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 .
Status of the Application
Claims 1-19 are pending
Claims 13-19 are withdrawn from examination as being drawn to a nonelected species.
Claims 1-12 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/05/2024, 12/10/2025, 01/30/2026 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of U.S. Provisional Application No. 63/388,239 filed on 07/11/2022.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-12) in the reply filed on 05/27/2026 is acknowledged.
Claims 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/27/2026.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ogru (WO 2012/171065, as disclosed in IDS).
Ogru is drawn towards a method of treating Allan-Herndon-Dudley syndrome (“AHDS”) comprising administering DITPA (see abstract). Ogru teaches “Such treatment would be given to females who are carriers with a normal phenotype, and then become identified in pregnancy as a mother carrying a fetus with the MCT8 deficiency.” (pg. 4, lines 29-31). Ogru teaches “In one embodiment, the dose may be given once a day. In an alternate embodiment, the daily dose is divided into 3 equal portions given close to 8 hours apart.” (pg. 14, lines 31-32). Ogru teaches oral administration of DITPA (see Examples 1A-1E).
Ogru does not explicitly teach wherein administration begins no more than ten weeks after conception of the subject.
It would have been obvious to one of ordinary skill in the art to treat AHDS wherein administration begins no more than ten weeks after conception of the subject, as suggested by Ogru, and produce the instant invention.
With regards to the limitation claimed in instant claims 1-7, which claims a specific start of administration, Ogru does not specifically teach the exact administration periods claimed in instant claims 1-7. However, it would be within the skill of an ordinary artisan to be able to modify the period of administration in order to obtain the desired safety and efficacy of DITPA. It is noted that "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6-8, and 10-18 of copending Application No. 18/350,116 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims both recite similar methods of treating AHDS. Application No. 18/350,116 recites administration within three days after birth of the subject (claim 1).
Application No. 18/350,116 does not explicitly recite wherein administration begins no more than ten weeks after conception of the subject.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to treat AHDS wherein administration begins no more than ten weeks after conception of the subject, as suggested by Application No. 18/350,116, and produce the instant invention.
Even though the range for administration period as taught by Application No. 18/350,116 is not the same as the claimed administration period, Application No. 18/350,116 does teach an overlapping range of time periods, and it has been held that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05(I). Furthermore, the determination of administration period is well within the purview of those skilled in the art through routine experimentation, and it has been held that “it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art to optimize the administration period in order to increase the efficacy of DITPA treatment.
The amounts of active agents to be used, the pharmaceutical forms, e.g., tablets, etc; mode of administration, flavors, surfactant are all deemed obvious since they are all within the knowledge of the skilled pharmacologist and represent conventional formulations and modes of administration.
Furthermore, no unobviousness is seen in the ratio claimed because once the usefulness of a compound is known to treat a condition, it is within the skill of the artisan to determine the optimum ratio.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/350,077 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims both recite similar methods of treating AHDS. Application No. 18/350,077 recites administration for a period of four weeks (claim 5).
Application No. 18/350,077 does not explicitly recite wherein administration begins no more than ten weeks after conception of the subject.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to treat AHDS wherein administration begins no more than ten weeks after conception of the subject, as suggested by Application No. 18/350,077, and produce the instant invention.
With regards to the limitation claimed in instant claims 1-7, which claims a specific start of administration, Application No. 18/350,0776 does not specifically teach the exact administration periods claimed in instant claims 1-7. However, it would be within the skill of an ordinary artisan to be able to modify the period of administration in order to obtain the desired safety and efficacy of DITPA. It is noted that "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 19/299,711 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims both recite similar methods of treating AHDS. Application No. 19/299,711 recites administration for a period of four weeks (claim 16).
Application No. 19/299,711 does not explicitly recite wherein administration begins no more than ten weeks after conception of the subject.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to treat AHDS wherein administration begins no more than ten weeks after conception of the subject, as suggested by Application No. 19/299,711, and produce the instant invention.
With regards to the limitation claimed in instant claims 1-7, which claims a specific start of administration, Application No. 19/299,711 does not specifically teach the exact administration periods claimed in instant claims 1-7. However, it would be within the skill of an ordinary artisan to be able to modify the period of administration in order to obtain the desired safety and efficacy of DITPA. It is noted that "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
