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 .
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) 1-8, 10-14 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yohanan (US PGPub 2013/0150956).
Regarding Claim 1, Yohanan teaches a prosthetic heart valve (abstract), comprising:
a radially expandable and compressible annular frame (302; Figure 15; Paragraph 0073) having an inflow end (end closest to element 314; Figure 15), an outflow end (end closest to element 324; Figure 15), a plurality of struts (310) defining the annular frame (Figure 15; Paragraph 0072), and a plurality of commissure support structures (322; Figure 15 and 15A; Paragraph 0073) each defining a commissure opening (spaces between 322; Figure 15A; Paragraph 0073) positioned along a circumference of the annular frame (Figure 15 and Figure 15A; Paragraph ;
a valvular structure (304; Figure 14; Paragraph 0071) mounted within the annular frame (Figure 14), the valvular structure (304) comprising a plurality of leaflets (308; Figure 14; Paragraph 0071) and a plurality of commissures (330; Paragraph 0073) each extending radially through a respective commissure opening to attach the valvular structure (304) to the frame (302; as seen in Figures 20-21; Paragraph 0085-0086), each commissure (330; Paragraph 0085-0086) having an outflow edge that extends from a radial outer surface of the frame (see annotated Figure 21 below); and
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a commissure cover (352 see annotated Figure 21 above, but also see Figure 24 which shows the cover deployed) disposed at least partially over the outflow edge of the commissure (330; see Figure 24 in which), the commissure cover (352) defining a ramped surface (354) that extends from the radial outer surface of the frame (302) to a radial outer surface of the commissure (330; see annotated Figure 24 below).
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Regarding Claim 2, Yohanan teaches the prosthetic heart valve of claim 1, wherein each leaflet (308) comprises two commissure tabs (334) on opposite sides of the leaflet (Figure 19), and wherein each commissure is formed by pairing a commissure tab (334a) with an adjacent commissure tab (334b) of an adjacent leaflet (Figure 23; Paragraph 0086).
Regarding Claim 3, Yohanan teaches the prosthetic heart valve of claim 1, wherein an outflow end portion of the commissure cover (354) is coupled to one or more struts (338, 340) of the plurality of struts (310; Paragraph 0089).
Regarding Claim 4, Yohanan teaches the prosthetic heart valve of claim 3, wherein the one or more struts of the plurality of struts (338, 340) are disposed at the outflow end of the frame (see Figure 20-21; Paragraph 0089).
Regarding Claim 5, Yohanan teaches the prosthetic heart valve of claim 1, wherein one or more struts of the plurality of struts comprise eyelets (344; Figure 21) and wherein the commissure cover (352) is coupled to the eyelets (344) via one or more sutures (364) extending through the eyelet (344; Paragraph 0089; Figure 21-22).
Regarding Claim 6, Yohanan teaches the prosthetic heart valve of claim 1, wherein the commissure cover (352) comprises a fabric member (Paragraph 0087, it’s the examiner’s position that fabric does not impart structure and that a flexible sheet of PET reads on a fabric; see also paragraph 0064 discussing the use of PET for the inner skirt).
Regarding Claim 7, Yohanan teaches the prosthetic heart valve of claim 1, further comprising an outer skirt disposed on a radial outer surface of the frame (not shown; Paragraph 0065).
Regarding Claim 8, Yohanan teaches the prosthetic device of Claim 7, wherein an inflow end portion of the commissure cover (352) is coupled to the outer skirt (not shown) (The examiner notes that when an outer skirt is disposed, since all the components are sutured together, it’s the Examiners position that even though there is no teaching of direct contact, the commissure cover (352) is coupled to the outer skirt because they are all one device which is implanted together and move together.
Regarding Claim 10, Yohanan teaches the prosthetic heart valve of claim 1, wherein the ramped surface (354) is pulled taut when the frame is in a radially compressed configuration (Paragraph 0089 discloses that the ramped surface is pulled taught towards the frame with sutures loops 364; Figure 22-23).
Regarding Claim 11, Yohanan teaches the prosthetic heart valve of claim 1, wherein an outflow end portion of the commissure cover (352) is rolled or folded to create a wedge member (254), and wherein the wedge member (354) is disposed adjacent the outflow edge of the commissure to create the ramped surface (as seen in Figure 24 and described in Paragraph 0088).
Regarding Claim 12, Yohanan teaches the prosthetic heart valve of claim 1, wherein the commissure cover (352) extends entirely over the radial outer surface of the commissure (330; see Figures 24-25).
Regarding Claim 13, Yohanan teaches the prosthetic heart valve of claim 1, wherein the commissure cover (352) comprises a piece of material rolled or folded into a wedge shape (Figure 24; Paragraph 0088).
Regarding Claim 14, Yohanan teaches the prosthetic heart valve of claim 1, wherein the commissure cover (352) has a first end portion coupled to a first end portion of the commissure (330), and a second end portion coupled to the annular frame (at element 332 in Figure 24; Paragraph 0088-0089).
Regarding Claim 18, Yohanan teaches the prosthetic heart valve of claim 1, wherein the commissure cover (352) comprises a ramp member (354) (annotated Figure 24 above as applied to claim 1).
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 (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 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) 15-17 and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yohanan (US PGPub 2013/0150956) as applied to claim 14 above, and further in view of Yohanan (US Patent 2013/0018458; now referred to as Yohanan-2)
Regarding Claim 15, Yohanan teaches the prosthetic heart valve of claim 14, but fails to disclose wherein the commissure cover is coupled to the prosthetic heart valve via a first suture extending through a first side portion of the commissure and diagonally over the commissure cover to couple a first strut of the frame, and a second suture extending through a second side portion of the commissure and diagonally over the commissure cover to couple a second strut of the frame.
Yohanan-2 teaches a prosthetic heart valve (abstract) comprising an annular frame (102; Figure 5; Paragraph 0053), a valve structure having a plurality of leaflets (104) defining a plurality of commissures (116; Figures 10-11), and a commissure cover (128; Figure 12-14) disposed over the outflow edge of the commissure (116; Figures 12 and 14), wherein the commissure cover (128) is coupled to the prosthetic heart valve via a first suture (154) extending through a first side portion of the commissure (104) and diagonally over the commissure cover to couple a first strut of the frame (102; as seen in Figure 14), and a second suture (154) extending through a second side portion of the commissure (104) and diagonally over the commissure (104) cover to couple a second strut of the frame (102; as seen in Figure 14).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the teachings of Yohanan with frame and commissure teachings of Yohanan-2 since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, substituting the frame cell configuration taught by Yohanan-2 around the commissure opening taught by Yohanan would still led to the obvious and predictable result of covering a commissure with a covering and attaching the covering to the frame using sutures.
Regarding Claim 16, Yohanan teaches the prosthetic heart valve of claim 1, but fails to disclose wherein the commissure cover comprises a V-shaped cutout at an outflow end portion, and wherein the outflow end portion is sutured to one or more struts of the frame along the V-shaped cutout.
Yohanan-2 teaches a prosthetic heart valve (abstract) comprising an annular frame (102; Figure 5; Paragraph 0053), a valve structure having a plurality of leaflets (104) defining a plurality of commissures (116; Figures 10-11), and a commissure cover (128; Figure 12-14) disposed over the outflow edge of the commissure (116; Figures 12 and 14), wherein the commissure cover (128) comprises a V-shaped cutout at an outflow end portion (See Figure 12 which shows one half of the V from the top view at element number 128 and then see Figure 14 which shows the slit between both sections of the V), and wherein the outflow end portion is sutured (154) to one or more struts of the frame along the V-shaped cutout (as seen in Figure 14).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the teachings of Yohanan with frame and commissure teachings of Yohanan-2 since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; In this case, substituting the commissure covering shape taught by Yohanan-2 around the commissure opening taught by Yohanan would still led to the obvious and predictable result of covering a commissure with a covering and attaching the covering to the frame using sutures.
Regarding Claim 17, the combination of references disclosed above teaches the prosthetic valve of claim 16, wherein Yohanan-2 teaches the V-shaped cutout (the two edges of 128 that meet when folded in Figure 12 and 14) is configured such that edges of the V-shape align with selected struts (Figure 14).
Regarding Claim 19, Yohanan teaches the prosthetic heart valve of claim 18, but fails to disclose wherein the ramp member comprises a first end portion having a first thickness and a second end portion having a second thickness greater than the first thickness.
Yohanan-2 teaches a prosthetic heart valve (abstract) comprising an annular frame (102; Figure 5; Paragraph 0053), a valve structure having a plurality of leaflets (104) defining a plurality of commissures (116; Figures 10-11), and a commissure cover (128; Figure 12-14) disposed over the outflow edge of the commissure (116; Figures 12 and 14), and a ramp member (120; Figure 11; Paragraph 0061), wherein the ramp member (120) comprises a first end portion having a first thickness (at legs 122) and a second end portion (at apex) having a second thickness greater than the first thickness (the thickness is the measurement taken at one leg which is smaller than the thickness taken at the apex, which is at least 2 legs thick; see Figure 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the prosthetic heart valve of Yohanan, to include a clip/ramp, as taught by Yohanan-2, for the advantage of functioning as a spacer between the frame 102 and the free edges of the leaflets to minimize direct contact of the free edges of the leaflets with the frame during systole to protect the leaflets against abrasion (Paragraph 0061; Yohanan-2).
Regarding Claim 20, the combination of references disclosed above teaches the prosthetic heart valve of claim 19, wherein Yohanan-2 teaches the second end portion (apex of clip) of the ramp member (120) is disposed directly adjacent the outflow edge of the commissure (as seen in Figure 11 and Figure 12).
Regarding Claim 21, the combination of references disclosed above teaches the prosthetic heart valve of claim 18, wherein Yohanan teaches the ramp member (120) comprises one or more openings extending through a thickness of the ramp member (the opening is the space between the legs (122) which the commissures 118 extend through (See Figure 11).
Regarding Claim 22, the combination of references disclosed above teaches the prosthetic heart valve of claim 21, Yohanan-2 teaches wherein the ramp member (120) is coupled to the commissure by one or more sutures (154) extending through the one or more openings (at the top inflow section, as seen in Figure 12; at least one suture is attached through that opening in Figure 14).
Allowable Subject Matter
Claims 9 and 23-25 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record fails to disclose:
Claim 9: the prosthetic heart valve of claim 7, wherein an inflow end portion of the commissure cover is formed integrally with the outer skirt.
Claim 23: the prosthetic heart valve of claim 18, further comprising one or more guide sutures extending from the commissure to one or more eyelets of selected struts of the plurality of struts such that the guide sutures define a ramped surface from the eyelets to a radial outer surface of the commissure.
Claims 24-25 are objected to by dependency to Claim 24-25.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMED G GABR/Primary Examiner, Art Unit 3771
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