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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/3/25 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 10/3/25. The claims 18-37 are pending. Claims 1-17 are cancelled. Claims 20-37 are new.
Response to Arguments
Applicant’s arguments, filed 10/3/25 with respect to the rejections of claims 18 under 103 as being unpatentable over Lashinski (US2017/0360549) in view of Anderson (US3828787) have been fully considered and are partially persuasive.
Applicant argues the previous rejection is flawed, stating the rejection relies on paragraph [0153] as a primary teaching, when it is a peripheral embodiment and the primary disclosure of Lashinski is for reshaping existing valve structures. Examiner disagrees, the disclosure of Lashinksi clearly states a heart valve is connected the implant in paragraph [0153]; “a replacement prosthetic heart valve may be operatively coupled to any implant described in this disclosure”. From the disclosure, the implant can additionally be used to deliver a replacement prosthetic heart valve in the same manner as the claimed invention.
Applicant further argues, the combination of Lashinski with Anderson lacks proper motivation. Without acquiescing to Applicant’s argument, a new grounds of rejection has been made over Lashinski (US2017/0360549).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 34-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 34 recites the limitation "reversible mechanical engagement". There is insufficient antecedent basis for this limitation in the claim.
Claim 35 recites “attaching coupling members of an actuation shaft and a support shaft”. The limitation is unclear, since it is not known if there are coupling members on the actuation shaft that attach to the support shaft OR the support shaft also has coupling members.
Claims 36 and 37 are rejected under 35 U.S.C. 112(b) by dependency from claim 35.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the articulating joint including a bead member and a barrel member must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 18-27 and 30-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lashinski (US2017/0360549).
Regarding claim 18, Lashinski discloses a method for delivering an implantable heart valve ([0153]), the method comprising:
attaching a first coupling member (1407) of an actuation shaft (1405) to a second coupling member (1406) of a support shaft (1400 and implant) ([0120]) of a medical device delivery system (shaft 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], [0115]), the medical device delivery system including the implantable heart valve (replacement heart valve, [0155]), wherein the support shaft includes one or more structures configured to hold the implantable heart valve on the support shaft (the support shaft 1400 would extend to the implant, [0061]; and the implant holds the prosthetic heart valve to the support shaft 1400 with structures are described hooks, clasps, tangs, clips, fasteners, and/or cogs, [0155])
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]).
Regarding claim 19, Lashinski discloses 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 discloses the method of claim 18, wherein the one or more structures 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 discloses 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 discloses the method of claim 18, wherein the one or more structures configured to hold the implantable heart valve comprise reversible mechanical engagement features (hook connection is reversible, [0155]).
Regarding claim 23, Lashinski discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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 discloses 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).
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 including 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]);
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 coupling members (different portions of hook 1407) of an actuation shaft (1405) and a support shaft (1400) of a medical device delivery system through reversible mechanical engagement without destructive release mechanisms ([0120]);
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 § 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 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 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 discloses 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
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, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774