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 . Claims 1-15 filed May 14, 2026 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group (II), claims 7-9 in the reply filed on 05/14/2026 is acknowledged.
Claims 1-6 and 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/14/2026. Secondly, Applicant’s election without traverse of propanediol mononitrate as the species of methane inhibitor in the reply filed on 05/14/2026 is acknowledged.
Priority
Acknowledgement is made of the national stage entry of PCT/EP2022/059716 filed 04/12/2022, which claims priority to foreign application EP21168703.3 filed 04/15/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/11/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112-Paragraph B
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 8-9 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 claims 8-9, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112-Paragraph D
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 embraces the range of from 0.05 to 100 g gossypol/animal/day. Claim 9 depends upon the methodology of claim 7 and comprises the limitation of “most preferably from 0.02 to 25 g gossypol/animal/day”. The range of 0.02 to 25 g gossypol/animal/day in claim 9 fails to further limit the range of 0.05 to 100 g gossypol/animal/day found in claim 7 as 0.02 g gossypol present in claim 9 is a broader endpoint to the range than the 0.05 to 100 g gossypol/animal/day range found within the claim from which it depends (claim 7). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Duval (WO2012/084629 published 06/28/2012), Grainger (J. Dairy Sci. Vol. 93 pages 2612-2619 published 2010), Morgan (Gossypol Toxicity in Livestock: Division of Agricultural Sciences and Natural Resources Oklahoma State University Published 2017) and Wang (Toxins Vol. 9 pages 1-12 published 03/08/2021).
Duval (WO2012/084629 published 06/28/2012) teaches compounds of Formula (I) as potent methane inhibitors for ruminants (abstract, claims 1-4, 8-10). Duval teaches that said compounds reduce the formation of methane without affecting microbial fermentations in a way that would be detrimental to the animal (page 3 lines 10-20). Duval teaches oral administration of the methane inhibitor 3-nitrooxypropanol in a dose of 500 mg/day to the ruminant of a dairy cow, resulting in a significant reduction in methane emission compared to control ruminants (pages 38-40, Table 9).
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As evidenced by CAS Registry Database, the methane inhibitor 3-nitrooxypropanol of Duval is also art-recognized as the elected methane inhibitor propanediol mononitrate. Said 500 mg/day of propanediol mononitrate to the ruminant lies inside the 0.01g to 100 g methane inhibitor embraced within the claims. Duval further teaches that the dose of said orally administered methane inhibitor can vary from 1 mg to 10 g per 1 kg of feed (pages 13-14, 17).
The difference between the present claims and that of Duval is that Duval does not specifically teach administration of gossypol with the methane inhibitor propanediol mononitrate, in a dose of 0.05 to 100 g gossypol/animal/day.
Grainger (J. Dairy Sci. Vol. 93 pages 2612-2619 published 2010) teaches the incorporation of whole cottonseed into a daily ruminant diet of alfalfa hay and ryegrass silage in dairy cows resulted in a persistent reduction in methane emissions in the fed livestock (abstract). Grainger teaches that whole cottonseed supplementation reduced methane emissions by 14% over the course of 12 week treatment cycle (page 2615 right col., page 2618 right col.). As evidenced by Morgan (Gossypol Toxicity in Livestock: Division of Agricultural Sciences and Natural Resources Oklahoma State University Published 2017), the claimed gossypol is present in the whole cottonseed administered with the daily ruminant diet of Grainger (pages 1-2).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to incorporate whole cottonseed which comprises gossypol into a ruminant feed for dairy cows comprising the methane inhibitor propanediol mononitrate, wherein the methane inhibitor is administered in a dose of 500 mg/day in view of Grainger, arriving at the presently claimed methodology.
MPEP 2143 provides a rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, motivation to administer the compositions together flows logically from the very fact each agent or combination of agents was known in the prior art to have the same therapeutic utility of reducing methane production in cows and, in turn, raises the reasonable expectation of success, that when combined, a composition comprising gossypol in whole cottonseed and 500 mg/day propanediol mononitrate would be efficacious at reducing methane production in cattle. The instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that 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 (MPEP 2144.06).
Regarding the limitation directed to the amount of gossypol is from 0.05 to 100g gossypol/animal per day, the optimum amount of gossypol administered with the methane inhibitor propanediol mononitrate would have been a matter well within the insight of one of ordinary skill in the art. Such a determination would have been made in accordance with a variety of factors, such as the pharmacological considerations, including activity, efficacy, pharmacokinetics and toxicology profiles of the combined regimen, as well as the age, weight, and sex of the ruminant. Thus, the amount of methane inhibitor and gossypol that would have been employed would have varied widely and, in the absence of evidence to the contrary, the current claimed specific administration regimen is not seen to be inconsistent with one that would have been determined by the skilled artisan.
Wang (Toxins Vol. 9 pages 1-12 published 03/08/2021) teaches that the maximum tolerable intake of gossypol in feeds is less than 500 mg per kg of animal (page 2, page 6). As Duval teaches that said dairy cows range from 550-800 kg (pages 38-40; Example 18), the maximum tolerable intake of gossypol is from 275 g gossypol/dairy cow/day, which overlaps the amount of 0.02-25 g gossypol/day found within the claims. Applicant is reminded of MPEP 2144.05 wherein 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Furthermore, absent and evidence demonstrating a patentable difference between the compositions administered and the criticality of the claimed amounts, the determination of the optimum or workable amounts of methane inhibitor and gossypol given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)(”[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the workable ranges by routine experimentation.”)
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 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-9 of copending Application No. 18554886 in view of Duval (WO2012/084629 published 06/28/2012).
Claims 8-9 of copending Application 18554886 are directed to the reducing methane emission in a ruminant comprising orally administering a dose of 25-150 g of gossypol/animal/day. Said dose of 25-150 g of gossypol/ruminant/day overlaps with the 0.02-25 g gossypol/animal/day embodied within the present claims. Applicant is reminded of MPEP 2144.05 wherein 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
The difference between the present claims and that of copending Application 18554886 is that claims 8-9 of copending Application 18554886 do not specifically teach combining said 25-150 g dose of gossypol/ruminant/day with 0.01-25 g of a methane inhibitor.
Duval (WO2012/084629 published 06/28/2012) teaches compounds of Formula (I) as potent methane inhibitors for ruminants (abstract, claims 1-4, 8-10). Duval teaches that said compounds reduce the formation of methane without affecting microbial fermentations in a way that would be detrimental to the animal (page 3 lines 10-20). Duval teaches oral administration of the methane inhibitor 3-nitrooxypropanol in a dose of 500 mg/day to the ruminant of a dairy cow, resulting in a significant reduction in methane emission compared to control ruminants (pages 38-40, Table 9).
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As evidenced by CAS Registry Database, the methane inhibitor 3-nitrooxypropanol of Duval is also art-recognized as the elected methane inhibitor propanediol mononitrate. Said 500 mg/day of propanediol mononitrate to the ruminant lies inside the 0.01g to 100 g methane inhibitor embraced within the claims. Duval teaches the dose of said orally administered methane inhibitor can vary from 1 mg to 10 g per 1 kg of feed (pages 13-14, 17).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to incorporate the methane inhibitor propanediol mononitrate, in a dose of 500 mg/animal/day to the methane inhibiting dose of 25-150 g gossypol/animal/day as taught by claims 8-9 of copending Application 18554886 in view of Duval, arriving at the presently claimed methodology.
MPEP 2143 provides a rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to obtain predictable results;
In the present case, motivation to administer the compositions together flows logically from the very fact each agent or combination of agents was known in the prior art to have the same therapeutic utility of reducing methane production in cows and, in turn, raises the reasonable expectation of success, that when combined, a composition comprising 25-150 g gossypol/animal/day and 500 mg/day propanediol mononitrate would be efficacious at reducing methane production in cattle. The instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that 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 (MPEP 2144.06).
Claims 7-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7-9 of copending Application No. 18555095
Claims 7-9 of copending Application 18555095 are directed to a method for reducing the production of methane emanating from the digestive activities of ruminants, said method comprising orally administering to the ruminant an effective amount of gossypol and the methane inhibitor propanediol mononitrate, wherein the effective amount of propanediol mononitrate is selected in the range from 0.05 to 5 g PDMN/ animal/ day and the effective amount of gossypol is selected in the range from 0.05 to 100 g gossypol/ animal/ day. The methodology of claims 7-9 of copending Application 18555095 lies inside the presently claimed methodology of orally administering to the ruminant an effective amount of gossypol and the genus of any methane inhibitor, wherein the effective amount of the methane inhibitor is selected in the range 0.01 to 100 g methane inhibitor/animal/day and the effective amount of gossypol is selected in the range from 0.05 to 100 g gossypol/ animal/ day.
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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