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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lindsay et al. 20210038596 A1, herein referred to as Lindsay.
Regarding claim 1, Lindsay discloses a method of treating Aortic valve Stenosis (AS) ([0104] Lindsay teaches treating an arterial stenosis model) in a patient in need thereof comprising administering to the patient a therapeutically effective amount of an EZH2 inhibitor ([0007] Lindsay teaches using HDAC inhibitors; [0012] Lindsey explicitly targets EZH2).
Regarding claim 2, Lindsay discloses wherein the patient suffers from a calcific aortic valve disease ([0018] “vascular calcification, [0074] aortic valve disease described would be accompanied by vascular calcification as discussed earlier in Lindsay).
Claim Rejections - 35 USC § 103
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.
Claim(s) 3-4, 7, And 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindsay in view of Rajamannan et al. US 20150306281 A1, herein referred to as Rajamannan.
Regarding claim 3, Lindsay discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches administration of the EZH2 inhibitor (Lindsay [0012]).
But fails to discloses preventing degeneration of an implanted bioprosthetic valve. But Rajamannan teaches preventing degeneration of an implanted bioprosthetic valve (Rajamannan teaches administering an inhibitor to prevent damage to an implanted bioprosthetic valve [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Lindsay to incorporate the steps of preventing degeneration of an implanted bioprosthetic valve, as taught and suggest by Rajamannan in order to improve life of valve [0028].
Regarding claim 4, Lindsay/ Rajamannan discloses the invention substantially as claimed and as discussed above with respect to claim 3, and additionally teaches wherein administration of the EZH2 inhibitor (Lindsay [0012]) delays or prevents calcification (Rajamannan [0069]) of a bioprosthetic valve after valve replacement either surgically (Rajamannan [0008]) or after transcatheter aortic valve implantation (TAVI) (Rajamannan [0008]).
Regarding claim 7, Lindsay/ Rajamannan disclose discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches a bioprosthetic valve (Rajamannan [0008]) comprising an amount of an EZH2 inhibitor ([0012] Lindsay explicitly targets EZH2).
Regarding claim 9, Lindsay/ Rajamannan disclose discloses the invention substantially as claimed and as discussed above with respect to claim 7, and additionally teaches aortic valve stenosis in a subject in need thereof, comprising, implanting the bioprosthetic valve of claim 7 into the subject (Lindsay [0027]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindsay in view of Jin et al. US 20160340674 A1, herein referred to as Jin.
Regarding claim 5, Lindsay discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches wherein the EZH2 inhibitor is selected from the group consisting of Tazemetostat (Lindsay [0027]) and GSK-343 (Lindsay [0014]). But does not disclose GSK-126 (Jin [0204). But Jin teaches GSK-126 (Jin [0204]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the method of Lindsay to in incorporate GSK-126 as taught and suggested by Jin in order to “increases the levels of KLF2 (FIG. 2A) and eNOS (FIG. 2B) mRNA in endothelial cells in a dose-dependent manner” (Jin [0014]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Radhakrishnan et al. US 5043165 A, herein referred to as Radhakrishnan, in view of Lindsay.
Regarding claim 6, Radhakrishnan discloses a method of preparing a bioprosthetic valve (Radhakrishnan Col 7, lines 44-65; Col. 9, lines 37-54), comprising during preparation of the bioprosthetic valve (Col 9, lines 37-54, cholesterol deposited liposomes containing drug in membranes in tricuspid valve leaflets), entrapping (a therapeutic drug) in cusps of the bioprosthetic valve (Col 9, lines 37-54, cholesterol deposited liposomes containing drug in membranes in tricuspid valve leaflets).
But fails to discloses where in the entrapped drug is an EZH2 inhibitor. But Lindsay teaches wherein the entrapped drug is an EZH2 inhibitor (Lindsay [0012]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Radhakrishnan to incorporate the steps of including an EZH2 inhibitor, as taught and suggested by Lindsey in order prevent calcification of the leaflets (Lindsay [0025]).
Conclusion
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/A.F./Patent Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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