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 .
Claims 1-11 are pending and have been examined on the merits.
Information Disclosure Statement (IDS)
The information disclosure statements (IDS) submitted on 11/6/2023, 3/7/2024, 4/30/2024, 6/27/2024, 8/9/2024, 11/12/2024; 3/11/2025, 4/18/2025, and 1/20/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner. Please note, in the 11/6/20203 IDS, that a plurality of Foreign and Non-Patent Literature references have been lined through as having no corresponding copy in the instant or preceding related parent application(s) and also one of the two citations of Huang et al Arch. Oral. Biol. (2011) has been lined-through as a being a duplicate citation. An initialed copy of each IDS has been placed in the instant Application file.
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.
Claim 11 is 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 claim 11, at line 1 the claim recites the limitation "claim 9, wherein said sodium bisulfate”. There is insufficient antecedent basis for this limitation in the claim - because claim 10, but not claim 9, recites the term “sodium bisulfate”. Appropriate correction 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.
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wei-qi (CN 104171737 A, of record)).
The instant claims are drawn to a method of inhibiting a virus in an animal feed or ingredients thereof, comprising introducing thereto/therein, a chemical mitigant comprising:
A medium chain fatty acid (MCFA)(claims 1-11) from among: (i) caproic, caprylic, capric, and/or lauric acids (as expressly required of claim 4-5 and implicit of claims 1-3); and optionally further comprising: (ii) an essential oil (claims 6-8) from among garlic oleoresin, turmeric oleoresin, capsicum oleoresin, rosemary extract, wild oregano essential oil, and mixtures thereof (as required of claim 7). Or in a feed or sodium bisulfate-added feed/dosage form.
Please note, as presently drafted, the method is drawn to preparing a composition or ingredients, inclusive of preventative preparations, and accordingly, where the prior art teaches or is suggestive the providing of the same/similar ingredients and amounts, the mitigant effect is considered to be present, even where the reference may not expressly recite the intrinsic function, and especially where the instant disclosure recognizes such effects as being present in such composition (e.g. by comparison, the instant method does not require the presence of or treating of African swine virus in a feed or an animal suffering therefrom, but merely that the ingredients be provided or combined into the resulting composition, and therefore the prior art remains inclusive of the instant effects where similar compositions are taught or suggested or otherwise obvious in view thereof) See also MPEP 2112.02 at Ex Parte Novitski and Dart cited therein regarding reference-silent features of the prior art remaining anticipating over claims directed to and appreciating such reference-silent properties as present in the biomaterials.
Wei-qi ‘737, although not exactly reciting (anticipating) of preparing the composition claimed to inhibit a virus as instantly claimed, would have at least been obvious to one of skill in the art at the time of the invention effective filing, to have provided amounts of medium chain fatty acids/blends, and/or essential oils, in that the reference teaches medium chain fatty acid mixtures and with essential oils in feed materials, including caprylic acid, capric acid triglyceride, and blends, the reference teaching, e.g.: “[0007] embodiment 1: The invention claims a deodorization effect for pig feed [broadly, a complete swine diet] additive composition according to weight percentage content of meter comprising the following components: Octanoic acid decanoic acid triglycerol ester [broadly caprylic acid, capric acid triglyceride, and blends thereof] 10 percent vitamin e acetate 3%- 7% of alkyl glycoside and fumigating and washing grass oil [broadly, an essential oil] 15% laurel azone 5% of the residual quantity of the soy powder. | [0008] the invention each ton of full price feed in the adding amount is 1.4 kg. [by weight]”. Further whereby the prior art teaches classical swine virus “and the like” effects of the composition: (i) there are a finite number of swine fever virus alternatives and would have at least been obvious to a person of ordinary skill and knowledge in the art to have tried thereamong (“and the like”) in a method of use or making thereof, particularly where the compositions of the prior art and claims are otherwise materially similar or the same to the extent claimed, and/or (ii) the claims are drawn to preparing a composition and the instant disclosure acknowledges the compositions in the same amounts having the intended use/effect upon both ASFV and CSFV (in an intended use/method of administering of the made composition), and the amounts present in the cited reference are broadly inclusive effective amounts of medium chain fatty acid present to provide the requisite therapeutic properties or effects. Accordingly, in the amounts where the prior art and instant claims, materially are similarly constituted (e.g. comprises an amount of a medium chain fatty acid, for example), then the same functions are expected to be present.
‘737 is relied upon for the reasons discussed above, which if not expressly taught thereby, based upon the overall beneficial teaching provided by this reference with respect to providing animal feed materials comprising essential oils and/or fatty acids and the like in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable proportions or ranges in which to perform such a feed-making/providing), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, 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.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art (including in the methods of making or using thereof), the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Claims 1-11 are rejected under 35 U.S.C. 103 as being obvious over Jones et al (1) (Jones , Cochrane, Woodworth, and Dritz US 10,772,343 B2).
The applied reference ‘343 patent has at least one common inventor and assignee with the instant ‘985 Application; however, each also names inventors not shared between ‘343 and the instant ‘985 Application (‘343: Cochrane RA vs. ‘985: Niederwerder MC; Rowland RRR). Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The claims are as of record, drawn to a process of inhibiting (process of making a chemical mitigant feed or feed material composition (introducing mitigant to a feed) or a method of using (inhibiting a virus therein resultant of the making) comprising said chemical mitigant, (i) wherein the mitigant: is a medium chain fatty acid (MCFA)(claims 11, 19-20) from among caproic, caprylic, capric, and/or lauric acids (claims 12-15); and when present in a feed of feed ingredient (when has been introduced at an inclusion rate) is present in an amount about 0.125 weight % to less than 2 weight %, and (ii) wherein the composition optionally further comprises an essential oil from among garlic oleoresin, turmeric oleoresin, capsicum oleoresin, rosemary extract, wild oregano essential oil, and mixtures thereof (claims 16-18).
Jones et al ‘343, however, teaches a chemical mitigant and animal feed composition comprising by percent weight thereof mitigant amounts of “about 0.01 weight % to about 5 weight % of a medium chain fatty acid and an essential oil, wherein said animal feed is selected from the group consisting of swine feed, blood meal, porcine meat and bone meal (MBM), spray-dried animal plasma, feather meal, avian blood meal, poultry by-product meal, vitamin D, lysine hydrochloride, choline chloride, soybean meal, and dry net food”, wherein said medium chain fatty acid and essential oil is selected from the group consisting of “caproic acid, caprylic acid, capric acid, lauric acid, garlic oleoresin, turmeric oleoresin, capsicum oleoresin, rosemary extract, wild oregano essential oil, and mixtures thereof.” The reference further teaches that sodium bisulfate may be applied to applied to the surface of kibble in amounts effective for the benefit of contaminating Salmonella inhibition (e.g. see ‘343, example V and tables 15, 16, claims 1-19; see instant claims 1-11).
Although the ‘343 claims are distinguished in that they do not recite African swine fever virus, the compositions of the prior art and the instant claims are materially nearly identical with respect to composition and the amounts, and the ‘343 patent discloses use with providing to pig diets, and therefore the differences in intended use of the composition and slight different in amounts of the medium change fatty acids, if any, would have been at least obvious to a person of ordinary skill at the time of the instant invention effective filing. Additionally, the reference teaches a product that appears at least obvious or an obvious variant of, the product set forth in a product-by-process claim although produced by a different process. See In re Marosi, 710 F.2d 799, 218 USPQ 289 (Fed. Cir. 1983) and In re Thorpe, 777 F.2d 695, 227 USPQ 964 (Fed. Cir. 1985). See also MPEP § 2113. Furthermore, regarding the product of the instant claims may differ from the asserted process of making the prior art product, MPEP 2113 asserts:
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted)
Jones et al is relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teaching provided by this reference with respect to formulating chemical mitigants, including medium chain fatty acids and/or essential oils and species thereof, and medium chain fatty acids and essential oils and in feeds, including pig feeds, in the manner disclosed therein, the adjustments of particular conventional working conditions (e.g., determining one or more suitable ingredient species from among those disclosed, and adjusting the amounts and proportions thereof), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. See also MPEP 2112.02 at Ex Parte Novitski and Dart therein regarding reference-silent and/or instant disclosure-recognized properties remaining anticipating (and thus at least obvious) over such properties.
From the teachings of the reference, 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
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 10,772,343 (claims 1-19).
Although the claims at issue are not identical (with respect to the properties intrinsic to the compositions, instantly ‘985 appreciating a ASFV vs ‘343 appreciating porcine epidemic diarrhea virus and Salmonella bacterial effects), they are not patentably distinct from each other because each of the instant and conflicting claims are drawn to the same providing of the component materials and administrable composition materially as claimed, namely a therapeutic composition comprising the same component materials comprising a medium chain fatty acid and/or an essential oil; the same species (see dependent claims in each reciting the same) of each fatty acid and/or essential oil from among: caproic acid, caprylic acid, capric acid, lauric acid, garlic oleoresin, turmeric oleoresin, capsicum oleoresin, rosemary extract, wild oregano essential oil, and mixtures/blends thereof, the same animal feed [which] is selected from the group consisting of swine feed, blood meal, porcine meat and bone meal (MBM), spray-dried animal plasma, feather meal, avian blood meal, poultry by-product meal, vitamin D, lysine hydrochloride, choline chloride, soybean meal, and dry pet food; optionally comprising sodium bisulfate; and although not identical, the respective ranges of the chemical mitigant amounts are overlapping and nearly identical in reciting “about” the same amounts, the mitigant suitable for each purpose of ‘985 and ‘343, by weight percent amounts, of: about 0.01wt.% to about 5wt% (‘343 at claims 1, 7, 14 for example) compared to the instant “about 0.125 weight % to less than 2 weight %” (‘985 at claims 1, 11).
Consequently practicing at least one of the inventions of the instant application (or conflicting patent) claims would have at least rendered obvious the conflicting patent (or instant application) invention as claimed.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655
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