DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, claims 1-6 drawn to in vitro sample testing and analysis, in the reply filed on 3/23/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 7-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/23/2026.
Examiner's Note
Due to the elected group, the Examiner and Art Unit (AU) has changed. The application was restricted by AU 3791 and is currently being examined in AU 1686.
Status of Claims
Claims 1-8 are pending.
Claims 7-8 withdrawn.
Claims 1-6 are examined on the merits.
Priority
The instant application filed on 6/20/2023 is a 371 national stage entry of PCT/US2021/064114 having an international filing date of 12/17/2021, and claims the benefit of priority to provisional U.S. Application No. 63/129,184 filed on 12/22/2020. Thus, the effective filing date of the claims is 12/22/2020.
The applicant is reminded that amendments to the claims and specification must comply with 35 U.S.C. § 120 and 37 C.F.R. § 1.121 to maintain priority to an earlier-filed application. Claim amendments may impact the effective filing date if new subject matter is introduced that lacks support in the originally filed disclosure. If an amendment adds limitations that were not adequately described in the parent application, the claim may no longer be entitled to the priority date of the earlier filing.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 6/20/2023 has been entered and considered. A signed copy of the corresponding 1449 form has been included with this Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding independent claims 1 and 5, the written description of the instant specification does not explicitly disclose a definition for "very long-chain fatty acids". There is no disclosed specific number of carbons in a carbon chain that would qualify as a "very long-chain fatty acid". To further prosecution, the limitation is interpreted as described below in the corresponding rejection under 35 USC 112(b).
Regarding independent claims 1 and 5, the written description of the instant specification does not explicitly disclose a definition for "a normal gilt vaginal lipidome profile". There is no disclosed lipidome profile derived from "a normal gilt vaginal swab" (claim 5), and no explicit definition for what "normal" is. To further prosecution, the limitation is interpreted as described below in the corresponding rejection under 35 USC 112(b).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 and 5 recite "a decreased level of arachidonic acid (AA), a decreased level of docosahexaenoic acid (DHA), and/or an increased level of very long-chain fatty acids (VLCFA)" in lines 6-7 and 7-8, respectively. The recitation of "and/or" is indefinite because it creates ambiguity regarding the scope of the invention, specifically whether the recited elements are alternative or cumulative. Additionally, the metes and bounds of the term "very long-chain fatty acid" are not clear because there is no specific number of carbons that would define or differentiate a long-chain fatty acid as or from a very long-chain fatty acid, and the instant specification is silent on the matter. To further prosecution, the limitation elements are interpreted as alternatives because claim 2 is limiting the elements as cumulative; and a "very long-chain fatty acid" is interpreted as a LCFA having at least an 18-carbon chain.
Claim 1 and 5 recite "compared to a normal gilt vaginal lipidome profile" and "compared to corresponding levels of a normal gilt vaginal lipidome profile" in lines 7-8 and 8-9, respectively. The metes and bounds of "a normal gilt vaginal lipidome profile" are not clear, and the specification does not provide a clear definition. To further prosecution, "a normal gilt vaginal lipidome profile" is interpreted as "a fertile gilt vaginal lipidome profile".
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
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.
Claims 1-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of a mental process, a mathematical concept, organizing human activity, or a law of nature or natural phenomenon without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Claim 1: “using the vaginal lipidome profile to assign the gilt as probable fertile or infertile, wherein: a decreased level of arachidonic acid (AA), a decreased level of docosahexaenoic acid (DHA), and/or an increased level of very long-chain fatty acids (VLCFA) compared to a normal gilt vaginal lipidome profile is/are indicative of infertility, whereupon a gilt is eliminated from selection for breeding” provides an evaluation (evaluating acid levels in a lipidome profile involves comparing these levels to a control to determine gilt elimination) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
Claim 5: “determining, or having determined, a decreased level of AA, a decreased level of DHA, and/or an increased level of VLCFA in the lipids compared to corresponding levels of a normal gilt vaginal lipidome profile, whereupon a lipidome profile of a gilt vaginal swab is analyzed” provides an evaluation (evaluating acid levels in a lipidome profile involves comparing these levels to a control) that may be performed in the human mind and is therefore considered a mental process, which is an abstract idea.
These recitations are similar to the concepts of collecting information, analyzing it, and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or are mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. As such, claims 1-6 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The judicial exceptions listed above are not integrated into a practical application because the claims do not recite an additional element or elements that reflects an improvement to technology. Specifically, the claims recite the following additional elements:
Claim 1: “obtaining a vaginal lipidome profile from a gilt at around the time of weaning” provides insignificant extra-solution activities (obtaining data is a pre-solution activity involving data gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
Claim 5: “receiving a vaginal swab obtained from a gilt at around the time of weaning” provides insignificant extra-solution activities (receiving swabs is a pre-solution activity involving sample gathering steps) that do not serve to integrate the judicial exceptions into a practical application.
“analyzing, or having analyzed, lipids obtained from the vaginal swab for at least one lipid selected from the group consisting of arachidonic acid (AA), docosahexaenoic acid (DHA), and very long-chain fatty acids (VLCFA)” provides insignificant extra-solution activities (obtaining data by analyzing a sample is a pre-solution activity involving data gathering and sample manipulation steps) that do not serve to integrate the judicial exceptions into a practical application.
The steps for obtaining data and samples are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application because they are pre-solution activities involving data and sample gathering steps (see MPEP 2106.04(d)(2)). Therefore, claims 1-6 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application, or equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
The limitations for obtaining data and samples are insignificant extra-solution activities that do not serve to integrate the recited judicial exceptions into a practical application. Furthermore, no inventive concept is claimed by these limitations as they are demonstrated to be well-understood, routine, and conventional.
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 1-6 are not patent eligible.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 and 5 rejected under 35 U.S.C. 103 as being unpatentable over Casey et al. (Journal of applied animal research 46.1 (2018): 667-676) in view of Vadakkemuri et al. (US-20170360073) in view of Brockmann et al. (DE-102010025837).
Regarding claims 1-2 and 5, Casey teaches a method of eliminating a gilt from selection for breeding and receiving a vaginal swab obtained from a gilt at around the time of weaning (Page 1 title "The potential of identifying replacement gilts by screening for lipid biomarkers in reproductive tract swabs taken at weaning").
Casey also teaches obtaining a vaginal lipidome profile from a gilt at around the time of weaning (Page 2 abstract "These exploratory studies indicate that the vaginal cell lipidome may reflect the postnatal nutritional environment, which defines to a large extent the gilt’s reproductive potential").
Casey also suggests a gilt is eliminated from selection for breeding (page 9 col 1 paragraph 2 "Biomarkers predictive of fertility outcomes may facilitate quick, applied research capable of producing farm-level management changes. Early identification of superior gilts using biomarkers has the potential to save the industry millions of dollars in feed and management costs of sub-fertile animals. Additionally, biomarkers can be used as a research tool to investigate the effects of bioactive compounds in colostrum/milk that can enhance reproductive potential, as well as identify the best or most cost effective neonatal supplements (e.g. fats, hormones, etc.) to improve lifetime production").
Casey does not explicitly teach using the vaginal lipidome profile to assign the gilt as probable fertile or infertile, wherein: a decreased level of arachidonic acid (AA), a decreased level of docosahexaenoic acid (DHA), and an increased level of very long-chain fatty acids (VLCFA) compared to a normal gilt vaginal lipidome profile is/are indicative of infertility.
However, Vadakkemuri teaches that AA and DHA are needed for embryo and fetal development, suggesting that a decreased level would be negative for fertility; i.e. reason for eliminating an animal as a breeder (para.0039 "Omega 6 LCPUFA arachidonic acid (AA) and omega 3 LCPUFA decosahexanoic acid (DHA) are needed for the development of nervous system and retina of embryos and fetus in uterus. This optimized nutrient fatty acid composition with 50-70% omega 3 and 6 fatty acid in 1:1 ratio will ensure balanced production of these two fatty acids in pregnant mothers and growing children there by an ideal supplement for pregnant and lactating mothers and growing children" and para.0077 "The balanced ratio of omega 6 and 3 fatty acids in the diet of the second group with increased dietary intake of omega 3 with DHA than the ordinary diet of first group is the reason for the improved fertility and reduced pregnancy complications").
However, Brockmann suggests a logical increase in overall fatty acids (which includes very long chain fatty acids) as a negative contributor to fertility (page 1 last paragraph "Depending on other influences, such as husbandry, animal care, health and climate, an excessive or prolonged negative energy balance may occur, resulting in increased lipid mobilization from depot fats. The increased release of fatty acids into the blood can overload the liver with these substrates. The limited ability of the liver to metabolize fatty acids and eventually remove them from the liver metabolism leads to obesity of the liver and to continuous organ dysfunction. This has a negative impact on the health and fertility of the dairy cow").
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Casey as taught by Vadakkemuri in order to identify predictive biomarkers of fertility outcomes (Casey, page 2 abstract "Together findings support further investigations to identify biomarkers predictive of fertility outcomes in the metabolome of gilt reproductive tracts" and page 9 col 1 paragraph 2 "Biomarkers predictive of fertility outcomes may facilitate quick, applied research capable of producing farm-level management changes. Early identification of superior gilts using biomarkers has the potential to save the industry millions of dollars in feed and management costs of sub-fertile animals. Additionally, biomarkers can be used as a research tool to investigate the effects of bioactive compounds in colostrum/milk that can enhance reproductive potential, as well as identify the best or most cost effective neonatal supplements (e.g. fats, hormones, etc.) to improve lifetime production"). One skilled in the art would have a reasonable expectation of success because both methods are concerned with livestock fertility.
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Casey as taught by Brockmann in order to identify predictive biomarkers of fertility outcomes (Casey, page 2 abstract "Together findings support further investigations to identify biomarkers predictive of fertility outcomes in the metabolome of gilt reproductive tracts" and page 9 col 1 paragraph 2 "Biomarkers predictive of fertility outcomes may facilitate quick, applied research capable of producing farm-level management changes. Early identification of superior gilts using biomarkers has the potential to save the industry millions of dollars in feed and management costs of sub-fertile animals. Additionally, biomarkers can be used as a research tool to investigate the effects of bioactive compounds in colostrum/milk that can enhance reproductive potential, as well as identify the best or most cost effective neonatal supplements (e.g. fats, hormones, etc.) to improve lifetime production"). One skilled in the art would have a reasonable expectation of success because both methods are concerned with livestock fertility.
Claims 3-4 and 6 rejected under 35 U.S.C. 103 as being unpatentable over Casey et al. (Journal of applied animal research 46.1 (2018): 667-676) in view of Vadakkemuri et al. (US-20170360073) and Brockmann et al. (DE-102010025837) as applied to claims 1-15 above, and further in view of Moore et al. (Reproduction, Fertility and Development 29.4 (2017): 658-669).
Casey et al. in view of Vadakkemuri et al. and Brockmann et al. are applied to claims 1-2 and 5.
Regarding claims 3-4 and 6, Casey in view of Vadakkemuri and Brockmann teach the method of Claim 1 on which this claim depends/these claims depend.
Casey, Vadakkemuri, nor Brockmann explicitly teach the VLCFA comprises (i) at least one of cerotic acid and ximenic acid and (ii) optionally at least one of nonadecanoic acid and pentadecanoic acid.
However, Moore teaches analyzing a variety of long-chain fatty acids including pentadecanoic acid (Page 9 col 2 last paragraph "Serum concentrations of pentadecenoic acid, heptadecenoic acid and heneicosanoic acid were greater in Fert+ than Fert- cows", additionally any of the listed species could be considered an obvious variant of VLCFA if running a lipidomic profile for fertility testing using GC- or LC-MS).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention to modify the methods of Casey and YYY as taught by ZZZ in order to identify biomarkers of fertility (page 1 abstract "The aims of the present study were to: (1) characterise the metabolome of follicular fluid and serum in dairy cows with similar genetic merit for milk production but with extremes of good (Fert+) or poor (Fert-) genetic merit for fertility; and (2) identify potential biomarkers of dairy cow fertility"). One skilled in the art would have a reasonable expectation of success because both method are concerned with livestock fertility.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert A. Player whose telephone number is 571-272-6350. The examiner can normally be reached Mon-Fri, 8am-5pm.
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/R.A.P./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686
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