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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
This application is a 371 of PCT/EP2022/082834 filed 11/22/2022.
This application also claims foreign benefit of EPO EP21209558.2 filed 11/22/2021.
Accordingly, claims 9-10 and 17-27 of this application are afforded the effective filing date of 11/22/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/17/2024 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Election/Restrictions
Applicant’s election of Group II, claims 9-10 and 15-16 drawn to methods of modulating microbial growth, in the reply filed on 04/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
In the Claim Amendments filed 04/13/2026, Applicant have canceled claims 1-8 and 11-16, and newly added claims 17-27.
Newly added claims 17-26 are drawn to methods of modulating microbial growth and thereby, rejoined with Group II (containing pending claims 9-10).
However, newly submitted (added) claim 27 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: it is drawn to a method of treatment, amelioration and/or prophylaxis of post weaning diarrhea by administering to an animal a composition comprising organic acid and hypophosphorous acid. This method of treatment, amelioration and/or prophylaxis of post weaning diarrhea of claim 27 differed from the scope of the original claims drawn to compositions (canceled claims 1-8 and 11-14) and methods of modulating microbial growth (pending claims 9-10 and canceled claims 15-16). It is noted that the elected methods of modulating microbial growth are drawn to using/applying the composition on a foodstuff, which materially differed in design, mode of operation, and function from the method of treatment, amelioration and/or prophylaxis of post weaning diarrhea, which operates to treatment, amelioration and/or prophylaxis of post weaning diarrhea by administering the composition of an animal. Furthermore, the common technical feature among claim 27 and elected Group II (claims 9-10 and 17-26) is “a composition comprising at least one organic acid and/or at least one salt thereof and hypophosphorous acid and/or at least one salt thereof,” which as discussed in the Restriction requirement dated 02/12/2026, said common technical feature is not a special technical feature, as it does not make a contribution over the prior art in view of Lee et al (US 2016/0168718 A1; cited in ISR filed 05/17/2024), see Restriction Requirement, pages 4-5, said pages being incorporated herein it entirety. Accordingly, claim 27 and elected Group II (claims 9-10 and 17-26) also lack unity of invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 27 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of the Claims
Claims 9-10 and 17-27 are pending in this instant application, of which claims 27 is withdrawn at this time being drawn to a nonelected groups/invention.
Claims 9, 10, and 17-26 are examined herein on the merits for patentability.
Claim Objections
Claim 9 is objected to because of the following informalities: it is noted that the recitation of “a food stuff, fodder feed, foodstuff additive, fodder additive, feed additive, silage additive, wet distillers grain, dried distiller grain with solubles nutritional supplement, prebiotic, probiotic and intermediate and/or mixtures thereof” is an improper Markush language. When materials recited in a claim are so related as to constitute a proper Markush groups, they may be recited in the conventional manner, or alternatively. For example, if “wherein R is a material selected from the group consisting of A, B, C and D” is a proper limitation, then “wherein R is A, B, C or D” shall also be considered proper. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: the recitation of “selected from the group consisting of … and/or at least one salt thereof” is an improper Markush language. Please see above for proper Markush language. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: the recitation of “selected from the group consisting of … or at least one salt thereof” is an improper Markush language. Please see above for proper Markush language. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: please add an “is” before “from” in line 3 of claim 22. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: please add an “is” before “from in line 3 of claim 23. 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.
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.
Claim(s) 9, 10, 17-19 and 21-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peh et al (PLOS ONE, 17 September 2020, pages 1-13; cited in IDS filed 05/17/2024) in view of Liu et al (US 2005/0202120 A1) and Rhodehamel el al (Journal of Food Proctection, January 1990, 53(1): 56-63; cited in IDS field 05/17/2024).
Regarding claim 9, Peh teaches an antimicrobial composition comprising a combination of organic acids including benzoic acid, propionic acid, acetic, and formic acid, wherein the antimicrobial composition is applied to feed additives to reduce growth of bacterial including Campylobacter spp. (Abstract; pages 1-5 and 8-11; Table 1).
However, Peh does not teach the hypophosphorous acid and/or at least one salt thereof of claim 9.
Regarding the hypophosphorous acid and/or at least one salt thereof of claim 9, Liu teaches an antimicrobial composition comprising a first aqueous solution containing a pH-adjusting agent such as citric acid, acetic acid, lactic acid, malic acid or mixtures thereof, and a second aqueous solution containing a high-pH adjusting agent containing sodium hypophosphite, wherein the antimicrobial composition is applied to a foodstuff (e.g., fruits, vegetables and mushrooms) for reducing microbial concentration on the foodstuff (Abstract; [0008], [0023]-[0024], [0032]; claims 7, 8 and 15).
It would have been obvious to one of ordinary skill in the art to include sodium hypophosphite to the antimicrobial composition of Peh and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because per Rhodehamel, sodium hypophosphite is known to be used as an antimicrobial food preservative for inhibiting growth of gram negative foodborne pathogenic and spoilage bacteria including Campylobacter jejuni strains, Escherichia coli, Pseudomonas fluorescens, Salmonella typhimurium, Vibrio parahaemolyticus, and Yersinia enterocolitica (Rhodehamel: Abstract; pages 56-63), and Liu establish that sodium hypophosphite can be used combination with organic acids such as citric acid, acetic acid, lactic acid, malic acid or mixtures to provide an antimicrobial composition that acid, lactic acid, malic acid or mixtures for reducing microbial concentration on foodstuff. Thus, an ordinary artisan seeking to provide an antimicrobial composition that inhibit or reduce microbial growth over broad spectrum of bacteria in food products such as foodstuff and feed would have looked to include sodium hypophosphite to the antimicrobial composition containing organic acids of Peh, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claim 10, as discussed above, Peh and Rhodehamel teach the microbes include Campylobacter jejuni strains, Escherichia coli, Pseudomonas fluorescens, Salmonella typhimurium, Vibrio parahaemolyticus, and Yersinia enterocolitica.
Regarding claim 17, as discussed above, Liu provides the guidance for including sodium hypophosphite in the antimicrobial composition of Peh.
Regarding claims 18 and 19, as discussed above, Peh teaches benzoic acid, propionic acid, acetic, and formic acid as the organic acids in the antimicrobial composition.
Regarding claims 21-23, Liu teaches the antimicrobial composition contains 1.1 to 7.9% by weight of the pH-adjusting agent such as citric acid, acetic acid, lactic acid, malic acid or mixtures, and 0.1 to 5.0% by weight of the high-pH adjusting agent such as sodium hypophosphite ([0023]-[0024], [0031]-[0032; claims 7-8 and 15]). It is noted that the weight amounts of pH-adjusting agent such as citric acid, acetic acid, lactic acid, malic acid or mixtures and the high-pH adjusting agent such as sodium hypophosphite of Liu overlap the claimed molar ratio as recited in claims 21-23. It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of molar ratio of the organic acid to the hyphophosphorous acid would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II). Regarding claim 24, as discussed above, Peh teaches benzoic acid, propionic acid, acetic, and formic acid as the organic acids in the antimicrobial composition, and Liu provides the guidance for including sodium hypophosphite in the antimicrobial composition of Peh.
Regarding claims 25 and 26, as discussed above, Peh teaches benzoic acid, propionic acid, acetic, and formic acid as the organic acids in the antimicrobial composition.
From the teachings of the references, 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 in art the before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peh et al (PLOS ONE, 17 September 2020, pages 1-13; cited in IDS filed 05/17/2024) in view of Liu et al (US 2005/0202120 A1) and Rhodehamel el al (Journal of Food Proctection, January 1990, 53(1): 56-63; cited in IDS field 05/17/2024), as applied to claims 9 and 18 above, and further in view of Consalo et al (US 2014/0275264 A1).
The methods of claims 9 and 18 are discussed above, said discussion being incorporated herein it entirety.
Regarding claim 20, Consalo teaches a method of controlling bacterial contamination using an antimicrobial composition containing organic acids including propionic acid, wherein the suitable salt form of the organic acid includes sodium propionate (Abstract; [0029]-[0045], [0077]-[0078]).
It would have been obvious to one of ordinary skill in the art to incorporate sodium propionate as the propionic acid in the antimicrobial composition of Peh, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Consalo provided the guidance to the do by teaching that the suitable salt form of propionic acid includes sodium propionate can be used in an antimicrobial composition used for controlling bacterial contamination. Thus, an ordinary artisan would look to suitable known salt forms of organic acids including sodium propionate to be used as the propionic acid in the antimicrobial composition of Peh per guidance Consalo, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, 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 in art the before the effective filing date of Applicant’s invention, 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 9, 10, and 17-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of copending Application No. 19131724 in view of Liu et al (US 2005/0202120 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the copending application ‘724 significantly overlap with the subject matter of the instant claims, i.e., both set of claims are drawn to using the substantially the same composition containing organic acids including benzoic acid for modulating growth of microbes.
While the claims in the instant application further contains a hypophosphorous acid in the composition, it would have been obvious to one of ordinary skill in the art to including a hypophosphorous acid such as sodium hypophosphite in the composition of copending application ‘724 in view of the guidance from Liu: (Abstract; [0029]-[0045], [0077]-[0078]))
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over copending Application No. 19131724 in view of Liu.
This is a provisional nonstatutory double patenting rejection.
Claims 9, 10, and 17-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19483756 in view of Peh et al (PLOS ONE, 17 September 2020, pages 1-13; cited in IDS filed 05/17/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the copending application ‘756 significantly overlap with the subject matter of the instant claims, i.e., both set of claims are drawn to using the same composition containing organic acids and hypophosphorous acid in feed additive.
While the claims in instant application is drawn to modulating microbial growth and the claims in the copending application ‘756 uses the composition for improving performance of animals, it would have been obvious that the composition containing organic acids of the instant claims could also be used for improving performance of animals, as per Peh antimicrobial composition containing organic acids can be use in feed additive that are fed to animal to improve the performance of the animal (Peh: Abstract; pages 1-5 and 8-11; Table 1).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over copending Application No. 19483756 in view of Peh.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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