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 .
Election/Restrictions
Applicant’s election without traverse of invention II (claims 8-17), species 1c (Figure 4), 2a (Figures 5-6), and species 3a (alignment markings are holes) in the reply filed on 11/14/25 is acknowledged.
While Applicant states claim 15 is withdrawn, the Examiner notes claim 15 appears to be drawn towards elected species 3a, and so does not withdraw this claim. Remaining claims drawn to withdrawn species have been cancelled, and so there are no withdrawn claims.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 is objected to for claiming the tab portion overlaps “a center portion” of the main body of the support strip when claim 8, from which this claim depends, has already identified that the tab portion is folded over “a portion” of the main body. It is unclear how, if it all, the “center portion” and “portion” of the main body are related. For the purposes of examination, claim 16 will be interpreted in a way in which “the portion” of the tab portion is a “center portion”.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “commissure support portions”, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because:
-item 240a-b are described in the specification but are not in the drawings
-item 272 appears to be pointing towards two distinct elements in figures 2a and 2b. Further, item 272 is supposed to represent “tertiary suture lines” but neither figure appears to have item 272 representing a tertiary suture line.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 8, 12, 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Girard et al. (US 20110295363 A1) hereinafter known as Girard.
Regarding claim 8 Girard discloses a prosthetic heart valve (Abstract, Figures 5b) comprising:
an annular frame (10) comprising a plurality of commissure support portions (11b), and
a plurality of leaflets (102), wherein each leaflet has a commissure tab (Figures 19a-20 item 111) that is coupled to an adjacent commissure tab of another leaflet (Figures 19a-20) via a support strip (Figures 19a-20 item 107.8) to form a commissure of an associated commissure tab pair (Figures 19a-20);
wherein for each commissure tab pair:
the support strip includes a main body (Figure 20 item 107.8, left half) and a tab portion (Figure 20 item 107.8, right half) extending from and folded over a portion of the main body (Figure 20), wherein a primary suture (Figure 20 item 101.2) passes through, in order or reverse order: a first side of the main body (left side of 107.8) , a first commissure tab of the pair (left tab 111), a second commissure tab of the pair (right tab 111), and a second side of the main body (right side of 107.8); and a secondary suture passes through the tab portion and main body to couple to the tab portion to the main body (see at least Figure 19c where multiple sutures 101.2 pass through the tab and main body (see also [0286] where the items 101.2 are identified in the plurality: at least one of these is considered to be a secondary suture), and
wherein each commissure is secured to a corresponding commissure support portion (11b) of the commissure support portions (Figure 20).
Regarding claim 11 Girard discloses the valve of claim 8 substantially as is claimed,
wherein Girard further discloses each commissure is secured to the corresponding commissure support portion via a tertiary suture extending through the support strip and coupling the first side of the main body of the support strip to the second side of the main body of the support strip (see at least Figure 19c where multiple sutures 101.2 pass through the tab and main body (see also [0286] where the items 101.2 are identified in the plurality: at least one of these is considered to be a tertiary suture which connects all the elements and sides thereof).
Regarding claim 12 Girard discloses the valve of claim 11 substantially as is claimed,
wherein Girard further discloses the support strip includes at least one tertiary suture line, wherein the tertiary suture extends through the tertiary suture line (a “tertiary suture line” is understood by the Examiner to be a line through which a tertiary suture extends, meaning it is inherent that the tertiary suture extends through the tertiary suture line by definition. See the explanation in the rejection to claim 11 above regarding the tertiary suture (and line) extending through the support strip).
Regarding claim 16 Girard discloses the valve of claim 8 substantially as is claimed,
wherein Girard further discloses the tab portion is folded at a horizontal fold line (considered to be at the center of the fold separating the tab portion from the main body portion, around where suture 101.1 is placed (Figure 20)) such that the tab portion overlaps a center portion of the main body of the support strip (Figure 20).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Girard as is applied above in view of Hariton et al. (CA 3031187 A1) hereinafter known as Hariton.
Regarding claim 9 Girard discloses the valve of claim 8 substantially as is claimed,
but is silent with regards to the support strip including edge alignment markings on the first and second side of the main body.
However, regarding claim 9 Hariton teaches that commissure elements of heart valves can include a first set of edge alignment markings on a first side of a main body of the commissure element and a second set of edge alignment markings on a second side of the main body of the commissure element (Figure 11a-b shows items 516, which can represent at least two sets of edge alignment markings), and
wherein a suture is designed to pass through the first and second set of edge alignment markings (Figure 11b; page 66 lines 10-13). Girard and Hariton 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 Girard so that there are edge alignment markings on the support strip’s main body as is taught by Hariton in order to guide the placement of stitches to ensure the commissure is sutured in the exact location and manner desired, thus increasing efficiency and accuracy in manufacture.
Regarding claim 10 Girard discloses the valve of claim 8 substantially as is claimed,
but is silent with regards to the support strip including a first and second set of alignment markings, so the secondary suture passes through the alignment markings.
However, regarding claim 10 Hariton teaches a heart valve with a commissure element that includes a first set of central alignment markings on a tab portion of a commissure element and a second set of central alignment markings on a main body of portion of the commissure element (Figure 11a-b shows items 516, which can represent at least two sets of central alignment markings), and wherein a suture passes through the first and second set of central alignment markings (Figure 11b; page 66 lines 10-13). Girard and Hariton 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 Girard so that there are central alignment markings on the support strip as is taught by Hariton in order to guide the placement of stitches to ensure the commissure is sutured in the exact location and manner desired, thus increasing efficiency and accuracy in manufacture.
Claims 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Girard as is applied above in view of Gray et al. (US 20230010851 A1) hereinafter known as Gray.
Regarding claim 13 Girard discloses the valve of claim 8 substantially as is claimed,
but is silent with regards to the support strip including one or more alignment indicators, where the tab portion is folded over the main body of the support strip in accordance with the alignment indicators.
However, regarding claim 13 Gray teaches a heart valve which includes one or more alignment indicators (Figures 3-6 item 220), wherein folding of an element of the valve is in an alignment that is in accordance with the alignment indicators (Figures 6 item 630). Girard and Gray 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 Girard so that the folding of the tab portion and main body portion of the support strip includes alignment indicators to indicate where the fold should occur as is taught by Gray in order to provide the manufacturer with guidance as to where the fold should occur in order to create an even support strip around the commissures of the valve, thus ensuring proper support on both sides of the commissure.
Regarding claim 14 the Girard Gray Combination teaches the valve of claim 13 substantially as is claimed,
wherein Gray further teaches the alignment indicators include a first notch along an outer edge of one portion of the valve element (corresponding to the tab portion of the support strip in the Combination) and an corresponding second notch along an outer edge of a second portion of the valve element (corresponding to the main body portion in the Combination) (Figures 5-6 show two triangle-shaped notches formed adjacent/joining one another at the outer edge of two halves of the folded valve element 210).
Regarding claim 15 the Girard Gray Combination teaches the valve of claim 13 substantially as is claimed,
wherein Girard further teaches the alignment indicators include at least a single column formed of apertures (Figures 3, 5 item 220 shows the notches/apertures in a single column orientation).
Claim 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Girard as is applied above in view of Gurovich et al. (US 20180028310 A1) hereinafter known as Gurovich.
Regarding claim 17 Girard discloses the valve of claim 8 substantially as is claimed,
but is silent with regards to the support strip being T-shaped before folding the tab over the main body.
However, regarding claim 17 Gurovich teaches a heart valve which includes a support strip can be T-shaped before folding the tab portion over the main body (see for example Figure 35 which shows support strip 322 which includes a leg (left side of the strip 322), and a top part with two outwardly extending arms (right side of the strip 322) The Examiner understands this shape to be generally in the shape of a T, or in the alternative, obvious to modify this shape to be T-shaped.). Girard and Gurovich 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 Girard so that the support strip is T-shaped as is taught by Gurovich since it has been held by the courts that a change in shape or configuration, without any criticality in operation of the device, is nothing more than one of numerous shapes that one of ordinary skill in the art will find obvious to provide based on the suitability for the intended final application. See MPEP 2144.04 (IV)(B). It appears that the disclosed device would perform equally well shaped as disclosed by Girard.
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.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 12/04/25