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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on April 8, 2026 has been entered.
Applicant’s amendment to claims received September 8, 2025, entered by the April 8, 2026 Request for Continued Examination, has overcome the objection to claims 246 and 251; the rejection under 35 USC § 102 over Sutherland, as evidenced by Ong et al. as applied to claims 228-230, 236, 238, 240, 242, and 244; rejection under 35 USC § 103 over Sutherland, as evidenced by Ong et al., and further in view Wright et al. as applied to claims 231-235, 241, and 247-250; and the rejection under 35 USC § 102 over Meale et al. as applied to claim 251.
An updated search for newly presented limitations regarding cell treatments, presented in the September 8, 2025 claim amendments, necessitates new grounds of rejection, as explained in the September 16, 2025 Advisory Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 8, 2026 has been considered by the examiner.
Specification
The use of the terms, “Montanide”, “Emulsigen”, and “ENABL”, which are a trade names or marks used in commerce, have been noted in at least paragraph [0285] of the instant published disclosure, USPgPub 2025/0186566. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 112
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 231-235 and 241 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 the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of claims recite, “at least about” a quantity of cells (claims 231-233) and a quantity of proteins (claims 234-235). The term “at least about” a relative phrase which renders the claims indefinite. A value of “about” encompasses quantities that are not “at least”. The phrase, “at least about”, is not defined by the respective claims, 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 invention. Therefore, recitation of “at least about” is an inadequate descriptive phrase for the values intended.
Claim 241 contains the trademark/trade names “Montanide”, “Emulsigen”, and “ENABL”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an adjuvant and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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 228, 231, 232, 236, 238, 240-244, and 246-251 are rejected under 35 U.S.C. 103 as being unpatentable over Sutherland (USPgPub 2021/0261912, of record), Baker (WO 95/11041), and Henderson et al. (Scientific reports. 2015 Oct 9;5 (1): 14567, of record).
Sutherland teaches a composition comprising inactivated or killed Methanobrevibacter archaebacteria cells in claim 18. Paragraph [0048] of Sutherland lists Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium encompassed by the genus of Methanobrevibacter archaebacteria cells listed in instant claims 242 and 244. Paragraphs [0095, 0263, and 0267] of Sutherland teach lyophilized cells, as required by instant claim 236. Claim 21 of Sutherland requires combining a carrier with the composition, required by instant claim 238.
Paragraph [0022]of Sutherland teaches that the population of Methanobrevibacter archaebacteria cells administered improve pathogen resistance and reduce intestinal inflammation. Also see claims 22-30. Increasing resistance to pathogens and therapeutically alleviating symptomology is naturally attributed to a “vaccine”, recited in instant claim 228.
Paragraphs [0017, 0085, 0090-0094] and claims 4-6 of Sutherland discuss inactivating the cells by heat or UV irradiation. However, Sutherland does not teach inactivating the cells with formaldehyde or including an adjuvant (interpreted as separate from any adjuvanting Methanobrevibacter archaebacteria cell components, consistent with paragraphs [0676-0687] of the instant published disclosure (USPgPub 2025/0186566)), recited in instant claims 228, 240, 241, and 251; or the percentage of cells recited in claim 231; or the quantity of cells recited in claim 232; or Methanobrevibacter ruminantium (strain M1), recited in instant claim 246; or that the administration induces an immune response against the at least one methanogen in a subject or reduces the activity/ type/ and/or number of methanogens in the digestive tract of a subject, as recited in claims 247 and 248; or that the immune response induced is the production of IgG, IgM, or IgA, recited in instant claims 250 and 251.
Baker teaches a vaccine comprising formaldehyde-killed Archaea cells of: Methanobacter formicium; Methanobrevibacter arboriphilus; Methanobrevibacter ruminantium (strains M1 and Z6); Methanobrevibacter smithii; and Methanosarcina barkeri, where each population is present as 2x109 cells (meeting the percentage recited, ranging between 50% to 100%, and quantity of cells of at least about 109), combined with Complete Freund’s Adjuvant (oil emulsion), resulting in reduced methane production in Figures 1d and 1f. See Example 1 beginning on page 4 to page 5, above, “The two control…”. In Example 2, beginning on page 8, the Archaea cocktail is combined with Freund’s complete adjuvant, Alum, and DEAE-dextran sulfate. Each vaccine induced IgG titers, depicted in Figure 2a and 2b. Also see claims 1, 3-5, 9-12, and 14-20.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have combined the Methanobrevibacter gottschalkii of Sutherland in the formaldehyde-killed Archaea cocktail vaccine of Baker to reduce methane production because Henderson et al. teach Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium are the most prevalent archaeal communities present in high methane emitting animals, see in the second full paragraph on page 4 and Supplementary Fig. 1:
Members of the Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium clades were found in almost all samples, and were the two largest groups, accounting for 74% of all archaea.
One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have combined the Methanobrevibacter gottschalkii of Sutherland in the formaldehyde-killed Archaea cocktail vaccine of Baker to reduce methane production because Baker teaches a cocktail of formaldehyde-killed Archaea, combined with an adjuvant reduces methane production in ruminants in Example 1 and Figures 1d and 1f.
While none of the references teach ratios of Methanobrevibacter ruminantium and Methanobrevibacter gottschalkii recited in claim 243, it would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have optimized the quantity of methanogen populations in a mixture, as discussed in Example 1 of Baker because
combining Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium clades in the composition of Sutherland would be efficacious against 74% of archaea present, as evidenced by the data of Henderson et al.
Claims 233-235 are rejected under 35 U.S.C. 103 as being unpatentable over Sutherland, Baker, and Henderson et al., as applied to claims 228, 231, 232, 236, 238, 240-244, and 246-251 above, and further in view of Wright et al. (Vaccine. 2004; 22: 3976-3985, of record).
See the teachings of Sutherland, Baker, and Henderson et al. above. None of the references teach cell quantities present between 109 and 1012 per mL, as required by instant claim 233 or mention the quantity of total protein in the composition, as recited in instant claims 234 and 235.
Wright et al. teach, in the second full paragraph on page 3978 under “Vaccine preparation”, that “1.0 mg/mL of protein is equivalent to 5 x 109 cells/ml”… and that “the primary vaccine was equivalent to 0.2 mg/ml protein, or 109 cells…and the antigen concentration of the second vaccine was three times higher at 0.6 mg/ml.”
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to have used the cells/ml and protein concentrations taught by Wright et al. as the dosage units of Sutherland, Baker, and Henderson et al. because the quantities of cells used by Sutherland and Wright et al. are equivalent, i.e., both Sutherland and Wright et al. administer 109 cells or 0.2 mg/ml of a Methanobrevibacter mixture, see “Vaccine preparation” on page 3978 of Wright et al. and paragraph [0048] and claims 18 and 19 of Sutherland. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have used the cells/ml and protein concentrations taught by Wright et al. as the dosage units of Sutherland, Baker, and Henderson et al. because Wright et al. teach a secondary administration of VF3+3 with three times the concentration in sheep produced a significant reduction of 12.8% less methane, see the paragraph bridging the columns on page 3982.
Claim 245 is rejected under 35 U.S.C. 103 as being unpatentable over Sutherland, Baker, and Henderson et al., as applied to claims 228, 231, 232, 236, 238, 240-244, and 246-251 above, and further in view of Miller et al. (International journal of systematic and evolutionary microbiology. 2002 May; 52 (3): 819-22, of record).
See the teachings of Sutherland, Baker, and Henderson et al. above. None of the references teach specific strain Methanobrevibacter gottschalkii DSM11977.
Miller et al. do, see the DSM 11977 description in “Description of Methanobrevibacter gottschalkii sp. nov.” on page 52. Miller et al. also teach Methanobrevibacter ruminantium M1 in Table 1.
One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have included the specific strain, Methanobrevibacter gottschalkii DSM11977 of Miller et al. in the formaldehyde-killed archaea cocktail of Sutherland, Baker, and Henderson to improve pathogen resistance and reduce intestinal inflammation in paragraphs [0022, 0048] and claims 18 and 22-30 of Sutherland and to reduce methane production in ruminants upon administration of inactivated methanogens in Figures 1d and 1f and claims 1, 3-5, 9-12, and 14-20 of Baker. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success for improving pathogen resistance, reducing intestinal inflammation, and reducing methane production in animals upon administration of Methanobrevibacter gottschalkii DSM11977 of Miller et al. in the formaldehyde-killed archaea cocktail of Sutherland, Baker, and Henderson because Sutherland lists Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium encompassed by the genus of Methanobrevibacter archaebacteria cells in claims 18 and 22-30; Henderson et al. teach Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium are the most prevalent archaeal communities present in high methane emitting animals, see in the second full paragraph on page 4 and Supplementary Fig. 1; Miller et al. teach Methanobrevibacter gottschalkii DSM11977 produces methane in the “Description of Methanobrevibacter gottschalkii sp. nov.” on page 52; and Baker teaches reducing methane production in ruminants by administering a cocktail of formaldehyde-killed archaea in Figures 1d and 1f and claims 1, 3-5, 9-12, and 14-20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Garcia-Ascolani et al. (184 President Oral Presentation Pick: “Supplementation of Angus crossbred steers with avian-derived polyclonal antibody preparations against ruminal methanogenic Archaea alters ruminal fermentation and decreases ex situ methane production.” Journal of Animal Science. 2020 Nov 3; 98 (Supplement_4):162-163) teach administration of polyclonal antibody mixtures to ruminants against ruminal methano-gens Methanobrevibacter gottschalkii Ho (PAP-Ho) and M. ruminantium M1 (PAP-M1) decreased ex situ methane production.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANON A FOLEY whose telephone number is (571)272-0898. The examiner can normally be reached M-F, generally 5:30 AM-5 PM, flexible.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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