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
Status of Application
1. Applicants’ arguments/remarks filed 4 February 2026 are acknowledged. Claims 2-14 and 16-22 are currently pending. Claims 1 and 15 have been cancelled. Claims 2, 11-12, and 14 have been amended. Claims 2-14 and 16-22 are examined on the merits within.
Terminal Disclaimer
2. The terminal disclaimer filed on 4 February 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,439,610, 9,566,232, 10,568,855, and 11,992,472 has been reviewed and is accepted. The terminal disclaimer has been recorded.
New Rejections
Claim Rejections – 35 U.S.C. 112(a) New Matter
3. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
4. Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
5. Claim 14 recites “wherein the composition reduces a motility of sperm to 0% in a mixture of the composition and semen at a ratio of 1:6.” Support for both “reduces a motility of sperm to 0%” and “a ratio of 1:6” could not be found in the specification. There is no mention of ratios or motility. Thus the claims lack sufficient written description for this amendment.
Claim Rejections – 35 U.S.C. 112(b)
6. 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.
7. Claim 14 is 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.
8. Claim 14 recites “wherein the composition reduces a motility of sperm to 0% in a mixture of the composition and semen at a ratio of 1:6.” Is the ratio 1:6 composition to semen or 1:6 semen to composition. Clarification is requested.
Modified Rejections
Claim Rejections – 35 U.S.C. 103
9. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
10. Claims 2-14 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Garg et al. (U.S. Patent Application No. 2004/0009223) in view of Cone (WO2009/155118).
Regarding instant claims 2, 7, and 14-16, Garg et al. teach antimicrobial and contraceptive compositions and methods which prevent and/or reduce the risk of transmission of sexually transmitted disease wherein the composition forms a semisolid matrix on contact with ejaculate, thereby trapping ejaculated microbes and spermatozoa. See abstract. The composition comprises a matrix-forming agent, a bio-adhesive agent, a buffering agent, optionally a humectant, optionally a preservative and water. See abstract. Buffering agents include lactic acid. See paragraph [0030]. The matrix-forming agents include alginic acid. See paragraph [0028]. Garg et al. teach a composition comprising 3 to 5 percent of matrix-forming agents, 2.5 to 6 percent of bio-adhesive agents, and 1 to 7 percent of buffering agents. See paragraph [0027].
Regarding instant claims 3-4, the humectant includes glycerol. See paragraph [0031].
Regarding instant claims 5-6, the preservative includes benzoic acid. See paragraph
[0032].
Regarding instant claim 8, generally the molecular weight of the alginic acid is 20 to about 300,000 g/mole, preferably in the range of 20,000 to 250,000 g/mole. See paragraph [0028].
Regarding instant claims 9-10, bio-adhesive agents include xanthan gum. See paragraph [0029].
Regarding instant claim 11, buffering agents include citric acid. See paragraph [0030].
Regarding instant claim 12, the composition may additionally comprise potassium bitartrate. See paragraph [0033].
Regarding instant claim 13, the pH of the formulation was adjusted to about 3.5. See Example 1.
Regarding instant claims 17-18, the composition is in the form of a tablet that is inserted intravaginally. See claim 35. Suitable dosage forms include gels, creams, lotions, foams, and the like. See paragraph [0017].
Regarding instant claims 19-21, each tablet was about 1.2 g/tablet which reads on values of about 4 g. See paragraph [0125]. It would have been well within the purview of the skilled artisan to modify the weight/amounts of ingredients dependent on the effect desired.
Regarding instant claim 22, the composition is in the form of gel. See paragraph [0004].
Garg et al. do not teach a composition essentially free of D-lactic acid.
Cone teaches a composition for inactivating pathogens of a genital tract of a female. The compositions include L-lactic acid, substantially free of D-lactic acid. See abstract. Cone teach that it has been surprisingly found that significant pathogens, including herpes simplex virus, are inactivated more efficiently by L-lactic acid then by D-lactic acid. See paragraph [0006]. Organisms may be selected to produce predominately the L-lactic acid stereoisomer, followed if needed by further purification to isolate L-lactic acid substantially free of D-lactic acid. See paragraph [0068].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use purified L-lactic acid to provide additional benefit of pathogen inactivation since Cone teaches a surprisingly significant difference in L-lactic acid versus D-lactic acid. One would have been motivated, with a reasonable expectation of success, to use L-lactic acid to provide enhanced inactivation of pathogens in the composition of Garg et al. Since the combination of Garg et al. and Cone teach the composition as instantly claimed, the composition should have the same properties (pH) and function when administered.
Response to Arguments
Applicant's arguments filed 4 February 2026 have been fully considered but they are not persuasive.
11. Applicants argued, “Applicant clarifies that the gel of Garg compared to Amphora does not contain nonoxynol-9. The pH of mixtures of Garg’s compositions are 5.5 and 6 which are greater than pH 5.0. Moench teaches away from using L-lactic acid in a contraceptive because Moench teaches that L-lactic acid is expected to be less toxic to human cells.”
In response to applicant’s arguments, the prior art of Cone teaches use of purified L-lactic acid and surprisingly shows that significant pathogens, including herpes simplex virus, are inactivated more efficiently by L-lactic acid then by D-lactic acid. The motivation to combine references does not need to be the same as the instant invention as long as motivation exists. In addition, there does not need to be a need for improvement in order for a motivation to improve to exist. In the instant case, the additional therapeutic effect against pathogens would motivate one to use L-lactic acid over other forms of lactic acid. Garg teach 1 to 7 percent of buffering agents, wherein a buffering agent includes lactic acid. This reads on the amount of L-lactic acid. Since the prior art makes obvious the same combination of ingredients in the same amounts, the resultant properties should be the same. The rejection is solely directed to substitution of L-lactic acid for lactic acid with motivation due to the increased effectiveness over D-lactic acid as taught by Cone. Sperm inactivation and maintaining the pH at 5.0 are functions/properties of the compound/composition. Since the prior art makes obvious the claimed invention through substitution of an isomer over racemic mixture, the compound and composition should have the same properties. The prior art teaches the pH of the formulation was adjusted to about 3.5. See Example 1. This reads on a pH of 5.0 or below. A lower toxicity to human cells does not equate to a teaching away, especially since the prior art provides motivation to use L-lactic acid over a racemic mixture as addressed above. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
The Declaration under 37 CFR 1.132 filed 28 October 2025 is insufficient to overcome the rejection of claims 2-14 and 16-22 based upon 35 U.S.C. 103 as set forth in the last Office action because:
With regards to the previously filed declaration, as stated above, Cone makes obvious substituting L-lactic acid for the lactic acid used in Garg. Cone also provides motivation for the substitution. Thus the resultant properties should be the same.
Thus this rejection is maintained.
Conclusion
12. 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.
Correspondence
13. No claims are allowed at this time.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615