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 03/14/2025, 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.
Priority
This Application filed on 01/12/2024, is a 371 of PCT/US22/37139, filed on 07/14/2022, which claims priority to U.S. Provisional Application No. 63/221,651, filed on 07/14/2021.
Status of the Claims
Claims 1-2, 4-9, 11, 13, 15-21, 23, 25 and 27 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-8 and 16-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 6-8 depend from the rejected claim 5 and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth below. Claims 18--20 depend from the rejected claim 16 and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth below.
As per MPEP 2173.02, “[d]uring prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude (emphasis added). See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc).”
If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is appropriate (emphasis added). See Morton Int’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
Each of claims 4-8 and 16-20, recites “comprises”, to describe a Markush group of: i) PTEN inhibitors (claims 4 and 16); and ii) a vanadate derivative (claims 5-8 and 17-20). The transitional term "comprising", is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Please see MPEP § 2111.03. However, a person skilled in the art cannot reasonably determine the meets and bounds of the recited limitation, because it is unclear to one skilled in the art as to, for example, what other PTEN inhibitors are included. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims. The recitation of “comprising”, is an improper Markush language which should be in alternative language, i.e., “selected from the group consisting of ...” A claim element defined by selection from a group of alternatives (a Markush grouping) requires selection from a closed group "consisting of" (rather than "comprising" or "including") the alternative members. Please see MPEP § 803.02 and MPEP § 2111.03.
It is recommended that Applicants amend, for example, claim 4 to recite “wherein the PTEN inhibitor is selected from the group consisting of β-glycerol phosphate disodium salt pentahydrate, a vanadate derivative, SF1670, thioredoxin-1, indolecarboxylic acid salts, nonenal, and a combination thereof”, in order to overcome the rejection. Appropriate correction is required.
This lack of clarity makes it impossible to ascertain with reasonable precision when that claim is infringed and when it is not. Lacking such clarity, the skilled artisan would not be reasonably apprised of the metes and bounds of the subject matter for which Applicants seek patent protection. Rather, a subjective interpretation of the claimed language would be required. However, as such is deemed inconsistent with the tenor and express language of 35 U.S.C. § 112, second paragraph, the claims are deemed properly rejected. Appropriate correction is required.
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 –
(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, 4-7, 9, 13, 15-19, 21, 23 and 27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xusheng (CN107375297A, published 11/24/2017, Machine Translation), as evidenced by Lai et al (hereinafter “Lai”, Brit. J. Pharmacology, 2007, 152, 1172-1184).
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.
Under the broadest reasonable interpretation (BRI), consistent with the specification, the claimed invention is being interpreted as a method for: i) treating hair loss (independent claim 1); and ii) promoting or activating hair follicle development (independent claim 15), in a subject in need thereof, comprising administering to the subject, an effective amount of a PTEN inhibitor.
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 abstract, ¶s 0011-0022, 0026-0043 (Examples 1-3) and reference claims 1-4.
Bpv(phen), is an abbreviation for potassium bisperoxo (1,10-phenanthroline) oxovanadate, as evidenced by Lai (see abstract).
Therefore, claims 1 and 15 are anticipated by Xusheng evidenced by Lai.
Regarding claims 4-7 and 16-19, Xusheng evidenced by Lai teaches a bisperoxovanadate potassium salt (see discussions above).
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).
Regarding claim 23, Xusheng teaches administration to mice (see discussions above).
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 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.
Claims 1, 4-7, 8-9, 13, 15-19, 20-21, 23 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), as applied to claims 1, 4-7, 9, 13, 15-19, 21, 23 and 27 above and in view of Schmid et al (hereinafter “Schmid”, FEBS Lett., 2004, 566, 35-38).
The limitation of claims 1, 4-7, 9, 13, 15-19, 21, 23 and 27, as well as the corresponding teaches of Xusheng and Lai are described above and hereby incorporated into the instant rejections.
The invention of claims 8 and 20 are similar to claims 5 and 16 respectively. However, claims 8 and 20 differ from claims 5 and 16 in that claims 8 and 20 require that the vanadate derivative is dipotassium bisperoxo(pyridine-2-carboxyl)oxovanadate (bpV(pic)).
Although Xusheng as evidenced by Lai is not explicit in disclosing, wherein the PTEN inhibitor is bpV(pic), a person skilled in the art would have had a reasonable expectation of success in employing bpV(pic).
This is because at the time of the instant invention, it was known in the art that bpV(pic) is a PTEN inhibitor. For example, Schmid teaches PTEN inhibitors including but not limited to bpv(phen) of Xusheng as evidenced by Lai and bpV(pic). Please see page 35.
Accordingly, at the time of the instant invention, one skilled in the art would have found it obvious to administer a PTEN inhibitor (e.g., bpV(pic) of Schmid), to a subject in need of: i) a treatment for hair loss; and/or ii) promoting or activating hair follicle development, with a reasonable expectation of, 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).
The skilled artisan would have found it obvious to substitute one known element (a PTEN inhibitor of Schmid, i.e., bpV(pic) for another (a PTEN inhibitor of Xusheng as evidenced by Lai, i.e., bpV9phen)), for the predictable result of, for example treating a subject suffering from hair loss.
The use of simple substitution of one known element for another to obtain predictable results as a requirement of a prima facie case of obviousness has been deemed as proper (please see MPEP § 2143). In the instant case, the one known element is a PTEN inhibitor and the predictable results is treating a disease or condition, in which the therapeutic intervention is at PTEN inhibition. It is therefore reasonable to conclude that the strength of correlation between the inhibition of PTEN and treating a disease or condition associated with activity (e.g., hair loss), gives rise to a reasonable expectation of success.
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.
Claims 1, 4-7, 9, 11, 13, 15-19, 21, 23, 25 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), as applied to claims 1, 4-7, 9, 13, 15-19, 21, 23 and 27 above and in view of Tremblay et al (hereinafter “Tremblay”, WO200130325A2, published 05/03/2001).
The limitation of claims 1, 4-7, 9, 13, 15-19, 21, 23 and 27, as well as the corresponding teaches of Xusheng and Lai are described above and hereby incorporated into the instant rejections.
The invention of claims 11 and 25 are similar to claims 1 and 23 respectively. However, claims 11 and 25 differ from claims 1 and 23 in that claims 11 and 25 require that the PTEN inhibitor is administered topically.
Although Xusheng teaches administering bpV(phen) by subcutaneous injection (see e.g., ¶ 0029), 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, Tremblay discloses that PTEN inhibitors such as bpV compounds (see e.g., abstract and page 7), can be formulated for topical, oral, or parenteral administration (see page 14).
Accordingly, at the time of the instant invention, one skilled in the art would have found it obvious to topically administer a PTEN inhibitor (e.g., bpV(phen) to a subject in need of: i) a treatment for hair loss; and/or ii) promoting or activating hair follicle development, with a reasonable expectation of, 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).
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.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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
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