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 10-12, 15-16, and 18.
Previous Rejections
Applicants' arguments, filed 7/14/2026, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 presently being applied to the instant application.
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) 10-12, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kort et al. (US 2002/0165264, Nov. 7, 2002) (hereinafter Kort).
Kort discloses compounds useful for treating diseases prevented by or ameliorated with potassium channel openers (Abstract). Potassium channel openers have been shown to promote hair growth. Therefore, potassium channel openers have utility in the treatment of hair loss and baldness also known as alopecia (¶ [0016]). An embodiment relates to a method of treating alopecia (¶ [0093]). An exemplary compound of the invention, 3-ethoxy-4-( 4-pyridinylamino )-3-cyclobutene-1,2-dione, is made using 4-aminopyridine (i.e., 4-aminopyridine derivative) (¶ [0688]). The pharmaceutical compositions of this invention can be administered to humans and other mammals orally or intravenously (satisfies claim 12) (¶ [1127]). For purposes of oral administration, more preferable doses of the compounds can be in the range of from about 0.01 to about 25 mg/kg/day (satisfies claim 15) (¶ [1168]).
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 a 4-aminopyridine derivative systemically, 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 discussed above, potassium channel openers have been shown to promote hair growth. As such, where Kort discloses utilizing such compounds in methods for treating hair loss or alopecia, a method of increasing hair growth would have been obvious.
Regarding claim 10 reciting systemic administration, as discussed above, Kort’s method involves oral or intravenous administration. This satisfies systemic administration. Accordingly, utilizing the methods of Kort for systemic administration would have been obvious.
Regarding claim 11, a rejection can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic. See MPEP 2112(II) and (III). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I). Further, if the composition is physically the same, it must have the same properties. See MPEP 2112.01(II). Kort discloses substantially the same methods, comprising substantially the same actives, in substantially the same dosages, utilizing substantially the same administration route. As such, it would be reasonable for one of ordinary skill in the art to conclude that the methods of Kort 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 Kort to treat a human would have been obvious.
Regarding the dosage of 4-aminopyridine or derivatives thereof recited in instant claim 15, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Kort’s dose of the compound is about 0.01 to about 25 mg/kg/day. Accordingly, because the range recited in the instant claims lies inside the range disclosed by Kort, the range disclosed by Kort meets the instantly recited limitations.
Therefore, the teachings of Kort render obvious claims 10-12, and 15.
2. Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kort et al. (US 2002/0165264, Nov. 7, 2002) (hereinafter Kort) in view of Aldhalimi et al. (ISRN Pharmacology, Volume 2014, Article ID 575423, 5 pages, Mar. 9, 2014) (hereinafter Aldhalimi).
The teachings of Kort are discussed above.
Kort differs from the instant claims insofar as not specifying a condition resulting in the alopecia they treat and not disclosing the use of an additional medical treatment.
However, Aldhalimi discloses that androgenic alopecia is a partial or complete loss of hair that occurs in a progressive pattern in genetically predisposed individuals (Pg. 1, Col. 1). Ketoconazole (KCZ) is an imidazole antifungal agent (Pg. 1, Col. 2). Minoxidil is a vasodilatory medication used primarily as antihypertensive drug (Pg. 1, Col. 2). The study demonstrated that topical Ketoconazole stimulates hair growth significantly (Pg. 4, Col. 1). Further, there was a significant increase in hair growth in the group treated with topical Minoxidil solution (Pg. 4, Col. 1).
Accordingly, where Kort discloses a method of treating alopecia, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have utilized the method of Kort in treating a patient with a condition such as androgenic alopecia since androgenic alopecia results in a partial or complete loss of hair as taught by Aldhalimi. It would have also been obvious for one of ordinary skill in the art, prior to the filing of the instant claims, to have modified the method of Kort to further comprise the use of an antifungal agent such as Ketoconazole or an antihypertensive drug such as Minoxidil motivated by the desire to utilize their significant hair growth results as taught by Aldhalimi in a method for treating alopecia.
Therefore, the combined teachings of Kort and Aldhalimi render obvious claims 16 and 18.
3. Claim(s) 10-12, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin et al. (US 2008/0206161, Aug. 28, 2008) (hereinafter Tamarkin) as evidenced by Kornstein (US 2013/0035539, Feb. 7, 2013) (hereinafter Kornstein).
Tamarkin discloses an emulsion steroid composition as well as methods of treatment using such a composition (Abstract). In an embodiment, the steroid is a hormone (satisfies claim 18). Such compositions containing hormones can be administered systemically, via the transdermal or transmucosal route (¶ [0234]). In many cases, the inclusion of an additional therapeutic agent in the foamable pharmaceutical composition, contributes to the clinical activity of the steroid. Thus, in an embodiment, the foamable composition further includes at least one additional therapeutic agent, in a therapeutically effective concentration (¶ [0246]). Suitable additional therapeutic agents include nonsteroidal anti-inflammatory drugs (¶ [0247]). In one or more embodiments, the NSAID is a potassium ion channel modulator where it has been shown that the potassium ion channel modulators can be used to control inflammation (¶ [0417]). Suitable potassium ion channel modulators include fampridine (i.e., 4-aminopyridine) (¶ [0418]). The composition may be applied to mammals such as humans (satisfies claim 12) (¶ [0618]). By including an appropriate steroid and optional active agents in the compositions any one of a variety of dermatological disorders such as disorders of hair follicles, alopecia, including male pattern baldness, alopecia greata, alopecia universalis and alopecia totalis (¶ [0638 & 0643]).
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 alopecia, they disclose methods for increasing hair growth and/or increasing hair regeneration.
Regarding claim 10 reciting systemic administration, as discussed above, Tamarkin’s composition is useful for systemic administration. Accordingly, utilizing the methods of Tamarkin for systemic administration would have been obvious.
Regarding claim 11, a rejection can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic. See MPEP 2112(II) and (III). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01(I). Further, if the composition is physically the same, it must have the same properties. See MPEP 2112.01(II). Tamarkin discloses substantially the same methods, comprising substantially the same actives, utilizing substantially the same administration route. As such, 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 16, as discussed above, Tamarkin’s composition is useful to treat disorders such alopecia greata, alopecia universalis and alopecia totalis. 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, the steroid administered may be a hormone. Accordingly, administering an additional medical treatment such as hormone therapy in the methods of Tamarkin would have been obvious.
Therefore, the teachings of Tamarkin as evidenced by Kornstein render obvious claims 10-12, 16, and 18
4. Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tamarkin et al. (US 2008/0206161, Aug. 28, 2008) (hereinafter Tamarkin) in view of SDFCL (4-Aminopyridine Safety Data Sheet, May 12, 2018) (hereinafter SDFCL).
The teachings of Tamarkin are discussed above. Tamarkin differs from the instant claim insofar as not disclosing the dosage of the fampridine used.
However, SDFCL discloses that 4-Aminopyridine is also known as Fampridine (Pg. 1). The lowest dose causing lethality in humans is 0.59 mg/kg (Pg. 10).
Accordingly, it would have been obvious for one of ordinary skill in the art, prior to the filing of the instant application, to have formulated the composition of Tamarkin to comprise fampridine in a dosage of less than 0.59 mg/kg motivated by the desire to avoid the dose causing lethality since 0.59 is the lowest dose causing lethality as taught by SDFCL.
Response to Arguments
Applicant’s arguments with respect to claims 10-12, 15-16, and 18 have been considered but are moot because new rejections necessitated by Applicant’s amendment have been made. The teachings of Kort as well as those of Tamarkin and Tamarkin in view of SDFCL are applied to meet the requirements of the new limitation of “wherein said method comprises systemically administering a composition”.
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 10-12, 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]). The compositions may be in the form of oral dosage forms (¶ [0217]).
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 10-12, 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]). The compositions may be in the form of oral dosage forms (¶ [0217]).
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 10-12, 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]). The compositions may be in the form of oral dosage forms (¶ [0217]).
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.
Response to Arguments
Applicant’s arguments with respect to claims 10-12, 15-16, and 18 have been considered but are not persuasive for the reasons that follow.
Regarding Applicant’s arguments that Li discloses 4-AP as one of several possible actives for treating bone loss, the Examiner submits that a reference is relied upon for all it teaches and suggests, even non-preferred embodiments. See MPEP § 2141.02 (VI). Where Li discloses compositions which utilize 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 and further discloses that suitable actives include 4-aminopyridine (4-AP), this provides enough guidance for one of ordinary skill in the art that such actives are known for use in treating such diseases. While it is understood that Li does not disclose the use of 4-AP, Li provides one of ordinary skill in the art with enough guidance to use a composition comprising such an active in a method of treating bone loss by disclosing that such an active is suitable for such use.
Regarding Applicant’s arguments that the instant claims recite systemically administering 4-AP to a mammal, the Examiner respectfully points to the fact that the patented/copending claims all either recite oral or systemic administration.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejection is maintained.
Conclusion
Claims 10-12, 15-16, and 18 are rejected.
Claims 1-2, 5-6, 8, 30-33, 40, 45, and 50 are withdrawn.
No claims are allowed.
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.
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
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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