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 .
Applicant’s reply has overcome the objection to the instant specification; the claim objections against claims 240 and 247; the rejections under 35 USC § 112(b); the rejection under 35 USC § 101; and the rejection under 35 USC § 102 over Sutherland (USPgPub 2021/0261912), (but not the rejection under 35 USC § 102 over Sutherland, as evidenced by Ong et al., both references of record).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 27, 2025 has been considered by the examiner.
Objections
Claim 246 remains objected to for reciting “Methanobrevibacter ruminantium M1” with no antecedent basis in the instant disclosure.
In reply to the objection, applicant asserts that antecedent basis for “Methanobrevibacter ruminantium M1” because the term further limits a specific strain of “Methanobrevibacter ruminantium” of claim 242.
Applicant’s reply and the amendment to claim 246, have been fully considered, but do not satisfy the objection to the claim. If claim 246 lacked antecedent basis in the claims, claim 246 would have been rejected (not objected to) under 35 U.S.C. § 112(d). The instant objection is based on the lack of antecedent basis in the instant disclosure. While there is antecedent basis for “Methanobrevibacter ruminantium” and “M. ruminantium” in the instant disclosure, there is no antecedent basis for “Methanobrevibacter ruminantium M1”, in the instant disclosure, as claimed.
MPEP § 608.01(o) Basis for Claim Terminology in Description states:
The meaning of every term used in any of the claims should be apparent from the descriptive portion of the specification with clear disclosure as to its import…
While an applicant is not limited to the nomenclature used in the application as filed, he or she should make appropriate amendment of the specification whenever this nomenclature is departed from by amendment of the claims so as to have clear support or antecedent basis in the specification for the new terms appearing in the claims. This is necessary in order to insure certainty in construing the claims in the light of the specification. See 37 CFR 1.75, MPEP § 608.01(i) and § 1302.01 and § 2103. Note that examiners should ensure that the terms and phrases used in claims presented late in prosecution of the application (including claims amended via an examiner’s amendment) find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description, see 37 CFR 1.75(d)(1). If the examiner determines that the claims presented late in prosecution do not comply with 37 CFR 1.75(d)(1), applicant will be required to make appropriate amendment to the description to provide clear support or antecedent basis for the terms appearing in the claims provided no new matter is introduced.
A review of the drawings and the instant disclosure finds no antecedent basis for “Methanobrevibacter ruminantium M1” recited in claim 246. The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: identifying antecedent basis for “Methanobrevibacter ruminantium M1” in the instant disclosure.
Claim 251 is objected to because the scientific name of “Methanobrevibacter gottschalkii” should be italicized. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 an 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.
Claims 228-230, 236, 238, 240, 242, and 244 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Sutherland (USPgPub 2021/0261912, of record), as evidenced by Ong et al. (Frontiers in cellular and infection microbiology. 2021 Oct 6; 11: 745016, of record).
Sutherland anticipates a composition comprising inactivated or killed Methanobrevibacter archaebacteria cells with preserved “microbe-associated molecular patterns” (MAMPs) in claim 18 . Paragraph [0048] of Sutherland lists Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium encompassed by the genus of Methanobrevibacter archaebacteria cells in claim 18.
While Sutherland does not mention “an adjuvant”, per se, as required by instant claims 228 and 240, Sutherland explains the significance of preserving “pathogen-associated molecular patterns” (PAMPs) and “microbe-associated molecular patterns” (MAMPs), which attract innate immune system cells in paragraphs [0051-0071] and claims 1, 18, and 22. Ong et al. teach PAMPs are adjuvant components, see the title and abstract. Therefore, the preservation of PAMPs and MAMPs on the inactivated Methanobrevibacter of Sutherland provide an adjuvanting immune stimulating complex, recited in instant claims 228 and 240.
Claim 228 has been amended to require that the vaccine composition reduces methane production by the at least one methanogen. However, the claim does not require actually using
the vaccine composition in that way. Reducing methane production is not an additional structural limitation further characterizing the claimed product. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002): “[T]he patentability of... composition claims depends on the claimed structure, not on the use or purpose of that structure.”). The claims are not drawn to methods of reducing methane emissions, they are drawn to products. There is nothing in the claims that requires the vaccine to have any specific function.
There is no structural difference between the claimed invention comprising Methanobrevibacter gottschalkii and the composition of Sutherland comprising Methanobrevibacter gottschalkii. Recitation of “vaccine” in the instant claims does not distinguish the instant composition from the composition of Sutherland because paragraph [0113] and claim 28 of Sutherland teaches that the composition of Methanobrevibacter archaebacteria cells is administered with a vaccine and paragraph [0022] teaches that the population of Methanobrevibacter archaebacteria cells administered improves pathogen resistance and reduces intestinal inflammation. Also see claims 22-30. Increasing resistance to pathogens and therapeutically alleviating symptomology is naturally attributed to a “vaccine”. Therefore, the teachings of Sutherland anticipate instant claims 228, 229, 242, and 244.
Paragraphs [0017, 0085, 0090-0094] and claims 4-6 of Sutherland anticipate inactivating the cells by heat or UV irradiation, as required by instant claim 230. Paragraphs [0095, 0263, and 0267] of Sutherland anticipate lyophilized cells, as required by instant claim 236. Claim 21 of Sutherland anticipates combining a carrier with the composition, anticipating instant claim 238.
In reply to the rejection of record, applicant contrasts the instant vaccine composition and the probiotic composition of Sutherland, pointing out that the probiotic composition of Sutherland reduces the side effects of vaccination in paragraph [0013], which is different from a vaccine.
Applicant’s arguments and a review of the teachings of Sutherland have been fully considered, but are found unpersuasive. Paragraph [0013] of Sutherland specifically teaches that the archaea improve immune system function. Paragraph [0022] and claims 22-30 state that the population of Methanobrevibacter archaebacteria cells administered improves pathogen resistance and reduces intestinal inflammation. Increasing resistance to pathogens and therapeutically alleviating symptomology is naturally attributed to therapeutic efficacy attributed to a “vaccine”.
Applicant points out that the list of methanogens of Sutherland is long and that the Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium are mentioned only once.
Applicant’s arguments and a review of the teachings of Sutherland have been fully considered, but are found unpersuasive. MPEP § 2131.02 (II) states, “A reference that clearly names the claimed species anticipates the claim no matter how many other species are named.” Therefore, Sutherland’s list of methanogenic archaebacteria species encompassed by the invention in paragraph [0048], including Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium, does not impair the anticipatory teachings of Sutherland.
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 231-235, 241, and 247-250 are rejected under 35 U.S.C. 103 as being unpatentable over Sutherland, as evidenced by Ong et al., supra, and Wright et al. (Vaccine. 2004; 22: 3976-3985).
See the teachings of Sutherland above. The Archaea extract listed in Table 5 in paragraph [0298] is dosed at 109 inactivated cells per gram. Paragraph [0099] and claim 19 teach the cell quantities ranging between 109 and 1012.
However, Sutherland does not teach that the cell quantities are present between 109 and 1012 per mL, as required by instant claims 232 and 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 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.
While neither Sutherland nor Wright et al. teach the percentage of cells present in the composition, as recited in instant claim 231, the ordinary artisan prior to the instant effective filing date would have been motivated to have incorporated more than half of total composition as Methanobrevibacter cell mixtures to at least improve pathogen resistance and reduce intestinal inflammation, as taught by Sutherland in paragraphs [0022, 0113] and claim 28 of Sutherland.
Sutherland teaches administering inactivated Methanobrevibacter archaebacteria cells in claims 18 and 22-30 to increase resistance to intestinal pathogen infections. Paragraph [0048] of Sutherland lists Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium encompassed by the genus of Methanobrevibacter archaebacteria cells in claim 18. Therefore, Sutherland teaches the composition and the active step of administering the composition recited in instant claims 247 and 248.
Sutherland does not teach 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 show that IgG, IgM, or IgA antibodies are produced upon administration.
However, Wright et al. teach administration of inactivated methanogens reduces methane production in VF3+3 vaccinated animals, see Figures 1 and 2. Wright et al. further depict IgA- and IgG-specific methanogen antibodies produced after methanogen immunizations in Figures 4 and 5.
Therefore, while Sutherland does not appreciate a reduction in methane as a consequence of having administered the inactivated Methanobrevibacter archaebacteria cells, this phenomenon would have been an inherent outcome, as evidenced by the VF3+3 vaccinated animals of Wright et al. One of ordinary skill in the art prior to the instant effective filing date would have been motivated to have induced IgA- and IgG-specific methanogen antibodies in ruminants because Wright et al. attributes the “significant 7.7% reduction in methane emissions” to the animal’s immune system producing antibodies against specific methanogens, see the paragraph bridging pages 3983-3984. One of ordinary skill in the art prior to the instant effective filing date would have had a reasonable expectation of success to have induced IgA- and IgG-specific methanogen antibodies in ruminants upon immunization of methanogens because Wright et al. teach high antibody titers achieved in plasma and saliva against methanogens in ruminants after vaccination are surviving the rumen environment and are continuously being replenished in active form, see the last paragraph on page 3982.
In reply to the rejection of record, applicant argues that one of ordinary skill would not have appreciated that ingesting a probiotic composition would induce an immune response or antibody protection against the probiotic composition because the rumen lacks an adaptive immune response.
Applicant’s arguments have been fully considered, but are found unpersuasive. Paragraph [0013] of Sutherland specifically teaches that the archaea improve immune system function, i.e., response. Paragraph [0022] and claims 22-30 state that the population of Methanobrevibacter archaebacteria cells administered improves pathogen resistance and reduces intestinal inflammation. Increasing resistance to pathogens and therapeutically alleviating symptomology is naturally attributed to therapeutic efficacy attributed to a “vaccine” and inducing an immune response.
Applicant argues that there is no reasonable expectation of success because neither the state of the art nor Sutherland provide guidance on selecting a specific methanogen out of the trillions of possible combinations.
Applicant’s arguments and a review of Sutherland have been fully considered, but are found unpersuasive because the instant claims are drawn to a composition comprising at least one methanogen, Methanobrevibacter gottschalkii in claim 228 and Methanobrevibacter ruminantium in claim 242, both of which are encompassed by Sutherland in paragraph [0048] in the composition comprising inactivated Methanobacter archaebacteria recited in claims 1, 4-6, 18, 19, and 22-30.
Applicant argues that Wright et al. do not cure the deficiencies of Sutherland because the VF7+3 vaccine includes 7 methanogens in a first immunization, followed by a second immunization including 3 methanogens, which failed to provide specific guidance for selecting the methanogens for a successful vaccine composition.
Applicant’s arguments have been fully considered, but are found unpersuasive. The instant claims are drawn to a composition comprising at least one methanogen, Methanobrevibacter gottschalkii in claim 228 and Methanobrevibacter ruminantium in claim 242, both of which are encompassed by Sutherland in paragraph [0048]. The trillions of methanogens discussed by applicant are also encompassed by the instant claims. Regarding the teachings of Wright et al., Wright et al. teach administration of inactivated methanogens reduces methane production in VF3+3 vaccinated animals, see Figures 1 and 2. "[T]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). 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.
MPEP § 2123 states: A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. In the instant case, Wright et al. teach that the sheep immunized with the 7 methanogen mix resulted in a 1% abatement of methane in the paragraph bridging the columns on page 3982, which is still an abatement. Therefore, the ordinary artisan prior to the instant effective filing date would have had a reasonable expectation of success for reducing methane emissions upon administration of a methanogen.
Applicant states that the instant composition results in a surprising result of reducing methane by at least 17%, which is more than double the methane reduction achieved by the VF3+3 formulation of Wright et al.
Applicant’s arguments have been fully considered, but are found unpersuasive. Figures 2 and 3 of the instant disclosure depict an approximate methane reduction of 17%. It appears from the information provided in the Figures that only Methanobrevibacter gottschalkii is administered. If this is the case, the instant composition comprising at least one methanogen, where the at least one methanogen is Methanobrevibacter gottschalkii, is not commensurate in scope with the surprising results pointed to by applicant.
See the teachings of Sutherland, as evidenced by Ong et al. above. Sutherland does not teach the inclusion of any of the adjuvants listed in instant claim 241.
Wright et al. teaches the inclusion of Saponin “Quil A” (“Saponin” is listed in line 3 of claim 241) and Montanide Incomplete Septic Adjuvant (ISA50), as adjuvants in section 2.4.
MPEP § 2144.06 recites the conclusions of In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA), “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” The claims require incorporation of an adjuvant. The preservation of PAMPs and MAMPs on the inactivated Methanobrevibacter of Sutherland provide an adjuvanting immune stimulating complex and the Saponin “Quil A” and Montanide Incomplete Septic Adjuvant (ISA50) of Wright et al. are adjuvants. Combining ingredients of known (adjuvanting) properties results in an additive effect, and would have rendered the invention prima facie obvious to one of ordinary skill prior to the instant effective filing date and does not exhibit an unexpected result.
Applicant argues that Ong et al. do not cure the deficiencies of Sutherland. However, since there are no deficiencies for Ong et al. to cure, the rejection remains.
Claims 243, 245, and 246 are rejected under 35 U.S.C. 103 as being unpatentable over Sutherland, as evidenced by Ong et al., and further in view of Wright et al. as applied to claims 228-238, 240-242, 244, and 247-250, above, and further in view of Miller et al. (International journal of systematic and evolutionary microbiology. 2002 May; 52 (3): 819-22) and Henderson et al. (Scientific reports. 2015 Oct 9;5 (1): 14567).
See the teachings of Sutherland and Wright et al. above. 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 in claim 18. Wright et al. lists Methanobrevibacter ruminantium M1 as a component in the “7-methanogen mix” in section 2.4.
Neither Sutherland nor Wright et al. 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. and the specific strain, Methanobrevibacter ruminantium M1 of Wright et al. and Miller et al. as the Methanobrevibacter archaebacteria cells in the composition of Sutherland to improve pathogen resistance and reduce intestinal inflammation in paragraphs [0022, 0048] and claims 18 and 22-30 and to reduce methane production in animals upon administration of inactivated methanogens, see Figures 1 and 2 of Wright et al. 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. and the specific strain, Methanobrevibacter ruminantium M1 of Wright et al. and Miller et al. as the Methanobrevibacter archaebacteria cells in the composition of Sutherland because Sutherland lists Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium encompassed by the genus of Methanobrevibacter archaebacteria cells in claims 18 and 22-30; Wright et al. teach administration of inactivated methanogens reduces methane production in VF3+3 vaccinated animals, see Figures 1 and 2; Wright et al. teach Methanobrevibacter ruminantium M1 is a methane source in section 2.3; and Miller et al. teach Methanobrevibacter gottschalkii DSM11977 produces methane in the “Description of Methanobrevibacter gottschalkii sp. nov.” on page 52.
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 section 2.4 of Wright et al., in the composition of Sutherland because Henderson et al. teach 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.
Therefore, combining Methanobrevibacter gottschalkii and Methanobrevibacter ruminantium clades in the composition of Sutherland would be efficacious against 74% of archeae present.
In reply to the rejection of record, applicant reiterates that Wright et al. fail to show any reduction in methane production in ruminants administered VF7+3.
Applicant’s arguments have been fully considered, but are found unpersuasive. "[T]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). 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.
MPEP § 2123 states: A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. In the instant case, Wright et al. teach that the sheep immunized with the 7 methanogen mix resulted in a 1% abatement of methane in the paragraph bridging the columns on page 3982, which is still an abatement. Therefore, the ordinary artisan prior to the instant effective filing date would have had a reasonable expectation of success for reducing methane emissions upon administration of a methanogen.
Claim Rejections - 35 USC § 102
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.
Claim 251 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meale et al. (Scientific Reports. 2021 Feb 4; 11 (1): 3003).
Meale et al. anticipate ruminal fluid samples fixed with formalin saline solution comprising formaldehyde in “Sampling”. Tables S6, S8 and Figures S3 and S9 list M. gottschalkii present in the samples. (A copy of the Supplemental Figures are not provided due to the enormity of the file size preventing attachment to the Office Action.)
Claim 251 recites that the vaccine composition reduces methane production by the at least one methanogen. However, the claim does not require actually using the vaccine composition in that way. Reducing methane production is not an additional structural limitation further characterizing the claimed product. See Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002): “[T]he patentability of... composition claims depends on the claimed structure, not on the use or purpose of that structure.”). The claim is not drawn to methods of reducing methane emissions, it is are drawn to a product. There is nothing in the claims that requires the vaccine composition to have any specific function.
There is no structural difference between the claimed invention comprising Methanobrevibacter gottschalkii and the composition of Meal et al. comprising Methanobrevibacter gottschalkii. Recitation of “vaccine” in the instant claim does not distinguish the instant composition from the composition of Meale et al. Therefore, the composition of Meale et al. anticipates instant claim 251.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Janet L Andres can be reached at 571-272-0867. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Shanon A. Foley/Primary Examiner, Art Unit 1671
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