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 .
Priority
This application is a continuation (CON) application of U.S. Application Serial Number 16/098,330, filed 11/01/2018, which is a 371 of PCT/US2017/030592, filed 5/02/2017. This application claims benefit to U.S. Provisional Application Serial Number 62/330,520, filed 5/02/2016. Claims 17, 20-22 and 28-32 are pending.
Election/Restrictions
Applicant’s election without traverse of Group III, claims 17 and 20-22 in the reply filed on 5/11/2026 is acknowledged. New claims 28-32 depend from claim 17 and all claims drawn to non-elected inventions have been canceled; thus, Group III, claims 17, 20-22 and 28-32 have been examined on the merits.
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 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 17, 20-22 and 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al., US 2015/0265685 (cite A, attached PTO-892; herein “Chen”) in view of Kumamoto et al., US Patent 7067254 (US Patent cite, IDS, 9/19/2024; herein “Kumamoto”).
Chen teaches methods of treating subjects with fibroproliferative disease wherein the disease is pulmonary arterial hypertension (PAH) by administering apyrases, such as CD39 apyrase; diagnosing the subject by assaying compounds in biological fluids and comparing to normal controls (Abst.; [0043]) wherein the PAH can be scleroderma-associated PAH [0011].
Chen teaches that extracellular ATP and ADP mediate inflammation in PAH [0063] and teaches that apyrase therapy, such as administration of CD39, reduces the extracellular ATP and ADP [0063].
Chen does not specifically teach administering a selective P2X1 antagonist to the subject; however, a person of ordinary skill in the art at the time of filing would have found it obvious to administer the P2X1 antagonist pyridoxalphosphate-6-azophenyl-2',4'-disulfonic acid (PPADS) or MRS 2159 to the subject in view of the disclosure of Kumamoto.
Kumamoto, like Chen, teaches administering nucleoside triphosphate diphosphohydrolases (NTPDases) to treat inflammatory responses associated with hyperactive immune conditions which elevate extracellular nucleotides (Abst.) wherein the NTPDase can be CD39 (col. 3, ll. 18-25).
Kumamoto further discloses that the inflammatory responses associated with hyperactive immune conditions which elevate extracellular nucleotides can be treated with P2X1 antagonists wherein the P2X1 antagonist can be PPADS or MRS2179 (col. 8, ll. 13-28).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method of Chen wherein the subject suffering from scleroderma-associated PAH is administered PPADS or MRS2179 in addition to the apyrase with a reasonable expectation of success because Kumamoto teaches that administering the P2X1 antagonists PPADS and/or MRS2179 treats the same inflammatory responses associated with hyperactive immune conditions which elevate extracellular nucleotides that are treated by the administration of apyrases; therefore, claims 17 and 20-21 are prima facie obvious.
Regarding claim 22, Kumamoto discloses that the P2X pathway can alternatively be inhibited by an anti-P2-receptor antibody (col. 8, ll. 13-28); hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by Chen in view of Kumamoto wherein the selective P2X1 antagonist is an antibody or antibody fragment; therefore, claim 22 is prima facie obvious.
As mentioned above, Chen teaches that extracellular ATP and ADP mediate inflammation in PAH [0063] and that CD39 reduces the extracellular ATP and ADP [0063]. Kumamoto discloses quantifying the expression of CD39 in samples from subjects (Figs. 2b-d; col. 9, ll. 51-67) and quantifying the levels of ATP and ADP in samples from subjects (Fig. 3b; col. 10, ll. 1-19).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious that subjects suffering from scleroderma-associated PAH would have a decreased level of CD39 expression and an elevated level of extracellular ATP and would find it obvious to assess CD39 expression and plasma ATP:adenosine ratio in the subject prior to administering the P2X1 antagonist in order to verify that the subject would benefit from selective P2X1 antagonist therapy; therefore, claims 29-32 are prima facie obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651
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