DETAILED ACTION
The following is a non-final office action is response to communications received on 02/13/2024. Claims 1-20 are currently pending and addressed below.
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 § 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.
Claim(s) 1, 2, 4, 7, 10-14, 16 & 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eberhardt et al. (US 10,413,401).
PNG
media_image1.png
603
766
media_image1.png
Greyscale
PNG
media_image2.png
658
766
media_image2.png
Greyscale
Regarding Claim 1, Eberhardt teaches a prosthetic heart valve (1200) comprising: an annular frame (1202); a leaflet structure (104) positioned within the frame; and an outer skirt (1260) positioned around an outer surface of the frame (Fig 12), wherein the outer skirt comprises a main body (1259) and at least one strip (1250) of material mounted on an outer surface of the main body (Fig 12), wherein the at least one strip protrudes outward from the outer surface of the main body and away from the frame (Fig 12 and Col 11: lines 21-26).
Regarding Claim 2, Eberhardt teaches wherein the at least one strip (1250) includes a plurality of strips spaced apart from one another around the main body (Figs 12 & 13).
Regarding Claim 4, Eberhardt teaches wherein the at least one strip comprises a non-stretchable material (e.g., Nitinol, as taught in Col 13: lines 2-6).
Regarding Claim 7, Eberhardt teaches wherein the at least one strip (strip and attachment mechanism) comprises a suture (Col 11: lines 42-45).
Regarding Claim 10, Eberhardt teaches wherein the outer skirt comprises an outflow edge portion (shown) and an inflow edge portion (shown), and wherein the outflow edge portion and the inflow edge portion are secured to the frame with sutures (via sutures taught in Col 11: lines 41-45 and Col 7: lines 65-67).
Regarding Claim 11, Eberhardt teaches wherein the outer skirt comprises an outflow edge portion (shown) and an inflow edge portion (shown), and wherein the outflow edge portion comprises a plurality of projections. The examiner interprets projections as the portion of swellable skirt (1260) that extend past (and radially beyond) strips (1250).
Regarding Claim 12, Eberhardt teaches wherein the frame (1200) comprises a plurality of rows of angled struts (shown) arranged between an inflow end and an outflow end of the frame, wherein the outer skirt (1260) comprises an outflow edge (shown) portion and an inflow edge (shown) portion, and wherein the inflow edge portion is attached to a first row of angled struts (shown) of the plurality of rows of angled struts that define the inflow end of the frame and the outflow edge portion is attached to a second row of angled struts (shown) of the plurality of rows of angles struts that is arranged between the inflow end and the outflow end.
Regarding Claim 13, Eberhardt teaches wherein the heart valve further comprises an inner skirt (shown) positioned around an inner surface of the frame and secured thereto.
Regarding Claim 14, Eberhardt teaches a prosthetic heart valve (1200) comprising: an annular frame (1200) comprising an inflow end (shown) and an outflow end (shown) and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration (Col 4: lines 48-53); a leaflet structure (104) positioned within the frame and secured thereto; and an outer skirt (1260) positioned around an outer surface of the frame (Fig 12), wherein the outer skirt comprises a main body (1259) and a plurality of strips (1250) mounted on an outer surface of the main body (Fig 12), wherein the plurality of strips forms a repeating U-shaped pattern (shown) around the main body .
Regarding Claim 16, Eberhardt teaches wherein the plurality of strips comprises a non-stretchable material (e.g., Nitinol, as taught in Col 13: lines 2-6).
Regarding Claim 17, Eberhardt teaches wherein spaces (shown) on the outer surface of the main body (1259) without the plurality of strips (1250) thereon are formed between adjacent strips of the plurality of strips.
Claim(s) 1, 3, 5, 6, 8, 14, 15 & 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braido et al. (US 8,808,356).
PNG
media_image3.png
589
700
media_image3.png
Greyscale
Regarding Claim 1, Braido teaches a prosthetic heart valve (Fig 10) comprising: an annular frame (10); a leaflet structure (70) positioned within the frame; and an outer skirt (shown) positioned around an outer surface of the frame, wherein the outer skirt comprises a main body (shown) and at least one strip (220) of material mounted on an outer surface of the main body (Fig 10), wherein the at least one strip protrudes outward from the outer surface of the main body and away from the frame (Fig 10).
Regarding Claim 3, Braido teaches wherein the at least one strip (220) includes a plurality of interconnected strips extending around the main body such that each strip is arranged end-to-end with two adjacent strips of the plurality of interconnected strips (as shown in Fig 10).
Regarding Claim 5, Braido teaches wherein the at least one strip (220) comprises a woven fabric (Col 7: lines 50-57).
Regarding Claim 6, Braido teaches wherein the at least one strip comprises a non-woven fabric (Col 7: lines 50-57).
Regarding Claim 8, Braido teaches wherein the main body comprises pericardial tissue (Col 7: lines 50-57).
Regarding Claim 14, Braido teaches a prosthetic heart valve (Fig 10) comprising: an annular frame (10) comprising an inflow end (shown) and an outflow end (shown) and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration (Col 2: lines 54-60); a leaflet structure (70) positioned within the frame and secured thereto; and an outer skirt (shown) positioned around an outer surface of the frame (Fig 10), wherein the outer skirt comprises a main body (shown) and a plurality of strips (220) mounted on an outer surface of the main body, wherein the plurality of strips forms a repeating U-shaped pattern (shown) around the main body.
Regarding Claim 15, Braido teaches wherein the plurality of strips (220) comprises an absorbent material (Col 7: lines 50-57).
Regarding Claim 18, Braido teaches wherein the main body comprises pericardial tissue (Col 7: lines 50-57).
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.
Claim(s) 9, 19 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Braido et al. (US 8,808,356) in view of Wang et al. (US 2017/0056164).
PNG
media_image4.png
295
413
media_image4.png
Greyscale
Regarding Claim 9, as set forth supra, Braido discloses the invention substantially as claimed. However, Braido does not specifically disclose wherein the pericardial tissue of the outer skirt has a fibrous parietal layer defining a first surface of the outer skirt and a serous parietal layer defining a second surface of the outer skirt.
Wang teaches an implantable prosthetic valve comprising: an annular frame (102) comprising an inflow end (near 118) and an outflow end (near 116) and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration [0030]; and an outer skirt (330/332) positioned around an outer surface of the frame (Figs 3 & 7-11), wherein the outer skirt comprises pericardial tissue [0039] having a fibrous parietal layer defining a first surface (fibrous layer of Fig 4) of the outer skirt and a serous parietal layer (parietal layer of Fig 4) defining a second surface of the outer skirt, for sealing and preventing paravalvular leakage [0038].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the pericardial tissue of the outer skirt, as taught by Braido, with the orientation as taught by Wang in order to seal and prevent paravalvular leakage. Said combination would result in a device wherein the pericardial tissue of the outer skirt has a fibrous parietal layer defining a first surface of the outer skirt and a serous parietal layer defining a second surface of the outer skirt.
Regarding Claim 19, Braido discloses the invention substantially as claimed. Braido teaches a prosthetic heart valve (Fig 10) comprising: an annular frame (10) comprising an inflow end (shown) and an outflow end (shown) and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration (Col 2: lines 54-60); a leaflet structure (70) positioned within the frame and secured thereto (Fig 10); and an outer skirt (shown) positioned around an outer surface of the frame, wherein the outer skirt comprises: a main body (shown) comprising pericardial tissue (Col 7: lines 50-57); and a plurality of strips (220) of material mounted on an outer surface of the main body (Fig 10).
However, Braido does not specifically disclose wherein the pericardial tissue having a fibrous parietal layer defining a first surface of the outer skirt and a serous parietal layer defining a second surface of the outer skirt.
Wang teaches an implantable prosthetic valve comprising: an annular frame (102) comprising an inflow end (near 118) and an outflow end (near 116) and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration [0030]; and an outer skirt (330/332) positioned around an outer surface of the frame (Figs 3 & 7-11), wherein the outer skirt comprises pericardial tissue [0039] having a fibrous parietal layer defining a first surface (fibrous layer of Fig 4) of the outer skirt and a serous parietal layer (parietal layer of Fig 4) defining a second surface of the outer skirt, for sealing and preventing paravalvular leakage [0038].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the pericardial tissue of the outer skirt, as taught by Braido, with the orientation as taught by Wang in order to seal and prevent paravalvular leakage.
Said combination would result in a device wherein the pericardial tissue of the outer skirt has a fibrous parietal layer defining a first surface of the outer skirt and a serous parietal layer defining a second surface of the outer skirt.
Regarding Claim 20, the combination teaches wherein the plurality of strips (220) is arranged end-to-end (shown) around the main body, and wherein each strip of the plurality of strips protrudes outward from the outer surface of the main body and away from the frame (Fig 10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN AINSLEY DUKERT whose telephone number is (571)270-3258. The examiner can normally be reached Mon-Fri 6am-4pm.
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 (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
Prosecution Insights