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 .
Claim Objections
Claim 1 is objected to because of the following informalities: (i) on the 8th line from the bottom, change “C1-C6alkyl, phenyl,” to --- C1-C6 alkyl or phenyl, ---; (ii) on the 7th line from the bottom, change “n is >3 the hydrocarbon” to --- n is >3, the hydrocarbon ---. 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 2-5 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 2-5, applicant recite that “the retention” of the compound of formula (I) “after at least 4 weeks” is at least 80%, at least 85%, at least 90% and at least 95%, respectively. However, applicant define the term “retention” by stating in present specification (pg.14, last two lines – pg.15, first two lines) that “[t]he term ‘retention’ as used therein refers to a retention of the compound of formula (I) . . . . over a storage time of at least 4 weeks (reclosed (i.e., a bag which has been rolled twice for closure and then fixated with a clip) PE or aluminum bag; 25oC, 50% relative humidity (r.H.)).” The phrase “after at least 4 weeks” as recited in claims 2-5 is different in its meaning from “over a storage time of at least 4 weeks”. Thus, it is confusing as to under what condition (the storage period) the retention rate of the compound of formula (I) is being measured. Furthermore, applicant also need to specify in the claims other condition(s) (such as temperature, humidity and whether the compound is being stored in the bag (as described on pg.15 of present specification) or not) for measuring the retention rate of the compound of formula (I).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lopes et al (“Effect of 3-nitrooxypropanol on methane and hydrogen emissions, methane isotopic signature, and ruminal fermentation in dairy cows”, Journal of Dairy Science, vol.99 (7), July 2016, pg.5335-5344) (with Chase (“Can we feed less starch to our cows?”, an internet article published in January 2007 and obtained from the website: https://www.researchgate.net/publication/268337730_Can_we_feed_less_starch_to_our_cows ), which is cited here merely to support the Examiner’s assertion that corn silage contains 20-45% starch (% based on dry matter (DM)) and corn grain contains 70-75% starch (% based on dry matter (DM))).
Lopes investigates the effect of 3-nitrooxypropanol as a methane inhibitor on enteric methane emission, methane isotopic composition and rumen fermentation and microbial profile in lactating dairy cows (see abstract). 3-nitrooxypropanol (“3NOP” hereinafter) (also known as 1,3-propandiol mononitrate) teaches instant compound of formula (I) (with n being 3 and R1 being -OH). The 3NOP supplement contained 3NOP (instant compound of formula (I)) on SiO2 (instant silica) and propylene glycol whereas the placebo supplement contained SiO2 and propylene glycol only (see pg.5336, last 9 lines under the heading “Animals and Experimental Design”). The 3NOP supplements (containing 3NOP, SiO2 and propylene glycol) were mixed with TMR (total mixed ration) to deliver the final 3NOP concentration. The TMR
(with which Lopes’s 3NOP supplement is to be mixed) as shown in Table 1 on pg.5337 includes corn silage and ground corn grain. It is well known in the art, as evidenced by Chase (see Table 1), that corn silage contains 20-45% starch (% of dry matter (DM)) and corn grain contains 70-75% starch (% of dry matter (DM)). Thus, Lopes’s TMR includes instant starch derived from maize. Therefore, Lopes teaches instant step of admixing a powderous formulation (3NOP supplement) comprising (i) instant compound of formula (I) and (ii) silica with a starch derived from maize. Since Lopes teaches instant step of admixing instant powderous formulation (comprising instant compound of formula (I) and instant silica) with instant starch derived from maize, Lopes’s method would naturally or inherently improve retention of the compound of formula (I) to achieve the retention of at least 80%, 85%, 90% or 95% after at least 4 weeks, as recited in instant claims 2-5.
Thus, Lopes teaches instant claims 1-5.
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 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,213,498 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reason:
Claim 1 of Pat.’498 teaches the following:
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Since the storage stable premix contains the component (a1) and component (a2), this implies that the premix was obtained by admixing the component (a1) (the powderous formulation containing the compound of formula (I) and silica) with the component (a2) (starch derived from potatoes, wheat, maize and/or cassava). Thus, claim 1 of Pat.’498 renders obvious instant method of claim 1. Furthermore, since claim 1 of Pat.’498 teaches instant step of admixing instant powderous formulation (comprising instant compound of formula (I) and instant silica) with instant starch derived from maize, the method impliedly taught by claim 1 of Pat.’498 would naturally or inherently improve retention of the compound of formula (I) to achieve the retention of at least 80%, 85%, 90% or 95% after at least 4 weeks, as recited in instant claims 2-5. Thus, claim 1 of Pat.’498 renders obvious instant claims 1-5.
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/SIN J LEE/Primary Examiner, Art Unit 1613 May 30, 2026
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