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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/19/2026 has been entered.
Response to Amendment
The amendment filed 06/19/2026 has been entered. Claims 1-8, 10-17, and 19-22 remain pending in the application. Claims 9 and 18 have been cancelled.
Response to Arguments
Applicant's arguments filed 06/19/2026 have been fully considered, and some are not persuasive, and some are moot in view of the newly applied rejection below.
Regarding the arguments that the amended claims overcome the previous rejection under Popp, the Examiner respectfully disagrees. The added amendment “and after the prosthetic heart valve self-expands to the radially expanded configuration” is read upon, as Popp discloses in paragraph [0120] denoting that after the prosthetic valve advances from the sheath and expands, then the inner shaft 120 is then retracted and the entire delivery device is withdrawn from the patient. Popp also discloses that the stent is self-expanding in paragraphs [0102].
Furthermore, the amendment “until a proximal end of the nosecone contacts a distal end of the outer shaft” is read upon in view of the newly applied reference, hereafter Kerr, as Popp distinctly discloses in paragraph [0127] that the final step of releasing the prosthetic valve by retracting the inner shaft by tip retractor 240, and paragraph [0112] further denotes that the 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, and that said proximal end 180 of the nose cone can be held in close contact with the distal end of the sheath 106 to protect surrounding tissue from coming into contact with the metal edge of the sheath, which would also be important for removing the device from the patient as the device would be moving relative to said surrounding tissue (see also Figure 17B below). The Examiner would also like to point out that “a proximal end” is broad, and therefore can be interpreted as any size of any proximal section of the nose cone. Since, however, Popp does not explicitly disclose the nose cone being abutted with the distal end of the outer sheath during removal (only delivery), of the device, a new reference (Kerr) has been applied below to illustrate and provide evidence that it is well known in the art to return the delivery device to the delivery configuration before removing the device from the body of the patient.
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Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-8, 10-17, and 19-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 20210038385 A1 (hereafter --Popp--), in view of US 20180140419 A1 (hereafter --Kerr--).
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 after the prosthetic heart valve self-expands to the radially expanded configuration (see paragraph [0120] denoting that after the prosthetic valve advances from the sheath and expands, then the inner shaft 120 is then retracted and the entire delivery device is withdrawn from the patient), 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 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, see also paragraph [0127] denoting the final step of releasing the prosthetic valve by retracting the inner shaft by tip retractor 240).
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Although Popp discloses a delivery configuration in which the nose cone abuts against the 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, and that said proximal end 180 of the nose cone can be held in close contact with the distal end of the sheath 106 to protect surrounding tissue from coming into contact with the metal edge of the sheath, see also Figure 17B above).
Popp, however, fails to disclose retracting the nosecone until a proximal end of the nosecone contacts a distal end of the outer shaft before withdrawing the device from the patient.
Kerr discloses a delivery device configured to deliver a prosthetic heart valve to the heart of a patient (see Abstract), said delivery device having an inner shaft, a nose cone attached to the inner shaft, and an outer shaft (see annotated inner and outer shaft and nose cone in Figures 2a and 2b below). Kerr teaches proximally retracting the inner shaft and a nosecone attached to a distal end of the inner shaft relative to the outer shaft and retracting the nosecone until a proximal end of the nosecone contacts a distal end of the outer shaft before withdrawing the device from the patient (see paragraph [0041], see also Figures 2a and 2b below).
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Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the invention, for the method to include retracting the nosecone until a proximal end of the nosecone contacts a distal end of the outer shaft before withdrawing the device from the patient, as by doing so would form a smooth continuous outer surface, whereupon the device can safely be removed from the apex of a patient's heart (see paragraph [0041]).
Regarding Claim 2, Popp as modified 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 as modified 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 as modified 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 as modified 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 as modified 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 as modified 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, as modified 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 10, Popp as modified 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 as modified 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 after the prosthetic heart valve self-expands to the radially expanded configuration (see paragraph [0120] denoting that after the prosthetic valve advances from the sheath and expands, then the inner shaft 120 is then retracted and the entire delivery device is withdrawn from the patient), 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) 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, see also Figure 17B below).
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Regarding Claim 12, Popp as modified 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 as modified 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 as modified 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 as modified 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 as modified 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 as modified 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 19, Popp as modified 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 as modified 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 as modified 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 as modified 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
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
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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