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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 2 and 5-7 in the reply filed on September 10, 2026 is acknowledged.
Claims 1, 3, and 4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 10, 2026.
Claim Objections
Claim 2 is objected to because of the following informalities: in line 4, either “phase” should follow “pre-ruminant” or “phase” (after “young ruminant”) should be amended to “phases”. Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities: the description for Figure 1 states, “dotted line: treatment group; solid line: control group” (p.14 lines 1-4). The Results section states that methane emissions in the treatment group was significantly reduced. However in Figure 1 the dottle line is above the solid line for the entire duration shown. Either one or more parts of the Specification (or Figure 1) is incorrect. Appropriate corrections are required.
The disclosure is also objected to because it contains an embedded hyperlink and/or other form of browser-executable code. See page 4, lines 19-22 (para.002, pre-grant publication US 2025/0098709). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Interpretation
Claims 2 and 5-7 recite “pre-ruminant”, “young ruminant”, and “adult ruminant(s)”. Applicant discloses, in “the present invention, the term 'pre-ruminant' refers to the animal which is still (at least partly) not yet weaned, while the term 'young ruminant' refers to the phase where the rumen is still not fully developed but the calf has been weaned (i.e. does not receive any milk anymore)” (para.0023 pre-grant publication US 2025/0098709).
Regarding “adult ruminant(s)” in claim 2, the disclosure also states, “[t]he final stage in the development to the adult ruminant occurs when the rumen is considered to be fully functioning, which generally happens at an age of 12 weeks” (id. para.0022). The disclosure here leads to rejection of the claim 2 under 35 U.S.C. 112(a) and one of the objections to the Specification.
Claim Rejections - 35 USC § 101
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.
Claim 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim does not fall within at least one of the four categories of patent eligible subject matter because it recites a process without setting forth any steps involved in the process. Therefore claim 1 is not a proper process claim under 35 U.S.C. 101.
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 2, 5, and 7 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.
Regarding claim 2 which recites “adult ruminant(s)”, the disclosure states, “[t]he final stage in the development to the adult ruminant occurs when the rumen is considered to be fully functioning, which generally happens at an age of 12 weeks” (id. para.0022). The sentence is unclear which “generally happens at an age of 12 weeks”: (i) “[t]he final stage in the development to the adult ruminant”, or (ii) “the rumen is considered to be fully functioning”. In the Example the treated group was administered 3-nitrooxypropanol until three weeks post-weaning or week 14 (para.0087 pre-grant publication). It is not specified whether the 14 week old ruminant is an “adult” or “young ruminant”. The disclosure cites “Teagasc 2017: Rumen development, Section 4; Chapter 12, page 60” with a hyperlink to an unavailable reference. Consequently the meaning of “adult ruminant(s)” is vague, and the standard for determining whether an animal is “adult” versus “young ruminant” also appears vague.
Regarding claim 5, attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claim 5 recites “[u]se of 3-nitrooxypropanol in pre-ruminants to mitigate climate change by reducing the total life-time methane emission…”. This is indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “by at least 5%”, and the claim also recites “preferably by at least 10%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez-Hess (Alvarez-Hess, P.S., et al., A partial life cycle assessment of the greenhouse gas mitigation potential of feeding 3-nitrooxypropanol and nitrate to cattle, Agricultural Systems 169 (2019) 14-23, Available online 03 December 2018) in view of Duin (Duin, E.C., et al., Mode of action uncovered for the specific reduction of methane emissions from ruminants by the small molecule 3-nitrooxypropanol, PNAS (May 31, 2016) 6172–6177).
Alvarez-Hess studied administering 3-nitrooxypropanol to calves to assess methane and other greenhouse gas reduction (title; abstract). The study involved five different cattle-farm types (Table 1 and accompanying text), with each herd “from birth to slaughter”, i.e., including cow in the pre-ruminant phase (p.15 Section 2.1.1, p.16 Section 2.2.1 ). The ABNP2 group comprising the entire herd had a net GHG abatement including enteric methane (Table 6 and accompanying text). Duin teaches that in “pure cultures, 3-NOP is demonstrated to inhibit growth of methanogenic archaea at concentrations that do not affect the growth of nonmethanogenic bacteria in the rumen” (abstract; see title; Fig.5 and accompanying text).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to use the method Alvarez-Hess to “influenc[e] the microbial colonization pattern of the rumen of a ruminant” by administering 3-nitrooxypropanol as recited in claim 6. The skilled person would have been suggested to do so because both are drawn to the effects of 3-nitrooxypropanol on methane production in ruminants, and Duin teaches that 3-nitrooxypropanol not only reduces methane generation but it also inhibits “growth of methanogenic archaea at concentrations that do not affect the growth of nonmethanogenic bacteria in the rumen”.
Regarding claim 7, it is noted that “simply expresses the intended result of a process step positively recited” in a method claim is not given weight. MPEP §2111.04(I)(citations omitted). Here claim recites a desired result from the administering step of claim 6. Thus the clause raises a question as to the limiting effect of the claim language. Such a clause “in a method claim is not given weight when it simply expresses the intended result of a process step positively recited”, as in the instant claim. MPEP § 2111.04 (citations omitted).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2 and 5-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 12193456 as evidenced by Duin (Duin, E.C., et al., Mode of action uncovered for the specific reduction of methane emissions from ruminants by the small molecule 3-nitrooxypropanol, PNAS (May 31, 2016) 6172–6177
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to a feeding method for reducing methane emissions in adult ruminants, comprising: (1) administering a diet comprising 3-nitrooxypropanol to said ruminant in its pre-ruminant and optionally young ruminant phase followed by (2) administering a diet which does not contain 3-nitrooxypropanol to the adult ruminant. The ‘456 patent’s claims recite feeding 3-nitrooxypropanol “up to an age of maximum 6 months”; however this means 3-nitrooxypropanol is not administered to an adult ruminant as in the present claims. Duin teaches that in “pure cultures, 3-NOP is demonstrated to inhibit growth of methanogenic archaea at concentrations that do not affect the growth of nonmethanogenic bacteria in the rumen” (abstract; see title; Fig.5 and accompanying text).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to use the method Alvarez-Hess to “influenc[e] the microbial colonization pattern of the rumen of a ruminant” by administering 3-nitrooxypropanol as recited in claim 6. The skilled person would have been suggested to do so because both are drawn to the effects of 3-nitrooxypropanol on methane production in ruminants, and Duin teaches that 3-nitrooxypropanol not only reduces methane generation but it also inhibits “growth of methanogenic archaea at concentrations that do not affect the growth of nonmethanogenic bacteria in the rumen”.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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H. SARAH PARK
Primary Examiner
Art Unit 1614
/H. SARAH PARK/Primary Examiner, Art Unit 1614
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