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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed application, Application No. 16/817,573, and prior-filed application, Application No. 15/159,801 each fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 2-20 include subject matter not supported in parent applications ‘573 and ‘801. In view of the specification, advancement of an implantable device through the catheter is understood to refer to movement of the implantable device toward the distal end of the catheter (i.e., delivery of the implantable device, not retrieval of the device). The only disclosure of contracting/expanding the radially adjustable structures during advancement of an implant through the catheter is in figs. 21A-C and their accompanying description (par. [00127] of instant application, noting figs. 21A-C also appear in parent applications ‘573 and ‘801). Note that figures 18a-18H and 19A-19J, which appear in each of the parent applications, show only retraction of an implantable device into a catheter. Claims 20a-20f show that waves of expansion and contraction (as well as a bulge) can be propagated along the length of the catheter by selective expansion and contraction of multiple radially adjustable structures, and that “such action can be thought of as gulping and/or swallowing of objects through the lumen 1815 to be removed by the catheter 1802” and that this selective expansion “need not be used for the purpose of capturing an object” ([00126] of instant application, and also appearing in both parent applications). However, there is no disclosure in parent applications ‘573 and ‘801 for the following method steps in claims 2-20: radially expanding each one of the radially adjustable structures that is immediately downstream of the implantable device as the implantable device is advanced through the catheter (claim 2); radially contracting the catheter by radially contracting the one or more radially adjustable structures via actuating the one or more motors after the implantable device is downstream of the one or more radially adjustable structures (claim 3); during the advancing of the implantable device through the opening, a distalmost one of the plurality of radially adjustable structures disposed at the distal end portion of the catheter is in the radially expanded state and one or more ones of the radially adjustable structures proximal to the distalmost one are in the radially contracted state, thereby forming a funnel configuration at the distal end portion of the catheter (claim 5, noting claims 6-12 depend from 5); after advancing the implantable device outwardly through the opening at the distal end portion, radially contracting the distalmost one of the radially adjustable structures to form a reduced profile configuration of the catheter which has a reduced profile relative to the funnel configuration (claim 6, noting claim 7 depends from claim 6); advancing an implantable device through the catheter while selectively actuating the motors to radially expand the radially adjustable structures to locally expand the catheter, thereby forming a bulging portion of the catheter that propagates along a length of the catheter such that the implantable device is contained within the bulging portion as the implantable device is advanced through the catheter (claims 13-16); advancing the implantable device through the catheter while radially expanding and contracting the plurality of radially adjustable structures in a wave pattern along the length of the catheter by selectively actuating the motors (claims 17-20; noting “advancing” is understood to refer to movement in the distal direction, i.e., delivery of the implant).
The continuation data of this application must be corrected to reflect that the instant case is a Continuation-in-Part (“CIP” of ‘573), as it adds disclosure not presented in the prior applications.
Note that claims 2-20 are considered fully supported under 35 USC 112a in the instant application as they are original claims in the instant application, filed on the same day as the application, and thus fully supported by the instant application as originally filed on 7/18/2024. Thus, the effective filing date of claims 2-20 is 7/18/2024.
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: antecedent basis for the steps presented in claims 2-20 should be added to the specification, as the only disclosure of these steps appears to be the claims themselves.
Claim Objections
Claims 5 and 6 are objected to because of the following informalities: for consistency with the claims from which they depend, “the radially adjustable structures” in line 7 of claim 5 and line 3 of claim 6 should read “the plurality of radially adjustable structures”. Appropriate correction is required.
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 2, 4, and 17-20 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 2 recites “the radially adjustable structures” in line 3. It is unclear if the claim is now requiring that there is a plurality of radially adjustable structures, or if “the radially adjustable structures” is meant to refer to the previously recited “one or more radially adjustable structures”. For purposes of claim interpretation, “the radially adjustable structures” in line 3 is being treated as though it reads “the one or more radially adjustable structures”.
Claim 4 recites “the radially adjustable structures” in line 2 and bridging lines 2-3. It is unclear if the claim is now requiring that there is a plurality of radially adjustable structures, or if “the radially adjustable structures” is meant to refer to the previously recited “one or more radially adjustable structures”. For purposes of claim interpretation, “the radially adjustable structures” in line 2 and bridging lines 2-3 is being treated as though it reads “the one or more radially adjustable structures”.
Claim 17 recites “the implantable device” in line 7, which lacks antecedent basis. For purposes of claim interpretation, “the implantable device” is being treated as though it reads “an implantable device”. Claims 18-20 are indefinite by virtue of their dependence from claim 17.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 is/are rejected under 35 U.S.C. 102a1 as being anticipated by (Volk et al. (US 2007/0249909). Volk discloses a method comprising inserting a catheter (40; figs. 11a-12) into a vessel of a patient ([0010]), wherein the catheter comprises one or more radially adjustable structures (catheter itself is radially adjustable near distal end; figs. 11a, 11b) and one or more motors (232 – EAP material considered a motor as it converts electrical energy into movement; note that 232 can be a single spiral or multiple circumferential rings as shown in fig. 12) wherein the one or more motors are configured to transition the one or more radially adjustable structure between a radially contracted state (fig. 11a) and a radially expanded state (fig. 11b), and advancing an implantable device (stent 35) through the catheter while radially expanding the catheter by radially expanding the one or more radially adjustable structures (98) via actuating the one or more motors (19) ([0012], [0102], and claim 23 of Volk; proximal retraction of the catheter while the catheter is expanded results in advancing of the implantable member through the distal opening of the catheter).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Volk. The one or more motors (232) of Volk are configured to transition the one or more radially adjustable structures (tube forming catheter 40) from the radially expanded state to the radially contracted state when the flow of ions into/out of the electroactive polymers forming the motors is reversed as understood by one of ordinary skill in the art. Volk does not expressly disclose radially contracting the catheter by radially contracting the one or more radially adjustable structures via actuating the one or more motors after the implantable device is downstream of the one or more radially adjustable structures.
However, Volk discloses that it is known to contract radially expandable delivery devices (balloon of balloon catheter; [0003]) prior to withdrawal of the delivery device from the body. Thus, it would have been obvious to one of ordinary skill in the art to have modified the method of Volk to include the step of radially contracting the catheter by radially contracting the one or more radially adjustable structures via actuating the one or more motors after the implantable device is downstream of the one or more radially adjustable structures (i.e., after implant has exited distal end of catheter) in order to facilitate atraumatic removal of the catheter from the patient by returning the catheter into its low profile configuration prior to its withdrawal.
Allowable Subject Matter
Claim 2 and 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 5-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 17-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 13-16 are allowed.
With respect to claims 2 and 4-12, the closest prior art of Volk fails to disclose or fairly suggest, in combination with the limitations of claim 1, the additional limitations recited in claims 2-12, noting with respect to claim 2 that none of the radially adjustable structures of Volk are downstream of the implantable device. The prior art of Seward et al. (US 6,872,433) discloses a catheter (20) having a plurality of adjustable structures (tube portions 21-24) and a plurality of motors (coil 25 in each tube portion, which converts light energy into movement and thus is considered a motor), and further discloses independently actuating the motors and adjustable structures to form an expanded area (see figs. 4-6; in fig. 6, central portion forms a bulge) and a contracted area along the length of the catheter in order to “grab and manipulate structures within the tube”. However, Seward fails to expressly disclose, or fairly suggest, any of the steps required in claims 2-12.
With respect to claims 13-16, the closest prior art of Volk and Seward fail to disclose or fairly suggest, in combination with the remaining limitations of claim 13, the step of advancing an implantable device through the catheter while selectively actuating the motors to radially expand the radially adjustable structures to locally expand the catheter, thereby forming a bulging portion of the catheter that propagates along a length of the catheter such that the implantable device is contained within the bulging portion as the implantable device is advanced through the catheter.
With respect to claims 17-20, the closest prior art of Volk and Seward fail to disclose or fairly suggest, in combination with the remaining limitations of claim 17, the step of advancing the implantable device through the catheter while radially expanding and contracting the plurality of radially adjustable structures in a wave pattern along the length of the catheter by selectively actuating the motors. Though the prior art of Forsell (US 2009/0240100) suggests a wave of expansion/contraction of radially adjustable structures (CSDE1-CSDE3; figs. 1F-1H) in the lengthwise direction to control flow of the contents of a tube (in particular, a patient’s intestine) (see figs. 1D-1E, or alternatively 1F-1H), there is no suggestion or motivation to provide such motion to a catheter having a plurality of radially adjustable structures for advancing an implantable device through the catheter.
Conclusion
The prior art made of record and not relied upon in any rejection is considered pertinent to applicant's disclosure:
US 2005/0102017 to Mattison discloses inserting a catheter (98) into a vessel of a patient ([0010]), wherein the catheter comprises one or more radially adjustable structures (catheter 98 comprises a radially adjustable tube) and one or more motors (19, considered a motor as it turns electrical power into movement; fig. 4; [0049]), wherein the one or more motors are configured to transition the one or more radially adjustable structure between a radially contracted state and a radially expanded state (as understood in view of par. [0052], the strips may effect both radial and axial forces) and advancing an implantable device through the catheter ([0047]).
US 11,648,115 to Passman discloses an introducer catheter that can locally expand and lengthen to form a bulge (see area between shoulders 48 in fig. 3B) that accommodates an implantable device (12) as the device is advanced through the catheter.
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KSH 11/25/2025
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771