LDETAILED 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 .
Allowable Subject Matter
Claims 4 and 13-15 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: the prior art fails to teach nor render obvious wherein the force control mechanism comprises a carriage, a first pulley, a second pulley, and a third pulley, wherein the carriage is movable relative to the handle, wherein the first and second pulleys are rotatably mounted to the carriage, wherein the third pulley is fixed relative to the handle, wherein the proximal end portions of the first and second actuation shafts are coupled together via the first pulley, wherein the third actuation shaft extends around the second pulley and the third pulley, wherein the proximal end portions of the first and second actuation shafts move axially relative to each other and the first pulley rotates when tension in the first actuation shaft is different than tension in the second actuation shaft, and wherein the proximal end portion of the third actuation shaft moves relative to the first and second actuation shafts and the second and third pulleys rotate when tension in the third actuation shaft is different than tension in the first or second actuation shafts and wherein the displacement control mechanism comprises a slidable outer gear configured to be moved between a first position and a second position, wherein in the first position, the slidable outer gear engages a plurality of first inner gears of the first gear assembly, and wherein in the second position, the slidable outer gear engages a plurality of second inner gears of the second gear assembly and herein the displacement control mechanism comprises a coupling member, an actuation member, and a gear assembly, wherein the coupling member is coupled to the distal end portions of the actuation shafts, wherein the actuation member extends through the first shaft, wherein a first end portion of the actuation member is coupled to the coupling member, and wherein the gear assembly is coupled to the proximal end portions of the actuation shafts, wherein axial movement of the actuation member relative to the first shaft results in simultaneous axial movement of the coupling member and the actuation shafts relative to the first shaft and the gear assembly, and wherein rotating the gear assembly relative to the first shaft results in simultaneous rotational movement of the actuation shafts relative to the first shaft, wherein the actuation member is coupled to an actuation mechanism.
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.
(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) 1-2 and 5-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paul et al. U.S. Publication 2014/0114405 A1.
Regarding Claim 1, Paul et al. discloses in Figures 2A-2B and 4 a delivery apparatus 100 for a prosthetic heart valve, the delivery apparatus comprising: a handle 120 (as seen in Figure 2A and paragraph [0049]); a first shaft 108/208 comprising a first end portion, a second end portion, and one or more lumens (as seen in Figures 2A-2B), the one or more lumens extending from the first end portion to the second end portion, the first end portion coupled to the handle 120; a plurality of actuation shafts 106a, 106b, each actuation shaft of the plurality of actuation shafts comprising a proximal end portion and a distal end portion, the plurality of actuation shafts extending through the one or more lumens of the first shaft 208 (paragraphs [0052]); and a control mechanism (see Figures 17A-17D, 20A-20C, 23A-23C rotary actuator in the handle, and paragraph [0074] and [0088-0090] and [0094]) coupled to the plurality of actuation shafts and to the handle (paragraphs [0050] and [0094]), wherein the control mechanism comprises a first mode of operation and a second mode of operation (paragraphs [0014], [0018], [0075]); wherein, when in the first mode of operation, the proximal end portions of the plurality of actuation shafts are configured to move axially relative to each other and relative to the first shaft (paragraphs [0014], [0018], [0075]); and wherein, when in the second mode of operation, the plurality of actuation shaft and wherein, when in the second mode of operation, the plurality of actuation shafts are configured to move axially simultaneously (paragraphs [0014], [0018], [0075]).
Regarding Claim 2, Paul et al. discloses wherein the control mechanism includes a force control mechanism (paragraph [0051], [0054], [0079] and [0088]).
Regarding Claim 5, Paul et al. discloses further comprising an actuation mechanism coupled to one of the actuation shafts and configured to move the actuation shafts axially simultaneously (paragraphs [0014], [0018], [0075]).
Regarding Claim 6, Paul et al. discloses wherein the actuation mechanism comprises a rotatable knob (paragraphs [0005], [0073], wherein rotation of the rotatable knob results in simultaneous axial movement of the actuation shafts (paragraphs [0005], [0073] and [0075]).
Claim(s) 1-3 and 5-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salahieh et al. U.S. Publication 2007/0112355 A1.
Regarding Claim 1, Salahieh et al. discloses in Figures 1-10E a delivery apparatus 10 for a prosthetic heart valve 600 (abstract and paragraphs [0063-0065]), the delivery apparatus comprising: a handle 200 (as seen in Figure 2 and paragraph [0067] and [0077]); a first shaft 308 comprising a first end portion, a second end portion, and one or more lumens (as seen in Figures 3B), the one or more lumens extending from the first end portion to the second end portion, the first end portion coupled to the handle 200 (as seen in Figure 3A); a plurality of actuation shafts 308a, 308b, 308c each actuation shaft of the plurality of actuation shafts comprising a proximal end portion and a distal end portion (as seen in Figures 5, 8D-8E, 8I, 8J), the plurality of actuation shafts 308a, 308b, 308c extending through the one or more lumens of the first shaft 18 (as seen in Figures 1B, 2, 3A-3B, 5-8E); and a control mechanism 522, 522a (see Figures 5 and 8D, 8I-8J, one or more pulleys in the handle, and paragraph [0074], [0079]) coupled to the plurality of actuation shafts and to the handle 200 (paragraphs [0050] and [0094]), wherein the control mechanism comprises a first mode of operation and a second mode of operation (paragraphs [0067], [0077], [0079-0082], [0084]), wherein, when in the first mode of operation, the proximal end portions of the plurality of actuation shafts are configured to move axially relative to each other and relative to the first shaft (paragraphs [0074-0075], [0077], [0079-0082], [0084]); and wherein, when in the second mode of operation, the plurality of actuation shaft and wherein, when in the second mode of operation, the plurality of actuation shafts are configured to move axially simultaneously (paragraphs [0017], [0077], [0079-0082], [0084] and [0092]).
Regarding Claim 2, Salahieh et al. discloses wherein the control mechanism includes a force control mechanism (paragraph [0044], [0046-0047], [0052], [0059], [0074], [0079]).
Regarding Claim 3, Salahieh et al. discloses wherein the force control mechanism comprises a pulley 522, wherein the proximal end portions of two of the actuation shafts 308a, 308b are coupled together via the pulley, wherein the proximal end portions of the two of the actuation shafts move axially relative to each other and the pulley rotates when tension in the two of the actuation shafts is uneven (as seen in Figure 8D and paragraphs [0017], [0059], [0079]).
Regarding 5, Salahieh et al. discloses further comprising an actuation mechanism 204a, 204b, 204c coupled to one of the actuation shafts (see Figure 8A) and configured to move the actuation shafts axially simultaneously (see Figure 8A and paragraphs [0017], [0079-0080] and [0090]).
Regarding Claim 6, Salahieh et al. discloses wherein the actuation mechanism comprises a rotatable knob (paragraphs [0042], [0080]), wherein rotation of the rotatable knob results in simultaneous axial movement of the actuation shafts.
Regarding Claim 7, Salahieh et al. discloses wherein the actuation mechanism 204 comprises an electric motor with a rotatable shaft, wherein rotation of the rotatable shaft results in simultaneous axial movement of the actuation shafts (see Figures 8I, 8J, paragraphs [0044-0045]).
Regarding Claim 8, Salahieh et al. discloses wherein the actuation mechanism comprises a spool configured for increasing and decreasing tension in the actuation shafts (see Figure 8A and paragraph [0079-0080]).
Claim(s) 16 and 18-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Calomeni et al. U.S. Publication 2019/0029854 A1.
Regarding Claim 16, Calomeni et al. discloses a delivery assembly 10 as seen in Figures 1-10 comprising: a delivery apparatus comprising: a handle 18; a first shaft 12 coupled to the handle 18 and comprising one or more lumens (as seen in Figures 1-3); a plurality of actuation shafts (see Figures 2-3, actuators 84 has its own lumen) extending through the one or more lumens of the first shaft, each actuation shaft of the plurality of actuation shafts comprising a proximal end portion and a distal end portion; and a control mechanism coupled to the plurality of actuation shafts 84 and to the handle 18, the control mechanism comprising a first mode of operation and a second mode of operation; and a mechanically-expandable prosthetic heart valve 18 comprising a frame 70 with a plurality of struts and a plurality of actuators 84 (paragraphs [0056-0058] and as seen in Figures 1-3), wherein: when the control mechanism is in the first mode of operation, the proximal end portions of the plurality of actuation shafts are configured to move axially relative to each other and relative to the first shaft (abstract and paragraph [0082-0083], [0087-0091], [0096-0097]); and when the control mechanism is in the second mode of operation, the plurality of actuation shafts are configured to move axially simultaneously (paragraph [0092], [0102-103]).
Regarding Claim 18, Calomeni et al. discloses wherein the plurality of actuation shafts of the delivery apparatus are releasably coupled to the plurality of actuators 84 of the mechanically- expandable prosthetic heart valve 16 such that relative axial movement between the actuation shafts and the first shaft moves the frame of the mechanically-expandable prosthetic heart valve between the radially compressed configuration and the radially expanded configuration (paragraphs [0054], [0058], [0060-0061]).
Regarding Claim 19, Calomeni et al. discloses wherein rotating the plurality of actuation shafts in a first direction is configured to couple the distal end portions of the plurality of actuation shafts with the plurality of actuators 84 of the mechanically-expandable prosthetic heart 16, and wherein rotating the plurality of actuation shafts in a second direction is configured to de-couple the distal end portions of the plurality of actuation shafts from the plurality of actuators of the mechanically-expandable prosthetic heart (paragraphs [0058], [0060-0061], [0070-0071], [0082-0083]and [0091]).
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.
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paul et al. U.S. Publication 2014/0114405 A1 in view of Maimon et al. U.S. Publication 2018/0153689 A1.
Regarding Claim 7, Paul et al. does not expressly disclose wherein the actuation mechanism comprises an electric motor with a rotatable shaft, wherein rotation of the rotatable shaft results in simultaneous axial movement of the actuation shafts. Maimon et al. teaches a delivery apparatus 1 in the same field of endeavor for delivery a prosthetic heart valve 14 (abstract and paragraphs [0149], [0251]), the apparatus comprising a handle 70, a first shaft 82 and a plurality of actuating members 76 (as seen in Figure 1), wherein the handle 70 can house one or more electric motors that are actuated by user to produce movement of one or more motors operable to produce linear movement of the actuating shafts 802 (see Figures 29C and 30 and paragraphs [0251-0253]). 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 Paul’s handle to further include one or more electric motors for the purpose of producing movement to one or more motors to produce linear movement of the actuating shafts and allow the radial expansion of the prosthetic heart valve (paragraph [0253]).
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh et al. U.S. Publication 2007/0112355 A1 in view of Calomeni et al. U.S. Publication 2018/0344456 A1.
Regarding Claims 9, 10, 11, 12, Salahieh et al. discloses the plurality of actuation shafts 308a, 308b, 308c extending through the one or more lumens of the first shaft 18 (as seen in Figures 1B, 2, 3A-3B, 5-8E); and a control mechanism 522, 522a (see Figures 5 and 8D, 8I-8J, one or more pulleys in the handle, and paragraph [0074], [0079]) coupled to the plurality of actuation shafts and to the handle 200 (paragraphs [0050] and [0094]), wherein the control mechanism comprises a first mode of operation and a second mode of operation (paragraphs [0067], [0077], [0079-0082], [0084]). However, Salahieh et al. does not expressly disclose wherein the control mechanism includes a displacement control mechanism, wherein the displacement control mechanism comprises a first gear assembly and a second gear assembly, wherein rotating the first gear assembly relative to the first shaft results in simultaneous axial movement of the actuation shafts relative to the first shaft, and wherein rotating the second gear assembly relative to the first shaft results in simultaneous rotational movement of the actuation shafts relative to the first shaft and wherein the first gear assembly is coupled to an actuation mechanism, and wherein the second gear assembly is coupled to a release mechanism. Calomeni et al. teaches a delivery apparatus in the same field of endeavor for delivery a prosthetic heart valve 16 as seen in Figures 1-10 (abstract and paragraphs [0004], [0019], [0048] and [0056]), the apparatus comprising a handle 18, a first shaft 142 and a plurality of actuating members 84 (paragraphs [0054], [0066], [0080], [0082-0083], [0106]) and a control mechanism including a displacement control mechanism comprising a first gear assembly 134/157 (paragraph [0083], [0096]) coupled to an actuation mechanism (paragraph [0083], coupled to the actuator) and a second gear assembly 162/160 (paragraphs [0083], [0096], [0106]) coupled to a release mechanism 88 (e.g. release pin) to irreversibly detaching or disconnect from the implant 16 (paragraph [0102]), wherein rotating the first gear assembly 157 relative to the first shaft results in simultaneous axial movement of the actuation shafts 84 relative to the first shaft 142 (paragraph [0082-0083], [0087-0091], [0096-0097]) and wherein rotating the second gear 162/160 assembly relative to the first shaft results in simultaneous rotational movement of the actuation shafts relative to the first shaft (paragraphs [0083], [0091], [0094], [0096-0097]) for the purpose of retaining the stent onto the delivery device until the gears are rotated to a first direction to cause axial translation of the actuator to release the implant into a delivery configuration (paragraph [0092], [0102]). 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 Salahieh’s delivery device to further include a displacement control mechanism wherein the displacement control mechanism comprises a first gear assembly and a second gear assembly, wherein rotating the first gear assembly relative to the first shaft results in simultaneous axial movement of the actuation shafts relative to the first shaft, and wherein rotating the second gear assembly relative to the first shaft results in simultaneous rotational movement of the actuation shafts relative to the first shaft as taught by Calomeni et al. for the purpose of retaining the stent onto the delivery device until the gears are rotated to a first direction to cause axial translation of the actuator to release the implant into a delivery configuration.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calomeni et al. U.S. Publication 2019/0029854 A1 in view of Barash et al. U.S. Publication 2018/0344456 A1.
Regarding Claims 17, Calomeni et al. does not expressly disclose wherein the struts of the frame are pivotably coupled together, and wherein the plurality of actuators are coupled to the struts of the frame and configured to move the frame between a radially compressed configuration and a radially expanded configuration. Barash et al. teaches a delivery assembly in the same field of endeavor for delivery a prosthetic heart valve 14 as seen in Figures 1-12 (abstract and paragraphs [0150]), the apparatus comprising a handle 70, a first shaft 72 coupled to the handle and a mechanically expandable prosthetic heart valve 14 comprising a frame 22 with a plurality of struts 32 (paragraphs [0129-0131]) and a plurality of actuators 76 (paragraphs [0151-0153] and as seen in Figure 8), wherein the struts 32 of the frame 22 are pivotably coupled together (as seen in Figure 8 and 21 and abstract and paragraphs [0028], [0131], [0133-0136], [0231-232]), and wherein the plurality of actuators 76 are coupled to the struts 32 of the frame 22 (as seen in Figures 1 and 8) and configured to move the frame between a radially compressed configuration and a radially expanded configuration (paragraph [0036], [0044], [0223] and [0232]). 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 Calomeni’s prosthetic heart valve to further comprise a frame having a plurality of struts that are pivotably coupled together for the purpose of allowing the struts to bend or pivot relative to each other to permit radial expansion and contraction of the frame (paragraph [0134]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774