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 .
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 79 and 80 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.
This rejection has been withdrawn in view of the Amendment filed 10/30/2025.
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 78 and 85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,419,881 (‘881). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘881 patent discloses a method of treating a neurodevelopmental disorder in a subject in need thereof, the method comprising orally administering to the subject of a pharmaceutical composition comprising: (i) 30 percent by weight of a compound of Formula I:
PNG
media_image1.png
95
311
media_image1.png
Greyscale
based on the total weight of the pharmaceutical composition, and (ii) a pharmaceutically acceptable excipient. Crystalline Form A is found in claim 10. Mannitol, crospovidone, microcrystalline cellulose, povidone, and polysorbate are found in claim 10.
Thus, it would have been prima facie obvious to one of ordinary skill in the at the time the invention was made to obtain the claimed invention given the claims of the ‘881 patent. This is because the ‘881 patent discloses an invention similar to that of the present invention, namely, an oral pharmaceutical composition comprising about 30% of the claimed compound (Formula I) in an anhydrous crystalline Form A, and the claimed excipients.
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.
Claims 78, 81-85, 89 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Higuera et al WO 2010006020 A1, in view of Genin et al. CA 3228004 A1.
Higuera teaches a composition comprising novel crystalline form of the claimed compound. See Abstract and Claims. Compositions including liquid and solid dosage forms comprising the claimed compound and pharmaceutically excipients are found in pages 8-10. Compositions comprising up to about 25% of the claimed compound is found in page 11, lines 7-11.
Higuera does not expressly teach the claimed excipients in the claimed amount.
However, Genin teaches a composition comprising about 10% by weight of an anhydrous crystalline form of the compound of Formula I based on the total weight of the composition, wherein the anhydrous crystalline form has an X-ray powder diffraction pattern with characteristic peaks between and including the following values of 20 in degrees: 7.8, 220, 23.7, 27.0 and 27.6 0.2 20; about 50% to 80% by weight of a filler selected from the group consisting of mannitol, microcrystalline cellulose, and a combination thereof, based on the total weight of the composition; about 5% by weight of crospovidone based on the total weight of the composition, about 4% of povidone based on the total weight of the composition, and about 1% of a polysorbate based on the total weight of the composition.
Thus, it would have been prima facie obvious to one of ordinary skills in the art to optimize the composition taught in Higuera to include the pharmaceutical excipients in view of the teaching of Genin to obtain the claimed invention. This is because Genin teaches a composition useful for the delivery of the claimed compound is known in the art, and this is because Higuera teaches the desirability to obtain a solid composition useful for the delivery of the claimed compound.
It is noted that Higuera does not expressly teach about 30% by weight of an anhydrous crystalline form of the claimed compound, however, Higuera teaches up to about 25% of the claimed compound, and the term “about” in Higuera is defined to include up to 10% or more of the given value. Hence, it would have been obvious to one of the ordinary skills in the art to, by routine experimentation select up to about 30% of the claimed compound given the teaching in page 3 of the Higuera reference.
Response to Arguments
Applicant's arguments filed 10/30/2025 have been fully considered but they are not persuasive.
Genin does not disclose the claimed weight percent of about 30% of Formula I, let alone disclose a 30% formulation containing specifically Form A as claimed. The Office acknowledges that Higuera does not teach the claimed excipients in the claimed amounts, and that Higuera does not expressly teach formulations comprising about 30% of radiprodil. However, Higuera does not disclose Form A as claimed. Rather, Higuera discloses radiprodil only as its crystalline Form C. The reference does not disclose the instantly claimed Form A. In particular, Table 1 of Higuera (page 5) shows the XRPD peaks of the disclosed Form C, none of which are the recited XRPD peaks of the instant Form A.
Applicant asserts that a person of skill in the art would not have been motivated to modify Higuera's formulations containing Form C with the excipients of Genin to arrive at a solid pharmaceutical composition containing Formula I as a completely different crystalline form, i.e., Form A. There has been no showing by the Office as to why the single crystalline Form C disclosed by Higuera could be replaced with a different solid form, Form A, at the claimed weight percentage of about 30%. It is well-known in the art that different crystalline solid forms of a compound could have different properties that impact their suitability in a drug formulation. Applicant submits that, based the disclosures of Higuera and Genin taken alone or in combination, there would have been no reasonable expectation, nor would a person of skill in the art have recognized, that Form C could be successfully replaced with Form A at the claimed drug loading. For at least these reasons, the Office has not established a proper prima facie case of obviousness using the cited references. Accordingly, Applicant submits that the instant claims would not have been obvious over the cited combination of references, and requests that the rejection be withdrawn.
However, Applicant’s arguments are not persuasive for the following reasons:
In response to Applicant’s argument that Genin does not disclose the claimed weight percent of about 30% of Formula I, let alone disclose a 30% formulation containing specifically Form A as claimed, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, Genin is cited solely for the teaching of compound of Formula I in an anhydrous crystalline form A is available and known in the art. Genin wasn’t cited for the amount of compound of Formula I;
In response to Applicant’s argument that Higuera does not disclose Form A as claimed. Rather, Higuera discloses radiprodil only as its crystalline Form C, it is noted that this argument is against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, Higuera is cited in view of the teaching in Genin for the teaching of radiprodil in an anhydrous crystalline Form A. More significantly, Genin teaches radiprodil in an anhydrous crystalline Form A or Form C. Accordingly, Genin teaches the equivalency in between both Form A and Form C. See Paragraphs 0005-0006 and Examples;
Furthermore, Applicant’s attention is called to the teaching in Genin’s teaching in paragraphs 0005-0006; Examples and Claims where Genin teaches the use of radiprodil in of both Form A and Form C in the same active loading amount in the composition, for example 1% or 10%. As such, these teachings show the equivalency between the two crystalline forms that lead to the same loading dose percent amount in the composition. Therefore, a person of ordinary skill in the art would have been motivated to modify Higuera's compositions comprising Form C in view of the teaching in Genin to obtain a solid pharmaceutical composition comprising Formula I in Form A because Genin discloses the use of crystalline Form A and Form C interchangeably; and
In response to Applicant’s argument that there has been no showing by the Office as to why the single crystalline Form C disclosed by Higuera could be replaced with a different solid form, Form A, at the claimed weight percentage of about 30%. It is well-known in the art that different crystalline solid forms of a compound could have different properties that impact their suitability in a drug formulation, again, Higuera is cited in view of Genin. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Genin shows that compositions comprise Formula I in crystalline form A or C are both useful for the same treatment and result in superior characteristics including accurate dosing. Genin further shows that solid oral compositions comprise Formula I in crystalline Form A or C both in 1% or 10% active loading dose. Genin reference did not show differences in properties that can impact the suitability in a drug formulation. This is evidence by the same composition, comprising the same amount of Formula I in either crystalline Form A or crystalline Form C. Therefore, one of ordinary skill in the art would have been motivated to, by routine experimentation select crystalline Form A in view of the teaching of Genin to modify Higuera's compositions with the expectation to arrive at a solid pharmaceutical composition comprising at least 25% of radiprodil useful in pharmaceutical art.
For at least the above reasons, the 103 rejection over Higuera in view of Genin is maintained.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 10/30/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ROBERT A. WAX can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SUSAN T TRAN/Primary Examiner, Art Unit 1615