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 .
Information Disclosure Statements
Information Disclosure Statements (IDS) filed on 07/25/2024 and 03/13/2026 have been considered by the Examiner. A signed copy of the IDS is included with the present Office Action.
Claims Status
Applicant's election with traverse of Group I, claims 1-6 and the species of: first antimicrobial agent of formula I is 4-hydroxyacetophenone; and second antimicrobial agent b) is glyceryl caprylate in the reply filed on 06/26/2026 is acknowledged. The traversal is on the ground(s) that the restriction fails to establish the identified groups are independent or distinct and that examination would impose serious search burden. Applicants argue that examination of claims 7-13 each requires the mixture of claim 1.
This is not found persuasive because per MPEP 808.02, the separate classification shows that each invention has attained recognition in the art as separate subject for inventive effort and a separate field of search. Furthermore, a search for one invention requires different queries or search stings than another. For example, the method of preserving a personal care formulation is not likely to yield the same results as a detergent composition, deodorizing composition or food composition. Furthermore, the species requirement set forth reasons why the claimed inventions are distinct, see pages 4-5 of the restriction requirement mailed on 04/29/2026. Accordingly, the restriction requirement is maintained.
Regarding the species election, Applicants argue that it fails to adequately explain why species encompassed by claim 1 are mutually exclusive or patentably distinct or why examination would impose a serious search burden.
In response, examiner respectfully submits that each of the disclosed species have mutually exclusive characteristics as a search for one species would require different search queries to another and different searches of the art would be required to determine the patentability of these independent and distinct species. For example, a search for 4-hydroxyacetophenone with glyceryl caprylate is a distinct search than the structure for 2-hydroxyacetophenone together with benzoic acid. Each of the first and second antimicrobial agents claimed would require different search queries/stings. Accordingly, there is a search burden for the species claimed.
Claims 4 and 7-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/26/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-3 and 5-6 are under current examination as being directed to the elected species of first and second antimicrobial agent of 4-hydroxyacetophenone and glyceryl caprylate.
Claim Rejections - 35 USC § 112(b)
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 1-3 and 5 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 1 recites a second antimicrobial agent “selected from”. It is unclear if the Markush group selections are selected from a closed list of alternatives (i.e. selected from the group consisting of) or whether the group is selected from an open list of alternatives. A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. It is unclear what other alternatives are intended to be encompassed by the claim. See In re Kiely, 2022 USPQ2d 532 at 2* (Fed. Cir. 2022).
Claims 2-3 and 5 do not rectify the indefinite Markush grouping of claim 1.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 6 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2 and 6 recite that the second antimicrobial agent includes glyceryl caprate. However, claim 1 does not include glyceryl caprate as the second active agent. Claim 1 recites glyceryl caprylic acid and esters thereof which is distinct from glyceryl caprate. It is believed that claims 2 and 6 meant to recite “glyceryl caprylate” and not glyceryl caprate. For the purpose of examination, both claims 2 and 6 will be interpreted as the elected species to glyceryl caprylate and not glyceryl caprate.
Applicants may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pruns et al. (WO2015144326) as evidenced by Pesaro et al. (EP2774481).
Pruns et al. teach a composition comprising 4-hydroxyacetophenone present at 0.6% by weight together with 0.2% by weight glycerylcaprylat (aka glyceryl caprylate) which is a ratio of 3:1, see sunblock example 3 at page 10. Although the composition is not taught as antimicrobial, as evidenced by Pesaro, both 4-hydroxyacetophenone and glyceryl caprylate (also known as glycerol monocaprylate) are antimicrobial agents, see claims 1-2. Thus, the composition having glycerol caprylate (also known as glyceryl caprylate) and 4-hydroxyacetophenone is necessarily antimicrobial. Furthermore, per MPEP 2112.01, products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
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 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Pesaro et al. (EP2774481).
Pesaro et al. teach acetophenone derivatives of formula I as an antimicrobial agent together with at least one second antimicrobial agent, see paragraph [0023]. The acetophenone derivative of formula 1 is inclusive of 4-hydroxyacetophenone, see claim 2 and paragraph [0021]. Second antimicrobial agents include glycerol monolaurate, see paragraph [0023] and claim 5. The weight ratio of acetophenone derivative to second antimicrobial agent is from 1:99 to about 99:1 including preferably about 40:60 to about 60:40.
Pesaro teaches that antimicrobial agents are inclusive of glycerol monolaurate or glycerol monocaprylate (also known as glyceryl caprylate) in the alternative to glycerol monolaurate, see paragraph [0056]. The mixtures of first and second agents are taught to be synergistic in antimicrobial effects, see paragraphs [0016]-[0017], and [0020].
It would have been prima facie obvious to substitute the second antimicrobial agent of glycerol monolaurate exemplified in Pesaro et al. for glycerol monocaprylate.
One of ordinary skill in the art would have been motivated to do so because Pesaro teaches that their formulation can include a second antimicrobial agent not limited to glycerol monolaurate and Pesaro teaches that in the alternative to glycerol monolaurate, glycerol monocaprylate can be used as a suitable antimicrobial agent, see paragraph [0056].
Regarding the weight ratio of the 4-hydroxyacetophenone to glycerol monocaprylate, Pesaro et al. teaches overlapping weight ratios of preferably about 40:60 to about 60:40. 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).
Accordingly claims 1-3 and 5-6 are considered prima facie obvious over the teachings of Pesaro et al.
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 1-3 and 5-6 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 17 of copending Application No. 18009288 reference application) in view of Pruns et al. (WO2015144326) as evidenced by Pesaro et al. (EP2774481).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of Application ‘288 are inclusive of a mixture of 4-hydroxyacetophenone together with glyceryl caprylate (see claim 17 of Application ‘288).
Although Application ‘288 does not disclose a ratio of each, Pruns et al. teach a composition comprising 4-hydroxyacetophenone present at 0.6% by weight together with 0.2% by weight glycerylcaprylat (aka glyceryl caprylate) which is a ratio of 3:1, see sunblock example 3 at page 10. Although the composition is not taught as antimicrobial, as evidenced by Pesaro, both 4-hydroxyacetophenone and glyceryl caprylate (also known as glycerol monocaprylate) are antimicrobial agents, see claims 1-2. Thus, the composition having glycerol caprylate (also known as glyceryl caprylate) and 4-hydroxyacetophenone is necessarily antimicrobial.
It would have been obvious for formulate the composition of Application ‘288 having a mixture of 4-hdyroyxacetophenone and glycerol monocaprylate in a ratio of 3:1 because Pruns discloses such a combination is suitable for sunscreen formulations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 and 5-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-6 of U.S. Patent No.10638755 in view of Pesaro (EP2774481).
Both the instant claims and that of Patent ‘755 claim antimicrobial mixtures with 4-hydroxyacetophenone. Patent ‘755 claims a second antimicrobial agent present at 1-25% by weight.
Patent ‘755 does not claim glyceryl monocaprylate or the amount of the 4-hydroxyacetophenone or the ratio of 1:5 to 5:1.
Pesaro et al. teach acetophenone derivatives of formula I as an antimicrobial agent together with at least one second antimicrobial agent, see paragraph [0023]. The acetophenone derivative of formula 1 is inclusive of 4-hydroxyacetophenone, see claim 2 and paragraph [0021]. Second antimicrobial agents include glycerol monolaurate, see paragraph [0023]. The weight ratio of acetophenone derivative to second antimicrobial agent is from 1:99 to about 99:1 including preferably about 40:60 to about 60:40.
Pesaro teaches that antimicrobial agents are inclusive of glycerol monolaurate or glycerol monocaprylate (aka glyceryl caprylate), see paragraph [0056]. Pesaro teaches such antimicrobial mixtures as synergistic, see paraph [0016]-[0017].
It would have been obvious to provide a combination of the 4- hydroxyacetophenone of Patent ‘755 with glycerol monocaprylate in a weight ratio that overlaps 40:60 to 60:40.
One of ordinary skill in the art would have been motivated to do so because Pesaro teaches that their formulation can include a second antimicrobial agent not limited to glycerol monolaurate and Pesaro further teaches that in the alternative to glycerol monolaurate, glycerol monocaprylate can be used as a suitable antimicrobial agent, see paragraph [0056]. Such antimicrobial mixtures are taught in Pesaro to provide synergism.
Conclusion
Currently, no claims are allowed, and all claims are rejected.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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