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 .
This office action is in response to the reply filed 3/23/2026.
Election/Restrictions
Claims 4, 12 and 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/13/2024.
Response to Arguments
All of Applicant’s arguments filed 3/23/2026 have been fully considered. The declaration of Christin Koch filed 3/23/2026 has been fully considered.
Claim Rejections – 103
Applicants arguments regarding unexpected results are not persuasive.
With respect to the new data presented in paragraph 12, Applicant have not explained why there are two Synergy Index values and how these values are related. It’s unclear why the SI values are so different when they are both directed to the same mixture. Furthermore, the data is not commensurate in scope with the instant claim. Applicant have tested a very specific ratio for a specific blends and only claims 5 and 27 have ratios recited.
Applicant argues that neither Morelli or Faegermann teach the claimed combination to result in synergistic antimicrobial efficacy.
This is not persuasive. as US2018/0092357 teaches that one or more organic compounds can be used, in preservative compositions, due to their ability to demonstrate cumulative synergy or cumulative effect when two or more organic compounds are combined together. Alkanediols like 2,3-octanediol, 1,2-heptanediol and 1,2-octanediol are listed as these types organic compounds which show synergy when combined. Therefore, based on the teachings of the prior art, a skilled artisan would have expected the claimed combinations to results in a synergistic effect and Applicant have not shown how the synergy of the working examples is unexpected. Even if we agreed that the claimed method provided synergistic results, more would be required to show nonobviousness, as synergism is not per se unexpected. See In re Diamond, 360 F. 2d 214, 218 ( CCPA 1966). ("What section 103 requires is 'unexpected synergism'... " (pg. 216, n.7); "we attribute no magic status to synergism per se since it may be expected or unexpected" (pg. 218)(emphasis added)).
Double Patenting
With regards to the ODP rejection(s), as Applicant has not addressed the merits of the rejection(s), the double patenting rejection(s) is/are maintained for the reasons of record.
New 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.
Claim(s) 18-19, 22-24, 26-27, 29 and 32-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huizenga (WO 2015/150520). Huizenga is cited on the 2/2/2026 IDS.
Regarding claim 18 and 26: Table 1 of Huizenga discloses stream 101 comprising 0.2% 1,2-hexanediol and 218ppm (i.e .0218%) 2,3-hexanediol, which reads on the a mixture of diols as claimed.
Regarding claim 27: Component (a) and (b) are present in a weight ratio of 9.14:1 which overlaps with the claimed ranges.
Regarding claims 19 and 29: The stream comprises Component (a) and (b) in a total amount of .2218% which falls within the claimed range.
Regarding claims 22-23 and 32-33: The stream comprises 1,3-propylene glycol which is a polyol reading on cosmetically or pharmaceutically acceptable additive.
Regarding claim 24 and 34: Huizenga anticipates the structure of the claimed composition and as such can be considered homecare product as this is a recitations of intended use and does not result in a structural difference.
Modified/Maintained 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.
Claim(s) 13, 17-19, 22-24, 26-29 and 32-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faergemann (US 2009/0221716). Faergemann is previously cited.
Claim Interpretation: The Examiner would like to note that claims 13 and 17-25, while containing a product consisting of (a) and (b), these are present in a composition or formulation comprising the composition of claim 1. Use of “comprising” opens up the composition to additional ingredients outside of the required (a) and (b).
Regarding the mixture of alkanediols and claim 26: Faergemann discloses a composition comprising at least 3 different diols including heptane-1,2-diol (component (a)), and heptane-2,3 -diol (component (b)) [0018], thus their combination and use is prima facie obvious.
Regarding claim 27: Faergemann discloses that the number of diols depends on which microbe is to be inactivated and these can be used in amounts of 0.25-50% v/v and wherein certain combinations of diol are effective against certain microbes. Therefore, it would have taken no more than the relative skill of one of ordinary skill in the art to have arrived at the claimed ratio through routine experimentation depending on the particular microbe to be inactivated.
Regarding claims 19 and 29: Faergemann teaches that the exact dose of the pharmaceutical composition is dependent on the activity of the compound, manner of administration, nature and severity of the disorder, age and body weight of the patient, and different doses may be needed. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount of diols through routine experimentation depending on these factors. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See MPEP 2144.05.
Regarding claim 22-23 and 32-33: Faergemann teaches that the composition can be formulated as a cosmetic or pharmaceutical composition and can comprise additives such as zinc oxide, emulsifiers, preservatives [0028 and 0036].
Regarding claim 13, 17 and 28: Faergemann teaches that the composition can be formulated as a cream, lotion, shampoo, spray, etc. (Faergemann – claim 21).
Regarding claims 13, 17-18, 24 and 34: Faergemann teaches the diol blend to be formulated as a cosmetic or pharmaceutical composition for topical application [0025], such as spray and shampoos, which reads on utility formulating topical compositions.
Claim(s) 13, 17-19, 20-21, 22-24, 25, 26-29, 30-31, 32-34 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faergemann (US 2009/0221716), as applied to claims 13, 17-19, 22-24, 26-29 and 32-34 above, and further in view of Stewart (US 6,284,227).
As discussed above, the prior art makes obvious the limitations of claims 13, 17-19, 22-24, 26-29 and 32-34, however, they do not teach the composition to further comprises an insect repellant as recited by instant claims 20-21, 25, 30-31 and 35.
Stewart discloses sunscreen and insect repellant compositions (Abs). Stewart teaches that for people who work and play outside it’s essential they protect themselves from insects and from the sun’s rays as these have been shown to cause cancer (Col. 1, lines 50-65).
Stewart teaches that a preferred insect repellant for use includes N,N-diethyl-m-toluamide (“DEET”), this can be present in amounts ranging from 7-33% (Col. 4, lines 45-55). Suitable sunscreen agents for use include zinc oxide (Col. 5, lines 25-31).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Faergemann with those of Stewart and add 7-13% of an insect repellant, such as DEET, the to the formulation of Faergemann as Stewart discussed the importance of protecting the skin from both the sun and insects and Faergemann teaches that zinc oxide can be added to the composition which is a well know sunscreen agent. One of skill in the art would have a reasonable expectation of success as both Morelli and Stewart discussed formulations comprising sunscreen agents such as zinc oxide.
Maintained 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, 5, 13, 26 and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,911,347 (also Application No. 18/301072). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose cosmetic compositions comprising a 1st linear alkanediol (1,2-heptanediol) and a 2nd linear alkanediol (2,3-heptanediol), reading on instant claims 1 and 3. The 1st and 2nd alkanediols are used in a ratio of 50:50 to 99.9:0.1; and are each present in amounts ranging from 0.001-15%, reading on instant claims 5-6. The composition further comprises additives such as emulsifiers, preservatives, etc. and can be formulated as creams, gel reading on instant claim 13 and 28.
Regarding the consisting of language of claim 1: US’347 discloses a mixture comprising 1,2-heptanediol and 2,3-heptanediol, nothing else is required in this mixture, as such the mixture itself reads on a composition consisting of (a) and (b).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 13, 26 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 27-29 and 31-39 of copending Application No. 18/301004 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose cosmetic compositions comprising a 1st linear alkanediol (1,2- heptanediol) and a 2nd linear alkanediol (2,3- heptanediol), reading on instant claims 1 and 3. The 1st and 2nd alkanediols are used in a ratio of 50:50 to 99.9:0.1; and are each present in amounts ranging from 0.001-15%, reading on instant claims 5-6. The composition further comprises additives such as emulsifiers, preservatives, etc. and can be formulated as creams, gel, reading on instant claim 13 and 29.
Regarding the consisting of language of claim 1: US’004 discloses a mixture comprising 1,2-heptanediol and 2,3-heptanediol, nothing else is required in this mixture, as such the mixture itself reads on a composition consisting of (a) and (b).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 13, 26 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-8, 10 and 12-21 of copending Application No. 18/009288 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose cosmetic compositions comprising a 1st linear alkanediol (1,2- heptanediol) and a 2nd linear alkanediol (2,3- heptanediol), reading on instant claims 1 and 3. The 1st and 2nd alkanediols are used in a ratio of 50:50 to 99.9:0.1; and are each present in amounts ranging from 0.001-15%, reading on instant claims 5-6. The composition further comprises additives such as emulsifiers, preservatives, etc. and can be formulated as creams, gel, reading on instant claim 13 and 26.
Regarding the consisting of language of claim 1: US’288 discloses a mixture comprising 1,2-heptanediol and 2,3-heptanediol, nothing else is required in this mixture, as such the mixture itself reads on a composition consisting of (a) and (b).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 13, 26 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-8, 10 and 12-21 of copending Application No. 18/009289 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both cosmetic compositions comprising a 1st linear alkanediol (1,2- heptanediol) and a 2nd linear alkanediol (2,3- heptanediol), reading on instant claims 1 and 3. The 1st and 2nd alkanediols are used in a ratio of 50:50 to 99.9:0.1; and are each present in amounts ranging from 0.001-15%, reading on instant claims 5-6. The composition further comprises additives such as emulsifiers, preservatives, etc. and can be formulated as creams, gel, reading on instant claim 13 and 28.
Regarding the consisting of language of claim 1: US’289 discloses a mixture comprising 1,2-heptanediol and 2,3-heptanediol, nothing else is required in this mixture, as such the mixture itself reads on a composition consisting of (a) and (b).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 13, 26 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-8 and 12-22 of copending Application No. 18/009291 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose cosmetic compositions comprising a 1st linear alkanediol (1,2- heptanediol) and a 2nd linear alkanediol (2,3- heptanediol), reading on instant claims 1 and 3. The 1st and 2nd alkanediols are used in a ratio of 50:50 to 99.9:0.1; and are each present in amounts ranging from 0.001-15%, reading on instant claims 5-6. The composition further comprises additives such as emulsifiers, preservatives, etc. and can be formulated as creams, gel, shampoo, reading on instant claim 9-11 and 13.
Regarding the consisting of language of claim 1: US’291 discloses a mixture comprising 1,2-heptanediol and 2,3-heptanediol, nothing else is required in this mixture, as such the mixture itself reads on a composition consisting of (a) and (b).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 13, 26 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-8 and 12-21 of copending Application No. 18/009312 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose cosmetic compositions comprising a 1st linear alkanediol (1,2- heptanediol) and a 2nd linear alkanediol (2,3- heptanediol), reading on instant claims 1 and 3. The 1st and 2nd alkanediols are used in a ratio of 50:50 to 99.9:0.1; and are each present in amounts ranging from 0.001-15%, reading on instant claims 5-6. The composition further comprises additives such as emulsifiers, preservatives, etc. and can be formulated as creams, gel, reading on instant claim 13 and 28.
Regarding the consisting of language of claim 1: US’312 discloses a mixture comprising 1,2-heptanediol and 2,3-heptanediol, nothing else is required in this mixture, as such the mixture itself reads on a composition consisting of (a) and (b).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 13, 26 and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-3, 5-8 and 12-22 of copending Application No. 18/009324 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose cosmetic compositions comprising a 1st linear alkanediol (1,2- heptanediol) and a 2nd linear alkanediol (2,3- heptanediol), reading on instant claims 1 and 3. The 1st and 2nd alkanediols are used in a ratio of 50:50 to 99.9:0.1; and are each present in amounts ranging from 0.001-15%, reading on instant claims 5-6. The composition further comprises additives such as emulsifiers, preservatives, etc. and can be formulated as creams, gel, reading on instant claim 13 and 28.
Regarding the consisting of language of claim 1: US’324 discloses a mixture comprising 1,2-heptanediol and 2,3-heptanediol, nothing else is required in this mixture, as such the mixture itself reads on a composition consisting of (a) and (b).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 5, 13 and 17-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 of copending Application No. 18/301090 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose cosmetic compositions comprising a 1st linear alkanediol (1,2- heptanediol) and a 2nd linear alkanediol (2,3- heptanediol), reading on instant claim 1 and 26. The 1st and 2nd alkanediols are used in a ratio of 50:50 to 99.9:0.1; and are each present in amounts ranging from 0.001-15%, reading on instant claims 19 and 29. The composition further comprises additives such as emulsifiers, preservatives, etc. and can be formulated as creams, gel, reading on instant claim 13 and 28.
The composition further comprise an insect repellant in amounts of 0.1-50%, such as N,N-diethyl-meta-toluamide, reading on instant claims 20, 25, 31 and 35.
Regarding the consisting of language of claim 1: US’090 discloses a mixture comprising 1,2-heptanediol and 2,3-heptanediol, nothing else is required in this mixture, as such the mixture itself reads on a composition consisting of (a) and (b).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowable.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 2/2/2026 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on (571) 272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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