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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/29/2026 has been entered.
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 6/29/2026. The claims 1, 3-9, 16-27 are pending. The claims 1, 3-6, 16, 18-21 are amended. Claim 22-27 are new. Claims 2, 10-15 have been cancelled.
Response to Arguments
Applicant’s arguments with respect to the drawing objection have been considered and the amendment to cancel the claims 10, 11, and 13 have overcome the objection.
Applicant’s amendment with respect to the interpretation of one or more claim elements under 25 U.S.C. 112(f) have been considered and the amendment overcomes the interpretation of “locking element” and “second locking element”. The interpretation of “first coupling member” “second coupling member” and “implant coupling member” with respect to claims 4, 6, and 8 have been maintained.
Applicant’s amendment has not overcome the double patenting rejection. Where amended claim 1 is unpatentable over claims 1 and 2 of U.S. Patent No. 11596771 in view of Bolduc (US2007/0073389).
Applicant’s arguments, filed 6/29/2026 with respect to the rejections of claims 1, 3-21 under 35 U.S.C. 103 as being unpatentable over Wu (US2022/0323216) in view of Bolduc (US2007/0073389) have been fully considered and the arguments are partially persuasive. Applicants argues, the office has not shown that Wu and Boldoc explicitly disclose the step of “advancing the proximal end of the implant subassembly into a distal end of the elongate tubular member”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection has been made in view of Gordon (US2005/0096666) in view of Bennett (US2015/0073524) and Bolduc (US2007/0073389).
Applicant further argues, the packages of Bolduc are consistently directed to endovascular graft assembly that are preloaded into the delivery component, and not separately packaged as recited in the instant claims. Examiner disagrees, where Bolduc teaches an endovascular system where various tools and devices comprising the system can be consolidated for use in a multiple piece functional kit 40 ([0052]). Where the kit 40 comprises an assemblage of individual packages comprising a sterile, wrapped, peel-pen assembly ([0053]). Bolduc therefore teaches packaging different components in separate individual packages and it would have been obvious to one having ordinary skill in the art with the teachings of Bolduc to arrive at the claimed invention.
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: “first coupling member” in claim 4. The claim limitation is interpreted as a “lock wire” stated in paragraph [0063] of the specification and equivalents thereof.
Such claim limitation(s) is/are: “second coupling member” in claim 6. The claim limitation is interpreted as a “loop” stated in paragraph [0063] of the specification and equivalents thereof.
Such claim limitation(s) is/are: “an implant coupling member” in claim 8. The claim limitation is interpreted as a “loop” or “arrowhead” stated in paragraph [0062] of the specification and equivalents thereof.
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.
Claim 8, 19, and 27 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 8 recites “a handle actuator”. Claim 1 from which claim 8 depends previously recited “a handle actuator”. It is unclear if the actuator from claim 1 is the same as the actuator from claim 8 or a separate actuator.
Claim 19 recites “the locking element”. There is insufficient antecedent basis for this limitation in the claim. For examination purposes “the locking element” is interpreted as the “lock”.
Claim 27 is rejected by dependency from claim 8.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11596771 in view of Bolduc (US2007/0073389).
Patent ‘771 discloses all limitations of claim 1, except for removing an implant subassembly from a first packaging and removing a handle assembly from a second packaging. Bolduc teaches an endovascular system where various tools and devices comprising the system can be consolidated for use in a multiple piece functional kit 40 ([0052]). Where the kit 40 comprises an assemblage of individual packages comprising a sterile, wrapped, peel-pen assembly ([0053]). It would have been obvious to one having ordinary skill in the art at the effective filing date of the application to have the implant subassembly and the handle subassembly, in a first and second package, respectively, and removing the assemblies from the packaging as taught by Bolduc in order to supply the components in a sterile condition to the user for the procedure ([0059] of Bolduc).
Instant Application
Patent US11596771
1. A method of assembling an implant subassembly and a handle subassembly, the method comprising:
(a) removing an implant subassembly from a first packaging, the implant subassembly comprising a proximal end and an implant in a collapsed state within a cartridge;
(b) removing a handle subassembly from a second packaging, the handle subassembly including a lock, a handle and an elongate handle tubular member in operable communication with a handle actuator, wherein actuation of the handle actuator causes axial movement of the elongate handle tubular member;
(c) advancing the proximal end of the implant subassembly into a distal end of the elongate handle tubular member, through the elongate handle tubular member and into the handle of the handle subassembly until the implant subassembly engages with an implant subassembly stopper in the handle thereby stopping the proximal end of the implant subassembly (see claim 2); and
(d) locking the proximal end of the implant subassembly in place within the handle relative to the handle subassembly with the lock engaging with the proximal end of the implant subassembly.
1. An implant and delivery system adapted to be coupled during a medical procedure that delivers the implant, comprising:
an implant subassembly including:
a cartridge and an implant disposed in a collapsed state within the cartridge, the implant having an implant proximal end,
an implant elongate flexible tubular member with a distal end adjacent the implant proximal end, and
an implant coupling mechanism including first and second coupling members that extend through the implant flexible tubular member, the first and second coupling members coupled to the implant proximal end in a first state and positioned and configured to release the implant proximal end when in a second state; and
a handle subassembly including:
a handle comprising an outer housing and a handle actuator,
a handle elongate tubular member in operable communication with the handle actuator, wherein actuation of the handle actuator causes axial movement of the elongate tubular member,
the handle elongate tubular member having a lumen sized to receive therein the proximal end of the implant subassembly, the implant flexible tubular member, and the first and second coupling members, and
the handle further comprising an implant subassembly locking mechanism (lock) that is positioned and adapted to lock a proximal end of the implant subassembly within the handle after the implant subassembly is moved proximally through the handle elongate tubular member and into the handle during a medical procedure to implant the implant.
2. The system of claim 1, wherein the handle assembly includes an implant subassembly stopper at least partially disposed within the handle, the implant subassembly stopper positioned within the handle to stop the proximal end of the implant subassembly from further proximal movement within the handle.
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 of this title, 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, 3-9, 16, 18-27 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon (US2005/0096666) in view of Bennett (US2015/0073524) and Bolduc (US2007/0073389).
Regarding claim 1, Gordon discloses a method of assembling an implant subassembly and a handle subassembly, the method comprising:
(a) the implant subassembly (202/208/216/218) comprising a proximal end (proximal ends of tether 216 and hitch wire 218) and an implant (202) in a collapsed state within a cartridge (208, [0057]);
(b) a handle (200) and an elongate handle tubular member (220) in operable communication with a handle actuator (sleeve 220 is supported by a slider on the handle housing and body of handle, [0059]), wherein actuation of the handle actuator causes axial movement of the elongate handle tubular member (actuator knobs 222 of slider actuate the sleeve 220, [0059], Figs. 14-16);
(c) the proximal end of the implant subassembly extending into a distal end of the elongate handle tubular member (the tether 216 and hitch wire 218 are passed through a distal end of the sleeve 220 by extending through lumen of pusher 210 which is within locking sleeve 220, see Fig. 15-17), through the elongate handle tubular member and into the handle of the handle subassembly (the proximal ends of the tether 216 and hitch wire 218 extend into and are attached to the handle, [0058], see Fig. 17 and 18; therefore these steps occur at some point during assembly of the device).
Gordon does not disclose the handle assembly including a first lock and a second lock, the advancing the proximal end of the implant subassembly into a distal end of the elongate tubular member, the implant subassembly engages with an implant subassembly stopper in the handle thereby stopping the proximal end of the implant subassembly; and (d) locking the proximal end of the implant subassembly in place within the handle relative to the handle subassembly with the first lock engaging with the proximal end of the implant subassembly.
Gordon discloses the tether and hitch wire are joined to the handle during manufacture by the crimp tubes 238, 246 engaging the discs 236, 244; respectively ([0061]-[0063]). Bennett teaches an implant delivery tool (catheter 19 and pull wire 16, the implant loaded into catheter). The proximal end of the pull wire 16 is loaded through funnel 12 formed in the distal end of handle 20 and into the handle (see Fig. 1-2B). The proximal end of catheter body 18 is received in funnel 12 but blocked into the handle by channel 15, which is sized to pass the pull wire but not the catheter (this funnel is interpreted as the claimed stopper, see Figs. 2A-2B). A grabber 24 comprising rocker arm 22 pivoted at 29 and biased by spring 23 so that the grabber elements close on pull wire 16 and locks the proximal end of the pull wire within the handle (see Figs. 2A-2B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the lock and stopper of Bennet for the first and second attachments of the tether and hitch wire of Gordon the since the substitution would have yielded the same predictable result of providing a feature for engaging the implant subassembly with the handle subassembly, while also providing the added benefit of allowing the implant subassembly to be replaced and the handle assembly reused ([0028] of Bennett). Where one having ordinary skill in the art would understand that the crimp tubes would act as the stop (funnel) in Bennett, with the tether and hitch wire extending distally and being clamped by respective grabber elements.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to advance the proximal end of the implant assembly into a distal end of the elongate tubular member, and have the implant subassembly engage with an implant subassembly stopper in the handle and then capture the proximal end with a spring biased lock inside the handle as taught by Bennett, to provide a reusable handle used with separately handled catheter assemblies that can be inserted into the handle and removed from the handle ([0028] of Bennett).
Gordon does not disclose removing an implant subassembly from a first packaging, and removing the handle subassembly from a second packaging. Wu teaches the implant subassembly separate from the handle subassembly ([0069]). Bolduc teaches an endovascular system where various tools and devices comprising the system can be consolidated for use in a multiple piece functional kit 40 ([0052]). Where the kit 40 comprises an assemblage of individual packages comprising a sterile, wrapped, peel-pen assembly ([0053]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the application to have the implant subassembly and the handle subassembly, in a first and second package, respectively, and removing the assemblies from the packaging as taught by Bolduc in order to supply the components in a sterile condition to the user for the procedure ([0059] of Bolduc).
Regarding claim 3, Gordon/Bennett/Bolduc makes obvious the method of Claim 1, Bennett further teaches wherein the step (d) comprises moving the lock into a locked position relative to the proximal end of the implant subassembly (wedge 26 is withdrawn, spring 23 pivots rocker arm 22 so the grabber element 25 moves from the open position toward grabber element 27 and grasps the proximal end of the pull wire 16, [0030]-[0031], see Figs. 2B, 3B).
Regarding claim 4, Gordon/Bennett/Bolduc makes obvious the method of Claim 3, wherein moving the lock into a locked position relative to proximal end of the implant subassembly comprises moving the lock into engagement with a detachable component of the implant subassembly (detachable component is interpreted as the crimp tube 246 attached to the proximal end of the hitch wire 218, [0063]), the detachable component secured to a first coupling member of the implant subassembly (first coupling member is interpreted as where the hitch wire 218 is coupled to the crimp tube 246, where the part of the hitch wire 218 is an equivalent structure to the “first coupling member” interpreted under 35 U.S.C. 112(f) as being a wire that gets locked by being held, [0063]), the first coupling member part of a coupling mechanism that is coupled to the implant in a first state, the first coupling member moveable relative to the implant to release the implant.
Regarding claim 5, Gordon/Bennett/Bolduc makes obvious makes obvious the method of Claim 4, the modified invention further teaches wherein step (d) comprises moving a second lock (second lock is interpreted as the substituted lock of Bennett for the disc 236 attachment of the tether 216) into engagement with the proximal end of the implant subassembly (the lock of Bennett would engage with the proximal end/tether 16 in the manner claimed).
Regarding claim 6, Gordon/Bennett/Bolduc makes obvious the method of Claim 5, the modified invention further teaches wherein moving the second lock comprises moving the second lock into engagement with a static component of the implant subassembly (static component is interpreted as the crimp tube 238 on tether 216, [0062] of Gordon; where the crimp tube 238 would engage the funnel of the lock as taught by Bennett, [0030]), the static component coupled to a second coupling member of the coupling mechanism (where the part of the tether 216 is an equivalent structure to the “second coupling member” interpreted under 35 U.S.C. 112(f) by having a looped end, [0061] of Gordon), the second lock and the second coupling member not movable axially after being locked in place relative to the handle (the substituted lock of Bennett would prevent axial movement by the grabber elements locking to the wire, [0031]).
Regarding claim 7, Gordon/Bennett/Bolduc makes obvious makes obvious the method of Claim 3, Bennett further teaches wherein locking the proximal end of the implant subassembly comprises actuating a handle lock actuator (thumb grip 34 is interpreted as the handle lock actuator, by slight retraction of the thumb grip 34 the slider 28 and wedge 26 moves out from beneath rocker arm 22 allowing grabber to grasp proximal end of wire 16, [0026], [0031]).
Regarding claim 8, Gordon/Bennett/Bolduc makes obvious the method of Claim 1, Gordon further discloses further comprising delivering the implant to a target location ([0062]), and releasing the implant, the releasing step comprising actuating a handle actuator (release knob 240) to move a detachable component (crimp tube 246) of the proximal end of the implant subassembly, the proximal end of the implant subassembly secured to an implant coupling member (looped end of tether 216, [0061], [0063]; where the structure is an equivalent structure to the “implant coupling member” interpreted under 35 U.S.C. 112(f) by having a looped end).
Regarding claim 9, Gordon/Bennett/Bolduc makes obvious the method of Claim 1, Gordon further discloses wherein the advancing step further comprises advancing an elongate implant tubular member (pusher 210) through the elongate handle tubular member ([0061]), the elongate implant tubular member having a distal end that is adjacent an implant proximal end (see Fig. 15).
Regarding claim 16, Gordon/Bennett/Bolduc makes obvious the method of Claim 7, Bennett further teaches wherein actuating the handle lock actuator comprises moving the lock radially inward toward the proximal end of the implant subassembly (actuating thumb grip 24 pivots rocker arm 22 so that grabber 25 moves toward grabber 27 to lock onto pull wire and therefore is directly radially inward, [0030]-[0031]).
Regarding claim 18, Gordon/Bennett/Bolduc makes obvious the method of Claim 1, the modified invention discloses wherein the implant subassembly comprises one or more depressions on the outer surface (the depression is interpreted as the stepped portion between the crimp tube 246 and hitch wire 218, see Fig. 18 of Gordon) that engages with the lock (engages with the lock by the stepped portion being against the grabber elements 25, 27).
Regarding claim 19, Gordon/Bennett/Bolduc makes obvious makes obvious the method of Claim 1, the modified invention discloses wherein the lock interfaces with a threaded member (release knob 240 is threaded onto handle housing 226 of Gordon) that is in threaded engagement with the handle actuator ([0079] of Gordon), wherein the actuation of handle actuator causes axial movement of the threaded member and the lock, thereby moving the implant subassembly (the entirety of the substituted lock, along with the hitch wire 218 is moved by the actuation of the handle actuator interpreted as the body of the handle being moved/rotated).
Regarding claim 20, Gordon/Bennett/Bolduc makes obvious the method of Claim 6, Gordon further discloses wherein the second lock does not engage with a threaded member that is in threaded engagement with the handle actuator, wherein the actuation of the handle actuator does not move the second lock (the hitch wire 218 extends through the release knob 240 and is moved by it; the tether 216 with crimp tube 238 is held at disc 236- substituted for the lock and remains fixed when knob 240 is rotated, [0079]).
Regarding claim 21, Gordon/Bennett/Bolduc makes obvious the method of Claim 1, Gordon further discloses wherein the implant subassembly comprises an implant flexible tube with a distal end adjacent the implant proximal end (pusher 210 is flexible, [0058]).
Regarding claim 22, Gordon/Bennett/Bolduc makes obvious the method of Claim 1, Bennett further teaches wherein the lock comprises a clip, a spring, or a fork (grabber elements 25 and 27 are clamped on the pull wire by spring 23 acting on rocker arm 22, [0030]).
Regarding claim 23, Gordon/Bennett/Bolduc makes obvious the method of Claim 5, Bennet further teaches wherein the second lock comprises a clip, a spring, or a fork (grabber elements 25 and 27 are clamped on the pull wire by spring 23 acting on rocker arm 22, [0030]).
Regarding claim 24, Gordon/Bennett/Bolduc makes obvious the method of Claim 22, wherein the lock comprises the spring (spring 23) and does not need a locking actuator to lock the proximal end of the implant subassembly (spring 23 closes the grabber as wedge 26 is withdrawn during initial travel of the thumb grip 34, [0031]).
Regarding claim 25, Gordon/Bennett/Bolduc makes obvious the method of Claim 4, the modified invention discloses wherein the first coupling member comprises a lock wire (where the hitch wire 218 is coupled to the crimp tube 246, [0063] of Gordon; interpreted as being a lock wire by being a wire engaging with the substituted locking element of Bennett).
Regarding claim 26, Gordon/Bennett/Bolduc makes obvious the method of Claim 6, Gordon further discloses wherein the second coupling member comprises a loop (tether 216 has a looped end, [0061]).
Regarding claim 27, Gordon/Bennett/Bolduc makes obvious the method of Claim 8, Gordon further discloses wherein the implant coupling member comprises a loop or an arrowhead (tether 216 has a looped end, [0061]).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Gordon (US2005/0096666) in view of Bennett (US2015/0073524) and Bolduc (US2007/0073389) as applied to claim 7, and further in view of Drake (US2021/0046281).
Regarding claim 17, Gordon/Bennett/Bolduc makes obvious the method of Claim 7; yet, does not explicitly disclose wherein actuating the handle lock actuator comprises depressing a handle button. Drake teaches a delivery catheter 14 through which an elongated inner tool 40 is received ([0035], see Fig. 1) and a clamping assembly in the handle that locks the received member against axial movement relative to the handle ([0030]). Where a user can depress the button 26 to actuate the lock ([0041]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted a button actuation for Bennetts thumb grip actuation of the modified invention since the substitution of one known locking actuator for another would yielded predictable results.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
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