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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/819232, 14229854, 14960354 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application 14229854 does not provide support for a prosthetic heart valve comprising: a continuous tubular shaped valve member comprising crosslinked, acellular pericardium tissue, said tubular shaped valve member further comprising a lumen, an outer wall, a longitudinal axis, an inlet portion, and an outlet portion, said outlet portion comprising a top edge, wherein said top edge is disposed proximate said inlet portion said outlet portion defining an outlet in fluid communication with said lumen of said tubular shaped valve member, said inlet portion defining an inlet in fluid communication with said lumen of said tubular shaped valve member.
The earliest effective filing date for claims 1-9 is 7/11/2016.
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cunanan et al. (Pub. No.: US 2012/0059487)
Cunanan et al. (hereinafter, Cunanan) discloses a prosthetic heart valve (abstract) comprising:
a continuous tubular shaped valve member (e.g., fig. 11) comprising crosslinked (para. 7), acellular (para. 7) pericardium (para. 39-40) tissue (abstract),
said tubular shaped valve member further comprising a lumen (fig. 11), an outer wall (fig. 11), a longitudinal axis, an inlet portion (fig. 11, bottom of figure), and an outlet portion (fig. 11, bottom of figure), said outlet portion comprising a top edge, wherein said top edge is disposed proximate said inlet portion (the portions can be arbitrarily assigned such that the top edge is disposed proximate the inlet)
said outlet portion defining an outlet in fluid communication with said lumen of said tubular shaped valve member (fig. 11, top of figure), said inlet portion defining an inlet in fluid communication with said lumen of said tubular shaped valve member (fig. 11).
For claim 2, Cunanan discloses the prosthetic heart valve of claim 1, wherein said continuous tubular shaped valve member further comprises a supplemental support structure (fig. 11).
For claim 3, Cunanan discloses the prosthetic heart valve of claim 1, wherein said crosslinked, acellular pericardium tissue comprises a tensile strength in the range of 9 MPa to 12 MPa (fig. 7, neonatal bovine pericardium).
For claim 4, Cunanan discloses the prosthetic heart valve of claim 1, wherein said crosslinked, acellular pericardium tissue comprises crosslinked, acellular bovine pericardium tissue (para. 39-40).
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.
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Cunanan et al. (Pub. No.: US 2012/0059487) in view of Sung et al. (Pub. No.: US 2005/0124560).
For claim 5-7, Cunanan lacks a pharmacological agent selected from the group consisting of desoximetasone, sirolimus, cyclosporine and prednisolone, or selected from the group consisting of 57atorvastatin, cerivastatin, fluvastatin and lovastatin. Sung teaches crosslinked acellular bovine pericardium (para. 17) suitable for implantation (abstract) including a pharmacological agent selected from the group consisting of desoximetasone, sirolimus, cyclosporine and prednisolone (para. 241), or selected from the group consisting of atorvastatin, cerivastatin, fluvastatin and lovastatin (para. 241). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the Cunanan pericardial prosthesis with pharmacologic agents including sirolimus and lovastatin as taught by Sung for the purpose of providing therapeutic treatment with the implantable material. This modification would have occurred using known methods and would have yielded predictable results.
For claim 8, Cunanan lacks said crosslinked, acellular pericardium tissue comprises a growth factor selected from the group consisting of fibroblast growth factor-2 (FGF-2), transforming growth factor beta (TGF-(3) and vascular endothelial growth factor (VEGF). Sung teaches including VEGF in order to promote angiogenesis (para. 240). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have provided the Cunanan pericardial prosthesis with growth factors as taught by Sung in order to promote angiogenesis. This modification would have occurred using known methods and would have yielded predictable results.
For claim 9, Cunanan lacks said crosslinked, acellular pericardium tissue is derived from pericardium tissue devoid of xenogeneic antigens. Sung teaches peicardial tissue which is acellular, including the process of cell extraction that removes lipid membranes and membrane associated antigens (para. 7). It would have been obvious to provide the pericardial tissue of Cunanan as devoid of xenogenic antigens as taught by Sung for the purpose of reducing the antigenic response to xenograft material. This modification would have occurred using known methods and would have yielded predictable results.
Conclusion
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/SUBA GANESAN/Primary Examiner, Art Unit 3774