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 .
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.
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) 1-4, 6-8, and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keidar et al. (US20100076549).
Regarding claim 1, Keidar discloses an annuloplasty ring (90, 110, 190; see Figs. 4A-D or 5A-D or 10A-D) for treating a heart valve (see paragraph [0011]) comprising: a first body portion (92, 112, or see annotated figure below); a second body portion (94, 114, or see annotated figure below); and a first deformable portion (102, 116, or see annotated figure below) situated between the first body portion and the second body portion; wherein the first body portion, the second body portion, and the first deformable portion are configured to be attached to an annulus portion of the heart valve (see paragraph [0011]).
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Regarding claim 2, Keidar further discloses the annuloplasty ring (190, see figs. 10A-D) further comprising an outer covering configured to surround the first body portion, the second body portion, and the first deformable portion (see paragraph [0081], covering is used to cover the core of the annuloplasty ring which includes the body and deformable portions).
Regarding claim 3, Keidar further discloses the first deformable portion (102) is configured to break in response to expansion forces (see paragraph [0060], restraint 102 may include breakable materials)
Regarding claim 4, Keidar further discloses the first deformable portion (116) is configured to bend in response to expansion forces (see paragraph [0061], restraint 116 is a plastically deformable material (e.g., a bendable metal)).
Regarding claim 6, Keidar further discloses wherein the first body portion, the second body portion, and the first deformable portion are configured to form a continuous ring (see Figs. 10A-D).
Regarding claim 7, Keidar further discloses the annuloplasty ring (see Figs. 10A-D) further comprising a second deformable portion (see annotated figure below) situated between the first body portion and the second body portion and across from the first deformable portion (see annotated figure below).
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Regarding claim 8, Keidar further discloses wherein the first body portion, the second body portion, the first deformable portion, and the second deformable portion are configured to form a continuous ring in a generally circular shape (see annotated figure above, the 4 portions form a continuous circular ring).
Regarding claim 11, Keidar further discloses the annuloplasty ring further comprising: a third body portion (see annotated figure below); a second deformable portion (see annotated figure below) situated between the second body portion and the third body portion (see annotated figure below); and a third deformable portion (see annotated figure below) situated between the first body portion and the third body portion (see annotated figure below).
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Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCarthy (WO2016200993).
Regarding claim 1, McCarthy discloses an annuloplasty ring (80) for treating a heart valve comprising: a first body portion (see annotated figure below); a second body portion (see annotated figure below); and a first deformable portion (90) situated between the first body portion and the second body portion; wherein the first body portion, the second body portion, and the first deformable portion are configured to be attached to an annulus portion of the heart valve (see paragraph [0034], describes the ring allows for normal stretching and function of the heart valve).
Regarding claim 5, McCarthy discloses the first body portion, the second body portion, and the first deformable portion are configured to form a partial ring with a gap between the first body portion and the second body portion (see annotated figure below).
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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) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keidar as applied to claim 1 above, and further in view of Lim et al. (US20050256569).
Regarding claim 9, Keidar fails to disclose wherein the first body portion, the second body portion, the first deformable portion, and the second deformable portion are configured to form a continuous ring having a first generally flat portion.
Lim also discloses an annuloplasty ring (see fig. 4) with a first body portion (22a), a second body portion (22e), a first deformable portion (22b), and a second deformable portion (24d). Lim teaches the first body portion (22a), the second body portion (22e), the first deformable portion (22b), and the second deformable portion (24d) are configured to form a continuous ring having a first generally flat portion (see Fig. 4, the ring is in a “D”-shape and 22a-e all lie on a generally straight part of the ring). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the annuloplasty ring of Keidar such that the first body portion, the second body portion, the first deformable portion, and the second deformable portion are configured to form a continuous ring having a first generally flat portion, as taught by Lim, in order for the ring to better conform to the valve annulus (see paragraph [0024]).
Regarding claim 10, Keidar as modified by Lim discloses wherein the first deformable portion (22b) is situated at the first generally flat portion (see fig. 4, 22b lies on the straight edge of the “D”-shaped ring).
Claim(s) 12-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keidar.
Regarding claim 12, Keidar discloses a method for treating a heart valve (see figs. 6B-D) comprising: delivering a deformable device (10) to an annulus (136) of the heart valve (Fig. 6B) and delivering a subsequent prosthetic heart valve (132; see figs. 6B-D and paragraph [0064], describes the catheter delivering a prosthetic heart valve); permanently deforming the annuloplasty ring (see paragraph [0066]); and attaching the prosthetic heart valve (132) at the heart valve (see paragraph [0067]).
Keidar teaches other embodiments of an annuloplasty ring (90, 110, 190) for treating a heart valve (see Figs. 4A-D or 5A-D or 10A-D) comprising: a first body portion (92, 112, or see annotated figure seen below); a second body portion (94, 114, or see annotated figure seen below); and a first deformable portion (102, 116, or see annotated figure seen below) situated between the first body portion and the second body portion; wherein the first body portion, the second body portion, and the first deformable portion are configured to be attached to an annulus portion of the heart valve (see paragraph [0011]).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the annuloplasty ring (10) of Figs. 6B-6D of Keidar with any of the annuloplasty rings (90, 110, 190) of Kiedar’s Figs. 4A-D, 5A-D, or 10A-D, as doing so would have yielded predictable results, namely, provided a suitable means for properly reshaping/repairing a damaged heart valve and for accommodating/assisting implantation of an expandable heart valve within the heart valve annulus (see paragraph [0010]).
Regarding claim 13, Keidar as modified further discloses the subsequent repair device is a replacement heart valve (132, see paragraph [0066] and [0067]).
Regarding claim 14, Keidar as modified further discloses the annuloplasty ring (190) further comprising an outer covering configured to surround the first body portion, the second body portion, and the first deformable portion (see paragraph [0081], covering is used to cover the core of the annuloplasty ring which includes the body and deformable portions).
Regarding claim 15, Keidar as modified further discloses the first deformable portion (102) is configured to break in response to expansion forces (see paragraph [0060], restraint 102 may include breakable materials).
Regarding claim 16, Keidar as modified further discloses the first deformable portion (116) is configured to bend in response to expansion forces (see paragraph [0061], restraint 116 is a plastically deformable material (e.g., a bendable metal)).
Regarding claim 18, Keidar as modified further discloses wherein the first body portion, the second body portion, and the first deformable portion are configured to form a continuous ring (see Figs. 10A-D or annotated figure above).
Regarding claim 19, Keidar as modified further discloses the annuloplasty ring (see Figs. 10A-D) further comprising a second deformable portion (see annotated figure below) situated between the first body portion and the second body portion and across from the first deformable portion (see annotated figure below).
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Regarding claim 20, Keidar as modified further discloses the annuloplasty ring further comprising: a third body portion (see annotated figure below); a second deformable portion (see annotated figure below) situated between the second body portion and the third body portion (see annotated figure below); and a third deformable portion (left most arrow in annotated figure below) situated between the first body portion and the third body portion (see annotated figure below).
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Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keidar as applied to claim 12 above, and further in view of McCarthy.
Regarding claim 17, Kaider fails to disclose wherein the first body portion, the second body portion, and the first deformable portion are configured to form a non-continuous ring with a gap between the first body portion and the second body portion.
McCarthy also discloses an annuloplasty ring (80) for treating a heart valve. McCarthy teaches the annuloplasty ring (80) comprises a first body portion (see annotated figure below); a second body portion (see annotated figure below); and a first deformable portion (90) situated between the first body portion and the second body portion; wherein the first body portion, the second body portion, and the first deformable portion are configured to be attached to an annulus portion of the heart valve (see paragraph [0034], describes the ring allows for normal stretching and function of the heart valve), wherein the first body portion, the second body portion, and the first deformable portion are configured to form a partial ring with a gap between the first body portion and the second body portion (see annotated figure below).
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Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the annuloplasty ring of Keidar with the annuloplasty ring taught by McCarthy, as doing so would have yielded predictable results, namely, provided a suitable means for properly reshaping/repairing a damaged heart valve and provided a suitable platform for receiving a prosthetic heart valve (see paragraphs [0006] and [0008]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN ZHI-DE YAO whose telephone number is (571)272-5449. The examiner can normally be reached Monday - Friday 8:00 am to 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN ZHI-DE YAO/Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774