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 .
Status of Claims
Claims 1-16 are pending.
Priority
Instant application 18/423,217, filed 07/08/2024 claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 04/04/2024 have been considered unless marked with a strikethrough. Cite No. 6 is marked with a strikethrough because the citation appears to contain a typographical error because the patent number is truncated and does not correspond to the listed Patentee (DEL RIO GANCEDO). Cite No. 12 and Cite No. 13 are marked with strikethroughs because the uploaded documents, which appear to depict poster presentations, are formatted in such a way that a significant portion of the content in each document is missing. Therefore, these references could not be considered.
Claim Interpretation
Instant claims 1-16 are drawn to methods of “treating” uremic pruritus. The as-filed Specification ([0023] defines the terms “treating” or “treatment” as including one or more of:
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Because the term “treating” is defined to include prophylaxis, the patient population of the claims is being interpreted as including subjects who do not yet experience or display uremic pruritus. This interpretation applies to the rejections below.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by BOUDES (US 20190105291 A1; cited in IDS).
Boudes discloses orally administering seladelpar to subjects who do not yet experience or display uremic pruritus as the L-lysine dihydrate salt in doses of 50 mg/day or 200 mg/day (Example 1, para. [0039]); or in doses of 5 mg/day or 10 mg/day (see Example 2, para. [0040]). In both examples, dosing was provided once/day.
Boudes therefore anticipates instant claims 1-8 and 10.
Claims 13 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’CARROLL (US 20220370467 A1; published 24 November 2022).
O’Carroll discloses orally administering (E)-[4-[3-(4-Fluorophenyl)-3-[4-[3-(morpholin-4-yl)propynyl]phenyl]allyloxy]-2-methyl-phenoxy]acetic acid (Compound 1), which is mavodelpar, to subjects who do not yet experience or display uremic pruritus in doses ranging from 10 to 200 mg per day (Example 3, [0263]; and [0011]).
O’Carroll therefore anticipates instant claims 13 and 15.
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 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.
Claims 9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over BOUDES (US 20190105291 A1; cited in IDS).
The teachings of Boudes are disclosed above and at least those teachings are incorporated herein by reference and applied to instant claims 9 and 11-12.
Boudes discloses orally administering seladelpar to subjects who do not yet experience or display uremic pruritus as the L-lysine dihydrate salt in doses of 50 mg/day or 200 mg/day (Example 1, para. [0039]); or in doses of 5 mg/day or 10 mg/day (see Example 2, para. [0040]). In both examples, dosing was provided once/day.
For claim 9, the examples in Boudes disclose oral administration, and Boudes does not disclose a specific example where seladelpar was administered topically.
However, Boudes contemplates “any route suitable to the subject” and includes topical and transdermal administration (see para. [0032]).
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationales (B) and/or (G), it would have been prima facie obvious to substitute oral administration for topical administration in view of Boudes’ teaching. A person having ordinary skill would have reasonably predicted success because topical formulations are well-established in the prior art and could have been prepared as taught by Boudes, which cites to “Remington: The Science and Practice of Pharmacy”, 20th ed., Gennaro, ed., Lippincott Williams & Wilkins, Philadelphia, Pa., U.S.A; the same text is cited in the instant application for topical formulations (see Specification, para. [0036])
Accordingly, claim 9 is obvious over Boudes.
For claims 11 and 12, the examples in Boudes disclose once/day administration, and Boudes does not disclose a specific example where seladelpar was administered more than once per day or between once/week and every other day.
However, Boudes contemplates alternative dosing schedules including “as frequent as more than once/day” or “less frequent than once/day, such as between once/week and every other day” (see para. [0037]).
Applying KSR example rationales (B) and/or (G), it would have been prima facie obvious to modify the dosing schedule in view of Boudes’ teaching. A person having ordinary skill would have reasonably predicted success because dosing schedules are routinely modified depending on factors such as age and body mass (see para. [0037] of Boudes). Modifying dosing schedules constitutes routine optimization of a known result-effective variable. MPEP 2144.05 notes that differences in result-effective variables will not support the patentability subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. The specification provides no evidence of criticality.
Accordingly, claims 11 and 12 are obvious over Boudes.
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over O’CARROLL (US 20220370467 A1; published 24 November 2022).
The teachings of O’Carroll are disclosed above and at least those teachings are incorporated herein by reference.
O’Carroll discloses orally administering (E)-[4-[3-(4-Fluorophenyl)-3-[4-[3-(morpholin-4-yl)propynyl]phenyl]allyloxy]-2-methyl-phenoxy]acetic acid (Compound 1), which is mavodelpar, to subjects who do not yet experience or display uremic pruritus in doses ranging from 10 to 200 mg per day (Example 3, [0263]; and [0011]).
For claim 14, the examples in O’Carroll disclose administration of mavodelpar or a pharmaceutically acceptable salt, O’Carroll does not disclose a specific example where mavodelpar was administered as the sodium salt.
However, O’Carroll contemplates pharmaceutically acceptable salts of mavodelpar and specifically teaches the sodium salt as an embodiment in para. [0144].
Applying KSR example rationales (B) and/or (G), it would have been prima facie obvious to substitute mavodelpar for mavodelpar sodium salt in view of O’Carroll’s teaching. A person having ordinary skill would have reasonably predicted success because topical formulations are well-established in the prior art and could have been prepared as taught by O’Carroll. Moreover, as taught by O’Carroll, “pharmaceutical salts typically are more soluble and more rapidly soluble in stomach and intestinal juices than non-ionic species and so are useful in solid dosage forms” (para. [0151]).
Accordingly, claim 14 is obvious.
For claim 16, the examples in O’Carroll disclose oral administration, and O’Carroll does not disclose a specific example where mavodelpar was administered topically.
However, O’Carroll contemplates other routes of administration including topical and transdermal administration (see para. [0157] and para. [0166]).
Applying KSR example rationales (B) and/or (G), it would have been prima facie obvious to substitute oral administration for topical administration in view of O’Carroll’s teachings. A person having ordinary skill would have reasonably predicted success because topical formulations are well-established in the prior art and could have been prepared as taught by O’Carroll, which cites to “Remington: The Science and Practice of Pharmacy,” Nineteenth Ed (Easton, Pa.: Mack Publishing Company, 1995); the 20th edition of the same text is cited in the instant application for topical formulations (see Specification, para. [0036]).
Accordingly, claim 16 is obvious.
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 1-8 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-37 of copending Application No. 17/128,195 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application recite orally administering seladelpar to subjects who do not yet experience or display uremic pruritus. Dependent claims specify the seladelpar L-lysine dihydrate salt, once/day administration, and 5 mg or 10 mg/day administration.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9 and 11-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-37 of copending Application No. 17/128,195 in view of O’CARROLL (US 20220370467 A1; published 24 November 2022).
The reference application recites administering seladelpar to subjects who do not yet experience or display uremic pruritus.
For claim 9, the reference application does not recite topical administration. However, as taught by O’Carroll (e.g. para. [0157] or [0166]), topical administration of PPAR-delta agonists, such as mavodelpar and seladelpar, was known in the art prior to the filing date of the instant application. It would have therefore been prima facie obvious to substitute oral administration with topical administration in the method recited by the reference application.
For claims 11 and 12, the reference application does not recite administering more than once/day or between once/week and every other day. However, as taught by O’Carroll (e.g. para. [0187]), dosing regiments of once/day or between once/week and every other day for PPAR-delta agonists, such as mavodelpar and seladelpar, was known in the art prior to the filing date of the instant application. It would have therefore been prima facie obvious to modify the dosing regimen in the method recited by the reference application. Modifying dosing schedules constitutes routine optimization of a known result-effective variable. MPEP 2144.05 notes that differences in result-effective variables will not support the patentability subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. The specification provides no evidence of criticality.
For claims 13-16, the reference application does not recite administering mavodelpar. However, as taught by O’Carroll (e.g. para. [0119]), mavodelpar and seladelpar are both PPAR-delta agonists (i.e. the compounds act by the same mechanism of action). It would have therefore been prima facie obvious to substitute seladelpar with mavodelpar in the method recited by the reference application
This is a provisional nonstatutory double patenting rejection.
Conclusion
Claims 1-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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