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 .
DETAILED ACTION
This action is in response to Applicant’s amendment filed April 24, 2026 in reply to the First Office Action on the Merits mailed January 27, 2026. Claim 1 has been amended. Claims 5-8, 10, 12-17, and 19 have been withdrawn. Claims 1-4, 9, 11, 18, and 20 are currently under examination.
Withdrawal of Prior Objection-Drawings
Figure 4 has been satisfactorily amended on a corrected drawing sheet in compliance with 37 CFR 1.121(d). Therefore, the objection to the drawings presented in the First Office Action on the Merits mailed January 27, 2026 is hereby withdrawn.
Withdrawal of Prior Claim Objections
Claim 1 has been satisfactorily amended. Therefore, the objections to claim 1 presented in the First Office Action on the Merits mailed January 27, 2026 are hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 112(b)
Claim 1 has been satisfactorily amended. Moreover, Applicant’s argument that the separately stated limitations in claim 1 that the composition contains “one or more monomeric polyols in a total amount of not more than about 15% by weight” and that the composition contains “propane-1,3-diol in an amount of less than 1% by weight” should be interpreted as the one or more monomeric polyols limitation includes the propane-1,3-diol limitation is accepted. Therefore, the 35 USC 112(b) rejection presented in the First Office Action on the Merits mailed January 27, 2026 is hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 103
Neither Cai et al. nor Buckheit, JR. et al. explicitly disclose an osmolality of “greater than or equal to 630 mOsm/kg and less than or equal to 1200 mOsm/kg”, as now stipulated in newly amended claim 1. Therefore, the 35 USC 103 rejection presented in the First Office Action on the Merits mailed January 27, 2026 is hereby withdrawn. Upon further search and consideration, however, new prior art has been procured, and a new ground of rejection has been formulated that addresses all pending claim limitations, including the newly added limitation, and is presented herein below.
Claim Interpretation
Claim 1 stipulates that the lubricant composition comprises “propane-1,3-diol in an amount of less than 1% by weight”. In view of the specification, this limitation is being interpreted to preferably include 0% propane-1,3-diol, i.e. that the composition thus does not contain any propane-1,3-diol.
Paragraph [0052] of the original specification states the following:
“Lubricant compositions that include propane-1,3-diol (propanediol) are often perceived by the consumer as having a light, water-like texture, with undesirable skin feel. Accordingly, the lubricant compositions of the present invention contain less than 1% propane-1,3-diol, preferably less than 0.5%, less than 0.1%, less than 0.05%, less than 0.01%, or substantially no propane-1,3-diol, preferably they are completely free from propane-1,3-diol”.
Hence, claim 1 is thus being interpreted as “less than 1% by weight” propane-1,3-diol includes, and in fact preferably includes, no propane-1,3-diol at all, i.e. “less than 1% by weight” in this case includes 0% by weight.
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 1-4, 9, 11, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cai et al. (Chinese Patent Application Pub. No. CN 102512388A), in view of Prugnaud (French Patent Application Pub. No. FR 2759297), and Sheth (Rebalancept [online]; 2019).
Applicant Claims
Applicant’s elected subject matter is directed to a lubricant composition comprising 3-8 wt% 1,2-propanediol, less than 1 wt% 1,3-propanediol, and not more than 0.25 wt% benzoic acid; wherein the composition can further comprise a carbomer, is free from polyquaternium-15, has a pH of 3.5-4.5, and has an osmolality of 630-1200 mOsm/kg.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Cai et al. disclose a lubricant composition for the human body (e.g. reproductive organ tissue) comprising 5-20 wt% propylene glycol (i.e. 1,2-propanediol, i.e. propane-1,2-diol), and 0.1-0.5 wt% benzoic acid; wherein the composition can further comprise a polyacrylate, need not comprise polyquaternium-15, and has a pH of 3.5-5.5.
Prugnaud disclose a lubricant for application to female genital organs comprising carbomer and an acidic pH close to that of vaginal secretion; wherein the lubricant is highly lubricating, improves suppleness and elasticity of the mucous membranes, is not greasy, is easy to spread, and does not form an adhesive film.
Sheth discloses that a lubricant for female reproductive organs, e.g. vagina, should have a pH of 3.8-4.5 and an osmolality from about 380-1200 mOsm/kg.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Cai et al. do not explicitly disclose that the polyacrylate is a carbomer, and that the composition has an osmolality of 630-1200 mOsm/kg. These deficiencies are cured by the teachings of Prugnaud and Sheth.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Cai et al., Prugnaud, and Sheth, outlined supra, to devise Applicant’s claimed composition.
Cai et al. disclose a lubricant composition for the human body (e.g. reproductive organ tissue) comprising 5-20 wt% propylene glycol (i.e. 1,2-propanediol, i.e. propane-1,2-diol), and 0.1-0.5 wt% benzoic acid; wherein the composition can further comprise a polyacrylate, need not comprise polyquaternium-15, and has a pH of 3.5-5.5. Since Prugnaud disclose a lubricant for application to female genital organs comprising carbomer and an acidic pH close to that of vaginal secretion; wherein the lubricant is highly lubricating, improves suppleness and elasticity of the mucous membranes, is not greasy, is easy to spread, and does not form an adhesive film; and since Sheth discloses that a lubricant for female reproductive organs, e.g. vagina, should have a pH of 3.8-4.5 and an osmolality from about 380-1200 mOsm/kg, wherein such lubricant will not be irritating; one of ordinary skill in the art would thus be motivated to employ carbomer as the polyacrylate in the Cai et al. lubricant, and to make the osmolality about 380-1200 mOsm/kg, with the reasonable expectation that the resulting lubricant will be suitable for application to female genital organs, e.g. vagina, and will be highly lubricating, will improve suppleness and elasticity of the mucous membranes, wont be greasy, will be easy to spread, will not be irritating, and will not form an adhesive film.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
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 art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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