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 RCE, amendment, and remarks of 18 June 2026 are entered.
Claims 1-230, 232, and 234-242 have been canceled. Claims 231, 233, and 243-280 are pending and are being examined on the merits.
The election requirement remains in effect.
The rejection of claims 231, 233, and 243-257 under 35 U.S.C. 112(a) is withdrawn in light of the amendment filed 18 June 2026.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 June 2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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.
Claims 231, 233, 243-257, 260, and 273 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “acceptable hemoglobin and/or platelet count” in claim 231is a relative term which renders the claim indefinite. The term “acceptable hemoglobin and/or platelet count” is 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. The specification offers specific examples or embodiments of acceptable hemoglobin and/or platelet counts, but does not offer a specific definition. While the skilled artisan might understand what is a normal level of hemoglobin and/or platelets, this is generally in the context of a normal patient. In the context of a patient with PAH suffering from cardiopulmonary remodeling as claimed, it is less clear that the skilled artisan would understand what is encompassed by an “acceptable hemoglobin and/or platelet count”. The term as written is relative to patient populations but without any clear parameters to understand what allows for a patient to receive a second dose. For example, it is not clear if the acceptable level of hemoglobin and/or platelets is in reference to a baseline “normal” patient, or if the clinician is determining an acceptable level specifically for a PAH patient with cardiopulmonary remodeling. In the absence of further detail, the skilled artisan cannot ascertain the metes and bounds of the claim. Dependent claims 233 and 243-256 do not remedy this deficiency.
Claim 257 similarly recites “acceptable hemoglobin and/or platelet counts”, and is indefinite for the same reasons as claim 231 is indefinite. Dependent claim 260 is indefinite because it does not remedy the deficiency.
The term “acceptable” in claim 273 is a relative term which renders the claim indefinite. The term “acceptable” is 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. This largely overlaps with the “acceptable hemoglobin and/or platelet counts” analysis presented above for claim 231. There is no clear guidance on any specific acceptable levels for any hematological parameters, which encompasses more than hemoglobin and/or platelet count as found above.
Allowable Subject Matter
Claims 258-259, 261-264, and 266 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to disclose or suggest treatment of cardiopulmonary remodeling associated with pulmonary arterial hypertension via administration of an ActRII fusion protein as claimed, including first doses of 0.3 mg/kg followed by a second dose of 0.7 mg/kg after particular thresholds for hemoglobin or platelet count are met.
Claims 267-272 and 274-280 are allowed.
The following is an examiner’s statement of reasons for allowance: For largely the same reasons as found above, the prior art does not recognize treatment of cardiopulmonary remodeling with an ActRIIA fusion protein of SEQ ID NO: 23 or 21 at a first dose of 0.3 mg/kg, monitoring of hematological parameters, and administration of a second maintenance dose.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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
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