DETAILED ACTION
Election/Restrictions
The amended claim set of 30 Jan 2026 has been entered and reviewed. Claims 1-35 are cancelled.
Claims 36-55 are pending.
Applicant’s election without traverse of Group I, claims 36-49, directed to a method of reducing methane production in a ruminant, in the reply filed on 30 Jan 2026 is acknowledged. Applicants also elected that the oxidizing agent is calcium peroxide in response to the species election requirement.
Claims 50-55 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 36-49 are under consideration to the extent of the elected species, i.e., that the oxidizing agent is calcium peroxide.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 29 Jan 2024 and 13 Jun 2024 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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 48 and 49 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.
Claims 48 and 49 recite “an additional anti-methanogenic agent.” None of the compounds previously recited are referred to as an “anti-methanogenic agent,” however, the term “additional” implies that such an agent is already present. As the term anti-methanogenic agent has not been used to refer to other components, it is unclear if this is intended to refer to one of the components already recited in the claims or if this refers to another component intended to be in the claims but not currently recited.
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.
The factual inquiries 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 nonobviousness.
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 as of the effective filing date of the claimed invention(s) 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 as of the effective filing date of the later invention 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.
Claims 36, 37, and 40-49 are rejected under 35 U.S.C. 103 as being unpatentable over Kiyoshi et al. (WO2010071222, published 24 Jun 2010 listed on IDS filed 29 Jan 2024) in view of Gago et al. (US 4,346,081, published 24 Aug 1982, listed on IDS filed 29 Jan 2024).
Kiyoshi teaches a feed composition for ruminant animals that is a methane production inhibitor (page 1 lines 12-15). Kiyoshi teaches that methane-producing bacteria in the rumen are hydrogen-assimilating bacteria which utilize hydrogen to reduce carbon dioxide and produce methane and that if a stronger reduction reaction exists that methane production is inhibited (page 1 lines 21-25). Kiyoshi teaches adding methane production inhibitor containing hydrogen peroxide as an active ingredient to the rumen (page 2 lines 21-25). Kiyoshi teaches the inhibitor as part of a feed additive or feed composition (page 3 lines 2-3, page 4 lines 22-25). Regarding claims 40-43, Kiyoshi teaches the ruminant may be cattle (page 4 lines 3-5) and adding the ingredient to the rumen (page 2 lines 23-24). Regarding claims 48 and 49, Kiyoshi teaches that in addition, cultures such as microorganisms producing hydrogen peroxide, such as lactic acid bacteria can be used as a source of hydrogen peroxide (page 4 lines 14-16). This inclusion of a lactic acid bacteria, as taught by Kiyoshi, is understood to meet the limitation of an additional anti-methanogenic agent. Regarding claims 44 and 45, Kiyoshi teaches that reducing methane improves the efficiency of utilization of feed energy of ruminant animals (page 7 lines 17-20), rendering obvious increasing feed efficiency.
Kiyoshi teaches that for the dosage of the methane production inhibitor, it is preferable that the concentration of hydrogen peroxide in the rumen solution immediately after administration be at least 0.0001 to 10 mM and that by administering at such a dosage that methane bacteria are preferentially sterilized or bacteriostasis without adversely affecting useful ruminal microorganisms such as fiber degrading bacteria (page 5 lines 1-7). Kiyoshi teaches the data from an example formulation indicate that it is necessary to administer hydrogen peroxide at a concentration of at least 0.5 mM or more to suppress methane production in rumen and that when hydrogen peroxide is administered from 0.5 to 5.0 mM that more hydrogen is generated than in other concentration ranges, which confirms that in this range, methane-producing bacteria are killed or bacteriostatic, but useful ruminal microorganisms such as fiber degrading bacteria are active (page 7 lines 5-11). Kiyoshi then teaches that in administration of the inhibitor to the actual ruminant that it is necessary to study conditions beforehand for each animal, region, and breeding method to be administered (page 7 lines 13-15).
Kiyoshi does not teach administration of calcium peroxide (the elected species of oxidizing agent) in the dose of claim 36. This deficiency is made up for in the teachings of Gago.
Gago teaches compositions for ingestion by ruminants which reduce the generation of methane in the rumen (col 1 line 62 – col 2 line 6). Gago teaches that the compositions comprise a metal of group 2 of the periodic table such as calcium (col 2 lines8-14), and teaches examples with calcium peroxide (col 6 table 2). Gago teaches that the proportion of peroxide in the composition is in general between 0.05 and 20% of the weight of the ingested dry materials (col 3 lines 8-12), rendering obvious the dose of claim 36. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered a peroxide such as calcium peroxide from 0.05 to 20% of the ingested dry material to the rumen of a cow as part of a method to inhibit methane production. Methods of reducing methane production with hydrogen peroxide are known from Kiyoshi and similar methods of reducing methane in ruminants with calcium peroxide are known from Gago. Thus, the teachings of Kiyoshi and Gago have similar goals of reducing methane production in ruminants through similar means of providing a methane inhibiting compound to the feed of the ruminant. Thus, it would have been obvious to one of ordinary skill to substitute the hydrogen peroxide with calcium peroxide as it is known for use in similar method of feeding ruminants for a similar goal of methane reduction. The use of calcium peroxide thus merely represents an alternative prior art element known for the same purpose of reducing methane in ruminant. The 0.05 to 20% of ingested dry material dosage of peroxide is known from Gago, rendering it an obvious dose for achieving methane reduction. Thus, the same method of the instant claims is obvious from the teachings of Kiyoshi and Gago.
Regarding the limitation of “substantially free of iodide or a source of iodide,” the addition of iodide or a source of iodide is not required from the art and thus this limitation is obvious. Regarding the limitation that the method reduces methane without “substantially defaunating the stomach” and “in a dose which provides an increase n the oxidation-reduction potential of the stomach of at least about +10 mV for a time period of at least about 1 hour,” these limitations are understood to be a result of administering the method of the claims. The same method of the instant claims is known from the prior art, namely administering a peroxide such as calcium peroxide in the same amount as the dose of the instant claims. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). The resulting effects of not substantially defaunating the stomach and of increasing the redox potential of the stomach occur from the administration of the method. As the same method of the instant claims is known from the prior art, the same results described above would necessarily be present.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 36, 37, and 40-49 are rejected under 35 U.S.C. 103 as being unpatentable over Kiyoshi et al. (WO2010071222, published 24 Jun 2010, listed on IDS filed 29 Jan 2024) in view of Gago et al. (US 4,346,081, published 24 Aug 1982, listed on IDS filed 29 Jan 2024) as applied to claims 36, 37, and 40-49 above and further in view of Ito et al. (CURRENT MICROBIOLOGY Vol. 47 (2003), pp. 231–236) as evidenced by Sakamoto et al. (JOURNAL OF FERMENTATION AND BIOENGINEERING Vol. 82, No. 3, 210-216. 1996).
The teachings of Kiyoshi and Gago are described supra.
As noted above, Kiyoshi teachings the inclusion of lactic acid bacteria that produce hydrogen peroxide (page 4 lines 14-15). Kiyoshi references the teachings of Ito for such lactic acid bacteria.
Kiyoshi and Gago do not teach the inclusion of a peroxidase-producing organism. This deficiency is made up for in the teachings of Ito.
Ito teaches hydrogen peroxide producing lactic acid bacteria (title). Ito teaches a variety of lactic acid bacteria that produce hydrogen peroxide, including lactobacillus planatarum (page 233 right column). As evidenced by Sakamoto lactobacillus planatarum produces NADH peroxidase (page 215 Table 3) and thus L. planatarum is a peroxidase producing organism.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included a lactic acid bacteria such as L. planatarum as part of the method of reducing methane production. The inclusion of lactic acid bacteria that produce hydrogen peroxide is taught by Kiyoshi and Kiyoshi specifically references the teachings of Ito for such bacteria. Ito teaches bacteria such as L. planatarum as producing hydrogen peroxide, rendering it obvious to include the bacteria as part of the method of methane reduction. As evidenced by Sakamoto, L. planatarum produceds NADH peroxidase, and thus the inclusion of L. planatarum renders obvious the inclusion of a peroxidase producing organism.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600