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 1, 5-24, 26-27, and 33-36 are pending in the instant application.
Claims 2-4, 25, and 28-32 have been canceled.
Claims 33-36 stand withdrawn from consideration.
Withdrawn Rejections/Objections
Applicant’s amendment is sufficient to overcome the rejection of Claims 1-27 under 35 U.S.C. 112(a). Claims 2-4 and 25 have been canceled, rendering the rejection thereof moot. This rejection is hereby withdrawn.
Applicant has canceled claim 2, rendering the rejection thereof under 35 U.S.C. 112(b) moot. This rejection is hereby withdrawn.
Applicant’s amendment is sufficient to overcome the rejection of Claim 24 under 35 U.S.C. 112(b). This rejection is hereby withdrawn.
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.
The provisional rejection of Claims 1, 5, and 7-8 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/279,379 (reference application) is maintained.
Applicant has traversed this rejection at Page 18 of the remarks filed November 12th, 2025 on the grounds that the claims at issue being drawn to an overlapping set of compounds is not a legally sufficient rationale for supporting nonstatutory double patenting, that differences in the claims have not been explained as to how they would have been obvious to a person of ordinary skill in the art, and cites 2144.08, II: “The fact that a claimed species or subgenus is encompassed by a prior art genus is not sufficient by itself to establish a prima facie case of obviousness. In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994) ("The fact that a claimed compound may be encompassed by a disclosed generic formula does not by itself render that compound obvious."); In re Jones, 958 F.2d 347, 350, 21 USPQ2d 1941, 1943 (Fed. Cir. 1992) (Federal Circuit has "decline[d] to extract from Merck [& Co. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989)] the rule that... regardless of how broad, a disclosure of a chemical genus renders obvious any species that happens to fall within it.").”
The examiner does not find this argument persuasive. First, the examiner notes that the MPEP section cited by the Applicant refers to establishing obvious to support a rejection under 35 U.S.C. 103. In the rationale described in the non-final rejection mailed May 16th, 2025, beginning at Page 10, the instant claims are not rejected due to being obvious over the copending claims, but rather for being anticipated by the claims. As noted above, 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).
As noted in the non-final rejection, Claim 1 of the reference application and instant Claims 1, 5, and 7-8 are drawn to an overlapping set of compounds. Therefore, the instant claims are anticipated by compounds that meet the limitations of Claim 1 of the reference application. For clarity of the record, a detailed explanation of such an overlapping set of compounds as noted in the non-final rejection mailed on May 16th, 2025, beginning at Page 10 is restated here:
Claim 1 of the reference application is drawn to a compound of formula (II), wherein formula (II) is:
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Based on the definitions of the variables thereof, substantial overlap exists between compounds of formula (II) in the reference application and compounds of formula (I) in the instant application.
When m and n are defined as 0 in both the reference application and instant application, defining formula (I) variables such that Y is O, L1 and L2 is -L3-L4-, wherein L3 is C6-cycloalkyl and L4 is absent, R9a becomes analogous to R1, and each of these variables can be 5, 6, 9, or 10-membered heteroaryl.
R2 in the instant application is then analogous to R3 in the reference application. Each of these can be H, C1-6-alkyl, C1-6-haloalkyl, or halo.
To this end, both the instant application and reference application are drawn to a mutual set of compounds. In other words, defining the variables in the instant application and reference application as noted above results in compounds that read on both instant Claims 1, 5, and 7-8 and Claim 1 of the reference application, and therefore these claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Analogously, the provisional rejection of Claims 1, 5, and 7-8 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/279,377 (reference application) is maintained.
Applicant has traversed this rejection for the same reasons as noted above for the rejection over copending Application No. 18/279,379.
For the same reasons as noted above, this argument is not persuasive.
As noted in the non-final rejection, Claim 1 of the reference application and instant Claims 1, 5, and 7-8 are drawn to an overlapping set of compounds. Therefore, the instant claims are anticipated by compounds that meet the limitations of Claim 1 of the reference application. For clarity of the record, a detailed explanation of such an overlapping set of compounds as noted in the non-final rejection mailed on May 16th, 2025, beginning at Page 11 is restated here:
Claim 1 of the reference application is drawn to a compound of formula (I), wherein formula (I) is:
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Based on the definitions of the variables thereof, substantial overlap exists between compounds of formula (I) in the reference application and compounds of formula (I) in the instant application.
Defining Y in the instantly claimed formula (I) as O, L1 and L2 is -L3-L4-, wherein L3 is C6-cycloalkyl and L4 is absent, R9a becomes analogous to R1b in the reference application formula (I) when R1a is defined as hydrogen, and each of R9a and R1a can be phenyl, naphthyl, a 5, 6, 9, or 10 membered heteroaryl, or a 3-to-8 membered heterocycloalkyl.
R2 in the reference application is then analogous to R3 in the instant application. Each of the definitions of the variable R3 in the instantly claimed formula (I) are allowed variables for R2 in the reference application.
In each formula, m can be defined as 0, 1, 2, or 3.
R3 in the reference application is then analogous to R2 in the instant application. In each application, these variables can be defined as H, C1-6-alkyl, C1-C6-haloalkyl, and halo.
R4 in the reference application is then analogous to R1 in the instant application. Each of these are defined as either C1-C6-alkyl or C1-C6-haloalkyl.
In each formula, n can be defined as 0, 1, 2, or 3.
To this end, both the instant application and reference application are drawn to a mutual set of compounds. In other words, defining the variables in the instant application and reference application as noted above results in compounds that read on both instant Claims 1, 5, and 7-8 and Claim 1 of the reference application, and therefore these claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant should note that despite the provisional nonstatutory double patenting rejections remaining the only rejections of record in this office action, they cannot be withdrawn, as this would require rejoinder of the withdrawn method claims 33-36, which require further consideration for compliance under 35 U.S.C. 112. Therefore, a rejection raised over any of the withdrawn method Claims 33-36 under 35 U.S.C. 112(a) for lack of enablement and/or written description, for example, requires maintaining the above nonstatutory double patenting rejections until, as these rejections would no longer be the only rejections of record.
Allowable Subject Matter
Claims 6, 9-24, and 26-27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 5, and 7-8 are rejected.
Claims 6, 9-24, and 26-27 are objected to.
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 DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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