FINAL REJECTION
Receipt is acknowledged of Applicants' Amendments and Remarks, filed Aug. 19, 2026.
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The rejections and/or objections set forth below are either maintained or newly applied, and constitute the complete set presently applied to the instant claims.
STATUS OF THE CLAIMS
Claims 14 and 17-22 have been canceled.
Claims 1-6, 10, and 11 have been amended to incorporate the limitations of canceled claim 14 and thus incorporate no new matter.
Claim 9 has been amended to correct a typographical error.
No new claims have been added.
Thus, claims 1-13, 15, and 16 now represent all claims currently pending and under consideration.
INFORMATION DISCLOSURE STATEMENT
The information disclosure statement (IDS) submitted on Aug. 19, 2026 was filed after the mailing date of the non-final action on May 20, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
MAINTAINED REJECTIONS
The following rejections are maintained from the previous Office Action dated May 20, 2026, on the ground that the references cited therein continue to read on the limitations of the amended claims.
Obviousness-Type Double Patenting
Claim 1 stands provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 53 of copending Application No. 18/393,940 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim would anticipate the examined claim.
Reference claim 53 is drawn to methods of treating interstitial lung disease in a subject in need thereof, the method comprising administering an LPA1 antagonist to the subject at one or more daily dosages lower than the standard daily dosage during a dose titration period of treatment then increasing the daily dosage to the standard daily dosage of the LPA1 antagonist,
wherein the standard daily dosage is about 120 mg/day of Compound A (BMS-986278) or an equivalent amount of a pharmaceutically acceptable salt thereof;
wherein Compound A comprises the identical crystal form of Compound A recited by examined claim 1.
Because reference claim 53 depends from reference claim 47, which in turn depends from reference claim 1, reference claim 53 encompasses the step of administering the identical crystal form of Compound A to a subject in need thereof at a dosage of about 120 mg/day, as recited by examined claim 1.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 54 and 62 of copending Application No. 18/394,402 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would be prima facie obvious over the reference claims.
Reference claim 54 is drawn to a method of treating interstitial lung disease in a subject in need thereof comprising administering to a subject in need thereof Compound A, or a pharmaceutically acceptable salt thereof, to the subject at one or more daily dosages lower than the standard daily dosage during a dose titration period of treatment then increasing the daily dosage to the standard daily dosage of Compound A,
wherein the standard daily dosage of is about 240 mg/day of Compound A or an equivalent amount of a pharmaceutically acceptable salt thereof;
wherein Compound A comprises the identical crystal form of Compound A recited by examined claim 1.
Reference claim 62 is drawn to a method of treating interstitial lung disease, the method comprising administering to a subject in need thereof about 240 mg/day of Compound A, or an equivalent amount of a pharmaceutically acceptable salt thereof,
wherein Compound A comprises the identical crystal form of Compound A recited by examined claim 1.
The reference claims differ from the examined claims in that the dosage of Compound A is 240 mg/day rather than 120 mg/day as recited by examined claim 1.
However, it would have been predictable to an ordinarily skilled clinician as of the filing date to optimize the amounts and dosages of Compound A to arrive at a dose of 120 mg/day as recited by the examined claims by routine experimentation, because it lies within the prior art range, and the prior art already recognizes the dose as a result-effective variable: higher or lower doses of Compound A were known to affect efficacy, safety, and pharmacokinetics.
As recognized by MPEP § 2144.05,
Generally, differences in concentration or tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO ARGUMENTS
Applicant's arguments filed Aug. 19, 2026 have been fully considered but they are not persuasive.
With respect to the rejection under 35 U.S.C. § 112(b), Applicant contends that the rejection is overcome because the terms “substantially the same as” and “substantially similar to” are no longer recited by the amended claims (Remarks, p. 5).
However, the amended claims continue to improperly refer to an external figure.
This rejection was applied to claim 14 in the non-final action dated May 20, 2026. Because the limitations of claim 14 are now incorporated into claim 1, and claim 14 is now canceled, this rejection is withdrawn as to canceled claim 14, and is newly applied to amended claims 1-13, 15, and 16, as set forth below.
With respect to the provisional rejections on the ground of obviousness-type double patenting, Applicant requests that these rejections be held in abeyance until allowable subject matter has been indicated (Remarks, p. 7).
However, because the newly amended claims remain rejected on other grounds, the obviousness-type double patenting rejections are maintained.
NEW REJECTIONS
Claim Rejections - 35 USC § 112(b) – Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13, 15, and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, amended claim 1 recites the crystalline polymorph of Compound A, characterized by at least one of the following conditions (a)-(g), including:
b) a powder x-ray diffraction pattern in accordance with the pattern shown in FIG. 1;
e) a differential scanning calorimetry thermogram as shown in FIG. 2;
and/or
g) a thermal gravimetric analysis thermogram as shown in FIG. 3.
However, the claims are to be complete in themselves. As recognized by MPEP § 2173.05(s), incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant's convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). Therefore, a claim which refers to an external figure or table renders the metes and bounds of the claim indefinite.
This rejection can be overcome by amending the claims to omit any reference to external figures, as in parts (b), (e), and (g) of claim 1.
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, 12, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 of copending Application No. 19/142,320 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the examined claims would be prima facie obvious over the reference claims.
Reference claims 15-17 are drawn to a method for treating interstitial lung disease in a subject in need thereof, comprising administering to the subject the identical crystalline form of Compound A recited by examined claim 1;
wherein the interstitial lung disease is idiopathic pulmonary fibrosis (IPF), as recited by examined claim 12; or progressive pulmonary fibrosis (PPF), as recited by examined claim 13.
The reference claims differ from the examined claims in that the dosage of Compound A is not specified, rather than 120 mg/day as recited by examined claim 1.
However, it would have been predictable to an ordinarily skilled clinician as of the filing date to optimize the amounts and dosages of Compound A to arrive at a dose of 120 mg/day as recited by the examined claims by routine experimentation, because it lies within the prior art range, and the prior art already recognizes the dose as a result-effective variable: higher or lower doses of Compound A were known to affect efficacy, safety, and pharmacokinetics.
As recognized by MPEP § 2144.05,
Generally, differences in concentration or tempera-ture will not support the patentability of subject mat-ter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
CONCLUSION
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
CORRESPONDENCE
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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