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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/04/2026, is in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Status of the Claims
Claims 1-2, 4-9, 13, 15-21 and 27 are pending.
Applicants’ arguments, filed on 06/16/2026, have been fully considered. Rejections and/or objections not reiterated from previous Office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Applicants’ amendments filed on 07/07/2026, have been entered into the record. Applicants have amended claims 1-2, 4-7, 9 13, 15-21 and 27. Applicants have cancelled claims 11, 23 and 25. Therefore, claims 1-2, 4-9, 13, 15-21 and 27 are subject of the Office Action below.
Withdrawn Rejections
The rejection of claims 4-8 and 16-20 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is overcome by the Applicants’ amendments and is hereby withdrawn. For example, Applicants have amended claim 4 to delete “comprising”.
The rejection of claims 1, 4-7, 9, 13, 15-19, 21, 23 and 27 under 35 U.S.C. 102(a)(1) as being anticipated by Xusheng of record (CN107375297A, published 11/24/2017, Machine Translation), as evidenced by Lai of record (Brit. J. Pharmacology, 2007), is overcome by the Applicants’ amendments and is hereby withdrawn. For example, Applicants have amended claim 1 to recite “topical administration”.
The rejection of claims 1, 4-9, 13, 15-21 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Xusheng (CN107375297A, published 11/24/2017, Machine Translation), as evidenced by Lai (Brit. J. Pharmacology, 2007, 152, 1172-1184) and in view of Schmid of record (FEBS Lett., 2004), is overcome by the Applicants’ amendments and is hereby withdrawn. For example, Applicants have amended claim 1 to recite “topical administration”.
Claim Rejections - 35 USC § 102
New Grounds of Rejection Necessitated by Applicant’s Amendments
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.
Claims 1-2, 4, 9, 13, 15-16, 21 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bernard et al (hereinafter “Benard”, U.S. Patent No. 6,448,285, issued 09/10/2002) as evidenced by Garlich et al (hereinafter “Garlich”, U.S. Pub. No. 20070203098, published 08/30/2007).
By way of a background, the Applicants’ invention (see, e.g., ¶s 0001), is directed to a method for using PTEN inhibitors for treating hair loss or inducing hair growth or regrowth in a subject in need thereof.
Independent claim 1 is directed to a method for treating hair loss in a subject in need thereof, comprising topically administering to the subject, an effective amount of a PTEN inhibitor to a location of the hair loss.
Independent claim 15 is drawn to a method for promoting or activating hair follicle development in a subject in need thereof, comprising topically administering to the subject, an effective amount of a PTEN inhibitor to location of the hair follicle.
The specification (see ¶ 0052), discloses the term “effective amount”, as referring to an amount that is delivered to a subject, either in a single administration or as part of a series, which achieves the desired effect. Accordingly, an amount of a PTEN inhibitor that is employed in order to achieve the desired outcome, is included in the interpretation of an “effective amount”.
Similar to the Applicants’ invention (see discussions above), Bernard teaches a method for treating androgenic alopecia (see claim 15), with a composition comprising an effective amount of an indolecarboxylic acid compound of formula (I’) or a pharmaceutically acceptable salt thereof (see claims 1 and 10). For topical application to the skin or hair follicles, the composition can be in the form of an aqueous or oily solution, an emulsion, lotion, cream or gel (see e.g., column 6, lines 31-40 and column 9, lines 5-10).
Although Bernard is not explicit in disclosing indolecarboxylic acid salts as PTEN inhibitors, indolecarboxylic acid salts are known in the art as PTEN inhibitors as evidence by Garlich (see ¶ 0005), who discloses indolecarboxylic acid salts among classes of compounds that have been identified as PTEN inhibitors.
Therefore, claims 1 and 15 are anticipated by Bernard evidenced by Garlich.
Regarding claim 2, Bernard teaches androgenic alopecia (see discussions above).
Regarding claims 4 and 16, Bernard evidenced by Garlich discloses indolecarboxylic acid salts (see discussions above).
Regarding claims 9 and 21, Bernard teaches an aqueous or oily solution, an emulsion, lotion, cream or gel (see discussions above).
Regarding claims 13 and 27, Bernard discloses that the composition can be applied daily for one or more months (see column 4, lines 3-9 and column 26, lines 13-16).
Maintained Rejections
Claim Rejections - 35 USC § 103-Maintained
Maintained/New Grounds of Rejection Necessitated by Applicant’s Amendments
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.
The rejection of claims 1, 4-7, 9, 13, 15-19, 21 and 27 is maintained and claims 8, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Xusheng of record (CN107375297A, published 11/24/2017, Machine Translation), as evidenced by Lai of record (Brit. J. Pharmacology, 2007, 152, 1172-1184) and in view of Tremblay of record (WO200130325A2), for the reasons of record set forth in the previous Office action of which, said reasons are herein reiterated.
By way of a background, the Applicants’ invention (see, e.g., ¶s 0001), is directed to a method for using PTEN inhibitors for treating hair loss or inducing hair growth or regrowth in a subject in need thereof.
Independent claim 1 is directed to a method for treating hair loss in a subject in need thereof, comprising topically administering to the subject, an effective amount of a PTEN inhibitor to a location of the hair loss.
Independent claim 15 is drawn to a method for promoting or activating hair follicle development in a subject in need thereof, comprising topically administering to the subject, an effective amount of a PTEN inhibitor to location of the hair follicle.
The specification (see ¶ 0052), discloses the term “effective amount”, as referring to an amount that is delivered to a subject, either in a single administration or as part of a series, which achieves the desired effect. Accordingly, an amount of a PTEN inhibitor that is employed in order to achieve the desired outcome, is included in the interpretation of an “effective amount”.
Similar to the Applicants’ invention (see discussions above), Xusheng teaches a method for promoting hair follicle development, hair growth or treating hair loss in mice, with a composition comprising PTEN inhibitor (bpv(phen)). Please see e.g., abstract, ¶s 0011-0022, 0026-0043 (Examples 1-3) and reference claims 1-4. Xusheng teaches administering bpV(phen) by subcutaneous injection (see e.g., ¶ 0029).
Bpv(phen), is an abbreviation for potassium bisperoxo (1,10-phenanthroline) oxovanadate, as evidenced by Lai (see abstract).
Although Xusheng teaches administering bpV(phen) by subcutaneous injection (see discussions above), Xusheng as evidenced by Lai is not explicit in disclosing, wherein the PTEN inhibitor is administered topically.
However, the claimed invention would have been obvious over Xusheng as evidenced by Lai, because at the time of the instant invention, it was known in the art that a PTEN inhibitor can be formulated for topical administration. For example, similar to Xusheng (see discussions above), Tremblay discloses that PTEN inhibitors compounds such as bpV(phen) and bpV(pic), (see e.g., abstract and page 7), can be formulated for subcutaneous injection, topical, oral, parenteral administration (see pages 14, 16 and claim 9).
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged a method comprising subcutaneously or topically administering a PTEN inhibitor (e.g., bpV(phen) or bpV(pic)), to a subject in need of: i) a treatment for hair loss; and/or ii) promoting or activating hair follicle development, from the disclosures of Xusheng as evidenced by Lai and Tremblay. A person skilled in the art would have had a reasonable expectation that the administration of the PTEN inhibitor (e.g., bpV(phen) or bpV(pic)), would, for example, treating hair loss in the subject.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Therefore, claims 1 and 15 are obvious over Xusheng as evidenced by Lai and Tremblay.
Regarding claims 4-8 and 16-20, the cited references (see discussions above), combine to disclose bpV(pic).
Regarding claims 9 and 21, Xusheng teaches emulsions (see ¶ 0014 and reference claim 2).
Regarding claims 13 and 27, Xusheng teaches daily administration, wherein the effect can be seen in 12-25 days (see ¶ 0016 and reference claim 2).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Thus, the claims fail to patentably distinguish over the state of the art as represented by the cited references.
Response to Applicants’ Arguments/Remarks
Applicants raised several issues (see pages 7-9 of Remarks), alleging that instant claims are non-obvious over the cited prior art on the grounds that:
1) Applicants merely cite MPEP § 2143, including a list of case law citations (see pages 7-8 of Remarks).
Response:
Applicants’ response fails to link the MPEP § 2143 and the legal concepts to the facts of the application under examination.
2) Applicants argue alleging what appears to be the Applicants’ position that the Examiner’s conclusion of obviousness is allegedly based on improper hindsight reasoning (see page 7 of Remarks).
Response:
In response to Applicants’ arguments on the grounds of what appears to be the Applicants’ position alleging that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the Applicants’ disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In the instant case:
a) the information regarding a method for: i) treating hair loss; and ii) promoting or activating hair follicle development, with an effective amount of a PTEN inhibitor, is gleaned from Xusheng evidenced by Lai, who teaches a method for promoting hair follicle development, hair growth or treating hair loss in mice, with subcutaneous injection of a PTEN inhibitor (bpv(phen)). Please see discussions above.
b) the information regarding formulation of a PTEN inhibitor in a form for topical application, is gleaned from Tremblay, who discloses that PTEN inhibitors compounds such as bpV(phen) and bpV(pic), can be formulated for subcutaneous injection, topical, oral, parenteral administration (see discussions above).
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged a method comprising subcutaneously or topically administering a PTEN inhibitor (e.g., bpV(phen) or bpV(pic)), to a subject in need of: i) a treatment for hair loss; and/or ii) a promotion or activation for hair follicle development, from the disclosures of Xusheng as evidenced by Lai and Tremblay. A person skilled in the art would have had a reasonable expectation that the administration of the PTEN inhibitor (e.g., bpV(phen) or bpV(pic)), would, for example, treating hair loss in the subject.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
3) Tremblay fails to disclose: i) treating hair loss; or ii) promoting or activating hair follicle development and Xusheng fails to discloses topical administration (see page 8 and page 9 of Remarks).
Response:
Xusheng evidenced by Lai, was cited for disclosing a method for promoting hair follicle development, hair growth or treating hair loss in mice, with subcutaneous injection of a PTEN inhibitor (bpv(phen)). Please see discussions above.
Tremblay was cited for disclosing that PTEN inhibitors compounds such as bpV(phen) and bpV(pic), can be formulated for subcutaneous injection, topical, oral or parenteral administration (see discussions above).
Accordingly, at the time of the instant invention, one skilled in the art would have envisaged a method comprising subcutaneously or topically administering a PTEN inhibitor (e.g., bpV(phen) or bpV(pic)), to a subject in need of: i) a treatment for hair loss; and/or ii) promoting or activating hair follicle development, from the disclosures of Xusheng as evidenced by Lai and Tremblay. A person skilled in the art would have had a reasonable expectation that the administration of the PTEN inhibitor (e.g., bpV(phen) or bpV(pic)), would, for example, treating hair loss in the subject.
Obviousness requires only a reasonable expectation of success, not complete confidence in a given outcome; "at least some degree of predictability" is all that is required. M.P.E.P. § 2143.02.
The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
Furthermore, in response to the Applicants’ arguments against the references individually (e.g., Tremblay fails to disclose: i) treating hair loss; or ii) promoting or activating hair follicle development and Xusheng fails to discloses topical administration (see page 7 of Remarks)), one cannot show nonobviousness by attacking references individually where the rejections are based on combination of references. In obviousness rejection a combination of references is used, and the references are relied upon in combination and are not meant to be considered separately as in a vacuum. It is the combination of all of the cited and relied upon references that make up the state of the art with regard to the claimed invention. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co.; 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
3) at the time of the instant invention, one skilled in the art would not have had a reasonable expectation of success with a topical administration of a PTEN inhibitor because Gorzelanny et al (Pharmaceutics, 2020), disclose that topical administration of drugs is still challenging (see pages 8-9 of Remarks).
Response:
Applicants’ arguments have been fully considered but they are not found to be persuasive. This is because there is nothing in Gorzelanny et al, which demonstrates that a topical administration of a PTEN inhibitor to a subject in need of: i) a treatment for hair loss; and/or ii) a promotion or activation for hair follicle development, fails to for example, treat hair loss in the subject.
Conclusion
No claim is allowable.
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.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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