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 . 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.
Priority
The instant application is a 371 of PCT/EP2022/059712 filed on 04/12/2022 and claims foreign priority to European application no. EP21179750.1 filed on 06/16/2021 and EP21168701.7 filed on 04/15/2021. The certified copies of the foreign priority applications filed on 10/11/2023 are acknowledged.
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.
Status of the Claims
The preliminary claim amendments filed on 10/11/2023 is acknowledged. Claims 5-8 and 11-12 are amended.
Accordingly, claims 1-15 are pending and being examined on the merits herein.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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 Objections
Claims 2, 4-5, 9-10, 13, and 15 are objected to because of the following informalities:
Claim 2 is missing an “and” between the definitions of the R3 and R4 groups.
Claims 4, 9, 13, and 15 recites “4-hydroxy-3-methoxybenzaldehyd”, which appears to be missing the letter “e” at the end and should recite “4-hydroxy-3-methoxybenzaldehyde”.
Claims 5 and 10 recite “PDMN/ ani-mal/ day”, which should be corrected to “PDMN/ animal/ day”.
Claims 9, 13, and 15 recite “2 hydroxybenzoates”, which appears to be missing a hyphen and should recite “2-hydroxybenzoates”.
Appropriate correction is required.
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 1-4, 7-13, and 15 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.
The recitation “Use of” in claims 1and 15 is suggestive of a method, however the claim recites a use without setting forth any steps involved in the use. See MPEP 2173.05(q).
Claims 2-4 and 7-8 depend from claim 1 but do not overcome the described indefinite issue above.
Claim 2 recites “R1 is selected from the group consisting of H … , preferably from H, methyl, …”, “R2 is selected from the group consisting of H … , preferably from H, methyl, …”, “R3 is selected from the group consisting of H … , preferably from H, OH, … “, and “R4 is selected from the group consisting of C1-5 alkyl, … preferably from benzyl … “.
The phrase “preferably” is exemplary language (see MPEP 2173.05(d)) and renders the claim indefinite as it is unclear if the limitations that follow, which are the narrower embodiments of the preceding limitation, are limiting features of the claimed invention or exemplary embodiments.
Claims 4, 9, and 13 recites “mixture of phenolic substances comprises at least six, preferably … 3-hydroxyphenol, …”.
The phrase “preferably” is exemplary language (see MPEP 2173.05(d)) and renders the claim indefinite as it is unclear if the limitations that follow, which are the narrower embodiments of the preceding limitation, are limiting features of the claimed invention or exemplary embodiments.
Under broadest reasonable interpretation, instant claims 4, 9, and 13 are being interpreted as requiring at least six of the recited phenolic substances in the respective claims.
Claims 5 and 10 recites “from 0.05 to 5 g PDMN/ animal/ day, preferably from 0.1 to 4 g PDMN/ animal/ day, most preferably from 0.25 to 3 g PDMN/ ani-mal/ day.”
The phrase “preferably” is exemplary language (see MPEP 2173.05(d)) and renders the claim indefinite as it is unclear if the limitations that follow, which are the narrower embodiments of the preceding limitation, are limiting features of the claimed invention or exemplary embodiments.
Claims 6 and 11 recites “0.1 to 150 mg/kg body weight per day, preferably 1 to 150 mg/kg body weight per day, more preferably 50 to 150 mg per kg body weight per day”.
The phrase “preferably” is exemplary language (see MPEP 2173.05(d)) and renders the claim indefinite as it is unclear if the limitations that follow, which are the narrower embodiments of the preceding limitation, are limiting features of the claimed invention or exemplary embodiments.
Claims 7 and 12 recites “selected from the group consisting of domestic cattle, preferably from beef cattle or dairy cows”.
The phrase “preferably” is exemplary language (see MPEP 2173.05(d)) and renders the claim indefinite as it is unclear if the limitations that follow, which are the narrower embodiments of the preceding limitation, are limiting features of the claimed invention or exemplary embodiments.
Claim 8 recites “wherein the methane production is reduced by at least 10 %, preferably by at least 15 %, more preferably by at least 20 %, and most preferably by at least 25 %”.
The phrase “preferably” is exemplary language (see MPEP 2173.05(d)) and renders the claim indefinite as it is unclear if the limitations that follow, which are the narrower embodiments of the preceding limitation, are limiting features of the claimed invention or exemplary embodiments.
Claim 15 recites “at least six phenolic substances, preferably selected … 3-hydroxyphenol … 2 hydroxybenzoates (salicylates), preferably benzyl salicylate and isoamyl salicylate, more preferably selected form the group consisting of 3-hydroxyphenol…”.
The phrase “preferably” is exemplary language (see MPEP 2173.05(d)) and renders the claim indefinite as it is unclear if the limitations that follow, which are the narrower embodiments of the preceding limitation, are limiting features of the claimed invention or exemplary embodiments.
Claim 6 recites “… the phenolic substances (total amount) …”, claim 11 recites “… the phenolic substances are administered …in an amount (total) …”.
Claims 6 and 11 are indefinite because claims 1 and 9 (claims 6 and 11 depend from claims 1 and 9, respectively) recite “at least six phenolic substances”, making it unclear if the recited parentheticals are meant to further limit the respective “phenolic substances”.
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.
Claims 1-8 and 15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claims do not fall within at least one of the four categories of patent eligible subject matter because it is unclear if the claim is directed toward a product (PDMN and a mixture of six phenolic substances) or a method (a method for reducing the formation of methane emanating from the digestive activities of ruminants and/or for improving the organic matter digestibility in ruminants). See MPEP 2173.05(q).
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.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Duval et al. (US20140147529A1 in PTO-892) in view of Losa et al. (US20060188604A1 in PTO-892).
Duval teaches a method for reducing the production of methane emanating from the digestive activities of a ruminant and/or for improving ruminant animal performance by using, as active compound at least one organic molecule substituted at any position with at least one nitrooxy group, or a salt thereof, which is administrated to the animal together with the feed (see Abstract). Duval teaches that the active compound can be 3-nitrooxypropanol (see Table 1, first compound on paragraph 0032). Here, 3-nitrooxypropanol is also referred to as propanediol mononitrate or PDMN as evidenced by the instant specification (see page 2 lines 1-5 in instant specification). Duval teaches the active compound is preferably administered from 50 mg to 500 mg per kg of feed (see paragraph 0046). Duval teaches the preferred animal species is domestic cattle, sheep and goat (see paragraph 0043). Duval teaches the methane production in ruminants calculated in liters per kilogram of dry matter intake is reduced most preferably at least 30% (see paragraph 0044).
Duval demonstrates in Example 18 (paragraphs 00157-0164) the in vivo effect of 3-nitrooxypropanol in dairy cows, in which the cows were administered 500 mg / day or 2500 mg / day of 3-nitrooxypropanol (paragraph 0163). As seen in Table 9 (paragraph 0164), methane production and methane yield were significantly reduced by the 3-nitrooxypropanol in dairy cows, in which methane production was 93 and 90% of control values when the 500 and 2500 mg/day doses were given, respectively.
The difference between Duval and the claimed invention is that Duval does not teach a mixture of at least six phenolic substances.
Losa teaches a method for reducing the production of methane emanating from the digestion of animal by using one or more essential oil compounds selected from the group consisting of limonene, eugenol, a silicylate, quinoline, vanilla, thymol and a cresol, which are administered to the animal feed (see Abstract). Losa teaches the active essential oil compounds are suitable administrated per day in an amount preferably 0.1-20 mg/kg bodyweight of the animal (see paragraph 0008). Losa teaches that the essential oil compounds are incorporated into an animal feed composition, further teaches a feed premix contains 0.1-20% by dry weight of the essential oil compounds (see paragraph 0012) as well as the feed containing preferably 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed) (paragraph 0012).
Losa demonstrates in Example 1 efficacy of the essential oil compounds obtainable from plants on the formation of methane and VFA in an in vitro system. Losa lists in Table 1 (paragraph 0025) specific essential oil compounds tested. Here in Table 1, resorcinol is 3-hydroxyphenol, guajacol is 2-methoxyphenol, m-cresol is 3-methylphenol, thymol is 2-(1-methylethyl)-5-methyl-phenol, eugenol is 4-allyl-2-methoxyphenol, and benzyl salicylate meets the limitation of a 2-hydroxybenzoate.
Losa demonstrates in Example 2 the effect of a blend of the essential oils disclosed in Example 1 on the production of methane and VFA in vivo on sheep, and further discloses that each sheep was fed the blend in a dosage of 110 mg per animal per day (see paragraph 0026). As seen in paragraph 0028, the methane production was lower when the diet contained the blend according their invention in comparison with a control.
It would have been prima facie obvious before the effective filing date of the claimed invention to have combined the 3-nitrooxypropanol composition of Duval with the essential oil composition of Losa to arrive at the claimed invention. One of ordinary skill in the art would have made this combination with a reasonable expectation of success because both Duval and Losa demonstrate that their respective compositions are useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combined teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 7,763,273 (’273) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘273 recites a method for reducing the production of methane emanating from the digestive activities of an animal by using a mixture of essential oil compounds, which are administered to the animal, wherein the mixture contains: (a) 5-60% by weight of a mixture of limonene and eugenol, (b) a mixture of at least 10% by weight benzyl salicylate, at least 10% by weight quinoline, and at least 10% by weight vanilla, and (c) a mixture of thymol and cresol in an amount of 10 to 50% by weight based on the total amount of the limonene and eugenol mixture. Claim 2 of ‘273 recites wherein the mixture of essential oil compounds is administered per day in an amount of 0.01-50 mg per kg of bodyweight of the animal. Claim 3 of ‘273 recites wherein the mixture of essential oil compounds is administered via a feed composition or drinking water.
The difference between the claims of ‘273 and the claimed invention is that the claims of ‘273 do not recite a PDMN and at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘273 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘273, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘273 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9,266,814 (’814) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 4 of ‘814 recites a method for reducing the production of methane emanating from the digestive activities of ruminants comprising orally administering to a ruminant a sufficient amount of between about 1 mg/kg of feed to about 10 g/kg of feed of 3-nitrooxy propanol, and observing a methane reduction by the ruminant by at least 10% calculated in liters per kilogram of dry matter intake when measured in a metabolic chamber.
The difference between the claims of ‘814 and the claimed invention is that the claims of ‘814 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘814 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘814, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘814 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 9,902,685 (’685) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘685 recites a feed composition or feed additive for a ruminant comprising an amount between about 1 mg to about 10 g/kg of feed of 3-nitrooxy propanol sufficient to reduce production of methane emanating from digestive activities of a ruminant by at least 10% calculated in liters per kilogram of dry matter intake when measured in a metabolic chamber.
The difference between the claims of ‘685 and the claimed invention is that the claims of ‘685 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘685 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘685, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘685 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,154,981 (’981) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘981 recites a feed composition or feed additive for a ruminant animal comprising: (i) at least one antibiotic, and (ii) at least one organic molecule or a salt thereof which is selected from the group consisting of 3-nitrooxypropanol, rac-4-Phenylbutane-1,2-diyl dinitrate, 2-(hydroxymethyl)-2 (nitrooxymethyl)-1,3-propanediol, N-ethyl-3-nitro-oxy-propionic sulfonyl amide, 5-nitrooxy pentanenitrile, 5-nitrooxy-pentane, 3-nitro-oxy-propyl propionate, 1,3-bis-nitrooxypropane, 1,4-bis-nitrooxybutane, 1,5-bis-nitrooxypentane, 3-nitro-oxy-propyl benzoate, 3-nitro-oxy-propyl hexanoate, 3-nitro-oxy-propyl 5-nitro-oxy-hexanoate, benzylnitrate, isosorbid-dinitrate, N-[2-(nitrooxy)ethyl]-3-pyridinecarboxamide, 3-nitrooxy propionic acid, methyl-3-nitrooxy propionate, ethyl-3-nitrooxy propionate, ethyl-4-nitrooxy butanoate, ethyl-3-nitrooxy butanoate, 5-nitrooxy pentanoic acid, ethyl-5-nitrooxy pentanoate, 6-nitrooxy hexanoic acid, ethyl-6-nitrooxy hexanoate, ethyl-4-nitrooxy-cyclohexylcarboxylate, 8-nitrooxy octanoic acid, ethyl-8-nitrooxy octanoate, 11-nitrooxy undecanoic acid, ethyl-11-nitrooxy undecanoate, 5-nitrooxy-pentanoic amide and 5-nitrooxy-N-methyl-pentanoic amide, wherein the at least one organic molecule is present in an amount sufficient to reduce formation of methane emanating from digestive activities of the ruminant animal and/or to improve performance of the ruminant animal, and wherein the at least one organic molecule and the at least one antibiotic are present in a weight ratio of the at least one organic molecule to the at least one antibiotic of between 0.05 and 50. Claim 6 of ‘981 recites wherein e organic molecule is present in an amount sufficient to reduce formation of methane emanating from digestive activities of ruminants calculated in liters per kilogram of dry matter intake by at least 10% when measured in metabolic chambers. Claim 8 of ‘981 recites wherein the amount of the at least one antibiotic is present in an amount from 0.5 to 150 mg per kg feed.
The difference between the claims of ‘981 and the claimed invention is that the claims of ‘981 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘981 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘981, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘981 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,191,288 (’288) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘288 recites a method for reducing the production of methane emanating from the digestive activities of ruminants and/or for improving ruminant animal performance comprising orally administering to the animal a feed composition or feed additive comprising 3-nitrooxypropanol and lauric acid in a mol ratio of the 3-nitrooxypropanol to the lauric acid of between 0.0025 and 0.1 sufficient to achieve an amount of the 3-nitrooxypropanol administered to the ruminant animal of from 1 mg to 10 g per kg feed, and an amount of the lauric acid administered to the ruminant animal of from 0.1 to 20 g per kg of feed.
The difference between the claims of ‘288 and the claimed invention is that the claims of ‘288 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘288 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘288, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘288 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,712,424 (’424) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘424 recites a non-therapeutic method for alleviating or reducing stress symptoms of a ruminant, the method comprising administering to the ruminant in need of alleviation or reduction of stress symptoms an effective amount of propanediol mononitrate or chloroform to increase endogeneous methyl donors in rumen fluid of the ruminant prior to experiencing stress, while experiencing stress and/or after having experienced stress.
The difference between the claims of ‘424 and the claimed invention is that the claims of ‘424 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘424 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘424, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘424 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,370,151 (’151) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘151 recite a method for the non-therapeutic alleviation or prevention of symptoms of stress in ruminants, wherein the method comprises the consecutive steps of: (a) assessing a present or future stress situation which induces a stress symptom in a ruminant, and (b) administering to the ruminant an amount of a methane inhibitor or an amount of a composition comprising the methane inhibitor, wherein the methane inhibitor is propanediol mononitrate or chloroform, which is sufficient to alleviate or prevent the stress symptom in the ruminant prior to the ruminant experiencing the stress situation, while the ruminant is experiencing the stress situation and/or after the ruminant having experienced the stress situation.
The difference between the claims of ‘151 and the claimed invention is that the claims of ‘151 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘151 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘151, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘151 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,193,456 (’456) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘456 recites a method for reducing methane emission in adult ruminants, said method comprising administering to said ruminants an effective amount of a composition comprising 3-nitrooxypropanol (3-NOP) from birth up to an age of a maximum of 6 months.
The difference between the claims of ‘456 and the claimed invention is that the claims of ‘456 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘456 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘456, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘456 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of copending Application No. 18/954,372 (‘372) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 2 of ‘372 recite a feeding regime for reducing methane emissions in adult ruminants, comprising: administering a diet comprising 3-nitrooxypropanol to said ruminant in its pre-ruminant and optionally young ruminant phase followed by administering a diet which does not contain 3-nitrooxypropanol to the adult ruminant.
The difference between the claims of ‘372 and the claimed invention is that the claims of ‘372 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘372 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘372, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘372 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/554,927 (‘927) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘927 recites use of gossypol and a methane inhibitor for reducing the formation of methane emanating from the digestive activities of ruminants, wherein the methane inhibitor is administered to the ruminant in an amount selected in the range from 0.01 to 100 g methane inhibitor/animal/day and gossypol is administered to the ruminant in an amount selected in the range from 0.05 to 100 g gossypol/animal/day.
The difference between the claims of ‘927 and the claimed invention is that the claims of ‘927 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘927 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘927, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘927 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/555,329 (‘329) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘329 recites use of limonene and PDMN for reducing the formation of methane emanating from the digestive activities of ruminants.
The difference between the claims of ‘329 and the claimed invention is that the claims of ‘329 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘329 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘329, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘329 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/555,095 (‘095) in view of Duval et al. (US20140147529A1 in PTO-892) and Losa et al. (US20060188604A1 in PTO-892).
Claim 1 of ‘095 recites use of gossypol and propanediol mononitrate (PDMN) for reducing the formation of methane emanating from the digestive activities of ruminants, wherein propanediol mononitrate is administered to the ruminant in an amount selected in the range from 0.05 to 5 g PDMN/animal/day and gossypol is administered to the ruminant in an amount selected in the range from 0.05 to 100 g gossypol/animal/day.
The difference between the claims of ‘095 and the claimed invention is that the claims of ‘095 do not recite at least six phenolic substances.
The independent teachings of Duval and Losa are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have further included in the composition recited in the claims of ‘095 the 3-nitrooxypropanol of Duval and the essential oil compounds of Losa. One of ordinary skill in the art would have made this modification with a reasonable expectation of success the claims of ‘095, Duval, and Losa are recite their respective compositions being useful in reducing the production of methane emanating from the digestion of animal. See In re Kerkhoven, MPEP 2144.06 I.
In regards to instant claim 14, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the PDMN and the mixture of phenolic compounds in the combined composition as taught by the combination of the claims of ‘095 and the teachings of Duval and Losa described above in the recited mg per kg feed because Duval provides guidance of an overlapping range of the 3-nitrooxypropanol being administered 50 mg to 500 mg per kg of feed, and Losa provides guidance of an overlapping range of a feed containing 1-1000 ppm of the essential oil compounds (converts to 1 mg / kg feed to 1000 mg / kg feed). See MPEP 2144.06 I.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693