DETAILED ACTION
Claims 1-2, 7, 9, 12, 15, 19 and 28 are currently pending in the instant application.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/22/2026 has been entered.
Response to Amendments/Arguments
Applicant’s amendments and arguments in a response filed 03/23/2026 and 04/22/2026 have been fully considered and entered into the Application.
The declaration under 37 CFR 1.132 filed 03/23/2026 is insufficient to overcome the rejection of claims 1-2, 7, 9, 12, 15, 19 and 28 based upon nonstatutory double patenting as set forth in the last Office action because: although Applicant argues that within the declaration, compounds having RH in the ortho position on the phenyl moiety (CY) of RD have greater activity than a corresponding 4-chloro regioisomer, one of ordinary skill in the art could still readily envisage RH in the ortho position given that there are only three possibilities (ortho, meta and para) for said variables.
MPEP 804 states that Nonstatutory double patenting includes rejections based on anticipation, a one-way determination of “obviousness,” or a two-way determination of “obviousness.” It is important to note that the “obviousness” analysis for “obviousness-type” double-patenting is “similar to, but not necessarily the same as, that undertaken under 35 U.S.C. 103.” In re Braat, 937 F.2d 589, 592-93, 19 USPQ2d 1289, 1292 (Fed. Cir. 1991) (citing In re Longi, 759 F.2d 887, 892 n.4, 225 USPQ 645, 648 n.4 (Fed. Cir. 1985)); Geneva Pharmaceuticals, 349 F.3d 1373, 1378 n.1, 68 USPQ2d 1865, 1869 n.1 (Fed. Cir. 2003). In addition, nonstatutory double patenting also includes rejections based on the equitable principle against permitting an unjustified timewise extension of patent rights. See In re Schneller, 397 F.2d 350, 158 USPQ 210 (CCPA 1968); see also subsection II.B.6, below.
Although Applicant shows through the affidavit, filed 03/23/2026, that compounds having RH in the ortho position on the phenyl moiety (CY) of RD have greater activity than a corresponding 4-chloro regioisomer, the instant claims would still read on the claims of US Pat. No. 10,526,298 as more fully described below.
As a result, the double patenting rejections have been maintained.
Maintained 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 1-2, 7, 9, 12, 15, 19, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 10,526,298 (hereafter referred to as ‘298). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘298 teaches compounds of formula
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and subsequent claims are drawn to compounds that read on those of the instant claims. For example, starting with claim 3, definitions correspond to those of instant claim 1. Notably, claims 1, 3, 6, 29-30, 33-37, 39-40 and 44-47 all teach compounds having RC as Cl. Additionally, claim 30 of ‘298 teaches
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, which correspond to compounds having a F substituent on the biphenyl ring while the other substituent on the biphenyl ring is H as claims 30 depends on claim 29 which depends on claim 6 which teaches that RH is H. Further, claim 30 depends on claim 29, which is drawn to RA is -C(=O)NHSO2RB and L1 is
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. Claim 33, which depends on claim 30 teaches RC is Cl, and in the CY ring, RH is Cl, RA is C(=O)NHSO2RB, RB is CH3, L1 is
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. Although claim 33 does not specify that the RC is in the ortho position as found in the instant claims, according to MPEP 2131.02: A reference disclosure can anticipate a claim when the reference describes the limitations but ‘does not expressly spell out’ the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination. Since there are only three possibilities for the Cl in the phenyl ring (ortho, meta and para), the variables of claim 33 of ‘298 would anticipate instant claim 12,
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as all the elements of the species is taught by claim 33 of ‘298. Namely that RC is Cl, in the CY ring, RH is Cl,
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, RA is C(=O)NHSO2RB, RB is CH3, L1 is
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, RG is -CH3 in an R configuration and Ring A is
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.
Further, since claim 33 of ‘298 teaches that RA as -C(═O)NHSO2RB and in claim 1 of ‘298, RA is also taught to be tetrazolyl, -C(═O)NH2, CONHRB, C(═O)NHSO2RB or -C(═O)NHCH2CH2SO3H, it would be obvious to substitute a group such as -C(═O)NH2 for C(═O)NHSO2RB for RA to arrive at instant claims 1-2, 7, 9 12, 15 and 28.
Additionally ‘298 teaches the compounds in a pharmaceutical composition (claim 45) and in a method for treating a lysophosphatidic acid-dependent disease, which reads on instant claim 19.
Thus, the double patenting rejections have been maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAREN CHENG whose telephone number is (703)756-4699. The examiner can normally be reached M-F, 9AM-6PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached at 571-270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAREN CHENG/Primary Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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