CTNF 18/030,492 CTNF 100703 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Information Disclosure Statement Two information disclosure statements (IDS) submitted on December 13 th , 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. 06-49-06 AIA The listing of references in the specification (starting on page 155) is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Status of the Claims Claims 1-6, 10-13, and 15-16 are pending in this application. Claims 7-9, 14, and 17-31 have been cancelled by applicant. 07-30-03-h AIA Claim Interpretation Claim 1 speaks to the compounds having the structure below, wherein the compound is for treating or preventing a neurological disorder in a subject. Applicant is advised that, the statement: “wherein the compound is for treating or preventing a neurological disorder in a subject” is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter. Therefore, for the purposes of applying art, the claims will be interpreted as being drawn to the compound having the structure below. PNG media_image1.png 165 201 media_image1.png Greyscale Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-6, 10-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cavalla et al. (WO 2012/143703 A1) . Regarding claims 1-3, Cavalla discloses the compounds of Formula I below ( abstract; page 3-4; and claim 1 ) for the treatment of conditions of the central nervous system ( page 1, para. 1 ), which read on the instant compounds when R 1 and R 3 (corresponding to instant R 1 and R 3 ) are H or C 1-6 alkyl; R 2 (corresponding to instant X) is a halogen; R 4 and R 5 can be H or C 1-6 alkyl; R 6 can be -C(O)O R 9 , -C(O) R 9 , wherein R 9 can be H or C 1-6 alkyl; X can be -CH 2 ; and m can be 1-10. PNG media_image2.png 541 486 media_image2.png Greyscale Regarding claim 4, Cavalla discloses their compounds, shown above, wherein the group corresponding to instant R 1 and R 3 (Cavalla’s R 1 and R 3 ) can be H and C 1 alkyl, respectively. Regarding claim 5, Cavalla discloses their compound above, wherein the group corresponding to instant R 1 and R 3 (Cavalla’s R 1 and R 3 ) can independently be H, C 1 -, or C 2 - alkyl. Regarding claim 6, Cavalla discloses their compound above, wherein the group corresponding to instant R 3 and R 1 (Cavalla’s R 3 and R 1 ) can be H and C 1 - alkyl, respectively. Regarding claim 13, Cavalla speaks to a pharmaceutical composition comprising their compounds of Formula I, together with a pharmaceutically acceptable adjuvant, diluent, or carrier ( Cavalla’s claim 18 ). Regarding claims 10-12 , Applicant is advised that one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by the disclosed formula; In re Susi , 440 F.2d 442, 169 USPQ 423 (CCPA 1971), See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds disclosed by Cavalla et al. ( Cavalla’s claim 1 ) which speaks to the compounds of Formula I and acceptable salts thereof. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims. Applicant is further advised that a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound . In re Norris , 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely , 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950). Regarding claims 15-16, Cavalla discloses their compounds of Formula I as being suitable for the treatment of a disease such as Huntington’s disease ( page 24, para. 3, lines 1-6 ). Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer Cavalla’s compounds of Formula I for the treatment of neurological conditions, such as Huntington’s disease. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Cavalla’s disclosure of their compounds of Formula I and pharmaceutical compositions thereof, further in view of Cavalla’s teachings that their compounds of Formula I are suitable for the treatment of Huntington’s disease. Applicant is advised that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak , 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder , 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter , 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)). Applicant is reminded that the arguments of counsel cannot take the place of evidence in the record. Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the teachings of the prior art references is fairly suggestive of the claimed invention . Double Patenting 08-33 AIA 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. 08-36 AIA Claim s 1-6, 10-13, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 4, 8-37 of U.S. Patent No. 10,183,919 B2 (US ‘919) in view of Cavalla et al. (WO 2012/143703 A1) . Regarding instant claims 1-6 and 10-13, US ‘919 speaks to the compounds below, which anticipate the instantly claimed compounds ( US ‘919’s claims 4 and 8-11 ): PNG media_image3.png 122 188 media_image3.png Greyscale PNG media_image4.png 225 180 media_image4.png Greyscale PNG media_image5.png 217 157 media_image5.png Greyscale ,etc. Further regarding instant claim 13, US ‘919 speaks to pharmaceutical compositions of their compounds ( US ‘919’s claims 12-16 and 25-26 ). While US ‘919 does not specifically disclose methods of treating neurological disorders, such as Huntington’s disease, by administering their related compounds (instant claims 15-16), the teachings of Cavalla et al. are relied upon for these disclosures. Cavalla discloses their compounds of Formula I as being suitable for the treatment of a disease such as Huntington’s disease ( page 24, para. 3, lines 1-6 ). Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer US ’919’s related compounds for the treatment of neurological conditions, such as Huntington’s disease, in view of Cavalla. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘919’s disclosure of their related compounds and pharmaceutical compositions thereof, further in view of Cavalla’s disclosure of their compounds of Formula I as suitable for the treatment of Huntington’s disease. Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Applicant is reminded that the arguments of counsel cannot take the place of evidence in the record . 08-36 AIA Claim s 1-6, 10-13, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-21 of U.S. Patent No. 10,844,027 B2 (US ‘027) in view of Cavalla et al. (WO 2012/143703 A1) . Regarding instant claims 1-6 and 10-13, US ‘027 speaks to the compounds below, which anticipate the instantly claimed compounds ( US ‘027’s claims 1-21 ): PNG media_image6.png 122 161 media_image6.png Greyscale PNG media_image7.png 156 161 media_image7.png Greyscale PNG media_image8.png 160 151 media_image8.png Greyscale etc. Further regarding instant claim 13, US ‘027 speaks to pharmaceutical compositions of their compounds ( US ‘027’s claim 9 ). While US ‘027 does not specifically disclose methods of treating neurological disorders, such as Huntington’s disease, by administering their related compounds (instant claims 15-16), the teachings of Cavalla et al. are relied upon for these disclosures. Cavalla discloses their related compounds of Formula I as being suitable for the treatment of a disease such as Huntington’s disease ( page 24, para. 3, lines 1-6 ). Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer US ’027’s related compounds for the treatment of neurological conditions, such as Huntington’s disease, in view of Cavalla. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘027’s disclosure of their related compounds and pharmaceutical compositions thereof, further in view of Cavalla’s disclosure of their compounds of Formula I as suitable for the treatment of Huntington’s disease. Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Applicant is reminded that the arguments of counsel cannot take the place of evidence in the record . 08-36 AIA Claim s 1-6, 10-13, and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-23 of U.S. Patent No. 11,787,772 B2 (US ‘772) in view of Cavalla et al. (WO 2012/143703 A1) . Regarding instant claims 1-6 and 10-13, US ‘772 speaks to the compounds below, which anticipate the instantly claimed compounds ( US ‘772’s claims 1-13 ): PNG media_image9.png 122 180 media_image9.png Greyscale PNG media_image10.png 121 188 media_image10.png Greyscale PNG media_image11.png 117 180 media_image11.png Greyscale ,etc. Further regarding instant claim 13, US ‘772 speaks to pharmaceutical compositions of their compounds ( US ‘772’s claim 15 ). While US ‘772 does not specifically disclose methods of treating neurological disorders, such as Huntington’s disease, by administering their related compounds (instant claims 15-16), the teachings of Cavalla et al. are relied upon for these disclosures. Cavalla discloses their related compounds of Formula I as being suitable for the treatment of a disease such as Huntington’s disease ( page 24, para. 3, lines 1-6 ). Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer US ’772’s related compounds for the treatment of neurological conditions, such as Huntington’s disease, in view of Cavalla. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘772’s disclosure of their related compounds and pharmaceutical compositions thereof, further in view of Cavalla’s disclosure of their compounds of Formula I as suitable for the treatment of Huntington’s disease. Applicant is reminded that similar properties may normally be presumed when compounds are very close in structure. (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Applicant is reminded that the arguments of counsel cannot take the place of evidence in the record. Claims 1-6, 10-13, and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 6, 8, 12, 19, 21, 35-39 of copending Application No. 18/030,496 (Copending ‘496). Regarding instant claims 1-6 and 10-13, Copending ‘496 speaks to the compounds below and pharmaceutical compositions thereof ( Copending ‘496 claims 1, 6, 8, 12, 19, and 35-38 ): PNG media_image12.png 162 197 media_image12.png Greyscale PNG media_image13.png 152 246 media_image13.png Greyscale Regarding instant claims 15-16, Copending ‘496 speaks to methods of treating neurological conditions, such as Huntington’s disease ( Copending ‘496 claims 21 and 39 ). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented . 08-30 AIA A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co. , 151 U.S. 186 (1894); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert , 245 F.2d 467, 114 USPQ 330 (CCPA 1957). A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101. Claims 1-6, 10-13, and 15-16 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1-6, 10-13, and 15-16 of copending Application No. 18/030,494 (Copending ‘494). Regarding instant claims 1-6, Copending ‘494 speaks to the compounds of the Formula below, wherein the compound is for treating or preventing a neurological disorder ( Copending ‘494 claims 1-5 ). PNG media_image14.png 167 212 media_image14.png Greyscale Regarding instant claims 10-12, Copending ‘494 speaks to the compounds below, which are the same as the instant compounds, and pharmaceutical compositions thereof ( Copending ‘494 claims 10-13 ): PNG media_image15.png 278 443 media_image15.png Greyscale PNG media_image16.png 282 443 media_image16.png Greyscale PNG media_image17.png 292 436 media_image17.png Greyscale Regarding instant claim 13, Copending ‘494 speaks to a pharmaceutical composition comprising their compounds and an acceptable carrier ( Copending ‘494 claim 13 ). Regarding instant claims 15-16, Copending ‘494 speaks to a method of treating a neurological disorder, such as Huntington’s disease, by administering their compounds ( Copending ‘494 claims 15-16 ). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5. Examiner interviews are available via telephone 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, Kortney L. Klinkel can be reached at (571) 270-5239. 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. /JACKSON J HERNANDEZ/Examiner, Art Unit 1627 /Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627 Application/Control Number: 18/030,492 Page 2 Art Unit: 1627 Application/Control Number: 18/030,492 Page 3 Art Unit: 1627 Application/Control Number: 18/030,492 Page 4 Art Unit: 1627 Application/Control Number: 18/030,492 Page 5 Art Unit: 1627 Application/Control Number: 18/030,492 Page 6 Art Unit: 1627 Application/Control Number: 18/030,492 Page 7 Art Unit: 1627 Application/Control Number: 18/030,492 Page 8 Art Unit: 1627 Application/Control Number: 18/030,492 Page 9 Art Unit: 1627 Application/Control Number: 18/030,492 Page 10 Art Unit: 1627 Application/Control Number: 18/030,492 Page 11 Art Unit: 1627 Application/Control Number: 18/030,492 Page 12 Art Unit: 1627