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 .
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Withdrawn Objections/Rejections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 rejection of Claims 16, 21, and 30 under 35 U.S.C. 102(a)(1). This rejection is hereby withdrawn.
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.
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The provisional rejection of Claims 16 and 21 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 and extended to Claims 44 and 47.
Applicant has requested, in the remarks filed December 15th, 2025, that this rejection be held in abeyance. This does not properly address the specific grounds of rejection as noted in the non-final rejection mailed September 16th, 2025. For clarity of the record, the basis for this rejection is revisited below.
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.
Claim 12 of the reference application is drawn to dosing animal feed or water with a specific MCFA, pelargonic acid. This 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 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.
The following rejections are necessitated by amendment:
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.
Claims 16, 21, 30, and 41-43 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 September 7th, 2022; cited in non-final rejection mailed September 16th, 2025; hereinafter referred to as Niderwerder).
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 chain fatty acids contained no detectable infectious 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 such 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 the at least 40% of the medium chain fatty acid composition comprising caprylic acid has not been demonstrated. In the remarks filed December 15th, 2025, Applicant states, “Applicant notes this recited value of caprylic acid demonstrated positive effects compared to a control in an experiment in Applicant’s specification. See Applicant’s specification at p. 19, lines 2-4.”
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 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, and 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% lauric acid. The composition comprising only 33% caprylic acid obviates this composition for the reasons noted above.
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 Naryanan et al. (“Effect of Citric Acid as Feed Additive in Swine Starter Diet”, Indian J. Anim. Res., 308-309, 2008; hereinafter referred to as Narayanan).
Niederwerder obviates Claim 21, from which Claim 44 depends, for the reasons noted above.
Niederwerder does not teach the 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 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 45-46 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 45 is drawn to the method of Claim 21, wherein the composition recited thereof further comprises “one or more stabilizers and/or emulsifiers”. An insufficient definition of stabilizers and/or emulsifiers has been provided that would instruct a person having ordinary skill in the art to understand which stabilizers and/or emulsifiers are suitable for use in the instantly claimed method. The context for inclusion of a stabilizer and/or emulsifier is provided at Page 11, Lines 23-30 of the instant specification, which states, “The composition according to some embodiments further comprises one or more stabilizers and / or emulsifiers which improve the mixability of the composition in animal drinking water. Such stabilizers may comprise glycerol. By preference, the composition comprises said emulsifiers in a concentration between 10% and 20% on the total weight of the composition. In a further or another embodiment, the composition comprises said stabilizers in a concentration between 0,5% and 2,% on the total weight of the composition.” This renders the metes and bounds of this claim unclear, as multiple ranges are provided for the additional compositional ingredients, and other than glycerol, it is unclear which stabilizers and/or emulsifiers are suitable for use in the context of the instantly claimed invention.
Claim 46 is drawn to the method of Claim 21, wherein the composition recited thereof further comprises “vitamins, minerals, trace elements or a combination thereof.” An insufficient definition of vitamins, minerals, and trace elements has been provided that would instruct a person having ordinary skill in the art to understand which stabilizers and/or emulsifiers are suitable for use in the instantly claimed method. The context for inclusion of vitamins, minerals, and/or trace elements is provided at Page 9, Lines 10-24. While exemplary lists of vitamins, minerals, and trace elements are provided, the phrase “include but are not limited to” renders the claim indefinite, as it is unclear which additional vitamins, minerals, and trace elements are suitable within the context of the instantly claimed invention.
Conclusion
Claims 16, 21, 30, and 41-48 are rejected.
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624