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 .
Election/Restrictions
In view of applicant’s claim amendments, the restriction requirement between inventions I and II as set forth in the Office action mailed on 18 December 2025 is hereby withdrawn, although the species election requirement is not withdrawn. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Applicant's election with traverse of MEK1/2 inhibitor species PD98059 in the reply filed on 18 February 2026 is acknowledged. The traversal is on the ground(s) that a search of all the alleged species could be made without an undue burden. This is not found persuasive because the species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries) as discussed in the species election requirement, which is sufficient to demonstrate a serious search and/or examination burden, including for example that the individual species have mutually exclusive characteristics in that they belong to various different chemical classes and have different chemical group constituents, for example PD98059 is a chromenone whereas SL327 has aminophenylthio structure.
The species election requirement is still deemed proper and is therefore made FINAL.
All non-elected species are withdrawn from further consideration as being drawn to a nonelected species. Applicant timely traversed the restriction (election) requirement in the reply filed on 18 February 2026.
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 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.
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.
Claim(s) 12-16 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (CN-1743006-A; published 08 March 2006; citations herein to English machine translation made 03 April 2026).
Regarding independent claim 12, Zhou discloses treating or preventing mammalian heart disease in a patient using an effective amount of a MAPK inhibitor (claim 1) wherein the MAPK inhibitor is PD098059 (claim 3) wherein the heart disease is heart failure (claims 6-7) wherein the MAPK inhibitor is prepared for use with a pharmacologically acceptable carrier (claim 12) wherein desired carriers include liposomes (page 10 paragraph 7).
Further regarding independent claim 12, although Zhou does not disclose an example including liposomes as carrier, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Zhou as discussed above and to administer to a mammalian patient with heart failure an effective amount of a composition of PD098059 MAPK inhibitor carried in liposome carrier, with a reasonable expectation of success, which reads on the claimed method to prevent, inhibit or treat heart failure in a mammal comprising administering to the mammal an effective amount of a composition comprising microparticles or liposomes comprising PD98059 MEK1/2 inhibitor.
Regarding dependent claim 13, Zhou discloses that the mammal is human (claim 5), which reads on the claimed mammal being a human.
Regarding dependent claim 14, Zhou discloses that the system can be used for any route of administration such as injection (page 10 paragraph 2). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Zhou as discussed above and to administer the PD098059 as discussed above via injection, with a reasonable expectation of success, which reads on the claimed composition being injected.
Regarding dependent claim 15, Zhou discloses local administration (page 10 paragraph 2). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Zhou as discussed above and to administer the PD098059 as discussed above locally, with a reasonable expectation of success, which reads on the claimed composition being locally administered.
Regarding dependent claim 16, Zhou discloses that the system can be used for any route of administration such as intravenous injection (page 10 paragraph 2). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Zhou as discussed above and to administer the PD098059 as discussed above via intravenous injection, with a reasonable expectation of success, which reads on the claimed composition being systemically administered.
Regarding dependent claim 26, Zhou discloses MAPK inhibitor PD098059 (claim 3), which reads on the claimed one or more MEK1/2 inhibitors comprising PD98059.
Claim(s) 17, 19-20, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou as applied to claims 12-16 and 26 above, and further in view of Wei et al. (Hypertension, vol. 67, issue 1, January 2016, pages 229-236).
Zhou is relied upon as discussed above.
Zhou does not disclose treating sympathetic nerve activation as in claim 17.
Regarding independent claim 17, Wei et al. discloses inhibition of mitogen-activated protein kinase (i.e., MAPK, MEK1/2) signaling to reduce sympathetic nerve activity in heart failure (title) wherein a 4-week infusion of PD98059 MEK1/2 inhibitor improved heart function (abstract) wherein an infusion is 0.25 µL/h; 0.6 mmol/L (Experimental Protocols page 230).
Further regarding independent claim 17, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhou and Wei et al. by using an amount of PD98059 effective to inhibit sympathetic nerve activation as suggested by Wei et al. in the composition and method of Zhou as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to improve heart function in a heart failure patient in need thereof as suggested by Wei et al. because Zhou is directed to treatment of heart failure.
Regarding dependent claim 19, Zhou discloses that the mammal is human (claim 5), which reads on the claimed mammal being a human.
Regarding dependent claim 20, Zhou discloses that the system can be used for any route of administration such as injection (page 10 paragraph 2). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Zhou as discussed above and to administer the PD098059 as discussed above via injection in the method of Zhou in view of Wei et al. as discussed above, with a reasonable expectation of success, which reads on the claimed composition being injected.
Regarding dependent claim 30, Zhou discloses MAPK inhibitor PD098059 (claim 3), which reads on the claimed one or more MEK1/2 inhibitors comprising PD98059.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Wei et al. as applied to claims 17, 19-20, and 30 above, and further in view of Thomas et al. (US 2016/0305934 A1; published 20 October 2016).
Zhou and Wei et al. are relied upon as discussed above.
Zhou and Wei et al. do not disclose cancer as in claim 18.
Regarding dependent claim 18, Thomas et al. discloses treatment of pre-cachexia (title) wherein patients have cancer (paragraph [0200]) and congestive heart failure (paragraph [0202]) comprising administration of PD98059 (claim 35).
Further regarding dependent claim 18, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhou, Wei et al., and Thomas et al. by using the method of Zhou in view of Wei et al. as discussed above on a patient that also has cancer as in Thomas et al., with a reasonable expectation of success, which reads on the claimed mammal having cancer. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to treat/prevent pre-cachexia in such patient as suggested by Thomas et al. given that both heart failure patients and cancer patients benefit from treatment of pre-cachexia by administration of PD98059 per Thomas et al.
Claim(s) 21-25, 27-29, and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Wei et al. as applied to claims 17, 19-20, and 30 above, and further in view of Shastri et al. (US 2004/0224030 A1; published 11 November 2004).
Zhou and Wei et al. are relied upon as discussed above.
Zhou and Wei et al. do not disclose microparticles formed of a polymer having a MW of about 24,000 to about 38,000 as in claim 21.
Regarding dependent claim 21, Shastri et al. discloses microsphere delivery systems (title) with controlled release profiles that include PLGA copolymers and a biologically active agent (abstract) wherein controlled release profiles can be used rather than multiple dose injections which are painful and reduce compliance (paragraph [0002]) wherein manipulating the PLGA molecular weight alters the quantity, duration, or timing of a first or second burst/pulse such that PLGA molecular weight of 30 KDal has lower first burst than 20 KDal, and PLGA molecular weight may be up to for example 100,000 KDal (paragraph [0036]) wherein burst refers to the release of biologically active agent from the microsphere (paragraph [0004]).
Further regarding claim 21, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Zhou, Wei et al., and Shastri et al. by using the method of Zhou in view of Wei et al. as discussed above wherein the carrier of the PD98059 in the composition thereof is PLGA microspheres having molecular weight of 30 KDal (i.e., microparticles formed of a polymer having a MW of about 24,000) as suggested by Shastri et al., with a reasonable expectation of success, which reads on the claimed composition comprising microparticles formed of a polymer having a MW of about 24,000 to about 38,000. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to provide for controlled release of the PD98059 rather than requiring multiple dose injections which are painful and reduce compliance as suggested by Shastri et al., given that Zhou discloses that more than one dose may be administered (page 10 paragraph 2) or reduction of illness may require continuous administration (page 4 paragraph 5).
Regarding dependent claim 22, Shastri et al. discloses sustained release (paragraph [0038]), which reads on the claimed composition providing for sustained release of the PD98059.
Regarding dependent claim 23, Shastri et al. discloses that the microspheres are biodegradable and biocompatible (paragraph [0011]), which reads on the claimed microparticles being biocompatible and biodegradable.
Regarding dependent claim 24, Shastri et al. discloses PLGA molecular weight of 30 KDal (paragraph [0036]), which reads on the claimed composition comprising microparticles formed of a polymer having a MW of about 24,000 to about 38,000.
Regarding dependent claim 25, Shastri et al. discloses PLGA microspheres (title; abstract), which reads on the claimed microparticles being formed of lactic acid, glycolic acid, or combinations thereof.
Regarding dependent claim 27, Shastri et al. discloses release including at 20 days (Fig. 2), which reads on / overlaps the claimed release over 1 to 3 weeks or 1 to 4 weeks.
Regarding dependent claim 28, Shastri et al. discloses sustained release (paragraph [0038]), which reads on the claimed composition providing for sustained release of the PD98059.
Regarding dependent claim 29, Shastri et al. discloses that the microspheres are biodegradable and biocompatible (paragraph [0011]), which reads on the claimed microparticles being biocompatible and biodegradable.
Regarding dependent claim 31, Shastri et al. discloses release including at 20 days (Fig. 2), which reads on / overlaps the claimed release over 1 to 3 weeks or 1 to 4 weeks.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617