DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Response to Amendment
The amendment filed 12/11/2025 has been entered. New claims 21-22 have been added. Claims 1-22 are pending in the application.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1 and 22 are objected to because of the following informalities:
Regarding Claim 1, the limitation "the tip retractor" in line 9 should read as "a tip retractor".. Appropriate correction is required.
Regarding Claim 22, the limitation “the handle” in line 1 should read as “a handle”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
Claims 1-22 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by US 20210038385 A1 (hereafter --Popp--).
Regarding Claim 1, Popp discloses a method of delivering and deploying a prosthetic valve, comprising: percutaneously advancing a catheter to a treatment site (see paragraph [0090]) the catheter including the prosthetic heart valve (10) disposed between an outer shaft (110, 106) and an inner shaft (120) of the catheter (see paragraphs [0103] and [0110], see also annotated shafts in Figure 8 below); the inner shaft including a lumen extending therethrough for receiving a guide wire therein (see paragraph [0103] denoting inner shaft receive a guide wire); proximally retracting the outer shaft relative to the inner shaft to expose the prosthetic heart valve such that the prosthetic heart valve self-expands to a radially expanded configuration (see paragraph [0118]); and proximally retracting the tip retractor (240) (see annotated handle and tip retractor in Figure 26 below) to proximally retract the inner shaft and a nosecone attached to a distal end of the inner shaft relative to the outer shaft (see paragraph [0103] denoting elongated shaft 120 has a nose cone attached to it, see paragraph [0120] denoting that the inner shaft 120 is proximally retracted, see also paragraph [0127] denoting that the portion 240 is attached to the main housing of the handle unless the side panels 242 are pressed to unlock portion 240 from the handle to be able to protract the inner shaft proximally).
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Regarding Claim 2, Popp discloses the method of claim 1, wherein proximally retracting the outer shaft comprises rotating an actuator (manually rotatable handle portion or a motorized mechanism) of a handle of the catheter (see paragraph [0118]).
Regarding Claim 3, Popp discloses the method of claim 1, wherein the tip retractor (240) is engaged with a handle of the catheter during the step of proximally retracting the outer shaft (see paragraph [0127] denoting that the portion 240 is attached to the main housing of the handle unless the side panels 242 are pressed to unlock portion 240 from the handle to be able to protract the inner shaft proximally).
Regarding Claim 4, Popp discloses the method of claim 21, wherein releasing the tip retractor from the handle comprises pushing at least one button (242) to release the tip retractor from the handle (see paragraph [0127] denoting that the portion 240 is attached to the main housing of the handle unless the side panels 242 are pressed to unlock portion 240 from the handle, see also annotated button 242 in Figure 26 above).
Regarding Claim 5, Popp discloses the method of claim 4, wherein pushing at least one button comprises pushing two buttons in a direction towards each other (see paragraph [0127] denoting that the portion 240 is attached to the main housing of the handle unless the side panels 242 are pressed inwards (depressed) to unlock portion 240 from the handle).
Regarding Claim 6, Popp discloses the method of claim 21, further comprising proximally retracting the handle with the tip retractor engaged thereto after releasing the prosthetic valve (see paragraph [0127] denoting portion 240 is retracted proximally to retract the inner shaft proximally after releasing the prosthetic valve, see also paragraph [0120] denoting that once the valve is released, the entire delivery apparatus can be withdrawn from the body which would involve proximally retracting the handle).
Regarding Claim 7, Popp discloses the method of claim 6, wherein releasing the tip retractor and proximally retracting the tip retractor are performed after the step of proximally retracting the handle (see paragraph [0118] denoting that once the sheath is retracted from off of the prosthetic valve via the handle the prosthetic valve is still connected to the inner shaft, see paragraph [0127] denoting the final step of releasing the prosthetic valve by retracting the inner shaft by tip retractor 240 which is on the handle main housing 244).
Regarding Claim 8, Popp discloses the method of claim 21, wherein releasing the tip retractor and proximally retracting the tip retractor are performed after the step of proximally retracting the outer shaft to release the prosthetic valve (see paragraph [0118] denoting that once the sheath is retracted from off of the prosthetic valve the prosthetic valve is still connected to the inner shaft, see paragraph [0127] denoting the final step of releasing the prosthetic valve by retracting the inner shaft by tip retractor 240).
Regarding Claim 9, Popp discloses the method of claim 8, wherein proximally retracting the tip retractor to retract the inner shaft and the nosecone relative to the outer shaft comprises retracting the nosecone until a proximal end of the nosecone contacts a distal end of the outer shaft (see paragraph [0127] denoting the final step of releasing the prosthetic valve by retracting the inner shaft by tip retractor 240, see also paragraph [0112] denoting nose cone 122 in the illustrated embodiment includes a proximal end portion 174 that is sized to fit inside the distal end of the outer shaft 106).
Regarding Claim 10, Popp discloses the method of claim 1, wherein proximally retracting the outer shaft relative to the inner shaft comprises [actuating a micro-actuator] or actuating a macro-actuator (manually rotatable handle portion or a motorized mechanism), [wherein actuation of the micro-actuator causes fine movement of the outer shaft and] actuation of the macro-actuator causes gross movement of the outer shaft (see paragraph [0118]).
Regarding Claim 11, Popp discloses a method of delivering and deploying a prosthetic heart valve, comprising: percutaneously advancing a catheter to a treatment (see paragraph [0090]) the catheter including the prosthetic heart valve (10) disposed between an outer shaft (110, 106) and an inner shaft (120) of the catheter (see paragraphs [0103] and [0110], see also annotated shafts in Figure 8 below); the inner shaft including a lumen extending therethrough for receiving a guide wire therein (see paragraph [0103] denoting inner shaft receive a guide wire); proximally retracting the outer shaft relative to the inner shaft to expose the prosthetic heart valve such that the prosthetic heart valve self-expands to a radially expanded configuration (see paragraph [0118]); and proximally retracting a tip retractor (240) (see annotated handle and tip retractor in Figure 26 below) to proximally retract the inner shaft and a nosecone attached to a distal end of the inner shaft relative to a handle of the catheter (see paragraph [0103] denoting elongated shaft 120 has a nose cone attached to it, see paragraph [0120] denoting that the inner shaft 120 is proximally retracted, see also paragraph [0127] denoting that the portion 240 is attached to the main housing of the handle unless the side panels 242 are pressed to unlock portion 240 from the handle main housing 244 to be able to protract the inner shaft proximally).
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Regarding Claim 12, Popp discloses the method of claim 11, wherein proximally retracting the outer shaft comprises rotating an actuator (manually rotatable handle portion or a motorized mechanism) of the handle (see paragraph [0118]).
Regarding Claim 13, Popp discloses the method of claim 22, wherein the tip retractor (240) is engaged with the handle during the step of proximally retracting the outer shaft (see paragraph [0127] denoting that the portion 240 is attached to the main housing of the handle unless the side panels 242 are pressed to unlock portion 240 from the handle to be able to protract the inner shaft proximally).
Regarding Claim 14, Popp discloses the method of claim 22, wherein releasing the tip retractor from the handle comprises pushing buttons to release the tip retractor from the handle (see paragraph [0127] denoting that the portion 240 is attached to the main housing of the handle unless the side panels 242 are pressed to unlock portion 240 from the handle, see also annotated button 242, one being on each side of the handle, in Figure 26 above).
Regarding Claim 15, Popp discloses the method of claim 22, further comprising proximally retracting the handle with the tip retractor engaged therewith after releasing the prosthetic valve (see paragraph [0120] denoting that once the valve is released, the entire delivery apparatus can be withdrawn from the body which would involve proximally retracting the handle).
Regarding Claim 16, Popp discloses the method of claim 15, wherein releasing the tip retractor and proximally retracting the tip retractor are performed after the step of proximally retracting the handle (see paragraph [0118] denoting that once the sheath is retracted from off of the prosthetic valve via the handle the prosthetic valve is still connected to the inner shaft, see paragraph [0127] denoting the final step of releasing the prosthetic valve by retracting the inner shaft by tip retractor 240 which is on the handle main housing 244).
Regarding Claim 17, Popp discloses the method of claim 22, wherein releasing the tip retractor and proximally retracting the tip retractor are performed after the step of proximally retracting the outer shaft to release the prosthetic valve (see paragraph [0118] denoting that once the sheath is retracted from off of the prosthetic valve the prosthetic valve is still connected to the inner shaft, see paragraph [0127] denoting the final step of releasing the prosthetic valve by retracting the inner shaft by tip retractor 240).
Regarding Claim 18, Popp discloses the method of claim 17, wherein proximally retracting the tip retractor to retract the inner shaft and the nosecone relative to the outer shaft comprises retracting the nosecone until a proximal end of the nosecone contacts a distal end of the outer shaft (see paragraph [0127] denoting the final step of releasing the prosthetic valve by retracting the inner shaft by tip retractor 240, see also paragraph [0112] denoting nose cone 122 in the illustrated embodiment includes a proximal end portion 174 that is sized to fit inside the distal end of the outer shaft 106).
Regarding Claim 19, Popp discloses the method of claim 11, wherein proximally retracting the outer shaft relative to the inner shaft comprises actuating a micro-actuator (manually rotatable handle portion or a motorized mechanism) [or actuating a macro-actuator], wherein actuation of the micro-actuator causes fine movement of the outer shaft (see paragraph [0118]) [and actuation of the macro- actuator causes gross movement of the outer shaft].
Regarding Claim 20, Popp discloses the method of claim 19, wherein actuation of the micro-actuator comprises rotating the micro-actuator (see paragraph [0118]) [and wherein actuation of the macro-actuator comprises depressing the macro- actuator and then translating the micro-actuator].
Regarding Claim 21, Popp discloses the method of claim 1, further comprising releasing the tip retractor from a handle of the catheter (see paragraph [0127] denoting that the portion 240 is attached to the main housing of the handle unless the side panels 242 are pressed to unlock portion 240 from the handle main housing 244 to be able to protract the inner shaft proximally).
Regarding Claim 22, Popp discloses the method of claim 11, further comprising releasing the tip retractor from the handle of the catheter (see paragraph [0127] denoting that the portion 240 is attached to the main housing of the handle unless the side panels 242 are pressed to unlock portion 240 from the handle main housing 244 to be able to protract the inner shaft proximally).
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 PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached 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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/PARIS MARIE BLASS/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774