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 .
Election/Restrictions
Applicant’s election without traverse of the species of male pattern baldness in the reply filed on 12/1/2025 is acknowledged. Claims 8-13 are withdrawn for pertaining to unelected species.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-7 and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loose et al. (US 2020/0121681), alone or alternatively in view of Sinha et al. (WO 2023/055740).
Loose teaches methods of treating hair loss with minoxidil compositions in controlled or slow-release tablet form featuring hydroxypropyl methylcellulose (HPMC) binder and enteric coating. See entire disclosure, especially abstract,[0004]-[0005],[0312]-[0313] and claims. Regarding the limitation on the amount of minoxidil one of ordinary skill in the art would optimize the amount of minoxidil in an amount effective to mitigate and/or treat hair loss for which it is needed without adverse side effects, commensurate with a reasonable risk/benefit ratio. Regarding the functional limitations or properties recited throughout the claims on release from stirred buffer solution, AUC0-inf compared to immediate release, blood level of minoxidil in the blood over a period of time, the dosage results in no tachycardia, hypotension, premature ventricular contractions or tachyarrhythmias, it follows that since the minoxidil formulation of Loose is within the scope of the claims and contains the excipients said to provide the desired release profile (HPMC, enteric coating) it will feature these same properties. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke, supra. Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 459 F.2d 531, 59 CCPA 1036, 173 USPQ 685 (1972). Regarding claims 2-3, Loose teaches once or twice daily administration. See [0225]
Additionally, the amount of minoxidil would be obvious when the teachings of Sinha are considered. Sinha teaches oral administration of minoxidil tablets for treating male pattern hair loss in amounts of 0.625-10 mg, an amount that overlaps the claimed range. See entire disclosure, especially abstract, [0020],[0021],[0023] and claims 1,10-11 and 23. A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. Therefor, based on the described overlap above, the instant claims would have been obvious to one of ordinary skill in the art. MPEP § 2144.05. Since Loose already teaches use of minoxidil tablets for treating hair loss one of ordinary skill would have a very high expectation of success in using the amounts taught within Sinha for treating male pattern baldness. Obviousness stems from the notion that the combination of art known elements that, when combined, do no more than serve their art-recognized functions is obvious. Thus the claimed invention would have been prima facie obvious 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 1-7 and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over JP 2009531461 in view of Sinha et al. (WO 2023/055740).
JP teaches oral administration of hair loss treating compositions, including male pattern baldness, the composition includes hair restorative agents in combination with minoxidil in controlled release tablets produced by dispersing the actives in HPMC and enterically coating the dosage. See entire disclosure of translation provided, especially abstract, page 8 3rd full ¶, page 9 2nd full ¶, ¶ bridging page 12-13 and claims 1,9. Regarding the limitations on the amount of minoxidil and once or twice daily administration recited in claims 2-3, one of ordinary skill in the art would optimize the amount of minoxidil and the times administered daily in an amount effective to mitigate and/or treat hair loss for which it is needed without adverse side effects, commensurate with a reasonable risk/benefit ratio. Regarding the functional limitations or properties recited throughout the claims on release from stirred buffer solution, AUC0-inf compared to immediate release, blood level of minoxidil in the blood over a period of time, the dosage results in no tachycardia, hypotension, premature ventricular contractions or tachyarrhythmias, it follows that since the minoxidil formulation of JP is within the scope of the claims and contains the excipients said to provide the desired release profile (HPMC, enteric coating) it will feature these same properties. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke, supra. Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products. See In re Brown, 459 F.2d 531, 59 CCPA 1036, 173 USPQ 685 (1972).
Additionally, the amount of minoxidil would be obvious when the teachings of Sinha are considered. Sinha teaches oral administration of minoxidil tablets for treating male pattern hair loss in amounts of 0.625-10 mg, an amount that overlaps the claimed range. See entire disclosure, especially abstract, [0020],[0021],[0023] and claims 1,10-11 and 23. A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. Therefor, based on the described overlap above, the instant claims would have been obvious to one of ordinary skill in the art. MPEP § 2144.05. Since Jp already teaches use of minoxidil tablets for treating hair loss one of ordinary skill would have a very high expectation of success in using the amounts taught within Sinha for treating male pattern baldness. Obviousness stems from the notion that the combination of art known elements that, when combined, do no more than serve their art-recognized functions is obvious. Thus the claimed invention would have been prima facie obvious 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
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 1-7 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,491,184. Although the claims at issue are not identical, they are not patentably distinct from each other because each claim minoxidil oral administration to treat hair loss, the primary difference is the patented method uses a different amount of active. However, adjusting the amount of active in this formulation in an amount effective to mitigate and/or treat hair loss would be obvious to one of ordinary skill.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618