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 .
Priority
This application is a national stage entry of PCT/EP2019/070312 filed on 07/29/2019 which claims benefit of U.S. Provisional Application No. 62/712,439 filed on 07/31/2018.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 14, 2026 has been entered.
Response to Amendment
By Applicant’s amendment filed on May 14, 2026, claims 1, 6 and 24 have been amended. Claims 2-5, 7-9, 29 and 30 were previously cancelled. Claims 6, 12-23 and 26-28 and 31-36 are withdrawn.
Claims 1, 10-11, 24 and 25 are being examined as they read on the elected species.
Response to Arguments
Applicant's arguments filed May 14, 2026 have been fully considered but they are not persuasive.
Applicant argues that the compounds disclosed in Sherer are distinct from the claimed compounds, and the fact that a claimed species or subgenus may be encompassed by a prior art genus is not sufficient by itself to establish a prima facie case of obviousness. Applicant argues that one must make multiple selections from the disclosure of Sherer to arrive at the instant compounds. Applicant argues that the Examiner relies on the compound numbers 553-567 as supplying the motivation for the suggested combinations, but that Sherer does not provide a motivation to look to compound numbers 553-567 from among the other disclosed compounds, nor does Sherer provide a motivation to modify the compounds in the particular way to arrive at the claimed compounds. Applicant argues that Sherer does not teach preferred compounds and provides no motivation to select a lead compound and modify it to arrive at the claimed compounds. Applicant further argues that Sherer does not teach any preference for -OMe as an R1 substituent. Thus Applicant argues that there is no motivation to arrive at a compound as claimed based on the teachings of Sherer.
These arguments are found not persuasive since claim 1 of the instant application claims a compound of formula I-a
PNG
media_image1.png
194
196
media_image1.png
Greyscale
wherein R1 is selected as CF3 or OMe; each R4 and R5 is independently -H, -R, halogen, -haloalkyl, -OR, -SR, -CN, -NO2, -SO2R, -SOR, -C(O)R, -CO2R, -C(O)N(R)2, -NRC(O)R, -NRC(O)N(R)2, -NRSO2R, or -N(R)2. Thus the claims of the instant application are drawn to a subgenus fully disclosed in Sherer.
Sherer et al. teaches a compound of formula I-b
PNG
media_image2.png
192
200
media_image2.png
Greyscale
wherein ring A is
PNG
media_image3.png
130
130
media_image3.png
Greyscale
X is CH2; R1 is -CF3 or -OMe, each R4 and R5 is the same as claimed in the instant claims which is independently -H, -R, halogen, -haloalkyl, -OR, -SR, -CN, -NO2, -SO2R, -SOR, -C(O)R, -CO2R, -C(O)N(R)2, -NRC(O)R, -NRC(O)N(R)2, -NRSO2R, or -N(R)2 , n and p may be 0 ([0066], [0069]-[0071], [0075]-[0076], [0090], [0108] and [0128]). Sherer et al. specifically exemplify compounds having the same core structure as the compounds claimed in the instant claims (see Table 1 compound numbers 553-567). Based on the teachings of Sherer et al., a person of ordinary skill in the art would have been motivated to selected any of the compounds disclosed therein with a reasonable expectation of similar success including compounds 553-567 which are taught as being very potent compounds (page 345). The only difference between said compounds 553-567 of Sherer et al. and the claimed compounds is the R1 substituent. However, Sherer et al. specifically teaches throughout that in certain embodiments R1 can be selected as -CF3 or -OMe [0084]-[0085].
Applicant’s elected species has the following structure:
PNG
media_image4.png
182
133
media_image4.png
Greyscale
. Sherer et al. specifically discloses compound 553
PNG
media_image5.png
222
190
media_image5.png
Greyscale
on page 167.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and/or similar utilities. “An obviousness rejection based on similarity in chemical structure and/or function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1991).
In the instant case, Sherer specifically teaches that in the place of methyl, R1 may be selected as -H, -CHF2, -CF3, -OMe or -CN [0066]. These teachings of Sherer provide the requisite motivation to make the claimed elected species compound with the expectation that these compounds similar in structure will have similar properties and given the teachings that R1 is variable and can be selected as OMe instead of Me.
Thus even though Sherer discloses alternatives for R1, a prima facie case of obviousness can still be established since picking one of a finite number of known solutions to a known problem is prima facie obvious. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007).
Accordingly, prior to the effective filing date of the instant claims, it would have been obvious to a person of ordinary skill in the art to substitute -OMe for the methyl group for R1 in the above compound with a reasonable expectation of success since Sherer et al. specifically teaches that -OMe is a suitable substituent for R1. Therefore, a person of ordinary skill in the art would have been motivated to prepare compound 553 of Sherer et al. by substituting the R1 position with -OMe to arrive at a compound as claimed.
It must be remembered that "[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect ....the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have selected the various combinations of features claimed from within the prior art disclosure to arrive at the instantly claimed subject matter.
Applicant’s argument that one must make multiple selections from the disclosure of Sherer to arrive at the instant compounds is found not persuasive since as detailed above, Sherer specifically discloses compound 553 which differs only in the R1 substituent. Moreover as detailed above, Sherer discloses other compounds falling within the genus of claimed compounds of instant claim 1 (see Table 1 compound numbers 553-567).
With respect to Applicant’s lead compound analysis, the rejected claims do not fall into the paradigm established by the lead compound analysis. Otsuka applied the lead compound analysis in the context of a claim to the specific compound, Ariprazole and was not drawn to a genus claim of thousands of compounds as in the instant fact pattern. Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1284 (Fed. Cir. 2012). Unlike Otsuka’s claim to a schizophrenia treating composition, the instant rejected claims do not encompass any particular “pertinent properties” or functional requirements nor is the formulation in claim 25 directed to any particular disease. Therefore, even the attempt to apply the lead compound analysis fails because the claims lack one specific activity or function to serve as the target for optimization using a lead compound. See Takeda, 492 F.3d 1353; Otsuka, 678 F.3d at 1285; and Daiichi, 619 F.3d at 1347.
Therefore, the lead compound analysis is inappropriate and rejected in favor of a fact pattern for which the analysis is appropriate. See KSR. Intern. Col. v. Teleflex Inc.,550 US 398, 419 (2007). In addition, as detailed above, consistent with Dillon, the Examiner has identified compound 553 of Sherer as a species structurally similar to the claimed genus of compounds, differing only in the R1 group. The Examiner further recognizes that Sherer suggests generic structures which teach the placement of substituents including -OMe substituents at that position. In response, Applicant has provided no evidence of secondary considerations. Thus, Applicant’s arguments are found not persuasive.
Thus, for reasons of record and for the reasons detailed above, the previous rejection under 35 USC 103 is hereby maintained and reproduced below.
With respect to the double patenting rejections, Applicant argues that the instant claims are non-obvious over, and are patentably distinct from, the claims of the '134 patent and the claims of the co-pending '917 application for at least the reasons discussed above and the double patenting rejections should therefore be withdrawn.
These arguments are found not persuasive for the same reasons as detailed above. Patent ‘134 specifically claims compound 553 and furthermore teaches that R1 may be selected as methyl or -OMe. Thus substituting -OMe for methyl for compound 553 to arrive at the claimed elected species is prima facie obvious for the same reasons as detailed above. In addition, the compounds as claimed are drawn to a subgenus that is fully disclosed in the claims of copending ‘917. Thus Applicant’s arguments are found not persuasive for the same reasons as detailed above.
Accordingly, the previous double patenting rejections are hereby maintained and reproduced below.
This action is FINAL.
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, 10-11, 24 and 25 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 10-11 of U.S. Patent No. 11,629,134 B2 (Provided on IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of ‘134 are drawn to compounds having the following structure
PNG
media_image1.png
194
196
media_image1.png
Greyscale
wherein R1 may be selected as -OMe or -CF3 as a suitable alternative for -CH3.
Thus the cited claims of the instant application would be rendered obvious over the cited claims of ‘134.
Claims 1, 10-11, 24 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/923,917 (U.S. Publication No. 2025/0059157 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the cited claims of the instant application and the cited claims of copending ‘917 are drawn to the same compounds.
Thus the cited claims of the instant application would be anticipated over the cited claims of copending ‘917.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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.
Claims 1, 10-11, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Sherer et al. U.S. Publication No. 2017/0174653 A1 (Provided on IDS).
Claims 1, 10-11, 24 and 25 of the instant application claim a compound for formula I such as
PNG
media_image4.png
182
133
media_image4.png
Greyscale
(example 151).
Sherer et al. teaches compounds of formula (I)
PNG
media_image6.png
210
207
media_image6.png
Greyscale
[0006] and [0063]-[0126]. Sherer et al. specifically discloses compound 553
PNG
media_image5.png
222
190
media_image5.png
Greyscale
(page 167). Sherer et al. further teaches compositions comprising said compounds and a pharmaceutically acceptable carrier [0143]-[0157].
Sherer et al. does not specifically exemplify the compound as detailed above.
However, Sherer et al. specifically teaches compound 553:
PNG
media_image5.png
222
190
media_image5.png
Greyscale
(page 167). Sherer et al. further teaches exemplary compounds of formula I
PNG
media_image6.png
210
207
media_image6.png
Greyscale
are wherein R1 is -H, -CHF2, -CF3, -OMe or -CN [0066].
Accordingly, prior to the effective filing date of the instant claims, it would have been obvious to a person of ordinary skill in the art to substitute -OMe for the methyl group for R1 in the above compound with a reasonable expectation of success since Sherer et al. specifically teaches that -OMe is a preferred substituent for R1. Therefore, a person of ordinary skill in the art would have been motivated to prepare compound 553 of Sherer et al. by substituting the R1 position with -OMe to arrive at the compound as disclosed in the instant application.
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 6, 12-23, 26-28, 31-36 are withdrawn. Claims 2-5, 7-9 and 29-30 are cancelled. Claims 1, 10-11, 24 and 25 are rejected. No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 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, Adam C. Milligan can be reached on (571)270-7674. 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.
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
Prosecution Insights