DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/10/2026 has been entered.
Applicants' arguments, filed 02/17/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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
The instant application claims foreign priority GB2019524.4 filed 12/10/2020. The instant application is a 371 of PCT/EP2021/084819 filed 12/08/2021.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Cole et al. (US Application Publication 20200024226A1).
Cole teaches the use of Methyl 4-fluoro-2-hydroxybenzoate (XLIIa) (Cole at [1247-1248])
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Cole teaches that to a solution of 100 g (0.64 mol, 1.0 eq.) of 1,4-fluoro-2-hydroxybenzoic acid (XLIa) in 1 L of MeOH at 0° C. was slowly added 100 mL of concentrated sulfuric acid at 0° C. The mixture was allowed to warm to room temperature and then heated at 70° C. for 16 h. The mixture was then allowed to cool to room temperature and concentrated under reduced pressure. The residue was redissolved in 1 L of ethyl acetate and washed with 500 mL of sat. NaHCO3 followed by 500 mL of brine. The organic phase was dried (Na2SO4), filtered and the solvent was removed in vacuo to provide 95 g (0.56 mol, 87%) of methyl 4-fluoro-2-hydroxybenzoate (XLIIa) (Cole at [1247-1248]). Cole further teaches that the composition is a tablets, capsules, caplets, pills, gel caps, troches, emulsions, dispersions, suspensions, solutions, syrups, granules, beads, transdermal patches, gels, powders, pellets, magmas, lozenges, creams, pastes, plasters, lotions, discs, suppositories, liquid sprays for nasal or oral administration, dry powder or aerosolized formulations for inhalation (Cole at [0698]). Cole further teaches formulations suitable for oral administration include, but are not limited to, a powdered or granular formulation, an aqueous or oily suspension, an aqueous or oily solution, a paste, a gel, toothpaste, a mouthwash, a coating, an oral rinse, or an emulsion (Cole at [0699]). Cole teaches liquid suspensions may be prepared using conventional methods to achieve suspension of the active ingredient in an aqueous or oily vehicle. Aqueous vehicles include, for example, water, and isotonic saline. Oily vehicles include, for example, almond oil, oily esters, ethyl alcohol, vegetable oils such as arachis, olive, sesame, or coconut oil, fractionated vegetable oils, and mineral oils such as liquid paraffin. Liquid suspensions may further comprise one or more additional ingredients including, but not limited to, suspending agents, dispersing or wetting agents, emulsifying agents, demulcents, preservatives, buffers, salts, flavorings, coloring agents, and sweetening agents (Cole at [0681]). Cole does not require or teach the use of methyl salicylate.
Cole differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Cole teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Cole to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 1, Cole teaches the use of Methyl 4-fluoro-2-hydroxybenzoate (XLIIa) (Cole at [1247-1248]). Cole further teaches that the composition is a tablets, capsules, caplets, pills, gel caps, troches, emulsions, dispersions, suspensions, solutions, syrups, granules, beads, transdermal patches, gels, powders, pellets, magmas, lozenges, creams, pastes, plasters, lotions, discs, suppositories, liquid sprays for nasal or oral administration, dry powder or aerosolized formulations for inhalation (Cole at [0698]). Liquid suspensions may further comprise one or more additional ingredients including, but not limited to, suspending agents, dispersing or wetting agents, emulsifying agents, demulcents, preservatives, buffers, salts, flavorings, coloring agents, and sweetening agents (Cole at [0681]). Cole further teaches formulations suitable for oral administration include, but are not limited to, a powdered or granular formulation, an aqueous or oily suspension, an aqueous or oily solution, a paste, a gel, toothpaste, a mouthwash, a coating, an oral rinse, or an emulsion (Cole at [0699]).
Regarding instant claim 2, Cole does not require or teach the use of methyl salicylate.
Regarding instant claim 3, Cole further teaches that the composition is a tablets, capsules, caplets, pills, gel caps emulsions, dispersions, suspensions, solutions, syrups, lozenges, (Cole at [0698]) which would be consumable.
Regarding instant claim 4, Cole teaches the use of Methyl 4-fluoro-2-hydroxybenzoate (XLIIa) (Cole at [1247-1248]).
Regarding instant claim 5, Cole teaches the use of Methyl 4-fluoro-2-hydroxybenzoate (XLIIa) (Cole at [1247-1248]). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01(I).
Regarding instant claim 6, Cole does not require or teach the use of methyl salicylate. Cole further teaches that the composition is a tablets, capsules, caplets, pills, gel caps emulsions, dispersions, suspensions, solutions, syrups, lozenges, (Cole at [0698]) which would be consumable.
Response to Arguments
Applicant’s arguments with respect to claims 1-6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-10, 14,15,17,18 and 20 of copending Application No. 18/275,080 in view of Cole et al. (US Application Publication 20200024226A1). The instant invention recites a consumer product comprising a methyl-fluoro- hydroxybenzoate selected from methyl 4-fluoro-2-hydroxybenzoate and methyl 2-fluoro- 6-hydroxybenzoate and a further ingredient (instant application at claim 1).
The reference application 080 recites a method of reducing an off-taste of a composition to be received orally, comprising adding to said composition 2'-HOPP and methyl-fluoro- hydroxybenzoate (080 at claim 1). There is not a statutory case of double patenting because the reference application 080 requires the use of 2’-HOPP which is not required by the instant invention.
The reference application 080 recites wherein the composition additionally comprises methyl-fluoro-hydroxybenzoate (080 at claims 7, 12, and 13).
The reference claims differ from the instant invention insofar as they do not specifically recite in the claims the use of the specific structures of methyl 4-fluoro-2-hydroxybenzoate and methyl 2-fluoro-6-hydroxybenzoate. The teachings of Cole cure this deficit.
The teachings of Cole are discussed in the obviousness rejections above.
It would be prima facie obvious to have combined the methyl-fluoro-hydroxybenzoate of 080 with the methyl 2-fluoro- 6-hydroxybenzoate of Cole for the predictable results of a methyl-fluoro-hydroxybenzoate in a product. See MPEP 2144.06(I). There would be a reasonable expectation of success because 080 teaches the use of 4-fluoro-2-hydroxybenzoate, and methyl 2-fluoro-6-hydroxybenzoate on page 3 of their specification as methyl-fluoro-hydroxybenzoates.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not persuasive.
Applicant argues that the double patenting rejection is premature and instant application is earlier filed, and therefore the double patenting rejection should be withdrawn.
The Examiner does not agree. Because the instant claims are not in condition for allowance, other rejections remain, the double patenting rejection stands as the provisions of MPEP 804(I)(B)(1)(b)(i-iii) apply. Since terminal disclaimers have not yet been filed, the non-statutory double patenting rejections are maintained.
Applicant argues that Shirely is improper and should not be used due to the amended claims.
Applicant’s arguments, see remarks page 8, filed 02/17/2026, with respect to the rejection(s) of claim(s) 1-6 under Shirely have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Cole.
Conclusion
No claims are presently allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup, can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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