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 .
Response to Amendment
This action is entered in response to Applicant's reply filed 5/21/26. The claims 1, 3-6, 8-22 are pending. Claim 1 has been amended. Claims 15-22 are new. Claims 2, 7, 9 are cancelled.
Response to Arguments
Applicant's arguments filed 3/28/25 with respect the rejection of claims 1, 3-8, 10-14 under 35 U.S.C. 103 in view of Justino (US2005/0137682) in view of Punga (US2013/0282113) have been fully considered and the rejection has been withdrawn. However, a new grounds of rejection has been made in view of Destefano (US9480558) in view of Menk (US2014/0194981) and Eberhardt (US6350282). Examiner advises Applicant amend to state the fabric covering sandwiches the openings of the row of cells of the downstream end and covers the inner surface of the openings of the row of cells of the upstream end.
Claim Objections
Claims 1, 8, 15, and 19 are objected to because of the following informalities:
Claim 1 recites “such that each strut is sandwiched by the fabric” should be changed to recite “such that each strut is sandwiched by the fabric covering”.
Claim 8 recites “the second portion of the fabric covering entirely covers a radially inner surface of each downstream protrusion and a radially-outer surface of each protrusion” should be changed to recite “the second portion of the fabric entirely covers a radially inner surface of each downstream protrusion and a radially-outer surface of each protrusion”.
Claim 15 recites “such that each strut is sandwiched by the fabric” should be changed to recite “such that each strut is sandwiched by the fabric covering”.
Claim 19 recites “the second portion of the fabric covering entirely covers a radially inner surface of each downstream protrusion and a radially-outer surface of each protrusion” should be changed to recite “the second portion of the fabric entirely covers a radially inner surface of each downstream protrusion and a radially-outer surface of each protrusion”.
Appropriate correction is required.
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 1, 3-8, 10-12, 15, 16, and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Destefano (US9480558) in view of Menk (US2014/0194981) and Eberhardt (US6350282).
Regarding claim 1, Destefano discloses an apparatus, for use at a native valve of a heart of a subject, the apparatus comprising a prosthetic valve (see Abstract) that comprises:
a frame (frame) comprising:
a plurality of struts (struts of the frame, see Fig. 2) arranged to form a tubular valve body of the frame (frame is cylindrical, see Fig. 2), the struts forming an upstream portion of the tubular valve body and forming a downstream portion of the tubular valve body, the tubular valve body having a downstream end (distalmost end at the downstream portion) and shaped to define a continuous lumen through the tubular valve body (see annotated Fig. 1);
at least one valve member (valve body 14), disposed within the lumen, and configured to facilitate unidirectional flow of blood of the subject from an upstream end of the tubular valve body to the downstream portion (C3:L46-48);
a covering (skirt 21 including the tabs 38, 39):
downstream protrusions (cell of the frame that supports commissures, C5:L61, see Fig. 1) which protrude away from the tubular valve body (see Fig. 1).
Destefano is silent regarding the covering being fabric. Menk teaches a replacement heart valve having a skirt 332 around the upstream portion. The skirt may be pericardial tissue or velour fabrics for tissue ingrowth ([0046]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the covering of Destefano for a fabric material as taught by Menk, since the substitution would have the same predictable result of providing a biocompatible material for tissue ingrowth ([0046] of Menk).
Destefano discloses lining an inner surface of the frame and sandwiching struts of the upstream end (the struts are sandwiched by the tabs 39 folding over the frame, C5:L19) and appears to cover the struts of the downstream end as shown in Fig. 1. However, Destefano does not explicitly disclose lining an inner surface of the frame, and sandwiching the struts that form the downstream portion of the tubular valve body of the frame by extending in contact with an inner surface of the struts that form the downstream portion of the tubular valve body of the frame, and around the downstream end of the frame to be disposed over and in contact with an outer surface of the struts that form the downstream portion of the tubular valve body of the frame, such that each strut that is sandwiched by the covering has an inner surface that is in contact with the covering and an outer surface that is in contact with the covering; wherein the covering extends along and entirely covers the entire outer perimeter of each of the downstream protrusions. Eberhardt teaches a frame 34 having struts 36 that extend to commissure posts 38, 40, 42 in the direction of outflow (downstream) (C4:L48-50). Where the struts 36 of the frame are covered by a sleeve 48 (covering) that is folded along the perimeter of the struts and then sutured to the folded portion along the perimeter of the struts 36 (C5:L17-20). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have covered the struts of Destefano in the same manner as the struts of Eberhardt, in order to enclosure the struts in a porous biocompatible fabric to be better received by the body (C5:L14-15). Where the modified invention of Destefano with Eberhardt would teach lining an inner surface of the frame, and sandwiching the struts that form the downstream portion of the tubular valve body of the frame by extending in contact with an inner surface of the struts (the covering would cover the struts and be sutured around to meet the claimed limitation) that form the downstream portion of the tubular valve body of the frame, and around the downstream end of the frame to be disposed over and in contact with an outer surface of the struts that form the downstream portion of the tubular valve body of the frame (covering would cover the struts and be sutured around, thereby sandwiching the struts to meet the claimed limitation), such that each strut that is sandwiched by the covering has an inner surface that is in contact with the covering and an outer surface that is in contact with the covering; wherein the covering extends along and entirely covers the entire outer perimeter of each of the downstream protrusions (Destefano as shown in Fig. 1 it appears the covering extends along the entirety of the outer perimeter, Eberhardt teaches the entirety of the struts are covered in C5:L17-20 and see Fig. 5).
PNG
media_image1.png
534
576
media_image1.png
Greyscale
Regarding claim 3, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 1, Destefano further discloses wherein the at least one valve member is coupled to the downstream portion (see annotated Fig. 1, where the valve is coupled to the struts at joints 27).
Regarding claim 4, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 1, Destefano further discloses wherein at least part of the fabric covering at the downstream portion is configured to be placed in contact with at least one papillary muscle of the heart (see C3:L20, the device is intended to be placed in an unspecified heart valve, the covering that encompasses the downstream portion of the device would be capable of contacting the ventricular papillary muscles as the downstream portion is disposed on an outer surface of the device).
Regarding claim 5, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 1, Destefano discloses each of the downstream protrusions extends away from a downstream end (see Fig. 1).
Regarding claim 6, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 5, Destefano further discloses wherein the valve body has a longitudinal axis therethrough (longitudinal axis through the frame, see Fig. 1), and comprises a circumferential lateral wall (circumferential lateral wall perimeter defined by the top of the struts, see Fig. 1) that defines a curved plane that circumscribes the longitudinal axis (see Fig. 1), and wherein the downstream protrusions lie on the plane (circumferential lateral wall is defined as the wall defined at the end of stent including the top of the struts as shown in Fig. 1, the lateral wall defines a curved plane by its tubular configuration that circumscribes the longitudinal axis as shown in Fig. 1, the protrusions are the commissures 24 that extend from the frame).
Regarding claim 7, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 6, Destefano further teaches wherein each downstream protrusion has a transverse cross-sectional shape of an arc (the commissures are curved, see Fig. 1; otherwise, since the commissures are arranged cylindrically by the tubular form of the stent, the commissures would have arc shaped cross sections when the transverse plane is taken at the locations of the curved plane defined by the struts along the wall of the valve body, see Fig. 1), and wherein the arc of each downstream protrusion lies on the curved plane defined by the valve body (see Fig. 1).
Regarding claim 8, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 5, the modified invention further discloses wherein:
the fabric covering comprises a first portion (portion of covering that covers the upstream portion, see Fig. 1) of the fabric covering and a second portion (portion of covering that covers the commissures 24) of the fabric covering,
the first portion of the fabric covering that lines the inner surface of the frame (the covering would line the inner surface of the frame in the same manner as claimed by folding over and enveloping struts as taught by Eberhardt), and sandwiches the struts that form downstream portion by extending in contact with the inner surface of the struts that form downstream portion (the covering would line the inner surface of the frame in the same manner as claimed by folding over and enveloping struts as taught by Eberhardt), and around the downstream end of the frame to be disposed over and in contact with the outer surface of the struts that form the downstream portion (the covering would envelope the struts and cover both inner and outer surfaces of the struts as taught by Eberhardt), and the second portion of the fabric covering covers a radially-inner surface of each protrusion and a radially-outer surface of each protrusion (the covering would envelope the struts and cover both inner and outer surfaces of the struts as taught by Eberhardt).
Regarding claim 10, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 1, the modified invention discloses wherein:
the plurality of struts is arranged so as to form a downstream row of cells (downstream cells are defined as openings of the stent in the downstream end in annotated Fig. 1, cells are discussed in C3:L10-12 of Destefano), and the fabric covering entirely covers the outer and inner surfaces of each strut of the plurality of struts that are arranged to form the downstream row of cells (where the modified invention of Destefano/Menk/Eberhardt would be covered in the same manner since the inner and outer surfaces of the struts are covered by the skirt going around an individual strut, C4:L20-21 of Destefano and taught by Eberhardt).
Regarding claim 11, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 10, the modified invention discloses wherein:
the plurality of struts is arranged so as to form a row of cells upstream (upstream cells are defined as openings of the frame at the upstream end in annotated Fig. 1, cells are discussed in C3:L10-12 of Destefano) to the downstream row of cells (downstream cells are defined as openings of the frame at the downstream end as in annotated Fig. 1, cells are discussed in C3:L10-15 of Destefano), and the fabric covering covers the entire inner surface of the struts that are arranged to form the row of cells upstream to the downstream row of cells (covering covers the entire inner surface of the struts by enveloping the strut as taught by Eberhardt), and covers only part of the outer surface of the struts that are arranged to form the row of cells upstream to the downstream row of cells (some of the struts of the upstream row of cells are not covered enveloped such as side seam 43, C4:L60, see Fig. 2 of Destefano).
Regarding claim 12, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 1, Destefano further discloses further comprising upstream protrusions (protrusions defined by inflow portion of the frame, the frame sections that extend upstream, see Fig. 1) which protrude away from the upstream end of the tubular valve body (see Fig. 1).
Regarding claim 15, Destefano discloses an apparatus, for use at a native valve of a heart of a subject, the apparatus comprising a prosthetic valve (see Abstract) that comprises:
a frame (frame) comprising:
a plurality of struts (struts of the frame, see Fig. 2) arranged to form a tubular valve body of the frame (frame is cylindrical, see Fig. 2), the struts forming an upstream portion of the tubular valve body and forming a downstream portion of the tubular valve body (see annotated Fig. 1 from the rejection of claim 1), the tubular valve body having a downstream end (distalmost end at the downstream portion) and shaped to define a continuous lumen through the tubular valve body (see annotated Fig. 1 from the rejection of claim 1);
at least one valve member (valve body 14), disposed within the lumen, and configured to facilitate unidirectional flow of blood of the subject from an upstream end of the tubular valve body to the downstream portion (C3:L46-48);
a covering (skirt 21 including the tabs 38, 39):
downstream protrusions (cell of the frame that supports commissures, C5:L61, see Fig. 1) which protrude away from the tubular valve body (see Fig. 1), each downstream protrusion separated from an adjacent one of the downstream protrusions by a circumferential gap (see Fig. 1).
Destefano is silent regarding the covering being fabric. Menk teaches a replacement heart valve having a skirt 332 around the upstream portion. The skirt may be pericardial tissue or velour fabrics for tissue ingrowth ([0046]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the material of the covering of Destefano for a fabric material as taught by Menk, since the substitution would have the same predictable result of providing a biocompatible material for tissue ingrowth ([0046] of Menk).
Destefano discloses lining an inner surface of the frame and sandwiching struts of the upstream end (the struts are sandwiched by the tabs 39 folding over the frame, C5:L19) and appears to cover the struts of the downstream end as shown in Fig. 1. However, Destefano does not explicitly disclose lining an inner surface of the frame, and sandwiching the struts that form the downstream portion of the tubular valve body of the frame by extending in contact with an inner surface of the struts that form the downstream portion of the tubular valve body of the frame, and around the downstream end of the frame to be disposed over and in contact with an outer surface of the struts that form the downstream portion of the tubular valve body of the frame, such that each strut that is sandwiched by the covering has an inner surface that is in contact with the covering and an outer surface that is in contact with the covering; wherein the covering extends along and entirely covers the entire outer perimeter of each of the downstream protrusions, wherein the covering entirely and independently envelops each of the downstream protrusions. Eberhardt teaches a frame 34 having struts 36 that extend to commissure posts 38, 40, 42 in the direction of outflow (downstream) (C4:L48-50). Where the struts 36 of the frame are covered by a sleeve 48 (covering) that is folded along the perimeter of the struts and then sutured to the folded portion along the perimeter of the struts 36 (C5:L17-20). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have covered the struts of Destefano in the same manner as the struts of Eberhardt, in order to enclosure the struts in a porous biocompatible fabric to be better received by the body (C5:L14-15). Where the modified invention of Destefano with Eberhardt would teach lining an inner surface of the frame, and sandwiching the struts that form the downstream portion of the tubular valve body of the frame by extending in contact with an inner surface of the struts (the covering would cover the struts and be sutured around to meet the claimed limitation) that form the downstream portion of the tubular valve body of the frame, and around the downstream end of the frame to be disposed over and in contact with an outer surface of the struts that form the downstream portion of the tubular valve body of the frame (covering would cover the struts and be sutured around, thereby sandwiching the struts to meet the claimed limitation), such that each strut that is sandwiched by the covering has an inner surface that is in contact with the covering and an outer surface that is in contact with the covering; wherein the covering extends along and entirely covers the entire outer perimeter of each of the downstream protrusions and would also entirely and independently envelops each of the downstream protrusions (Destefano as shown in Fig. 1 it appears the covering extends along the entirety of the outer perimeter and envelops the downstream protrusions, Eberhardt teaches the entirety of the struts and therefore downstream protrusions being covered in C5:L17-20 and see Fig. 5)
Regarding claim 16, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 15, Destefano further discloses wherein at least part of the fabric covering at the downstream portion is configured to be placed in contact with at least one papillary muscle of the heart (C3:L20, the device is intended to be placed in an unspecified heart valve, the covering that encompasses the downstream portion of the device would be capable of contacting the ventricular papillary muscles as the downstream portion is disposed on an outer surface of the device).
Regarding claim 18, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 15, Destefano further discloses wherein each of the downstream protrusions extends away from a downstream end of the tubular valve body (see Fig. 1).
Regarding claim 19, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 18, the modified invention discloses wherein:
the fabric covering comprises a first portion (portion of the covering that covers the upstream portion, see Fig. 1) of the fabric covering and a second portion (portion of the covering that covers the commissures 24) of the fabric covering, the first portion of the fabric covering lines the inner surface of the frame (the covering would line the inner surface of the frame in the same manner as claimed by folding over and enveloping struts as taught by Eberhardt), and sandwiches the struts that form the downstream portion by extending in contact with the inner surface that form the struts of the downstream portion (the covering would line the inner surface of the frame in the same manner as claimed by folding over and enveloping struts as taught by Eberhardt), and around the downstream end of the frame to be disposed over and in contact with the outer surface of the struts that form the downstream portion (the covering would envelope the struts and cover both inner and outer surfaces of the struts as taught by Eberhardt), and the second portion of the fabric covering entirely covers a radially-inner surface of each downstream protrusion and a radially-outer surface of each protrusion (the covering would envelope the struts and cover both inner and outer surfaces of the struts as taught by Eberhardt).
Regarding claim 20, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 15, the modified invention discloses wherein: the plurality of struts is arranged so as to form a downstream row of cells (downstream cells are defined as openings of the stent in the downstream end in annotated Fig. 1, cells are discussed in C3:L10-12 of Destefano), and the fabric covering entirely covers the outer and inner surfaces of each strut of the plurality of struts that are arranged to form the downstream row of cells (where the modified invention of Destefano/Menk/Eberhardt would be covered in the same manner since the inner and outer surfaces of the struts are covered by the skirt going around an individual strut, C4:L20-21 of Destefano and taught by Eberhardt).
Regarding claim 21, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 20, wherein: the plurality of struts is arranged so as to form a row of cells upstream (upstream cells are defined as openings of the frame at the upstream end in annotated Fig. 1, cells are discussed in C3:L10-12 of Destefano) to the downstream row of cells (downstream cells are defined as openings of the frame at the downstream end as in annotated Fig. 1, cells are discussed in C3:L10-15 of Destefano), and the fabric covering covers the entire inner surface of the struts that are arranged to form the row of cells upstream to the downstream row of cells (covering covers the entire inner surface of the struts by enveloping the strut as taught by Eberhardt), and covers only part of the outer surface of the struts that are arranged to form the row of cells upstream to the downstream row of cells (some of the struts of the upstream row of cells are not covered enveloped such as side seam 43, C4:L60, see Fig. 2 of Destefano).
Claims 14 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Destefano (US9480558) in view of Menk (US2014/0194981) and Eberhardt (US6350282) as applied to claim 10, and further in view of Punga (US2013/0282113)
Regarding claim 14, Destefano/Menk/Eberhardt makes obvious the apparatus according to claim 10; yet, does not explicitly disclose wherein a number of the downstream protrusions is less than a number of the cells of the downstream row of cells. Punga teaches the number of protrusions of the downstream portion and a number of cells of the downstream row of cells is a result effective variable (cells at valve section can be of different sizes and/or shapes, [0032]) and further describes the outflow loops 42 span at least one cell 34 of valve section ([0041]). Thus, it would have been obvious to one of ordinary skill in the art to change the number of downstream protrusions to be less than a number of cells of the downstream row of cells. As the it would have been obvious to modify the number of downstream protrusions, this number could be changed to be less than the number of downstream cells. Therefore, the claimed limitation is considered at least obvious to one of ordinary skill in the art. “[W]here 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); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Regarding claim 22, Destefano/Menk/Eberhardt makes obvious makes obvious the apparatus according to claim 20; yet, does not explicitly disclose wherein a number of the downstream protrusions is less than a number of the cells of the downstream row of cells. Punga teaches the number of protrusions of the downstream portion and a number of cells of the downstream row of cells is a result effective variable (cells at valve section can be of different sizes and/or shapes, [0032]) and further describes the outflow loops 42 span at least one cell 34 of valve section ([0041]). Thus, it would have been obvious to one of ordinary skill in the art to change the number of downstream protrusions to be less than a number of cells of the downstream row of cells. As the it would have been obvious to modify the number of downstream protrusions, this number could be changed to be less than the number of downstream cells. Therefore, the claimed limitation is considered at least obvious to one of ordinary skill in the art. “[W]here 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); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
Allowable Subject Matter
Claims 13 and 17 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 following is a statement of reasons for the indication of allowable subject matter:
With regard to claim 13, no prior art of record teaches or discloses “the fabric covering does not cover the upstream protrusions” in combination with the other limitations as claimed in claims 1 and 12.
With regard to claim 17, no prior art of record teaches or discloses “further comprising upstream protrusions which protrude away from the upstream end of the tubular valve body, wherein the fabric covering does not cover the upstream protrusions” In combination with the other limitations claimed in claim 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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, Thomas Barrett can be reached at (571)272-4746. 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.
/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights