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 Status
Applicant’s remarks and amendments, filed 31 October 2025 in response to the non-final rejection mailed 2 July 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 31 October 2025 replaces all prior versions and listings of the claims.
Claims 10, 16, 19, 28, 30, and 33-45 are pending and amended. Claims 10, 16, 19, 28, 30, and 33-45 are being examined on the merits.
Response to Amendment
Any previous rejection or objection not mentioned herein is withdrawn.
Applicant’s arguments and amendments with respect to the rejection of Claims 28 and 43 under 35 USC § 112(b) have been fully considered. The rejections of Claims 28 and 43 are withdrawn due to amendment of Claim 28.
Applicant’s arguments and amendments, on pages 6-8 of the reply filed 31 October 2025 with respect to the rejection of Claims 10, 16, 19, 28, 30, and 33-45 under 35 USC § 102(a)(1) or in the alternative under 35 USC § 103 have been fully considered. The rejections of Claims 10, 16, 19, 28, 30, and 33-45 are withdrawn due to amendment of Claim 10.
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.
Claims 10, 16, 19, 28, 30, and 33-45 are rejected under 35 U.S.C. 103 as obvious over Kaneda et al. (US 9,238,048 B2) in view of Grant and Kononoff (U of Neb-Linc, 2007, 5 pages) as evidenced by De Koster and Opsomer (Vet Clin Food Anim, 2013, 299-322) and Qiao et al. (Animals, 2024, 17 pages).
The instant claims are as of record, drawn to a method of suppressing insulin resistance of a female ruminant comprising administering cashew nut shell liquid for a period of at least 14 days at any time point between 30 days before parturition and time of parturition.
Kaneda et al. teach a method of treating a periparturient cow to reduce the incidence of perinatal diseases including fatty liver and ketosis (Kaneda et al., col. 2, lines 5-10). The method comprises administering a therapeutically effective amount of a cashew nut shell liquid for three or more days, preferably nine days or more, (at least 14 days; Kaneda et al., col. 12, lines 18-20) from 30 days before to 30 days after calving (parturition; Kaneda et al., Claims 1 and 2, col. 28; as required for instant Claims 10 and 19). The non-heated cashew nut shell liquid contains 55-80% anacardic acid, 5-20% cardanol, and 5-30% cardol by mass (Kaneda et al., col. 6, ln. 45-49; as required for instant Claims 34-45) and is administered in an amount from 1-100 g per ruminant per day (Kaneda et al., Claim 2, col. 28; as required for instant Claims 16, 28, 30, and 33). Additionally, the cashew nut shell liquid can be administered in a feed (Kaneda et al., col. 10, lines 48-50; as required for instant Claim 10).
Kaneda et al. do not teach wherein the method is for suppressing insulin resistance or wherein the feed has 12-30% crude protein and 20-50% neutral detergent fiber.
Grant and Kononoff teach feeding regimens to maximize milk protein and fat yields in dairy cows, which includes maintaining a proper fiber level of 26-32% neutral detergent fiber and a proper crude protein level of 16-18% (Grant and Kononoff, Summary, page 4; as required for instant Claim 10).
De Koster and Opsomer teach that cows that suffer from fatty liver are more insulin resistant (De Koster and Opsomer, page 308, as required for instant Claim 10). This is further supported by more recent data in the art which suggests that negative energy balance triggers periparturient diseases, including insulin resistance, and that early detection and management of metabolic disorders such as ketosis and fatty liver helps prevent and mitigate negative energy balances (Qiao et al., Conclusions, page 11).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide the composition of Kaneda et al. in a feed comprising the crude protein and neutral detergent fiber levels of Grant and Kononoff because appropriate levels of these components in feed maximizes milk protein and fat yields in the milk of dairy cows. A skilled artisan could therefore reasonably provide the composition of Kanda et al. in the feed composition of Grant and Kononoff with a reasonable expectation of success.
Additionally, because the composition of Kaneda et al. was provided to cows suffering from fatty liver, the claimed intended use of suppressing insulin resistance would be inherent because the same composition is administered in the same dose to cows suffering from fatty liver, and those cows are more insulin resistant as taught by De Koster and Opsomer and as is further evidenced by the more recent review of Qiao et al. Controlling the periparturient disease of fatty liver, as presented by Kaneda et al., would therefore also have the effect of suppressing insulin resistance in that group of cows.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
(grounds modified as necessitated by amendment)
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 10, 16, 19, 28, 30, and 33-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 2, and 5 of U.S. Patent No. 9,238,048 B2 (Kaneda et al.) in view of Grant and Kononoff (U of Neb-Linc, 2007, 5 pages) as evidenced by De Koster and Opsomer (Vet Clin Food Anim, 2013, 299-322).
Although the claims at issue are not identical, they are not patentably distinct from each other because ‘048 teaches a method of treating a periparturient ruminant (female ruminant) to reduce the incidence of perinatal disease comprising administering a therapeutically effective amount of a cashew nut shell liquid for three or more days from 30 days before to 30 days after calving (parturition; ‘048 Claims 1 and 2; instant Claims 10 and 19). The non-heated cashew nut shell liquid contains 55-80% anacardic acid, 5-20% cardanol, and 5-30% cardol by mass (‘048, col. 6, ln. 45-49 and Claim 5, col 28; instant Claims 34-45) and is administered in an amount from 1-100 g per ruminant per day (‘048 et al., Claim 2, col. 28; instant Claims 16, 28, 30, and 33). De Koster and Opsomer teach that cows suffering from fatty liver are inherently more insulin resistant (De Koster and Opsomer, pg. 308), thus the cows of ‘048 suffering from the perinatal disease of fatty liver encompass the same patient population of the claimed method and the intended use of suppressing insulin resistance is inherent. Additionally, Grant and Kononoff teach feeding regimens to maximize milk protein and fat yields in dairy cows, which includes maintaining a proper fiber level of 26-32% neutral detergent fiber and a proper crude protein level of 16-18% (Grant and Kononoff, Summary, page 4). A skilled artisan would therefore know that the claimed feed components are necessary for a cow to produce milk with maximized protein and fat yields, and thus including this limitation would be obvious.
Response to Arguments
Applicant's arguments and affidavit filed 31 October 2025 have been fully considered but they are not persuasive.
Applicant argues that the reasoning in the office action regarding treating fatty liver, a perinatal disease disclosed by Kaneda et al., would inherently treat insulin resistance is an oversimplification of a complex metabolic process and is contradicted by more recent findings in the art. Zachut et al. disclose that high-yielding periparturient dairy cows do not exhibit hepatic insulin resistance and that insulin resistance is specific to adipose tissue.
Firstly, it is noted that De Koster and Opsomer indicate that cows suffering from fatty liver were more insulin resistant whereas Zachut et al. discusses insulin resistance in specific tissues of periparturient cows. The patient population of cows suffering from fatty liver disease encompassing those which are insulin resistant is further supported by the more recent review of Qiao et al., which indicates that early detection and management of metabolic diseases such as fatty liver and ketosis are crucial for preventing and mitigating negative energy balances that ultimately lead to insulin resistance (Qiao et al., Conclusions, page 11).
Since the patient population of Kaneda et al. (e.g., cows suffering from fatty liver and ketosis) encompasses the insulin resistant cow population of the instant claims, it is additionally noted that the composition provided to these cows is the same. When the same composition is administered with the same amounts of anacardic acid, cardanol, and cardol in a feed comprising neutral detergent fiber and a proper crude protein known to be beneficial to dairy cows, to a patient population known to have higher insulin resistance, the property of suppressing insulin resistance in those cattle would be inherent.
Finally, the affidavit at item 18 on page 2 indicates that periparturient insulin resistance is not universal and is rather cow-dependent and tissue-specific, and at items 22-24 indicate specific measurable changes in NEFA and RQUIKI index. The arguments at page 7 also indicate that there is synergy related to the nutritional parameters and CNSL, however such limitations regarding the specifically targeted patient population and specific outcomes are not recited in the claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant’s arguments with respect to the composition of the feed amended into Claim 10 have been considered but matter specifically challenged in the argument is directed to the previous combination of references (Kaneda/DeKoster), however, is not persuasive over the new ground of rejection necessitated by the claim amendments and the new combination of references relied upon (Kaneda/Grant/DeKoster/Qiao).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/J.L.C./Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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