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 § 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 21 and 29-32 are 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 21, the rays lack antecedent basis.
Claim 22, it is the examiner’s position that applicant’s device is not axisymmetric. Axisymmetric is three dimensional not just an end view.
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Claim 29, “first end is the securing member” is unclear. Should this read -- first end is the securing end--?
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)(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 16-17, 21-24 and 29-31 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duran (5,545,215).
Referring to all figures, Duran teaches a device for heart valve repair configured to be implanted around a heart valve of a subject (see at least the abstract and 3:16-21), the heart valve comprising, an annulus and at least two leaflets, the device comprising:
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a base (depicted) configured to fit around the annulus of the heart valve, so as to limit a radially outward displacement of said annulus;
at least two elongated members (depicted) extending from the base, each elongated member extending parallel to a longitudinal axis and ending in a free top opposite to the base and being sized to extend between the annulus of the heart valve and a commissure between the at least two leaflets (self-evident);
a securing member (depicted) configured to join at least two free tops (as shown), so as to limit an outward displacement of said free tops when the device is implanted around the heart valve.
Claim 17, the securing member is a band as shown and made of plastic, biocompatible resorbable material which is inherent flexible to some degree or point in time. See claims 15-17.
Claim 21, see figure 1a showing the base is annular and the elongated members are spaced apart 120 degrees.
Claim 22, see at least figure 1a wherein the device is axisymmetric with respect to the longitudinal axis.
Claim 23, the longitudinal axis is perpendicular to the base as shown.
Claim 24, the device is sized to be applied to support the aortic root like applicant’s device. Additionally, given the large range of between 20% and 40%, the examiner takes the position that the claim is meet.
Claim 29: An aortic root replacement prosthesis comprising a tubular portion 28 having a first end (generally 28) configured to be implanted as replacement of a portion of an ascending aorta which begins at the aortic root and a second end configured to be implanted as replacement of the aortic root 48, said second end forming at least two lobes, each lobe closely fitting the space between two adjacent elongated members of the device according to claim 16, and wherein the first end is the securing member. See at least figure 9-10.
Claim 30, wherein the elongated members and the base are made of metal or metal alloy or polymers; see at least claims 15-17.
Claim 31 is interpreted as a product-by-process claim which fails to differentiate the final product.
Claims 16-31 are are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bulman-Fleming et al (2006/0015179).
Referring to all figures including 4-6, Bulman-Fleming et al et al teaches a device for heart valve repair configured to be implanted around a heart valve of a subject (see at least par. 0059-0062), the heart valve comprising, an annulus and at least two leaflets, the device comprising:
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a base (depicted, 211) configured to fit around the annulus of the heart valve, so as to limit a radially outward displacement of said annulus;
at least two elongated members (212) extending from the base, each elongated member extending parallel to a longitudinal axis (see at least par. 0119 and figures 21B-21G) and ending in a free top (terminal ends, for example 218) opposite to the base and being sized to extend between the annulus of the heart valve and a commissure between the at least two leaflets (self-evident);
a securing member (for example 300) configured to join at least two free tops so as to limit an outward displacement of said free tops when the device is implanted around the heart valve.
Claim 17, wherein the securing member is a flexible band 501.
Claim 18, wherein each elongated member is surrounded by a fabric 600.
Claim 19, wherein each elongated member is surrounded by at least one strip of fabric 600, see at least par. 0081.
Claim 20, wherein the device is fully capable functioning in a cardiac cycle and flexing wherein it does not have an axis of symmetry.
Claim 21, base is annular and the elongated members are spaced apart such that the angles defined by the rays emanating from the center of the annular base to two consecutive elongated members and are comprised between 110° and 190° which is inherently fulfilled aligning with the commissures.
Claim 22, wherein the device is axisymmetric with respect to the longitudinal axis; see at least figures 14, 22B-22C.
Claim 23, the longitudinal axis is perpendicular to the base as shown in figure 6 above.
Claim 24, the device is sized to be applied to support the aortic root like applicant’s device. Additionally, given the large range of between 20% and 40%, the examiner takes the position that the claim is meet.
Claim 25 is self-evident.
Claim 26, the two linear portions of adjacent arc-shaped members are joined together via the securing member along a length of 75% or less of the total length of the linear portion. See the figure 6 above.
Claim 27, device according to claim 25, is fully capable of: the device is configured to be wrapped from an open configuration in which the device is roughly planar and the base has an elongated shape, to a wrapped configuration in which the device is cylindrical and the base has an annular shape. See at least par. 0133-0134 and figures 23A-23C.
Claim 28, see at least par. 0133-0134 and figures 23A-23C teaching a detachable link 391 and 392.
Claim 29, an aortic root replacement prosthesis comprising a tubular portion having a first end 75 configured to be implanted as replacement of a portion of an ascending aorta which begins at the aortic root and a second end configured to be implanted as replacement of the aortic root, said second end forming at least two lobes 75, each lobe closely fitting the space between two adjacent elongated members of the device according to claim 16, and wherein the first end is the securing member (end?).
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Claim 30, wherein the elongated members and the base are made of metal or metal alloy or polymers; see at least par. 0063 teaching titanium-alloy, stainless steel, etc.
Claim 31 is interpreted as a product-by-process claim which fails to differentiate the final product.
Claim 32, see at least par. 0081.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRUCE E SNOW/ Primary Examiner, Art Unit 3774
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