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
Applicants’ participation in the TrackOne program was discontinued as of 6 March 2026, as no request for prioritized examination accompanied the Request for Continued Examination. See MPEP 708.02(b).
The election requirement remains in effect.
The RCE, amendment, and remarks of 6 March 2026 are entered.
Claims 1-212, 218, 227, and 238-240, and 242 have been canceled. Claims 213-217, 219-226, 228-237, 241, and 243-266 are pending and are being examined on the merits.
New grounds of rejection are presented below in response to Applicants’ amendment filed 6 March 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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 6 March 2026 has been entered.
Claim Rejections - 35 USC § 112
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 213-217, 219-226, 228-237, 241, and 244-247 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 213 and 248 is 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 of acceptable hemoglobin and/or platelet counts, but only as specific embodiments rather than an explicit definition. While the skilled artisan might understand what is a normal level of hemoglobin and/or platelet, this is generally in the context of a normal patient. In the context of a patient with PAH as claimed, it is less clear that there would be an understanding of what is acceptable hemoglobin and/or platelet levels. The term as written is relative to patient populations but without any clear definition of the parameters that allow for the patient to receive a second dose. For example, it is not clear if the acceptable level of hemoglobin and/or platelet is in reference to a baseline “normal” patient, or if the clinician is determining an acceptable level specifically for a PAH patient. In the absence of further detail, the skilled artisan cannot determine the metes and bounds of the claims.
Claims 219-226, 228-237, and 241 all depend from canceled claim 218. Since claim 218 has been canceled, it is not clear what metes and bounds are associated with each of these claims.
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.
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.
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.
Claims 213-217 and 253-260 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar R and Knopf J (WO 2018/013936 A1, published 18 January 2018, hereafter referred to as ‘936) and Cappellini et al. (Haematologica 104:477-484, published 18 October 2018, hereafter referred to as Cappellini).
The ‘936 application claims a method of treating pulmonary hypertension, including pulmonary arterial hypertension, by administering a GDF/BMP antagonist that inhibits ActRIIA (see e.g. claims 2-5). ‘936 further claims that the GDF/BMP antagonist is an ActRIIA polypeptide, including a fusion with Fc comprising SEQ ID NO: 32 (see e.g. claims 118-124). SEQ ID NO: 32 is identical to SEQ ID NO: 23 as instantly claimed, and comprises SEQ ID NO: 2 and an Fc of SEQ ID NO: 32 with a linker between the two elements. The method is claimed as decreasing ventricular hypertrophy. The ‘936 application further guides one of ordinary skill to monitor treatment by analyzing hematological parameters including hemoglobin so that they are within an acceptable range (see e.g. p.144). ‘936 further suggests using ActRIIA-Fc at 1 mg/kg to 10 mg/kg for pharmacokinetic studies and at 10 mg/kg in the Examples (See e.g. Examples 1 and 14). The ‘936 application discloses that treatment improves 6MWD by 10-100 meters (see e.g. p.138-139, claim 147).
The difference between ‘936 and the claimed invention is that ‘936 does not disclose or further suggest the doses as claimed.
Cappellini discloses administration of sotatercept, i.e. a ActRIIA-Fc fusion protein, at doses of 0.1 mg/kg to 1 mg/kg at three-week intervals (see e.g. Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the method of ‘936 could have been utilized to treat a patient with PAH by administering an ActRIIA-Fc fusion, and modified to utilize the dosing amounts and schedule of Cappellini as well as the monitoring of dosing through hematological parameters including hemoglobin levels as in ‘936. The rationale for the hemoglobin monitoring comes directly from ‘936, and the overlapping subject matter concerning ActRIIA antagonists of ‘936 and Cappellini offers the rationale to utilize the dosing within the range as claimed. There would have been a reasonable expectation of success because ‘936 already provides for treatment and monitoring, and the overlapping subject matter is such that one of ordinary skill would have expected applying dosing protocols for a known ActRIIA antagonist would be similarly successful for the method of ‘936. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claims 214-217, the peptide of ‘936 reads upon the peptides as claimed.
Please note that it is not possible to determine the scope of claims 219-226, 228-235, 237, and 241 as they all depend from a canceled claim. However, the subject matter of ‘936 and Cappellini would likely render those claims obvious.
With respect to claim 253, as discussed above ‘936 and Cappellini provide for an overlapping ActRIIA fusion protein, the dosing and timing, and a rationale to monitor hematological parameters to provide for further dosing.
With respect to claims 254-258, as noted above ‘936 and Cappellini provide for dosing within these ranges and time periods.
With respect to claim 259 and 260, ‘936 indicates that administration may be delayed due to abnormal hematological parameters (see e.g. p.143).
Allowable Subject Matter
Claims 243, 248-252, and 266 are allowed. Claims 261-265 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 an examiner’s statement of reasons for allowance and for the indication of allowable subject matter: As noted above, the WO 2018/013936 A1 reference is considered the closest prior art as it discloses treatment of pulmonary arterial hypertension with an ActRIIA fusion protein. The ‘936 art also provides for criteria to monitor dosing, including checking a patient’s hemoglobin levels. The ‘936 art does not provide for administration of the ActRIIA fusion protein to a PAH patient and a 50% reduction in risk of death as found in claim 243. The prior art does not provide for this limitation. The claim and its dependents are therefore novel and unobvious.
As pertaining to claim 266, the ‘936 application is again the closes prior art. The ‘936 application does not suggest evaluation of hemoglobin levels and platelet count, nor the specific criteria for administering a second dose of the ActRIIA fusion protein. The prior art does not provide for this limitation. The claim is therefore novel and unobvious.
As pertaining to the objected claims, again the ‘936 application is the closest art as it discloses treatment and monitoring. It does not, however, provide rationale to monitor hemoglobin level and platelet count, nor the specific levels as claimed. The prior art does not provide a rationale to monitor these criteria specifically or set specific levels as claimed. The claimed subject matter is novel and unobvious pending consideration of any amendments Applicants may make in response to this action.
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 on (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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