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 1-19 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.
Regarding claim 1, lines 5-6, the Examiner is not clear what does the applicant’s representative means with the following: “interior channel housing substantially the valve component…”. “substantially the size of the valve component” ? or substantially what? Correction or clarification is required.
In claim 2, lines 3 and 4, the Examiner is not clear on the location of the “first and second attachment positions. Do the attachment positions are located in the valve component or the frame?
Claim 2, lines 4-6 are indefinite because the claim is positively claiming a first and second patch. However, claim 1 is already claiming a patch in the valve component.
The Examiner believes “the valve component” should be replaced by ---the patch---.
Additionally, how does the first and second patches are distinct from one another. The Examiner has not found in the written specification how the patches are different.
Claim 3, line 14, discloses “the free edge being supported at an attachment position”. the Examiner is not clear on the location of the “attachment position”. Does the attachment position is located in the valve component or the frame? Correction or clarification is required.
Claim 3, lines 17 and 18, what does the applicant is trying to say with the following sentence: “extending to the attachment position and/or to neighboring tissue, for reinforcing the valve member near and/or at the attachment position”. Correction or clarification is required.
Claim 4, lines 3-5 are indefinite because the claim is positively claiming a first and second extensions. However, claim 1 is already claiming an extension in the valve component.
The Examiner believes “the valve member” should be replaced by ---the extension---.
Claim 4, lines 5-7 are indefinite because the claim is positively claiming a first and second patch. However, claim 1 is already claiming a patch in the valve component.
The Examiner believes “the valve component” should be replaced by ---the patch---.
Claim 4, line 8, how does the first and second patches are distinct from one another. The Examiner has not found in the written specification how the patches are different.
Claim 5, lines 2-3 are unclear. The Examiner is not clear about the junction. Does the junction is part of the valve member or is between the valve member and the frame or is part of the frame. Correction or clarification is required.
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 1-13, 15-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braido et al US patent Pub. 2015/0265401A1.
Regarding claims 1 and 20, Braido et al discloses a prosthetic valve (100) comprising a frame (110) and a valve component (208), the frame and valve component, the frame (110) having an interior channel housing (see Fig. 3C) substantially the valve component, the valve component comprising a valve member of biological tissue (see paragraph 27). The valve member comprising a leaflet body (108 or 208) with a free edge, and an extension integral with the leaflet body, the leaflet body capable of flexing with respect to the extension between an open condition and a closed condition of the leaflet body, the leaflet body being a primary leaflet of the valve component spanning a majority of the interior channel, at least in the closed condition of the leaflet body, and the extension extending in a circumferential direction with respect to the frame (see Fig. 3C). The valve component further comprising a patch (28) of flexible reinforcing material overlapping partly and in face-to-face contact with the leaflet body
Regarding claim 2, see Fig. 3B showing the first and second ends (212) and two patches attached to the ends. Regarding the first and second attachment positions, the Examiner is interpreting those areas as the areas that are connected to the frame of the implant as shown in Fig. 3C. Finally, the patches are different from each other since they are two separated components.
Regarding claim 3, the attachment portion has been interpreted as the area that the commissures are located in the implant, therefore, the free edge being supported at the attachment position.
Regarding claim 4, the free edge is element (210) in Fig. 3B, the two ends is where element 210 and 212 join. The first and second extensions are the left and right element (300) as shown in Fig. 3B. Regarding the patches, the right and left patches are different since they are two separated structures.
Regarding claim 5, the first and second extensions are coupled to each other by element 214, see Fig. 3B. Element 214 is the junction.
Regarding claims 6 and 7, the patches extend adjacent to a first portion (see below) of a free edge of the leaflet body, the free edge includes a free portion without the patch (see figure below).
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Regarding claim 8, it is inherent to have a coaptation and a non-coaptation faces.
Regarding claim 9 and 10, see Fig. 3B showing the patches joined to the leaflet body and see paragraph 32, lines 9-11 disclosing sutures to attach the patches.
Regarding claim 11, see paragraph 27.
Regarding claim 12, as disclosed in paragraph 31, the patches can be made of fabric material. Therefore, the fibers will have at least one alignment direction and will have a predetermined orientation with respect to a fiber orientation of the tissue of the leaflet body.
Regarding claim 13, it will be inherent to have at least one layer to create the patch.
Regarding claim 15, see paragraph 29.
Regarding claim 16, see figure above disclosing that the 1st portion is less than 30%.
Regarding claim 17, the patch does not project further than the free edge.
Regarding claim 18, as disclosed in paragraph 27 the tissue can be pericardiac tissue.
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.
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.
Claims 14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al US patent Pub. 2015/0265401A1 in view of Nguyen et al US Patent Pub. 2012/0089223A1.
Braido et al discloses the invention substantially as claimed. However, Braido et al does not disclose a reinforcement patch clearly mentioning that the fabric sheet is made of a woven configuration.
Nguyen et al discloses an implantable heart valve comprising a reinforcement patch (220, see Fig. 28) made of a woven configuration (see paragraph 86). It is well known that sheets made of woven fabric comprises a set of weft and warp that runs parallel and perpendicular from each other.
It would have been obvious to one ordinary skill in the art to use a reinforcing patch having a woven fabric, as disclosed by the Nguyen et al reference, in the Braido et al reference in order to have a configuration having a perpendicular and parallel fibers.
Regarding claim 14, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the patch of the Braido et al reference by using a woven fabric because Applicant has not disclosed that by having a woven fabric provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the fabric of the Braido et al reference because it would perform equally as well.
Therefore, it would have been an obvious matter of design choice to modify the Braido et al reference to obtain the invention as specified in claim 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/ Primary Examiner, Art Unit 3799 7/8/26
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