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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/25 has been entered.
Status of the Claims
Receipt of Remarks/Amendments to Claims and Specification, and Substitute Drawing filed on 11/12/2025 is acknowledged. Claims 13-14, 16, and 22 have been amended. Claims 1-12 and 15 are cancelled. Claims 23-26 are new.
Newly submitted Claim 26 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 13 is drawn to a method of making a porcine epidemic diarrhea virus-inhibited swine animal feed mixture; New Claim 26 is drawn to a method of inhibiting transmission of PEDV to a swine animal comprising: (a) providing the PEDV-inhibited swine animal feed mixture, and (b) feeding the feed mixture to the swine animal. These claims would have been restricted out as different inventions had they been presented previously as the originally filed claim set. Since Applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claim 26 is withdrawn from consideration. See MPEP § 821.03. Claims 13-14 and 16-25 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/12/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement was considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 20-21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends
Claims 20 and 21 depend from Claim 13, which requires (a) 0.25 to 0.475 weight-% of benzoic acid (BA), (b) a powder comprising 0.010 to 0.019 weight-% of a combination of eugenol and thymol. Claim 20 requires the ratio of BA to eugenol is at least 833:1 and/or the ratio of BA to thymol is at least 333:1; Claim 21 requires the ratio of BA to eugenol is at least 2500:1 and/or the ratio of BA to thymol is at least 500:1. However, it is not possible to obtain such ratios given the required % ranges in (a) and (b) for the components in Claim 13. At the highest weight of benzoic acid, 0.475 wt%, and lowest weight of eugenol/thymol possible ~0.01 wt%, the ratio is only up to 47.5:1. As such, Claims 20-21 broaden the scope of Claim 13 from which they depend, and therefore these claims are rejected.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 13-14, 16-17, and 20-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gebhardt et al. (Transl. Anim. Sci. 2019.3:94–102; cited in the IDS), hereinafter Gebhardt2, in view of Zhai et al. (Animal Feed Science and Technology, 262, 2020, 114426; cited in the IDS).
Gebhardt2 teaches the mitigation of porcine epidemic diarrhea virus (PEDV) by adding feed additives 0.5% BA and 0.02% essential oil (EO) (Abstract). The BA and EO are obtained from DSM Nutritional Products Inc., and are combined to treat the feed matrices (p. 94, Material and Methods Section). Gebhardt2 teaches that the combination of EO and BA enhanced degradation of PEDV RNA in feed (p. 100, last paragraph). bioassay. Viral RNA quantification was performed
at 7 sampling days post-laboratory inoculation (d 0,1, 3, 7, 14, 21, and 42) and infectivity was assessed via bioassay with 10-d-old pigs (Abstract).
Regarding Claim 13, step (i), Gebhardt2 teaches mixing the feed additive with the feed, mixing for 3 mins, which is adequate time to achieve a coefficient of variation (CV) of <10% (p. 95, Chemical Treatment section). The amount of benzoic acid and essential oil is very close to the claimed (a) benzoic acid and (b) powder comprising a combination of eugenol and thymol. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05.
Gebhardt2 does not expressly teach the composition of its EO from DSM Nutritional Products Inc. Zhai is in the same field and discloses the effects of BA and EO on growth performance etc. in nursery pigs (Abstract). Zhai also used the EO from DSM Nutritional Products, and lists the main ingredients to comprise thymol, eugenol, and piperine. Zhai showed that the BA and EO (BE) additive improved the growth rate and feed intake in nursery pigs (Abstract).
As such, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use the EO from DSM Nutritional Products, CRINA®, comprising thymol, eugenol, and piperine per the teaching of Zhai. CRINA®, One would have been motivated to do so with a reasonable expectation that the combination of EO and BA in the feed would not only enhance the degradation of PEDV RNA in the feed per the teaching of Gebhardt2 but also improve the growth rate and feed intake in nursery pigs per the teaching of Zhai.
Regarding the powder feature of the EO, Gebhardt2 teaches adding the EO product and BA at 0.02% and 0.5% to the swine gestation diet comprising all solid components (Table 1). It follows that the EO commercially obtained would also be in solid form for ease of quantification.
Regarding Claim 13, step (ii), Gebhardt2 teaches mixing the feed additive with the feed, mixing for 3 mins, which is less than 7 days (p. 95, Chemical Treatment section). Gebhardt2 further teaches that following mixing of feed matrix and feed additives, 22.5 g of treated feed matrix was sampled from multiple locations within the mixer and placed in the appropriate bottle to be analyzed on 7 sampling days (d 0, 1, 3, 7, 14, 21, and 42 days) post-inoculation, which thereby also reads on Claims 23-25 (p. 95, Chemical Treatment section; Table 2). Gebhardt2 teaches that, overall, the combination of EO and BA was most effective at reducing the quantity of genetic material (P < 0.001), regardless of feed matrix or day post-inoculation (p. 96, Quantity of Detectible Viral RNA Section; Table 4).
Regarding Claims 14 and 16, one skilled in the art requiring benzoic acid in solid form would look to purchase the ingredient in commercially available solid forms such as flakes, powders, or forms commonly used in food preservative and industrial applications. A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05. One of ordinary skill in the art would find it obvious to modify the amounts as a matter of experimentation and optimization. The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Regarding Claim 17, there is nothing in Gebhardt2 that indicates that the EO comprising thymol and eugenol requires inclusion of any type of fat and, reading on the feature of "…less than 5 weight% of fully hydrogenated fat, partially hydrogenated fat or non-hydrogenated fat.”
Regarding the ratios in Claims 20-21, Zhai teaches the effective levels of BA and CRINA® are 5000 mg/kg and 200 mg/kg, respectively, when used separately (p. 2, Section 2.2). The Examiner notes that the indefiniteness issue with these claims preclude proper searching and analysis. Nevertheless, one of ordinary skill in the art would find it obvious to modify the ratio of BA to EO as a matter of experimentation and optimization.
Regarding Claim 22, Gebhardt2 teaches that the combination treatment of EO and BA on feed, had a greater (P < 0.05) PEDV Ct value than other treatments (Abstract; p. 95, Real-Time PCR Analysis section; Quantity of Detectible Viral RNA section). At d21, EO+BA gave a Ct value of 42.6, as determined by real-time qRT-PCR, which meets the required Ct value of 38 or above.
Claims 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gebhardt2 in view of Zhai, as applied to Claims 13 and 17 above, and in further view of Crina® Poultry Plus (EFSA Journal 2014;12(11):3896; Of record), hereinafter EFSA-Crina.
The teachings of Gebhardt2 and Zhai have been set forth supra. Gebhardt2 does not teach auxiliary compounds in its EO component.
Regarding Claims 18-19, EFSA-Crina teaches Crina® Poultry Plus (CPP) is a light brown, free flowing powder consisting of four main active substances: 80% BA, 1% thymol, 0.5% eugenol, and 0.05% piperine. In addition, CPP contains silicic acid, diatomaceous earth, monopropylene glycol and soy oil as carriers to a total weight of 13.6%, which reads on the auxiliary compounds and amounts in these claims(Table 2; p. 16, Appendix, 2nd paragraph).
Carriers are typically relied on to impart bulk and/or stability in a premix to facilitate uniform dispersion of the ingredients in a larger mix/feed. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use the carriers taught by EFSA-Crina as auxiliary compounds in the EO component of Gebhardt2. Therefore, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. Note: MPEP 2141 KSR International CO. v. Teleflex Inc. 82 USPQ 2d 1385 (Supreme Court 2007).
Response to Remarks:
Applicant traversed the rejection over Frehner does not disclose or suggest a method of making a PEDV-inhibited swine animal feed mixture comprised of benzoic acid and a powder comprised of eugenol and thymol in the specific amounts.
Applicant’s arguments have been considered but are moot because the new ground of rejection necessitated by the amendment does not rely on Frehner for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
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/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792