DETAILED ACTION
Background
The preliminary amendment dated October 13, 2023 (amendment) amending claims 3-6, 9 and 12 has been entered. Claims 1-15 as filed with the amendment have been examined.
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 .
Claim Objections
Claims 3, 5, 11 and 15 are objected to because of the following informalities:
In claim 3, at line 4 after “PDMN/” replace [[ani-mal]] with --animal;
In claim 5, at lines 2-3 after “comprised between” on line 2 replace [[100 and 1]] with --100:1 and 1:1--; at line 3, after “preferably between” replace [[75 to 1]] with --75:1 to 1:1--, and, after “more preferably between” replace [[60 to 5]] with --60:1 to 5:1--, and at lines 3-4, after “most preferably between” replace [[25 to 5]] with --25:1 to 5:1--;
In claim 11, at line 2 after “comprised between” replace [[100 and 1]] with --100:1 and 1:1--; at line 2, after “preferably between” replace [[75 to 1]] with --75:1 to 1:1--; at lines 2-3, after “more preferably between” on line 3 replace [[60 to 5;]] with --60:1 to 5:1,--, and, at line 3 after “most preferably between” replace [[25 to 5]] with --25:1 to 5:1--; and,
In claim 15, at line 1 after “ratio of” replace [[limonene]] with --D-limonene; and,
at line 2 after “comprised between” replace [[100 and 1]] with --100:1 and 1:1--; at line 2, after “preferably between” replace [[75 to 1]] with --75:1 to 1:1--; at lines 2-3, after “more preferably between” on line 3 replace [[60 to 5;]] with --60:1 to 5:1,--, and, at line 3 after “most preferably between” replace [[25 to 5]] with --25:1 to 5:1--.
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 1-15 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.
In claims 1-6 and 14-16, the recited use is indefinite because the claims do not recite any affirmative method steps; and it is not clear whether the claims recite a method or a composition of matter. The claims must say what one must do to carry out to recited use. Alternatively, the claims may recite a composition and an intended use.
The Office interprets the claimed use as comprising a method of administering the claimed propanediol mononitrate and limonene to a ruminant.
Regarding instant claims 3, 4, 5, 6, 8, 9, 11 and 14-15, 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, the claims recite a broad range or limitation together with a narrow range or limitation, as follows:
Claim 3 recites the broad limitation “from .05 to 5 g PDMN/ animal/ day” and the claim also recites “ preferably 0.1 to 4 g PDMN/ animal/ day, most preferably from 0.25 to 3 g PDMN/ ani-mal/ day” which is the narrower statement of the range/limitation; claim 4 recites the broad limitation “from 0.05 to 100 g limonene/ animal/ day” and the claim also recites “preferably from 0.1 to 50 g limonene/ animal/ day, most preferably from 0.2 to 25 g limonene/ animal/ day” which is the narrower statement of the range/limitation; claim 5 recites the broad limitation “a molar ratio of limonene to propanediol mononitrate is comprised between 100:1 and 1:1” and the claim also recites “preferably between 75:1 to 1:1, more preferably between 60:1 to 5:1, most preferably between 25:1 to 5:1” which is the narrower statement of the range/limitation; claim 6 recites the broad limitation “selected from the group of domestic cattle” and the claim also recites “most preferably from beef cattle or dairy cows” which is the narrower statement of the range/limitation; claim 8 recites the broad limitation “from 0.1 to 4 g PMDN/ animal/ day” and the claim also recites “most preferably from 0.25 to 3 g PMDN/ animal/ day” which is the narrower statement of the range/limitation; claim 9 recites the broad limitation “from 0.1 to 50 g limonene/ animal/ day” and the claim also recites “most preferably from 0.2 to 25 g limonene/ animal/ day” which is the narrower statement of the range/limitation; claim 11 recites the broad limitation “a molar ratio of limonene to propanediol mononitrate is comprised between 100:1 and 1:1” and the claim also recites “preferably between 75:1 to 1:1, more preferably between 60:1 to 5:1, most preferably between 25:1 to 5:1” which is the narrower statement of the range/limitation; claim 14 recites the broad recitation “limonene” and the claim also recites “preferably D-limonene” which is the narrower statement of the range/limitation; and, claim 15 recites the broad recitation “a molar ratio of limonene to propanediol mononitrate is comprised between 100:1 and 1:1” and the claim also recites “preferably between 75:1 to 1:1, more preferably between 60:1 to 5:1, most preferably between 25:1 to 5:1” which is the narrower statement of the range/limitation.
Each of 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.
Claims 7, 10 and 12-13 are rejected as depending from a rejected base claim.
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.
Claims 1, 3-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US2014/0147529 A1 to Duval et al. (Duval) in view of US 7,763,273 B2 to Losa (Losa).
US2014/0147529 A1 is equivalent to WO2012/084629 A1, of record. US7,763,273 B2 is equivalent to WO03/094628 A1, of record.
Regarding instant claims 1, 3, 6-7 and 8, Duval at [0014] discloses a method for reducing the production of methane emanating from the digestive activities of ruminants (also “reducing the formation of methane emanating from the digestive activities of ruminants” - claim 1) comprising orally administering to a ruminant (claim 7, as a “use” in claim 1) a compound of formula (I) comprising at least one nitrooxy group including (at [0031]) 3-nitrooxypropanol, which is the same compound as the claimed propanediol mononitrate. At [0039]-[0040], Duval discloses the use of compounds of formula (I) together with essential oils that also reduce methane formation in the rumen, wherein the amount of propanediol mononitrate disclosed (at [0071]) ranges from about 1 mg to about 10 g per kg of feed. At Example 18 and [0157]-[0159] and accompanying Table 8, Duval discloses administering 500 mg/day and 2500 mg/day of the propanediol mononitrate (PMDN) to dairy cows (claim 6), or about 0.5 to 2.5 g PMDN/ animal/day (claims 3 and 8).
Further, and regarding instant claims 4-5 and 9-11, Duval does not disclose limonene as its essential oil as in claim 1; further, Duval does not disclose administering the limonene to the ruminant in an amount selected in the range from 0.05 to 100 g limonene/ animal/ day, from 0.1 to 50 g limonene/ animal/ day as in claims 4 and 9, or from 0.2 to 25 g limonene/ animal/ day as in claims 4 and 9, or from 0.25 to 3 mg limonene/ animal/ day as in claim 4; still further, Duval does not disclose a use as in claim 5 or a method as in claim 11 wherein the molar ratio of limonene to propanediol mononitrate is comprised between 100:1 and 1:1, between 75:1 to 1:1, between 60:1 to 5:1 or between 25:1 to 5:1; and, Duval does not disclose a feed composition or feed additive comprising limonene and propanediol mononitrate, wherein the feed composition is a ruminant feed comprising limonene in an amount selected in the range from 5 mg to about 5 g limonene per kg dry matter feed and propanediol mononitrate in an amount selected in the range from 20 mg to 250 mg propanediol mononitrate per kg dry matter feed as in claim 10.
However, Duval at [0051] discloses feeds comprising from 50 to 500 mg per kg of feed, which the claimed 20 to 250 mg overlaps. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", the Office considers that a prima facie case of obviousness exists. See MPEP 2144.05.I. The ordinary skilled artisan in Duval would have found it obvious to use the claimed amount of propanediol mononitrate or PDMN in its feed because Duval discloses that the claimed amount of PDMN provides a desirable animal feed for reducing methane production in ruminants.
Further, given that Duval in Example 3 at [0106] discloses that PDMN has a MW 121.04, Duval discloses in Example 18 administering 0.5 to 2.5 g PDMN/ animal/ day or about 0.5/121 to about 2.5/121 moles PDMN/ animal/ day or about 0.0041 to about 0.021 moles PDMN/ animal/ day. Still further, Table 9 of Duval discloses in its Example 18 administering 18.9 Kg feed/ animal/ day or about 500 to 2500 mg/18.9 Kg feed/day or about 26.5 to about 132 mg propanediol mononitrate per kg dry feed as in claim 10.
Losa at Abstract discloses methods for reducing the production of methane emanating from the digestion of animals by administering to the animal feed one or more essential oil compounds selected from the group consisting of limonene. In Example 1 at col. 4, lines 35-40 and Table 1, Losa discloses methane reduction in the digestion of ruminants. At col. 2, lines 24-31, Losa discloses its active essential oil compounds including 100% limonene suitably administrated per day in an amount from 0.01-50 mg/Kg bodyweight of the animal per day.
The cows in disclosed in Example 18 of Duval at [0157] weigh from 550 to 800 Kg. Accordingly, Losa at col. 2, lines 24-31 a discloses using or administering to cows from a minimum of 550 Kg x 0.01 mg/Kg or 5.5 mg to a maximum of 800 Kg x 50 mg/Kg or 40,000 mg or 40 g limonene per animal per day or 0.0055 to 40 g limonene/ animal/ day which the claimed 0.1 to 50 g limonene/ animal/ day in claims 4 and 9 overlaps. See MPEP 2144.05.I. The ordinary skilled artisan in Losa would have found it obvious in view of Losa to administer or use the claimed amount of limonene/ animal/ day because Losa discloses that the claimed amount of limonene provides desirable reduction in methane production in ruminants.
Limonene as depicted at page 2 of the instant specification has a molecular weight (MW) of about 136 g/mol. Accordingly, the 0.0055 to 40 g limonene/ animal/ day disclosed in Losa at col. 2, lines 24-31 equals from 0.0055 g/136 g/mol to 40g/136 g/mol or 4.04 x 10-5 or about 0.00004 to about 0.29 mol limonene/ animal/ day.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Losa for Duval to use or administer the claimed 0.1 to 50 g limonene/ animal/ day as its essential oil as in claims 4 and 9. Both references disclose administering essential oils to ruminants as feed additives or in feeds to reduce methane production in ruminant digestion. The ordinary skilled artisan would have desired to use the limonene of Losa as the essential oil of Duval to help reduce methane production in ruminants as disclosed in Losa at col. 2, lines 24-31. Further, the ordinary skilled artisan in Duval would found it obvious to use the claimed molar ratio of limonene to propanediol mononitrate of between 100:1 and 1:1 as in claims 5 and 15 to reduce methane emissions because Losa discloses 0.00004 to 0.29 mol limonene to reduce methane production while Example 18 of Duval discloses 0.0041 to about 0.021 moles propanediol mononitrate to reduce methane production, or a molar ratio of limonene to propanediol mononitrate of from a maximum of 0.29 limonene: 0.021 propanediol mononitrate or about 14:1 to a minimum of 0.00004 limonene: 0.0041 propanediol mononitrate or about 1:100, which the claimed molar ratio of between 100:1 and 1:1 overlaps. See MPEP 2144.05.I.
Further, in Duval as modified by Losa the 0.0055 to 40 g limonene/ animal disclosed in Losa at col. 2, lines 24-31 when used with 18.9 kg dry feed in Example 18 of Duval equates to about 0.3 mg to about 2.1 g limonene per kg fry feed, which the claimed 5 mg to 5 g limonene per kg dry matter feed overlaps. See MPEP 2144.05.I.
The ordinary skilled artisan in Duval would have found it obvious in view of Losa to administer or use the claimed molar ratio of limonene to propanediol mononitrate and the claimed mass of limonene and of propanediol mononitrate per kg dry matter feed because Duval discloses that the claimed amount of propanediol mononitrate in moles and per kg of dry matter feed provides desirable reduction in methane production in ruminants and includes an essential oil, while Losa discloses that the claimed amount of the essential oil limonene in moles and per kg of dry matter feed provides the desired reduction in methane production.
Regarding instant claim 13, Duval at [0050] discloses the composition as a feed or feed additive that is a mineral premix, a vitamin premix or a bolus.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over US2014/0147529 A1 to Duval et al. (Duval) in view of US 7,763,273 B2 to Losa (Losa) as applied to claims 1 and 7 above, and further in view of WO2021/163148 A1 to Farmer et al. (Farmer).
As applied to claims 1 and 7, Duval at [0014], [0031] and [0039]-[0040] as modified by Losa at col. 2, lines 24-31 discloses a use of limonene and propanediol mononitrate for reducing the formation of methane emanating from the digestive activities of ruminants and method for reducing the production of methane emanating from the digestive activities of ruminants comprising orally administering to a ruminant propanediol mononitrate and limonene.
Duval does not disclose D-limonene as in claims 2 and 12;
Farmer at page 4, lines 12-20 discloses methods for reducing greenhouse gas emissions from livestock comprising methane by administering to the animals (at page 6, lines 14-22) 3-nitrooxy propanol or propanediol mononitrate and D-limonene as a terpene.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Farmer for Duval as modified by Losa to use D-limonene as its limonene. All references disclose methods of reducing the production of methane emanating from the digestive activities of ruminants using essential oils. The ordinary skilled artisan in Duval as modified by Losa would have desired to use the D-limonene of farmer as its active essential oil because Farmer discloses that D-limonene provides a desirable methane reduction when fed with propanediol mononitrate to ruminants.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over US2014/0147529 A1 to Duval et al. (Duval) in view of US 7,763,273 B2 to Losa (Losa) and WO2021/163148 A1 to Farmer et al. (Farmer).
Duval at [0014] discloses reducing the formation of methane emanating from the digestive activities of ruminants comprising orally administering to a ruminant a compound of formula (I) of Duval, the use comprising at least one nitrooxy group including (at [0031]) 3-nitrooxypropanol, which is the same compound as the claimed propanediol mononitrate. At [0039]-[0040], Duval discloses the use of compounds of formula (I) together with essential oils that also reduce methane formation in the rumen, wherein the amount of propanediol mononitrate disclosed (at [0071]) ranges from about 1 mg to about 10 g per kg of feed.
Duval does not disclose using D-limonene as in claim 14 and does not disclose a use as in claim 15 wherein the molar ratio of limonene to propanediol mononitrate is comprised between 100:1 and 1:1, between 75:1 to 1:1, between 60:1 to 5:1 or between 25:1 to 5:1. However, given that Duval in Example 3 at [0106] discloses that PDMN has a MW 121.04, Duval discloses in Example 18 administering 0.5 to 2.5 g PDMN/ animal/ day or about 0.5/121 to about 2.5/121 moles PDMN/ animal/ day or about 0.0041 to about 0.021 moles PDMN/ animal/ day.
Farmer at page 4, lines 12-20 discloses methods for reducing greenhouse gas emissions from livestock comprising methane by administering to the animals (at page 6, lines 14-22) 3-nitrooxy propanol or propanediol mononitrate and D-limonene as a terpene.
Losa at Abstract discloses methods for reducing the production of methane emanating from the digestion of animals by administering to the animal feed limonene as one or more essential oil compounds. In Example 1 at col. 4, lines 35-40 and Table 1, Losa discloses methane reduction in the digestion of ruminants. At col. 2, lines 24-31, Losa discloses the active essential oil compounds suitably administered in an amount from 0.01-50 mg/Kg bodyweight of the animal per day. Accordingly, given that the cows in disclosed in Example 18 of Duval at [0157] weigh from 550 to 800 Kg. Therefore, Losa at col. 2, lines 24-31 a discloses using or administering to cows from 550 x 0.01 mg/Kg or 5.5 mg to a maximum of 800 x 50 mg/Kg or 40,000 mg or 40 g limonene per animal per day or 0.0055 to 40 g limonene/ animal/ day.
Limonene as depicted at page 2 of the instant specification has a molecular weight (MW) of about 136 g/mol. Accordingly, the amount of 0.0055 to 40 g limonene/ animal/ day disclosed in Losa at col. 2, lines 24-31 equals 0.0055 g//136 g/mol to 40g 136 g/mol or 4.04 x 10-5 or from 0.00004 to 0.29 mol limonene/ animal/ day.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Losa for Duval to use or administer the claimed 0.1 to 50 g limonene/ animal/ day as its essential oil as in claims 4 and 9. Both references disclose administering essential oils to ruminants as feed additives or in feeds to reduce methane production in ruminant digestion. The ordinary skilled artisan would have desired to use the limonene of Losa as the essential oil of Duval to help reduce methane production in ruminants as disclosed in Losa at col. 2, lines 24-31. Further, the ordinary skilled artisan in Duval would have desired to use the claimed molar ratio of limonene to propanediol mononitrate of between 100:1 and 1:1 as in claims 5 and 15 because Losa discloses 0.00004 to 0.29 mol limonene/ animal/ day and Example 18 of Duval discloses 0.0041 to about 0.021 moles PDMN/ animal/ day, or a molar ratio of limonene to propanediol mononitrate of from a maximum of 0.29:0.021 or about 14:1 to a minimum of 0.00004:0.0041 or about 1:100, which the claimed molar ratio of between 100:1 and 1:1 overlaps. See MPEP 2144.05.I.
Limonene as depicted at page 2 of the instant specification has a molecular weight (MW) of about 136 g/mol. Accordingly, the amount of 0.0055 to 40 g limonene/ animal/ day disclosed in Losa at col. 2, lines 24-31 equals 0.0055 g//136 g/mol to 40g 136 g/mol or 4.04 x 10-5 or from 0.00004 to 0.29 mol limonene/ animal/ day.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Farmer for Duval to use D-limonene as its limonene. Both references disclose methods of reducing the production of methane emanating from the digestive activities of ruminants using essential oils. The ordinary skilled artisan in Duval as would have desired to use the D-limonene of Farmer as its active essential oil because Farmer discloses that D-limonene provides a desirable methane reduction when fed with propanediol mononitrate to ruminants. Further, the use of Duval as modified by Farmer is substantially the same as the claimed use. Accordingly, absent a clear showing as to how the effect of the use of Duval as modified by Farmer differs from that as claimed, the Office considers the use of propanediol mononitrate and D-limonene as in Duval as modified by Farmer at page 6, lines 14-21 to synergistically reduce methane reducing properties of the propanediol mononitrate in Duval as in claim 15. See MPEP 2112.01.I.
Before the effective filing date of the present invention, the ordinary skilled artisan would have found it obvious in view of Losa for Duval as modified by Farmer to use or administer the claimed 0.1 to 50 g limonene/ animal/ day as its essential oil as in Losa. All references disclose administering essential oils to ruminants as feed additives or in feeds to reduce methane production in ruminant digestion. The ordinary skilled artisan would have desired to use the limonene of Losa as the essential oil of Duval as modified by Farmer to help reduce methane production in ruminants as disclosed in Losa at col. 2, lines 24-31. Further, the ordinary skilled artisan in Duval as modified by Farmer =would have desired to use the claimed molar ratio of D-limonene to propanediol mononitrate of between 100:1 and 1:1 because Losa discloses 0.00004 to 0.29 mol limonene/ animal/ day and Example 18 of Duval discloses 0.0041 to about 0.021 moles propanediol mononitrate per day, or a molar ratio of D-limonene to propanediol mononitrate of from a maximum of 0.29:0.021 or about 14:1 to a minimum of 0.00004:0.0041 or about 1:100, which the claimed molar ratio of between 100:1 and 1:1 overlaps. See MPEP 2144.05.I. The ordinary skilled artisan in Duval as modified by Farmer and Losa would have found it obvious to use the claimed molar ratio of D-limonene to propanediol mononitrate because Losa and Duval disclose that the claimed molar ratios of the D-limonene to propanediol mononitrate provide desirable methane reduction in ruminants.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over US2014/0147529 A1 to Duval et al. (Duval) in view of US 7,763,273 B2 to Losa (Losa) and WO2021/163148 A1 to Farmer et al. (Farmer)
Regarding instant claims 1-2 and 14-15, Farmer at page 4, lines 12-20 discloses methods for reducing greenhouse gas emissions from livestock comprising methane by administering to the animals (“orally administering to a ruminant) a 3-nitrooxy propanol or propanediol mononitrate and D-limonene (claims 2 and 15) as a terpene (at page 6, lines 14-22 as “reducing the formation of methane emanating from the digestive activities of ruminants”). Further, the recited reducing the formation of methane emanating from the digestive activities of ruminants comprising orally administering to a ruminant includes the method disclosed in Farmer.
While Farmer does not disclose an example of administering propanediol mononitrate and D-limonene together, Farmer discloses at page 4, lines 12-20 administering a combination of those compounds to a ruminant. Accordingly, the ordinary skilled artisan would have found it obvious in Farmer to administer to a ruminant both of propanediol mononitrate and D-limonene because Farmer discloses that administering such a combination desirably reduces methane formation in digestion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW E MERRIAM whose telephone number is (571)272-0082. The examiner can normally be reached M-H 8:00A-5:30P and alternate Fridays 8:30A-5P.
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/ANDREW E MERRIAM/Examiner, Art Unit 1791