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 amendment and reply of 6/19/26. The claims 18-37 are pending. Claims 18, 20-22, 33, and 35 have been amended.
Response to Arguments
Applicants amendments have overcome the previous 112(b) rejections.
Applicant argues the drawing objection and points to Figure 2 to show a bead member 41 and a barrel member 43. The arguments are persuasive and the objection has been withdrawn.
Applicant’s arguments, filed 6/19/26 with respect to the rejections of claims 18-27 and 30-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lashinski (US2017/0360549) have been fully considered and are partially persuasive. Applicant argues, Lashinski does not disclose “attaching a first delivery device section to a second delivery device section by attaching a first coupling member of an actuation shaft that is part of the first delivery device section to a second coupling member of a support shaft that is part of the second delivery device section, the second delivery device section including a support structure configured to releasably hold the implantable heart valve on the support shaft”. Applicant argues, Lashinski describes connecting a shaft directly to the implant (member 1400) and therefore does not anticipate the claimed invention. Examiner makes notice, the amendment does not recite the shaft not being directly connected to the implant and the argument is unclear. However, Examiner partially agrees Lashinski does not explicitly disclose “a support structure configured to releasably hold the implantable heart valve”. Therefore, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lashinski.
The amendments to claims 33 and 35 fail to overcome the previous rejection. The rejection has been maintained as addressed in the rejections below.
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 33-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lashinski (US2017/0360549).
Regarding claim 33, Lashinski discloses a method for delivering an implantable heart valve through a patient's vasculature ([0153]), the method comprising:
providing a medical device delivery system with a reversible mechanical engagement (where the reversible mechanical engagement is interpreted as the engagement between the coupling hooks 1406, 1407, where the coupling hooks are engaged and disengaged, [0120]]) that includes an actuation shaft (1405) having a first coupling member (1407) with interlocking projections and recesses (see annotated Fig. 14), and a support shaft (1400) having a second coupling member (1406) with interlocking projections and recesses (see annotated Fig. 14) ([0120]), and a locking collar (cover 1401, where the cover performs locking by engaging with stopper 1402 to stabilize the connection between the driver 1405 and member 1400, [0120]) in order to couple first and second sections of the medical device delivery system (first section is interpreted as the section of the medical device delivery that includes the hook 1407, the second section is interpreted as the section of the medical device delivery that includes the hook 1406; [0120]);
wherein the medical device delivery system releasably secures the implantable heart valve (where this is interpreted as releasably securing the implantable heart valve since the engagement is securing the device when the cover is slid over the clasping hooks 1406, 1407 and disengagement is releasing the clasping hooks and therefore the device from the rotational coupling, the replacement heart valve in combination with the implant is interpreted as the implantable heart valve and is discussed in [0155]);
mechanically coupling the actuation shaft to the support shaft by positioning projections into recesses ([0120]) and disposing the locking collar around both coupling members (see Fig. 14);
advancing the medical device delivery system percutaneously through the patient's vasculature to a target site adjacent the heart ([0057]);
deploying the implantable heart valve at the target site ([0153], [0156]); and
disconnecting the medical device delivery system from the implantable heart valve ([0009]).
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Regarding claim 34, Lashinski discloses the method of claim 33, wherein the reversible mechanical engagement comprises interlocking projections and recesses that maintain connection during valve delivery ([0120], where the engagement occurs during valve delivery and is therefore interpreted as maintained).
Regarding claim 35, Lashinski discloses a method for delivering an implantable heart valve ([0153]), the method comprising:
attaching a coupling member (different portions of hook 1407) of an actuation shaft (1405) and a coupling member (different portions of hook 1406) of a support shaft (1400) of a medical device delivery system through reversible mechanical engagement without destructive release mechanisms ([0120]), the coupling member of the actuation shaft and the coupling member of the support shaft of the medical device delivery system distinct from the implantable heart valve (the implant connected to the assembly discussed in paragraph [0120] is independent and distinct of the heart valve as discussed in paragraph [0155]);
advancing the medical device delivery system to a target site adjacent the heart via a percutaneous approach ([0057]);
deploying the implantable heart valve at the target site using mechanical coupling structures that maintain structural integrity (the mechanical coupling structures are interpreted as the coupling of the implant to the prosthetic heart valve, the structures are described hooks, clasps, tangs, clips, fasteners, and/or cogs, [0155]); and
detaching the medical device delivery system from the implantable heart valve without cutting supporting structures ([0009]).
Regarding claim 36, Lashinski discloses the method of claim 35, wherein the mechanical coupling structures comprise hooks configured for controlled engagement and disengagement (hooks are used to connect to the valve, [0153]).
Regarding claim 37, Lashinski discloses the method of claim 35, wherein the percutaneous approach is selected from the group consisting of transapical, transseptal, and transfemoral approaches (see Fig. 2A-E, [0052]).
Claim Rejections - 35 USC § 102/103
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.
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 of this title, 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.
Claims 18-27 and 30-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lashinski (US2017/0360549) or, in the alternative under 35 U.S.C. 103 as obvious over Lashinski (US2017/0360549).
Regarding claim 18, Lashinski discloses a method for delivering an implantable heart valve ([0153]), the method comprising:
attaching a first delivery device section (distal section of shaft as shown in annotated Fig. 14) to a second delivery device section (proximal section of shaft as shown in annotated Fig. 14 and implant) by attaching a first coupling member (1407) of an actuation shaft (1405) that is part of the first delivery device section to a second coupling member (1406) of a support shaft (1400 and implant) ([0120]) that is part of the second delivery device section, the second delivery device section including a support structure (implant) configured to releasably hold the implantable heart valve on the support shaft (the shaft 1400 is part of the medical device delivery system by adjusting the implant 1200 to expand the replacement valve, where the member 1400 adjusts the implant in the same manner as the member 1300, [0120], [0117]; where the second delivery device section as shown in annotated Fig. 14 engages with and holds the implantable heart valve as described in paragraph [0155] and can disengage the implantable heart valve after rotation in the same manner as described with member 1300, [0117]),
wherein attaching the first coupling member (1407) of the actuation shaft to the second coupling member (1406) of the support shaft includes positioning a projection of the first coupling member (projection of hook 1407, see Fig. 14) into a recess of the support shaft (recess of hook 1406, see Fig. 14), and positioning a projection of the second coupling member (projection of hook 1406, see Fig. 14) into a recess of the first coupling member (recess of hook 1407, see Fig. 14);
advancing the medical device delivery system to a target site adjacent the heart ([0057]); and
deploying the implantable heart valve at the target site ([0153], [0156]).
If Applicant should disagree, that Lashinski discloses the support structure configured to releasably hold the implantable heart valve on the support shaft. Lashinski teaches adjusting the implant to a final size and shape to be left as a permanent implant ([0009]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Lashinski to have the support structure releasably hold the implantable heart valve in order to reposition or adjust the implant when it is delivered improperly ([0009]).
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Regarding claim 19, Lashinski makes obvious the method of claim 18, wherein attaching the first coupling member of the actuation shaft to the second coupling member of the support shaft further includes disposing a locking collar (cover 1401, where the cover performs locking by engaging with stopper 1402 to stabilize the connection between the driver 1405 and member 1400, [0120]) around at least a portion of both the first coupling member and the second coupling member (see Fig. 14, [0120]).
Regarding claim 20, Lashinski makes obvious the method of claim 18, wherein the support structure configured to hold the implantable heart valve comprise mechanical coupling structures that do not require cutting for valve release (different connection types may not involve cutting as described in [0155]).
Regarding claim 21, Lashinski makes obvious the method of claim 18, wherein the support shaft includes a plurality of mechanical coupling structures arranged to releasably engage the implantable heart valve without destructive release mechanisms (different connection types may not be destructive as described in [0155]).
Regarding claim 22, Lashinski makes obvious the method of claim 18, the modified invention teaches wherein the support structure configured to hold the implantable heart valve comprise reversible mechanical engagement features (the reversible mechanical features include nuts, clips, and/or cables that are actuated by rotational drivers and the actuation is reversible by compressing and expanding the implant, [0009]).
Regarding claim 23, Lashinski makes obvious the method of claim 18, wherein the implantable heart valve comprises a replacement prosthetic heart valve configured to replace a native heart valve function ([0153]).
Regarding claim 24, Lashinski makes obvious the method of claim 18, comprising disconnecting the medical device delivery system from the implantable heart valve after deploying the implantable heart valve ([0153], [0155], [0156]), wherein the disconnecting does not require cutting a supporting structure (the disconnecting can be a done by one of the connections as described in [0155] that do not require cutting).
Regarding claim 25, Lashinski makes obvious the method of claim 18, wherein advancing the medical device delivery system includes advancing through a patient's vasculature via a transapical approach (see Fig. 2A-E, [0053]).
Regarding claim 26, Lashinski makes obvious the method of claim 18, wherein advancing the medical device delivery system includes advancing through a patient's vasculature via a transseptal approach (see Figs. 2A-E, [0053]).
Regarding claim 27, Lashinski makes obvious the method of claim 18, wherein the first coupling member and second coupling member comprise interlocking mechanical couplers designed for repeated engagement and disengagement (the components 1407, 1406 are intended to be disengaged and re-engaged, [0120]).
Regarding claim 30, Lashinski makes obvious the method of claim 18, wherein the target site comprises a native heart valve annulus selected from the group consisting of aortic, mitral, tricuspid, and pulmonary valve annuli ([0153]).
Regarding claim 31, Lashinski makes obvious the method of claim 18, wherein the implantable heart valve comprises prosthetic leaflets configured to provide unidirectional blood flow control (prosthetic leaflets can be attached to stent frame, where it is known that leaflets provide unidirectional blood flow, [0153]).
Regarding claim 32, Lashinski makes obvious the method of claim 19, wherein the locking collar includes at least one locking tab (tab defined by ridge of the cover 1401, see Fig. 14, [0120]) designed to engage within a locking channel (channel defined by the corner of stopper 1402, see Fig. 14) extending circumferentially around the actuation shaft (ridge and/or tab of cover 1401 extends circumferentially around at least a portion of the actuation shaft 1405, see Fig. 14).
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Lashinski (US2017/0360549) in view of Paulo (US2018/0055347).
Regarding claims 28 and 29, Lashinski makes obvious the method of claim 18; yet, does not explicitly disclose wherein the actuation shaft includes a plurality of articulating joints disposed proximal of the first coupling member, wherein each articulating joint includes a bead member and an adjacent barrel member. Paulo teaches a surgical device for a cardiac procedure having a probe that articulates and receives devices for a surgical procedure ([0039]). The probe having a series of units for articulation, each unit comprises a ball joint ([0039], where a ball joint would include a bead and a barrel). 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 shaft of the articulation shaft for the articulating shaft having a series of ball joint units as taught by Paulo, since the substitution would have yielded the same predictable result of a shaft that can articulate for passage through the vasculature of the human body.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on (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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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/ Primary Examiner, Art Unit 3774
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