DETAILED ACTION
RESPONSE TO AMENDMENT
1. Receipt of Applicants’ amendments/remarks filed 10/21/2025 are acknowledged.
INFORMATION DISCLOSURE STATEMENT
2. No new Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 101
4. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-15 and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Claim 1 is directed to composition comprising organohalogen and organosulfur compounds. These include bromoform and allicin. The compositions further include polyphenol and bioflavonoids such as naringin.
In accordance with the 2019 Revised Patent Subject Mater Eligibility Guidance (aka 2019 PEG), the following revised flowchart found in MPEP §2106(III), is used when considering whether or not a claimed invention recites eligible subject matter:
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The invention recited in claims 1-15 and 20-22 are drawn to a composition of matter, in this case a composition comprising a organohalogen and organosulfur.
Step 1 is satisfied.
Step 2 has now been broken out into a two-prong analysis:
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Step 2A first asks whether or not the claimed invention is directed to a judicial exception such as a natural phenomenon (e.g., product of nature). Here, the answer is yes, since the only compositional requirement set forth in the composition comprises naturally occurring ingredients such as bromoform and allicin.
The second leg of the analysis evaluates whether the claim recites additional elements that integrate the established judicial exception into a practical application of the exception. Based on the recitations provided in claims 1-15 and 20-22, the answer is no. There is not a practical application of the law of nature. These claims recite further ingredients that may be naturally occurring (e.g., naringin which is citric extract). The fact that the composition is used to reduce methane emission is regarded as intended use of the composition.
Lastly, step 2B asks if the claim recites additional elements that amount to “significantly more” than the judicial exception. Asked another way, do the claims recite anything additional demonstrating that the recited composition provides an inventive concept? Here, again, the answer is no because the claims simply do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from a natural product. Reciting the intended use of a natural product (e.g., for reduction in methane emissions) does not amount to significantly more than the judicial exception. The composition contains naturally occurring ingredients that do not have markedly different characteristics from what occurs in nature. The recitation of the amounts of the ingredients which are naturally occurring do not arrive at any change in characteristics (structural or functional) that are different from what occurs in nature. The claim encompasses combination of naturally occurring ingredients. Even if the claimed subject matter recites specific amounts or ratios, the claims are still patent ineligible because each naturally occurring product would still be structurally identical to what exists in nature.
The composition as claimed is composed of all naturally occurring ingredients. The composition contains naturally ingredients that do not have markedly different characteristics from the natural components that occurs in nature. The recitation of the amounts of ingredients do not arrive at any change in the characteristics (structural or functional) of the naturally occurring ingredients. The test is not whether if said ingredients are all found combined together in nature but rather if they are the same ingredient that exists in nature. Claim 1 is a nature-based product (i.e., combination of naturally occurring substances). In the instant case, the claim encompass ingredients that exist in nature thus the composition is formed of naturally occurring ingredients. It does not have markedly different characteristics from any naturally occurring counterpart(s) in their natural state. For example, gunpowder comprising a finely ground mixture of 75 % potassium nitrate, 15 % charcoal and 10 % sulfur. The three counterparts occur naturally in nature. None of them are explosive in nature. When the substances are finely ground and intimately nixed in the claimed ratio, the claimed combination is explosive upon ignition. The explosive property of the claimed combination is markedly different from the non-explosive properties of the substances by themselves in nature and thus the claimed combination has markedly different characteristics. In the instant case, there is no evidence that the combination has any markedly different characteristics. There is no indication that the claimed ingredients has any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients. Another example involves an inoculant for leguminous plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacterial of the genus Rhizobium, said strains being unaffected by each other in respect to their ability to fix nitrogen in the leguminous plant for which they are specific. Here, there is no indication that the claimed mixture of bacteria has any characteristics (structural, functional or otherwise) that are different from the naturally occurring bacteria. Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of non-inhibition. The test is not whether the ingredients all occur naturally together in nature. There is no indication that the claimed ingredients has any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients. Applicants can overcome the rejection by reciting a non-naturally occurring and synthetic ingredient which needs to be supported by the specification.
As such, the claims fail to recite subject matter that is patent eligible, and thus the claims do not amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
5. 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 1, 4-15 and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Graz et al. (WO 2018220340), “The Remarkable Ruminant Digestive System”, Machado et al. (US 20160339067), Cows Fed Seaweed Contribute Less Methane Emissions to Atmosphere” and Bromoform as evidenced by Kamra et al. “Garlic as a rumen modifier for eco-friendly and economic livestock production”.
Graz et al. (WO 2018220340) (hereinafter Graz et al.) disclose animal feed supplements comprising one organosulfur compounds and one phenolic (bioflavonoid) ( page 1, lines 1-5). Graz et al. disclose reducing methane emission or production and/or increase availability of nutrients to an animal (page 1, lines 25-26). The organosulfur compounds include diallyl disulphide and allicin (page 8, lines 25-30 and page 9, lines 1-5). Graz et al. disclose polyphenol (page 4, lines 19-21). The bioflavonoids include naringin (see page 3, lines 29-35). Narigin is a citrus extract. The compositions are for ruminant animals. As taught by “The Remarkable Ruminant Digestive System”, ruminant animals include cattle, sheep and goats. While Graz et al. does not specifically disclose inhibiting methanogens, it utilizes the same organosulfur compounds, e.g., allicin, to inhibit methane emissions. As evidenced by Kamra et al. “Garlic as a rumen modifier for eco-friendly and economic livestock production” disclose allicin are selective inhibitors of methanogenesis.
Gratz et al. does not disclose organohalogen compounds such as bromoform.
Machado et al. (US 20160339067) (hereinafter Machado et al.) disclose methods of reducing total gas production and/or methane production in a ruminant animal comprising administering Asparagopsis species such as A. taxiformis (claims 1-3 and 20). Biomass of wild Asparagopsis taxiformis in the benthic gametophyte phase collected from a site near Humpy Island, Keppel Bay contained approximately 0.22 mg/g DM halogenated metabolites, predominantly: 57% dibromoacetic acid; 26 % bromoform; and 17% dibromochloromethane (para 0207). As shown in FIG. 18, the inclusion of Asparagopsis in feed also significantly decreased methane production by the sheep (para 0214-0216).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to further include bromoform in the animal feed compositions of Gratz et al. One would have been motivated to do so as taught by Machado et al. for the purpose of reducing methane production. "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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
The modified Gratz et al. has been discussed supra and does not disclose the ratio of organohalogen to organosulfur.
Gratz et al. disclose the animal feed may contain 0.0001 wt % to about 10 wt % of total organosulfur compounds which include allicin (page 19, lines 29-page 20, line 7).
“Cows Fed Seaweed Contribute Less Methane Emissions to Atmosphere” (hereinafter the Seaweed reference) discloses that addition of less than 2 % of dried seaweed to a cow’s diet can reduce methane emissions by 99 % (first paragraph). The reference teaches the researchers tested a species of red algae called Asparagopsis taxiformis that grows off the coast of Queensland, Australia, they found it reduced methane production by more than 99 percent in the lab. In addition, it only required a dose of less than 2 percent to work effectively. Upon digestion, Asparagopsis produces a compound called Bromoform (CHBR3), which interacts with enzymes in ruminant stomachs and halts the cycle of methane production before the gas is released into the atmosphere. Thus low amounts of bromoform at any less than 2 % would be suitable to reduce methane admission. Combined with Graz et al. of up to 10 wt % organosulfur, and amounts as little as 0.01 % are suitable for methane production and meet the ratio of 1:1000. It is well known in the art that bromoform is toxic and long term oral exposure can have effects on liver, kidney and the central nervous system of animals (see Bromoform-General information) and thus it would be desirable to use as little as possible.
RESPONSE TO ARGUMENTS
6. Applicants’ arguments have been fully considered and are not persuasive for the reasons below.
Applicant argues that the claimed combination has markedly different characteristics as Applicant has demonstrated a synergistic effect in examples i and ii, and Table 1.
In response, the Examiner respectfully submits that this argument is not found persuasive because the Examples and Table 1 is not commensurate in scope with the showing of unexpected results. The Table 1 does not show a 1:10 ratio encompassed by claim 1.
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100C). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F .2d 731,741,218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.). To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
MPEP 716.02(d) states “The nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979) (Claims directed to mixtures of an herbicide known as "FENAC" with a diphenyl ether herbicide in certain relative proportions were rejected as prima facie obvious. Applicant presented evidence alleging unexpected results testing three species of diphenyl ether herbicides over limited relative proportion ranges. The court held that the limited number of species exemplified did not provide an adequate basis for concluding that similar results would be obtained for the other diphenyl ether herbicides within the scope of the generic claims. Claims 6-8 recited a FENAC:diphenyl ether ratio of 1:1 to 4:1 for the three specific ethers tested. For two of the claimed ethers, unexpected results were demonstrated over a ratio of 16:1 to 2:1, and the effectiveness increased as the ratio approached the untested region of the claimed range. The court held these tests were commensurate in scope with the claims and supported the nonobviousness thereof. However, for a third ether, data was only provided over the range of 1:1 to 2:1 where the effectiveness decreased to the "expected level" as it approached the untested region. This evidence was not sufficient to overcome the obviousness rejection.); In re Lindner, 457 F.2d 506, 509, 173 USPQ 356, 359 (CCPA 1972) (Evidence of nonobviousness consisted of comparing a single composition within the broad scope of the claims with the prior art. The court did not find the evidence sufficient to rebut the prima facie case of obviousness because there was "no adequate basis for reasonably concluding that the great number and variety of compositions included in the claims would behave in the same manner as the tested composition.").”
While the argument to the synergy is noted, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support”. Here the Examples are not commensurate in scope with the claims and as such the unexpected results of synergy are not persuasive.
Applicants argue that Kamra et al. teach that allicin was ineffective to inhibit methane emission.
In response, the Examiner respectfully submits that this argument is noted but not persuasive because Kamra et al. discloses
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In other words, allicin at these levels reduced methane production. Kamra et al. also states the results indicated that methane emission was adversely affected without disturbing rumen fermentation with inclusion of allicin in the reaction mixture, The reference also recognizes allicin as a natural antibiotic and the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. Claim 1 recites a ratio of 1:10 and the Examples do not demonstrate synergy at this level however, claim 25 requires the synergy and thus would be allowable over the prior art because no synergy is recognized. Claim 25 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
CONCLUSION
7. 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.
CORRESPONDENCE
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615