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 .
Priority
The instant application is a 35 USC 371 National Stage filing of International Application PCT/US2022/076156, filed September 9, 2022, which claims the benefit of an effective US filing date from US Provisional Application 63/242,566, filed September 10, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) filed March 8, 2024 and August 14, 2025 in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and a signed copy of the 1449 form is attached.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, 12-14, 17, 24-26, 31-32 and 34 drawn to methods of treatment comprising administration of at least one androgen, in the reply filed June 8, 2026 is acknowledged. Further, Applicant’s election without traverse of testosterone as the androgen to be administered in the same reply is also acknowledged. Claims 1-9, 13-14, 17, 24, 26 and 34 within the elected group read on the elected species.
In accordance with the MPEP, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species and the claims drawn to the elected species are allowable, the search of the Markush-type claim will be extended (see MPEP 803.02). If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As indicated above, the Examiner searched the claimed invention based on the elected species above, wherein: the elected species was not found to be allowable over the prior art. Accordingly, the scope of search and consideration has not been expanded further.
Status of Claims
Currently, claims 1-9, 12-14, 17, 24-26 and 31-35 are pending in the instant application. Claims 12, 25, 31-33 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention and/or species. Claims 1-9, 13-14, 17, 24, 26 and 34 read on an elected invention and species and are therefore under consideration in the instant application to the extent that they read on the elected embodiment.
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.
Claims 1-9, 14, 17, 24 and 34 are rejected under 35 U.S.C. 103 as obvious over US 2018/0353460 in view of WO 2006/127057.
The instant claims are drawn to a method of treating stress urinary incontinence or fecal incontinence comprising local delivery of at least one androgen to a human subject, wherein said administration is to the pelvic floor or other area in contact with the pelvic floor.
Determining the scope and contents of the prior art
The ‘460 publication discloses methods of treating and preventing pelvic floor disorders, such as stress urinary incontinence (SUI) and fecal incontinence (FI), in a female subject, by administering a selecting androgen receptor modulator (SARM) (see paragraphs [0002]-[0009], [0012]-[0018], [0050], [0063], [0068], [0188]-[0189], [0234]-[0242]). The reference describes several routes of administration, including vaginal, rectal or urethral administration ([0234]-[0242]), and further describes androgen supplementation as a treatment option for pelvic floor disorders as androgen receptors are heavily expressed in the pelvic floor. The ’460 publication further cites a study evaluating the use of testosterone in rat models of SUI, where the results of the study showed that testosterone has both preventative and curative effects on rat models of SUI. The reference also notes the potential for side effects with testosterone treatment in females.
Ascertaining the differences between the prior art and the claims at issue
There is no specific example where testosterone is administered locally for the treatment of SUI or FI.
Resolving the level of ordinary skill in the pertinent art
To this end, it is noted that MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
The skilled artisan seeking to develop effective SUI and/or FI treatment, especially for females, would be aware of the side effects described in the ‘460 publication but also aware of the efficacy of androgens such as testosterone in the treatment of pelvic floor conditions. To this end, the ‘057 publication describes non-systemic (i.e. local) administration of an estrogen and/or androgen to the vaginal, vulvar and/or urethral area of a female patient specifically to overcome the side effects of systemic administration (paragraphs [0002]-[0003], [0013] – [0018], [0028], [0048], [0055], claims 1, 6-10, 16-18). In the absence of showing unobvious results, it would have been obvious to one of ordinary skill in the art at the time of the invention when faced with the prior art to use the known technique of local delivery of androgens to avoid unwanted side effects (KSR rationale (C)) in order to improve the process described in the ‘460 publication for treating SUI or FI with testosterone.
Therefore, it would have been prima facie obvious at the time of filing for one of ordinary skill in the art to conduct the administration and treatment recited in the instant claims with a reasonable expectation that local delivery of testosterone would treat pelvic floor conditions such as SUI and FI. The art teaches the use of testosterone for the same therapeutic purpose and describes a reasonable and predictable alternative to systemic delivery in order to avoid unwanted side effects. Accordingly, the instantly claimed invention is found to be obvious.
Claims 13 and 26 are rejected under 35 U.S.C. 103 as obvious over US 2018/0353460 in view of WO 2006/127057, and further in view of Rizk et al.
The instant claims are drawn to a method of treating stress urinary incontinence or fecal incontinence comprising local delivery of at least one androgen to a human subject, wherein said administration is to the pelvic floor or other area in contact with the pelvic floor and where the dependent claims require combined administration with ghrelin or a ghrelin analog.
Determining the scope and contents of the prior art
The combined teachings of the ‘460 and ‘057 publications are described in paragraphs 10-14 above and incorporated by reference herein.
Ascertaining the differences between the prior art and the claims at issue
The combination of the ‘460 and ‘057 publications does not disclose a combination with ghrelin or a ghrelin analog for the claimed method of treatment.
Resolving the level of ordinary skill in the pertinent art
To this end, it is noted that MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
Rizk et al. specifically describes the combination of an androgen and ghrelin for the treatment of pelvic floor muscles where it was found that “estrogen/ghrelin administration reversed pelvic floor muscle ageing changes” (see Abstract). The art teaches the relation of normative aging on deterioration of urinary and fecal control. Rizk et al. found that “the preliminary results showed that the post-ovariectomy adverse changes in urethral and anal canal submucosal vessel counts and collagen I/III ratio can only be restored in old rats by adding anti-ageing drugs like ghrelin to estrogen.” To this end, MPEP 2166.04 states the following: “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Further, the prior art explicitly describes the need for combining ghrelin with the administered androgen in order to achieve the observe effects on ageing pelvic floor muscles.
Therefore, it would have been prima facie obvious at the time of filing for one of ordinary skill in the art to combine ghrelin with an androgen such as testosterone to arrive at the instantly claimed method of treatment, since both substances are described in the prior art for treating pelvic floor diseases and specifically incontinence, with an explicit suggestion to combine them for the same purpose. The compounds are described in the art as being useful for the same therapeutic purpose, which would have provided the requisite reasonable expectation of success.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached Monday - Thursday 8:00 AM - 6:00 PM.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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