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 .
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.
Claim(s) 1 and 5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Bialas et al (WO 2020123230 A1) “Bialas” in view of Wang et al (US 20160310272 A1) “Wang”.
Regarding Claim 1, Bialas teaches a delivery apparatus for an expandable prosthetic heart valve (Abstract, par. [014], delivery apparatus 100, par. [030], Fig. 2), the delivery apparatus comprising:
a handle (handle 102, par. [033], Fig. 2);
a shaft (first shaft 104, second shaft 106, third shaft 108, par. [033], Figs. 2 and 3) having a proximal portion (portion of shafts 104, 106, and 108 coupled to handle 102, par. [035]) and a distal portion (portion of shafts connected to nosecone 114, par. [035]), the proximal portion being coupled to the handle (par. [033]);
and a nosecone (nose cone 114, par. [033], Fig. 3) coupled to the distal portion of the shaft (par. [035]), but does not disclose a nosecone with proximal and distal portions that flexibly curve and are made of materials of different hardness.
However, Wang, in the same field of art, teaches a delivery system for delivering and deploying a medical implant such as a prosthetic heart valve (Abstract) including a nosecone (tip 132, par. [0040], See Annotated Fig. 5, below) comprising a proximal portion and a distal portion coupled to the proximal portion, wherein the distal portion is configured to flexibly curve relative to the proximal portion and the proximal portion is formed of a first material that is relatively harder than a second material forming the distal portion (par. [0040]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include a nosecone with proximal and distal portions that flexibly curve and are made of materials of different hardness, as taught by Wang, in order to ensure enough flexibility to follow the guidewire through a patient’s vasculature (Wang, par. [0040]).
Regarding Claim 5, Bialas does not teach a proximal portion with an outer surface, outer ridge, and flush ports. However, Wang, in the same field of art, teaches a delivery system for delivering and deploying a medical implant such as a prosthetic heart valve (Abstract), wherein the proximal portion comprises an outer surface (outer body 152, par. [0039], Fig. 9), an outer ridge (collar 148, par. [0038], Fig. 9) extending outwardly from and circumferentially around the outer surface, and one or more flush ports (conduits 360, par. [0048], Fig. 12) extending through and along the outer surface and outer ridge of the proximal portion. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include a proximal portion with an outer surface, outer ridge, and flush ports, as taught by Wang, in order to seal fluid in place or enhance fluid communication (Wang, pars. [0038] and [0048]).
Regarding Claim 6, Bialas does not teach a tapering distal portion next to a proximal portion. However, Wang, in the same field of art, teaches a delivery system for delivering and deploying a medical implant such as a prosthetic heart valve (Abstract), wherein the distal portion comprises a first end proximate the proximal portion and a second end distal the first end, and wherein the distal portion tapers from the first end to the second end (See Annotated Fig. 5, below). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include a tapering distal portion next to a proximal portion, as taught by Wang, in order to facilitate atraumatic insertion in a body lumen (Wang, par. [0032]).
Regarding Claim 7, Bialas further teaches the delivery apparatus of claim 1, wherein the shaft comprises a first shaft (first shaft 104, par. [033], Fig. 2) and the delivery apparatus further comprises a second shaft (second shaft 106, par. [033], Fig. 2) extending over the first shaft and a delivery capsule (distal shoulder 112, par. [042], Figs. 2 and 3) coupled to the second shaft,
wherein the delivery capsule is configured to receive the proximal portion of the nosecone and retain an expandable prosthetic heart valve in a radially-compressed configuration for delivery into a patient (par. [042], Fig. 3).
Regarding Claim 8, Bialas further teaches the delivery apparatus of claim 7, wherein the delivery capsule (distal shoulder 112) comprises a tapered distal end portion configured to extend partially over the distal portion of the nosecone (par. [043], distal end portion of distal shoulder 112 touching nosecone 114 is smaller in diameter compared to the flared end portion 130 of the distal shoulder, Fig. 3).
Regarding Claim 9, Bialas does not teach distal and proximal portions with first and second lumens sized to receive a guidewire. However, Wang, in the same field of art, teaches a delivery system for delivering and deploying a medical implant such as a prosthetic heart valve (Abstract), wherein the proximal portion of the nosecone (tip 132, par. [0040], See Annotated Fig. 5, below) comprises a first lumen (central lumen 27, par. [0036], Fig. 6) and the distal portion of the nosecone comprises a second lumen (lumen 136, par. [0036], Fig. 6), and wherein the first and second lumens are sized to receive a guidewire therethrough (par. [0036]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include distal and proximal portions with first and second lumens sized to receive a guidewire, as taught by Wang, in order to help hold in place the support shaft, which supports the guidewire (Wang, par. [0036]).
Regarding Claim 10, Bialas does not teach a second lumen with the same curvature as the distal portion. However, Wang, in the same field of art, teaches a delivery system for delivering and deploying a medical implant such as a prosthetic heart valve (Abstract), wherein the second lumen (lumen 136, par. [0036], Fig. 6) is configured to have the same curvature as the distal portion when the distal portion curves relative to the proximal portion of the nosecone (par. [0052], Fig. 14). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include a second lumen with the same curvature as the distal portion, as taught by Wang, in order for the distal portion to deflect away from the walls of the patient's vasculature and likely not engage lesions or calcified tissue (Wang, par. [0052]).
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Claim(s) 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Bialas et al (WO 2020123230 A1) “Bialas” in view of Wang et al (US 20160310272 A1) “Wang” in further view of Chow (US 20070282254 A1) “Chow”.
Regarding Claim 2, Bialas in view of Wang does not teach a nosecone with a plurality of circumferential grooves. However, Chow, in the same field of art, teaches a delivery device such as a catheter assembly (par. [0016]), wherein the distal portion (distal portion 530. par. [0034], Fig. 5A) of the nosecone comprises a plurality of axially spaced circumferential grooves (groove 590, par. [0034], Fig. 5A). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas in view of Wang to include a nosecone with a plurality of circumferential grooves, as taught by Chow, in order for enhanced fluid communication and increased flexibility (Chow, par. [0034]).
Regarding Claim 3, Bialas in view of Wang does not teach a plurality of ribs that move relative to each other. However, Chow, in the same field of art, teaches a delivery device such as a catheter assembly (par. [0016]), wherein the plurality of circumferential grooves defines a plurality of ribs that move relative to each other when the distal portion flexibly curves relative to the proximal portion (par. [0036], distal portion 720 contains extending body 790 that twist to create shaft 785, which flexibly curves within the tissue region, Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas in view of Wang to include a nosecone with a plurality of ribs that move relative to each other, as taught by Chow, in order for the nosecone to be more flexible for penetration into the tissue region and therefore adapt to the patient’s vasculature (Chow, par. [0036]).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bialas et al (WO 2020123230 A1) “Bialas” in view of Wang et al (US 20160310272 A1) “Wang” in further view of Fenouil et al (KR 20200123093 A) “Fenouil”.
Regarding Claim 4, Bialas in view of Wang does not teach a projection received in a cavity within the distal and proximal portions. However, Fenouil, in the same field of art, teaches a delivery device for an endovascular prosthesis (par. [0010]), wherein the proximal and distal portions of the nosecone (tip 101, par. [0169], Fig. 15a) are coupled by a projection (harpoon member 102, par. [0169], Fig. 15a) received in a cavity (cavity formed from proximal extension 106, par. [0169], Fig. 15a), wherein one of the proximal portion and the distal portion comprises the projection and the other of the proximal portion and distal portion comprises the cavity (pars. [0018] and [0169], Fig. 15a). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas in view of Wang to include a projection received in a cavity within the distal and proximal portions, as taught by Fenouil, in order to hold or release the device when in a certain position (Fenouil, par. [0018]).
Claim(s) 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bialas et al (WO 2020123230 A1) “Bialas” in view of Fenouil et al (KR 20200123093 A) “Fenouil”.
Regarding Claim 11, Bialas teaches a delivery apparatus for an expandable prosthetic heart valve (Abstract, par. [014], delivery apparatus 100, par. [030], Fig. 2), the delivery apparatus comprising:
a handle (handle 102, par. [033], Fig. 2);
and a first shaft and a second shaft extending over the first shaft (first shaft 104, second shaft 106, par. [033], Fig. 2), each shaft comprising a distal portion (portion of shafts connected to nosecone 114, par. [035]) and a proximal portion (portion of shafts connected to nosecone 114, par. [035]) coupled to the handle (par. [033]), the distal portion of the second shaft being coupled to a delivery capsule (distal shoulder 112, par. [042], Figs. 2 and 3) of the delivery apparatus,
wherein the delivery capsule comprises a main body (body 126, par. [043], Fig. 3) configured to retain an expandable prosthetic heart valve in a radially-compressed configuration for delivery into a patient, but does not teach a tapered-distal tip portion extending from the main body.
However, Fenouil, in the same field of art, teaches a delivery device for an endovascular prosthesis (par. [0010]) with a tapered-distal tip portion (first gripping part 15, third gripping part 51, par. [0147], Fig. 6) axially extending from the main body (body 46, par. [0147], Fig. 6) and tapering in a distal direction (Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include a tapered-distal tip portion extending from the main body, as taught by Fenouil, in order to move more easily within the patient’s vasculature (Fenouil, pars. [0072] and [0147]).
Regarding Claim 12, Bialas does not teach a tapered-distal tip portion with less hardness than the main body. However, Fenouil, in the same field of art, teaches a delivery device for an endovascular prosthesis (par. [0010]), wherein a material forming the tapered-distal tip portion has a hardness less than a material forming the main body (pars. [0016] and [0059], tapered-distal tip portion may be made of plastic to allow for more movement and rotation, while the main body may be made of harder metal alloys). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include a tapered-distal tip portion with less hardness than the main body, as taught by Fenouil, in order to move more easily within the patient’s vasculature (Fenouil, pars. [0072] and [0147]).
Regarding Claim 13, Bialas does not teach a tapered-distal tip portion that extends circumferentially around a distal portion of the main body. However, Fenouil, in the same field of art, teaches a delivery device for an endovascular prosthesis (par. [0010]), wherein the tapered-distal tip portion (first gripping part 15, third gripping part 51, par. [0147], Fig. 6) extends circumferentially around a distal portion of the main body (body 46, par. [0147], Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include a tapered-distal tip portion that extends circumferentially around a distal portion of the main body, as taught by Fenouil, in order to move more easily within the patient’s vasculature and change the device to different configurations (Fenouil, pars. [0072], [0134], and [0147]).
Regarding Claim 14, Bialas does not teach a tapered-distal tip portion comprises a cylindrical and a tapered portion. However, Fenouil, in the same field of art, teaches a delivery device for an endovascular prosthesis (par. [0010]), wherein the tapered-distal tip portion comprises a cylindrical portion (first gripping part 15, par. [0147], Fig. 6) and a tapered portion (third gripping part 51, par. [0147], Fig. 6), and wherein the cylindrical portion extends circumferentially around a distal end portion of the main body and the tapered-distal tip portion tapers in a direction extending distally from the cylindrical portion and forms an opening to the delivery capsule (Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include a tapered-distal tip portion comprises a cylindrical and a tapered portion, as taught by Fenouil, in order to move more easily within the patient’s vasculature and change the device to different configurations (Fenouil, pars. [0072], [0134], and [0147]).
Regarding Claim 15, Bialas further teaches the delivery apparatus of claim 11, wherein an outer surface of the main body and an outer surface of the tapered-distal tip portion form a continuous outer surface of the delivery capsule (Fig. 3).
Regarding Claim 16, Bialas further teaches the delivery apparatus of claim 11, wherein an inner surface of the main body and an inner surface of the tapered-distal tip portion form a continuous inner surface of the delivery capsule (Fig. 3).
Regarding Claim 17, Bialas does not teach a main body comprising an outer surface and a tapered-distal tip portion comprising an inner surface. However, Fenouil, in the same field of art, teaches a delivery device for an endovascular prosthesis (par. [0010]), wherein the main body (body 46, par. [0147], Fig. 6) comprises an outer surface and the tapered-distal tip portion (first gripping part 15, third gripping part 51, par. [0147], Fig. 6) comprises an inner surface, and wherein the outer surface of the main body and the inner surface of the tapered-distal tip portion form an interface where the tapered-distal tip portion extends circumferentially over the main body (Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Bialas to include a main body comprising an outer surface and a tapered-distal tip portion comprising an inner surface, as taught by Fenouil, in order to move more easily within the patient’s vasculature (Fenouil, pars. [0072] and [0147]).
Regarding Claim 18, Bialas further teaches the delivery apparatus of claim 17, wherein the delivery capsule comprises at least one radiopaque marker band located at the interface formed by the main body and the tapered-distal tip portion (pars. [014] and [059]).
Regarding Claim 19, Bialas further teaches the delivery apparatus of claim 18, further comprising a nosecone coupled to the distal portion of the first shaft, wherein the delivery capsule is configured to move to a closed position in which the tapered-distal tip portion of the delivery capsule extends along an outer surface of the nosecone (par. [042]).
Regarding Claim 20, Bialas further teaches the delivery apparatus of claim 19, wherein the radiopaque marker band is configured to limit relative axial movement between the delivery capsule and the nosecone when the delivery capsule is in a closed position (pars. [057] - [059]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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/NATALIE N THOMAS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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