DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Applicant’s Remarks filed 14 April 2026 have been entered. Claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see remarks, filed 14 April 2026, with respect to the rejection(s) of claims 1 and 10 under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “engagement features” in claims 1 and 10. Examiner interprets “engagement features” to be tabs and other known prior art equivalents, as described in paragraph 60.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-2, 5-7, 10, 12, 16-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US Pat. No. 10779941 B2), “Chang” in view of Nyuli et al. (2017/0165064) "Nyuli".
Regarding claim 1, Chang teaches a delivery device comprising: a handle assembly (Fig. 1, handle 122); an inner catheter (Fig. 1, outer catheter 124) connected to the handle assembly and having a distal portion configured to receive an implant (Fig. 1, delivery cylinder 200 configured to hold valve 102); an outer catheter (Fig. 5, introducer sheath 264) connected to the handle assembly and coaxially positioned over the inner catheter (Fig. 1, outer); and a capsule assembly (Fig. 9, delivery cylinder 200) including: a proximal capsule secured to a distal end of the inner catheter (Fig. 3, first tubular portion 204 is coupled to distal end portion of outer catheter 124 (col. 5, lines 31-34)), the proximal capsule defining a plurality of slats separated by a plurality of slits (Fig. 10, delivery cylinder 200 comprises strut members 212); wherein the capsule assembly (Fig. 9, delivery cylinder 200 coupled with flexible member 242) includes engagement features (Figs. 4 and 11, retaining mechanisms 244) to releasably secure the distal capsule to the proximal capsule with the capsule assembly in a loaded arrangement (Figs. 9-10, flexible member 242 is retained on distal end portions 222 of strut members 212 by retaining mechanisms 244 (cols. 7-8, par. 5-1)); wherein the engagement features are configured to be disengaged (Fig. 11, extension portions 246 of retaining mechanisms 244 are able to bend or deflect radially outward (col. 8, par. 1)), but fails to teach a distal capsule connected to a capsule shaft that extends within the inner catheter, the capsule shaft interconnecting the distal capsule to the handle assembly, and enabling the proximal capsule and the distal capsule to separate to a deployed arrangement.
Nyuli teaches a delivery system comprising a distal capsule (Fig. 8, distal capsule 14) connected to a capsule shaft (Fig. 7, distal section 32) that extends within the inner catheter (Fig. 7, catheter 30), the capsule shaft (Fig. 7, distal section 32 of guidewire catheter 30) interconnecting the distal capsule (Fig. 8, distal capsule 14) to the handle assembly (Fig. 1, delivery handle assembly 4) and enabling the proximal capsule and the distal capsule to separate to a deployed arrangement (Figs. 11A-E). Nyuli discloses that the distal capsule and its controlling features are flexible by virtue of their construction [0065]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the distal capsule taught by Nyuli with the proximal capsule taught by Chang in order to provide an adaptable and atraumatic delivery device.
Regarding claim 2, Chang teaches wherein the distal capsule is positioned partially over the proximal capsule with the capsule assembly in a loaded arrangement with the engagement features engaged (Figs. 9-10, flexible member 242 is retained on distal end portions 222 of strut members 212 by retaining mechanisms 244 (cols. 7-8, par. 5-1)). Chang discloses that the flexible member elastically deforms upon insertion of a prosthetic implant into the delivery cylinder (cols. 5-6, par. 6-1). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the distal capsule taught by Nyuli with the proximal capsule and engagement features taught by Chang in order to avoid damage to the implant.
Regarding claim 5, Chang teaches a delivery cylinder for a prosthetic implant comprising engagement features that include interlocking tabs (Figs. 4 and 11, retaining mechanisms 244 secure with flexible member 242).
Regarding claim 6, Chang teaches a delivery cylinder for a prosthetic implant comprising interlocking tabs are each hook shaped (Figs. 4 and 11, retaining mechanisms 244 secure with flexible member 242 and further comprise extension portions 246 and tip portions 248). Chang discloses that the tip portions are able to resist longitudinal movement of the flexible member attached thereto so as to avoid detachment of the flexible member during deployment of the prosthetic valve (col. 8, par. 1). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the distal capsule taught by Nyuli with the interlocking tabs that are hook shaped taught by Chang in order to resist separation of the capsule assembly prior to proper positioning and deployment of the prosthesis.
Regarding claim 7, Chang teaches a delivery cylinder for a prosthetic implant wherein the proximal capsule has an uncompressed arrangement having a flared distal end (Fig. 10, delivery cylinder 200 comprising strut members 212 which flare outwardly without flexible member 242 on the distal end) as compared to a compressed arrangement when the distal end is engaged with the distal capsule (Fig. 9, flexible member 242 closes strut members 212 together). Chang discloses that the flexible member elastically deforms upon insertion of a prosthetic implant into the delivery cylinder (cols. 5-6, par. 6-1). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the distal capsule taught by Nyuli with the proximal capsule taught by Chang in order to avoid damage to the implant.
Regarding claim 10, Chang teaches a method of releasing an implant from a delivery device, the method comprising: providing a delivery device in a loaded arrangement having an implant loaded within a proximal capsule and a distal capsule of the capsule assembly (Fig. 9, delivery device 200 comprising valve 102); wherein a plurality of engagement features releasably secure the distal capsule and the proximal capsule together in the loaded arrangement (Figs. 9-10, flexible member 242 is retained on distal end portions 222 of strut members 212 by retaining mechanisms 244 (cols. 7-8, par. 5-1)), and with the engagement features disengaged (Fig. 11, extension portions 246 of retaining mechanisms 244 are able to bend or deflect radially outward (col. 8, par. 1)), but fails to teach disengaging the engagement features to disengage the distal capsule from the proximal capsule and separating the proximal capsule and the distal capsule to transition the delivery device to a deployed arrangement to deploy the implant from the capsule assembly.
Nyuli teaches a delivery device comprising disengaging the engagement features to disengage the distal capsule from the proximal capsule (Figs. 1 and 11A-D, “illustrated the valve 1100 in staged deployment after the proximal capsule 13 has been translated away from the valve 1100” [0072]) and separating the proximal capsule and the distal capsule to transition the delivery device to a deployed arrangement to deploy the implant from the capsule assembly (Figs. 11A-E). Nyuli discloses that the distal capsule and its controlling features are flexible by virtue of their construction [0065]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the distal capsule taught by Nyuli with the proximal capsule taught by Chang in order to provide an adaptable and atraumatic delivery device.
Regarding claim 12, Chang teaches a delivery cylinder for a prosthetic implant wherein the distal capsule is positioned partially over the proximal capsule with the delivery device is in a loaded arrangement (Figs. 9-10, flexible member 242 is retained on distal end portions 222 of strut members 212 by retaining mechanisms 244 (cols. 7-8, par. 5-1)).
Regarding claim 16, Chang teaches a delivery cylinder for a prosthetic implant comprising interlocking tabs are each hook shaped (Figs. 4 and 11, retaining mechanisms 244 secure with flexible member 242 and further comprise extension portions 246 and tip portions 248).
Regarding claim 17, Chang teaches wherein a distal end of the proximal capsule that flares outwardly when the proximal capsule disengages from the distal capsule (Fig. 10, delivery cylinder 200 comprising strut members 212 which flare outwardly without flexible member 242 on the distal end).
Regarding claim 19, Chang fails to teach the limitations of claim 19. However, Nyuli teaches wherein the corresponding engagement features include threads (Fig. 8C, threaded portions 460, 470, and 480 allow distal and proximal capsules 13, 14 respectively, to move in tandem concentrically over various catheters which enable deployment [0065, 0071-0072]). Examiner notes that the claimed “threads” are interpreted as the “threaded interface 940” and “threaded surface 942” as defined by the specification due to plurality usage in the claim. Nyuli discloses that the distal capsule and its controlling features are flexible by virtue of their construction [0065]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the distal capsule taught by Nyuli with the proximal capsule taught by Chang in order to provide an adaptable and atraumatic delivery device.
Claims 3-4, 11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US Pat. No. 10779941 B2), “Chang” in view of Nyuli et al. (2017/0165064) "Nyuli", and further in view of Miller et al. (US 2018/0256139 A1), “Miller”.
Regarding claim 3, Chang teaches a delivery cylinder for a prosthetic implant comprising engagement features including tabs (Figs. 4 and 11, retaining mechanisms 244), but fails to teach apertures.
Miller teaches a delivery device comprising: apertures (Figs. 9-12 necessarily show that inwardly-projecting tangs 240 slide out of windows 245 and 265 each have ramped chamfered edges). Miller teaches that the windows allow for locking the two members into position relative to one another (Fig. 40 and [0062]) and further control the movement of the sections of the delivery device while it places an implant [0068]. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the tabs taught by Chang with the apertures taught by Miller in order to provide more control of the moving pieces of the delivery device.
Regarding claim 4, Chang fails to teach the limitations of claim 4. Miller teaches a delivery device wherein each aperture includes a ramp (Miller, Figs. 9-12, windows 245 and 265 each have ramped chamfered edges). Miller discloses that the chamfered distal edge helps facilitate movement of the inwardly-projecting tangs out of their respective windows [0145]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the the engagement features taught by Chang and the ramped apertures taught by Miller to ease the separation of the proximal and distal capsules, therefore simplifying delivery of the implant.
Regarding claim 11, Chang fails to teach the limitations of claim 11. Miller teaches a disposable delivery device wherein the step of disengaging further includes rotating about a central axis (Figs. 122-125, rotation of knob 620 rotates the distal implant delivery tube 310 and releases it from distal implant locking tube 220, and further releasing two-part fastener 200 from the delivery device [0172]). Miller discloses that this embodiment of the delivery device allows it to be reused multiple times during a single procedure [0173]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the rotational disengaging methods taught by Miller with the capsule assembly taught by Chang in order to create a reusable delivery device which decreases operational costs.
Regarding claim 13, Chang teaches a delivery cylinder for a prosthetic implant comprising engagement features that include tabs (Figs. 4 and 11, retaining mechanisms 244 secure with flexible member 242). Chang discloses that the tip portions are able to resist longitudinal movement of the flexible member attached thereto so as to avoid detachment of the flexible member during deployment of the prosthetic valve (col. 8, par. 1). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the distal capsule taught by Nyuli with the tabs taught by Chang in order to resist separation of the capsule assembly prior to proper positioning and deployment of the prosthesis. However, Chang fails to teach apertures.
Miller teaches a delivery device comprising: apertures (Figs. 9-12 necessarily show that inwardly-projecting tangs 240 slide out of windows 245 and 265 each have ramped chamfered edges). Miller teaches that the purpose of these inwardly-projecting tangs and windows is to allow for locking the two members into position relative to one another (Fig. 40 and [0062]) and further control the movement of the sections of the delivery device while it places an implant (0068). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the engagement features taught by Chang with the apertures taught by Miller in order to provide more control of the moving pieces of the delivery device.
Regarding claim 14, Chang teaches a delivery cylinder for a prosthetic implant comprising tabs (Figs. 4 and 11, retaining mechanisms 244 secure with flexible member 242). However, Chang fails to teach a ramp.
Miller teaches a delivery device wherein each aperture includes a ramp (Figs. 9-12, windows 245 and 265 each have ramped chamfered edges) and tabs that slide in and out of windows when the capsules shift (Figs. 9-12 necessarily show that inwardly-projecting tangs 240 slide out of windows 265 and enter windows 265). Miller discloses that the chamfered distal edge helps facilitate movement of the inwardly-projecting tangs out of their respective windows (0145). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the capsule assembly taught by Nyuli with the tabs taught by Chang and the ramped apertures taught by Miller to ease the separation of the proximal and distal capsules, therefore simplifying delivery of the implant.
Regarding claim 15, Chang teaches a delivery cylinder for a prosthetic implant wherein the plurality of corresponding engagement features include tabs that are interlocking in the loaded arrangement (Figs. 4 and 11, retaining mechanisms 244 secure with flexible member 242). However, Chang fails to teach releasing from interlocking engagement by pushing the proximal capsule distally prior to the step of advancing the distal capsule distally.
Miller teaches a delivery device releasing from interlocking engagement by pushing the proximal capsule distally prior to the step of advancing the distal capsule distally (Figs. 100-101, proximal implant 210 is advanced distally relative to distal implant 205 so that tangs 300 slide out of windows 265 [0145]). Miller discloses that the tangs and windows are utilized to set the orientation of each implant relative to each other [0147]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the engagement features taught by Chang with the windows and releasing abilities taught by Miller in order to better control the deployment of the capsule assembly.
Claims 8-9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US Pat. No. 10779941 B2), “Chang” in view of Nyuli et al. (2017/0165064) "Nyuli", and further in view of Kinkade et al. (US 2013/0289703 A1), “Kinkade”.
Regarding claim 8, Chang teaches a delivery cylinder for a prosthetic implant comprising a distal end of each slat (Fig. 10, regions of strut members 212 nearest retaining mechanisms 244). However, Chang fails to teach in a pull wire.
Kinkade teaches a delivery system comprising a pull wire (Fig. 6, temporary attachment loops 540) secured to a distal end of each slat (Fig. 6, temporary attachment loops 540 engage/extend around finger-like elements 520 of tip capture spindle 512 [0038]). Kinkade discloses that the attachment loops increase the distance between the first end of the stent and the delivery system spindle so that a greater length of prosthesis is able to deploy or expand within the vessel wall [0042]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the slats taught by Chang with the pull wires taught by Kinkade in order to increase the amount of apposition against the vessel wall the prosthesis requires in order to ensure secure placement.
Regarding claim 9, Chang teaches a delivery cylinder for a prosthetic implant comprising slats (Fig. 10, strut members 212). However, Chang fails to teach a pull wire.
Kinkade teaches a delivery system wherein a pull wire is secured to each slat (Fig. 6, temporary attachment loops 540 engage/extend around finger-like elements 520 of tip capture spindle 512 [0038]). Kinkade discloses that the attachment loops increase the distance between the first end of the stent and the delivery system spindle so that a greater length of prosthesis is able to deploy or expand within the vessel wall [0042]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the slats taught by Chang with the pull wire taught by Kinkade in order to increase the amount of apposition against the vessel wall the prosthesis requires in order to ensure secure placement.
Regarding claim 18, Chang teaches a delivery cylinder for a prosthetic implant comprising a plurality of slats (Fig. 10, strut members 212) and a distal end of each slat (Fig. 10, regions of strut members 212 nearest retaining mechanisms 244). However, Chang fails to teach a pull wire secured to a distal end of each slat; the method further comprising proximally tensioning each pull wire to disengage the proximal capsule from the distal capsule.
Kinkade teaches a delivery system comprising a pull wire (Fig. 6, temporary attachment loops 540) secured to a distal end of each slat (Fig. 6, temporary attachment loops 540 engage/extend around finger-like elements 520 of tip capture spindle 512 [0038]); the method further comprising proximally tensioning each pull wire to disengage the proximal capsule and distal capsule (Fig. 6, temporary attachment loops 540 are pulled back or retracted toward stent 206A [0040]). Kinkade discloses that the attachment loops increase the distance between the first end of the stent and the delivery system spindle so that a greater length of prosthesis is able to deploy or expand within the vessel wall [0042]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the distal capsule taught by Nyuli with the proximal capsule comprising slats taught by Chang, and further to combine the slats taught by Chang with the pull wires taught by Kinkade in order to increase the amount of apposition against the vessel wall the prosthesis requires in order to ensure secure placement.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US Pat. No. 10779941 B2), “Chang” in view of Nyuli et al. (2017/0165064) "Nyuli", and further in view of Solem (US 2001/0056295 A1), “Solem”.
Regarding claim 20, Chang fails to teach the limitations of claim 20. However, Nyuli teaches disengaging the distal capsule from the proximal capsule to push the distal capsule away from the proximal capsule (Figs. 11A-E). Nyuli discloses that the distal capsule and its controlling features are flexible by virtue of their construction [0065]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the distal capsule taught by Nyuli with the proximal capsule taught by Chang in order to provide an adaptable and atraumatic delivery device. However, Chang in view of Nyuli fails to teach inflating a balloon.
Solem teaches a delivery system comprising inflating a balloon to facilitate deployment (Figs. 17-19, balloon 2 is inflated to open capsule 5 along perforation lines 7 and stent 4 will be deployed [0047]). Solem discloses that the perforated capsule is soft and flexible and acts as a backpack around or outside of a catheter [0052]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the capsule assembly taught by Nyuli with the inflatable balloon taught by Solem in order to increase the flexibility of the capsule assembly to prevent injury to the patient during deployment of the implant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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