DETAILED ACTION
Examiner acknowledges receipt of the reply filed 8/27/2025, in response to the restriction requirement mailed 2/27/2025.
Claims 1-11, 13-15, 18, 31, 36, and 38 are pending. Claims 1-11, 18, 31, 36, and 38 are withdrawn for the reasons set forth below.
Claims 13-15 are being examined on the merits in this office action.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 13-15) in the reply filed on 8/27/2025 is acknowledged.
Claims 1-11, 18, 31, 36, and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/27/2025.
Applicant’s election of the following representative species is acknowledged:
FP receptor antagonist- Formula I
Pigmentation – hair
Claims 13 and 14 read on the elected species. The restriction between pigmentation of hair and skin is withdrawn herein. Claim 15 is rejoined herein.
The restriction requirement between species as relating to pigmentation set forth in the Office action mailed on 2/27/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01
The status identifiers of withdrawn claims should be revised in a reply to this office action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in the specification at paras. [00148] and [00150]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 should be amended to recite “the method comprising administering to a subject in need thereof” to correlate with a patient population that is, in fact, in need of the recited method of inhibiting pigmentation.
Further regarding claim 13, the acronym “FP receptor” should be written out in full name in the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 13-15 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.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient” (MPEP § 2163).
A claimed genus may be satisfied through sufficient description of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with a known or disclosed correlation between function and structure (MPEP § 2163(3)a(II)). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure, and (d) representative number of samples.
In the instant case, the claims are directed to a method of inhibiting pigmentation of hair, skin, or both, the method comprising administering to a subject a safe and effective amount of a FP receptor antagonist.
The issue at question is whether a person of ordinary skilled in the art would be able to determine what structural features of an FP receptor antagonist are required for the functional characteristics of inhibiting pigmentation of hair or skin.
(a) actual reduction to practice and (b) disclosure of drawings or structural chemical formulas:
The term FP receptor antagonist is defined in the specification as
a compound or compounds that inhibit activation or function of FP receptors. FP receptor antagonists further include prostaglandin analogs that act as prostaglandin antagonists, specifically, PGF antagonists. FP receptor antagonists selectively inhibit activation of the FP receptor and may not activate any other receptors that would negate the effect of inhibiting the FP receptor.
As used herein “hyperpigmented region” means a localized region having high melanin content. Examples of these include, but are not limited to age spots, lentigines, melasma, chloasma, freckles, photoaging pigmentation changes, post inflammatory hyperpigmentation, post-trauma hyperpigmentation, ultraviolet light-induced pigmented blemishes, sun-induced pigmented blemishes, suntan, and the like.
Specification at p. [0028] and [0045], respectively.
In the instant case, the instant specification discloses 5 FP receptor antagonists (Exs. 1-5). Example 6 relates to assessment of a reduction in hair growth comprising structures of Ex 2 (compound ANT 1) and Example 3 (compound ANT 2) (Fig 1). Examples 7-12 and 16-20 relate to formulations (body washes, shampoos, creams, sunscreens). Examples 13-15 purport assays for prevention of chemotherapy-related alopecia and FP receptor antagonists are tested for their potential to inhibit pigmentation of the skin or hair. The examples appear to be prophetic as no data is presented. There are NO examples of any FP receptor antagonists inhibiting pigmentation of hair or skin.
Taken all these together, the instant specification does not describe a general correlation between structure and function for the claimed genus of FP receptor antagonists.
(c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure:
As discussed above, in the instant case, the specification does not describe the physical and/or chemical properties of FP receptor antagonists that possess the ability to inhibit pigmentation of hair or skin that would allow a skilled artisan to distinguish FP receptor antagonists from those FP receptor antagonists that meet both the structural requirements and the functional requirements of the definition for FP receptor antagonists recited in the specification. The specification does not describe a correlation between the structure of a FP receptor antagonist that can inhibit pigmentation of hair/skin and a FP receptor antagonist that has the functional property of being useful in a method of inhibiting pigmentation of hair/skin.
Regarding the term “FP receptor antagonists” the specification fails to sufficiently show which structural elements of a FP receptor antagonist are required to inhibit pigmentation of hair or skin. Thus, one of ordinary skill in the art would assume that any of the numerous FP receptor antagonists would conceivably be acceptable for inhibiting pigmentation of hair or skin.
The present application is attempting to patent what has not yet been invented and the fact that one of skill in the art can test for the effect used to determine the compounds does not necessarily confer sufficient written description.
The claimed invention would entail testing limitless potential FP receptor antagonists and one of skill in the art could afterwards still be faced with no hits with the desired functionality.
(d) representative number of samples:
In the instant case, the genus encompassed by “FP receptor antagonists” is very broad and the five disclosed species are not representative of it. Additionally, there are no examples reduced to practice where any FP receptor antagonist inhibited pigmentation of hair or skin.
Considering the scope of the genus of instant claimed FP receptor antagonists, the instant specification fails to provide sufficient examples and guidance to describe the entire genus of FP receptor antagonist that further have the functionality of inhibiting pigmentation of hair/skin. Absent this information, the skilled artisan cannot readily envision which FP receptor antagonists are not only FP receptor antagonists but can also be used in the claimed method of inhibiting pigmentation of hair/skin.
In conclusion, for these reasons, the skilled artisan would not reasonably conclude that the inventor(s), at the time the application was filed, had possession of the full scope of the claimed invention.
Claim Rejections - 35 USC § 102
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim 13 and 15 are rejected under 35 U.S.C. 102(b) as being anticipated by DeLong (U.S. 7,115,659).
DeLong teach a method of inhibiting pigmentation of skin, the method comprising administering to a subject a safe and effective amount (cols. 19 and 26). Thus, the limitations of claim 13 and 15 are satisfied.
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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.
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(a) 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.
Claims 13 and 15 are rejected under 35 U.S.C. 103(a) as being unpatentable over DeLong (U.S. 7,115,659), in view of Sharif et al. (U.S. 6,441,033), as evidenced by Griffin et al. (J. Pharma. Exp. Therap. 290:1278-1284 (1999)).
DeLong teach a method of inhibiting pigmentation of skin, the method comprising administering to a subject a safe and effective amount (cols. 19 and 26). DeLong do not explicitly teach an FP receptor antagonist of Formula I.
Sharif et al. teach 11β-fluoro-15β-hydroxy PGF2α (FP) receptor antagonists (abstract). Specifically, Sharif et al. teach compositions of instant formula I at Col. 5, Compounds II and III and Claim 1. Claim 1 of Sharif et al. recites “a method of inhibiting FC receptor-mediated response in a biological system where FP receptors are present, comprising introducing in the biological system a receptor antagonizing effective amount of a compound of formula I”. Sharif et al teach that the selective FP receptor antagonist can be used to treat “various conditions, diseases or untoward effects associated with FP receptor activation” (col 2, ll. 51-59). Claim 7 is drawn to a method of treating an FP receptor related disorder including iris hyperpigmentation and iris melanogenesis. See also col. 3; claim 8. As evidenced by Griffin et al, AL-8810 (compound III of Sharif et al.) is an FP receptor antagonist (abstract; Fig 1). Griffin et al. teach that AL-8810 is the most potent FP receptor antagonist identified (p. 1282, para. 2).
It would have been obvious to one of ordinary skill in the art at the time of the invention to use an FP receptor antagonist of Sharif et al in the method of Delong to inhibit pigmentation of skin. The skilled artisan would have been motivated to do so given that Delong teach that FP receptor antagonists can be used for such treatment (cols. 19 and 26). The skilled would further have known that Sharif et al taught that the FP receptor antagonists could be used to inhibit hyperpigmentation and melanogenesis. The skilled artisan would have had a reasonable expectation of success because the compounds of Sharif et al, e.g., compound III, was known to be a potent FP receptor antagonist, as evidenced by Griffin et al.
Accordingly, instant claims 13 and 15 are rendered obvious.
Claims 13-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over DeLong (U.S. 7,115,659), and Sharif et al. (U.S. 6,441,033), as evidenced by Griffin et al. (J. Pharma. Exp. Therap. 290:1278-1284 (1999)), as applied to claims 13 and 15 above, and further in view of Grierson et al (Jpn J Ophthalmol 48:602–612 (2004)).
The teachings of Delong, Sharif et al, and Griffin are set forth above. The references do not explicitly teach that a FP receptor antagonist can be used in a method to inhibit pigmentation of hair.
However, Grierson et al. teach that latanoprost was a selective FP receptor agonist (p. 610). Latanoprost was capable of increasing pigmentation in the iris, eyelash, and periocular skin region (abstract, pp. 603, 607-608, 610-611). Thus, a selective FP receptor agonist was known to be associated with increased pigmentation of eyelashes (hair follicles) and skin. Id.
It would have been obvious to the skilled artisan at the time of the invention to use an FP receptor antagonist of Sharif et al. to inhibit hair pigmentation because Sharif specifically teaches that selective FP receptor antagonists can be used to treat “various conditions, disease or untoward effects associated with FP receptor activation”. Sharif et al teach that a FP receptor antagonist of instant Formula I can be used to treat iris hyperpigmentation and iris melanogenesis. Delong further taught the use of an FP receptor antagonist for inhibiting pigmentation of skin. As taught by Grierson et al., latanoprost, a selective FP receptor agonist was associated with increased pigmentation of hair follicles. Thus, activation of the FP receptor by a FP receptor agonist led to increased pigmentation of hair. The skilled artisan would therefore understand, that administration of an FP receptor antagonist (e.g., compound III of Sharif- a potent FP receptor antagonist) to a condition that involved FP activation would have the reverse effect, or this instance, inhibition of hair pigmentation.
Accordingly, claim 14 is rendered obvious.
Claims 13-15 are obvious in view of the teachings of the cited references.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9655833 (hereinafter referred to as “the ‘833 patent”), in view of DeLong (U.S. 7,115,659), and Sharif et al. (U.S. 6,441,033), as evidenced by Griffin et al. (J. Pharma. Exp. Therap. 290:1278-1284 (1999)), and further in view of Grierson et al (Jpn J Ophthalmol 48:602–612 (2004)).
Claims 1-9 of the ‘833 patent are drawn to a method of inhibiting hair growth, the method comprising administering to a subject a safe and effective amount of a compound, wherein the compound is selected from a compound of Formula I or Formula II, wherein the method of inhibiting hair growth treats a condition selected from the group consisting of at least one of hirsutism, unwanted androgen related hair growth, hypertrichosis excluding eyelash growth, and a combination thereof. Claims 10-15 of the ‘833 patent are drawn to a method of inhibiting hair growth, the method comprising administering to a subject a safe and effective amount of a compound, wherein the compound is selected from a compound of Formula I or Formula II, wherein the method treats unwanted facial hair.
Regarding instant claims 13 and 15, Delong teach that FP receptor antagonists can be used to inhibit pigmentation of skin. Sharif et al further teach that FP receptor agonists can be used to inhibit iris pigmentation and melanogenesis. Claims 6 and 15 of the ‘833 patent teach the structure
PNG
media_image1.png
157
217
media_image1.png
Greyscale
which is the same structure as compound III of Sharif (Fig 1; AL-8810 of Griffin).
Regarding instant claim 14, as taught by Grierson et al., latanoprost, a selective FP receptor agonist was associated with increased pigmentation of hair follicles. Thus, activation of the FP receptor by a FP receptor agonist led to increased pigmentation of hair. The skilled artisan would therefore understand, that administration of an FP receptor antagonist (e.g., compound
PNG
media_image1.png
157
217
media_image1.png
Greyscale
of claim 6 and 15 of the ‘833; compound III of Sharif (Fig 1; AL-8810 of Griffin), to a condition that involved FP activation would have the reverse effect, or this instance, inhibition of hair pigmentation.
Accordingly, claims 13-15 are obvious in view of claims 1-15 of the ‘833 patent and teachings of the cited references.
Claims 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9707169 (hereinafter referred to as “the ‘169 patent”), in view of DeLong (U.S. 7,115,659), and Sharif et al. (U.S. 6,441,033), as evidenced by Griffin et al. (J. Pharma. Exp. Therap. 290:1278-1284 (1999)), and further in view of Grierson et al (Jpn J Ophthalmol 48:602–612 (2004)).
Claims 1-13 of the ‘169 patent are drawn to a method of inhibiting a condition selected from the group consisting of chemotherapy-related hair loss and radiation-related hair loss, the method comprising administering to a subject a safe and effective amount of a compound selected from the group consisting formula I and II.
Regarding instant claims 13 and 15, Delong teach that FP receptor antagonists can be used to inhibit pigmentation of skin. Sharif et al further teach that FP receptor agonists can be used to inhibit iris pigmentation and melanogenesis. Claim 9 of the ‘169 patent teach the structure
PNG
media_image1.png
157
217
media_image1.png
Greyscale
which is the same structure as compound III of Sharif (Fig 1; AL-8810 of Griffin).
Regarding instant claim 14, as taught by Grierson et al., latanoprost, a selective FP receptor agonist was associated with increased pigmentation of hair follicles. Thus, activation of the FP receptor by a FP receptor agonist led to increased pigmentation of hair. The skilled artisan would therefore understand, that administration of an FP receptor antagonist (e.g., compound
PNG
media_image1.png
157
217
media_image1.png
Greyscale
of claim 6 and 15 of the ‘833; compound III of Sharif (Fig 1; AL-8810 of Griffin), to a condition that involved FP activation would have the reverse effect, or this instance, inhibition of hair pigmentation.
Accordingly, claims 13-15 are obvious in view of claims 1-13 of the ‘169 patent and teachings of the cited references.
Claims 13 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10159634 (hereinafter referred to as “the ‘634 patent”), in view of DeLong (U.S. 7,115,659).
Claims 1-20 of the ‘634 patent are drawn to a method of inhibiting hair growth, the method comprising administering to a subject in need thereof a safe and effective amount of a compound of Formula III, or a pharmaceutically acceptable salt thereof.
Regarding instant claims 13 and 15, the claims of the ’634 patent compound of formula III. Claim 11 of the ‘634 patent teaches
PNG
media_image2.png
650
468
media_image2.png
Greyscale
. As indicated at col. 10-11 and 23 of the ‘634 patent, the compounds are FP receptor antagonists. “[The specification] may be used to learn the meaning of terms and interpreting the coverage of a claim." In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008). Delong teach that FP receptor antagonists can be used to inhibit pigmentation of skin. Thus, the skilled artisan would have recognized that the compounds of formula III of the ‘634 patent could be used in a method of inhibiting pigmentation of skin, as taught by Delong.
Accordingly, claims 13 and 15 are obvious in view of claims 1-20 of the ‘634 patent and Delong.
Conclusion
No claims are allowed.
Claims 1-11, 13-15, 18, 31, 36, and 38 are pending. Claims 1-11, 18, 31, 36, and 38 are withdrawn.
Claims 13-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISTINA M HELLMAN/Examiner, Art Unit 1654