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 1-20 are pending and examined below.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0039] refers to the outer skirt with reference character 60, however, 60 was used to reference an inner skirt in [0038].
Paragraph [0040] appears to have a typographical error, “lafket tabs 96”. Examiner recommends it to be corrected to “leaflet tabs.”
Appropriate correction 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cohen-Tzemach et al. (US 20200352710 A1) hereinafter, Cohen.
Regarding claim 1, Cohen teaches a balloon-expandable (¶0033) prosthetic heart valve (10, Fig. 1) comprising:
a collapsible and expandable stent (12, Fig. 1) comprising a plurality of commissure attachment features (48, Fig. 3); and
a valve assembly (14, Fig. 2) coupled to the collapsible and expandable stent (12, Fig. 1),
the valve assembly (14, Fig. 2) comprising a plurality of leaflets (24, Fig. 2), and
a pleated outer cuff having a plurality of shape-set pleats (18, 20, & 22, Fig. 1),
the pleated outer cuff being coupled (sutured at 52 to 12, Fig. 1) to the collapsible and expandable stent (12, Fig. 1) at positions between the plurality of shape-set pleats (Fig. 1, ¶0045).
Regarding claim 2, Cohen teaches
wherein the pleated outer cuff (18, 20, & 22, Fig. 1) comprises three pleats (Fig. 1).
Regarding claim 3, Cohen teaches
wherein each of the three pleats (18, 20, & 22, Fig. 1) has a same shape and size (can have the same height, Figs. 1 & 5, ¶0042).
Regarding claim 4, Cohen teaches
wherein the three pleats (18, 20, & 22, Fig. 1) are uniformly spaced apart from one another (lightly axially spaced from each other along the length of the frame, ¶0044).
Regarding claim 5, Cohen teaches
wherein the three pleats (18, 20, & 22, Fig. 1) are non-uniformly spaced apart from one another (spacing between adjacent outer skirts can vary along the length of the frame, ¶0044).
Regarding claim 6, Cohen teaches
wherein the three pleats (18, 20, & 22, Fig. 1) include a proximalmost pleat (18, Fig. 1) that is spaced from a proximal edge of the pleated outer cuff (30 can be attached to lower edge of inner skirt, there is excess material between 30 and 32, which causes the skirt to billow outwardly, Figs. 1 & 5, ¶0043 & 0047).
Regarding claim 7, Cohen teaches
wherein the three pleats (18, 20, & 22, Fig. 1) include a distalmost pleat (22, Fig. 1) that is spaced from a distal edge of the pleated outer cuff (32 can be attached frame 12, there is excess material between 30 and 32, which causes the skirt to billow outwardly, Figs. 1 & 5, ¶0043 & 0047).
Regarding claim 8, Cohen teaches
wherein each of the three pleats (18, 20, & 22, Fig. 1) radially extends between 1.5 mm and 2 mm from an inner diameter of the outer cuff (valve extends to about 10-16 mm, and sealing zone is approximately 12-20 mm, therefore there is a 2-4 mm clearance for the pleats to extend, ¶0052). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
Regarding claim 9, Cohen teaches
wherein the pleated outer cuff has a path length of between 16 mm and 17 mm (valve extends to about 10-16 mm, therefore the path length would fall within the given ranges of between 16 and 17 mm, ¶0052). It has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)).
Regarding claim 10, Cohen teaches
wherein the pleated outer cuff comprises six pleats (six outer skirts, ¶0042).
Regarding claim 11, Cohen teaches
wherein the pleated outer cuff is formed of a flat sheet (Fig. 5) that is joined together at a seam (sutured or otherwise secured, Fig. 1, ¶0043).
Regarding claim 12, Cohen teaches
wherein the pleated outer cuff is formed of a unitary tubular structure (tubular or cylindrical shape, Fig. 1, ¶0041).
Regarding claim 13, Cohen teaches
further comprising an inner cuff (16, Fig. 1) coupled to the outer cuff (18, 20, & 22, Fig. 1).
Regarding claim 14, Cohen teaches a balloon-expandable (¶0033) prosthetic heart valve (10, Fig. 1) comprising:
a collapsible and expandable stent (12, Fig. 1) comprising a plurality of commissure attachment features (48, Fig. 3), and
a plurality of cells disposed in rows of cells (Fig. 3); and
a valve assembly (14, Fig. 2) coupled to the collapsible and expandable stent (12, Fig. 1),
the valve assembly (14, Fig. 2) comprising a plurality of leaflets (24, Fig. 2) and a pleated outer cuff having a plurality of pleats (18, 20, & 22, Fig. 1),
the plurality of pleats (18, 20, & 22, Fig. 1) being coupled to selected ones of the plurality of cells (coupled to 44, Fig. 3); wherein,
in an expanded condition, the plurality of pleats is configured to form independent, axially-spaced apart sealing rings around an entire circumference of the valve assembly (18, 20, & 22, Fig. 1).
Regarding claim 15, Cohen teaches
wherein the pleated outer cuff comprises three pleats (18, 20, & 22, Fig. 1).
Regarding claim 16, Cohen teaches
wherein a number of the plurality of pleats and a number of the rows of cells is equal (3 pleats and 3 rows of cells, Figs. 1 & 3).
Regarding claim 17, Cohen teaches
further comprising a plurality of connection points (52 at 34, Fig.1) disposed in rows of connection points (Fig. 1), the rows of connection points alternating with the plurality of pleats (36 and 38 of one outer skirt can be angularly or circumferentially offset from the notches and the openings of another outer skirt, ¶0046, therefore the rows of connection points would alternate with the connecting points).
Regarding claim 18, Cohen teaches
wherein the plurality of pleats (18, 20, & 22, Fig. 1) includes a proximalmost pleat (18, Fig. 1) that is spaced from a proximal edge of the pleated outer cuff (30 can be attached to lower edge of inner skirt, there is excess material between 30 and 32, which causes the skirt to billow outwardly, Figs. 1 & 5, ¶0043 & 0047).
Regarding claim 19, Cohen teaches
wherein the plurality of pleats (18, 20, & 22, Fig. 1) includes a distalmost pleat (22, Fig. 1) that is spaced from a distal edge of the pleated outer cuff (32 can be attached frame 12, there is excess material between 30 and 32, which causes the skirt to billow outwardly, Figs. 1 & 5, ¶0043 & 0047).
Regarding claim 20, Cohen teaches a balloon-expandable (¶0033) prosthetic heart valve (10, Fig. 1) comprising:
a collapsible and expandable stent (12, Fig. 1) comprising a plurality of commissure attachment features (48, Fig. 3), and
a plurality of cells disposed in rows of cells (Fig. 3); and
a valve assembly (14, Fig. 2) coupled to the collapsible and expandable stent (12, Fig. 1),
the valve assembly (14, Fig. 2) comprising a plurality of leaflets (24, Fig. 2),
an inner cuff (16, Fig. 1) covering a first set of the plurality of cells (Fig. 4), and
a pleated outer cuff (18, 20, & 22, Fig. 1) covering a second set of the plurality of cells (Figs. 1 & 4),
the pleated outer cuff having a plurality of pleats (18, 20, & 22, Fig. 1), the plurality of pleats being coupled to selected ones of the plurality of cells (52 at 34, Fig.1); wherein,
the second set is greater than the first set (Fig. 4), and
in an expanded condition (Fig. 6), the inner cuff and the outer cuff are configured and arranged to receive fluid therebetween so that the plurality of pleats form independent, axially-spaced apart sealing rings around an entire circumference of the valve assembly (physical obstruction to the flow, forming a good fluid tight seal between the valve and the native annulus, 72 represent retrograde blood flow that flows in the opposite direction on the outside of the prosthetic valve, Figs. 1 & 6, ¶0049 & ¶0051).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 EST.
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, Jerrah Edwards can be reached at (408) 918-7557. 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.
/K.X.W./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
