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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/17/2025 has been entered.
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Claims 4, 12 and 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and/or species, there being no allowable generic or linking claim.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 7/17/2025 and 9/2/2025 have been fully considered. The declaration of Christin Koch filed 7/17/2025 has been fully considered.
Claim Rejections – 103
In view of the amendments to the claims, all rejections over Morelli plus other references have been withdrawn. However, new claim 26 is rejected over Morelli.
In summary Applicant remarks that the specification and the data presented in the declaration show the claimed blends to have synergy.
Applicant’s arguments regarding synergy are 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)).
Applicant argues that the Example A2, A4 and B1 tested multiple ratios and these are representative of the claimed ratio, see declaration ¶¶17-21.
This is persuasive with respect to claim 5, none of the other claims contains ratios and as such those claims are not commensurate in scope with the tested data.
Applicant arguments regarding the carrier not being essential to the composition, see declaration ¶¶13-16, are considered and persuasive.
Applicant arguments, see declaration ¶¶22-23, that the declaration and examples test both individual alkanediols and combinations is persuasive.
Examiner would like to note that Applicant presentation of unexpected results is also not persuasive as Applicant has not compared the instant invention to the closest prior art, Morelli, who strongly suggests the use of alkanediol blends, nor with Faegermann who teaches combinations of diols such as those claimed.
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.
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) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morelli (EP 1238651).
Morelli discloses sunscreen formulations comprising caprylyl glycol or an analog therefore and a combination of preservative agents (Abs). Morelli teaches caprylyl glycol to refer to 1,2-octanediol and teaches suitable analogues to include C5-20, preferably C6-12, alkanediols, such as 2,3-octanediol and 1,2-heptanediol (reading on component (a)). Morelli teaches that “caprylyl glycol or an analog therefore” is meant to comprise a mixture of caprylyl glycol and one or more of its analogues, or mixture of two or more caprylyl analogues [0023 and 0026].
However, Morelli does not specifically teach 2,3-heptanediol, Morelli teaches the use of C6-12 alkanediols, such as 2,3-octanediol to be suitable for use. However, it is noted that a 2,3-octanediol and 2,3-heptanediol are homologs that vary by one CH2 group and thus have a sufficiently close structural similarity, that there is a presumed expectation that such compounds possess similar properties, absent evidence to the contrary.
MPEP 2144.09: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991) as is stated in MPEP 2144.09.
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).
New Claim Rejections - 35 USC § 103
Claim Interpretation: The Examiner would like to note that claims 13 and 17-26, while containing a product consisting of (a) and (b), 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).
Claim(s) 1, 5, 13, 17-19, 22-24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faergemann (US 2009/0221716). Faergemann is previously cited.
Regarding claim 1 and 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. This reads on the claimed “consisting of” of instant claim 1 and “comprising” of instant claim 26.
Regarding claim 5: 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 claim 19: 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 : 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 and 17: Faergemann teaches that the composition can be formulated as a cream, lotion, shampoo, spray, etc. (Faergemann – claim 21).
Regarding claims 13, 17-18 and 24: 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) 1, 5, 13, 17-19, 20-21, 22-24, 25 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Faergemann (US 2009/0221716), as applied to claims 1, 5, 13, 17-19, 22-24 and 26 above, and further in view of Stewart (US 6,284,227).
As discussed above, the prior art makes obvious the limitations of claims 1, 5, 13, 17-19, 22-24 and 26, however, they do not teach the composition to further comprises an insect repellant as recited by instant claims 20-21 and 25.
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.
Regarding claim 29: As discussed above, Faergemann teaches the composition to be formulated as a cosmetic product and formulated as a creams, shampoos, etc. [0038], therefore it would have been prima facie obvious to formula the composition as a cream comprising the insect repellant made obvious above.
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, 5-6, 9-11 and 13 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 9-11 and 13.
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 1-3, 5-6, 9-11 and 13 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 9-11 and 13.
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 1-3, 5-6, 9-11 and 13 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 9-11 and 13.
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 1-3, 5-6, 9-11 and 13 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 9-11 and 13.
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 1-3, 5-6, 9-11 and 13 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 1-3, 5-6, 9-11 and 13 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 9-11 and 13.
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 1-3, 5-6, 9-11 and 13 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 9-11 and 13.
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 1-3, 5-11, 13 and 16-17 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 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 9-11 and 13.
The composition further comprise an insect repellant in amounts of 0.1-50%, such as N,N-diethyl-meta-toluamide, reading on instant claims 7-8 and 16-17.
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.
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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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613