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 .
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.
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 08/10/2026 is acknowledged.
Claims 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species B and Species C, there being no allowable generic or linking claim. Claims 4 and 13 are canceled. Claims 5 and 8 are amended.
Claim Objections
Claim 6 is objected to because of the following informalities: In line 1, “wherein the cover” is assumed to be a typo. The examiner suggests amending this to be “wherein a cover” and has been examined as such. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: In lines 1-2, “the first and second paddle frames” is assumed to be a typo. The examiner suggests amending this to be “a first paddle frame and a second paddle frame” and has been examined as such. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: In lines 2-3, “the one or more actuation elements” is assumed to be a typo. The examiner suggests amending this to be “one or more actuation elements” and has been examined as such. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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, 5-7, 9-10, and 18-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Delgado et al. (US PG Pub No. 2019/0000613 A1).
Regarding claim 1, Delgado discloses an implantable device (Figs. 28-61 and 70-71, implantable device 500) comprising: a coaptation element (Figs. 28-61 and 70-71, coaption element 510) that defines a first area (Paragraph [0281], Figs. 47 and 71, X47B, 5 mm) when viewed from above; one or more anchors (Figs. 28-61 and 70-71, see annotated Fig. 47 below, Fig. 30, anchors 508) coupled to the coaptation element (510), the one or more anchors (see annotated Fig. 47 below, Fig. 30, anchors 508) being movable between an open position (Figs. 49-51) and a closed position (Figs. 47-48) and configured to attach to (Paragraph [0285], Figs. 47-48, gripping element 530) one or more leaflets of a native heart valve (Paragraph [0285]), each of the one or more anchors (see annotated Fig. 47 below, Fig. 30, anchors 508) comprising a paddle frame (Paragraph [0284], Figs. 47-61, paddle frame 524), wherein the paddle frame (524) defines an outer portion (see annotated Fig. 71 below) of the implantable device (500) when viewed from above (Fig. 71) and the one or more anchors (see annotated Fig. 47 below, Fig. 30, anchors 508) are in the closed position (Figs. 47-48), wherein the outer portion (see annotated Fig. 71 below) of the implantable device (500) has a second area (Paragraph [0281], Fig. 71, X67D, 10 mm) when viewed from above (Fig. 71), and wherein a ratio of the second area (X67D) to the first area (X47B) is greater than or equal to 2 (Paragraph [0281], X67D, 10 mm) to 1 (Paragraph [0281], X47B, 5 mm).
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Regarding claim 5, Delgado discloses wherein the one or more anchors (see annotated Fig. 65 below) comprise a first anchor (see annotated Fig. 65 below) and a second anchor (see annotated Fig. 65 below), the first anchor comprising a first paddle frame (see annotated Fig. 65 below, 524) and the second anchor comprising a second paddle frame (see annotated Fig. 65 below, 524), each of the first and second paddle frames comprising an inner frame portion (Figs. 28-61 and 70-71Figs. 28-61 and 70-71Figs. 28-61 and 70-71, inner paddles 522) and an outer frame portion (Figs. 28-61 and 70-71, outer paddles 520).
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Regarding claim 6, Delgado discloses wherein a cover (Fig. 37, cover 540) creates a canopy (see annotated Fig. 37 below) that extends between the first (see annotated Fig. 37 below) and second anchors (see annotated Fig. 37 below).
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Regarding claim 7, Delgado discloses wherein each of a first paddle frame (see annotated Fig. 65 , 524) and a second paddle frame (see annotated Fig. 65 below, 524) comprise: a paddle frame that includes an inner frame portion (Figs. 28-61 and 70-71, inner paddles 522) and an outer frame portion (Figs. 28-61 and 70-71, outer paddles 520), wherein the outer frame portion (520) is configured to be moved between a narrowed position (Paragraph [0292], Figs. 37 and 59) and expanded position (Figs. 36 and 52); and a flexible cover (Paragraph [0241], cover 540 is made of fabric therefore can be in a taut state and stretch state) configured to be in a taut state (Fig. 36) when the outer frame portion is in the narrowed position (Paragraph [0292], Figs. 37 and 59), and wherein the flexible cover (540) is configured to stretch (Fig. 37) when the outer frame portion (520) is in the expanded position (Figs. 36 and 52).
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Regarding claim 9, Delgado discloses further comprising a cap (Figs. 28-61, cap 514) operatively connected (Paragraph [0242]) to the one or more anchors (Figs. 28-61 and 70-71, anchor portion see annotated Fig. 47 below, Fig. 30, anchors 508) such that movement of the cap (514) relative to the coaptation element (510) by one or more actuation elements Figs. 28-61, actuation wire 512) of the delivery device (500) causes the one or more anchors (see annotated Fig. 47 below, Fig. 30, anchors 508) to move between the open and closed positions (Paragraph [0242]), wherein the cap (514) comprises a distal opening (Fig. 31, distal opening 515) that is in communication with a lumen (Fig. 31, 510 is hollow and slidably attached to 512) of the coaptation element (510), and a distal cover element (Fig. 31, sealing projection 516) that is positioned to inhibit blood from moving through the distal opening (515) of the cap (514) and into an interior of the implantable device (Paragraph [0246]).
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Regarding claim 10, Delgado discloses a valve repair system for repairing a native valve of a patient (Paragraphs [0181, 0235, and 0283]), the valve repair system comprising: a delivery device (Fig. 35, delivery sheath 502) ; an implantable device (Figs. 28-61 and 70-71, implantable device 500) coupled (Paragraphs [0264 and 0265]) to the delivery device (502), the implantable device comprising: a coaptation element (Figs. 28-61 and 70-71, coaption element 510) that defines a first area (Figs. 47 and 71, X47B) when viewed from above; one or more anchors (Figs. 28-61 and 70-71, anchor portion see annotated Fig. 47 below, Fig. 30, anchors 508) coupled to the coaptation element (510), the one or more anchors (see annotated Fig. 47 below, Fig. 30, anchors 508) being movable between an open position (Figs. 49-51) and a closed position (Figs. 47-48) and configured to attach to (Paragraph [0285], Figs. 47-48, gripping element 530) one or more leaflets of a native heart valve (Paragraph [0285]), each of the one or more anchors (see annotated Fig. 47 below, Fig. 30, anchors 508) comprising a paddle frame (Paragraph [0284], Figs. 47-61, paddle frame 524), wherein the paddle frame (524) defines an outer portion (see annotated Fig. 71 below) of the implantable device (500) when viewed from above (Fig. 71) and the one or more anchors (see annotated Fig. 47 below, Fig. 30, anchors 508) are in the closed position (Figs. 47-48), wherein the outer portion (see annotated Fig. 71 below) of the implantable device (500) has a second area (Fig. 71, X67D) when viewed from above (Fig. 71), and wherein a ratio of the second area (X67D) to the first area (X47B) is greater than or equal to 2 (Paragraph [0281], X67D, 10 mm) to 1 (Paragraph [0281], X47B, 5 mm).
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Regarding claim 18, Delgado discloses an implantable device (Figs. 6A-6B, 28-61 and 70-71, implantable device 500), comprising: an anchor portion (see annotated Fig. 47 below, Fig. 30, anchors 508) comprising a first anchor (see annotated Fig. 47 below) and a second anchor (see annotated Fig. 47 below); each of the first and second anchors comprising a paddle frame (Paragraph [0284], Figs. 47-61, paddle frame 524) that includes an outer frame portion (see annotated Fig. 32 below); wherein the outer frame portion has a proximal end (see annotated Fig. 32 below) and a distal end (see annotated Fig. 32 below); wherein the outer frame portion (see annotated Fig. 32 below) is configured to be moved between a narrowed position (Fig. 66) and an expanded position (Fig. 32); wherein a proximal width (see annotated Fig. 32 below) of the proximal end (see annotated Fig. 32 below) of the outer frame portion is greater (see annotated Fig. 32 below) than a distal width (see annotated Fig. 32 below) of the distal end (see annotated Fig. 32 below) of the outer frame portion (see annotated Fig. 32 below) when the outer frame portion is in the expanded position (see annotated Fig. 32 below); and wherein the first (see annotated Fig. 47 below) and second anchors (see annotated Fig. 47 below) are configured to be moved to a closed position (Fig. 46) such that the implantable device (500) is secured to the native valve (Fig. 46, mitral valve MV, leaflets 20 and 22).
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Regarding claim 19, Delgado discloses wherein engagement between the paddle frame (Figs. 6A-6B, 524) and the native valve (Figs. 6A-6B, Mitral Valve MV, leaflets 20,22) when the implantable device (500) is secured to the native valve causes a force (Paragraphs [0247 and 0271]) on an annulus of the native valve that reshapes the annulus (Paragraph [0271], Figs. 6A-6B).
Regarding claim 20, Delgado discloses in a first phase, starting at the expanded position (see annotated Fig. 32 above, Fig. 54) and moving to an intermediate position (Fig. 55), the distal width (see annotated Fig. 32 above, Figs. 54-55) narrows at a faster rate than the proximal width (Fig. 54 to Fig. 55).
Regarding claim 21, Delgado discloses wherein the first (see annotated Fig. 65 below) and second anchors (see annotated Fig. 65 below) are configured to be moved to a closed position (Fig. 45) in which the inner frame portion (Figs. 28-61 and 70-71, inner paddles 522) of each of the first and second anchors compress native valve leaflets between an inner pinch point (Paragraph [0249], see annotated Fig. 32 below, Fig. 44) and the outer frame portion (Figs. 28-61 and 70-71, outer paddles 520) of each of the first and second anchors compress the native valve leaflets between an outer pinch point (Paragraph [0249], see annotated Fig. 32 below, Fig. 44) such that the implantable device is secured to the native valve leaflets (Paragraph [0249]).
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Regarding claim 22, Delgado discloses further comprising a cover (Figs. 30 and 37, cover 540) attached to at least one of the inner frame portion (522) and the outer frame portion (520) of the first and second anchors (Fig. 30, anchors 508) to provide a compressive force against the native valve leaflets (Paragraph [0247]) in an area between the inner (see annotated Fig. 32 above) and outer pinch points (see annotated Fig. 32 above) when the implantable device is secured to the native valve leaflets (Paragraph [0249]).
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.
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 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Delgado et al. (US PG Pub No. 2019/0000613 A1).
Regarding claim 2, Delgado discloses the second area (Paragraph [0281], Fig. 71, X67D) and first area (Paragraph [0281], Figs. 47 and 71, X47B) wherein the ratio of the second area (X67D) to the first area (X47B) is greater than or equal to 2 (Paragraph [0281], X67D, 10 mm) to 1 (Paragraph [0281], X47B, 5 mm). However, Delgado does not expressly disclose the ratio of the second area to the first area is greater than or equal to 3 to 1 as required by the claim. Delgado discloses that the measurements, and therefore the ratio, of the second area and the first area needs to be optimized to “minimize the number of implants a patient will require, while at the same time maintaining low transvalvular gradients” (minimizing blood flow through the device) (Paragraph [0281]). As seen in Fig. 71, the second area is greater than the first area and as such the second area and the first area is disclosed to be a result effective variable in that changing the second area to the first area as needed changes the ratio which affects the number of implants a patient will require and maintains low transvalvular gradients. Further, it appears one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Delgado to have a ratio of the second area to the first area of 3 to 1 as claimed, as it involves only adjusting the dimension of the components disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Delgado by modifying the second area and first area to be a ratio of 3 to 1 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 11, Delgado discloses the second area (Paragraph [0281], Fig. 71, X67D) and first area (Paragraph [0281], Figs. 47 and 71, X47B) wherein the ratio of the second area (X67D) to the first area (X47B) is greater than or equal to 2 (Paragraph [0281], X67D, 10 mm) to 1 (Paragraph [0281], X47B, 5 mm) However, Delgado does not expressly disclose the ratio of the second area to the first area is greater than or equal to 3 to 1 as required by the claim. Delgado discloses that the measurements, and therefore the ratio, of the second area and the first area needs to be optimized to “minimize the number of implants a patient will require, while at the same time maintaining low transvalvular gradients” (minimizing blood flow through the device) (Paragraph [0281]). As seen in Fig. 71, the second area is greater than the first area and as such the second area and the first area is disclosed to be a result effective variable in that changing the second area to the first area as needed changes the ratio which affects the number of implants a patient will require and maintains low transvalvular gradients. Further, it appears one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Delgado to have a ratio of the second area to the first area of 3 to 1 as claimed, as it involves only adjusting the dimension of the components disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Delgado by modifying the second area and first area to be a ratio of 3 to 1 as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Delgado et al. (US PG Pub No. 2019/0000613 A1) as applied to claims 1 and 10 above, and further in view of Goldfarb et al. (US PG Pub No. 2019/0261997 A1).
Regarding claim 3, Delgado fails to disclose wherein the coaptation element is injection molded. Goldfarb also discloses an implantation device (Fig. 28, fixation device 14) with a coaptation element (Fig. 28, coupler 150). Goldfarb teaches wherein the coaptation element (150) is injection molded (Paragraph [0166]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coaptation element of Delgado wherein the coaptation element is injection molded, as taught by Goldfarb, in order to be formed from a polymer (Paragraph [0166]).
Regarding claim 12, Delgado fails to disclose wherein the coaptation element is injection molded. Goldfarb also discloses a valve repair system (Paragraphs [0002 and 0016]), a delivery device (Paragraph [0118]), an implantation device (Fig. 28, fixation device 14) with a coaptation element (Fig. 28, coupler 150). Goldfarb teaches wherein the coaptation element (150) is injection molded (Paragraph [0166]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coaptation element of Delgado wherein the coaptation element is injection molded, as taught by Goldfarb, in order to be formed from a polymer (Paragraph [0166]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Delgado et al. (US PG Pub No. 2019/0000613 A1) as applied to claim 7 above, and further in view of Schwartz et al. (US PG Pub No. 2019/0192296 A1).
Regarding claim 8, Delgado discloses the flexible cover (Paragraph [0241], cover 540 is made of fabric therefore can be in a taut state and stretch state) to stretch when the paddle frame (Paragraph [0284], Figs. 47-61, paddle frame 524) is in the expanded position (Figs. 36 and 52), but fails to disclose wherein the flexible cover comprises one or more stretchable portions. Schwartz also discloses a flexible cover (Fig. 46, cover member 1000) for an implantable device (Paragraphs [0005 and 0192]). Schwartz teaches wherein the flexible cover (Fig. 46, cover member 1000) comprises one or more stretchable portions (Paragraph [0192]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Delgado’s flexible cover wherein the flexible cover comprises one or more stretchable portions, as taught by Schwartz, in order for the flexible cover to stretch in specific portions during expansion (Paragraph [0192]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Freschauf et al. (US Patent No. 11,207,181 B2) also discloses an implantable device (Fig. 21A, implantable prosthetic device 400A) comprising a coaptation element (Fig. 21A, coaption portion 404A), one or more anchors (Fig. 21A, anchors 408A), and a paddle frame (Fig. 21A, paddle frames 424A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.L.C./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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