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 .
Response to Arguments
In view of the appeal brief filed on 8 October 2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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, 7, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nyuli et al. (2017/0165064) "Nyuli" in view of Byrne et al. (US 2020/0368051 A1), “Byrne”, and further in view of Rabito et al. (US 2018/0296338 A1), “Rabito”.
Regarding claim 1, Nyuli teaches a delivery device comprising: a handle assembly (Fig. 1, delivery handle assembly 4); an inner catheter (Fig. 7, catheter 30) connected to the handle assembly and having a distal portion configured to receive an implant (Fig.7, distal capsule 14 receives prosthetic valve 808 (Fig. 2E), [0065]); an outer catheter (Fig. 7, catheter 41) connected to the handle assembly and coaxially positioned over the inner catheter (Fig. 7, catheters are nested (i.e., coaxially positioned over each other), [0065]); and a capsule assembly (Fig. 1, capsule assembly 8) including: a proximal capsule (Fig. 1, proximal capsule 13) secured to a distal end of the inner catheter (Fig. 7, sheath catheter 41 couples to proximal capsule 13, [0065]), and 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); wherein the capsule assembly (Fig. 1, capsule assembly 8) includes engagement features (Fig. 8C, threaded portion 460) to releasably secure the distal capsule (Fig. 8, distal capsule 14) to the proximal capsule (Fig. 1, proximal capsule 13) with the capsule assembly in a loaded arrangement (Fig. 8C depicts loaded arrangement with proximal capsule 13 and distal capsule 14 engaged), but fails to explicitly teach wherein the engagement features are configured to be disengaged to enable the proximal capsule and the distal capsule to separate to a deployed arrangement.
Byrne teaches the deployment of an expandable implant wherein the engagement features (Fig. 2A, coupling members 234, 235) are configured to be disengaged to enable the proximal capsule (Fig. 2A, primary sleeve 208) and the distal capsule (Fig. 2A, primary sleeve 209) to separate to a deployed arrangement (Fig. 3C, coupling members 234, 235 are activated to release sleeves 208, 209, respectively, and allow for deployment of implant [0032-0035, 0043]). Byrne discloses that the coupling members and sleeves maintain the main component (i.e., the endoprosthesis) at a reduced diameter that is suitable for endoluminal delivery [0032]. 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 Byrne with the proximal and distal capsules taught by Nyuli in order to prevent injury to patient vasculature by ensuring the implant is conformed to a minimal size during delivery. However, Nyuli in view of Byrne fails to teach a plurality of slats separated by a plurality of slits.
Rabito teaches a delivery device wherein a method of deploying a stent-graft prosthesis a plurality of slats (Fig. 14, flared end pieces of outer elongate hollow member 116) separated by a plurality of slits (Fig. 14, spaces between flared end pieces of outer elongate hollow member 11). Rabito discloses that this delivery device allows for the controlled deployment of a prosthesis to a position within the body [0007]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the shape of the proximal capsule taught Nyuli to reflect the slats and slits taught by Rabito in order to ensure a safe and controlled delivery of the prosthesis.
Regarding claim 7, Nyuli teaches the proximal (Fig. 1, proximal capsule 13) and distal capsules (Fig. 1, distal capsule 14). However, Nyuli in view of Byrne fails to teach that the proximal capsule has an uncompressed arrangement having a flared distal end.
Rabito teaches a delivery device wherein the proximal capsule (Fig. 10, outer elongate hollow member 116) has an uncompressed arrangement having a flared distal end (Fig. 15B, outer elongate hollow member 116 comprises flared distal end and is moved away from nose cone 118 to deploy prosthesis 30 (i.e., uncompressed arrangement) [0103]) as compared to a compressed arrangement when the distal end is engaged with the distal capsule (Fig. 10, delivery system 100 is in preliminary configuration (i.e., compressed arrangement) with outer elongate hollow member 116 engaging with nose cone 118 [0077]). Rabito discloses that this delivery device allows for the controlled deployment of a prosthesis to a position within the body [0007]. 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 proximal capsule taught by Nyuli with the flared proximal capsule taught by Rabito in order to provide a more controlled delivery of a prosthesis that would work to prevent injury during deployment.
Regarding claim 17, Nyuli teaches the proximal (Fig. 1, proximal capsule 13) and distal capsules (Fig. 1, distal capsule 14). However, Nyuli in view of Byrne does not teach a distal end of the proximal capsule that flares outwardly when the proximal capsule disengages from the distal capsule.
Rabito teaches a delivery device wherein a distal end of the proximal capsule flares outwardly when the proximal capsule disengages from the distal capsule (Fig. 15B, outer elongate hollow member 116 comprises flared distal end and is moved away from nose cone 118 to deploy prosthesis 30 [0103]). Rabito discloses that this delivery device allows for the controlled deployment of a prosthesis to the a position within the body [0007]. 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 proximal capsule taught by Nyuli with the flared proximal capsule taught by Rabito in order to provide a more controlled delivery of a prosthesis that would work to prevent injury during deployment.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Nyuli et al. (2017/0165064) "Nyuli" in view of Byrne et al. (US 2020/0368051 A1), “Byrne” and Rabito et al. (US 2018/0296338 A1), “Rabito”, and further in view of Rabito et al. (US 2015/0342736 A1), “Rabito 736”.
Regarding claim 2, Nyuli in view of Byrne and Rabito does not disclose that the distal capsule is positioned partially over the proximal capsule with the capsule assembly in a loaded arrangement with the engagement features engaged.
Rabito 736 teaches a delivery device including a distal capsule (Fig. 1A, receiving member 112) that is positioned partially over the proximal capsule (Fig. 1A, outer elongate hollow member 110) with the capsule assembly in a loaded arrangement with the engagement features engaged (Fig. 1A, prosthesis is within outer elongate hollow member 110 and pull wires 114 are engaged). Rabito 736 discloses that access to certain anatomical features can be difficult due to limited space to maneuver surgical tools and instruments within [0010]. Rabito 736’s placement of the hollow member layered underneath the receiving member allows for the hollow member to be withdrawn during deployment and less need for a longer, more rigid delivery device. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the capsule assembly as taught by Nyuli with a distal capsule placed partially over the outside of a proximal capsule, as taught by Rabito 736 in order to ease the delivery of the prosthesis and so the delivery device takes up less space during delivery and is more maneuverable within the region.
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Nyuli et al. (2017/0165064) "Nyuli" in view of Byrne et al. (US 2020/0368051 A1), “Byrne” and Rabito et al. (US 2018/0296338 A1), “Rabito”, and further in view of Miller et al. (2018/0256139) "Miller".
Regarding claim 3 Nyuli in view of Byrne and Rabito do not teach engagement features that include apertures and tabs.
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) and tabs (Figs. 9-12, tangs 240). 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 modify the engagement features of Nyuli with apertures and tabs as taught by Miller in order to provide more control of the moving pieces of the delivery device.
Regarding claim 4, Nyuli in view of Byrne and Rabito do not teach apertures that include ramps.
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 delivery device of Nyuli in view of Rabito to include ramped apertures to ease the separation of the proximal and distal capsules, therefore simplifying delivery of the implant.
Regarding claim 5, Nyuli in view of Byrne and Rabito do not teach engagement features that include interlocking tabs.
Miller teaches a delivery device that comprises interlocking tabs (Figs. 9-12, tangs 240 and windows 245 and 265 each have ramped chamfered edges). Miller teaches that the purpose of these locking tangs is to lock legs 235 in their radially-expanded condition (see Fig. 29), and allow(s) for locking the two members into position relative to one another (Fig. 40 and [0062]). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the engagement features of Nyuli to include interlocking tabs as taught by Miller that secure the delivery device members into position during use in order to ensure efficient delivery of the implant and stability of the device while in vitro to further prioritize patient safety.
Regarding claim 6, Nyuli in view of Byrne and Rabito do not teach interlocking tabs that are hook shaped.
Miller teaches interlocking tabs (Figs. 9-12, tangs 240 and windows 245 and 265) that are each angled to be hook shaped (Figs. 58-61, inwardly projecting tangs 300E that can be reversed to “outwardly-projecting” [0080]). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the engagement features of Nyuli to include interlocking tabs that are hook shaped as taught by Miller in order to secure the proximal and distal capsules together during the delivery process so that the implant does not release in an improper location.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Nyuli et al. (2017/0165064) "Nyuli" in view of Byrne et al. (US 2020/0368051 A1), “Byrne”, and Rabito et al. (US 2018/0296338 A1), “Rabito”, and further in view of Kinkade et al. (US 2013/0289703 A1), “Kinkade”.
Regarding claim 8, Nyuli in view of Byrne and Rabito fails to teach the limitations of claim 8. However, Kinkade teaches 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 modify the shape of the proximal capsule taught by Nyuli to reflect the slats taught by Kinkade, and further to combine the slats 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, Nyuli in view of Byrne and Rabito fails to teach the limitations of claim 8. However, Kinkade teaches 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 modify the shape of the proximal capsule taught by Nyuli to reflect the slats taught by Kinkade, and further to combine the slats 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.
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nyuli et al. (2017/0165064) "Nyuli" in view of Byrne et al. (US 2020/0368051 A1), “Byrne”.
Regarding claim 10, Nyuli teaches a method of releasing an implant from a delivery device (Figs. 11B-D show releasing of implant), the method comprising: providing a delivery device in a loaded arrangement (Fig. 11B, shows loaded arrangement) having an implant loaded within a proximal capsule and a distal capsule of the capsule assembly (Figs. 11B-D, trans-catheter valve prosthesis 1100 entrained within the valve capsule assembly 8 [0071] which comprises proximal capsule 13 and distal capsule 14); 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]), but fails to teach wherein a plurality of engagement features releasably secure the distal capsule and the proximal capsule together in the loaded arrangement; and with the engagement features disengaged, 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.
Byrne teaches the deployment of an expandable implant wherein a plurality of engagement features (Fig. 2A, coupling members 234, 235) releasably secure the distal capsule (Fig. 2A, primary sleeve 209) and the proximal capsule (Fig. 2A, primary sleeve 208) together in the loaded arrangement (Fig. 2A depicts an undeployed arrangement); and with the engagement features disengaged (Fig. 3C, coupling members 234, 235 are activated to release sleeves 208, 209 and allow for deployment of implant [0032-0035, 0043]), separating the proximal capsule (Fig. 2A, primary sleeve 208) and the distal capsule (Fig. 2A, primary sleeve 209) to transition the delivery device to a deployed arrangement to deploy the implant from the capsule assembly (Fig. 3C, coupling members 234, 235 are activated to release sleeves 208, 209 respectively, and allow for deployment of implant [0032-0035, 0043]). Byrne discloses the techniques for delivery are particularly useful for deployment of an expandible endoprosthesis within a complex vasculature [0003]. 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 Byrne with the delivery device taught by Nyuli in order to simplify the delivery of an implant within complex vasculature.
Regarding claim 19, 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.
Claims 11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nyuli et al. (2017/0165064) "Nyuli" in view of Byrne et al. (US 2020/0368051 A1), “Byrne” and further in view of Miller et al. (US 2018/0256139 A1), “Miller”.
Regarding claim 11, Nyuli teaches the proximal (Fig. 1, proximal capsule 13) and distal capsules (Fig. 1, distal capsule 14) of the capsule assembly (Fig. 1, capsule assembly 8), but Nyuli in view of Byrne and Rabito fails to teach wherein the step of disengaging further includes rotating about a central axis.
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 proximal and distal capsules of the capsule assembly taught by Nyuli in order to create a reusable delivery device which decreases operational costs.
Regarding claim 13, Nyuli in view of Byrne do not teach engagement features that include apertures and tabs.
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) and tabs (Figs. 9-12, tangs 240). 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 modify the engagement features of Nyuli with apertures and tabs as taught by Miller in order to provide more control of the moving pieces of the delivery device.
Regarding claim 14, Nyuli in view of Byrne do not teach apertures that include a ramp which the tabs slide when the distal and proximal capsules are disengaged.
Miller teaches 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 delivery device of Nyuli in view of Rabito to include ramped apertures to ease the separation of the proximal and distal capsules, therefore simplifying delivery of the implant.
Regarding claim 15, Nyuli in view of Byrne do not teach a plurality of engagement features.
Miller teaches a delivery device in loaded arrangement (Fig. 58) comprising: apertures (Figs. 9-12, windows 245 and 265 each have ramped chamfered edges) and tabs (Figs. 9-12, tangs 240). Miller further teaches a release from interlocking feature involving the use of force (Figs. 58-61, “distal implant locking tube 220E will separate from distal implant delivery tube 310E when subjected to twists, torques, bending” [0112]). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the engagement features of Nyuli to include interlocking tabs released by force as taught by Miller in order to secure the proximal and distal capsules together during the delivery process so that the implant does not release in an improper location.
Regarding claim 16, Nyuli in view of Byrne do not teach interlocking tabs that are hook shaped.
Miller teaches interlocking tabs (Figs. 9-12, tangs 240 and windows 245 and 265) that are each angled to be hook shaped (Figs. 58-61, inwardly projecting tangs 300E that can be reversed to “outwardly-projecting” [0080]). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the engagement features of Nyuli to include interlocking tabs that are hook shaped as taught by Miller in order to secure the proximal and distal capsules together during the delivery process so that the implant does not release in an improper location.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Nyuli et al. (2017/0165064) "Nyuli" in view of Byrne et al. (US 2020/0368051 A1), “Byrne” and further in view of McHugo et al. (US 2011/0190865 A1), “McHugo”.
Regarding claim 12, Nyuli teaches the proximal (Fig. 1, proximal capsule 13) and distal capsules (Fig. 1, distal capsule 14) of the delivery device in loaded arrangement (Fig. 8C depicts loaded arrangement with proximal capsule 13 and distal capsule 14 engaged), but Nyuli in view of Byrne and Rabito fails to teach wherein the distal capsule is positioned partially over the proximal capsule when the delivery device is in the loaded arrangement.
McHugo teaches a mechanically expandable delivery system wherein the distal capsule is positioned partially over the proximal capsule when the delivery device is in the loaded arrangement (Figs. 15-18, distal outer sheath 633 extends over a distal portion 635 of stent 628 [0086]). McHugo discloses that the distal outer sheath covering the distal portion of the stent allows the stent to be moved between expanded and constrained configurations before full release [0090]. 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 partially overlapping positioning taught by Hugo in order to allow the operator to make adjustments to the implant during deployment and ensure proper delivery of the implant.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nyuli et al. (2017/0165064) "Nyuli" in view of Byrne et al. (US 2020/0368051 A1), “Byrne” and further in view of Kinkade et al. (US 2013/0289703 A1), “Kinkade”.
Regarding claim 18, Nyuli in view of Byrne fails to teach the limitations of claim 8. However, Kinkade teaches 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 modify the shape of the proximal capsule taught by Nyuli to reflect the slats taught by Kinkade, and further to combine the slats 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 Nyuli et al. (2017/0165064) "Nyuli" in view of Byrne et al. (US 2020/0368051 A1), “Byrne”, as applied to claim 10 above, and further in view of Solem (US 2001/0056295 A1), “Solem”.
Regarding claim 20, Nyuli teaches disengaging a distal capsule (Fig. 1, distal capsule 14) and a proximal capsule (Fig. 1, proximal capsule 13) comprises pushing the distal capsule away from the proximal capsule (Figs. 11A-E, distal capsule 14 translates away from proximal capsule 13 and valve 1100 within capsule assembly 8 [0071-0072]). However, Nyuli in view of Byrne fails to teach inflating a balloon to facilitate deployment.
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 proximal and distal capsules and their separation abilities as taught by Nyuli with the inflatable balloon used to separate a capsule as 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