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
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- 5 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cartledge et al. US 20180104077 A1, herein referred to as Cartledge.
Regarding claim 1, Cartledge discloses a delivery apparatus (Figs 105-107,10500) for a prosthetic heart valve (limitation is directed toward intended use; [0003]; Figs 71-83, 7100), the delivery apparatus comprising:
a handle body (Fig 108-118, 10800; [0337]) having a first end (section near 11040), a second end (section near 11300 arrow), a cavity (area filled by 11030) between the first end and the second end (Fig 108), and a longitudinal axis (defined by 11030) extending through the first end, the cavity, and the second end (Fig 108);
an actuator driver (Fig 7, 740) having a first driver end portion disposed within the cavity (end near 750), a second driver end portion disposed outside the cavity (end near 710), and a first axial axis extending through the first driver end portion and the second driver end portion (Fig 7; axis defined by center of 740);
a sleeve member (752) operatively coupled to the actuator driver ([0284]), the sleeve member having a first sleeve end portion disposed within the cavity ([0284]), a second sleeve end portion disposed outside the cavity ([0284-0285]), and a second axial axis (defined by center of 752) extending through the first sleeve end portion and the second sleeve end portion (Fig 7), wherein the second axial axis is parallel to the first axial axis (axes as described align in parallel);
and a pull body (Fig 112, 10804) disposed within the cavity and coupled to the first sleeve end portion (Fig 112), the pull body movable along the longitudinal axis such that movement of the pull body axially displaces the sleeve member relative to the handle body ([0340-0341]).
Regarding claim 2, Cartledge discloses wherein the second driver end portion comprises an engagement member (Fig 16-17, 748) to releasably couple the actuator driver to an actuator of the prosthetic heart valve ([0284]), and wherein the sleeve member is extendible over the engagement member and retractable from the engagement member by movement of the pull body along the longitudinal axis [0284].
Regarding claim 3, Cartledge discloses further comprising a gearbox (Annotated Fig 117 below) disposed within the cavity and coupled to the actuator driver for rotation of the actuator driver ([0346-0348]), wherein the gearbox comprises a gearbox housing enclosing a gear train (Fig 117, 11653/11652/11651; [0349] recites self-contained assembly that encloses the shown gear assembly), and wherein the pull body is movably coupled to the gearbox housing ([0346-0348]).
PNG
media_image1.png
509
650
media_image1.png
Greyscale
Regarding claim 4, Cartledge discloses further comprising a knob coupled to the pull body, wherein rotation of the knob relative to the handle body moves the pull body along the longitudinal axis [0348].
Regarding claim 5, Cartledge discloses wherein the pull body comprises a first pull body portion, a second pull body portion, (distal and proximal ends of 10804 see Fig 112) and a third axial axis extending through a center of the first pull body portion and a center of the second pull body portion (Fig 112), wherein the third axial axis (defined by the center of 10804) is parallel to the longitudinal axis (defined by the center of 10804, would be parallel as claimed).
Regarding claim 20, Cartledge discloses a method of implanting a prosthetic heart valve ([0003]; Fig 7100 Figs 71-83), comprising: engaging an end portion of an actuator driver (Fig 7, 740) coupled to a handle(Fig 108-109, 10800) with an end portion of an actuator (10816) coupled to a frame of the prosthetic heart valve ([0317] and [0358-0359]);
moving a pull body (Fig 112, 10804) along a longitudinal axis of the handle in a first direction to extend an end portion of a sleeve member (752) coupled to the pull body over the engaged end portions of the actuator driver and actuator ([0284-0285]);
delivering the prosthetic heart valve to an implantation location (Figs 66 and 68); radially expanding the prosthetic heart valve to a functional size (Figs 68-69; [0352]);
moving the pull body along the longitudinal axis of the handle in a second direction that is opposite to the first direction to retract the end portion of the sleeve member from the engaged end portions of the actuator driver and actuator [0395];
and releasing the end portion of the actuator driver from the end portion of the actuator [0444].
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.
Claim(s) 6, 7, 9, 10 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view Cohen et al. US 20180311039 A1, herein referred to as Cohen.
Regarding claim 6, Cartledge discloses the invention substantially as claimed and as
discussed above with respect to claim 5, but fails to explicitly disclose wherein the first pull body portion comprises a pin member disposed radially to the third axial axis and positioned on a periphery of the pull body, wherein the knob comprises a cam slot, and wherein the knob is disposed around the pull body such that the pin member extends into the cam slot.
However, in the same field of invention, Cohen discloses a delivery apparatus comprising: a handle body (70); an actuator driver (76); a sleeve member (82); a pull body (86) and teaches wherein the first pull body portion comprises a pin member (Fig 26a-d, 620/610) disposed radially to the third axial axis and positioned on a periphery of the pull body [0155], wherein the knob (Fig 20, 604) comprises a cam slot (625), and wherein the knob is disposed around the pull body such that the pin member extends into the cam slot (Fig 13, [0155].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Cartledge to incorporate wherein the first pull body portion comprises a pin member disposed radially to the third axial axis and positioned on a periphery of the pull body, wherein the knob comprises a cam slot, and wherein the knob is disposed around the pull body such that the pin member extends into the cam slot, as taught by Cohen, in order to allow device locking of gear/actuation mechanism (Cohen [0155]).
Regarding claim 7, Cartledge as modified by Cohen discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the knob (Cohen Fig 20, 604) comprises an inner surface forming a cylindrical lumen (shows engagement with element, therefore including a receiving lumen), wherein the cylindrical lumen defines a fourth axial axis (Cohen defined by center of knob) that is oriented parallel to the longitudinal axis (would be parallel), and wherein the cam slot comprises an angled slot portion formed in the inner surface and extending along a path that is angled relative to the fourth axial axis (All axes would be parallel).
Regarding claim 9, Cartledge as modified by Cohen discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally wherein the second pull body portion comprises a socket (see annotated Cartledge Fig 112 below, lumen the pull body 110804 is located) extending in a direction parallel to the third axial axis (Cartledge Fig 112), and wherein the first pull body portion comprises an opening forming an extension of the socket (See annotated Cartledge Fig 112 below).
PNG
media_image2.png
493
658
media_image2.png
Greyscale
Regarding claim 10, Cartledge as modified by Cohen discloses the invention substantially as claimed and as discussed above with respect to claim 9, and additionally discloses further comprising an actuation tube (Cartledge 11030) extending through the opening and socket (Cartledge Fig 112); but fails to explicitly disclose wherein the sleeve member is rigidly coupled to the actuation tube, and wherein the actuation tube is rotationally fixed relative to the pull body.
However, in another embodiment, Cartledge further teaches wherein the sleeve member (Cartledge Fig 128, 12752) is rigidly coupled to the actuation tube (Fig 128, 12630), and wherein the actuation tube is rotationally fixed relative to the pull body (Cartledge [0358]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify Cartledge as modified by Cohen to incorporate wherein the sleeve member is rigidly coupled to the actuation tube, and wherein the actuation tube is rotationally fixed relative to the pull body, as taught by Cartledge (Cartledge [0358]) in order to allow drive screw coupling of members.
Regarding claim 18, Cartledge as modified by Cohen discloses the invention substantially as claimed and as discussed above with respect to claim 7, and additionally teaches wherein the second pull body portion comprises a pair of slider arms (see annotated Fig 116 below) projecting in a direction parallel to the third axial axis and spaced from each other in a direction transverse to the third axial axis (Cartledge [0342-0343]; [0422] teaches symmetrical construction, second arm is on the non-shown side of Fig 116).
PNG
media_image3.png
761
656
media_image3.png
Greyscale
Regarding claim 19, Cartledge as modified by Cohen discloses the invention substantially as claimed and as discussed above with respect to claim 18, and additionally wherein the pair of slider arms extend into the pair of slots (See annotated Fig 116 above) and are movable along the pair of slots in response to movement of the pull body along the longitudinal axis (Cartledge Fig 116); and wherein each of the slots of the gearbox housing comprises a pair of opposed stop surfaces spaced along the longitudinal axis and positioned to selectively engage and stop movement of the slider arms in predetermined directions (fully capable).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view Cohen as applied to claim 6 above, and further in view of Conklin et al. US 20180289477 A1, herein referred to as Conklin.
Regarding claim 8, Cartledge as modified by Cohen discloses the invention substantially as claimed and as discussed above with respect to claim 6, and additionally teaches wherein the first pull body portion comprises a central hub (Cohen Figs 26a-b, 640/660); and the pin member is formed at [the central hub] (Cohen Figs 26a-d, 620/610).
However, Cartledge [as modified by Cohen] fails to explicitly disclose wherein [a] pin member is formed at an end of the radial arm [of the central hub].
Moreover, in the same field of invention, Conklin discloses a delivery apparatus for delivery a heart valve (Fig 3,100; [0045]) comprising: a handle body ([0061]); a pull body (Fig 3, 140); wherein the first pull body portion comprises a central hub (114) and a radial arm (110) projecting from the central hub (Fig 5a-c). Conklin teaches wherein the pin member (120) is formed at an end of the radial arm (110) [of the central hub] (Fig 3, 114).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify the invention of Cartledge as modified by Cohen further to incorporate wherein the pin member is formed at an end of the radial arm [of the central hub], in order to allow engagement recesses in the arm spaces (Conklin [0053]).
Claim(s) 11 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view of Wilson et al. US 20180214269 A, herein referred to as Wilson.
Regarding claim 11, Cartledge discloses the invention substantially as claimed and as discussed above with respect to claim 5, but fails to teach wherein the first pull body comprises a plurality of pin members disposed radially to the third axial axis and positioned on a periphery of the pull body, and wherein the pin members are angularly offset from each other.
However, in the same field of invention, Wilson discloses a delivery apparatus [0011] comprising: a handle body (Fig 14a-e, 335); an actuator driver (1290); a sleeve member (1232); a pull body (Fig 38c, 1234) and wherein the first pull body portion comprises a pin member (Fig 38c-d, 1240), a cam slot ([0211]); slots for pin described). Wilson teaches the first pull body comprises a plurality of pin members (Figs 38c-d, 1240; plurality shown) disposed radially to the third axial axis and positioned on a periphery of the pull body (Fig 38c-d), and wherein the pin members are angularly offset from each other (offset consistent with the applicant’s instant application, see Fig 24c).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify the invention of Cartledge to incorporate wherein the first pull body comprises a plurality of pin members disposed radially to the third axial axis and positioned on a periphery of the pull body, and wherein the pin members are angularly offset from each other, as taught by Wilson, in order to allow anchoring (Wilson [0211]).
Regarding claim 15, Cartledge as modified by Wilson discloses the invention substantially as claimed and as discussed above with respect to claim 11, and additionally discloses further comprising additional actuator drivers (Cartledge Fig 169, 770) and additional sleeve members (Cartledge 16940), each additional sleeve member operatively coupled to one of the additional actuator drivers (Cartledge [0376]).
Regarding claim 16, Cartledge as modified by Wilson discloses the invention substantially as claimed and as discussed above with respect to claim 15, and additionally Cartledge discloses each of the openings forming an extension of one of the sockets (Cartledge Fig 112 dotted lines show receiving sections in 10804).
Yet, the combination of Cartledge and Wilson does not explicitly disclose wherein the second pull body portion comprises a plurality of sockets extending in a direction parallel to the third axial axis.
However, in another embodiment Wilison teaches wherein the second pull body portion comprises a plurality of sockets (Wilson [0211]) extending in a direction parallel to the third axial axis (Wilson Figs 38c-d), wherein the first pull body portion comprises a plurality of openings (Cartledge Fig 112, holes for rods shown with dotted lines ),
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify the invention of Cartledge to incorporate discloses wherein the second pull body portion comprises a plurality of sockets extending in a direction parallel to the third axial axis, as further taught by Wilson, in order facilitate the deployment of anchors in the system (Wilson [0211]).
Regarding claim 17, Cartledge as modified by Wilson discloses the invention substantially as claimed and as discussed above with respect to claim 16, and additionally discloses further comprising a plurality of actuation tubes (Cartledge Fig 112), each of the actuation tubes extending through one of the sockets and the corresponding opening, wherein each of the sleeve member and additional sleeve members is rigidly coupled to one of the actuation tubes (Cartledge Fig 112; includes locking), and wherein each of the actuation tubes is rotationally fixed relative to the pull body (Cartledge [0344]).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view of Wilson as applied to claim 11 above, and further in view of Cohen.
Regarding claim 12, Cartledge as modified by Wilson discloses the invention substantially as claimed and as discussed above with respect to claim 11, but fails to disclose wherein the knob comprises a plurality of cam slots, and wherein the knob is disposed around the pull body such that each of the pin members is received in one of the cam slots.
However, in the same field of invention, Cohen discloses a delivery apparatus comprising: a handle body (70); an actuator driver (76); a sleeve member (82); a pull body (86), pin members (Fig 26a-d, 612), and a knob (Fig 20, 604). Cohen teaches the knob comprises a plurality of cam slots (604 shows plurality), and wherein the knob is disposed around the pull body such that each of the pin members (612) is received in one of the cam slots (Fig 22).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify the invention of Cartledge to incorporate wherein the knob comprises a plurality of cam slots, and wherein the knob is disposed around the pull body such that each of the pin members is received in one of the cam slots, as taught by Cohen in order to allow device locking of gear/actuation mechanism (Cohen [0155]).
Regarding claim 13, Cartledge as modified by Wilson and Cohen discloses the invention substantially as claimed and as discussed above with respect to claim 12, but does not explicitly disclose wherein the knob comprises an inner surface forming a cylindrical lumen, wherein the cylindrical lumen defines a fourth axial axis, and wherein each of the cam slots comprises an angled slot portion formed in the inner surface and extending along a path that is angled relative to the fourth axial axis.
However, in another embodiment, Cohen also teaches wherein the knob (Cohen Fig 20, 604) comprises an inner surface forming a cylindrical lumen (Defined by 611 filling 604 see Cohen Fig 21), wherein the cylindrical lumen defines a fourth axial axis (Cohen Fig 21), and wherein each of the cam slots comprises an angled slot portion formed in the inner surface and extending along a path that is angled relative to the fourth axial axis (Cohen [0152]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify the invention of Cartledge/Cohen/Wilson to incorporate disclose wherein the knob comprises an inner surface forming a cylindrical lumen, wherein the cylindrical lumen defines a fourth axial axis, and wherein each of the cam slots comprises an angled slot portion formed in the inner surface and extending along a path that is angled relative to the fourth axial axis, as further taught by Cohen in order to allow toggling of threaded components (Cohen [0151]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view of Wilson as applied to claim 11 above, and further in view of Conklin.
Regarding claim 14, Cartledge as modified by Wilson discloses the invention substantially as claimed and as discussed above with respect to claim 11, but fails to explicitly disclose wherein the first pull body portion comprises a central hub and a plurality of radial arms projecting from the central hub and angularly offset from each other, and wherein each of the pin members is formed at an end of one of the radial arms.
However, Conklin also discloses a delivery apparatus for delivery a heart valve (Fig 3,100; [0045]) comprising: a handle body ([0061]) and a pull body (Fig 3, 140). Conklin teaches wherein the first pull body portion comprises a central hub (Conklin Fig 5a-c, 114) and a plurality of radial arms (Conklin Fig 5a-c,110) projecting from the central hub and angularly offset from each other (Conklin Fig 5a-c), and wherein each of the pin members (Annotated Conklin Fig 3 below) is formed at an end of one of the radial arms (Conklin [0053]).
PNG
media_image4.png
513
448
media_image4.png
Greyscale
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention modify the invention of Cartledge as modified by Wilson further to incorporate wherein the first pull body portion comprises a central hub and a plurality of radial arms projecting from the central hub and angularly offset from each other, and wherein each of the pin members is formed at an end of one of the radial arms, as taught by Conklin, in order to allow engagement recesses in the arm spaces (Conklin [0053]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Zimmerman III et al. US 20220079755 A1 discloses a cardiac delivery apparatus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adrian Flores whose telephone number is (571)272-1450. The examiner can normally be reached M-F, 9-5.
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 at (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.
/A.F./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights