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 .1
This application has been reassigned from Examiner Samantha Shterengarts to Examiner William Lee, in Art Unit 1623. In order to expedite accurate processing of the application papers, all future correspondence with the office should reflect this change.
Status of Claims and Priority
Claims 12-31 are pending. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I and the species caproic acid in the reply filed on March 2 2026 is acknowledged. Examined claims 12-18 and 26 read upon elected Group I and elected species. Note, while the restriction requirement and species election are maintained, the species of elected species of organic has been expanded to include acetic acid and propionic acid.
Claims 19-25 and 27-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups II and III and nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 2 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Sept 5 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claim 12 recites the preamble of inhibiting or mitigating viral infections with the method comprising dosing pelargonic acid (C9, a nine carbon organic acid, medium chain fatty acid (MCFA), also known as nonanoic acid, CAS Reg. No. 112-05-0), where the use of the term “comprising” allowing for inclusion of other MCFAs and ingredients.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 12-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 1 123 701 B1) (8/16/2001). EP 701 is cited as For Ref No. 2 on the IDS dated Sept 5 2023.
Regarding claims 12 and 14-16, EP 701 teaches a formulation of 6-12 carbon fatty acids, (9 carbon pelargonic acid and 6 carbon caproic/capric acid), used for fish feed or as a fish feed additive. See claims 1-3 and 5. Paragraph 19 states preferably at least one of teaches caproic/capric acid (C6), along with pelargonic acid (C9) used as compositions to treat viral diseases. See also paragraph 24 and 82 (medium chain fatty acids known antivirals).
Regarding claims 13 and 18 (limitations of 1-104 ppm; solid or liquid pelargonic acid), EP 701 teaches a solution concentration of C6-C12 fatty acids in the form of a solution, granules and tablets, in a solution concentration of 80-200 ppm. See paragraph 34.
Claim 12, 14-15, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2013/059012. WO 012 is cited as For Ref No. 4 on the IDS dated Sept 5 2023.
Regarding claims 12 and 14-15, WO 012 teaches a method for extending shelf-life of water, feed/feed ingredients effective against viruses comprising 5-15% or 5-25% pelargonic acid (aka nonanoic acid), 10-20% of acetic acid and 40-50% propionic acid. See claims 7-8 and 12.
Regarding claim 18, WO 012 pelargonic (aka nonanoic) acid is an oily, colorless fluid, which becomes a solid at lower temps. See page 7, last full paragraph.
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.
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 12-17 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over WO 03/043441 (WO 441) in view of English Translation of CN 106234770 A (CN 770) (published 12-21-2016, downloaded from PE2E search). WO 441 was cited on the IDS and CN 770 English Translation is cited on the PTO-892.
With regard to claims 12-16, WO 441 teaches a composition comprising a medium chain fatty acid (MCFA), pelargonic acid (C9, aka nonanoic acid) including a mixture with caproic acid (C6). See claim 3. WO 441 teaches the composition’s use as an antimicrobial (antiviral) at page 18, line 21, for livestock (poultry/pig). See claims 22-23 and 26.
Prior to the filing of the instant application a PHOSITA following the teachings of WO 441 would have found it prima facie obvious to use not only the MCFA pelargonic acid but also a combination of such with another MCFA capric acid to inhibit or mitigate viral infections by dosing the MCFAs to animal feed, feed ingredients or drinking water. See MPEP 2143 (a), combining prior art elements according to known methods to yield predictable results.
The total teachings of claims 3, 22, 23 and 26 of WO 441 recite a composition comprising pelargonic acid, mixtures thereof with other MCFAs, i.e. caproic acid (C6), used in livestock feed as an antimicrobial (defined by the specification, page 18, line 21 as an antiviral).
Note while WO 441 teaches pelargonic acid and/or caproic acids for use as antivirals in animal feeds intended for swine and poultry, etc., it does not teach the particular species of claim 12, as exemplified by the species of Avian Influenza A, African Swine Fever Virus (ASFV) and Porcine Reproductive and Respiratory Syndrome Virus (PRRS), where these particular species of claim 12 are recited in dependent claim 26.
Regarding these particular virus species of claim 12 (Avian Influenza A, ASFV, PRRS), recited in dependent claim 26, WO 441 teaches its animal feed to be treated with pelargonic acid alone, or in combination with caproic acid, are intended for livestock such as swine, suckling pigs, piglets and poultry such as chickens. See page 16, line 32 bridging to page 17, line 2. Also note page 18, noting antimicrobial efficacy against viruses. WO 441 does not teach treatment of the specific viral infections listed in claim 26.
CN 770 English Translation teaches feed additives can comprise various fatty acids, including pelargonic acid and caproic acid. See page 2, about 7th paragraph. CN 770 English Translation teaches the feed additive is used to prepare a medicine (feed) to prevent and treat an animal subject of numerous viral infections such as swine influenza virus, poultry influenza virus (see bullet point (D) page 2) and African Swine Fever virus (ASFV), as claimed (see bullet point (O) on page 3). See also page 3 last full paragraph noting the need to treat avian influenza, suggestive of Avian Influenza A as claimed. See also page 4, bullet point c) noting the need to treat Porcine Reproductive and Respiratory Syndrome Virus (PRRS) as claimed.
Regarding claim 13 (between 1 to 104 ppm limitation), WO 441 teaches concentrations in animal feed, of up to 1x105, 5x104, 1x104, 5x103, 1.5x103 and concentrations as low as 102 ppm of MCFA were effective. See page 9, lines 13-16.
Regarding claims 14-16, as detailed above, mixtures of pelargonic acid are with various other MCFA, including caproic acid (C6). See above claims 3, 22, 23 and 26 and specification page 18.
While WO 441 renders claims 12-16, obvious, it does not explicitly recite claim 17’s ratio between pelargonic acid and sum of MCFAs between 50:1 to 1:1. However such a ratio would prima facie obvious where WO 441 teaches in one embodiment, the MCFAs are selected from the group of MCFAs, specifically, caproic acid (C6), (C7), (C8), pelargonic acid (C9) and (C10), including mixtures of each other. See page 8, lines 7-13. As elected species C6 and C9 are taught as mixtures, it would be obvious to try2 arriving at the claimed ratio range, such as 1:1, as a number of identified, predicted fatty acids, pelargonic acid and elected species caproic acid are taught.
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 12-18 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 21, 30 and 41-48 of copending Application No. 17909979 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Applicant’s invention is a method of inhibiting or mitigating viral infections comprising dosing pelargonic acid (C9), known to be an oily liquid or solid at lower temps, with or without another MCFA (caproic acid (C6)) to animal feed, feed ingredients and drinking water; at concentrations of 1 to 104 ppm; ratios of C9 to sum total MCFA (50:1 to 1:1); to treat African Swine Fever virus (ASFV) infection ; see claims 12-18 and 26.
Regarding claims 12-16 and 26, the reference application’s claims are directed to inhibiting Asfarviridae (African Swine Fever ASFV) in domestic pig/warthog livestock with two or more MCFAs 5 carbons to 12 carbon atoms in length, specifically, including caproic acid (C6) and pelargonic acid (C9), among other MCFAs claimed. See reference claims 21, 30 and 42-43. See also reference claims 44-47, noting other organic acids claimed by Applicant, propionic acid, acetic acid, or combinations, thereof, as well as other excipients, and various forms of composition administered (liquid, solids, etc.). Further, reference claims 30 and 41 overlap the claimed range, where they disclose concentration ranges between 250 to 104 ppm and 1500 ppm to 5000 ppm. Note that reference claims 43 and 48 teaches ranges of pelargonic acid C9 caproic acid to C6 (0 to 40% respectively for both) that overlap the ratio range of claim 17
A PHOSITA following the teachings of WO 441 would have found it prima facie obvious to rely on the teachings of the reference application’s conflict claims directed to similarly teaching African Swine Fever Virus with the same fatty acid, pelargonic or combination thereof with caproic as claimed.. See MPEP 2143 (a), combining prior art elements according to known methods to yield predictable results.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion and Correspondence
In summary no claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a 371 of PCT/EP2022/056248 03/10/2022
FOREIGN APPLICATIONS
BELGIUM 2021/5180 03/10/2021
2 MPEP 2143.03 (e) choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
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