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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 23 Jun 2026 has been entered.
Claims 36-59 remain pending in the application.
Claims 48 and 49 are amended.
Claims 1-35 are canceled.
Claims 56-59 are new.
Claims 50-55 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.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 and 56-59 are under consideration to the extent of the elected species, i.e., that the oxidizing agent is calcium peroxide.
Objections Withdrawn
Objections to the Specification
The specification objections set forth in the Non-Final Office Action mailed 25 Feb 2026 are hereby withdrawn in light of applicant’s amendments of the specification.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejection of claims 48 and 49 pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 25 Feb 2026 is hereby withdrawn in light of applicant’s amendment of the claims.
Rejections Maintained- in modified form
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.
The rejections below were made previously and are made again with modifications to address the claim amendments and new claims.
Claims 36, 37, 40-49, and 56-59 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). Kiyoshi teaches that 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). Regarding claims 48 and 49, Kiyoshi teaches that feeding ionophores, fumaric acid, and nitrate are known in methods for suppressing methane generation (page 1 lines 25- page 2 line 2), thus rendering it obvious to include such components as they are known for a similar purpose of reducing methane. 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. Regarding claims 56-59, Kiyoshi teaches that it is preferable to administer the methane production inhibitor immediately before or at the same time as feed administration (page 4 lines 20-22).
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) or the dose of claim 36 or the form of solid feed as in claims 56-59. These deficiencies are 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 lines 8-14), 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). Gago teaches feeding compositions in various forms including compacted or granulated forms and powder forms and teaches incorporating the compositions in a complementary form to normal feed, including powders and solids, and mixing them with the feeding rations (col 3 lines 22-39).
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 and to incorporate the peroxide component as a solid as part of a feeding composition. 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. It is known from Kiyoshi to administer the peroxide at the same time as the feeding composition and it is known from Gago that the peroxide component may be incorporated as a solid as part of normal feed, thus rendering the incorporation of peroxide into solid feed as an obvious means of administration. 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.
Response to Arguments
Applicant's arguments filed 23 Jun 2026 have been fully considered but they are not persuasive. Applicant states that there is no data is Kiyoshi showing that any mode of oral administration actually achieves a reduction in methane production from a ruminate and that the effects would not be predictable and would be uncertain (page 7 of remarks). Applicant argues that the disclosure of Kiyoshi teaches away from implementing in vivo (page 7 of remarks). Applicant argues that the preferred concentration of peroxide in Kiyoshi is based on Example 1 which is directed to in vitro testing (page 8 of remarks). Applicant points to figure 2 of Kiyoshi and argues that this shows increased hydrogen production and that this would lead to inhibition of fermentation, inhibiting biological function, and lack of predictability that the method of Kiyoshi would be suitable for ruminants (pages 8-9 of remarks). Applicant argues that Kiyoshi teaches administration of liquid hydrogen peroxide directly into artificial rumen solution but provides no guidance on how to translate this to oral administration (page 9 of remarks). Applicant argues that there is nothing in Kiyoshi to show that its methods would work if the liquid hydrogen peroxide was replaced with a solid oxidizing agent as claimed (page 10 of remarks). Applicant argues that Gago does not show data on the reduction of methane production from oral administration. Applicant argues that one skilled in the art would have approached the suggestions in Gago with caution as more recent review articles would impart unpredictability around the efficacy of the Gago method and entirely defaunating the rumen to remove protozoa (page 10 of remarks). Applicant argues that one would not combine Kiyoshi with Gago as Gago’s method works by entirely defaunating the rumen whereas Kiyoshi teaches away from defaunation (page 11 of remarks). Applicant argues that the claimed method does not have complete defaunation and that is in contradiction to Gago (page 11 of remarks). Applicant argues claims 40 and 41 recite that the ruminant is cattle whereas Gago teaches for sheep and the change from sheep to cattle wouldn’t be a predictable (page 12 of remarks). Applicant argues that there is a lack of predictability for feed based modes of administration with Kiyoshi and Gago (page 13 of remarks).
The examiner is not persuaded by these arguments. The applicant’s argument relies on a lack of data or a specific embodiment that matches the instant claims. The examiner notes, however, the rejection was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. Thus, it is not necessary that specific data be provided to render the method obvious and pointing to the lack of specific data does not in itself provide a lack of predictability sufficient to overcome the rejection. While Kiyoshi does provide some in vitro testing, the teaching of Kiyoshi is directed to ruminate feed additives and feed compositions (e.g. page 1 lines 10-15). Noting the in vitro data highlighting aspects of hydrogen peroxide testing does not provide a lack of predictability or teach away from a feed composition, which is an oral administration method. Similarly, even if the applicant is able to determine a possible difficulty in in peroxide administration such as “inhibition of fermentation,” this does not go against the clear teachings of Kiyoshi to implement such a method and what would have been obvious to one of ordinary skill. The teachings of Kiyoshi do not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). A fair reading of Kiyoshi directs one of ordinary skill to administering peroxide for methane reduction in cattle through feed compositions.
Regarding the combination of Kiyoshi with Gago, the examiner notes that a person of ordinary skill is also a person of ordinary creativity, not an automaton, and in many cases will be able to fit teachings of multiple patents together like pieces of a puzzle. Furthermore, "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art." In the instant case Gago teaches administration of calcium peroxide as part of reducing methane in a ruminant (col 2 lines 5-6) thus indicating a similar purpose as that of Kiyoshi. Gago is not relied upon for its method and thus the specifics regarding the complete defaunation of Gago is not persuasive. From Kiyoshi and Gago one of ordinary skill would recognize peroxide compounds such as hydrogen peroxide and calcium peroxide as used in part of reducing methane production and it would be obvious to use them for that purpose. It is known that from Kiyoshi that the dosage is related to effect the peroxide will have at sterilizing methane bacteria versus affecting useful ruminal microorganisms (page 5 lines 1-7) and thus it would have been obvious to incorporate the calcium peroxide in a way (e.g. a particular dosage regimen) that does not defaunate. Further, it would be well within the skill level of one of ordinary skill in the art to incorporate the solid calcium peroxide instead of the liquid peroxide into feed compositions. Similarly, even though Gago does teach ruminants, Gago is not relied upon for teaching cattle, which is obvious from Kiyoshi.
Thus, the examiner maintains that the claims are obvious over the teachings of Kiyoshi and Gago.
Claims 38 and 39 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, 40-49, and 56-59 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 produces 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.
Response to Arguments
Applicant's arguments filed 23 Jun 2026 have been fully considered but they are not persuasive. Applicant states that one would not have exchanged the hydrogen peroxide in Kiyoshi for lactic acid bacteria of Ito. Applicant notes that Kiyoshi only mentions lactic acid bacteria as a possible source of hydrogen peroxide and not as an alternative to peroxide (pages 13-14 of remarks). Applicant argues that Ito discusses the use of lactic acid bacteria to inhibit growth of food spoilage bacteria and does not provide teaching that lactic acid could be administered to ruminants (page 14 of remarks).
The examiner does not find this persuasive. First, the examiner notes that the rejection is not based on removing hydrogen peroxide or calcium peroxide from the method, but rather the obviousness of combining lactic acid bacteria with the method of Kiyoshi. Hydrogen peroxide is known from Kiyoshi to be produced from lactic acid bacteria and specific bacteria such as L. planatraum are known from Ito for producing hydrogen peroxide. The association of the bacteria with food, as taught by Ito, further indicates that such bacteria are known to be associated with food type related substances. As such, it would be obvious to incorporate such a bacterium as part of the method as a source of hydrogen peroxide which is known from Kiyoshi for methane reduction. The incorporation of such a bacterium is obvious and within the ability of one of ordinary skill in the art.
New Grounds of Rejections
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 “alternative hydrogen sinks.” The use of the term “alternative” implies that “hydrogen sinks” are in the composition. This is indefinite as no components are identified as “hydrogen sinks” and it is unclear that this is in reference to.
Claims 48 and 49 recite a large list of various components. Some of the components overlap in content, for example, bromoforms are a type of C1-C2 hydrocarbon and it is thought that the intention may be to have the components listed as alternative components for administration. The claim, however, does not clearly recite the components in the alternative. It is not clear if the components are intended to be listed as alternative components that may be administered or if it is intended that all of these components are to be administered in the same method.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
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
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