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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/02/26 has been entered.
Response to Arguments
Applicant's arguments filed 12/01/25 have been fully considered but they are not persuasive.
On page 5 regarding 112a rejections, Applicant argues amendments overcome the rejections of record.
The Examiner respectfully disagrees, noting the amendment keeps new matter within the claim. Please see the 112 rejection below.
On page 6 regarding 112b rejections Applicant argues paragraphs [0099]-[0100], [0114]-[0115], and Figures 8-9, 17-18 make claim 12 clear.
The Examiner respectfully disagrees, noting amendments keep the confusing language regarding a belly stitch in the claim, and so the rejection is maintained.
On page 7 regarding prior art rejections Applicant argues Yohanan does not disclose connecting a leaflet assembly to the laser cut frame, and also does not disclose connecting the leaflet to the frame at lashed crossing points and loops. Applicant argues Yohanan teaches securing a leaflet to a skirt which is then secured to the frame. The Applicant argues further that the Examiner has defined the lashed crossing points and looping structures as one element.
The Examiner respectfully disagrees. The rejection of record defines the “leaflet assembly” as including the structures of figures 6-7, which includes the skirt 16. Thus, suggestions that the leaflet is secured to the skirt which is secured to the frame, supports the Examiner’s assertion that the leaflet assembly (the structure represented by both structures of figures 6-7) is secured to the frame. Yohanan thus adequately meets the language of the claim. A regards the suggestion that the loops and crossing points are the same structure, the Examiner disagrees, pointing out, as the rejection of record states, that the loops can be seen via the “struts that form structures which loop circumferentially around the inflow and outflow end to form the frame”, and the crossing points are represented by “the lashed crossing points of the frame are considered to be the points at which sutures cross the frame to secure the leaflet assembly thereto”. These structures are accordingly distinct, as the rejection of record supports.
On pages 7-8 Applicant argues further that it is “incorrect” that Yohanan can be modified by Boudjemline, since Boudjemline does not disclose a leaflet assembly being connected to a tubular braided frame at lashed crossing points, but instead also teaches their stent can include a covering, and that the valve can be sutured within the tubular portion.
The Examiner respectfully disagrees, noting that it is not incorrect to modify a reference by a second reference, and understands this to be the reasoning behind rejections made under 35 U.S.C. 103. Further, it is unclear to the Examiner what Boudjemline’s stent including a covering has to do with the claimed invention. A stent’s covering, whether present or not, does not appear to affect whether or not a “leaflet assembly” attaches to the frame. Further, since the rejection of record defines the skirt as being a part of the assembly, the covering of Boudjemline appears to correspond perfectly to the prior art of Yohanan.
Special Definitions:
[0099] “A belly stitch”: a stitch originating at the edge seams of the Z-valve insert and following a wire to define an edge of a leaflet, with the option to attach to one of the wires of the frame and/or cuff
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12 is rejected for having new matter for claiming “the leaflet assembly is connected to the tubular braided frame by at least a belly stitch angled from a distal outer section of the leaflet assembly towards a middle center of the leaflet assembly”, when the originally filed description fails to have support for the belly stitch to connect the leaflet assembly to the tubular braided frame.
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.
Claim 12 is 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 12 is indefinite for claiming “the leaflet assembly is connected to the tubular braided frame by at least a belly stitch angled from a distal outer section of the leaflet assembly towards a middle center of the leaflet assembly”. However, the special definition provided by Applicant’s specification (see above), indicates that a “belly stich” is defined as a stitch originating at the edge seams of a Z-valve insert and following a wire to define an edge of a leaflet with the option to attach to one of the wires of the frame and/or cuff. However, this is unclear, since there is no “edge seams”, “z-valve insert”, “wire”, or even a “leaflet” in the claimed invention, making it unclear how this “belly stitch” exists and how it relates to the claimed invention, since the claimed invention apparently has nothing to do with the “special definition” of a belly stitch that Applicant provided in [0099] of their specification. The Examiner is unable to understand the meaning of the claim.
The claim is further indefinite for claiming “the leaflet assembly is connected to the tubular braided frame by at least a belly stitch” when claim 1, from which this claim depends, states that “the leaflet assembly is connected to the tubular frame at lashed crossing points”. It is unclear how, if at all, the “lashed crossing points” and the “belly stitch” are related, if at all.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 6-11, 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yohanan et al. (US 9168131 B2) hereinafter known as Yohanan in view of Boudjemline (US 20090198315 A1).
Regarding claims 1-2, Yohanan discloses a replacement heart-valve system comprising:
a tubular frame (Figure 1 item 12), wherein the frame comprises an inflow (Figure 1 item 24) and outflow (Figure 1 item 26) end, and a plurality of loops on the inflow/outflow end (see Figure 1 which shows struts that form structures which loop circumferentially around the inflow and outflow end to form the frame);
a leaflet assembly (Figures 6-7 items 14, 16 together),
wherein the leaflet assembly is connected to the tubular frame at lashed crossing points with a stitch (clm 2) (Column 15 lines 45-54 the lashed crossing points of the frame are considered to be the points at which sutures cross the frame to secure the leaflet assembly thereto), and wherein the leaflet assembly is connected to one or more of the plurality of loops(Figure 7 shows the leaflet assembly connecting to the frame around the circumferential loops);
but is silent with regards to the tubular frame being braided with a braided wire so there are a plurality of sliding crossing points.
However, regarding claims 1-2 Boudjemline teaches wherein valve systems can have a tubular braided frame with a braided wire (Figures 1-6 item 10) which include a plurality of sliding crossing points ([0018], [0087]) with a leaflet assembly connected thereto at lashed crossing points with a stitch ([0123]). Yohanan and Boudjemline are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the system of Yohanan by having the frame include a braided configuration such as is taught by Boudjemline since this is one of many known alternative configurations to a strut construct within the art. The simple substitution of one known element/construct with another to yield predictable results constitutes adequate motivation for obviousness (see MPEP 2143(I)(B)).
Regarding claim 3 the Yohanan Boudjemline Combination teaches the system of claim 1 substantially as is claimed,
wherein Yohanan further discloses the frame comprises one or more loops on both of the ends (Figure 1 shows the structures that loop circumferentially throughout the entirety of the frame, including at both ends).
Regarding claim 4 the Yohanan Boudjemline Combination teaches the system of claim 2 substantially as is claimed,
wherein the Combination further teaches the stitch that connects the frame to the leaflet assembly is stitched along the inflow end of the frame (Figure 1 item 60 shows at least one stitch along the inflow end of the frame; Column 8 lines 45-47)
Regarding claim 6 the Yohanan Boudjemline Combination teaches the system of claim 1 substantially as is claimed,
wherein Yohanan further discloses the material is made of Nitinol, stainless steel, cobalt chrome, or nylon (Column 5 lines 8-10 Nitinol), and
Boudjemline further teaches the braided frame is a braid of one or more wires with an over-under braid ([0021]).
Regarding claim 7 the Yohanan Boudjemline Combination teaches the system of claim 1 substantially as is claimed,
wherein Yohanan further discloses a cuff along one of the ends of the frame which is positioned either inside or outside of the frame (Figure 1 item 16).
Regarding claim 8 the Yohanan Boudjemline Combination teaches the system of claim 1 substantially as is claimed,
wherein Yohanan further discloses a skirt along one end of the frame (Figure 1 item 16).
Regarding claim 9 the Yohanan Boudjemline Combination teaches the system of claim 1 substantially as is claimed,
wherein Yohanan further discloses two or more leaflets connected to form a Y-shape (Figure 1 shows the top of leaflets forming a Y-shape).
Regarding claim 10 the Yohanan Boudjemline Combination teaches the system of claim 9 substantially as is claimed,
wherein Yohanan further discloses the leaflets are connected via sewing, fusing, or stitching (Figure 1 shows stitches 60 connecting the tabs and outflow ends of the leaflets around the commissure posts).
Regarding claim 11 the Yohanan Boudjemline Combination teaches the system of claim 10 substantially as is claimed,
wherein Yohanan further discloses the valve leaflet is made of an animal tissue and/or polymer (Column 4 lines 61-62).
Regarding claims 13-16, 18-20 see the rejections to claims 1-4, 6-8 above.
Claims 5 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yohanan in view of Boudjemline as is applied above, further in view of Salahieh et al. (US 20060058872 A1) hereinafter known as Salahieh.
Regarding claim 5 the Yohanan Boudjemline Combination teaches the system of claim 1 substantially as is claimed,
but is silent with regards to the frame including one or more wire coils extending horizontally from one of the ends.
However, regarding claim 5 Salahieh teaches a heart valve which includes one or more wire coils extending horizontally away from one of the ends (Figures 15b and 21-22). Yohanan and Salahieh are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the valve of the Yohanan Boudjemline Combination to include horizontal coils on the end of the valve of the Combination as is taught by Salahieh in order to provide an anchoring structure on the valve that prevents its migration after implantation around a valve annulus, which would create a more securely implanted heart valve at less risk for migration, thus lengthening the service of the valve and increasing safety for the patient.
Regarding claim 17 see the rejection to claim 5 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm 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 on 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.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/14/26
Prosecution Insights