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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and 11 are rejected under 35 U.S.C 112(b) as indefinite because the recitation that the bendable rods are “disconnected from each other” is unclear. The specification describes individual rods having gaps therebetween, but also describes coverings extending between and at least partially enclosing the rods and the rods being fused or coupled to a common proximal portion. It is therefore unclear whether “disconnect” means that the rods are not directly joined to one another, are separated along their lengths, or lack any direct or indirect structural connections.
In addition, the disclosure describes spaced individual rods but does not reasonably convey possession of rods that are wholly disconnected from one another, particularity where the disclosed coverings extend between the rods and the rods may be coupled through the proximal portion.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-12, 14-17 & 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dwork (US 2011/0257733) in view of Zhou et al. (US 2016/0296332) and further in view of Hogendijk et al. (US 2008/0255501).
Claim 1.
Dwork et al. discloses:
An implant delivery system:
E.G. via the disclosed delivery system 38 that includes delivery device 40 configured to percutaneously deliver prosthetic heart valve 30 ([0037]; Figs. 3-4).
…a distal portion configured to expand in response to insertion of an implant device through its distal opening…
E.G. via the disclosed stability tube 46 including distal region 52 terminating at distal end 114 and configured to radially expand from a first diameter to a larger second diameter ([0044]; Figs.5A-6B).
…implant-driven expansion…
E.G. via the disclosed distal region 52 being advanced over capsule 50 containing prosthetic heart valve 30. The rigidity of capsule 50 and resistance of valve 30 apply an internal radial force that expands distal region 52 and increases the circumferential width of cuts 118 ([0046], [0051]; Figs. 8A-8B).
…a proximal cylindrical portion configured to maintain its width…
E.G. via the disclosed proximal region 110 that is a polymer tube connected to distal region 52; the distal and proximal regions may be portions of a single homogeneous tubular stability tube, with cuts 118 limited to the distal region to permit distal expansion ([0045]-[0048]). The proximal-region inner diameter continues to approximate the shaft outer diameter while distal region 52 expands to receive capsule 50 ([0050]-[0052]).
Dwork does not expressly disclose the distal portion comprising two or more disconnected bendable rods covered by an expandable covering.
Zhou teaches:
An expandable sheath having an elastic tubular layer that temporarily expands to permit passage of an implant and returns toward its original diameter following passage ([0009]-[0011], [0051], [0090]).
A plurality of longitudinally extending rods coupled to the expandable wall and spaced circumferentially around the lumen ([0014]-[0016], [0075], [0087]-[0088]; Fig. 6B).
An elastic outer tubular layer extending around at least partially covering the longitudinal members ([0011], [0014]-[0016]).
Longitudinal gaps defining discrete distal fingers, with the gaps and fingers facilitating expansion of the distal sheath portion ([0076]-[0078], [0084]; Figs. 8A-8D)
Under the broadest reasonable interpretation, the circumferentially spaced individual rodor discrete fingers correspond to two or more rods that are not directly connected to one another along their lengths, notwithstanding their association with the common elastic covering.
It would have been obvious to configure Zhou’s spaced longitudinal members in the modified Dwork system to bend outward as taught by Hogendijk because such bending permits an implant structure larger than the resting lumen to pass through a reduced-profile distal portion while distributing the expansion force among the separated longitudinal members. The resulting arrangement predictably increases both the width of the distal portion and the distance between adjacent rods during insertion.
Claim 2.
The implant delivery system of claim 1
E.G. The rejection and mapping of claim 1 are incorporated herein.
Wherein the proximal portion is not configured to expand in response to the implant device extending into or against the proximal portion.
E.G. Dwork discloses stability tube 46 having expandable distal region 52 and proximal region 110. Cuts 118 and the resulting radial expansion are confined to distal region 52, while proximal region 110 remains substantially cylindrical and maintains an inner diameter approximating the outer diameter of shaft 60 when capsule 50 is received within distal region 52 ([0037]-[0045]; Figs. 4-8B).
Therefore, Dworks’s proximal region 110 is not configured to expand in response to the capsule or implant-carrying assembly extending into or against the proximal region.
Claim 4.
The implant delivery system of claim 1
E.G. The rejection and mapping of claim 1 are incorporated herein.
…wherein the expandable covering further comprises a first coating configured to extend across inner surfaces of the two or more bendable rods to form an inner diameter of the distal portion.
E.G. Zhou discloses inner lubricious layer 26 coating the inside surface of expandable layer 24 and forming the inner surface of lumen 32 ([0057], [0067]; Fig. 3). Zhou further discloses rods 50 supported by, embedded in, or extending through the innermost surface defining lumen 32 ([0072], [0075], [0088]-[0089]; Figs. 6B and 7)
It would have been obvious to extend Zhou’s inner lubricious coating across the inward-facing surfaces of the rods in the modified Dwork device to form a continuous inner diameter, reduce friction during passage of the implant, and protect the implant from direct contact with the reinforcing rods.
Claim 5.
The implant delivery system of claim 4
E.G. The rejection and mapping of claim 1 are incorporated herein.
…wherein the expandable covering further comprises a second coating configured to extend across outer surfaces of the two or more bendable rods to form an outer diameter of the distal portion…
E.G. Zhou discloses elastic outer tubular layer 20 or 62 extending around and externally encapsulating the expandable sheath structure ([0057], [0062], [0071]-[0072]; Figs. 2-3 & 6B).
Dwork similarity discloses shape-memory metal strips embedded within a polymer tube [0041].
It would have been obvious to position the reinforcing rods between Zhou’s inner lubricious coating and outer elastic coating to provide a sealed outer diameter, retain the rods, permit radial expansion, and produce a smooth implant-contacting lumen.
Claim 6.
The implant delivery system of claim 1
E.G. The rejection and mapping of claim 1 are incorporated herein.
…wherein the two or more bendable rods extend longitudinally along the distal portion:
E.G. Zhou discloses multiple elongate rods extending longitudinally and generally parallel to the elongate axis of sheath 3 ([0072], [0075], [0088]-[0089]; Figs. 6A-B and 7).
In the proposed combination, these longitudinal rods are incorporated into Dwork’s expandable distal region 52.
Claim 7.
The implant delivery system of claim 1
E.G. The rejection and mapping of claim 1 are incorporated herein.
…wherein the proximal portion comprises a braided network of fibers…
E.G. Zho discloses intermediate mesh layer 22 comprising a plurality of braided fibers. The mesh layer extends through the proximal portion of sheath 3 between the expandable layer and outer elastic layer ([0057], [0063]-[0064]; Fig. 3 and 5)
It would have been obvious to provide Zhou’s braided-fiber network in the proximal portion of Dworks’s stability tube to improve pushability, torque transmission, flexibility, and resistance to buckling.
Claim 8.
The implant delivery system of claim 1
E.G. The rejection and mapping of claim 1 are incorporated herein.
…further comprising a nose cone configured to provide a leading end for the implant device…
E.G. Dwork discloses retention member 80 having distal tip 90. Tip 90 expressly forms a nose cone having a distally tapering outer surface configured to provide atraumatic advancement through bodily tissue ([0036]; Fig. 4). Tip 90, therefore, provides a leading end for the implant-carrying delivery assembly.
Claim 9.
The implant delivery system of claim 8
E.G. The rejection and mapping of claim 1 are incorporated herein.
…wherein the nose cone is configured to extend at least partially over the distal end of the distal portion…
E.G. Zhou discloses distal tip 28 having a proximal taper, a distal taper, a rounded leading edge, and a recessed inner annular surface 42 configured to receive the distal edge of the sheath layers ([0058]-[0061]; Fig. 4). The recessed proximal portion of tip 28 thereby extends at least partially around or over the received distal end of the sheath.
It would have been obvious to configured Dwork’s nose cone 90 with Zhou’s recessed and overlapping tip-to-sheath interface to provide a smooth transition, support the distal end, and reduce trauma during advancement.
Claim 10.
The implant delivery system of claim 1
E.G. The rejection and mapping of claim 1 are incorporated herein.
…wherein the proximal portion is configured to receive a tubular portion of the implant device…
E.G. Dwork discloses stability tube 46 defining lumen 112 and being slidably positioned over delivery-sheath assembly 42. Proximal region 110 receives shaft 60, which is a tubular portion of the implant-carrying delivering assembly. ([0035], [0037], [0042], [0044]-[0046]; Figs. 4 and 7A-9B).
Claim 11.
Claim 11 recites substantially the same delivery-device structure as claim 1. Accordingly, the findings and rationale stated above for claim 1 regarding Dwork as modified by Zhou and Hogendijk are incorporated herein.
…delivering the delivery device carrying an implant device into a blood vessel…
E.G. Dwork teaches percutaneously delivering device 40 carrying prosthetic heart valve 30 through a patient’s vasculature to an implantation site ([0047]-[0050]; Figs. 10 and 11A-D)
…extending at least the distal member beyond the distal end to cause the rods to assume a shape-set form…
E.G. Dwork teaches positioning the implant-carrying capsule distally beyond the distal end of the stability tube.
E.G. Zhou teaches that removal of the implant-generated expansive force permits the elastic rod-supported sheath to return toward its predetermined form ([0068], [0070]-[0073], [0090]-[0091]; Figs. 6A-6B).
…retracting the distal member into the distal portion to cause the rods to bend and increase the distal width…
E.G. Dwork teaches retracting capsule 310 into distal region 320, thereby forcibly expanding the distal region ([0052]-[0056]; Figs. 12A-C)
E.G. Zhou teaches that the implant passage stretches the elastic wall and increases the spacing between longitudinal rods 50 ([0072]-[0073]; Figs. 6A-6B)
E.G. Hogendijk teaches separated sides bending outward and moving apart in response to passage of an oversized implant ([0164]; Figs. 29A-B).
It would have been obvious to perform Dwork’s disclosed delivery and retraction method using the modified delivery structure of claim 1 because doing so constitutes the intended use of that structure and predictably permits passage of the enlarged implant member through a reduced-profile distal portion.
Claim 12.
Claim 12 corresponds to claim 2 in method form. The findings stated for claim 2 and 11 are incorporated herein.
Dwork teaches that expansion occurs in distal region 52, while substantially cylindrical proximal region 110 maintains its nominal diameter during retraction of the implant-carrying capsule ([0037]-[0045]; Figs. 4-8B).
Claim 14.
Claim 14 corresponds to claim 7 in method form. The findings stated for claim 7 and 11 are incorporated herein.
Zhou teaches a proximal sheath portion containing mesh layer 22 formed from a braided network of fibers ([0063]-[0064]; Figs. 3 and 5).
Claim 15.
Claim 15 corresponds to claim 10 in method form. The findings stated for claim 10 and 11 are incorporated herein.
Dwork teaches proximal region 110 defining lumen 112 and receiving tubular shaft 60 of the implant-carrying delivery assembly. ([0035], [0037], [0042] and [0044]-[0046]; Fig. 4 and 7A-9B)
Claim 16.
Claim 16 recites substantially the same distal and proximal structure as claim 1, but characterizes the structure as an implant delivery shaft. The findings and rationale stated for claim 1 and incorporated herein.
Dwork expressly identifies stability tube 46 as a stability shaft having distal region 52 and proximal region 110. Accordingly, Dwork’s stability shaft, as modified by Zhou and Hogendijk for the reasons stated for claim 1, renders claim 16 obvious ([0037], [0042]; Fig. 4).
Claim 17.
Claim 17 corresponds to claim 2 in method form and depends from structurally corresponding claim 16. The finding stated for claims 2 and 16 are incorporated herein.
Dwork teaches that proximal region 110 maintains its substantially cylindrical configuration while distal region 52 expands ([0037]-[0045]; Figs. 4-8B).
Claim 19.
Claim 19 corresponds to claim 7 and depends from structurally corresponding claim 16. The findings stated for claims 7 and 16 are incorporated herein.
Zhou teaches a proximal sheath portion containing mesh layer 22 formed from a braided network of fibers ([0063]-[0064]; Figs. 3 and 5).
Claim 20.
Claim 20 corresponds to claim 10 and depends from structurally corresponding claim 16. The findings stated for claims 10 and 16 are incorporated herein.
Dwork teaches proximal region 110 defining lumen 112 and receiving tubular shaft 60 of the implant carrying delivery assembly ([0035], [0037], [0042] & [0044]-[0046]); Figs 4 and 7A-9B)
Claims 21-23
Claims 21-23 add the same continuous-lumen limitation to claims 1, 11 and 16, respectively. The findings stated for the corresponding parent claims are incorporated herein.
Dwork teaches that distal region 52 and proximal region 110 form a single homogenous stability tube defining lumen 112. The single homogeneous tube necessarily provides a continuous lumen through the distal and proximal portions ([0037], [0039], [0042]; Fig. 4)
Response to Arguments
Applicant’s arguments filed in response to the prior office action have been fully considered.
Applicant argues that the primary reference, Dwork et al., does not disclose or suggest the amended limitations requiring two or more bendable rods that are disconnected from each other and configured to bend to increase both the width of the distal portion and the distance between the rods.
The argument is persuasive to the extent that Dwork, standing alone, does not expressly disclose the amended rod arrangement. Accordingly, the previous anticipation rejection under 35 U.S.C. § 102 is withdrawn. However, the claims remain unpatentable under 35 U.S.C § 103 over Dwork in view of Zhou et al. and Hogendijk et al.
Dwork teaches the underlying implant-delivery system having a distal portion that expands when an implant-carrying capsule is received therein and a substantially cylindrical proximal portion that maintains it width ([0037]-[0045], [0052]-[0056]; Fig. 4-8B and 12A-12C).
Zhou teaches an expandable sheath having multiple longitudinal rods 50 covered or supported by an elastic tubular layer. The rods are circumferentially spaced and are not directly connected to each other, and the distance between the rods increases as the elastic wall expands during passage of capsule 13 ([0068], [0070]-[0075], [0088]-[0091]; Figs 6A-7).
Hogendijk et al. teaches separate flexible sides of a slotted delivery structure that bend outward and move apart when an oversized implant is advanced through the structure ([0164]; Fig. 29A-B).
It would have been obvious to modify Dwork’s expandable distal region using Zhou’s space longitudinal rods and elastic covering to provide longitudinal support, reduce implant-contact friction, buckle resistance, and controlled temporary expansion. It further would have been obvious to configure the separated rods to bend outward in response to the implant, as taught by Hogendijk, to permit passage of an oversized implant through a reduced-profile distal portion.
The proposed modification represents the predictable use of known expandable delivery-sheath structures to perform their established function. A person of ordinary skill would have had a reasonable expectation that applying an internal radial force to the resulting rod-supported distal portion would cause the disconnected rods to bend outward, thereby increasing both the width of the distal portion and the distance between the rods.
Applicant’s argument addressing Dwork individually does not establish nonobviousness because the present rejection is based on the combined teachings of Dwork, Zhou and Hogendijk. One cannot establish nonobviousness by attacking references individually when the rejection is based upon teachings of a combination of references. In re Keller, 642 F. 2d 413, 425 (CCPA 1981).
Regarding independent method claim 11, the claimed delivery-device structure corresponds substantially to the structure of claim 1. Dwork additionally teaches delivering the device through the vascular and retracting the implant-carrying capsule into the expandable distal region. In the modified device, that retraction causes the separated rods to bend outward and increase the width of the distal portion for the reasons stated above ([0047]-[0056]; Figs. 10-12C)
Independent shaft claim 16 likewise recites substantially the same structure as claim 1, characterized as an implant delivery shaft. Dwork expressly identifies stability tube 46 as a stability shaft having distal and proximal regions. Accordingly, the findings and rationale stated for claim 1 apply equally to claim 16. ([0037], [0042]; Fig. 4).
Applicant has not presented separate arguments establishing patentability of the dependent claims apart from their respective parent claims. The additional limitations of those claims are addressed individually in the rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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