DETAILED ACTION
This action is in response to Applicant’s submission dated February 9, 2024, in which Applicant amended claims 1-11 and added new claims 12-20.
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 .
Information Disclosure Statement
The references contained in the IDS dated October 21, 2024 and March 12, 2025 are made of record.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 non-obviousness.
Determining the scope and contents of the prior art.
Claims 1-20 are rejected under 35 U.S.C. § 103 as being unpatentable over Lee, et al., Vaginal pH-balanced gel for the control of atrophic vaginitis among breast cancer survivors: a randomized controlled trial, Obstet. Gynecol., Vol. 117, No. 4, pp. 922-927 (2011) in view of EP 3 501 507 and Henneicke-von Zepelin Hans-Heinrich, et al., Clinical trial shows lasting function of a new moisturizing cream against vaginal dryness, Wiener Medizinische Wochenschrift, Springer Wien, Vol. 167, No. 7, pp. 189-195 (2017), all of which can be considered the closest prior art.
Lee, et al. discloses lactic acid-containing vaginal gels having a pH of 4.0 for treatment of atrophic vaginitis. Further, it teaches in table 2 a significant improvement in the VMI (vaginal maturation index), pH, painful vaginal dryness and vaginal health index.
EP 3 501 507 teaches vaginal tablets and vaginal capsules containing 15 to 50 mg of lactic acid per dosage unit for therapy of vaginal atrophy.
Henneicke-von Zepelin Hans-Heinrich, et al. discloses the results of a clinical trial on remifemin moisturizing cream containing lactic acid for therapy of vaginal dryness. A significant improvement in the subjective symptoms of vaginal dryness were shown in figure 3.
Ascertaining the difference between the prior art and the claims at issue.
Simply put, none of the three references teach an amount of at least 120 mg of lactic acid and/or one or more lactic acid salts per dosage as required by instant claim 1.
Resolving the level of skill in the art.
The Court has addressed this obviousness issue: “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 12 (2007). “When there is a design need or market pressure to solve a problem and there are finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, … the fact that a combination was obvious to try might show that it was obvious”. Id. at 17. That is exactly the case here.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
According to the application, the increased amount of lactic acid unexpectedly showed a distinct improvement in cellular differentiation (on the basis of parabasal cells, intermediate cells and superficial cells of vaginal tissue), expressed by the VMI. According to the specification, only slightly altered cell differentiation was found with the hormone-free gel of Lee, et al. Just as unexpected was the fact that the invention involved an improvement in the quality of life of the postmenopausal women treated, which was surprisingly even found to the symptom-independent.
It should be emphasized; however, that merely asserting an improved effect in relation to the closest prior art is not sufficient basis for acknowledging non-obviousness. Instead, comparative tests must be carried out for this purpose.
A surprising effect, advantageous effects or beneficial properties, demonstrated by means of a comparative test can accordingly be considered to be an indication of non-obviousness. If comparative tests are carried out in order to demonstrate non-obviousness with an improved effect across the full scope of the claims, the comparison must be made with the closest prior art and be structured in such a way that the alleged advantages or beneficial effects can be attributed convincingly to the distinguishing feature of the invention in relation to the closest prior art
The present application does not show any comparative tests. Examples 4 and 5 merely shows a statistically significant change in the VMI between day 1 and day 43 and also an improvement in the quality of life within the same period when using the preparation according to the invention in the form of a suppository, but without any comparative groups.
According to the specification, the higher dosage apparently also leads to the surprising finding of an improvement in cellular differentiation in vaginal epithelial tissue. Unlike in the prior art, the effect of lactic acid thus, completely unexpectedly, lies not only in the adjustment or maintenance of the acidic pH to support the vaginal flora, but also even shows a cellular influence.
Here, express reference should be made to table 2 in Lee, et al., which definitely shows a significant improvement in the vaginal maturation index. Therefore, the effect of lactic acid thus does not involve a cellular influence completely unexpectedly, as asserted in the specification. A significant cellular influence, expressed by the vaginal maturation index VMI, has already been disclosed in Lee, et al.
In the absence of comparative tests, the problem to be solved can, as defined in the specification (p. 2, second paragraph), be considered to be that of providing effective hormone-free prevention and therapy of vaginal atrophy and/or vaginal dryness in postmenopausal women.
According to the specification, only a slight effect by lactic acid-containing vaginal compositions is shown in the prior art. Reference should be made here; however, to the three references supra, all of which already show a significant improvement in vaginal dryness, VMI and/or vaginal health index. Therefore, for the lactic acid-containing compositions of the prior art, there is evidence of an efficacy not only in the therapy of the claimed disorders, but also at the cellular level (VMI).
In the absence of an unexpected technical effect, non-obviousness cannot be acknowledged in the provision of a further lactic acid-containing vaginal composition for therapy of vaginal dryness and/or vaginal atrophy.
Even if an improved effect in relation to the closest prior art could be shown, an improved effect as a result of increasing the proportion of active ingredient would be an expected, not surprising effect, and thus not a sufficient basis for acknowledging non-obviousness.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932
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