DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Species I (claims 21-27) in the reply filed on 07/29/2026 is acknowledged. Species II (claims 28-37) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species.
Claim status
Claims 21-37 filed 07/29/2026 are pending in the application. Claims 21-27 are previously presented. Claims 28-37 are withdrawn without traverse in responding to the restriction requirement. Claims 21-27 are hereby examined on the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 25-27 are rejected under 35 USC 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a composition which is a mixture of pelargonic acid, propionic acid and trans-2-hexenal in varying ratios. However, each of pelargonic acid, propionic acid and trans-2-hexenal are naturally occurring (see [0007] of Smiley US Patent Application Publication No. 2002/0068680 A1; [0011] of Hebert US Patent Application Publication No. 2004/0029830 A1; and page 5753, 2nd para. from the end of Kubo, “Naturally occurring anti-salmonella agents”, J. Agric. Food Chem., 2001, 49(12), 5750-55, which evidence that each of the three compounds above are naturally occurring). It does not appear that the mixture of the three compounds provide significant more than the naturally occurring counterparts would be expected to contribute individually. This judicial exception is not integrated into a practical application because for treating a solid animal feed at an effective amount is merely an intended use of the mixture which does not impart material characteristics to the mixture. The claims do not include additional elements or ingredients that are sufficient to amount to significantly more than the judicial exception.
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 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,021,901 (hereinafter “’901”). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘901 recites an antimicrobial composition comprising 5-25% pelargonic acid (e.g., nonanoic acid), 50-70% propionic acid, and 15-20% trans-2-hexenal, which overlap with or encompass the ranges as recited in instant claims 25-26.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 25-27, 21-22 and 24 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Li US Patent Application Publication No. 2010/0021557 A1 in view of Subbiah US Patent No. 5,698,599 and Lanciotti, “Application of Hexanal, (E)-2-Hexenal, and Hexyl Acetate To Improve the Safety of Fresh-Sliced Apples”, J. Agric. Food Chem. 2003, 51, 10, pp. 2958–2963, hereinafter referred to as Li, Subbiah and Lanciotti, respectively (each of Li, Subbiah and Lanciotti are cited in the IDS submitted 07/26/2024).
Regarding claims 25-27, Li teaches an antimicrobial composition comprising inter alia, sulfoperoxycarboxylic acid at a concentration of as little as 10 ppm (claim 16), and at least two of a carboxylic acid including propionic acid, and pelargonic acid (e.g., nonanoic acid), etc. ([0013]; [0073-0075]); Li further teaches that the composition includes 0.1-80% of a carboxylic acid recited above ([0073-0075]).
Li also teaches that the composition is used as an antimicrobial composition for treating animal feed ([0013; 0021; 0032]).
Li is silent regarding the composition comprising trans-2-hexenal.
Subbiah teaches a method of inhibiting mycotoxins or microbial infection in animal feed by contacting the animal feed with an effective amount of trans-2-hexenal so as to inhibit mycotoxin production (column 2, line 26-33; column 3, line 1-5 and 43-45).
Lanciotti teaches that trans-2-hexenal has a significant inhibitory effect against pathogen microorganisms such as E. coli, S. enteritidis and L. monocytogenes, and can be used as an antimicrobial agent in food (abstract; page 2962-2963, “Discussion”).
Both Li and Subbiah are directed to the compositions for treating animal feed for anti-mycotoxin or antimicrobial purpose. Both Li and Lanciotti are directed to antimicrobial compounds for food use. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Li by including trans-2-hexenal in the antimicrobial composition that comprises pelargonic acid and propionic acid for anti-mycotoxin or antimicrobial effects. One of ordinary skill in the art, before the effective filing date of the claimed invention, would have had a reasonable expectation of success for doing so because prior art has established that trans-2-hexenal is antimicrobial agent and is safe for use in animal feed. Further, as stated in MPEP 2144.06, "it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding the proportions of pelargonic acid, propionic acid and trans-2-hexenal in the antimicrobial composition, Li as recited above teaches that the composition includes 0.1-80% of a carboxylic acid comprising pelargonic acid and propionic acid thus reasonably encompassing the proportions as recited in claims 25-26 (the proportion of each of pelargonic acid and propionic acid is reasonably 0-100% within 0.1-80 wt%) thus a prima facie case of obviousness exists. Further, Subbiah discloses that an effective amount of trans-2-hexenal is needed to inhibit mycotoxin (column 2, line 30-33), recognizing that the amount of trans-2-hexenal in the composition is a result effect variable. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have optimized the amount of trans-2-hexenal in the composition such that it could effectively inhibit fungi, bacterial or mycotoxin when added to an animal feed. Further, where prior art has recognized that each of three compounds are anti-microbial agents suitable for use in an animal feed, one of ordinary skill in the art would have been motivated to vary the amount of each so as to ensure that combination could effectively reduce the number of microbes when added to an animal feed.
The preamble languages about the composition being “anti-salmonella”, and about the composition being for treating a solid animal feed at an effective amount such as 1-3 kg per metric ton animal feed as recited in claims 25 and 27 are not considered to further limit the composition. It is the Examiner’s position that the intended use recited in the present claims do not result in a structural difference between the presently claimed composition and the prior art composition and further that the composition of the prior art is capable of performing the intended uses. Given that Li in view of Subbiah and Lanciotti teaches the essentially same composition as that recited in the instant claims and that the composition is used as an antimicrobial composition for treating animal feed , it is clear that the antimicrobial composition of Li in view of Subbiah and Lanciotti would be capable of performing the intended uses, i.e., used as an anti-salmonella composition in a solid animal feed at an effective amount such as 1-3 kg per metric ton animal feed.
Regarding claims 21-22, Li in view of Subbiah and Lanciotti teaches an anti-salmonella composition in connection with claims 25-27, the entirety of which is incorporated herein by reference. Further, Li in view of Subbiah and Lanciotti as recited above teaches adding pelargonic acid, propionic acid and trans-hexenal to an animal feed for antimicrobial purpose, therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have added the composition comprising the three compounds as an anti-microbial composition to an animal feed. Further, it would have been obvious to have added the composition to an animal feed in any suitable form (solid or liquid) and reasonably expect the composition will function.
Regarding the limitation that an effective amount of the composition is included in the animal feed, Subbiah teaches that trans-2-hexenal is contacted with the foodstuff in an amount effective to inhibit mycotoxin condition (column 2, line 30-33), therefore, one of ordinary skill in the art would have been motivated to manipulate the amount the composition in the animal feed so as to ensure that a sufficient amount of microbes are eliminated by the composition. The effective amount to eliminate a microbes necessarily meets the effective amount to combat salmonella, since the latter belong to the former.
Regarding claim 24, given that Li in view of Subbiah and Lanciotti teaches applying essentially the same antimicrobial composition at essentially the same dose, it logically follows that the prior art method will have the resistance property to S. typhimurium as recited in the claim, when subjected to the test as recited in the claim. See In re Best.
Claim 23 is under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Li in view of Subbiah and Lanciotti as applied to claim 21 above, and further in view of Lanter US Patent Application Publication No. 2010/0124582 A1 (hereinafter referred to as Lanter).
Regarding claim 23, Li in view of Subbiah and Lanciotti teaches adding an effective amount of a composition comprising pelargonic acid, propionic acid and trans-2-hexenal to an animal feed for antimicrobial purpose, but is silent regarding that the effective amount is 1-3 kg/metric ton of animal feed.
Lanter in the same field of endeavor teaches adding a preservative comprising propionic acid to an animal feed so as to minimize the number of microbes in the animal feed, in particular, Lanter teaches an application rate of 0.25-8% (0014). Therefore, it would have been obvious to one skilled in the art to manipulate the amount of the anti-microbial composition added to the animal feed so as to ensure that the composition is sufficient in minimizing the of microbes in the animal feed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANGQING LI whose telephone number is (571)272-2334. The examiner can normally be reached 9:00-5:00.
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/CHANGQING LI/Primary Examiner, Art Unit 1791
