DETAILED ACTION
This office action is in response to applicant’s filing dated February 9, 2026 and March 25, 2026.
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 Claims
Claims 248-264 and 266-289 is/are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed March 25, 2026. Acknowledgement is made of Applicant's amendment of claims 248, 266, 271, and 273; and addition of new claim 289. Claims 1-247 and 265 were previously canceled.
Applicants elected without traverse Group I, drawn to compounds and the compound of II-12:
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in the reply filed on October 17, 2024. The requirement is still deemed proper.
Compound II-12 is construed as a compound of Formula (II-Ia) wherein n is 1; R5 is hydrogen; R3 is unsubstituted alkyl (-CH3); R6a and R6b are each hydrogen; R1 is a substituted heteroaryl (pyrrole substituted with a CN); R12a and R12b are each hydrogen; R16a and R16b are each hydrogen; and
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represents a single bond.
Compound II-12 is construed as a compound of Formula (II-Ib) wherein R1 is a substituted heteroaryl (pyrrole substituted with a CN).
Compound II-12 is construed as a compound of Formula (II-Ie) wherein p is 1; m is 1; and R32 is cyano.
New claim 289 is directed to the elected invention. Thus, claim 289 is presently under examination.
Claims 251, 252, 255, 269, 270, and 276-288 remain withdrawn.
Claim 248-250, 253, 254, 256-264, 266-268, 271-275, and 289 are presently under examination as they relate to the elected species: Compound II-12
The provisional nonstatutory double patenting rejection over US Application No. 17/620,303 was withdrawn in the Office Action dated May 28, 2025.
Priority
The present application is a 371 of PCT/US2018/067277 filed on December 21, 2018, which claims benefit of US Provisional Application Nos. 62/610,069; 62/611,983; 62/620,095; 62/722,781; and 62/734,718 filed on December 22, 2017; December 29, 2017; January 22, 2018; August 24, 2018; and September 21, 2018, respectively.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, US Provisional Application No. 62/610,069, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In a review of the prior-filed application, all the disclosed compounds are of formula (I):
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The instant application requires an ethyl in the position denoted by an arrow. Thus, the prior-filed application fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for the instant claims. The effective filing date of the instant claims is December 29, 2017.
Maintained Objections and/or Rejections
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.
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 248-250, 253, 254, 256-264, 266-268, and 271-275 are rejected under 35 U.S.C. 103 as being unpatentable over Botella et al (WO 2014/169833 A1, cited in a previous Office Action).
Botella teaches 19-nor C3,3-disubstituted C21-pyrazolyl steroids of Formula (I) useful for the treatment of a variety of CNS-related conditions, for example, treatment of sleep disorders, mood disorders, schizophrenia spectrum disorders, convulsive disorders, disorders of memory and/or cognition, movement disorders, personality disorders, autism spectrum disorders, pain, traumatic brain injury, vascular diseases, substance abuse disorders and/or withdrawal syndromes, and tinnitus (Abstract). Botella teaches a compound of formula (I) (claim 1):
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wherein
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represents a single bond; R1 (which is equivalent to instantly claimed R3) is substituted or unsubstituted alkyl; the position equivalent to instantly claimed R5, R12a, R12b, R16a, and R16b are hydrogen; R4a and R4b (which are equivalent to instantly claimed R6a and R6b) are independently hydrogen; R3a is hydrogen; R3b is hydrogen; R5 and R7 include hydrogen; and R6 can be -CN (claim 1). Moreover, Botella teaches Compound SA-4 (page 122, Example 20):
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SA-4 is listed as an exemplary compound having TBPS IC50 (nM) <10 nM (Table 1). Compound SA-4 differs from the elected compound in the position denoted with an arrow. In particular, Compound SA-4 includes a hydrogen in this position, wherein the instantly elected compound contains an ethyl in this position. Botella does not explicitly teach compounds having an ethyl in this position. However, Botella also teaches Compound SB-18:
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wherein R2 is methyl (claim 42). Moreover, Botella teaches R2 can also be -CH2CH3 (claim 10). Compound SA-4 having a -CH2CH3 in position R2 would result in a positional isomer of the instantly elected compound. MPEP 2144.09 states: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and 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) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In the instant case, it would have been prima facie obvious to select Compound SA-4 as a compound to modify as Botella teaches Compound SA-4 as an exemplary compound of formula (I); to include -CH2CH3 as R2 and to produce positional isomers to arrive at the elected compound with a reasonable expectation of success. The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds such as positional isomers would possess similar activity. There would be a reasonable expectation of success in producing and using the instantly claimed compounds and compositions in view of the compounds and compositions taught by Botella.
Claims 248-250, 253, 254, 256-264, 266-268, and 271-275 are rejected under 35 U.S.C. 103 as being unpatentable over Martinez Botella et al (WO 2016/061527 A1, published April 21, 2016, cited in a previous Office Action).
Martinez Botella teaches neuroactive steroids of Formula (I) which behave as GABA modulators for inducing sedation and/or anesthesia (abstract). Botella teaches a compound of formula (I) (claim 1):
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wherein A is a heteroaryl; R2a, R2b, R3a, R3b, R4a, R4b, R7a, and R7b include hydrogen; R1 includes C1-5 alkyl; R5 includes H; and
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represents a single bond (claim 1). Moreover, Martinez Botella teaches Compound 10 (page 106, Example 6):
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Compound 10 is listed as an exemplary compound having TBPS IC50 (nM) <10 nM (Table 1). Compound 10 differs from the elected compound in the position denoted with an arrow. In particular, Compound 10 includes a methyl in this position, wherein the instantly elected compound contains an ethyl in this position. Martinez Botella does not explicitly teach compounds having an ethyl in this position. However, MPEP 2144.09 states: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and 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) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In the instant case, it would have been prima facie obvious to select Compound 10 as a compound to modify as Martinez Botella teaches Compound 10 as an exemplary compound of formula (I) and to produce homolog including an additional -CH3 to arrive at the elected compound with a reasonable expectation of success. The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds such as homologs containing an addition of a -CH3 would possess similar activity. There would be a reasonable expectation of success in producing and using the instantly claimed compounds and compositions in view of the compounds and compositions taught by Martinez Botella.
Response to Arguments
Botella I
Applicant argues:
The Examiner does not assert that any compound of Botella I renders the instant claims obvious. Instead, the Examiner alleges that Compound SA-4, Compound SB-19 (which includes a methyl and not an ethyl), and Formula (I) of Botella I render obvious an entirely new compound, Compound A, that is outside the scope of the instant claims. This new compound serves as an allegedly obvious positional isomer of claimed Compound II-12. Even assuming, arguendo, that one of ordinary skill in the art would select Compound SA-4 as a lead compound for modification, Botella I fails to suggest making the specific modifications necessary to achieve the claimed compounds. Botella I fails to provide any synthetic methods for producing an ethyl moiety at C10. In fact, all compounds and intermediates described in Botella I include a hydrogen at C10. Accordingly, the Applicant respectfully submits that the Examiner-proposed ring walking modification necessary to arrive at the claimed compounds is far from routine based on the prior art of record. The Applicant also respectfully submits that Botella I fails to provide any motivation to replace the C2 hydrogen of Compound SA-4 with an ethyl moiety and then ring-walk the resultant ethyl moiety to C10. Unlike Takeda Chem. Indus., where the prior art compound already possessed a methyl for homologation, Compound SA-4 lacks any alkyl moiety at C2.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The rejected claims do not fall into the paradigm established by the lead compound analysis. In Takeda, the court applied the lead compound analysis to a claim to a specific compound, not a genus of compounds as in instant claim 248, finding that "in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound." Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007). That is, the Takeda court was not analyzing a claim drawn to millions of compounds, like instant claim 248, but rather was analyzing a claim drawn to a compound with one specific chemical formula. Id. at 1353. Similarly, Otsuka also applied the lead compound analysis in the context of a claim to the specific compound,Ariprazole, and Daiichi to the specific compound Olmesartan, so neither decision was drawn to a genus claim of millions of compounds as in the instant fact pattern. Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1284 (Fed. Cir. 2012); Daiichi Sankyo Co., Ltd. v. Matrix Labs., Ltd., 619 F.3d 1346 (Fed. Cir. 2010). The Examiner notes that Formula (I) of Botella I:
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encompasses thousands of compounds, differing from the instantly claimed Formula (II-Ia) in that it requires a pyrazole in the position corresponding to R1, which is claimed to be a substituted or unsubstituted heteroaryl and an H instead of an ethyl at C10. However, as set forth above, Botella explicitly teaches R2 can be ethyl. As set forth above, MPEP 2144.09 states: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and 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) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In the instant case, it would have been prima facie obvious to arrive at a compound of the instant claims with a reasonable expectation of success. The Examiner further notes that it would have been prima facie obvious to one of ordinary skill in the art to arrive at the elected compound with a reasonable expectation of success in view of the disclosed modifications taught by Botella I. The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds such as positional isomers would possess similar activity. There would be a reasonable expectation of success in producing and using the instantly claimed compounds and compositions in view of the compounds and compositions taught by Botella.
Applicant argues:
Data of Table A and Table B show that homolog pairs and positional isomer groups resulted in distinct, rather than similar, biological activity profiles.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 716.02 states:
Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." It is not unexpected that differences in the compound structures disclosed have different efficacies for inhibiting TBPS or % efficacy at GABA. However, most of the compounds of Table A show similar efficacy at GABA (α1β2γ2). Similarly, compounds of Table B show different efficacies for TBPS, EC50, Emax, Q-patch, however all the compounds appear to have TBPS inhibitory function. Applicant has not provided sufficient evidence to support that the full scope of the instant compounds possess unexpected properties.
Botella II
Applicant argues:
Botella II provides that the C10 position must be substituted with a methyl moiety, not an ethyl moiety. All genera, subgenera, and exemplified compound species described in Botella II possess a C10 position substituted with a methyl moiety. Thus, the Botella II disclosure teaches an ordinarily skilled artisan away from modifying the C10 position with the β-ethyl moiety that the instantly claimed compounds possess. The Examiner's selection of Compound 10 of Botella II for further modification appears to rest on its TBPS binding activity (an IC50 < 10 nM). However, Botella II discloses more than 250 exemplified compounds, over 40 of which exhibit an IC5o < 10 nM. For this reason, TBPS binding activity alone cannot serve as the basis for selecting Compound 10 as a starting point for further medication.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
The rejected claims do not fall into the paradigm established by the lead compound analysis. In Takeda, the court applied the lead compound analysis to a claim to a specific compound, not a genus of compounds as in instant claim 248, finding that "in cases involving new chemical compounds, it remains necessary to identify some reason that would have led a chemist to modify a known compound in a particular manner to establish prima facie obviousness of a new claimed compound." Takeda Chemical Industries, Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350, 1357 (Fed. Cir. 2007). That is, the Takeda court was not analyzing a claim drawn to millions of compounds, like instant claim 248, but rather was analyzing a claim drawn to a compound with one specific chemical formula. Id. at 1353. Similarly, Otsuka also applied
the lead compound analysis in the context of a claim to the specific compound, Ariprazole, and Daiichi to the specific compound Olmesartan, so neither decision was drawn to a genus claim of millions of compounds as in the instant fact pattern. Otsuka Pharm. Co., Ltd. v. Sandoz, Inc., 678 F.3d 1280, 1284 (Fed. Cir. 2012); Daiichi Sankyo Co., Ltd. v. Matrix Labs., Ltd.,
619 F.3d 1346 (Fed. Cir. 2010). The Examiner notes that Formula (I) of Martinez Botella:
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encompasses thousands of compounds, differing from the instantly claimed Formula (I) in
that it requires a pyrazole in the position corresponding to R1, which is claimed to be a
substituted or unsubstituted heteroaryl and an H instead of an ethyl at C10. However, as set
forth above, Martinez Botella explicitly teaches R2 can be ethyl. As set forth above, MPEP 2144.09 states:
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and 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) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In the instant case, it would have been prima facie obvious to arrive at a compound of the instant claims with a reasonable expectation of success. The Examiner further notes that it would have been prima facie obvious to one of ordinary skill in the art to arrive at the elected compound with a reasonable expectation of success in view of the disclosed modifications taught by Martinez Botella. The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds such as positional isomers would possess similar activity. There would be a reasonable expectation of success in producing and using the instantly claimed compounds and compositions in view of the compounds and compositions taught by Martinez Botella.
Applicant argues:
Botella II fails to suggest making the specific modifications necessary to generate Compound II-12 or any other of the compounds recited in the pending independent claims. Botella II describes only compounds possessing a C10 position substituted with methyl, Botella II necessarily fails to provide any synthetic processes for producing a compound including a C10 ethyl substituent. As set forth above, Table A provides data that evidences the unpredictability associated with homologation of Ring A substituents. That homologation of the C3 position of Ring A can have a deleterious effect on TBPS binding activity.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
MPEP 716.02 states:
Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." It is not unexpected that differences in the compound structures disclosed have different efficacies for inhibiting TBPS or % efficacy at GABA. However, most of the compounds of Table A show similar efficacy at GABA (α1β2γ2). Applicant has not provided sufficient evidence to support that the full scope of the instant compounds possess unexpected properties.
Moreover, MPEP 716.02(e) states:
Applicant must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). In the instant case, as set forth above, Martinez Botella teaches Compound 10 (page 106, Example 6):
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Compound 10 differs from the elected compound in the position denoted with an arrow. In particular, Compound 10 includes a methyl in this position, wherein the instantly elected compound contains an ethyl in this position. Thus, Compound 10 is considered the closes prior art. Applicant has not provided sufficient evidence to support unexpected properties compared to the closest prior art.
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 248-250, 253, 254, 256-264, 266-268 and 271-275 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 12,065,463. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a compound of Formula (II-Ia):
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wherein R1 is a substituted or unsubstituted heteroaryl, including the elected compound:
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.
The previously allowed claims are directed to a compound of formula:
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The previously allowed compound differs in the position denoted by an arrow. In particular, the previously allowed compound includes a methyl in this position, wherein the instantly elected compound contains an ethyl in this position.
MPEP 2144.09 states: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and 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) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). In the instant case, it would have been prima facie obvious to modify the compound of the copending claims to produce a homolog including an additional -CH3 to arrive at the elected compound with a reasonable expectation of success. The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds such as homologs containing an addition of a -CH3 would possess similar activity. There would be a reasonable expectation of success in producing and using the instantly claimed compounds and compositions in view of the compounds and compositions of the previously allowed claims.
Response to Arguments
Applicant argues:
Because the compound of the '463 Patent and Compound 10 of Botella II are similar, but for the stereochemistry of the C5 hydrogen, the Applicant respectfully submits that the arguments set forth above in respect of Botella II apply mutatis mutandis to this nonstatutory double patenting rejection. In other words, the pending claims are patentably distinct from the claims of the '463 Patent at least because one of ordinary skill in the art would not modify the compound of the '463 Patent to arrive at a compound of the instant claims.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicant has not independently argued the merits of this rejection. Arguments regarding Botella II have been addressed above. Therefore, the rejection is maintained for the reasons set forth on the record and for those set forth in the response to the arguments above.
Conclusion
Claims 248-250, 253, 254, 256-264, 266-268 and 271-275 are rejected.
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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