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 .
DETAILED ACTION
This action is in response to a Request for Continued Examination received June 24th, 2026.
Status of Claims
Claims 16, 21, 30, and 41-48 are pending in the instant application.
Claims 1-15, 17-20, 22-29, and 31-40 have been canceled.
Withdrawn Objections/Rejections
Applicant’s amendment is sufficient to overcome the rejections of Claims 45-46 under 35 U.S.C. 112(b). These rejections are hereby withdrawn.
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 16, 21, 30, 41-48 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.
Claim 21 is drawn to a method of inhibiting viruses of Asfaraviridae comprising dosing animal feed or drinking water with a composition comprising two or more medium-chain fatty acids and/or derivatives thereof. The recitation of “derivatives thereof” renders the claim indefinite, as a person having ordinary skill in the art would not be able to reasonably ascertain the metes and bounds of this limitation.
At Page 4 of the instant specification, Lines 9-10, MCFA derivative is defined as “a fatty acid chain of which the carboxyl group is reversibly converted to a different group”. Further, non-limiting examples of such groups are stated. No direction or guidance is given, however, that would instruct a person having ordinary skill in the art to understand which groups are acceptable for use within the context of the instantly claimed invention, nor would it be understood based on the content of the instant disclosure the motivation for utilizing a composition comprising an MCFA derivative as opposed to the MCFA itself.
Claims 16, 30, and 41-48 depend from Claim 21, and do not further clarify the limitation of a derivative of MFCFA, and therefore are also rendered indefinite. Appropriate clarification is required.
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.
Claims 16, 21, 30, 41-43, and 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over Niederwerder et. al. (WO 2019/169256 A1; cited on Applicant’s Information Disclosure Statement filed on September 7th, 2022; cited in final rejection mailed January 26th, 2026; hereinafter referred to as Niderwerder).
Applicant has traversed this rejection.
First, Applicant notes beginning at Page 4 of the remarks filed June 24th, 2026, that Niederwerder teaches a composition of equal parts of caproic acid, caprylic acid, and capric acid, and therefore the caprylic acid is necessarily present in an amount less than 40%, as instantly claimed, for example, at Claim 21.
Further, Niederwerder points to page 20, lines 8-13 of the instant specification, noting that “[t]he 100% C8 MCFA mixture and the 1:1 C8:C9 scored best.” Further, Applicant states, “This can be seen in Table 1 on page 20, where the 100% C8 MCFA mixture led to low destruction of the cells. When compared to the 1:1:1 C6/C8/C10 mixture, there was less destruction in the 100% C8 mixture as compared to the 1:1:1 C6/C8/C10 mixture.” Applicant asserts “Niederwerder does not teach the criticality of the 100% C8 mixture as shown in Example 2 and Table 1 of the instant specification.
The examiner does not find this argument persuasive.
First, with respect to Applicant’s assertion of criticality of the 100% C8 formulation, Table 1 from Page 20 is reproduced below:
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438
602
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As this table demonstrates, the score from the 100% C8 MCFA mixture and the 1:1:1:1 C6/C8/C9/C10 MCFA mixture is the same. Additionally, the 1:1:1 C6/C8/C10 mixture scored the same as the 100% C8 mixture in its second test. Therefore, these results are insufficient to support Applicant’s assertion that a 100% C8 MCFA mixture is superior to mixtures with less than 40% of C8 in the mixture.
For clarity of the record, the grounds of the rejection raised in the final rejection mailed January 26th, 2026 are revisited below:
Regarding Claim 21, Niederwerder teaches beginning at Page 10, Example I, a method of inhibiting African swine fever virus, a species of the genus of the instantly claimed viruses of Asfaraviridae. At Lines 24-25, Niederwerder teaches a composition comprising an equal amount of caproic acid (C6), caprylic acid (C8) and capric acid (C10), all of which are recited at instant Claim 42. At Page 13, third paragraph, Niederwerder teaches animal feed treated with such a composition of medium contained no detectable infectious virus in contrast to the untreated feed samples, which did contain infectious virus, thereby demonstrating the composition’s efficacy in inhibiting African swine fever virus in animal feed.
Niederwerder does not teach a composition in which at least 40% of the medium chain fatty acid in a composition is caprylic acid. Per MPEP 2144.05, II., A., “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating sch concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)”. Such a showing that at least 40% of the medium fatty acid composition comprising caprylic acid has not been demonstrated. As shown above, compositions for which less than 40% of caprylic acid are present are scored to be as effective as compositions for which more than 40% of caprylic acid are present. Determining the ideal concentration of caprylic acid would be a matter of routine optimization of the composition taught by Niederwerder. No showing of unexpected results of the instantly claimed composition has been demonstrated.
To this end, at Page 19, Lines 2-4 of the instant specification, it is stated, “Results demonstrate that all compositions, including F1, F2, F3, and F4, significantly increase the Cq value for ASFV when compared to the positive control (P<0.01) at highest doses of 3750 and 5000 ppm.” At Pages 14-15 of the instant specification, the composition of F1, F2, F3, and F4 is disclosed. F1 comprises 100% caprylic acid, F2 comprises 33% caprylic acid, F3 comprises 100% caprylic acid, and F4 comprises 95% caprylic acid. Therefore, compositions F1, F3, and F4 each read on the limitations recited instantly at Claim 21. At Page 18, under “Real-time PCR”, the instant specification teaches “Results of the real-time PCR protocol are expressed in quantification cycles (Cq) required to detect viral nucleic acid. Hence, high Cq values need to be interpreted in the sense that less viral nucleic acid is present.” A review of Figure 1 demonstrates, then, that at a concentration of 1250 ppm, composition F2 was superior to the other aforementioned compositions in inhibiting ASFV. At concentrations of 2500, 3750, and 5000 ppm, composition F2 is at least within the margin of error of, if not superior to, compositions F1, F3, and F4. Therefore, Applicant has failed to demonstrate that the limitation of a composition comprising at least 40% caprylic acid is critical to the method of inhibiting viruses Asfaraviridae in animal feed, nor have unexpected results been established. Therefore, the instantly claimed method is obviated by the method taught by Niederwerder.
Regarding Claim 16, at Pages 4-5, Last Paragraph of Page 4 through First Paragraph of Page 5, Niederwerder teaches that a blend of caproic acid, caprylic acid, and capric acid was effective in inactivating viruses and improving growth of pigs when administered orally.
Instant Claim 30 recites the limitation that the composition of MCFAs are dosed in animal feed between 250 and 10000 ppm. This corresponds to a range of 0.025 weight % to 1 weight %. Instant Claim 41 recites a dosage range between 1500 ppm and 5000 ppm. This corresponds to a range of 0.15 weight % and 0.5 weight %. Niederwerder, at Claim 1, teaches an overlapping range of 0.125 weight % to less than 2 weight %. Further, Niederwerder teaches at Page 13, last Paragraph that ASFV was not detected in feed treated with 1% MCFAs. Per MPEP 2144.05, I., “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F. 2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. For the same reasons, this composition overlaps with the range claimed instantly at Claim 48, and therefore obviates this claim as well.
Regarding instant Claim 43, as mentioned above, at Page 10, Lines 24-25, Niederwerder teaches a composition of equal amounts of caproic, caprylic, and capric acids. This reads on the instantly recited ranges at instant Claim 43, as this would be a composition of 33% caproic acid, 33% capric acid, 0% lauric acid, and 0% pelargonic acid.
Regarding instant Claim 46, at Page 7, Lines 24-25, Niederwerder teaches the compositions can further comprise Vitamin D.
Regarding Claim 47, at Page 19, Niederwerder teaches vortexing the composition comprising MCFAs as a liquid with animal feed ingredients.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Niederwerder in view of Narayanan et. al. (“Effect of Citric Acid as Feed Additive in Swine Starter Diet”, Indian J. Anim. Res., 308-309, 2008; cited in Final Rejection mailed January 26th, 2026; hereinafter referred to as Narayanan).
Niederwerder obviates Claim 21, from which Claim 44 depends, for the reasons noted above.
Applicant’s traversal of this rejection was based on the traversal for the rejection of Claim 21, above. For the same reasons as above, this is not found to be persuasive.
Niederwerder does not teach inclusion of an organic acid as recited at Claim 44.
Narayanan teaches the inclusion of citric acid in swine feed as being routine and known in the art. At the abstract, Narayanan teaches inclusion of citric acid as a feed additive in swine starter diet yielded the positive results of reduced counts of E. coli, improved weight gain, and reduced mortality. Therefore, a person having ordinary skill in the art would be motivated to include citric acid in a swine food additive, as these positive results would be recognized as providing additional benefit to a swine feed additive as taught by Niederwerder.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Niederwerder in view of Lammers et. al. (“Growth performance, carcass characteristics, meat quality, and tissue histology of growing pigs fed crude glycerin-supplemented diets”, J. Anim. Sci., 2008; hereinafter referred to as Lammers).
As noted above, Niederwerder obviates the method of Claim 21, from which Claim 47 depends.
Niederwerder does not teach inclusion of glycerol in the composition.
At Page 2963, First Paragraph, Lammers teaches glycerin is a highly available energy source in swine, and that pigs can be fed up to 10% glycerin with little effect on pig performance.
At Page 2966, Lammers discloses in Table 4 various parameters examined from pigs fed a 10% diet of crude glycerol. At Page 2965, second to last paragraph, Lammers teaches no diet x sex interaction was observed in pigs fed 10% crude glycerol.
Taken together, applying KSR exemplary rationale A, it would have been prima facie obvious to a person having ordinary skill in the art to incorporate glycerol in a swine feed composition, as this was known in the art to be well tolerated by pigs. Regarding the recited range of glycerol, per MPEP 2144.05, I., “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”.
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.
The provisional rejection of Claims 16, 21, 44, and 47 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 14-18, 26-27, and 29 of copending Application No. 18/280,357 (reference application) is maintained. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to inhibiting viruses of Asfaraviridae in animal feed or drinking water by dosing animal feed or drinking water with medium-chain fatty acids (MCFAs) and/or derivatives thereof.
Applicant has requested, in the remarks filed June 24th, 2026, that this rejection be held in abeyance. This does not properly address the specific grounds of rejection as noted in the final rejection mailed June 24th, 2026. For clarity of the record, the basis for this rejection is revisited below.
Claim 12 of the reference application is drawn to dosing animal feed or water with a specific MCFA, pelargonic acid. The scope is expanded however, for example at Claims 14-16, in which it is recited the method can comprise dosing animal feed or drinking water with additional MCFAs. While Claim 12 of the reference application is drawn to inhibiting or mitigating viral infections in general, dependent claims 26 and 29 recite viruses of Asfaraviridae. Dosing animal feed and/or water with pelargonic acid in combination with other MCFAs or derivatives thereof reads on the limitations recited instantly at Claim 21, which is drawn to dosing animal feed or drinking water comprising MCFAs including at least 40% caprylic acid. This amount of caprylic acid is accommodated, for example, in the reference application’s Claim 17, which is drawn to a composition up to a 1:1 ratio of pelargonic acid to another MCFA. This allows for up to 50% caprylic acid, thereby reading on instant Claim 21. Regarding instant Claim 44, reference Claim 15 includes organic acids recited at instant Claim 44. Regarding instant Claim 47, reference claim 18 is drawn to the composition being in liquid form.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 16, 21, 30, and 41-48 are rejected.
No claim is allowed.
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/D.J.B./ Examiner, Art Unit 1624 /BRENDA L COLEMAN/ Primary Examiner, Art Unit 1624
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