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 . Claims 1, 3-7, and 21-22 are pending and examined below.
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 1, 3-7, 21, and 22 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.
Claim 1, 21, and 22 recites the limitation "the heart" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
All dependent claims are likewise rejected.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-7, and 21-22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kofidis (US 20220047387 A1).
Regarding claim 1, Kofidis teaches
a heart valve repair system (100, Fig. 1B, ¶0008) comprising:
an implantable leaflet (2, Fig. 1B) having a coaptation edge (edge of 2, Fig. 2) and an annulus edge (edge of 1, Fig. 2);
multiple chords (3, Fig. 1B) for connecting said coaptation edge to a native structure (4, Fig. 2) of the heart (Fig. 2, ¶0074),
each said chord (3, Fig. 2) having a proximal end and a distal end (ends of 3, Figs. 1A & 2);
a fixation mechanism (8, Fig. 1B) associated with each said chord (3, Fig. 1B) for attaching said distal end of each said chord to said native structure (4, Fig. 2) of said heart (Fig. 2, ¶0074); and
at least one annulus attachment device for securing said annulus edge (edge of 1, Fig. 2) of said implantable leaflet to an annulus of said heart valve (sutures used to attach ring portion 601A to the patient's annulus, ¶0093); wherein:
the coaptation edge is rolled up (601A, Fig. 6A ¶0089);
the annulus edge is rolled up (605A, Fig. 6A ¶0089; and
the native structure is a papillary muscle (4, Fig. 2).
Regarding claim 3, Kofidis teaches
wherein the implantable leaflet comprises a tissue material (human, bovine or porcine pericardium, ¶0077).
Regarding claim 5, Kofidis teaches
wherein said tissue material comprises mammal tissue (human, bovine or porcine pericardium, ¶0077).
Regarding claim 6, Kofidis teaches
wherein the tissue material comprises a synthetic material (biodegradable polymers, ¶0077).
Regarding claim 7, Kofidis teaches
further comprising a fixation mechanism (9, Fig. 1A) for attaching a proximal end of each said chord (3, Fig. 1A) to said implantable leaflet (2, Fig. 1A).
Regarding claim 21, Kofidis teaches
a heart valve repair system (100, Fig. 1B, ¶0008) comprising:
an implantable leaflet (2, Fig. 1B) having a coaptation edge (edge of 2, Fig. 2) and an annulus edge (edge of 1, Fig. 2);
multiple chords (3, Fig. 1B) for connecting said coaptation edge to a papillary muscle (4, Fig. 2) of the heart (Fig. 2, ¶0074),
each said chord (3, Fig. 2) having a proximal end and a distal end (ends of 3, Fig. 2);
a fixation mechanism (8, Fig. 1B) associated with each said chord (3, Fig. 1B) for attaching said distal end of each said chord to said papillary muscle (4, Fig. 2) of said heart (Fig. 2, ¶0074); and
at least one annulus attachment device for securing said annulus edge (edge of 1, Fig. 2) of said implantable leaflet to an annulus of said heart valve (sutures used to attach ring portion 601A to the patient's annulus, ¶0093).
Regarding claim 22, Kofidis teaches
a heart valve repair system (100, Fig. 1B, ¶0008) comprising:
an implantable leaflet (2, Fig. 1B) having a coaptation edge (edge of 2, Fig. 2) and an annulus edge (edge of 1, Fig. 2);
a chord (3, Fig. 1B) for connecting said coaptation edge to a papillary muscle (4, Fig. 2) of the heart (Fig. 2, ¶0074),
said chord (3, Fig. 2) having a proximal end and a distal end (ends of 3, Fig. 2);
a fixation mechanism (8, Fig. 1B) associated with said chord (3, Fig. 1B) for attaching said distal end of said chord to said papillary muscle (4, Fig. 2) of said heart (Fig. 2, ¶0074); and
at least one annulus attachment device for securing said annulus edge (edge of 1, Fig. 2) of said implantable leaflet to an annulus of said heart valve (sutures used to attach ring portion 601A to the patient's annulus, ¶0093); wherein:
the coaptation edge is rolled up (601A, Fig. 6A ¶0089); and
the annulus edge is rolled up (605A, Fig. 6A ¶0089).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kofidis in view of Neethling et al. (US 20060193885 A1) hereinafter, Neethling.
Regarding claim 4, Kofidis does not teach wherein said tissue material comprises a calcification-resistant implantable biomaterial. However, Neethling teaches an implantable biomaterial (abstract, Neethling)
wherein said tissue material comprises a calcification-resistant implantable biomaterial (calcification resistant biomaterial comprising cross-linked collagen, ¶0058, Neethling).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Kofidis by incorporating the teaching above as taught by Neethling in order to prevent calcification, calcification can result in undesirable stiffening or degradation of the biomaterial (¶0128, Neethling).
Conclusion
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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