant has
 provided an adequate written description of the invention and whether the applicant
 has disclosed the best mode of practicing the claimed invention (Chemcast
 Corp. v. Arco Indus. Corp., 913 F.2d 923, 927-928, 16 USPQ2d 1033,
 1036-1037 (Fed. Cir. 1990)). See also Transco Products Inc. v. Performance Contracting Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed.
 Cir. 1994); Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 34 USPQ2d 1565 (Fed. Cir. 1995). The
 fact that an applicant has disclosed a specific utility for an invention and provided
 a credible basis supporting that specific utility does not provide a basis for
 concluding that the claims comply with all the requirements of 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph. For example, if an applicant has claimed a process of treating a certain
 disease condition with a certain compound and provided a credible basis for asserting
 that the compound is useful in that regard, but to actually practice the invention as
 claimed a person skilled in the relevant art would have to engage in an undue amount
 of experimentation, the claim may be defective under 35 U.S.C. 112 ,
 but not 35 U.S.C.
 101 . To avoid confusion during examination, any rejection under
 35
 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, based on grounds other than “lack of utility” should be imposed separately
 from any rejection imposed due to “lack of utility” under 35 U.S.C. 101 
 and 35
 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph.
 

 

 
 2107.02 Procedural Considerations Related to Rejections for Lack of
 Utility [R-07.2022]
 
 I. THE CLAIMED INVENTION IS THE FOCUS OF THE UTILITY REQUIREMENT The claimed invention is the focus of the assessment of whether an
 applicant has satisfied the utility requirement. Each claim (i.e., each “invention”),
 therefore, must be evaluated on its own merits for compliance with all statutory
 requirements. Generally speaking, however, a dependent claim will define an invention
 that has utility if the independent claim from which the dependent claim depends is
 drawn to the same statutory class of invention as the dependent claim and the
 independent claim defines an invention having utility. An exception to this general
 rule is where the utility specified for the invention defined in a dependent claim
 differs from that indicated for the invention defined in the independent claim from
 which the dependent claim depends. Where an applicant has established utility for a
 species that falls within an identified genus of compounds, and presents a generic
 claim covering the genus, as a general matter, that claim should be treated as being
 sufficient under 35
 U.S.C. 101 . Only where it can be established that other species
 clearly encompassed by the claim do not have utility should a rejection be imposed on
 the generic claim. In such cases, the applicant should be encouraged to amend the
 generic claim so as to exclude the species that lack utility. 
 

 It is common and sensible for an applicant to identify several
 specific utilities for an invention, particularly where the invention is a product
 (e.g., a machine, an article of manufacture or a composition of matter). However,
 regardless of the category of invention that is claimed (e.g., product or process),
 an applicant need only make one credible assertion of specific utility for the
 claimed invention to satisfy 35 U.S.C. 101 and
 35 U.S.C.
 112 ; additional statements of utility, even if not “credible,”
 do not render the claimed invention lacking in utility. See, e.g.,
 Raytheon v. Roper, 724 F.2d 951, 958, 220 USPQ 592, 598 (Fed. Cir. 1983),
 cert. denied, 469 U.S. 835 (1984) (“When a properly claimed
 invention meets at least one stated objective, utility under 35 U.S.C. 101 
 is clearly shown.”); In re Gottlieb, 328 F.2d 1016, 1019, 140 USPQ
 665, 668 (CCPA 1964) (“Having found that the antibiotic is useful for some purpose,
 it becomes unnecessary to decide whether it is in fact useful for the other purposes
 ‘indicated’ in the specification as possibly useful.”); In re
 Malachowski, 530 F.2d 1402, 189 USPQ 432 (CCPA 1976);
 Hoffman v. Klaus, 9 USPQ2d 1657 (Bd. Pat. App. & Inter. 1988). Thus, if
 applicant makes one credible assertion of utility, utility for the claimed invention
 as a whole is established.
 

 Statements made by the applicant in the specification or incident to
 prosecution of the application before the Office cannot, standing alone, be the basis
 for a lack of utility rejection under 35 U.S.C. 101 or
 35 U.S.C.
 112 . Tol-O-Matic, Inc. v. Proma Produkt-Und Mktg. Gesellschaft m.b.h., 945 F.2d 1546, 1553,
 20 USPQ2d 1332, 1338 (Fed. Cir. 1991) (It is not required that a particular
 characteristic set forth in the prosecution history be achieved in order to satisfy
 35 U.S.C.
 101 ). An applicant may include statements in the specification
 whose technical accuracy cannot be easily confirmed if those statements are not
 necessary to support the patentability of an invention with regard to any statutory
 basis. Thus, the Office should not require an applicant to strike nonessential
 statements relating to utility from a patent disclosure, regardless of the technical
 accuracy of the statement or assertion it presents. Office personnel should also be
 especially careful not to read into a claim unclaimed results, limitations or
 embodiments of an invention. See Carl Zeiss Stiftung v. Renishaw PLC, 945 F.2d 1173, 20 USPQ2d 1094 (Fed. Cir. 1991);
 In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Doing so
 can inappropriately change the relationship of an asserted utility to the claimed
 invention and raise issues not relevant to examination of that claim.
 

 II. IS THERE AN ASSERTED OR WELL-ESTABLISHED UTILITY FOR THE CLAIMED
 INVENTION? Upon initial examination, the examiner should review the
 specification to determine if there are any statements asserting that the claimed
 invention is useful for any particular purpose. A complete disclosure should include
 a statement which identifies a specific and substantial utility for the invention. 
 

 A. An Asserted Utility Must Be Specific and Substantial A statement of specific and substantial utility should fully and
 clearly explain why the applicant asserts the invention is useful. Such statements
 will usually explain the purpose of or how the invention may be used (e.g., a
 compound is believed to be useful in the treatment of a particular disorder).
 Regardless of the form of statement of utility, it must enable one ordinarily
 skilled in the art to understand why the applicant asserts the claimed invention
 is useful. 
 

 Except where an invention has a well-established utility, the
 failure of an applicant to specifically identify why an invention is believed to
 be useful renders the claimed invention deficient under 35 U.S.C.
 101 and 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph. In such cases, the applicant
 has failed to identify a “specific and substantial utility” for the claimed
 invention. For example, a statement that a composition has an unspecified
 “biological activity” or that does not explain why a composition with that
 activity is believed to be useful fails to set forth a “specific and substantial
 utility.” Brenner v. Manson, 383 US 519, 148 USPQ 689 (1966) (general assertion of
 similarities to known compounds known to be useful without sufficient
 corresponding explanation why claimed compounds are believed to be similarly
 useful insufficient under 35 U.S.C. 101 ); In re
 Ziegler, 992 F.2d 1197, 1201, 26 USPQ2d 1600, 1604 (Fed. Cir. 1993)
 (disclosure that composition is “plastic-like” and can form “films” not sufficient
 to identify specific and substantial utility for invention); In re
 Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967) (indication that compound
 is “biologically active” or has “biological properties” insufficient standing
 alone). See also In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA
 1967); Kawai v. Metlesics, 480 F.2d 880, 890, 178 USPQ 158, 165 (CCPA 1973)
 (contrasting description of invention as sedative which did suggest specific
 utility to general suggestion of “pharmacological effects on the central nervous
 system” which did not). In contrast, a disclosure that identifies a particular
 biological activity of a compound and explains how that activity can be utilized
 in a particular therapeutic application of the compound does contain an assertion
 of specific and substantial utility for the invention.
 

 Situations where an applicant either fails to indicate why an
 invention is considered useful, or where the applicant inaccurately describes the
 utility should rarely arise. One reason for this is that applicants are required
 to disclose the best mode known to them of practicing the invention at the time
 they file their application. An applicant who omits a description of the specific
 and substantial utility of the invention, or who incompletely describes that
 utility, may encounter problems with respect to the best mode requirement of
 35
 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph.
 

 B. No Statement of Utility for the Claimed Invention in the Specification
 Does Not Per Se Negate Utility Occasionally, an applicant will not explicitly state in the
 specification or otherwise assert a specific and substantial utility for the
 claimed invention. If no statements can be found asserting a specific and
 substantial utility for the claimed invention in the specification, Office
 personnel should determine if the claimed invention has a well-established
 utility. An invention has a well-established utility if (i) a person of ordinary
 skill in the art would immediately appreciate why the invention is useful based on
 the characteristics of the invention (e.g., properties or applications of a
 product or process), and (ii) the utility is specific, substantial, and credible.
 If an invention has a well- established utility, rejections under
 35 U.S.C.
 101 and 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph, based on lack of utility should
 not be imposed. In re Folkers, 344 F.2d 970, 145 USPQ 390 (CCPA
 1965). For example, if an application teaches the cloning and characterization of
 the nucleotide sequence of a well-known protein such as insulin, and those skilled
 in the art at the time of filing knew that insulin had a well-established use, it
 would be improper to reject the claimed invention as lacking utility solely
 because of the omitted statement of specific and substantial utility.
 

 If a person of ordinary skill would not immediately recognize a
 specific and substantial utility for the claimed invention (i.e., why it would be
 useful) based on the characteristics of the invention or statements made by the
 applicant, the examiner should reject the application under 35 U.S.C.
 101 and under 35 U.S.C. 112(a) or
 pre-AIA 35
 U.S.C. 112 , first paragraph, as failing to identify a
 specific and substantial utility for the claimed invention. The rejection should
 clearly indicate that the basis of the rejection is that the application fails to
 identify a specific and substantial utility for the invention. The rejection
 should also specify that the applicant must reply by indicating why the invention
 is believed useful and where support for any subsequently asserted utility can be
 found in the specification as filed. See MPEP § 2701 .
 

 If the applicant subsequently indicates why the invention is
 useful, Office personnel should review that assertion according to the standards
 articulated below for review of the credibility of an asserted utility.
 

 III. EVALUATING THE CREDIBILITY OF AN ASSERTED UTILITY 
 

 A. An Asserted Utility Creates a Presumption of Utility In most cases, an applicant’s assertion of utility creates a
 presumption of utility that will be sufficient to satisfy the utility requirement
 of 35 U.S.C.
 101 . See, e.g., In re Jolles, 628 F.2d
 1322, 206 USPQ 885 (CCPA 1980); In re Irons, 340 F.2d 974, 144
 USPQ 351 (CCPA 1965); In re Langer, 503 F.2d 1380, 183 USPQ 288
 (CCPA 1974); In re Sichert, 566 F.2d 1154, 1159, 196 USPQ 209,
 212-13 (CCPA 1977). As the Court of Customs and Patent Appeals stated in
 In re Langer :
 

 
 As a matter of Patent Office practice, a specification which
 contains a disclosure of utility which corresponds in scope to the subject
 matter sought to be patented must be taken as sufficient
 to satisfy the utility requirement of § 101 for the entire
 claimed subject matter unless there is a reason for one
 skilled in the art to question the objective truth of the statement of utility
 or its scope.
 

 
 In re Langer, 503 F.2d at 1391, 183 USPQ at 297 (emphasis in
 original). The “Langer” test for utility has been used by both the Federal Circuit
 and the Court of Customs and Patent Appeals in evaluation of rejections under
 35
 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, where the rejection is based on a deficiency under 35 U.S.C.
 101 . In In re Brana, 51 F.3d 1560, 34
 USPQ2d 1436 (Fed. Cir. 1995), the Federal Circuit explicitly adopted the Court of
 Customs and Patent Appeals formulation of the “Langer” standard for
 35
 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph rejections, as it was expressed in a slightly reworded format in
 In re Marzocchi, 439 F.2d 220, 223, 169 USPQ 367, 369 (CCPA
 1971), namely:
 

 
 [A] specification disclosure which contains a teaching of the
 manner and process of making and using the invention in terms which correspond
 in scope to those used in describing and defining the subject matter sought to
 be patented must be taken as in compliance with the
 enabling requirement of the first paragraph of § 112 
 unless there is reason to doubt the objective truth of the statements contained
 therein which must be relied on for enabling support. (emphasis added).
 

 
 Thus, Langer and subsequent cases direct the
 Office to presume that a statement of utility made by an applicant is true. See
 In re Langer, 503 F.2d at 1391, 183 USPQ at 297; In
 re Malachowski, 530 F.2d 1402, 1404, 189 USPQ 432, 435 (CCPA 1976);
 In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995).
 For obvious reasons of efficiency and in deference to an applicant’s understanding
 of the invention, when a statement of utility is evaluated, Office personnel
 should not begin by questioning the truth of the statement of utility. Instead,
 any inquiry must start by asking if there is any reason to question the truth of
 the statement of utility. This can be done by simply evaluating the logic of the
 statements made, taking into consideration any evidence cited by the applicant. If
 the asserted utility is credible (i.e., believable based on the record or the
 nature of the invention), a rejection based on “lack of utility” is not
 appropriate. Clearly, Office personnel should not begin an evaluation of utility
 by assuming that an asserted utility is likely to be false, based on the technical
 field of the invention or for other general reasons.
 

 Compliance with 35 U.S.C. 101 is a question of
 fact. Raytheon v. Roper, 724 F.2d 951, 956, 220 USPQ 592, 596 (Fed. Cir. 1983)
 cert. denied, 469 U.S. 835 (1984). Thus, to overcome the
 presumption of truth that an assertion of utility by the applicant enjoys, Office
 personnel must establish that it is more likely than not that one of ordinary
 skill in the art would doubt (i.e., “question”) the truth of the statement of
 utility. The evidentiary standard to be used throughout ex
 parte examination in setting forth a rejection is a preponderance of
 the totality of the evidence under consideration. In re
 Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443, 1444 (Fed. Cir. 1992)
 (“After evidence or argument is submitted by the applicant in response,
 patentability is determined on the totality of the record, by a preponderance of
 evidence with due consideration to persuasiveness of argument.”); In re
 Corkill, 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). A
 preponderance of the evidence exists when it suggests that it is more likely than
 not that the assertion in question is true. Herman v. Huddleston, 459 U.S. 375, 390 (1983). To do this, Office
 personnel must provide evidence sufficient to show that the statement of asserted
 utility would be considered “false” by a person of ordinary skill in the art. Of
 course, a person of ordinary skill must have the benefit of both facts and
 reasoning in order to assess the truth of a statement. This means that if the
 applicant has presented facts that support the reasoning used in asserting a
 utility, Office personnel must present countervailing facts and reasoning
 sufficient to establish that a person of ordinary skill would not believe the
 applicant’s assertion of utility. In re Brana, 51 F.3d 1560, 34
 USPQ2d 1436 (Fed. Cir. 1995). The initial evidentiary standard used during
 evaluation of this question is a preponderance of the evidence (i.e., the totality
 of facts and reasoning suggest that it is more likely than not that the statement
 of the applicant is false). 
 

 B. When Is an Asserted Utility Not Credible? Where an applicant has specifically asserted that an invention
 has a particular utility, that assertion cannot simply be dismissed by Office
 personnel as being “wrong,” even when there may be reason to believe that the
 assertion is not entirely accurate. Rather, Office personnel must determine if the
 assertion of utility is credible (i.e., whether the
 assertion of utility is believable to a person of ordinary skill in the art based
 on the totality of evidence and reasoning provided). An assertion is credible
 unless (A) the logic underlying the assertion is seriously flawed, or (B) the
 facts upon which the assertion is based are inconsistent with the logic underlying
 the assertion. Credibility as used in this context refers to the reliability of
 the statement based on the logic and facts that are offered by the applicant to
 support the assertion of utility.
 

 One situation where an assertion of utility would not be
 considered credible is where a person of ordinary skill would consider the
 assertion to be “incredible in view of contemporary knowledge” and where nothing
 offered by the applicant would counter what contemporary knowledge might otherwise
 suggest. Office personnel should be careful, however, not to label certain types
 of inventions as “incredible” or “speculative” as such labels do not provide the
 correct focus for the evaluation of an assertion of utility. “Incredible utility”
 is a conclusion, not a starting point for analysis under 35 U.S.C.
 101 . A conclusion that an asserted utility is incredible can
 be reached only after the Office has evaluated both the assertion of the applicant
 regarding utility and any evidentiary basis of that
 assertion. The Office should be particularly careful not to start with a
 presumption that an asserted utility is, per se, “incredible”
 and then proceed to base a rejection under 35 U.S.C. 101 on that
 presumption.
 

 Rejections under 35 U.S.C. 101 based on a lack
 of credible utility have been sustained by federal courts when, for example, the
 applicant failed to disclose any utility for the invention or asserted a utility
 that could only be true if it violated a scientific principle, such as the second
 law of thermodynamics, or a law of nature, or was wholly 
 inconsistent with contemporary knowledge in the art. In re
 Gazave, 379 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967). Special care
 should be taken when assessing the credibility of an asserted therapeutic utility
 for a claimed invention. In such cases, a previous lack of success in treating a
 disease or condition, or the absence of a proven animal model for testing the
 effectiveness of drugs for treating a disorder in humans, should not, standing
 alone, serve as a basis for challenging the asserted utility under
 35 U.S.C.
 101 . See MPEP § 2107.03 for additional
 guidance with regard to therapeutic or pharmacological utilities.
 

 IV. INITIAL BURDEN IS ON THE OFFICE TO ESTABLISH A PRIMA FACIE 
 CASE AND PROVIDE EVIDENTIARY SUPPORT THEREOF To properly reject a claimed invention under 35 U.S.C. 101 ,
 the Office must (A) make a prima facie showing that the claimed
 invention lacks utility, and (B) provide a sufficient evidentiary basis for factual
 assumptions relied upon in establishing the prima facie showing.
 In re Gaubert, 524 F.2d 1222, 1224, 187 USPQ 664, 666 (CCPA
 1975) "Accordingly, the PTO must do more than merely question operability - it must
 set forth factual reasons which would lead one skilled in the art to question the
 objective truth of the statement of operability." If the Office cannot develop a
 proper prima facie case and provide evidentiary support for a
 rejection under 35
 U.S.C. 101 , a rejection on this ground should not be imposed.
 See, e.g., In re Oetiker, 977 F.2d 1443, 1445, 24 USPQ2d 1443,
 1444 (Fed. Cir. 1992) (“[T]he examiner bears the initial burden, on review of the
 prior art or on any other ground, of presenting a prima facie case
 of unpatentability. If that burden is met, the burden of coming forward with evidence
 or argument shifts to the applicant.... If examination at the initial stage does not
 produce a prima facie case of unpatentability, then without more
 the applicant is entitled to grant of the patent.”). See also
 Fregeau v. Mossinghoff, 776 F.2d 1034, 227 USPQ 848 (Fed. Cir. 1985)
 (applying prima facie case law to 35 U.S.C. 101 );
 In re Piasecki, 745 F.2d 1468, 223 USPQ 785 (Fed. Cir. 1984). 
 

 The prima facie showing must be set forth in a
 well-reasoned statement. Any rejection based on lack of utility should include a
 detailed explanation why the claimed invention has no specific and substantial
 credible utility. Whenever possible, the examiner should provide documentary evidence
 regardless of publication date (e.g., scientific or technical journals, excerpts from
 treatises or books, or U.S. or foreign patents) to support the factual basis for the
 prima facie showing of no specific and substantial credible
 utility. If documentary evidence is not available, the examiner should specifically
 explain the scientific basis for the examiner's factual conclusions.
 

 Where the asserted utility is not specific or substantial, a
 prima facie showing must establish that it is more likely than
 not that a person of ordinary skill in the art would not consider that any utility
 asserted by the applicant would be specific and substantial. The prima
 facie showing must contain the following elements:
 

 
 (A) An explanation that clearly sets forth the reasoning used in
 concluding that the asserted utility for the claimed invention is neither both
 specific and substantial nor well-established;
 

 (B) Support for factual findings relied upon in reaching this
 conclusion; and
 

 (C) An evaluation of all relevant evidence of record, including
 utilities taught in the closest prior art.
 

 
 Where the asserted specific and substantial utility is not credible,
 a prima facie showing of no specific and substantial credible
 utility must establish that it is more likely than not that a person skilled in the
 art would not consider credible any specific and substantial utility asserted by the
 applicant for the claimed invention. The prima facie showing must
 contain the following elements:
 

 
 (A) An explanation that clearly sets forth the reasoning used in
 concluding that the asserted specific and substantial utility is not
 credible;
 

 (B) Support for factual findings relied upon in reaching this
 conclusion; and
 

 (C) An evaluation of all relevant evidence of record, including
 utilities taught in the closest prior art.
 

 
 Where no specific and substantial utility is disclosed or is
 well-established, a prima facie showing of no specific and
 substantial utility need only establish that applicant has not asserted a utility and
 that, on the record before the examiner, there is no known well-established
 utility.
 

 It is imperative that Office personnel use specificity in setting
 forth and initial rejection under 35 U.S.C. 101 and support any
 factual conclusions made in the prima facie showing. 
 

 By using specificity, the applicant will be able to identify the
 assumptions made by the Office in setting forth the rejection and will be able to
 address those assumptions properly.
 

 Use form paragraphs 7.04.01 and
 7.05.02 
 through 7.05.04 to reject claims under 35 U.S.C. 101 
 for failure to satisfy the utility requirement.
 

 ¶ 7.05.02 Rejection, 35 U.S.C. 101, Utility Lacking

 the claimed invention lacks patentable utility. [1] 

 Examiner Note:

 In bracket 1, provide explanation of lack of utility. See
 MPEP §§ 2105
 - 2107.03 .
 

 

 ¶ 7.05.03 Rejection, 35 U.S.C. 101, Inoperative

 the disclosed invention is inoperative and therefore lacks utility. [1] 

 Examiner Note:

 In bracket 1, explain why invention is inoperative.

 

 ¶ 7.05.04 Utility Rejections Under 35 U.S.C. 101 and 35 U.S.C. 112(a) or 35
 U.S.C. 112 (pre-AIA), First Paragraph
 

 Claim [1] rejected under
 35 U.S.C.
 101 because the claimed invention is not supported by either a
 [2] asserted utility or a well established utility.
 

 [3] 

 Claim [4] also rejected
 under 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first paragraph.
 Specifically, because the claimed invention is not supported by either a [5] 
 asserted utility or a well established utility for the reasons set forth above, one skilled in
 the art clearly would not know how to use the claimed invention.
 

 Examiner Note:
 
 1. Where the specification would not enable one skilled in the art to
 make the claimed invention, or where alternative reasons support the enablement
 rejection, a separate rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C.
 112 , first paragraph, enablement should be made using the factors
 set forth in In re Wands , 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir.
 1988) and an undue experimentation analysis. See MPEP §§ 2164 - 2164.08(c) .
 

 2. Use Format A, B, or C below as
 appropriate. 
 
 Format A: (a) Insert the same claim numbers in
 brackets 1 and 4.
 

 (b) Insert --specific and substantial--
 in inserts 2 and 5.
 

 (c) In bracket 3, insert the explanation
 as to why the claimed invention is not supported by either a specific and
 substantial asserted utility or a well established
 utility.
 

 (d) Format A is to be used when there is
 no asserted utility and when there is an asserted utility but that
 utility is not specific and substantial.
 

 
 

 
 Format B: (a) Insert the same claim numbers in
 brackets 1 and 4.
 

 (b) Insert --credible-- in inserts 2 and
 5.
 

 (c) In bracket 3, insert the explanation
 as to why the claimed invention is not supported by either a credible
 asserted utility or a well established utility.
 

 
 

 
 Format C: For claims that have multiple utilities, some of which
 are not specific and substantial, some of which are not credible, but none of
 which are specific, substantial and credible:
 
 (a) Insert the same claim numbers in brackets 1 and
 4.
 

 (b) Insert --specific and substantial asserted
 utility, a credible-- in inserts 2 and 5.
 

 (c) In bracket 3, insert the explanation as to why the
 claimed invention is not supported by either a specific and substantial
 asserted utility, a credible asserted utility or a well established
 utility. Each utility should be addressed.
 

 
 

 
 
 
 
 
 
 V. EVIDENTIARY REQUESTS BY AN EXAMINER TO SUPPORT AN ASSERTED UTILITY In appropriate situations the Office may require an applicant to
 substantiate an asserted utility for a claimed invention. See In re
 Pottier, 376 F.2d 328, 330, 153 USPQ 407, 408 (CCPA 1967) (“When the
 operativeness of any process would be deemed unlikely by one of ordinary skill in the
 art, it is not improper for the examiner to call for evidence of operativeness.”).
 See also In re Jolles, 628 F.2d 1322, 1327, 206 USPQ 885, 890
 (CCPA 1980); In re Citron, 325 F.2d 248, 139 USPQ 516 (CCPA 1963);
 In re Novak, 306 F.2d 924, 928, 134 USPQ 335, 337 (CCPA1962).
 In In re Citron, the court held that when an “alleged utility
 appears to be incredible in the light of the knowledge of the art, or factually
 misleading, applicant must establish the asserted utility by acceptable proof.” 325
 F.2d at 253, 139 USPQ at 520. The court approved of the board’s decision which
 affirmed the rejection under 35 U.S.C. 101 “ in view
 of the art knowledge of the lack of a cure for cancer and the absence of any
 clinical data to substantiate the allegation .” 325 F.2d at 252, 139
 USPQ at 519 (emphasis in original). The court thus established a higher burden on the
 applicant where the statement of use is incredible or misleading. In such a case, the
 examiner should challenge the use and require sufficient evidence of operativeness.
 The purpose of this authority is to enable an applicant to cure an otherwise
 defective factual basis for the operability of an invention. Because this is a
 curative authority (e.g., evidence is requested to enable an applicant to support an
 assertion that is inconsistent with the facts of record in the application), Office
 personnel should indicate not only why the factual record is defective in relation to
 the assertions of the applicant, but also, where appropriate, what type of
 evidentiary showing can be provided by the applicant to remedy the problem.
 

 Requests for additional evidence should be imposed rarely, and only
 if necessary to support the scientific credibility of the asserted utility (e.g., if
 the asserted utility is not consistent with the evidence of record and current
 scientific knowledge). As the Federal Circuit recently noted, “[o]nly after the PTO
 provides evidence showing that one of ordinary skill in the art would reasonably
 doubt the asserted utility does the burden shift to the applicant to provide rebuttal
 evidence sufficient to convince such a person of the invention’s asserted utility.”
 In re Brana, 51 F.3d 1560, 34 USPQ2d 1436 (Fed. Cir. 1995)
 (citing In re Bundy, 642 F.2d 430, 433, 209 USPQ 48, 51 (CCPA
 1981)). In Brana, the court pointed out that the purpose of
 treating cancer with chemical compounds does not
 suggest, per se, an incredible utility. Where the prior
 art disclosed “structurally similar compounds to those claimed by applicants which
 have been proven in vivo to be effective as chemotherapeutic
 agents against various tumor models . . ., one skilled in the art would be without
 basis to reasonably doubt applicants’ asserted utility on its face.” 51 F.3d at 1566,
 34 USPQ2d at 1441. As courts have stated, “it is clearly improper for the examiner to
 make a demand for further test data, which as evidence would be essentially redundant
 and would seem to serve for nothing except perhaps to unduly burden the applicant.”
 In re Isaacs, 347 F.2d 887, 890, 146 USPQ 193, 196 (CCPA
 1965).
 

 VI. CONSIDERATION OF A REPLY TO A PRIMA FACIE REJECTION FOR
 LACK OF UTILITY If a rejection under 35 U.S.C. 101 has been properly
 imposed, along with a corresponding rejection under 35 U.S.C.
 112(a) or pre-AIA 35 U.S.C. 112 , first
 paragraph, the burden shifts to the applicant to rebut the prima
 facie showing. In re Oetiker, 977 F.2d 1443, 1445, 24
 USPQ2d 1443, 1444 (Fed. Cir. 1992) (“The examiner bears the initial burden, on review
 of the prior art or on any other ground, of presenting a prima
 facie case of unpatentability. If that burden is met, the burden of
 coming forward with evidence or argument shifts to the applicant. . . After evidence
 or argument is submitted by the applicant in response, patentability is determined on
 the totality of the record, by a preponderance of evidence with due consideration to
 persuasiveness of argument.”). An applicant can do this using any combination of the
 following: amendments to the claims, arguments or reasoning, or new evidence
 submitted in an affidavit or declaration under 37 CFR 1.132 , or in a printed
 publication. New evidence provided by an applicant must be relevant to the issues
 raised in the rejection. For example, declarations in which conclusions are set forth
 without establishing a nexus between those conclusions and the supporting evidence,
 or which merely express opinions, may be of limited probative value with regard to
 rebutting a prima facie case. In re Grunwell, 
 609 F.2d 486, 203 USPQ 1055 (CCPA 1979); In re Buchner, 929 F.2d
 660, 18 USPQ2d 1331 (Fed. Cir. 1991). See MPEP § 716.01(a) through
 MPEP
 § 716.01(c) .
 

 If the applicant responds to the prima facie 
 rejection, Office personnel should review the original disclosure, any evidence
 relied upon in establishing the prima facie showing, any claim
 amendments, and any new reasoning or evidence provided by the applicant in support of
 an asserted specific and substantial credible utility. It is essential for Office
 personnel to recognize, fully consider and respond to each substantive element of any
 response to a rejection based on lack of utility. Only where the totality of the
 record continues to show that the asserted utility is not specific, substantial, and
 credible should a rejection based on lack of utility be maintained. If the record as
 a whole would make it more likely than not that the asserted utility for the claimed
 invention would be considered credible by a person of ordinary skill in the art, the
 Office cannot maintain the rejection. In re Rinehart, 531 F.2d
 1048, 1052, 189 USPQ 143, 147 (CCPA 1976).
 

 VII. EVALUATION OF EVIDENCE RELATED TO UTILITY There is no predetermined amount or character of evidence that must
 be provided by an applicant to support an asserted utility, therapeutic or otherwise.
 Rather, the character and amount of evidence needed to support an asserted utility
 will vary depending on what is claimed (Ex parte Ferguson, 117
 USPQ 229 (Bd. App. 1957)), and whether the asserted utility appears to contravene
 established scientific principles and beliefs. In re Gazave, 379
 F.2d 973, 978, 154 USPQ 92, 96 (CCPA 1967); In re Chilowsky, 
 229 F.2d 457, 462, 108 USPQ 321, 325 (CCPA 1956). Furthermore, the applicant does not
 have to provide evidence sufficient to establish that an asserted utility is true
 “beyond a reasonable doubt.” In re Irons, 340 F.2d 974, 978, 144
 USPQ 351, 354 (CCPA 1965). Nor must an applicant provide evidence such that it
 establishes an asserted utility as a matter of statistical certainty.
 Nelson v. Bowler, 626 F.2d 853, 856-57, 206 USPQ 881, 883-84 (CCPA 1980)
 (reversing the Board and rejecting Bowler’s arguments that the evidence of utility
 was statistically insignificant. The court pointed out that a rigorous correlation is
 not necessary when the test is reasonably predictive of the response). See also
 Rey-Bellet v. Englehardt, 493 F.2d 1380, 181 USPQ 453 (CCPA 1974) (data from
 animal testing is relevant to asserted human therapeutic utility if there is a
 “satisfactory correlation between the effect on the animal and that ultimately
 observed in human beings”). Instead, evidence will be sufficient if, considered as a
 whole, it leads a person of ordinary skill in the art to conclude that the asserted
 utility is more likely than not true .
 

 

 
 2107.03 Special Considerations for Asserted Therapeutic or
 Pharmacological Utilities [R-08.2012]
 

 The federal courts have consistently reversed rejections by the Office
 asserting a lack of utility for inventions claiming a pharmacological or therapeutic
 utility where an applicant has provided evidence that reasonably supports such a
 utility. In view of this, Office personnel should be particularly careful in their
 review of evidence provided in support of an asserted therapeutic or pharmacological
 utility.
 

 I. A REASONABLE CORRELATION BETWEEN THE EVIDENCE AND THE ASSERTED UTILITY IS
 SUFFICIENT As a general matter, evidence of pharmacological or other biological
 activity of a compound will be relevant to an asserted therapeutic use if there is a
 reasonable correlation between the activity in question and
 the asserted utility. Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985);
 In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980);
 Nelson v. Bowler, 626 F.2d 853, 206 USPQ 881 (CCPA 1980). An applicant can
 establish this reasonable correlation by relying on statistically relevant data
 documenting the activity of a compound or composition, arguments or reasoning,
 documentary evidence (e.g., articles in scientific journals), or any combination
 thereof. The applicant does not have to prove that a correlation exists between a
 particular activity and an asserted therapeutic use of a compound as a matter of
 statistical certainty, nor does he or she have to provide actual evidence of success
 in treating humans where such a utility is asserted. Instead, as the courts have
 repeatedly held, all that is required is a reasonable correlation between the
 activity and the asserted use. Nelson v. Bowler, 626 F.2d 853, 857, 206 USPQ 881, 884 (CCPA 1980).
 

 II. STRUCTURAL SIMILARITY TO COMPOUNDS WITH ESTABLISHED UTILITY Courts have routinely found evidence of structural similarity to a
 compound known to have a particular therapeutic or pharmacological utility as being
 supportive of an assertion of therapeutic utility for a new compound. In In
 re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980), the claimed
 compounds were found to have utility based on a finding of a close structural
 relationship to daunorubicin and doxorubicin and shared pharmacological activity with
 those compounds, both of which were known to be useful in cancer chemotherapy. The
 evidence of close structural similarity with the known compounds was presented in
 conjunction with evidence demonstrating substantial activity of the claimed
 compounds in animals customarily employed for screening anticancer agents. Such
 evidence should be given appropriate weight in determining whether one skilled in the
 art would find the asserted utility credible. Office personnel should evaluate not
 only the existence of the structural relationship, but also the reasoning used by the
 applicant or a declarant to explain why that structural similarity is believed to be
 relevant to the applicant's assertion of utility.
 

 III. DATA FROM IN VITRO OR ANIMAL TESTING IS GENERALLY
 SUFFICIENT TO SUPPORT THERAPEUTIC UTILITY If reasonably correlated to the particular therapeutic or
 pharmacological utility, data generated using in vitro assays, or
 from testing in an animal model or a combination thereof almost invariably will be
 sufficient to establish therapeutic or pharmacological utility for a compound,
 composition or process. A cursory review of cases involving therapeutic inventions
 where 35 U.S.C.
 101 was the dispositive issue illustrates the fact that the
 federal courts are not particularly receptive to rejections under 35 U.S.C. 101 
 based on inoperability. Most striking is the fact that in those cases where an
 applicant supplied a reasonable evidentiary showing supporting an asserted
 therapeutic utility, almost uniformly the 35 U.S.C. 101 -based rejection was
 reversed. See, e.g., In re Brana, 51 F.3d 1560, 34 USPQ 1436 (Fed.
 Cir. 1995); Cross v. Iizuka, 753 F.2d 1040, 224 USPQ 739 (Fed. Cir. 1985);
 In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA 1980);
 Nelson v. Bowler, 626 F.2d 853, 856, 206 USPQ 881, 883 (CCPA 1980);
 In re Malachowski, 530 F.2d 1402, 189 USPQ 432 (CCPA 1976);
 In re Gaubert, 530 F.2d 1402, 189 USPQ 432 (CCPA 1975);
 In re Gazave, 379 F.2d 973, 154 USPQ 92 (CCPA 1967);
 In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA 1962);
 In re Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961). Only in
 those cases where the applicant was unable to come forward with any relevant evidence
 to rebut a finding by the Office that the claimed invention was inoperative was a
 35 U.S.C.
 101 rejection affirmed by the court. In re
 Citron, 325 F.2d 248, 253, 139 USPQ 516, 520 (CCPA 1963) (therapeutic
 utility for an uncharacterized biological extract not supported or scientifically
 credible); In re Buting, 418 F.2d 540, 543, 163 USPQ 689, 690
 (CCPA 1969) (record did not establish a credible basis for the assertion that the
 single class of compounds in question would be useful in treating disparate types of
 cancers); In re Novak, 306 F.2d 924, 134 USPQ 335 (CCPA 1962)
 (claimed compounds did not have capacity to effect physiological activity upon which
 utility claim based). Contrast, however, In re Buting to
 In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973),
 reh'g denied, 480 F.2d 879 (CCPA 1973), in which the court held
 that utility for a genus was found to be supported through a showing of utility for
 one species. In no case has a federal court required an applicant to support an
 asserted utility with data from human clinical trials.
 

 If an applicant provides data, whether from in
 vitro assays or animal tests or both, to support an asserted utility,
 and an explanation of why that data supports the asserted utility, the Office will
 determine if the data and the explanation would be viewed by one skilled in the art
 as being reasonably predictive of the asserted utility. See, e.g., Ex parte
 Maas, 9 USPQ2d 1746 (Bd. Pat. App. & Inter. 1987); Ex parte
 Balzarini, 21 USPQ2d 1892 (Bd. Pat. App. & Inter. 1991). Office
 personnel must be careful to evaluate all factors that might influence the
 conclusions of a person of ordinary skill in the art as to this question, including
 the test parameters, choice of animal, relationship of the activity to the particular
 disorder to be treated, characteristics of the compound or composition, relative
 significance of the data provided and, most importantly, the explanation offered by
 the applicant as to why the information provided is believed to support the asserted
 utility. If the data supplied is consistent with the asserted utility, the Office
 cannot maintain a rejection under 35 U.S.C. 101 .
 

 Evidence does not have to be in the form of data from an
 art-recognized animal model for the particular disease or disease condition to which
 the asserted utility relates. Data from any test that the applicant reasonably
 correlates to the asserted utility should be evaluated substantively. Thus, an
 applicant may provide data generated using a particular animal model with an
 appropriate explanation as to why that data supports the asserted utility. The
 absence of a certification that the test in question is an industry-accepted model is
 not dispositive of whether data from an animal model is in fact relevant to the
 asserted utility. Thus, if one skilled in the art would accept the animal tests as
 being reasonably predictive of utility in humans, evidence
 from those tests should be considered sufficient to support the credibility of the
 asserted utility. In re Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA
 1962); In re Krimmel, 292 F.2d 948, 953, 130 USPQ 215, 219 (CCPA
 1961); Ex parte Krepelka, 231 USPQ 746 (Bd. Pat. App. & Inter.
 1986). Office personnel should be careful not to find evidence unpersuasive simply
 because no animal model for the human disease condition had been established prior to
 the filing of the application. See In re Chilowsky, 229 F.2d 457,
 461, 108 USPQ 321, 325 (CCPA 1956) (“The mere fact that something has not previously
 been done clearly is not, in itself, a sufficient basis for rejecting all
 applications purporting to disclose how to do it.”); In re Wooddy, 
 331 F.2d 636, 639, 141 USPQ 518, 520 (CCPA 1964) (“It appears that no one on earth is
 certain as of the present whether the process claimed will operate in the manner
 claimed. Yet absolute certainty is not required by the law. The mere fact that
 something has not previously been done clearly is not, in itself, a sufficient basis
 for rejecting all applications purporting to disclose how to do it.”).
 

 IV. HUMAN CLINICAL DATA Office personnel should not impose on applicants the unnecessary
 burden of providing evidence from human clinical trials. There is no decisional law
 that requires an applicant to provide data from human clinical trials to establish
 utility for an invention related to treatment of human disorders (see In re
 Isaacs, 347 F.2d 889, 146 USPQ 193 (CCPA 1963); In re
 Langer, 503 F.2d 1380, 183 USPQ 288 (CCPA 1974)), even with respect to
 situations where no art-recognized animal models existed for the human disease
 encompassed by the claims. Ex parte Balzarini, 21 USPQ2d 1892 (Bd.
 Pat. App. & Inter. 1991) (human clinical data is not required to demonstrate the
 utility of the claimed invention, even though those skilled in the art might not
 accept other evidence to establish the efficacy of the claimed therapeutic
 compositions and the operativeness of the claimed methods of treating humans). Before
 a drug can enter human clinical trials, the sponsor, often the
 applicant, must provide a convincing rationale to those
 especially skilled in the art (e.g., the Food and Drug
 Administration (FDA)) that the investigation may be successful. Such a rationale
 would provide a basis for the sponsor’s expectation that the investigation may be
 successful. In order to determine a protocol for phase I testing, the first phase of
 clinical investigation, some credible rationale of how the drug might be effective or
 could be effective would be necessary. Thus, as a general rule, if an
 applicant has initiated human clinical trials for a therapeutic product or
 process, Office personnel should presume that the applicant has established that
 the subject matter of that trial is reasonably predictive of having the asserted
 therapeutic utility. 

 V. SAFETY AND EFFICACY CONSIDERATIONS The Office must confine its review of patent applications to the
 statutory requirements of the patent law. Other agencies of the government have been
 assigned the responsibility of ensuring conformance to standards established by
 statute for the advertisement, use, sale or distribution of drugs. The FDA pursues a
 two-prong test to provide approval for testing. Under that test, a sponsor must show
 that the investigation does not pose an unreasonable and significant risk of illness
 or injury and that there is an acceptable rationale for the study. As a review
 matter, there must be a rationale for believing that the compound could be effective.
 If the use reviewed by the FDA is not set forth in the specification, FDA review may
 not satisfy 35
 U.S.C. 101 . However, if the reviewed use is one set forth in
 the specification, Office personnel must be extremely hesitant to challenge utility.
 In such a situation, experts at the FDA have assessed the rationale for the drug or
 research study upon which an asserted utility is based and found it satisfactory.
 Thus, in challenging utility, Office personnel must be able to carry their burden
 that there is no sound rationale for the asserted utility even though experts
 designated by Congress to decide the issue have come to an opposite conclusion. “FDA
 approval, however, is not a prerequisite for finding a compound useful within the
 meaning of the patent laws.” In re Brana, 51 F.3d 1560, 34 USPQ2d
 1436 (Fed. Cir. 1995) (citing Scott v. Finney, 34 F.3d 1058, 1063, 32 USPQ2d 1115, 1120 (Fed. Cir.
 1994)).
 

 Thus, while an applicant may on occasion need to provide evidence to
 show that an invention will work as claimed, it is improper for Office personnel to
 request evidence of safety in the treatment of humans, or regarding the
 degree of effectiveness. See In re
 Sichert, 566 F.2d 1154, 196 USPQ 209 (CCPA 1977); In re
 Hartop, 311 F.2d 249, 135 USPQ 419 (CCPA 1962); In re
 Anthony, 414 F.2d 1383, 162 USPQ 594 (CCPA 1969); In re
 Watson, 517 F.2d 465, 186 USPQ 11 (CCPA 1975); In re
 Krimmel, 292 F.2d 948, 130 USPQ 215 (CCPA 1961); Ex parte
 Jovanovics, 211 USPQ 907 (Bd. Pat. App. & Inter. 1981).
 

 VI. TREATMENT OF SPECIFIC DISEASE CONDITIONS Claims directed to a method of treating or curing a disease for
 which there have been no previously successful treatments or cures warrant careful
 review for compliance with 35 U.S.C. 101 . The credibility of
 an asserted utility for treating a human disorder may be more difficult to establish
 where current scientific understanding suggests that such a task would be impossible.
 Such a determination has always required a good understanding of the state of the art
 as of the time that the invention was made. For example, prior to the 1980’s, there
 were a number of cases where an asserted use in treating cancer in humans was viewed
 as “incredible.” In re Jolles, 628 F.2d 1322, 206 USPQ 885 (CCPA
 1980); In re Buting, 418 F.2d 540, 163 USPQ 689 (CCPA 1969);
 Ex parte Stevens, 16 USPQ2d 1379 (Bd. Pat. App. & Inter.
 1990); Ex parte Busse, 1 USPQ2d 1908 (Bd. Pat. App. & Inter.
 1986); Ex parte Krepelka, 231 USPQ 746 (Bd. Pat. App. & Inter.
 1986); Ex parte Jovanovics, 211 USPQ 907 (Bd. Pat. App. &
 Inter. 1981). The fact that there is no known cure for a disease, however, cannot
 serve as the basis for a conclusion that such an invention lacks utility. Rather,
 Office personnel must determine if the asserted utility for the invention is credible
 based on the information disclosed in the application. Only those claims for which an
 asserted utility is not credible should be rejected. In such
 cases, the Office should carefully review what is being claimed by the applicant. An
 assertion that the claimed invention is useful in treating a symptom of an incurable
 disease may be considered credible by a person of ordinary skill in the art on the
 basis of a fairly modest amount of evidence or support. In contrast, an assertion
 that the claimed invention will be useful in “curing” the disease may require a
 significantly greater amount of evidentiary support to be considered credible by a
 person of ordinary skill in the art. In re Sichert, 566 F.2d 1154,
 196 USPQ 209 (CCPA 1977); In re Jolles, 628 F.2d 1322, 206 USPQ
 885 (CCPA 1980). See also Ex parte Ferguson, 117 USPQ 229 (Bd.
 Pat. App. & Inter. 1957).
 

 In these cases, it is important to note that the Food and Drug
 Administration has promulgated regulations that enable a party to conduct clinical
 trials for drugs used to treat life threatening and severely-debilitating illnesses,
 even where no alternative therapy exists. See 21 CFR 312.80-88 (1994). Implicit in
 these regulations is the recognition that experts qualified to evaluate the
 effectiveness of therapeutics can and often do find a sufficient basis to conduct
 clinical trials of drugs for incurable or previously untreatable illnesses. Thus,
 affidavit evidence from experts in the art indicating that there is a reasonable
 expectation of success, supported by sound reasoning, usually should be sufficient to
 establish that such a utility is credible .
 

 

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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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 03/09/2026 20:49:31