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
Applicant’s response dated 29 June 2026 to the previous Office action dated 07 April 2026 is acknowledged. Pursuant to amendments therein, claims 12-15, 17-21, 23-27, and 29-31 are pending in the application.
The rejections under 35 U.S.C. 103 made in the previous Office action are withdrawn in view of applicant’s claim amendments, but new (modified) rejections under 35 U.S.C. 103 are made herein in view of applicant’s claim amendments.
Election/Restrictions
Applicant's election with traverse of MEK1/2 inhibitor species PD98059 in the reply filed on 18 February 2026 stands. All non-elected species stand withdrawn from further consideration as being drawn to a nonelected species.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) 12-15 and 23-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou (CN-1743006-A; published 08 March 2006; of record; citations herein to English machine translation made 03 April 2026; of record) in view of Shastri et al. (US 2004/0224030 A1; published 11 November 2004; of record).
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 (i.e., a microsphere, a microparticle) (page 10 paragraph 7) wherein administration can be any route such as subcutaneous injection and can be local (page 10 paragraph 2).
Further regarding independent claim 12, Zhou does not explicitly disclose that the release is sustained as claimed.
Further regarding independent claim 12, 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]) wherein release may be sustained for 60 days (paragraph [0038]).
Further regarding independent claim 12, 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 Shastri et al. by administering to a mammalian patient with heart failure an effective amount of a composition of PD098059 MAPK inhibitor carried in microsphere carrier via subcutaneous local injection as suggested by Zhou, wherein the microsphere carrier comprises PLGA copolymers having molecular weight of 30 KDal for sustained release of up to 60 days as suggested by Shastri et al., with a reasonable expectation of success, which reads on the claimed method to prevent, inhibit or treat heart failure in a mammal comprising subcutaneously administering to the mammal an effective amount of a composition comprising microparticles or liposomes comprising PD98059 MEK1/2 inhibitor, wherein the microparticles or liposomes provide for the sustained release of the MEK1/2 inhibitor.
Further regarding independent claim 12, 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 13, Zhou discloses that the mammal is human (claim 5), which reads on the claimed mammal being a human. 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 practice the method of Zhou in view of Shastri et al. wherein the administration is to a human mammal, with a reasonable expectation of success, which reads on the claimed mammal being 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), and that one or more than one dose may be administered (unit dose, multi-dosage) (page 10 paragraph 2) or reduction of illness may require continuous administration (page 4 paragraph 5). 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 in the method of Zhou in view of Shastri et al. to administer via a single subcutaneous injection, with a reasonable expectation of success, which reads on the claimed administration being a single subcutaneous injection. Regarding the claimed sustained release over a period of two weeks, the release time of up to 60 days as discussed above overlaps such claimed time of 14 days, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding dependent claim 15, Zhou discloses local administration (page 10 paragraph 2) as discussed above, which reads on the claimed composition being locally administered.
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, in the method of Zhou in view of Shastri et al. as discussed above, the microsphere carrier includes PLGA copolymers having molecular weight of 30 KDal (i.e., 30,000), which reads on the claimed microparticles formed of a polymer having a MW of about 24,000-38,000.
Regarding dependent claim 25, in the method of Zhou in view of Shastri et al. as discussed above, the PLGA microspheres read on the claimed microparticles being formed of lactic acid, glycolic acid, or combinations thereof.
Regarding dependent claim 26, Zhou discloses MAPK inhibitor PD098059 (claim 3), which reads on the claimed one or more MEK1/2 inhibitors comprising PD98059.
Regarding dependent claim 27, in the method of Zhou in view of Shastri et al. as discussed above, the release time of up to 60 days as discussed above overlaps such claimed time of 1-3 or 1-4 weeks, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Claim(s) 12-15, 17, 19-21, 23-27, and 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Shastri et al. as applied to claims 12-15 and 23-27 above, and further in view of Wei et al. (Hypertension, vol. 67, issue 1, January 2016, pages 229-236; of record).
Zhou and Shastri et al. are relied upon as discussed above.
Zhou and Shastri et al. do 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, Shastri et al., 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 in view of Shastri et al. 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, see above regarding claim 13.
Regarding dependent claim 20, see above regarding claim 14.
Regarding dependent claim 21, see above regarding claim 24.
Regarding dependent claim 29, see above regarding claim 23.
Regarding dependent claim 30, see above regarding claim 26.
Regarding dependent claim 31, see above regarding claim 27.
Claim(s) 12-15, 17-21, 23-27, and 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou in view of Shastri et al. and Wei et al. as applied to claims 12-15, 17, 19-21, 23-27, and 29-31 above, and further in view of Thomas et al. (US 2016/0305934 A1; published 20 October 2016; of record).
Zhou, Shastri et al., and Wei et al. are relied upon as discussed above.
Zhou, Shastri et al., 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, Shastri et al., Wei et al., and Thomas et al. by using the method of Zhou in view of Shastri et al. and 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.
Response to Arguments
Applicant's arguments filed 29 June 2026 have been fully considered but they are not persuasive.
Applicant argues that the cited art does not teach and teaches away from administration of particulate MEK1/2 inhibitor formulation subcutaneously for heart failure (remarks pages 5-6). In response, Zhou teaches administration of MAPK inhibitor such as PD098059 (i.e., MEK1/2 inhibitor) for heart failure wherein administration may be using carrier such as liposome (i.e., microparticulate) and may be via subcutaneous injection, as discussed in the rejection above.
Applicant argues that Wei et al. does not teach subcutaneous administration (remarks pages 6-7). In response, the primary reference of Zhou teaches subcutaneous administration, and moreover Zhou also teaches single administration as discussed in the rejection above.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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