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 papers filed October 27, 2025. Applicant’s reply to the restriction/election requirement of August 28, 2025 has been entered. Claims 1, 3, 4, 6-14, 16, and 17 have been amended; and claims 18-20 have been newly added. Claims 1-20 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/GB2022/050134, filed January 18, 2022 under 35 U.S.C. 365(c), is acknowledged.
Acknowledgment is also made of Applicant’s claims for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies of British Patent Application No. GB2100631.7, and Thai Patent Application No. TH2101007077, filed in the United Kingdom of Great Britain and Northern Ireland, and the Kingdom of Thailand, respectively, have been received as required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-12 and 18-20, is acknowledged. Applicant’s elections of i) “viscosity-modifying polymer” as the species of further requisite constituent, ii) “polyquaternium-15” as the species of compound which the composition is free of, and iii) “carbomer” as the species of viscosity-modifying polymer are all also acknowledged. The Examiner has determined that claims 1-4, 9, 11, 18, and 20 read on the elected subject matter.
The traversal is on the ground(s) that “Griffiss does not disclose a composition that includes propane-1,3-diol in an amount of less than 1% by weight”; and that “the office cites the use of propylene glycol as a preservative in Griffiss” but “the article does not teach this use of 1,3-propanediol”.
This is not found persuasive for the following reasons:
1. First, as noted below under the section “Claim Interpretation”, the limitation in claim 1 of “propane-1,3-diol in an amount of less than 1% by weight”, interpreted in light of the specification, is being interpreted to mean 0% up to 1% by weight of propane-1,3-diol. In other words, the composition need not include propane-1,3-diol at all, and preferably does not according to the specification.
2. Claim 1 thus requires a monomeric polyol and benzoic acid, with a specific pH and osmolality. Since “less than 1% by weight” propane-1.3-diol can include 0% propane-1,3-diol, the composition need not contain propane-1,3-diol.
3. Griffiss discloses a composition that contains propylene glycol (i.e. a monomeric polyol), and benzoic acid, with specific pH and osmolality values that fall within the scope of the claim. Even assuming, arguendo, that Griffiss does not disclose the special technical feature, Buckheit, JR. et al., the reference cited below, does. The invention lacks unity a posteriori.
Accordingly, claims 5-8, 10, 12-17, and 19 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected subject matter, there being no allowable generic or linking claim. The restriction/election requirement is still deemed proper, maintained, and is therefore made FINAL.
Applicant timely traversed the restriction (election) requirement in the reply filed on October 27, 2025. Claims 1-4, 9, 11, 18, and 20 are currently under examination.
Drawings
The drawings are objected to because of the following:
1. In Figure 4, it’s not clear for each of the individual photos which photo represents which formulation 1-4, and which photo represents which comparative formulation 1-4.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following:
1. In claim 1, there is an extraneous colon between “comprising” and “benzoic acid”. There should be a semicolon rather than a comma between “1% by weight” and “wherein the lubricant composition has a pH”.
Appropriate correction is required.
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 1-4, 9, 11, 18, and 20 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 is indefinite for the following reasons:
1. Claim 1 first stipulates that the composition contains “one or more monomeric polyols in a total amount of not more than about 15% by weight”, and then, in a separate clause, stipulates that the composition contains “propane-1,3-diol in an amount of less than 1% by weight”. As one of ordinary skill in the art would immediately recognize, propane-1,3-diol is, in fact, a monomeric polyol. One of ordinary skill in the art thus cannot definitively ascertain whether the “one or more monomeric polyols in a total amount of not more than about 15% by weight” necessarily includes, or rather excludes, the additional limitation of “propane-1,3-diol in an amount of less than 1% by weight”.
2. Claim 1 stipulates that benzoic acid is present in the amount of “not more than about 0.25%”; stipulates that one or more monomeric polyols are present in an amount of “not more than about 15%”; and stipulates that the osmolality is “not more than about 1200”. While “more than” or “about” when employed separately are generally considered definite, the expression “more than about” is considered indefinite.
Claims 2-4, 9, 11, 18, and 20 are indefinite for depending from an indefinite claim.
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 Buckheit, JR. et al. (U.S. Patent Application Pub. No. 2017/0281657).
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 not more than 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.
Buckheit, JR. et al. disclose e.g. a lubricant composition for the human body (e.g. reproductive organ tissue) comprising 1-10 wt% propylene glycol (i.e. 1,2-propanediol, i.e. propane-1,2-diol), and 0.05-0.75 wt% benzoic acid; wherein the composition can further comprise CARBOPOL (i.e. carbomer, i.e. polyacrylate), need not comprise polyquaternium-15, has a pH of e.g. 4, and has an osmolality of e.g. 200-500 mOsm/kg (abstract; paragraphs 0008, 0009, 0025, 0026, 0052, 0083, 0106-0108, 0111, 0112, 0153, 0154, 0156, 0158, 0203).
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 not more than 1200 mOsm/kg. These deficiencies are cured by the teachings of Buckheit, JR. et al.
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. and Buckheit, JR. et al., outlined supra, to devise Applicant’s presently 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 Buckheit, JR. et al. disclose that personal lubricant compositions for vaginal use advantageously have a “low” osmolality of about e.g. 200-500 mOsm/kg to preserve the integrity of sperm and thus promote successful fertilization, wherein the lubricant composition can comprise 1-10 wt% propylene glycol (i.e. 1,2-propanediol, i.e. propane-1,2-diol), 0.05-0.75 wt% benzoic acid, and CARBOPOL (i.e. carbomer, i.e. polyacrylate), need not comprise polyquaternium-15, and has a pH of e.g. 4; one of ordinary skill in the art would thus be motivated to employ specifically CARBOPOL (i.e. carbomer) as the polyacrylate in the Cai et al. composition, and to ensure the resulting composition has an osmolality of e.g. about 200-500 mOsm/kg, with the reasonable expectation that the resulting lubricant composition, when applied to the vagina before sexual activity, will successfully protect the integrity of sperm and promote the chances of fertilization.
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.
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/DAVID BROWE/Primary Examiner, Art Unit 1617