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
The preliminary amendment filed 03/14/2023, amended claims 1-5.
Claims 1-5 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Specification
The use of the term Vaseline on pgs. 4 and 10-11, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(a)-Written Description
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.
Claims 1-5 are 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.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2163.
Independent claim 1 recites an ester group-containing aromatic propionamide compound administered to a subject in need of urinary incontinence treatment.
However, the instant specification provides no definition of such a compound.
Thus, it is not known how the “ester group” connects to the “propionamide” group, let alone how such a compound could be classified as aromatic. For example, it is not known if an aromatic compound comprises both an “ester group” and a “propionamide group” as a single group at a single point of attachment to the aromatic, or if a single aromatic bridges the “ester group” and the “propionamide group,” or if an “aromatic” is a single aromatic group or can be multiple aromatic groups, etc.
An STN File Reg Search (PTO-892) of an ester group, a propionamide group, and a benzene ring, a single aromatic, yielded 598,334 compounds, with structures such as:
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Claim 6 recites the ester group-containing aromatic propionamide compound as C25H17F3N4O4.
However, the instant specification provides no definition or core structure of such a compound.
A Sci-Finder Substance Search (PTO-892) of C25H17F3N4O4, yielded 185 compounds, such as:
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The instant specification provides a single example of an ester-containing aromatic propionamide compound, wherein that compound is EG-017. However, the instant specification does not even provide the structure of EG-017. CN103772238 (Original and Translation, IDS of 03/14/2023 and PTO-892) provides a structure of EG-017 as follows:
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, ([0034], Original). This compound additionally has the molecular formula C25H17F3N4O4.
In view of the above, it is not possible to determine a core structure of the ester group-containing aromatic propionamide compounds, as recited in instant claim 1, or the C25H17F3N4O4 compounds, as recited in claim 5. It is further not possible to determine a structure-function relationship between the compounds recited in claims 1 and 5 that is critical to impart these compounds’ usefulness in treating urinary incontinence.
The instant disclosure only appears to have possession of only a single compound, EG-017, with the structure activity claimed.
For these reasons, the recitation of an ester-containing aromatic propionamide compound and an ester-containing aromatic propionamide compound of C25H17F3N4O4, is 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, at the time the application was filed, had possession of such compounds.
Claim Rejections - 35 USC § 112(a)-Scope of Enablement
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.
Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating urinary incontinence by administering EG-017,
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, does not reasonably provide enablement for a method of treating urinary incontinence by administering any ester group-containing aromatic propionamide compound. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The criteria for enablement set out in the In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the Claims
The instant claims are directed toward a method of treating urinary incontinence by administering any compound with an ester, a propionamide, and an aromatic, to a patient. Since the compound encompasses an innumerable number of species, the breadth of the claims is great.
Level of Skill in Art
The level of the skill in the art is a clinician or an artisan with a PhD.
State of the Prior Art
Xue (Androgen receptor modulators-EG-017, a first-in-class drug for the treatment of urinary incontinence, dry eyes, and myasthenia,” Google Translation from STIC, published 04/18/2019, PTO-892) teaches the androgen receptor modulator EG-017 for the treatment of urinary incontinence. Thus, the prior art teaches a single ester group containing aromatic propionamide compound for the treatment of urinary incontinence.
US 2016/0106702 to Narayanan (published 2016, IDS of 04/01/2025) teaches a method of treating urinary incontinence by administering a selective androgen receptor modulator (SARM) compound (pg. 47, claim 1). Narayanan teaches SARMS with the following structure:
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(pg. 47, claim 1). Thus, while the prior art teaches selective androgen receptor modulators for the treatment of urinary incontinence, it does not teach ester group containing aromatic propionamide compounds other than EG-017.
CN103772238 (Original and Translation, IDS of 03/14/2023 and PTO-892) teaches ester group-containing aromatic propionamide compounds as nonsteroidal androgen receptor modulators that can be administering orally, without hepatotoxicity, without hormonal side effects, with better physicochemical, pharmacokinetic, and pharmacological properties, as compared to steroid hormones. (“Background technique,” translation).
CN ‘238 exemplifies:
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([0019]),
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([0022]),
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[0025],
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([0028]),
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([0031]),
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(EG-017), and others in [0040]-[0070], as ester group-containing aromatic propionamide compounds ([0034], Original).
All of these compounds have one of three core structures:
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(pg. 1, claim 1, Original). Thus, while the prior art teaches a small number of ester group containing aromatic propionamide compounds for therapeutic use, these compounds are limited to three core structures and are not taught for the treatment of urinary incontinence.
An STN File Registry Search (PTO-892) of an ester group, a propionamide group, and a benzene ring, a single aromatic, yielded 598,334 compounds with structures such as:
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Claim 6 recites the ester group-containing aromatic propionamide compound as C25H17F3N4O4. A Sci-Finder Substance Search (PTO-892) of C25H17F3N4O4, yielded 185 compounds, such as:
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Thus, the prior art teaches an innumerable number of compounds encompassed by “ester group-containing aromatic propionamide compounds.”
Predictability in the Art
In view of the above, it is not predictable what ester group containing aromatic propionamide compounds are useful for the treatment of urinary incontinence. The art provides no structure function relationship between ester group containing aromatic propionamide compounds and the treatment of urinary incontinence.
Working Examples
The instant specification provides a single example wherein the effect of EG-017 on ameliorating beagles’ and rats’ stress urinary incontinence is studied, wherein EG-017, at specific dosages, is shown to ameliorate the urinary incontinence symptoms (pgs. 3-12, specification).
Direction and Guidance
In view of the single example showing a single compound for the treatment of urinary incontinence, the instant disclosure lacks sufficient direction and guidance.
Quantity of Experimentation
In view of the number of compounds encompassed by “ester group-containing aromatic propionamide compound,” the amount of experimentation required to determine which ester group-containing aromatic propionamide compounds treat urinary incontinence, would be astronomical, starting with proof-of-concept, and proceeding through all levels of lead identification and optimization, which amounts to invention and not development.
Thus, while being enabling for a method of treating urinary incontinence by administering EG-017,
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, the instant specification does not reasonably provide enablement for a method of treating urinary incontinence by administering any ester group-containing aromatic propionamide compound.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xue (Androgen receptor modulators-EG-017, a first-in-class drug for the treatment of urinary incontinence, dry eyes, and myasthenia,” Google Translation from STIC, published 04/18/2019, PTO-892).
Xue teaches the androgen receptor modulator EG-017 for the treatment of urinary incontinence. Specifically, Xue teaches a method of orally administering EG-017 to treat urinary incontinence in beagle dogs (abstract).
As evidenced by pg. 3 of the instant specification, EG-017 is C25H17F3N4O4.
EG-017 is a non-steroidal small molecule that does not produce the toxic side effects of external natural androgens in the body. EG-017 is a selective non-steroidal androgen receptor agonist that significantly activates androgen receptors.
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 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0106702 to Narayanan (published 2016, IDS of 04/01/2025) in view of CN103772238 (Original and Translation, IDS of 03/14/2023 and PTO-892).
Narayanan teaches a method of treating urinary incontinence by administering a selective androgen receptor modulator (SARM) compound (pg. 47, claim 1).
Narayanan teaches that SARMS provide a new therapeutic option for pelvic floor and lower urinary tract disorders, as both testosterone and its more potent metabolite converted by 5-alpha reductase, dihydrotestosterone, have anabolic effects on muscle. SARMS increase urethral baseline pressure the amplitude of urethral responses during sneezing ([0017]-[0022]).
Narayanan specifically teaches that androgen supplementation augments pelvic floor muscle response and improves objective and subjective outcomes for stress urinary incontinence (SUI) ([0012]). The para-urethral extracellular matrix is a target for sex steroid hormones; androgen receptors are densely expressed in both muscle and stromal cells of the levator ani muscle and fascia in women, wherein the levator ani muscle is one of the most androgen sensitive tissues in the body ([0013]). Narayanan teaches that urinary incontinence generally results from a decrease in ability to regulate the urethra due to extension of the levator ani ([0005]), and teaches that although anabolic steroids may increase muscle mass and strength, lack of oral bioavailability and the known potential risks of anabolic steroids have limited their use. Narayanan teaches that SARMS have great potential to achieve similar benefits of anabolic steroid therapy ([0017]).
In summary, Narayanan teaches that despite the number of FDA approved agents for treating urinary incontinence, there remains a need for new agents with novel mechanisms of action, and that the use of nonsteroidal androgens to strengthen the pelvic flood and support urogenital structures is one such novel approach to treating urinary incontinence ([0021]).
Regarding claim 1, while Narayanan teaches a method of treating urinary incontinence by administering a SARM, it differs from that of instant claim 1 in that it does not teach an ester group containing aromatic propionamide compound.
CN ‘238 teaches ester group-containing aromatic propionamide compounds as nonsteroidal androgen receptor modulators that can be administering orally, without hepatotoxicity, without hormonal side effects, with better physicochemical, pharmacokinetic, and pharmacological properties, as compared to steroid hormones. (“Background technique,” translation).
CN ‘238 exemplifies:
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, as an ester group-containing aromatic propionamide compound ([0034], Original).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention to select
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, as taught by CN ‘238, to treat urinary incontinence, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Narayanan teaches that androgen supplementation augments pelvic floor muscle response and improves objective and subjective outcomes for stress urinary incontinence, and teaches that although anabolic steroids may increase muscle mass and strength, lack of oral bioavailability and known potential risks of anabolic steroids have limited their use,
-Narayanan teaches the use of nonsteroidal androgens, such as SARMS, to strengthen the pelvic flood and support urogenital structures as one such novel approach to treating urinary incontinence, and
-CN ‘238 teaches
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and other ester group-containing aromatic propionamide compounds as nonsteroidal androgen receptor modulators, for pharmacological use, that have decreased hepatotoxicity, no hormonal side effects, and better physicochemical, pharmacokinetic, and pharmacological properties, as compared to steroids hormones.
As such, an artisan having ordinary skill in the art would have been motivated to make such a selection, to predictably arrive at a nonsteroidal treatment for urinary incontinence that stimulates androgen receptors to treat stress urinary incontinence, without the negative side effects of steroid hormones.
Regarding claim 2, Narayanan teaches stress urinary incontinence (abstract; pgs. 48, 52 claims 5, 8, 27).
Regarding claim 3, Narayanan teaches drops as a form of administration ([0278]).
Regarding claim 4, CN ‘238 teaches administration of 5mg/kg of its compounds (Example 18), and Narayanan teaches that a therapeutically effective amount is that amount which provides a therapeutic effects for a given condition and administration regiment ([0266]).
The optimization of known percent amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claim 5, CN ‘238 teaches
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Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622