NON-FINAL REJECTION
This application, filed Dec. 22, 2023, claims benefit of priority to Provisional Application 63/519,692, filed Aug. 15, 2023 and Provisional Application 63/476,992, filed Dec. 23, 2022.
Claims 1-18, as amended, are pending.
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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Jul. 2, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
Claim 14 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 14 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.
Claims 17-18 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 pre-AIA the applicant regards as the invention.
As recognized by MPEP § 2173.05(g), when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear.
Here, claims 17-18 are drawn to methods of administering 120 mg/day of Compound A, or the equivalent amount of a pharmaceutically acceptable salt thereof, to treat interstitial lung diseases to a subject in need thereof, wherein the subject experiences:
a smaller increase in cough domain score as measured by the Living with Pulmonary Fibrosis (L-PF) questionnaire over a treatment period than an untreated subject, as recited by claim 17; or
a smaller increase in dyspnea score as measured by the Living with Pulmonary Fibrosis (L-PF) questionnaire over a treatment period than an untreated subject, as recited by claim 18.
However, the specification fails to demonstrate that any subject actually experiences these effects; and fails to set forth any objective criteria to distinguish between subjects who experience these effects, and subjects who do not.
Furthermore, it is unclear (1) which of the recited effects must be achieved; (2) to what degree each must occur; or (3) whether all of them or some combination thereof, rendering the metes and bounds of the claims indefinite.
As recognized by MPEP § 2111.04, claim scope is not limited by claim language that does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. Giving the claims the broadest reasonable interpretation in light of the specification, the active method step to be carried out is administering to a subject in need thereof about 120 mg/day of Compound A, or an equivalent amount of a pharmaceutically acceptable salt thereof, which in turn may achieve the recited results or effects. However, claims 17-18 simply describe the result that the active step of administering is supposed to accomplish, and thus fail to further limit the scope of claim 1 from which claims 17-18 depend.
"A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited." Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005).
Thus, for examination purposes, the results and/or effects of administering the claimed compound as recited by claims 17-18 are construed as intended use limitations and are given no patentable weight.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-13 and 15-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Cheng et al. (USPN 10,576,062), in view of Tirucherai et al. (Eur. Resp. Journal 54 (suppl 63): PA1398 (2019)); and Cheng et al. (J. Med. Chem. 64, 15549-15581 (2021)), (all cited on the IDS dated 7/2/2024).
Cheng et al. (the '062 patent) 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 represented by formula:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
,
a.k.a. BMS-986278; admilparant (claim 10), which is Compound A as recited by claim 1.
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), as recited by claims 2-4.
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), as recited by claim 6.
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), as recited by claims 7-9.
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), as recited by claims 10-11.
Regarding claims 12-13, 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), as recited by claims 12 and 13, respectively.
Regarding claims 15-16, 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, as recited by claim 16.
However, 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, as recited by claims 15-16, are intrinsic in the methods of Cheng et al., even if those effects or results were not recognized. As evidenced by, e.g., the instant specification (Example 4; Figs. 8-16), administering BMS-986278 to treat interstitial lung diseases, e.g., IPF or PPF, results in a smaller decline in forced vital capacity (FVC), as recited by claim 15; and a greater time to first disease progression event, as recited by claim 16.
While the references 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 intrinsic in the methods of Cheng et al.
As noted above, the results experienced by the subject, as recited by claims 17-18, are intended use limitations which are given no patentable weight, and fail to further limit claim 1.
The cited references differ from the claims in that the dosage of 120 mg/day, as recited by claim 1, is not specifically disclosed.
However, as noted above, Tirucherai et al. report that administering the claimed compound in doses ranging from 30-150 mg were generally well tolerated.
In addition, Cheng et al. (2021) disclose that compound 33 (the claimed compound, BMS-986278) is a potent LPA1 antagonist. On the basis of its in vivo efficacy in rodent chronic lung fibrosis models and excellent overall ADME properties in multiple preclinical species, compound 33 was advanced into clinical trials, including an ongoing Phase 2 clinical trial in patients with lung fibrosis (abstract).
Specifically, in a 21-day study in the chronic rat bleomycin lung fibrosis model, compound 33 demonstrated robust antifibrotic efficacy, by significantly decreasing lung fibrosis area in the bleomycin-treated rats at doses of 3 and 10 mg/kg BID (p. 15560, left col.).
While those of ordinary skill in the art understand that dosage concentrations are not directly translatable from animal models to human patients, these dosages equate to 210 mg and 700 mg for an average adult human weighing 70 kg. While these doses are somewhat higher than the dose of 120 mg recited by claim 1, Tirucherai et al. report the administration of the claimed compound to humans in lower doses, from 30-150 mg, establishing a range of values.
Furthermore, claim 1 recites a method of administering the claimed compound to a "subject" in need thereof, which is defined by the instant specification as follows:
The terms “subject” and “participant” are used interchangeably and encompass mammals. Examples of mammals include, but are not limited to, humans, chimpanzees, apes, monkey, cattle, horses, sheep, goats, swine, rabbits, dogs, cats, rodents, rats, mice guinea pigs, and the like. In one aspect, the mammal is a human (para. [0054]).
Thus, "subject" encompasses mammals, e.g., rats, and is not limited to human patients.
Therefore, it would have been predictable to an ordinarily skilled clinician as of the filing date to optimize the amounts and dosages of BMS-986278 disclosed by the cited references to arrive at a dose of 120 mg/day 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 BMS-986278 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).
Statutory 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 1-18 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-18 of copending Application No. 19/142,304 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Obviousness-Type 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.
1. Claims 1, 12, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-22 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 the reference claims would anticipate the examined claims.
The reference claims are drawn to uses of about 120 mg/day of Compound A, or an equivalent amount of a pharmaceutically acceptable salt thereof, for treating interstitial lung disease, which is idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). These are interpreted as claims to methods of treating interstitial lung disease, idiopathic pulmonary fibrosis (IPF), and progressive pulmonary fibrosis (PPF), as recited by examined claims 1, 12, and 13.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2. Claims 1, 4, and 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47-59 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 the reference claims would anticipate the examined claims.
Reference claims 47-59 are 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 the standard daily dosage of Compound A is about 60 mg twice daily or an equivalent amount of a pharmaceutically acceptable salt thereof;
wherein Compound A comprises the crystal form recited by examined claim 14;
wherein the subject experiences a smaller decline in forced vital capacity (FVC) after a treatment period compared to an untreated subject;
wherein the subject experiences a greater time to first disease progression event after a treatment period than an untreated subject, wherein the first disease progression event is selected from: absolute predicted forced vital capacity (ppFVC) decline of > 10% from baseline; acute exacerbation of lung fibrosis; respiratory-related hospitalization; and all-cause mortality; and
wherein the LPA1 antagonist is Compound A, or a pharmaceutically acceptable salt thereof, and the standard daily dosage is about 120 mg/day of Compound A or an equivalent amount of a pharmaceutically acceptable salt thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 1-4, 7, and 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47, 62, 68, and 75-77 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 reference claims would anticipate the examined claims.
Reference claim 47 is drawn to methods 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 the standard daily dosage of Compound A is about 120 mg twice daily or an equivalent amount of a pharmaceutically acceptable salt thereof.
Reference claims 62, 68, and 75-77 are drawn to a method of treating interstitial lung disease 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 the subject is concomitantly being treated with one or more therapies for interstitial lung disease;
wherein Compound A comprises the crystal form recited by examined claim 14;
wherein the subject experiences a smaller decline in forced vital capacity (FVC) after a treatment period compared to an untreated subject; and
wherein the subject experiences a greater time to first disease progression event after a treatment period than an untreated subject, wherein the first disease progression 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.
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.
4. Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-17 of copending Application No. 18/394,928 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims would anticipate the examined claims.
Reference claims 15-17 are drawn to the crystal form of Compound A recited by examined claim 14, for use in treating interstitial lung disease, which is idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
5. Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47, 53-58, and 62-82 of copending Application No. 19/142,317 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims would anticipate the examined claims.
Reference claims 47 and 53-58 are drawn to methods 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 Compound A is about 120 mg twice daily or an equivalent amount of a pharmaceutically acceptable salt thereof;
wherein about 60 mg twice daily of Compound A, or an equivalent amount of a pharmaceutically acceptable salt thereof, is administered during the third treatment period;
wherein Compound A comprises the crystal form recited by examined claim 14;
wherein the subject experiences a smaller decline in forced vital capacity (FVC) after a treatment period compared to an untreated subject;
wherein the subject experiences a greater time to first disease progression event after a treatment period than an untreated subject, wherein the first disease progression event is selected from: absolute predicted forced vital capacity (ppFVC) decline of > 10% from baseline; acute exacerbation of lung fibrosis; respiratory-related hospitalization; and all-cause mortality;
wherein the subject experiences a smaller increase in cough domain score as measured by the Living with Pulmonary Fibrosis (L- PF) questionnaire over a treatment period than an untreated subject;
wherein the subject experiences a smaller increase in dyspnea score as measured by the Living with Pulmonary Fibrosis (L-PF) questionnaire over a treatment period than an untreated subject.
Reference claims 62-82 are drawn to methods of treating interstitial lung disease 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 is administered once daily;
wherein Compound A is administered twice daily;
wherein about 120 mg of Compound A is administered twice daily;
wherein Compound A is administered orally;
wherein Compound A is administered as a tablet;
wherein the subject is concomitantly being treated with one or more therapies for interstitial lung disease, selected from pirfenidone or nintedanib;
wherein Compound A is administered with food, or without food;
wherein the fibrosis is idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF);
wherein Compound A comprises the crystal form recited by examined claim 14;
wherein the subject experiences a smaller decline in forced vital capacity (FVC) after a treatment period compared to an untreated subject;
wherein the subject experiences a greater time to first disease progression event after a treatment period than an untreated subject, wherein the first disease progression 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;
wherein the subject experiences a smaller increase in cough domain score as measured by the Living with Pulmonary Fibrosis (L- PF) questionnaire over a treatment period than an untreated subject; and
wherein the subject experiences a smaller increase in dyspnea score as measured by the Living with Pulmonary Fibrosis (L-PF) questionnaire over a treatment period than an untreated subject.
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.
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.
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/SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629
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