DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
1) Applicants’ preliminary amendment filed 06/14/24 and the claims set filed 04/23/26 are acknowledged.
Election
2) Acknowledgment is made of Applicants’ elections filed 06/29/2026 and 04/23/26 in response to the restriction and species election requirement mailed 02/25/2026 are acknowledged. Applicants have elected invention I with traverse. Applicants have further elected the Bifidobacterium and Limosilactobacillus combination species, the oral administration species, and the Holstein cattle breed species. Applicants’ traversal is on the basis that a serious search and examination burden has not been established. Applicants opine that the inventions share overlapping subject matter as all groups relate to methods of improving cattle fertility using microbiome-based interventions and would likely be found in the same field of search.
Applicants’ arguments have been carefully considered, bur are not persuasive. As set forth previously, inventions I, II, III and V are drawn to different methods which differ from one another in method objectives, method steps and parameters, reagents or elements used, and the ultimate goals accomplished. The product of invention IV is not required to practice the methods claimed. The inventions belong to different classes and/or subclasses. A search for one invention is not expected to reveal potential art on the other inventions. Additionally, there is an examination burden since, for example, the composition of invention IV requires analysis and examination under subject matter eligibility statute. Therefore, the restriction requirement as set forth previously is proper, is maintained and is hereby made FINAL.
Status of Claims
3) Claims 1-37 have been canceled via the preliminary amendment filed 06/14/24.
New claims 38-53 have been added via the preliminary amendment filed 06/14/24.
Claims 38-53 are pending.
Claims 39, 42, 43 and 45-53 are withdrawn from consideration as being directed to a non-elected invention or species. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 38, 40, 41 and 44 are examined on the merits.
Drawings
4) Applicants’ drawings filed 04/04/2024 are acknowledged.
Information Disclosure Statement
5) Applicants’ information disclosure statement filed 11/25/24 is acknowledged. The information referred to therein has been considered and a signed copy of the same is attached to this Office Action.
Priority
6) The instant AIA application, filed 04/04/24, claims priority to the U.S. provisional application 63/494,139 filed 04/04/23.
Rejection(s) under 35 U.S.C § 112(a) or (pre-AIA ), First Paragraph
7) The following is a quotation 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 35 U.S.C. § 112 (pre-AIA ), first paragraph:
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 the invention.
8) Claims 38, 40, 41 and 44 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for the (pre-AIA ), the Applicant. This is a written description rejection.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicant has demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant application, an analysis of the scope of the claims and of the variable genus encompassed therein indicates the following.
Claims 38 and 40 are representative of the claimed method. Claim 38 is drawn to a method of increasing fertility in cattle comprising administering a microbiome supplement composition comprising a combination of Bifidobacterium and Limosilactobacillus bacteria, the elected combination species. While the microbiome supplement is administered orally in the method of claim 41, the administering in the methods of claims 38, 39 and 44 encompass administering by any route including non-oral routes such as intravenous, intramuscular, subcutaneous, intraperitoneal, intrathecal, intratracheal etc routes. The combination of Bifidobacterium and Limosilactobacillus bacteria represents a huge genus encompassing a variety and number of structurally, antigenically and/or genetically divergent Bifidobacterium species and Limosilactobacillus species and divergent strains thereof within each genus. The as-filed specification does not identify specific species of the Bifidobacterium genus and of the Limosilactobacillus genus that were administered to cattle in the claimed method. A review of the literature indicates that as of January 2026, the genus of Limosilactobacillus includes 34 validly published species, all validated according to the International Code of Nomenclature of Prokaryotes (ICNP) and listed in the List of Prokaryotic names with Standing in Nomenclature (LPSN). An exemplary list of the various species within the genus Limosilactobacillus identified in the art are: Limosilactobacillus reuteri, Limosilactobacillus agrestimuris, Limosilactobacillus caecicola, Limosilactobacillus kribbianus, Limosilactobacillus avium, Limosilactobacillus difficilis, Limosilactobacillus galli, Limosilactobacillus pulli, Limosilactobacillus viscerum, Limosilactobacillus allomucosae, L. fermentum, L. secaliphilus, L. mucosae, L. oris, L. pontis and so on. See the document entitled, Limosilactobacillus - Grokipedia, pages 1-12. Likewise, the Bifidobacterium genus includes B. longum, B. bifidum, B. breve, B. adolescentis, B. catenulatum, B. dentium, B. moukalabense, B. pseudocatenulatum, B. ruminantium, B. bombi, B. jacchi, B. hapali, B. ramosum, B. commune, B. samirii and so on. See the document entitled, Bifidobacterium, WIKIPEDIA, pages 1-9. The divergent members or species of said huge genus are required to increase fertility in cattle including the Holstein cattle breed. A review of the as-filed specification indicates that not a single species, let alone a representative number and variety of species, within the large Bifidobacterium genus and the large Limosilactobacillus genus, are identified, the specific combination of which increases the fertility in cattle including the Holstein cattle breed. Clearly, at the time of the invention, Applicants were not in possession of the full scope of the variable genus and of the method as claimed broadly.
The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics, and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002). Sufficient description to show possession of a genus may be achieved by means of description of a substantial number of the members or species of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed two genus, which would allow the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described even a single combination, let alone a combination of a representative number and variety of Bifidobacterium species and Limosilactobacillus species that are representative of each of the huge genus encompassing antigenically, genetically, taxonomically and/or functionally highly variable species, the combination having the requisite capacity to increase the fertility in cattle including the Holstein cattle breed. A representative number and variety of the Bifidobacterium genus and the Limosilactobacillus genus have not been correlated with the requisite fertility-increasing function identified supra. Note that possession may not be shown by merely describing how to obtain members of the claimed genus or how to identify their common structural features. Applicants should note that written description requires more than a mere statement that something is a part of the invention and a reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. A mere statement that the invention includes the elements and steps recited in the claims is insufficient to meet the adequate written description requirement of the claimed invention. A convincing structure-function relationship must exist between the structure of a representative number and variety of the species of the combination of the two bacteria comprised in the administered supplement and the function(s) of said species. This is important because the written description inquiry is case-specific and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372. [Emphasis added]. According to MPEP 2163 [Emphasis added]:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. This is important in the instant application because the art recognizes that functional activities of probiotic species is strain-specific. For example, Gao et al. (Peer J. 7: e7117, pages 1/24-24/24, June 2019) taught that the probiotic effects are dependent on the nature of the strain by stating that “.... the efficacy ..... varies, depending on the types and strains of probiotics”. See third paragraph of page 2 of Gao et al. Further, see title; the 3rd full sentence of 1st full paragraph and the last full sentence of the paragraph bridging the two columns of page 6; and the last sentence under section ‘5. Conclusion’ of Fang et al. Strain-specific ameliorating effect of Bifidobacterium longum on atopic dermatitis in mice. J. Function. Foods 60: 103426, pages 1-9, September 2019. With regard to the use of combinations of probiotics in human health, Hmar et al. (Endocr. Metab. Immune Disord. Drug Targets 24: 1-12, 2024) taught that even though a product contains more probiotic strains, that does not always guarantee that the health benefits will be more significant. Hmar et al. further taught that “For specific combinations to be justified, there must be clinical proof ........ picking the right probiotic is essential yet tricky because of several factors, including probiotic products with the disease and strain-specific effectiveness exists ... various probiotic strains have diverse modes of action”. See Abstract of Hmar et al. All these clearly indicate that not all species and strains of probiotics or Lactobacteria encompassed within the broad scope of each of the recited genus can be predicted to be capable of increasing fertility in cattle. Clearly, at the time of the invention, Applicants were not in possession of the method of increasing fertility in cattle as claimed broadly, the method comprising administering a combination of Bifidobacterium and Limosilactobacillus as claimed broadly. A mere idea or unsubstantiated function is insufficient for written description; characterization of a representative number of species in an unpredictable art, with their precise structure correlated with the requisite functions, is required in order to claim the broad genus. Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) states:
"When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus" [Emphasis added].
A convincing structure-function correlation is lacking for the variant genus in the instant application. The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicant was in possession of each of the variant genus identified supra and the full scope of the claimed invention at the time of filing. Clearly, the specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the full scope of the Bifidobacterium genus and the Limosilactobacillus genus and the full scope of the claimed method at the time of filing.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Possession may be shown in a variety of ways including by showing that the invention was “ready for patenting”. MPEP 2163. MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided that the purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 U.S.C § 112(a) or 35 U.S.C § 112(pre-AIA ), first paragraph is severable from its enablement provision. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph. Clearly, Applicants did not describe the invention of the instant claims sufficiently to show that he/she had possession of the claimed broad method. Instant claims do not meet the provision of 35 U.S.C § 112 (pre-AIA ), first paragraph or 35 U.S.C § 112(a).
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ), Second Paragraph
9) 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.
10) Claims 38, 40, 41 and 44 are 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 inventor or a joint inventor, or for the pre-AIA the Applicant regards as the invention.
(a) Claims 38 and 40 are ambiguous and indefinite in the limitation “increasing” fertility, because it is a relative term. The term is not specifically defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the claims. What precise level of increase is encompassed, and increase compared to what, is unclear.
(b) Claims 41 and 44, which depend from claim 38 or claim 40, are also rejected as being indefinite due to the ambiguity and indefiniteness identified supra in the base claim.
Notice Re Prior Art Available under Both Pre-AIA and AIA
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 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.
Rejection(s) under 35 U.S.C § 102
11) The following is a quotation of the appropriate paragraphs of 35 U.S.C § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
12) Claims 38, 40 and 41 are rejected under 35 U.S.C § 102(a)(1) or 35 U.S.C § 102(a)(2) as being anticipated by US 20180071347 A1.
US 20180071347 A1 disclosed a method of administering to bovine livestock animal subjects such as bulls, oxen etc a formulation, a probiotic supplement, an animal feed supplement, or a food comprising a combination of Bifidobacterium longum and L. rhamnosus that increased fertility in said subjects. The administering was oral or via consumption or ingestion. See title, Abstract, claims 23-34, sections [0008], [0009], [0015], [0021], [0022], [0081], [0062], [0060], [0043], [0006], [0007], [0041], [0046] and [0047].
Claims 38, 40 and 41 are anticipated by US 20180071347 A1.
Rejection(s) under 35 U.S.C § 103
13) 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 of this title, 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 claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 148 USPQ 459, that are applied for establishing a background for determining obviousness under 35 U.S.C § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or unobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C § 102(b)(2)(C) for any potential 35 U.S.C § 102(a)(2) prior art against the later invention.
14) Claim 44 is rejected under 35 U.S.C § 103 as being unpatentable over over US 20180071347 A1 as applied to claim 38 or claim 40 above and further in view of Hering et al. Animal Reproduction Science 146: 89-97, 2014; and Thundathil et al. Theriogeneology 86: 397-405, 2016.
The disclosure of US 20180071347 A1 as applied to claims 38 and 40 is set forth supra, which is silent on the bovine animal subjects such as bulls being of the Holstein breed.
However, Hering et al. taught poor fertility traits such as poor sperm motility in Holstein bulls, which decreases reproductive capacity and leads to subfertility. See title; and 1st two full sentences of 2nd full paragraph under section “1. Introduction”.
Along with the teaching that poor reproductive performance is the most common cause for culling beef cows, Thundathil et al. taught that improving reproductive efficiency of beef cattle, especially bull fertility is particularly critical since one bull can breed thousands of females, thus identifying a need in the art for improving reproductive efficiency of beef cattle, especially bull fertility. See first two sentences of ABSTRACT; and 3rd sentence under section “1. Introduction”.
Given the identified need in the art for improving reproductive efficiency of beef cattle, especially bull fertility as taught by Hering et al. and Thundathil’s calling for improving reproductive efficiency of beef cattle, especially bull fertility, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application to use Holstein bulls in the method of US 20180071347 A1 of administering the probiotic combination supplement formulation of Bifidobacterium longum and L. rhamnosus to produce the instant invention. One of ordinary skill in the art would have been motivated to produce the instant invention for the expected benefit of increasing fertility in Holstein bull subjects having poor fertility traits such as poor sperm motility.
Claim 44 is prima facie obvious over the prior art of record.
Relevant Art
15) The art made of record and not relied upon in any of the rejections is considered pertinent to Applicant’s disclosure:
l Ksiezarek et al. (Microbial Genomics 2022 :8 :000847, Abstract) teach that the formerly known Lactobacillus genus is the Limosilalactobacillus genus. See 1st line under Abstract.
Claim(s) Objections - Suggestions
16) The specification and claims 38, 40 and 44 are objected to for the following reason(s):
(a) All non-italicized recitations of names of the various bacterial species and genera such as Limosiactobacillus, Bifidobacterium, Bacteroides and so on, throughout the specification are objected to. To be consistent with the practice in the art of scientific nomenclature of bacterial genus and species and of microorganisms, all such recitations should be italicized via deletion of the non-italicized limitations via strikethrough, for example, Limosilactobacillus, Bifidobacterium, Bacteroides.
(b) Claims 38 and 40 are objected to for the non-italicized recitation of “Limosilactobacillus” and “Bifidobacterium”. To be consistent with the practice in the art of scientific nomenclature of bacterial genus and species, said limitation should be italicized via deletion of the non-italicized limitation via strikethrough, for example, Limosilactobacillus and Bifidobacterium.
(c) Claim 44 is objected to for the use of the Markush language ‘selected from the group consisting of’ with the coordinating conjunction “or” instead of –and-- after the limitation “Red” in line 2.
Correspondence
17) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Supervisor of AU 1645, Jeffrey Stucker, can be reached at (571) 272-0811. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
18) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/S. DEVI/
S, Devi, Ph.D.Primary Examiner
Art Unit 1645
September, 2026
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