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 . Claims included in prosecution are claims 10-13, 15-16, and 18.
Response to Restriction Requirement
Applicant’s election without traverse electing Group II, claims 10-13, 15-16, and 18 in the reply filed on 2/20/26 is acknowledged.
Claims 1-3, 5-6, 8, 30-33, 40, 45, and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
1. Claim 10 is objected to because of the following informalities: “4-AP” in line 2 and line 3 should be recited as --- 4-aminopyridine ---. Appropriate correction is required.
2. Claim 15 is objected to because of the following informalities: “4-AP” in line 2 and line 3 should be recited as --- 4-aminopyridine ---. Appropriate correction is required.
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.
1. Claims 16 and 18 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
For example, in the present instance, claim 16 recites the broad recitation “wherein said mammal has a disease, disorder, or condition associated with said hair loss”, and the claim also recites “and optionally wherein said disease, disorder, or condition associated with said hair loss is selected from the group consisting of traction alopecia, alopecia areata, trichotillomania, a skin graft, and a scar” which is the narrower statement of the range/limitation.
Claim 18 contains a similar recitation with the term “optionally”.
In the instant case, optionally is used in the same context, and with the same meaning, as the term "preferably."
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
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.
1. Claim(s) 10-13, 15-16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin et al. (WO 2008/110872, Sep. 18, 2008) (hereinafter Tamarkin) (ISR reference) as evidenced by Kornstein (US 2013/0035539, Feb. 7, 2013) (hereinafter Kornstein).
Tamarkin discloses foamable pharmaceutical compositions comprising, among other components a therapeutically effective concentration of at least one active agent selected from the group consisting of a channel agent, a cholinergic agent, and a nitric oxide donor. Tamarkin also discloses methods of treating, alleviating, or preventing a disorder of mammalian subject, comprising administering such a composition to an afflicted target site (satisfies step (a)) (Abstract). Suitable channel agents include potassium channel blockers such as 4-aminopyridine (satisfies active of claim 10) (¶ [0045]). A therapeutically effective concentration of the active agent is to be administered (¶ [0080]). Suitable disorders to be treated include hair loss (¶ [0084]). The foamable compositions are useful in topical foam applications (satisfies claim 13) (¶ [0142]). In some embodiment, at least one composition further comprises an additional active agent other than a channel agent; a cholinergic agent; a nitric oxide donor, or a related agent (satisfies claim 18) (¶ [0278]). The mammals may be humans (satisfies claim 12) (¶ [0293]). By including an effective amount of an appropriate active agent, the compositions are useful in treating a variety of dermatological disorders including trauma or injury to the skin, post-operative or post-surgical skin conditions baldness, alopecia, and scarring (satisfies claim 16) (¶ [0309]).
The prior art is not anticipatory insofar as this combination must be selected from different lists/locations in the reference. It would have been obvious, however, to have formulated a method for increasing hair growth, comprising administering a composition comprising 4-aminopyridine, as instantly claimed, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding claim 10 reciting increasing hair growth and hair regeneration, as evidenced by Kornstein, treating hair loss/thinning involves promoting the maintenance, growth, and restoration of hair (Abstract). Accordingly, where Tamarkin discloses methods of treating, alleviating, or preventing a disorder such as hair loss, they disclose methods for increasing hair growth and/or increasing hair regeneration.
Regarding claim 11, Tamarkin disclosed methods are substantially the same as the instantly claimed methods where Tamarkin discloses methods of treating, alleviating, or preventing a disorder such as hair loss that comprises the administration of an active agent such as 4-aminopyridine. Accordingly when delivering 4-aminopyridine with the vehicles of Tamarkin and applying to hair, it would be reasonable for one of ordinary skill in the art to conclude that the methods of Tamarkin would be effective to increase hair growth by at least 1.5 fold as instantly claimed.
Regarding claim 12, as discussed above, mammals may be humans. Accordingly, utilizing the methods of Tamarkin to treat a human would have been obvious.
Regarding claim 13, as discussed above, Tamarkin’s composition is useful for topical administration. Accordingly, utilizing the methods of Tamarkin for local administration would have been obvious.
Regarding the dosage of 4-aminopyridine recited in instant claim 15, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). As discussed above, Tamarkin discloses that a therapeutically effective concentration of the active agent is to be administered. Furthermore, 4-aminopyridine is a suitable active agent for use in the compositions/methods of Tamarkin, which makes amounts thereof a result effective variable, since amounts directly impact the therapeutic effect. Accordingly, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed dosage of 4-aminopyridine to yield the desired therapeutic profile.
Regarding claim 16, as discussed above, Tamarkin’s composition is useful to treat dermatological disorders such as trauma or injury to the skin, post-operative or post-surgical skin conditions baldness, alopecia, and scarring. Accordingly, utilizing the methods of Tamarkin to treat a disease, disorder, or condition associated with hair loss would have been obvious.
Regarding claim 18, as discussed above, a second composition with a separate active may be used. Accordingly, administering an additional medical treatment in the methods of Tamarkin would have been obvious.
Therefore, the teachings of Tamarkin as evidenced by Kornstein render obvious claims 10-13, 15-16, and 18
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.
1. Claims 10-13, 15-16, and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,268,677 B2 in view of Li et al. (US 2011/0300152, Dec. 8, 2011) (hereinafter Li).
The pending claims differ from the patented claims insofar as reciting a method for treating a mammal having osteoporosis or bone insufficiency etc.
However, Li discloses compositions which can small molecule inhibitors of the SK4 channels and find use in preventing and/or treating various diseases or disorders including bone loss and cancer metastasis (Abstract). Suitable actives include 4-aminopyridine (4-AP) (¶ [0183]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have utilized the patented composition into methods for treating a mammal having osteoporosis or bone insufficiency etc. since the active used, 4-aminopyridine, may be used to treat bone loss or cancer metastasis as taught by Li.
2. Claims 10-13, 15-16, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of copending Application No. 18/270,969 in view of Li et al. (US 2011/0300152, Dec. 8, 2011) (hereinafter Li).
The pending claims differ from the copending claims insofar as reciting a method for treating a bone loss.
However, Li discloses compositions which can small molecule inhibitors of the SK4 channels and find use in preventing and/or treating various diseases or disorders including bone loss (Abstract). Suitable actives include 4-aminopyridine (4-AP) (¶ [0183]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have utilized the copending composition into methods for bone loss since the active used, 4-aminopyridine, may be used to treat bone loss as taught by Li.
This is a provisional nonstatutory double patenting rejection.
3. Claims 10-13, 15-16, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 19/068,442 in view of Li et al. (US 2011/0300152, Dec. 8, 2011) (hereinafter Li).
The pending claims differ from the copending claims insofar as reciting a method for increasing a level of BMP-2 polypeptide and a disease associated with decreased levels of BMP-2 polypeptide such as bone loss, bone cancer, osteoporosis, etc..
However, Li discloses compositions which can small molecule inhibitors of the SK4 channels and find use in preventing and/or treating various diseases or disorders including bone loss and cancer metastasis (Abstract). Suitable actives include 4-aminopyridine (4-AP) (¶ [0183]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have utilized the copending composition into methods for bone loss since the active used, 4-aminopyridine, may be used to treat bone loss and cancer metastasis as taught by Li.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 10-13, 15-16, and 18 are rejected.
Claims 1-3, 5-6, 8, 30-33, 40, 45, and 50 are withdrawn.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A./Examiner, Art Unit 1612
/LEZAH ROBERTS/Primary Examiner, Art Unit 1612
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