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 .
RCE
Receipt is acknowledged of the Request for Continued Examination (RCE) under 1.114, the Amendment and Response, all filed 1/6/26.
Claims 2-6, 9-20 are pending. Claims 6, and 9-13 are pending and have been examined on the merits. Claims 2-5, 14-20 were previously withdrawn. Claim 7 has been cancelled. Claims 1 and 8 were previously cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/6/26 has been entered.
Withdrawn Rejections
The 112(d) rejection of claim 7 has been withdrawn due to the cancellation of the claim.
The 103(a) rejections of claims 6, 7, 9, 10 and 11 over Mizrahi (WO 2017/187443) in view of Weidenbach et al. “Characterization of Blf4, an Archaeal Lytic Virus Targeting a Member of the Methanomicrobiales” Viruses Sept 2021 vol. 13 pgs. 1-13, Murthy et al. (US 2008/0038322), Hoffmann Pegoraro et al. (US 2014/0099406), and Krupovic et al. “Virus of archaea: Structural, functional, environmental, and evolutionary genomics” Virus Research vol. 244 2018 pages 181-193 have been withdrawn.
The 103(a) rejections of claims 6, 7, 9, 10, and 11 e over Weidenbach et al. “Characterization of Blf4, an Archaeal Lytic Virus Targeting a Member of the Methanomicrobiales” Viruses Sept 2021 vol. 13 pgs. 1-13 in view of Mizrahi (WO 2017/187443), Murthy et al. (US 2008/0038322), Hoffmann Pegoraro et al. (US 2014/0099406), and Krupovic et al. “Virus of archaea: Structural, functional, environmental, and evolutionary genomics” Virus Research vol. 244 2018 pages 181-193 have been withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 6, 9, 10, 11, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Bellare (WO 2016/007173) in view of Murthy et al. (US 2008/0038322).
Regarding Claim 6: Bellare discloses a solid/feed composition for ruminants comprising an anti-protozoan component which may be pharmaceutical, a bacterium, fungus, or virus in order to control methane production caused by methanogenic microorganisms [abstract; 0048; 0050]. Bellare discloses the anti-protozoan component in the form of a virus [0048]. Bellare discloses that certain protozoa have a symbiotic relationship with methane producing microorganisms (Archaea) and that eliminating the protozoa also reduces or eliminates methane production as the methanogens are unable to survive or unable to produce methane effectively without the protozoa [0048]. Bellare discloses Methanobacterium amongst other methane producing microorganisms [0048] which are known in the art to be classified as Archaea.
Bellare does not disclose controlled release of the virus to the ruminant.
Murthy discloses including polymers in its composition for controlled release of bacteriophages (viruses) [0050; 0053]. Murthy also discloses a varied time release and different rate release [0044; 0045; 0061].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Bellare to provide it in a controlled release form at varied times and rates as in Murthy in order to delay or time the release of the different methane reducing components in the animal feed.
Regarding Claim 9: Bellare as modified discloses as discussed above in claim 6. Bellare disclose wherein the composition is dosed for the needs of the animal wherein amounts for the feed are disclosed [0049] and therefore discloses wherein the composition is capable of releasing a predetermined dose.
Regarding Claim 10: Bellare as modified discloses as discussed above in claim 6. Bellare does not disclose wherein the virus is immobilized to a substrate.
Murthy discloses wherein the composition containing bacteriophages (bacterial virus) are immobilized on a substrate in order to control or orchestrate the release of the bacteriophage [0036; 0041; 0066].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Bellare to provide the anti-protozoa virus agent in an immobilized substrate as in Murthy in order to aid in delaying or timing the release of the agent in the animal feed when administered to an animal.
Regarding Claim 11: Bellare as modified discloses as discussed above in claim 6. Bellare disclose wherein the composition further contains sugars (carbohydrates), and lipids/fats for the needs of the animal [abstract; 0026; 0042].
Regarding Claim 12: Bellare as modified discloses as discussed above in claim 6. Bellare discloses including an anti-protozoa virus composition along with a pharmaceutical agent such as imidazole or a bacterium or fungus in order to control methane production [0048].
Regarding Claim 13: Bellare as modified discloses as discussed above in claim 12. Bellare does not disclose wherein the composition is configured to release the virus and the non-viral substance and/or second substance at different times.
Murthy discloses including polymers in its composition for controlled release of bacteriophages (viruses) [0050; 0053]. Murthy also discloses a varied time release and different rate release [0044; 0045; 0061].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Bellare to provide it in a controlled release form at varied times and rates as in Murthy in order to delay or time the release of the different methane reducing components in the animal feed.
Claims 6, 9, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mizrahi (WO 2017/187433) in view of Lobo et al. “Ruminal Phages-A Review” Frontiers in Microbiology vol. 12 December 2021 and Murthy et al. (US 2008/0038322).
Regarding Claim 6: Mizrahi discloses a composition for decreasing the production of methane in a ruminant using an agent [Abstract; pg. 37, lines 1-10]. Mizrahi discloses that the agent can be a bacteriophage (a type of virus that infects bacteria) [pg. 37, line 12]. Mizrahi discloses that the composition containing the agent can be in the form of feed or silage [pg. 5, lines 16-19; claims 23 , 24]. Mizrahi discloses a feed or silage and therefore discloses feed in solid form [claims 23 and 24]. Mizrahi discloses that the invention relates to rumen microflora [pg. 10, lines 28-32]. Mizrahi acknowledges methanogenic microorganisms in the rumen microbiome and that they are more sensitive to changes in microbial diversity and richness [pg. 50, lines 18-20; pg. 61, lines 22-27]. Mizrahi discloses the presence of methanogenic archaeon in the rumen [pg. 55, lines 17-20; Table 5].
Mizrahi discloses a list of “bacteria” that correlate with high methane production and amongst the list of “bacteria” Mizrahi includes Methanobrevibacter sp., Methanobacterium sp., Methanomicrobium sp., Methanosphaera sp. [Table 5]. Mizrahi also discloses that the invention seeks to decrease any one of the “bacterial” species in [Table 5]. It is clear, since Mizrahi discloses that the list of microorganisms in Table 5 are “bacteria”, and since the methanogens are also listed there, that Mizrahi characterized the methanogens as “bacteria” and that the invention of Mizrahi was also directed to the reduction of the archaea as well as bacteria since specific methanogens are listed along with the bacteria.
Lobo discloses a study of ruminal phages [abstract]. Lobo discloses phage (viral) therapy as advantageous over antibiotic therapy due to its high target specificity which preserves the local microbiome [pg. 5, The Prospectus of Phage therapy in Ruminants 2nd paragraph]. Lobo discloses phage therapy targeting methanogens as a means for reducing methane production in the rumen [pg. 5, The Prospectus of Phage therapy in Ruminants 3rd paragraph].
Given that Lobo discloses ruminal methanogens and using phage therapy for the reduction of methanogens it would have been obvious that Mizrahi would have been utilized for the reduction of growth of archaea.
Mizrahi does not disclose controlled release of the virus to the ruminant.
Murthy discloses including polymers in its composition for controlled release of bacteriophages (viruses) [0050; 0053]. Murthy also discloses a varied time release and different rate release [0044; 0045; 0061].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Mizrahi to provide it in a controlled release form as in Murthy in order to delay or time the release of the archaeal viruses.
Regarding Claim 9: Mizrahi as modified discloses as discussed above in claim 6. Mizrahi disclose wherein the composition is dosed for the needs of the animal [pg. 36, lines 23-27] and therefore discloses wherein the composition is capable of releasing a predetermined dose.
Regarding Claim 10: Mizrahi as modified discloses as discussed above in claim 6. Mizrahi does not disclose wherein the virus is immobilized to a substrate.
Murthy discloses wherein the composition containing bacteriophages (a type of virus) are immobilized on a substrate in order to control or orchestrate the release of the bacteriophage [0036; 0041; 0066].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Mizrahi to provide it in an immobilized substrate as in Murthy in order to delay or time the release of the bacteriophage in the animal feed.
Regarding Claim 11: Mizrahi as modified discloses as discussed above in claim 6. Mizrahi disclose wherein the composition further contains sugars (carbohydrates), peptides for the needs of the animal [pg. 28, lines 30-31; pg. 29, lines 1-3].
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mizrahi (WO 2017/187433) in view of Lobo et al. “Ruminal Phages-A Review” Frontiers in Microbiology vol. 12 December 2021 and Murthy et al. (US 2008/0038322) as applied to claim 6 above and in further view of Bellare (WO 2016/007173).
Regarding Claim 12: Mizrahi as modified discloses as discussed above in claim 6. Mizrahi does not disclose, wherein the composition further comprises a non-viral substance and/or a second substance capable of reducing methane production in the ruminant.
Bellare discloses including anti-protozoa composition along with a virus in order to control methane production [abstract; pg. 19, [0048].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Mizrahi to include an anti-protozoa composition as in Bellare in order to increase the effectivity of the reduction of methane since the anti-protozoa component will reduce the protozoa that have a symbiotic relationship with methanogenic bacteria.
Regarding Claim 13: Mizrahi as modified discloses as discussed above in claim 12. Mizrahi does not disclose wherein the composition is configured to release the virus and the non-viral substance and/or second substance at different times.
Bellare discloses including anti-protozoa composition along with a virus in order to control methane production [abstract; pg. 19, [0048].
Murthy discloses including polymers in its composition for controlled release of bacteriophages [0050; 0053]. Murthy also discloses a varied time release and different rate release [0044; 0045; 0061].
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Mizrahi to include an anti-protozoa composition as in Bellare in order to increase the effectivity of the reduction of methane since the anti-protozoa component will reduce the protozoa that have a symbiotic relationship with methanogenic bacteria.
At the effective filing date of the invention it would have been obvious to one of ordinary skill in the art to modify the composition of Mizrahi to provide it in a controlled release form at varied times and rates as in Murthy in order to delay or time the release of the different methane reducing components in the animal feed.
Response to Arguments
The 112(d) rejection of claim 7 has been withdrawn due to the cancellation of the claim.
The 103(a) rejections of claims 6, 7, 9, 10 and 11 over Mizrahi (WO 2017/187443) in view of Weidenbach et al. “Characterization of Blf4, an Archaeal Lytic Virus Targeting a Member of the Methanomicrobiales” Viruses Sept 2021 vol. 13 pgs. 1-13, Murthy et al. (US 2008/0038322), Hoffmann Pegoraro et al. (US 2014/0099406), and Krupovic et al. “Virus of archaea: Structural, functional, environmental, and evolutionary genomics” Virus Research vol. 244 2018 pages 181-193 have been withdrawn.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Mizrahi (WO 2017/187443) in view of Weidenbach et al. “Characterization of Blf4, an Archaeal Lytic Virus Targeting a Member of the Methanomicrobiales” Viruses Sept 2021 vol. 13 pgs. 1-13, Murthy et al. (US 2008/0038322), Hoffmann Pegoraro et al. (US 2014/0099406), and Krupovic et al. “Virus of archaea: Structural, functional, environmental, and evolutionary genomics” Virus Research vol. 244 2018 pages 181-193 as applied to claim 6 above and in further view of Bellare (WO 2016/007173) have been withdrawn.
The 103(a) rejections of claims 6, 7, 9, 10, and 11 over Weidenbach et al. “Characterization of Blf4, an Archaeal Lytic Virus Targeting a Member of the Methanomicrobiales” Viruses Sept 2021 vol. 13 pgs. 1-13 in view of Mizrahi (WO 2017/187443), Murthy et al. (US 2008/0038322), Hoffmann Pegoraro et al. (US 2014/0099406), and Krupovic et al. “Virus of archaea: Structural, functional, environmental, and evolutionary genomics” Virus Research vol. 244 2018 pages 181-193 have been withdrawn.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Weidenbach et al. “Characterization of Blf4, an Archaeal Lytic Virus Targeting a Member of the Methanomicrobiales” Viruses Sept 2021 vol. 13 pgs. 1-13 in view of Mizrahi (WO 2017/187443), Murthy et al. (US 2008/0038322), Hoffmann Pegoraro et al. (US 2014/0099406), and Krupovic et al. “Virus of archaea: Structural, functional, environmental, and evolutionary genomics” Virus Research vol. 244 2018 pages 181-193 as applied to claim 6 above and in further view of Bellare (WO 2016/007173) have been withdrawn.
The Newbold declaration dated Dec 17, 2025 has been acknowledged:
The declarant asserts that the rumen environment is different than the biogas generator described in the Weidenbach reference. The declarant asserts that the types of archaea that inhabit the rumen are different than the archaea that are able to thrive in biogas generator.
The Examiner notes that Weidenbach has been withdrawn as a reference.
The declarant asserts that the Examiner’s statement that there are structural similarities between bacteriophages and archaeal viruses are meaningless. The declarant asserts that all viruses share common features. The declarant asserts again that the types of archaea differ in the rumen versus a biogas reactor.
The Examiner notes that the comparison between bacteriophages and archaeal viruses was made in relation to showing similarities between the viruses themselves, those affecting bacteria and those affecting archaea.
The declarant asserts that the Pegoraro does not disclose reducing the production of rumen by administering a virus.
The Examiner notes that Pegoraro has been withdrawn as a reference.
The Clokie declaration dated Aug 21, 2021 has been acknowledged:
The declarant asserts that Mizrahi does not explicitly disclose that the bacteriophage targets Archaea. The declarant discloses Bellare is directed towards feed compositions that incorporate anti-protozoal agents. The declarant asserts that one would not think that a virus effective against bacteria would be effective against archaea. The declarant also asserts that the use of the word “may” in relation to the effect that protozoa have on the growth of methanogens is conjecture.
The Examiner notes that in the previous rejection Bellare was incorporated to meet the limitation where the composition further included methane reducer other than the virus. The Examiner maintains Bellare because it does disclose the reduction of methane by using an anti-protozoal agent and it meets the claim limitation.
Further in response to the arguments that the statements in Bellare are conjecture, the Examiner notes that every patent is presumed valid and that presumption includes the presumption of operability. MPEP 716.07
The Declarant asserts that Mizrahi focuses on administering an agent that increases Megaspera sp. and utilizes antibiotics and antimicrobial peptides. The Declarant asserts that Mizrahi is concerned with reducing bacteria in the rumen and not archaea and therefore does not teach the mitigation of methane formation by targeting archaea. The Declarant asserts that contradictions in Mizrahi concerning the growth or inhibition of methanogens essentially render the reference insignificant.
The Examiner notes the arguments, disagrees, and maintains that Mizrahi does acknowledge the reduction of methanogens. However, Mizrahi as presently used has been modified by Lobo for the teaching of using phage therapy to inhibit the growth of methanogens.
The Declarant asserts that Klieve is a 25 year old reference and that it discloses using biocontrol agents to control reduce rumen methane. The Declarant asserts that Klieve discloses three possible strategies using archaeal viruses, bacteriocin, and elimination of protozoa. The Declarant asserts that Klieve does not explore using archaeal viruses or the elimination or protozoa. The Declarant asserts that Klieve discloses that archaeal viruses may be suitable for biocontrol agents and that this use of the word “may” is conjecture.
The Examiner acknowledges the argument and notes that the Klieve reference was not used in the previous or in the instant rejection.
The Examiner does note that the date on the declaration is questionable as it predates the first action on the merits and even the filing date of the invention.
Conclusion
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/Felicia C Turner/Primary Examiner, Art Unit 1793