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 .
DETAILED ACTION
Claims 1-2, 7-8, 13, 18-20, 24-25, 30-31, 36-38, 40, 45-55 and 58-59 are pending and are under consideration in the instant office action.
Election/Restrictions
Applicant’s election without traverse of the following species in their response dated 05/26/2026 is acknowledged.
Specie 1: Compound: A with the following structure
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Examination of the claims are conducted to the extent they read on the elected species..
Claims 1-2, 7-8, 13, 18-20, 24-25, 30-31, 36-38, 40, 45-55 and 58-59 are under examination and the requirement for restriction is made final.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/02/2024 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims the priority benefit of U.S. Provisional Application No.
63/476,995, filed December 23, 2022, and U.S. Provisional Application No. 63/519,703, filed August 15, 2023
Claim Rejections - 35 USC § 112
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.
Claim 53 is 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, claim 52 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 substantially the same as shown in FIG. 1;
e) a differential scanning calorimetry thermogram substantially similar to the one as shown in FIG. 2; and/or
g) a thermal gravimetric analysis thermogram substantially similar to the one as shown in FIG. 3.
However, the terms "substantially the same as" and "substantially similar to" are relative terms which render the claim indefinite. These terms are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
In addition, 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.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2, 7-8, 13, 18-20, 24-25, 30-31, 36-38, 40, 45-55 and 58-59 are rejected under 35 U.S.C. 103(a) as being unpatentable over Cheng et al. (USPN 10,576,062) and Tirucheria et al. (European Respiratory Journal, 1, 2019, XP093151699) in view of Corte et al. (BMJ, Open Resp Res, 2021, pages 1-9) (All References cited in IDS dated 07/02/2024).
Instant claims are drawn to a method of treating interstitial lung disease in a subject in need thereof, the method comprising administering an LPA1 antagonist to the subject at a daily dosage lower than the standard daily dosage during an initial period of treatment, followed by administering the dosage at a daily dosage higher than the initial period but lower than the standard daily dosage for a second period of treatment, then increasing the dosage to the standard daily dosage of the LPA1 antagonist, wherein the LPA1 antagonist is the following compound A:
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Cheng et al. disclose and claim a method of treating idiopathic pulmonary fibrosis (IPF) in a mammal comprising administering a therapeutically effective amount of a compound, or a stereoisomer or pharmaceutically acceptable salt thereof, to the mammal in need thereof, wherein the compound is instantly claimed compound of formula A shown above. The compounds of Cheng et al. are disclosed to be administered to the mammal every 24 hours, i.e., once daily; or every 12 hours, i.e., twice daily (col. 72, lines 47-62). The compounds of Cheng et al. are disclosed to be formulated in compositions for oral administration (col. 72, lines 26-27), as recited by claim 5; e.g., as a tablet (col. 69, lines 43-48. The compounds of Cheng et al. are disclosed for administration to a patient that is already being administered one or more additional therapeutically active agents (i.e., concomitantly), e.g., pirfenidone or nintedanib (col. 70, lines 10-33).
Tirucherai et al. disclose that the claimed compound, BMS-986278, is a potent LPA1 receptor antagonist being investigated for the treatment of IPF (abstract). Following dose escalation studies evaluating the safety, tolerability, and PK of oral BMS-986278 in healthy subjects, Tirucherai et al. report that doses of 30-150 mg were generally well tolerated, and can be administered with or without food (conclusion),
Regarding claims 45-46, the instant specification evidences that, "[b]ecause of the clinical and pathophysiological similarities among IPF and other forms of progressive pulmonary fibrosis (PPF), it has been suggested that such disorders have a common pathobiologic mechanism regardless of the cause, with resultant progressive lung fibrosis, and thus [PPF] could have a similar response to treatment as IPF. Furthermore, the IMPULSIS and INBUILD trials demonstrated that IPF and PPF patients were similar with respect to their rate of FVC decline" (para. [0005]). Therefore, an ordinarily skilled clinician would reasonably expect the claimed compound, BMS-986278, to have similar efficacy in patients with idiopathic pulmonary fibrosis (IPF) and with progressive pulmonary fibrosis (PPF).
Cheng et al. and Tirucherai et al. fails to disclose the instantly claimed dosage titration in a subject where there is a initial dose , second dosage and a third dosage of compound A at different concentrations.
However, Corte et al. teaches (BMS-986278) for use in treating IPF and various ILDs, administrated at different doses and dosing regimens than the instant claims. It would be considered routine practice to titrate doses of active agents, multiple dosages, adjust dosages to be lower/higher dependent on patient response, including the daily dosage, frequency, number of days, and any combination thereof, etc. Additional therapies (instant claim 40) is taught in Corte et al, pg. 2, col. 2, para 2. Regarding the dosages and administration frequency in the claims, (taught on p. 64), see MPEP as follows: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Applicants can rebut a prima facie case of obviousness based on ranges by showing the criticality of the claimed range and regimen. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 716.02 - § 716.02(g) for a discussion of criticality and unexpected results. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Further see MPEP 2144.05.I: I. OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1- 5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms].' The court stated that "by stating that "suitable protection' is provided if the protective layer is 'about' 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant's] claimed range.") Absent any evidence demonstrating a patentable difference between the methods and the criticality of the claimed amounts with the overlapping ranges, the determination of the optimum or workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan.
Regarding claims 54-55 and 58 the cited references do not explicitly disclose that administration of the claimed compound, BMS-986278, to treat interstitial lung diseases, results in the subject experiencing: a smaller decline in forced vital capacity (FVC) after a treatment period compared to an untreated subject, as recited by claim 15; or a greater time to first disease progression event after a treatment period than an untreated subject, wherein the event is selected from: absolute predicted forced vital capacity (ppFVC) decline of ≥10% from baseline; acute exacerbation of lung fibrosis; lung fibrosis-related hospitalization; and all-cause mortality or that the improvement comprising: reducing the incidence of cardiovascular adverse events in the subject. However, first by disclosing the oral administration of a therapeutically effective amount of BMS-986278 to a patient in need of treatment for interstitial lung diseases, the concomitant results, , are inherent in the methods of Cheng et al., even if those effects or results were not recognized. While the references above do not show a specific recognition of these results, their discovery is tantamount only to identifying physiological effects intrinsic in carrying out an old method. Because the cited references disclose methods of administering the same compounds to treat the same conditions in the same patient population, the results or effects experienced by the subject of the claimed methods are inherent in the methods taught by the references above. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is also noted that, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430,433 (CCPA 1977). See also MPEP § 2112.01 with regard to inherency and product-by-process claims. In addition,. It is also noted that “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Accordingly, the references above explicitly shows that method of treating idiopathic pulmonary fibrosis (IPF) in a mammal comprising administering a therapeutically effective amount of a compound A instantly claimed . As recited above optimization of concentrations of the agents and the treatment regimen with guidance provided by Cheng et al,. Tirucheria et al. and Corte et al. would be obvious and routine to one of ordinary skill in the art.. As such a person of ordinary skill in the art would be imbued with a reasonable expectation of success in treating Interstitial lung disease with the optimized regimen which includes the instantly claimed method with the instantly claimed compound, absence of evidence to the contrary.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process may obtain a patent therefor " (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller V. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-2, 7-8, 13, 18-20, 24-25, 30-31, 36-38, 40, 45-55 and 58-59 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1-66 of copending Application No. 19/142,31 (‘311). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Non-statutory 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/applving-online/eteminal-disclaimen
Claims 1-2, 7-8, 13, 18-20, 24-25, 30-31, 36-38, 40, 45-55, and 58-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-8, 13, 18-19, 24-25, 30-31, 40, 47-48, 50, 52, 54-56, 62, 68, and 75-77 of copending Application No. 18/394.402 (‘402) and claims 1-79 of copending Application No 19/142.317 (’317)
Although the claims at issue are not identical, they are not patentably distinct from each other because claims the claims of ‘402 and ‘317 anticipates the instant claims.
Instant claims are drawn to a method of treating interstitial lung disease in a subject in need thereof, the method comprising administering an LPA1 antagonist to the subject at a daily dosage lower than the standard daily dosage during an initial period of treatment, followed by administering the dosage at a daily dosage higher than the initial period but lower than the standard daily dosage for a second period of treatment, then increasing the dosage to the standard daily dosage of the LPA1 antagonist.
Claims of ‘402 and ‘317 are drawn to a method of treating interstitial lung disease in a subject in need thereof, the method comprising administering to a subject in need thereof Compound A:
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Or a pharmaceutically acceptable salt thereof, to the subject at a daily dosage lower than the standard daily dosage during an initial period of treatment, than increasing the daily dosage to the standard daily dosage of Compound A, wherein the standard daily dosage is about 242 mg/day of Compound A or an equivalent amount of the pharmaceutically acceptable salt thereof.
The specific compound A claimed in the method of ‘402 and ‘317 is a specie of the genus of LPA1 antagonist claimed in the instantly claimed method. . Therefore subject matter disclosed in claims instant claims of the instant application is fully taught in the claims of ‘402 and ‘317 and hence anticipates the instant claims
Instant claims does not recite the specific concentration claimed in ‘402 and ‘317 However, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Applicants can rebut a prima facie case of obviousness based on ranges by showing the criticality of the claimed ranges.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 7-8, 13, 18-20, 24-25, 30-31, 36-38, 40, 45-55, and 58-59 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/394.005 (‘005) and claims 1-18 of copending Application No 19/142.304 (’304) in view of Corte et al. (BMJ, Open Resp Res, 2021, pages 1-9) ( Reference cited in IDS dated 07/02/2024)
Although the claims at issue are not identical, they are not patentably distinct from each other because claims the claims of ‘005 and ‘304 render obvious the instant claims.
Instant claims are drawn to a method of treating interstitial lung disease in a subject in need thereof, the method comprising administering an LPA1 antagonist to the subject at a daily dosage lower than the standard daily dosage during an initial period of treatment, followed by administering the dosage at a daily dosage higher than the initial period but lower than the standard daily dosage for a second period of treatment, then increasing the dosage to the standard daily dosage of the LPA1 antagonist.
Claims of ‘005 and ‘304 are drawn to a method of treating interstitial lung disease in a subject in need thereof, the method comprising administering to a subject in need thereof 120 mg/day of Compound A:
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Or a pharmaceutically acceptable salt thereof.
The specific compound A claimed in the method of ‘005 and ‘304 is a specie of the genus of LPA1 antagonist claimed in the instantly claimed method. . Therefore subject matter disclosed in cl instant claims of the instant application is fully taught in the claims of ‘005 and ‘304 and hence anticipates the instant claims
Instant claims does not recite the specific concentration claimed in ‘005 and ‘304 and the copending applications does not recite the dosage titration with initial lower dose followed by the standard dose, instantly claimed/. However, Corte et al. teaches (BMS-986278) for use in treating IPF and various ILDs, administrated at different doses and dosing regimens than the instant claims. It would be considered routine practice to titrate doses of active agents, multiple dosages, adjust dosages to be lower/higher dependent on patient response, including the daily dosage, frequency, number of days, and any combination thereof, etc. Additional therapies (instant claim 40) is taught in Corte et al, pg. 2, col. 2, para 2. Regarding the dosages and administration frequency in the claims, (taught on p. 64), see MPEP as follows: "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Applicants can rebut a prima facie case of obviousness based on ranges by showing the criticality of the claimed range and regimen
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-2, 7-8, 13, 18-20, 24-25, 30-31, 36-38, 40, 45-55 and 58-59 are rejected. No claims are allowed
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7 am to 4 pm..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/ Primary Examiner, Art Unit 1691
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