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 .
This office action was written in response to the Applicants Remarks filed 6/11/26. 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 Claims 2-5, 14-20 were previously withdrawn. Claims 1, 7, and 8 were previously cancelled.
Withdrawn Rejections
The 103(a) rejections of 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 (US 2008/0038322) have been withdrawn due to the amendment to claim 6.
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, 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.
Further, it is noted that Applicant’s specification as published (US 2024/0074458) states that “archaea” refers to any single-celled prokaryotic organism [Firth, (US 2024/0074458) para 0026]. Applicant’s specification also states that a “virus” includes double-stranded or single-stranded RNA or DNA viruses, which infect cells of bacteria archaea, plants, and/or animals. As used herein, the term "virus" in the singular can refer to one or more viruses. Thus, the term "virus" in the singular encompasses both the singular and the plural, i.e., it can refer to one virus or multiple viruses [Firth, (US 2024/0074458); para 0024]. Applicant’s specification also states that, in some embodiments, the virus may be a bacteriophage [Firth, (US 2024/0074458); para 0047].
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 to modify Mizrahi to utilize phage therapy directed by archaeal viruses as in Lobo in order to reduce the growth of archaea in the rumen.
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 further modify the composition of Mizrahi to provide the virus in a controlled release form as in Murthy in order to delay or time the release of the archaeal viruses.
As discussed above, since Applicant’s own specification indicates that archaea can be any single-celled prokaryotic organism and since Mizrahi discloses using bacteriophages to target methane producing bacteria, it would have been obvious to one of ordinary skill in the art to try archaeal virus (which has the equivalent relationship that a bacteriophage has to bacteria) directed methods to inhibit the growth of archaea.
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 Applicant 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 Applicant asserts that one of ordinary skill in the art would not have been motivated to target methane producing archaea and would not have had a reasonable expectation of success in doing so based on what was taught in Mizrahi.
The Examiner notes the arguments, disagrees, and maintains that Mizrahi does acknowledge the reduction of methanogens which includes archaea. Further, Mizrahi as presently used has been modified by Lobo for the teaching of using phage therapy to inhibit the growth of methanogens. One of ordinary skill in the art having the teachings of Mizrahi and Lobo would have been motivated to utilize archaeal virus therapy in targeting methane producing archaea in rumen since Mizrahi discloses using bacteriophages to target methane producing bacteria.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Meat and Livestock Australia “Reducing Emissions form Livestock Research Program” March 2011 discloses archaeaphage therapy to infect and control methanogens in rumen [pg. 1, 2nd para].
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 FELICIA C TURNER whose telephone number is (571)270-3733. The examiner can normally be reached Mon-Thu 8:00-4:00 pm.
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/Felicia C Turner/Primary Examiner, Art Unit 1793
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