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 the Application
The amendment and remarks of 4 December 2025 are entered.
Claims 1-230, 232, and 234-242 have been canceled. Claims 231, 233, and 243-257 are pending and are being examined on the merits.
The election requirement remains in effect.
The rejection of claim 232 under 35 U.S.C. 112(b) is withdrawn in light of the amendment filed 4 December 2025.
The rejection of claims 231-33 under 35 U.S.C. 102(a)(1) as being anticipated by ‘936 or Joshi is withdrawn in light of the amendment filed 4 December 2025.
The rejection for nonstatutory double patenting over the copending ‘145 application is withdrawn after further consideration of the amendment filed 6 March 2026 in ‘145 removing any claim limitation to a second dose three weeks after the first dose.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 231, 233, and 243-257 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating cardiopulmonary remodeling associated with pulmonary hypertension, does not reasonably provide enablement for a method of preventing cardiopulmonary remodeling associated pulmonary hypertension. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
“[T]o be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation.’” Genentech Inc. v. Novo Nordisk 108 F.3d 1361, 1365, 42 USPQ2d 1001, 1004 (Fed. Cir. 1997); In re Wright 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); See also Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir. 1991); In re Fisher 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Further, in In re Wands 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) the court stated:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman [230 USPQ 546, 547 (BdPatAppInt 1986)]. They include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredict-ability of the art, and (8) the breadth of the claims.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Nature of the Invention
The invention is drawn to a method of treating or preventing cardiopulmonary remodeling in subjects via administration of an ActRII fusion protein.
Breadth of the Claims
The claims are relatively narrow, with the only breadth being that the claims encompass both standard treatment as well as preventative methods.
State of the Prior Art
As indicated previously in the WO 2018/013936 A1 application, the art recognizes the ActRII fusion proteins and use in treatment of PAH.
Other art suggests that cardiovascular remodeling is a primary cause of death in PAH patients leading to an average 5 to 7-year period from diagnosis to death (see e.g. Taguchi and Hattori, Circulation Research 112:227-229k, published 18 January 2013).
Relative Skill of those in the Art
The relative skill of those in the art is high.
Predictability or Unpredictability of the Art
There is a general lack of predictability in the pharmaceutical art. In re Fisher, 427, F. 2d 833, 166, USPQ 18 (CCPA 1970).
Amount of Direction or Guidance Given
The specification offers no particular guidance on the parameters or definition of what is meant by “preventing” as claimed.
Presence/Absence of Working Examples
No working examples show prevention of cardiopulmonary remodeling in PAH patients via administration of an ActRII fusion protein as claimed. The working examples support treatment of cardiopulmonary remodeling in PAH patients.
Quantity of Experimentation Necessary
At issue is the prevention of cardiopulmonary remodeling. As discussed above, there is typically a 5 to 7-year period from diagnosis of PAH to eventual death. The remodeling which occurs is a consequence of PAH, i.e. it generally occurs in all patients. The underlying PAH cannot be prevented since there is no clear understanding of what causes PAH (see e.g. https://www.nhlbi.nih.gov/health/pulmonary-hypertension/causes). Accordingly, one cannot prevent a consequence of an unpreventable condition. Put another way, the skilled artisan in this case would have to have knowledge that a subject would be afflicted with PAH, and as such be able to preemptively administer the ActRII fusion proteins to prevent the eventual cardiopulmonary remodeling. This is not possible and therefore the experimentation would be undue since it would require determining causative factors for PAH and as a consequence the cardiopulmonary remodeling.
In view of the Wands factors as discussed above, it is the Examiner’s opinion that the claims are not fully enabled and one of skill in the art would have to engage in undue experimentation to practice the invention as claimed herein, without a reasonable assurance of success.
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 ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached M-F 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658