DETAILED ACTION
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 .
Priority
2. The instant application claims priority to U.S. Provisional Application nos. 63/476,997 and 63/519,723, filed December 23, 2022 and August 15, 2023, respectively.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on July 2, 2024 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS document was considered. A signed copy of form 1449 is enclosed herewith.
Status of Claims
4. Claims 1-2, 7-8, 13, 18-19, 24-25, 30-31, 40, 47-48, 50, 52, 54-56, 62, 68, and 75-77 are pending and under consideration herein.
Claim Rejections - 35 USC § 102
5. 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.
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claim(s) 62, 68, 76, and 77 is/are rejected under 35 U.S.C. 102(a) as being clearly anticipated by Tirucherai et al. [Tirucherai, Giridhar. BMS-986278, a lysophosphatidic acid 1 (LPA1) receptor antagonist, in healthy participants: A single/multiple ascending dose (SAD/MAD) phase 1 study, European Respiratory Society, European Respiratory Journal, 1 January 2019, XP093151699].
Tirucherai et al. teaches (BMS-986278) for use in treating IPF, an interstitial lung disease, administrated at a dose of 250 mg per day, anticipating the instant claims ‘about 240 mg/day’ administration of Compound A.
Regarding the limitations of instant claims 76 and 77 detailing what the subject experiences, the prior art is silent to those characteristics. Artisans of ordinary skill may not recognize inherent characteristics or functioning of the prior art. However, the 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. See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347-49 (Fed. Cir. 1999); accord Toro Co. v. Deere & Co., 355 F.3d 1313, 1320-21 (Fed. Cir. 2004). MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)). In the present case, the active step of administering to a subject in need thereof of about 240 mg/day of Compound A is occurring in the anticipated method and the resulting effects are inherent and also anticipated.
Claim Rejections - 35 USC § 103
8. 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
9. Claims 1-2, 7-8, 13, 18-19, 24-25, 30-31, 40-47,48, 50, 52, and 55-56 are rejected under 35 U.S.C. 103 as being unpatentable over Corte et al. [Corte, Tamera J. Phase 2 trial design of BMS-986278, a lysophosphatidic acid receptor 1 (LPA1) antagonist, in patients with IPF or OF-ILD, BMJ Open Resp Res, 2021, 1-9].
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 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. “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. . . . In such a 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 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.
Double Patenting
10. 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.
11. Claims 1-2, 7-8, 13, 18-19, 24-25, 30-31, 40, 47-48, 50, 52, 54-56, 62, 68, and 75-77 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of 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. 19/142,317 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
12. 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.
13. Claims 1-2, 7-8, 13, 18-19, 24-25, 30-31, 40, 47-48, 50, 52, 54-56, 62, 68, and 75-77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-8, 13, 18-20, 24-25, 30-31, 36-38, 40, 45-55, and 58-59 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 claims 1-2, 7-8, 13, 18-20, 24-25, 30-31, 36-38, 40, 45-55, and 58-59 of copending Application No. 18/393,940 render obvious the instant claims. For example, claim 1 is drawn to a method of treating interstitial lung disease comprising administering compound A in a standard daily dosage of about 120 mg/day vs. the instant claims of 240 mg/day.
“[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. “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. . . . In such a 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. Furthermore, absent any evidence demonstrating a patentable difference between the administration of the criticality of the claimed amounts, 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. Claims 1-2, 7-8, 13, 18-19, 24-25, 30-31, 40, 47-48, 50, 52, 54-56, 62, 68, and 75-77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/394,005 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-18 of copending Application No. 18/394,005 render obvious the instant claims. For example, claim 1 is drawn to a method of treating interstitial lung disease comprising administering compound A in a standard daily dosage of about 120 mg/day vs. the instant claims of 240 mg/day.
“[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. “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. . . . In such a 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. Furthermore, absent any evidence demonstrating a patentable difference between the administration of the criticality of the claimed amounts, 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
15. Claims 1-2, 7-8, 13, 18-19, 24-25, 30-31, 40, 47-48, 50, 52, 54-56, 62, 68, and 75-77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19/142,304 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-22 of copending Application No. 19/142,304 render obvious the instant claims. For example, claim 1 is drawn to a method of treating interstitial lung disease comprising administering compound A in a standard daily dosage of about 120 mg/day vs. the instant claims of 240 mg/day.
“[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. “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. . . . In such a 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. Furthermore, absent any evidence demonstrating a patentable difference between the administration of the criticality of the claimed amounts, 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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
16. No claims allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha Shterengarts whose telephone number is (571)270-5316. The examiner can normally be reached on Monday thru Thursday 9-6pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Adam Milligan can be reached on 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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/SAMANTHA L SHTERENGARTS/Primary Examiner, Art Unit 1623
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