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 .
Response to Amendment
The amendments to figures 26, 27, and 34 are acknowledged and the previous drawing objections are withdrawn.
The amendments to paras. 0226-0227 of the specification are acknowledged and the previous specification objection is withdrawn.
The amendments to claims 14 and 21 are acknowledged and the previous claim objections are withdrawn.
The amendments to claims 1, 5, 6, 8, 21, and 23 are acknowledged and the previous 112(b) rejections are withdrawn. However, claim 19 is still rejected under 112(b) in light of the amendment to claim 14 (see explanation below).
Regarding the previous 112(f) interpretations of the “valve stabilization mechanism” and “engager”, the amendments to include structural language is acknowledged and the 112(f) interpretation for these elements are withdrawn.
Response to Arguments
Applicant’s arguments, see pages 3-5, filed 08/03/2026, with respect to the rejection(s) of claim(s) 1 under Hacohen in view of Khairkhahan, Khairkhahan ‘666, Rabito, and Casley have been fully considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because the combination of modified Hacohen in view of Rabito are silent regarding “a tether looped through or coupled to one or more openings on a lower ventricular portion of the valve stent and through the valve stabilization mechanism tube to a proximal end of the valve delivery system” as recited in claim 1.
In regards to the Casely reference being silent regarding “a plurality of longitudinal slots configured to receive a respective DGF tail member of the plurality of DGF tail members during deployment of the valve stent to organize the DGF tail members” as recited in amended claim 1. The limitation is interpreted as functional language and intended use of the plurality of longitudinal slots. Therefore, “the respective DGF tail member of the plurality of DGF tail members” is interpreted as a functional component that the claimed connector hole is capable of receiving. Casley teaches the structural component of the claim i.e. the plurality of longitudinal slots to perform the functional limitation (para. 0067: “In some embodiments catheter 100 may include multiple lumens 114”) and further teaches that the plurality of longitudinal slots is designed to receive a guidewire which is structurally similar to a tether since they are both a type of elongated member (see Figs. 1C-D, para. 0068). The reference thereby teaches the functional limitation of the plurality of longitudinal slots being capable of receiving the DGF tail members. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
Claim 17 recites “wherein each of the DGF locking mechanisms comprises a hollow conical shape with a plurality of teeth rising from a circular base configured to selectively open up to allow one-way passage of the DGF locking unit on the DGF body member”. The written description describes the DGF locking member as the hollow conical shape with the plurality of teeth rising from the circular base (para. 0018). However, the DGF locking mechanism in the written description is described as the DGF locking unit that passes through the DGF locking member, not the DGF locking member (see para. 0166). Therefore, the limitation lacks proper antecedent bases. For examination purposes, the DGF locking mechanism in claim 17 is interpreted as the DGF fixation mechanism.
Claim 19 recited “wherein each of the DGF locking mechanisms comprises a hollow DGF locking member with at least one tab bent radially inward, wherein the at least one tab is selectively pushable outward radially to allow the locking member of the fixation mechanisms to travel over the DGF tail member and DGF locking unit, and then releasable to press against the DGF locking unit to lock the locking member in place”. The written description describes the DGF locking member as the hollow conical shape with the plurality of teeth rising from the circular base (para. 0018). However, the DGF locking mechanism in the written description is described as the DGF locking unit that passes through the DGF locking member, not the DGF locking member (see para. 0166). Therefore, the limitation lacks proper antecedent bases. For examination purposes, the DGF locking mechanism in claim 19 is interpreted as the DGF fixation mechanism.
Claim Objections
Claims 1, 6, 10, 22, and 28 are objected to because of the following informalities:
Claim 1, line 30: “lower ventricular struts” should recite “lower ventricular struts of the lower ventricular portion”.
Claim 6, line 3: “a DGF tail member” should recite “a respective DGF tail member of the DGF tail members”.
Claim 6, line 5: “the DGF tail member” should recite “the respective DGF tail member of the DGF tail members”.
Claim 10, line 5: “annular tissue” should recite “annular tissue of the annulus of the diseased heart valve”.
Claim 22, line 6: “the valve stabilization mechanism tether” should recite “the tether”.
Claim 28, line 2: “the longitudinal slots” should recite “the plurality of longitudinal slots”.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
“DGF locking mechanism” in claim 8, 15-16. The limitation describing the DGF locking mechanism fails to include sufficient structure to perform the recited function of "locking ". The specification describes the DGF locking mechanism as a structure that can include “at least one DGF locking unit 67, including but not limited to, ridge engaging teeth, barbs, zip ties, pliable barb or key element, a cone shape, a square shape, an arrow shape, a circular shape, a triangular shape, a dome shape, and the like” (Fig. 4A, para. 0166). Therefore, the DGF locking mechanism is interpreted as at least one DGF locking unit comprising any of the structures listed above or any structural equivalent thereof that is configured with a means for locking the stent in the operative position at the implanted DGF members (para. 0166).
“fixation mechanism” in claim 10, 14. The limitation describing the fixation mechanism (for locking the prosthetic heart valve to the implanted DGF members; functional language) fails to include sufficient structure to perform the recited function of "locking" or “fixation”. The specification describes the fixation mechanism as “consisting of a plurality of DGF locking units” that “can be configured with an additional locking member which can engage the DGF locking unit to fixate the valve stent” (para. 0015). Therefore, the fixation mechanism is interpreted as consisting of the plurality of DGF locking units that can be configured with the locking member or any structural equivalent thereof that locks the prosthetic heart valve to the implanted DGF members.
“DGF locking member” in claims 14 and 21. The limitation describing the DGF locking member (“configured to accept passage of the DGF tail member… configured such that the locking member cannot pass through the prosthetic heart valve”; functional language) fails to include sufficient structure to perform the recited function of "locking”. The specification describes the DGF locking member as a structure having a conical shape with a base and a plurality of 3-6 deflectable teeth (para. 0018). Therefore, the DGF locking member is interpreted as the conical shape having the plurality of 3-6 deflectable teeth or any structural equivalent thereof that is capable of accepting passage of the DGF tail member and capable of preventing the DGF locking member from passing through the prosthetic heart valve.
“DGF locking unit” in claim 14, 17, 19. The limitation describing the DGF locking unit (configured to pass through the locking member in one direction only; functional language) fails to include sufficient structure to perform the recited function of "locking". The specification describes the DGF locking unit as a structure “including but not limited to, ridge engaging teeth, barbs, zip ties, pliable barb or key element, a cone shape, a square shape, an arrow shape, a circular shape, a triangular shape, a dome shape, and the like” (Fig. 4A, para. 0166). Therefore, the DGF locking unit is interpreted as the structure described above or any structural equivalent thereof that is capable of passing through the locking member in one direction only.
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 § 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.
Claims 19 and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 (line 2) recites the limitation “a hollow DGF locking member”. It is unclear to the examiner if the hollow DGF locking member is meant to further define the locking member introduced in claim 14. For examination purposes “a hollow DGF locking member” is interpreted as “the locking member that is hollow”.
Claim 21 (line 3) recites the limitation “a plurality of DGF tail members”. It is unclear to the examiner if the plurality of DGF tail members is meant to further define the DGF tail members introduced in claim 1 or if it’s meant to introduce new, additional, DGF tail members. For examination purposes, “a plurality of DGF tail members” is interpreted as “the DGF tail members”.
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, 3-5, 8-9, 12-13, 16, 18, 21, 22, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Hacohen (US 20110224785) in view of Khairkhahan et al. (US 20150119981) [hereinafter Khairkhahan], Khairkhahan et al. (US 20150366666) [hereinafter Khairkhahan ‘666], Rabito et al. (US 20150238315) [hereinafter Rabito], Arnault De La Menardiere et al. (US 20070167955) [hereinafter Arnault De La Menardiere], Casley et al. (US 20140371841) [hereinafter Casley], and Gloss et al. (US 20140330368) [hereinafter Gloss].
The examiner notes that embodiment of Fig. 3A-B is relied upon in the rejection. However, Figs. 1-2B are relied upon to disclose like features not discussed in Figs. 3A-B.
Regarding claims 1 and 22, Hacohen discloses a multi-stage and multi-lumen (MSML) delivery system for treatment of a diseased heart valve within a patient's body (see Figs. 2A-3B), the MSML delivery system comprising:
a prosthetic heart valve 10 comprising a valve stent 20 for implantation at an annulus 32 of the diseased heart valve (Fig. 1, para. 0077);
a plurality of DGF members 50 (Fig. 3B, para. 0085) comprising DGF tail members 70 extending from DGF head members 52 (Fig. 3A, para. 0085);
a dual-guiding-and-fixation (DGF) system for implanting the plurality of DGF members 50 (see Figs. 3A-3B, para. 0085), the DGF system comprising a torque-driving shaft 71 (Fig. 2B, para. 0083);
a valve delivery system comprising a valve sheath 72 within which a proximal portion of the valve stent 20 is crimped for delivery to the diseased valve (Fig. 2A, para. 0082).
Hacohen further discloses that the prosthetic valve delivery may be conducted with one or more catheters (para. 0076), thereby contemplating the use of other delivery catheter/sheaths in the delivery system.
However, Hacohen fails to disclose a docking system comprising a docking sheath and a docking controller, the DGF system further comprising a DGF sheath through which the DGF tail members extend and a DGF controller, and the valve delivery system comprising a lock housing structure.
Khairkhahan in the same field of endeavor of implant delivery systems for use in the heart (para. 0039-0040) teaches that it is known in the art to include a docking system 110 comprising a docking sheath 120 and a docking controller (interpreted as actuator described in para. 0073) (Fig. 7, para. 0058, 0073) for the purpose of facilitating navigation into a target site by way of a deflectable tip 122 (para. 0058) and for accommodating various instruments inserted therein, thereby protecting the instrument during delivery (para. 0058-0059);
a DGF system for implanting a plurality of DGF members 146 (Fig. 8, para. 0170) comprising a DGF sheath 112 through which DGF tail members 160 extend from (Fig. 8, para. 0062), a drive shaft 150 positioned within the delivery catheter 112 and DGF controller 156 (Fig. 8, para. 0061) for the purpose of navigating the DGF members to the target site and enabling manipulation of a position of the DGF members by way of a deflectable tip 144 (para. 0060-0061); and
a valve delivery system 116 comprising a lock housing structure sheath 186 and a DGF locking member sheath 196 to retain locking elements 192, 194 of the DGF members 146 (Figs. 10, 12A para. 0068, 0080) for the purpose of facilitation navigation and manipulation of the locking elements of the DGF members to the target site by way of deflectable tip 190 (Figs. 12A-D, para. 0080).
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 multi-stage and multi-lumen (MSML) delivery system in Hacohen to include the docking system comprising the docking sheath and controller, the DGF system comprising the DGF sheath and controller, and the valve delivery system comprising the lock housing structure with DGF locking member sheath of Khairkhahan in order to provide controlled navigation and delivery of the valve sheath, the plurality of DGF members, and the plurality of locking elements of the DGF members to the heart valve by way of their deflectable tips, thereby providing the user with easier navigation to the target site (para. 0067, 0073-0074 of Khairkhahan).
Hacohen in view of Khairkhahan further teaches that the lock housing structure 116 comprises a plurality of lumens (para. 0167 of Khairkhahan).
However, Hacohen in view of Khairkhahan is silent regarding the use of a plurality of DGF locking member sheaths.
Khairkhahan ‘666 in the same field of endeavor in the same field of endeavor of heart implant delivery devices teaches that it is known in the art to have a plurality of DGF locking member sheaths 1010, 1020, 1030 delivered from a lock housing structure sheath 1000 (Figs. 10A-B, para. 0142) for the purpose of locking a plurality of DGF members simultaneously (para. 0142).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the valve delivery system of modified Hacohen with the plurality of lock member sheaths, as taught by Khairkhahan ‘666, since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)
Hacohen further contemplates an additional implant delivery device comprising a sheath cap 222 having a conical distal tip, attached to a distal end of the implant stabilization mechanism 216 (Figs. 8A-D, 0104-0106 of Hacohen), and configured to facilitate navigation of a valve sheath 220 is known in the art. The implant stabilization mechanism 216 is delivered downstream of the target site such that the lower portion of an implant 214 is positioned adjacent to the sheath cap 222 Figs. 8A-D, 0104-0106 of Hacohen).
However, Hacohen in view of Khairkhahan and Khairkhahan ‘666 is silent regarding a valve delivery controller and a valve stabilization mechanism, wherein the valve stabilization mechanism further comprises: a valve stabilization mechanism tube extending proximally through the valve sheath; a tether looped through or coupled to one or more openings the valve stent and through the valve stabilization mechanism tube to a proximal end of the valve delivery system; a valve sheath cap attached to a distal end of the valve stabilization mechanism, wherein the valve sheath cap comprises a distal portion and a proximal portion, wherein the proximal portion of the valve sheath cap is positioned over a distal portion of the crimped valve stent such that lower ventricular struts of the valve stent are covered during a valve deployment, and a rounded or conical distal tip configured to facilitate navigation of the valve sheath.
Rabito in the same field of endeavor of prosthetic valve delivery teaches a valve stabilization mechanism 10 (Fig. 1A, para. 0066), wherein the valve stabilization mechanism 10 further comprises:
a valve stabilization mechanism tube extending proximally through a valve sheath 12 (see annotated Fig. 4B of Rabito below);
a tether 32 looped through or coupled to one or more openings on another portion of the crimped valve stent (Figs. 1B, 4B, para. 0074);
a valve sheath cap 28 attached to a distal end of the valve stabilization mechanism 10 (Fig. 1A, para. 0069) by way of a valve stabilization mechanism tube (see annotated Fig. 4B below), wherein the valve sheath cap 28 comprises a distal portion and a proximal portion (see annotate Fig. 4B below), wherein the proximal portion of the valve sheath cap 28 is positioned over a portion of the crimped valve stent 30 such that ventricular struts of the valve stent 39 are covered during a valve deployment (Fig. 4B, para. 0075), and a conical distal tip configured to facilitate navigation of a valve sheath 24 (Fig. 4B, para. 0066) and a valve delivery controller (interpreted as handle described in para. 0067).
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Annotated Fig. 4B of Rabito
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 valve delivery system in modified Hacohen to include the valve stabilization mechanism comprising a valve sheath cap, valve stabilization mechanism tube and tether and valve delivery controller of Rabito in order to provide controlled expansion to the prosthetic valve from a proximal end to a distal end (para. 0074 of Rabito), thereby preventing premature expansion of the prosthetic valve and controlled placement of the prosthetic valve to the heart valve (para. 0007 of Rabito).
The combination of modified Hacohen in view of Rabito would result in a product wherein the proximal portion of the valve sheath cap 28 of Rabito is positioned over a distal portion of the crimped valve stent 20 of Hacohen such that lower ventricular struts of the valve stent 29 of Hacohen are covered during the valve deployment since the valve stent is delivered in a downstream direction (see Figs. 3A-B, para. 0086-0087 of Hacohen).
However, the combination of Hacohen in view of Khairkhahan, Khairkhahan ‘666, and Rabito is silent regarding the tether being looped through or coupled to one or more openings on the lower ventricular portion of the valve stent.
Arnault De La Menardiere in the same field of endeavor of prosthetic valve delivery devices teaches that it is known for a tether 132 to be looped through one or more openings 130 on a lower ventricular portion 126 of a valve stent 120 adjacent to a valve sheath cap 46 (Fig. 5C, para. 0105: “At the distal tips of crowns or apexes 126 of main body 122 and crowns or apexes 128 of side branch 124 may be eyelet loops 130 for receiving attachment strings 132 (shown only in FIG. 5C)”).
In light of this teaching, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the location of the tether shown in modified Hacohen to be positioned on and constrain the lower ventricular portion adjacent to the valve sheath cap, as taught by Arnault De La Menardiere, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (CCPA 1950).
However, the combination of Hacohen in view of Khairkhahan, Khairkhahan ‘666, Rabito, and Arnault De La Menardiere is silent regarding wherein the valve sheath cap further comprises a plurality of longitudinal slots configured to receive a respective DGF tail member of the DGF tail members during deployment of the valve stent to organize the DGF tail members.
Casley in the same field of endeavor of prosthetic valve delivery devices (Fig. 1A, para. 0059, 0073) teaches a cap 110 comprising a plurality of longitudinal slots 114 (Fig. 1C, para. 0067), each slot is configured to receive an elongated member 400 during deployment of the valve stent (para. 0064, see note below regarding functional language).
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 valve sheath cap in modified Hacohen to include the plurality of longitudinal slots of Casley in order to guide the plurality of DGF tail members during delivery of the valve stent (para. 0047 of Casley), thereby preventing the plurality of DGF tail members from being tangled during delivery.
Note: “a plurality of longitudinal slots configured to receive a respective DGF tail member of the plurality of DGF tail members during deployment of the valve stent to organize the DGF tail members” as recited in amended claim 1. The limitation is interpreted as functional language and intended use of the plurality of longitudinal slots. Therefore, “the respective DGF tail member of the plurality of DGF tail members” is interpreted as a functional component that the claimed connector hole is capable of receiving. Since Casley teaches the structural component of the claim i.e. the plurality of longitudinal slots to perform the functional limitation (para. 0067: “In some embodiments catheter 100 may include multiple lumens 114”) and further teaches that the plurality of longitudinal slots are designed to receive a guidewire which is structurally similar to a tether since they are both a type of elongated member (see Figs. 1C-D, para. 0068). The reference thereby teaches the functional limitation of the plurality of longitudinal slots being capable of receiving the DGF tail members. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The combination of Hacohen in view of Khairkhahan, Khairkhahan ‘666, Rabito, Arnault De La Menardiere, and Casley would result in a product wherein the docking system, the DGF system, and the valve delivery system are collectively configured to advance the DGF head members 52 to an operative position (Fig. 3A, para. 0080, 0085 of Hacohen; Figs. 11A-D, para. 0074, 0076 of Khairkhahan), to deliver and implant the DGF head members 52 to engage tissue on or around the annulus through the valve stent in the operative position (Fig. 3B, para. 0086-0087 of Hacohen; Figs. 11A-D, para. 0074, 0076 of Khairkhahan), and to guide, deliver and fixate the prosthetic heart valve to the operative position (Figs. 3B, para. 0087 of Hacohen; Figs. 11A-D, para. 0077 of Khairkhahan; Figs. 1A-4B para. 0069, 0075 of Rabito).
However, the combination of Hacohen in view of Khairkhahan, Khairkhahan ‘666, Rabito, Arnault De La Menardiere, and Casley is silent regarding the valve stabilization mechanism tether extending through the valve stabilization mechanism tube to a proximal end of the valve delivery system, and a grabber to selectively fixate two free ends of the valve stabilization mechanism tether.
Gloss in the same field of endeavor of tethered prosthetic valve delivery devices teaches that it is known the art to have a valve stabilization mechanism tether 140 looped around a portion of a prosthetic valve 20 and through a valve stabilization mechanism tube 150 to a proximal end of a valve delivery system (see Figs. 33-34B, para. 0206, 0209), and a grabber (interpreted as one or more tensioning apparatus and actuation elements as described in para. 0209) to selectively fixate two free ends of the valve stabilization mechanism tether 140 (Fig. 34B, para. 0209).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Gloss (to have the valve stabilization mechanism tether extend through the valve stabilization mechanism tube and include the grabber to selectively fixate the two free ends of the valve stabilization mechanism tether) to the valve stabilization mechanism of modified Hacohen would have yielded predicable results, namely, a way to retain a portion of the valve stabilization mechanism tether by way of the valve stabilization mechanism tube and a way to actuate the valve stabilization mechanism tether by way of the grabber (para. 0206, 0209 of Gloss); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)
Regarding claim 3, modified Hacohen discloses wherein the DGF sheath 112 comprises a distal portion (interpreted as portion that includes shaft 142, and deflectable tip 144; Fig. 8, para. 0060 of Khairkhahan) and a proximal portion (interpreted as portion that includes handle 154; Fig. 8, para. 0061), wherein the DGF sheath 112 is configured with a steerable section 144 at the distal portion of the DGF sheath which has a greater flexibility than the proximal portion of the DGF sheath (Fig. 8, para. 0060, para. 0074 of Khairkhahan); and wherein the DGF controller 154 is configured to operatively bend the steerable section of the DGF sheath up to 180 degrees (Figs. 9A and 11B, para. 0074 of Khairkhahan).
Regarding claim 4, modified Hacohen discloses wherein the torque-driving shaft 71 (Fig. 2B, para. 0083 of Hacohen) is configured to fit inside a lumen of the DGF sheath 112 (see Fig. 8, para. 0061 of Khairkhahan which teaches a drive shaft positioned within the DGF sheath), engage each of the DGF body members such that the torque-driving shaft 71 can drive the DGF head members 52 into the tissue (Fig. 3A, para. 0085-0086 of Hacohen), and wherein the torque-driving shaft 71 is configured to bend together with the distal portion of the DGF sheath 112 by operating the DGF controller 154 (Figs. 11B-C, para. 0061, 0074 of Khairkhahan).
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Annotated Fig. 3A of Hacohen
Regarding claim 5, modified Hacohen discloses wherein the torque-driving shaft 71 is configured with an inner lumen to house the DGF tail members 70 (Fig. 3A, para. 0086 of Hacohen) and wherein the DGF tail members 70 are configured to couple with a grabber (interpreted as knob 156) at a proximal end of the DGF system to fixate the DGF tail members during the DGF member delivery (para. 0061 of Khairkhahan).
Regarding claim 8, modified Hacohen discloses wherein each of the plurality of DGF members 50 comprises a DGF body member (see annotated Fig. 3A of Hacohen above; interpretation is explained in claim 4 above) and a DGF locking mechanism 73 (interpreted as the DGF locking unit; see 112(f) interpretation above; Figs. 3B, para. 0088 of Hacohen).
Regarding claim 9, modified Hacohen discloses wherein the DGF head member 52 of the plurality of DGF members 50 is configured to have a spiral shape configured to engage heart tissues. (Figs. 3A-B, para. 0080 of Hacohen).
Regarding claim 12, modified Hacohen discloses wherein each of the DGF locking mechanisms 73 (interpreted as the DGF locking unit, see 112f interpretation above) comprises a protrusion (interpreted as tapered protrusion shown in annotated Fig. 3A above) on a proximal portion of the DGF body member (para. 0088 of Hacohen).
Regarding claim 13, as discussed above, the combination of Hacohen in view of Khairkhahan, Khairkhahan ‘666, Rabito, Arnault De La Menardiere, Casley, and Gloss makes obvious the device of claim 1. Additionally, Hacohen discloses further discloses wherein each DGF tail member 70 is configured to selectively attach to and detach from the respective DGF body member of the plurality of DGF body members (para. 0085, 0088 of Hacohen).
However, modified Hacohen is silent regarding wherein the DGF body member comprises a loop or ring shape at a proximal portion of the DGF body member such that the DGF tail member can be looped through to attach to the DGF body member, and can be detached from the DGF body member by pulling one end of the DGF tail member.
Khairkhahan further discloses that it is known in the art for a DGF body member 152 to comprise a loop or ring shape 158 at a proximal portion of a DGF body member 152 such that the DGF tail member 160/210 can be looped through to attach to the DGF body member (Figs. 8, 12A-C of Khairkhahan, para. 0062), and can be detached from the DGF body member by pulling one end of the DGF tail member (Fig. 12D, para. 0081 of Khairkhahan).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Khairkhahan (including the loop or ring shape) to the DGF body members in modified Hacohen would have yielded predicable results, namely providing a means for directly connecting the DGF body members to the DGF tail members (para. 0061 of Khairkhahan).
Regarding claim 16, modified Hacohen discloses wherein the DGF locking mechanism 73 is configured as a distinct structure from the valve stent (Fig. 3B, para. 0088 of Hacohen).
Regarding claim 18, modified Hacohen discloses wherein each of the DGF locking mechanisms comprises at least one locking unit 73 configured as a cone shape (see Fig. 3B) on a proximal portion of the DGF body member to allow for one-way passage of the valve stent in a first direction, and resist subsequent movement of the valve stent in a second direction opposite to the first direction (Fig. 3B, para. 0088 of Hacohen).
Regarding claim 21, modified Hacohen discloses wherein the lock housing structure sheath comprises a plurality of lumens for separating a plurality of DGF locking members 73 and a plurality of DGF tail members (interpreted as the DGF tail members 70, see 112b rejection above; Figs. 3A-B, para. 0087-0088 of Hacohen) of each of the DGF locking members (Fig. 10, para. 0067 of Khairkhahan; The examiner notes that this is as evidenced by Figs. 10A-B, para. 0142 of Khairkhahan ‘666).
Regarding claim 26, modified Hacohen discloses wherein the valve sheath cap is configured to cover the lower ventricular struts on the valve stent to prevent the DGF members from getting caught under the valve stent during valve release (The examiner notes that the valve sheath cap of Rabito is capable of covering the lower ventricular struts on the valve stent as discussed above in the rejection of claim 1 and shown in Fig. 4B, para. 0074 of Rabito. This is further evidenced by Hacohen which discloses that the valve stent is delivered downstream of the heart valve such that the lower ventricular struts would be positioned in the nosecone (see Figs. 3A-B, para. 0086-0087 of Hacohen)).
Regarding claim 27, modified Hacohen discloses wherein the valve sheath cap is configured to be retracted back into the MSML delivery system and removed from the patient’s body after releasing the valve stent (see Figs. 20B-21B of Rabito which illustrates the valve sheath cap being retracted once the prosthetic valve is released, para. 0107 states that when the prosthetic valve is released, the delivery system is removed from the body. Therefore, the valve sheath cap is also removed from the body).
Regarding claim 28, modified Hacohen discloses wherein the longitudinal slots are provided in the proximal portion of the valve sheath cap as taught by Casley (Figs. 1C, para. 0064, 0067 of Casley) and are configured to receive the respective DGF tail members to organize the DGF tail members during deployment of the valve stent (para. 0064, 0067 of Casley teach that the longitudinal slots are capable of receiving DGF tail members to achieve the functional limitation described above).
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hacohen (US 20110224785) in view of Khairkhahan et al. (US 20150119981) [hereinafter Khairkhahan], Khairkhahan et al. (US 20150366666) [hereinafter Khairkhahan ‘666], Rabito et al. (US 20150238315) [hereinafter Rabito], Arnault De La Menardiere et al. (US 20070167955) [hereinafter Arnault De La Menardiere], Casley et al. (US 20140371841) [hereinafter Casley], and Gloss et al. (US 20140330368) [hereinafter Gloss], as applied to claim 4 above, and further in view of West et al. (US 20130006287) [hereinafter West].
Regarding claim 6, modified Hacohen discloses all of the limitations set forth above in claim 4. Modified Hacohen further discloses wherein the torque-driving shaft 71 comprises a hollow tube with an inner lumen, such that it can house a DGF tail member 70 and transmit torque from a proximal end of the torque-driving shaft to a distal end of the torque-driving shaft in bent configurations without perturbing the DGF tail member (Fig. 3A, para. 0086 of Hacohen).
However, modified Hacohen fails to disclose the torque-driving shaft comprises one of a hollow coil, a plurality of twisted wires, or a plurality of cords.
West teaches a torque-driving shaft 111 formed of a plurality of twisted wires or a plurality of cords (Fig. 14, para. 0202) for the purpose of providing flexibility to the shaft without impeding the steering capabilities of an endoscope (para. 0202).
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 torque-driving shaft in modified Hacohen to form the shaft with the plurality of twisted wires or the plurality of cords, as taught by West, in order to provide flexibility to the torque-drive shaft, thereby allowing independent manipulation of the torque-drive shaft for anchor placement during use (para. 0202 of West).
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Hacohen (US 20110224785) in view of Khairkhahan et al. (US 20150119981) [hereinafter Khairkhahan], Khairkhahan et al. (US 20150366666) [hereinafter Khairkhahan ‘666], Rabito et al. (US 20150238315) [hereinafter Rabito], Arnault De La Menardiere et al. (US 20070167955) [hereinafter Arnault De La Menardiere], Casley et al. (US 20140371841) [hereinafter Casley], and Gloss et al. (US 20140330368) [hereinafter Gloss], as applied to claim 5 above, and further in view of Hong (US 20050216044).
Regarding claim 7, modified Hacohen discloses all of the limitations set forth above in claim 5.
However, modified Hacohen fails to disclose wherein the DGF system fails to disclose an expandable compartmentalization sheath with a plurality of lumens to organize the DGF tail members during each DGF member delivery, wherein inner walls separating the plurality of lumens are flexible, bendable, and collapsible, and are configured to be pushed to either side to allow passage of other members of the DGF system during the DGF member delivery.
Hong in the same field of endeavor teaches an expandable compartmentalization sheath (interpreted as delivery catheter 66) with a plurality of lumens 64, 68 to organize interventional medical devices such a balloon catheter 60 during delivery of the devices (Fig. 10, para. 0049), wherein inner walls separating the plurality of lumens are flexible, bendable, and collapsible, (Fig. 10, para. 0018, 0024, 0049) and are configured to be pushed to either side to allow passage of other devices during delivery (Fig. 10, para. 0049).
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 DGF system in Modified Hacohen to include the expandable compartmentalization sheath of Hong in order to organize the DGF tail members such that the tail ends do not tangle during delivery (para. 0024 of Hong) and allow individual accommodation of each of the DGF members during delivery via. the expandability and collapsibility of the lumens (para. 0049 of Hong).
Claim(s) 10, 14-15, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hacohen (US 20110224785) in view of Khairkhahan et al. (US 20150119981) [hereinafter Khairkhahan], Khairkhahan et al. (US 20150366666) [hereinafter Khairkhahan ‘666], Rabito et al. (US 20150238315) [hereinafter Rabito], Arnault De La Menardiere et al. (US 20070167955) [hereinafter Arnault De La Menardiere], Casley et al. (US 20140371841) [hereinafter Casley], and Gloss et al. (US 20140330368) [hereinafter Gloss], as applied to claim 8 above, and further in view of Khairkhahan et al. (US 20150366556) [hereinafter Khairkhahan ‘556) and Flores et al. (US 20050251207) [hereinafter Flores].
Regarding claim 10, modified Hacohen discloses all of the limitations set forth above in claim 8. Modified Hacohen further discloses wherein each DGF body member (see annotated Fig. 3B above of Hacohen) of the plurality of DGF body members 50 is configured to link to the respective DGF head member 52 of the plurality of DGF head members 50 (Fig. 3A, para. 0085 of Hacohen) and (ii) a fixation mechanism comprising a locking member (interpreted as singular DGF locking unit 73 and DGF locking member 74; see 112(f) interpretation above) for locking the prosthetic heart valve 10 to the implanted DGF members 50 (Fig. 3B, para. 0088 of Hacohen).
However, modified Hacohen fails to disclose a plurality of DGF locking units.
Khairkhahan ‘556 in the same field of endeavor of anchor fixation mechanisms teaches that it is known in the art for a locking member 266 (analogous to the locking member of modified Hacohen) to lock with a suture 288 connected to a hub (interpreted as element in between a DGF head member 284 and suture 288; This interpretation is supported by the embodiment of Fig. 24D, para. 0129) of the DGF head member 284 (Fig. 12, para. 0113).
Flores in the same field of endeavor of anchor fixation mechanisms teaches that the suture 168 may comprise a plurality of DGF locking units 170 to locking with a locking member 162 (analogous to the locking member of modified Hacohen) (Fig. 8C, para. 0117).
In light of these teachings, it would have been obvious to substitute the hub connected suture having the plurality of DGF locking units as taught by Khairkhahan ‘556 and Flores for the singular cone-shaped DGF locking unit of modified Hacohen, since Khairkhahan ‘556 and Flores teaches that this DGF locking unit configuration is known in the art and would yield predictable results, namely an alternative way to lock the valve stent by way of the locking member grabbing on the plurality of DGF locking units of the suture (para. 0113 of Khairkhahan ‘556 and para. 0117 of Flores).
However, modified Hacohen fails to disclose wherein the DGF body member comprises (i) an engager comprising a protrusion for selectively engaging and disengaging the torque-driving shaft configured to embed the DGF head member into an annular tissue.
Khairkhahan further teaches that it is known in the art for a DGF body member 158 to include (i) engager comprising a protrusion 152 (analogous to the hub as taught by Khairkhahan ‘556 which is also between the DGF head member 146 and suture; para. 0062 of Khairkhahan teaches that the drive continuation 152 can be a square continuation of the anchor helix. However, the drive continuation 152 may be of any shape, such as triangular or hexagonal) for selectively engaging and disengaging a torque-driving shaft 150 configured to embed a DGF head member 146 into an annular tissue for the purpose of directly connecting the DGF member to the torque-driving shaft (para. 0061-0062 of Khairkhahan).
In light of these teachings, 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 hub in modified Hacohen to be the engager, as taught by Khairkhahan, in order to allow direct transmission of torque to the DGF member imparted by the torque-drive shaft (para. 0061 of Khairkhahan).
Regarding claim 14, modified Hacohen discloses wherein each of the locking member 74 of each of the fixation mechanisms is configured to accept passage of the respective DGF tail members 70 (Figs. 3A-B, para. 0088 of Hacohen), and further comprises a DGF locking unit (interpreted as one protrusion of the plurality of protrusions 170) configured to pass through the locking member in one direction only (Fig. 8C, para. 0116-0117 of Flores), wherein the locking member 74 of each of the fixation mechanisms is further configured such that the locking member 74 cannot pass through the prosthetic heart valve (Fig. 3B, para. 0088 of Hacohen).
Regarding claim 15, modified Hacohen discloses wherein each of the DGF locking mechanisms (interpreted as DGF locking units 170 of Flores, see 112(f) interpretation above) is configured to attach directly to the valve stent (see Fig. 3B, para. 0088 of Hacohen which discloses that the valve stent would be between the DGF locking units and locking members 30 such that the DGF locking units 170 of Flores would be capable of attaching directly to the valve stent).
Regarding claim 17, modified Hacohen discloses wherein each of the DGF locking mechanisms (interpreted as the fixation mechanism, see specification objection and 112(f) interpretation above) comprises a hollow conical shape with a plurality of teeth rising from a circular base (see element 74 of Hacohen) configured to selectively open up to allow one-way passage of the respective DGF locking unit 170 of Flores on the DGF body member (Fig. 3B, para. 0088 of Hacohen; Fig. 8C, para. 0116-0117 of Flores).
Regarding claim 19, modified Hacohen discloses wherein each of the DGF locking mechanisms (interpreted as the fixation mechanism, see specification objection and 112(f) interpretation above) comprises a hollow DGF locking member 74 with at least one tab bent radially inward (Fig. 3B, para. 0088 of Hacohen), wherein the at least one tab is selectively pushable outward radially to allow the locking member 74 of each of the fixation mechanisms to travel over the DGF tail member 70 and DGF locking unit 170 of Flores, and then releasable to press against the DGF locking unit 170 of Flores to lock the DGF locking member 74 of each of the fixation mechanism in place (Fig. 3B, para. 0088 of Hacohen; para. 0116-0117 of Flores).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hacohen (US 20110224785) in view of Khairkhahan et al. (US 20150119981) [hereinafter Khairkhahan], Khairkhahan et al. (US 20150366666) [hereinafter Khairkhahan ‘666], Rabito et al. (US 20150238315) [hereinafter Rabito], Arnault De La Menardiere et al. (US 20070167955) [hereinafter Arnault De La Menardiere], Casley et al. (US 20140371841) [hereinafter Casley], Gloss et al. (US 20140330368) [hereinafter Gloss], Khairkhahan et al. (US 20150366556) [hereinafter Khairkhahan ‘556) and Flores et al. (US 20050251207) [hereinafter Flores], as applied to claim 10 above, and further in view of Goble et al. (US 5851219) [hereinafter Goble].
Regarding claim 11, modified Hacohen discloses all of the limitations set forth above in claim 10. However, modified Hacohen fails to disclose wherein each engager of the engagers of the DGF body members comprises a male protrusion, wherein the male protrusion is configured to engage the recess with the corresponding shape on a distal tip of the torque-driving shaft.
Goble in the same field of endeavor of anchor delivery devices teaches that it is known in the art to have an engager 14 comprise a male protrusion (Fig. 1, col. 4 lines 59-63: “As may be seen in FIG. 1, the continuous screw thread 16 extends from the anchor free end 22 to the anchor connector portion 14. Because the anchor connector portion 14 is removed from the head portion 12 and comprises a male connector means”, wherein the male protrusion is configured to engage a recess 66 with a corresponding shape on a distal tip of a torque-driving shaft 50 (Fig. 4, col. 5 lines 54-58: “The polygonal cross-sectional configuration of the recess 66 of the socket portion 64 is complementary to the polygonal cross-sectional configuration of the connector portion 14 of the anchor body 10”.).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Goble (incorporating a male protrusion) to the engager of modified Hacohen would have yielded predicable results namely, an alternative way for the torque-driving shaft to receive the DGF body member for transmission of torque forces (col. 5 lines 58-60 of Goble: “ As a result, the connector portion of the anchor body 10 is drivingly received in the shaft tip socket portion 64”).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hacohen (US 20110224785) in view of Khairkhahan et al. (US 20150119981) [hereinafter Khairkhahan], Khairkhahan et al. (US 20150366666) [hereinafter Khairkhahan ‘666], Rabito et al. (US 20150238315) [hereinafter Rabito], Arnault De La Menardiere et al. (US 20070167955) [hereinafter Arnault De La Menardiere], Casley et al. (US 20140371841) [hereinafter Casley], and Gloss et al. (US 20140330368) [hereinafter Gloss] as applied to claim 1 above, and further in view of Stevens-Wright (US 5383852).
Regarding claim 20, modified Hacohen discloses all of the limitations set forth above in claim 1. However, modified Hacohen fails to disclose wherein the valve sheath has three sections with different stiffnesses: a proximal section, a middle section and a distal section; wherein the proximal section is a longer shaft and is stiffer than the middle and distal sections; wherein the middle section is the most flexible among the three sections and is configured to bend up to 180 degrees without kinking; wherein a length of the middle section ranges from 60 to 150 mm; wherein the distal portion is a straight and stiff portion that resists deformation to load the crimped prosthetic heart valve; and wherein the length of the distal portion ranges from 15 to 35 mm.
Stevens-Wright in the field of steerable catheter devices teaches that it is known in the art for a shaft (see Figs. 13a-c) to comprise three sections with different stiffnesses (col. 6 lines 1-4: “To provide this result, it is necessary that the shaft 10 be stiffer than proximal section 15 and that the proximal section 15 be stiffer than the distal section 16”: a proximal section 10, a middle section 15 and a distal section 16 (Figs. 13a-c); wherein the proximal section 10 is a longer shaft and is stiffer than the middle and distal sections (see Figs. 13a-c, col. 6 lines 1-4 above); wherein the middle section 15 is the most flexible among the three sections (Figs. 13a-c, col. 6 lines 11-13: it is at least theoretically possible that the distal section could be stiffer than the proximal section) and is configured to bend up to 180 degrees without kinking (col. 4 lines 15-20: “Although the illustrated embodiment provides perpendicular planes of proximal and distal movement, the relative orientation between these two planes may vary with different catheter applications and desired tip-shapes and the two planes may form angles between zero degrees and one hundred eighty degrees”); wherein a length of the middle section ranges from 60 to 150 mm (col 7 lines 3-4: “The length of the proximal section 15 may be 1.5-8.0 cm” which is within the claimed range (6 cm to 15 cm equates to 60 to 150 mm)) and wherein the distal portion is a straight and stiff portion (figs. 13a-c, see col. 6 lines 11-13 above) that resists deformation to load the crimped prosthetic heart valve that resists deformation to load the crimped prosthetic heart valve (The examiner notes that distal section needs only to be capable of resisting deformation to load the crimped prosthetic heart valve and only structurally requires a stiff and straight distal section. Since Stevens-Wright teaches a stiff and straight distal section designed to resist bending (see col. 6 lines 11-13 above), it meets the functional limitation of the claim); and wherein the length of the distal portion ranges from 15 to 35 mm (col. 7 lines 10-12: “The distal section 16, also an extrusion, may be made of PELLETHANE elastomer (hardness 90 Shore A). Its length may be 2.0-8.0 cm” which is within the claimed range (1.5 cm to 3.5 cm equates to 15 to 35 mm).
In light of this teaching, 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 valve sheath in modified Hacohen to include the proximal, middle, and distal sections having three different stiffnesses and the claimed lengths, as taught by Stevens-Wright in order to allow the proximal section to resist buckling along its length, to provide the middle section with improved steerability while navigating to the heart valve, and to provide the distal section with a level of rigidity to prevent bending during loading and deployment of the prosthetic valve (Figs. 13a-c, col. 6 lines 1-4 and 11-13 of Steven-Wright) and since the claimed lengths are acceptable and known in the art for a steerable catheter treating the heart (col. 1 lines 33-38: Some of these additional sites include atrial sites above the tricuspid and mitral valves, ventricular sites circumferential to the mitral and tricuspid valve leaflets, distal areas of the coronary Sinus and great cardiac vein, the AV nodal area and the left ventricle, to name a few.).
Claim(s) 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hacohen (US 20110224785) in view of Khairkhahan et al. (US 20150119981) [hereinafter Khairkhahan], Khairkhahan et al. (US 20150366666) [hereinafter Khairkhahan ‘666], Rabito et al. (US 20150238315) [hereinafter Rabito], Arnault De La Menardiere et al. (US 20070167955) [hereinafter Arnault De La Menardiere], Casley et al. (US 20140371841) [hereinafter Casley], and Gloss et al. (US 20140330368) [hereinafter Gloss], as applied to claim 22 above, and further in view of Forster et al. (US 20070203561) [hereinafter Forster ‘561].
Regarding claim 23, modified Hacohen discloses all of the limitations set forth above in claim 22. Modified Hacohen further discloses wherein the valve stabilization mechanism tube is configured with a controller at the proximal end of the valve delivery system (para. 0065 teaches that any one embodiment discussed in Rabito can be combined with features of other embodiments. para. 0068 of Rabito states that the handle “can include various control mechanisms that be used to control the movement of the various subassemblies” and para. 0078 of the embodiment of Fig. 9 states “the handle 110 can include a plurality of switches, levers, or other actuatable mechanisms which can be used to control the movement of the one or more shafts of the delivery system 100 and/or to control the operation of other components of the delivery system 100”). However, modified Hacohen does not explicitly disclose that the controller is operable to adjust a position of the valve stent after release of the valve stent from the valve sheath.
Forster ‘561 in the same field of endeavor of prosthetic valve delivery devices teaches that it is known in the art for a valve stabilization mechanism tube 136 to be configured with a controller 102 at a proximal end (Figs. 2, 23A-C, para. 0119), wherein the controller 102 is operable to adjust a position of a prosthetic valve 30 by way of a tensioning member 336 (Figs. 23A-C, para. 0119).
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 valve stabilization mechanism tube in modified Hacohen to include the tensioning member of Forster ‘561 in order to provide the valve stabilization mechanism tube with steering capabilities, thereby providing the ability to manipulate the distal end of the valve stabilization mechanism tube to allow proper placement of the prosthetic valve (para. 0119 of Forster).
The combination of modified Hacohen in view of Forster would result in a product wherein the controller is operable to adjust a position of the valve stent, as taught by Forster ‘561 (Figs. 23A-C, para. 0119) after release of the valve stent from the valve sheath when the valve stent is still connected the valve stabilization mechanism tether and valve sheath cap (see Fig. 4B, para. 0074 of Rabito).
Allowable Subject Matter
Claim 25 is allowed.
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
