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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 21, 2023; July 11, 2023; September 6, 2024; January 3, 2025; August 7, 2025; January 5, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 4-10 and 15-18 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 4 depends from claim 1 and recites “a longitudinal axis of the adaptor body” in line 2. Claim 4 is unclear as to whether this longitudinal axis refers to the “longitudinal axis of the adaptor body” recited in 7 of claim 1 or is provided in addition thereto, thus rendering the claim indefinite. For examination purposes, claim 4 is interpreted as referring to the same longitudinal axis of the adaptor body recited in claim 1.
Claims 5-10 are rejected as being dependent upon rejected claim 4 and failing to remedy the indefiniteness issue.
Claim 15 depends from claim 11 and recites “a longitudinal axis of the adaptor body” in line 2. Claim 15 is unclear as to whether this longitudinal axis refers to the “longitudinal axis of the adaptor body” recited in 8 of claim 11 or is provided in addition thereto, thus rendering the claim indefinite. For examination purposes, claim 15 is interpreted as referring to the same longitudinal axis of the adaptor body recited in claim 11.
Claims 16-18 are rejected as being dependent upon rejected claim 15 and failing to remedy the indefiniteness issue.
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.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McArthur et al. (U.S. Patent Application Publication No. 20180326197; hereinafter “McArthur”).
Regarding claim 1, McArthur discloses an adaptor (110) engaging a torquer (158) comprising:
the adaptor including an adaptor body (140) having a pathway therethrough includes a receptacle portion (annotated Fig. 4A below; para. [0040])) defining a cavity having an opening at a first end of the adaptor body (Figs. 4A-4B) receiving the torquer (150) within the cavity through the opening (Figs. 4A-4B; para. [0040]); and
the receptacle portion including an engagement member (143; Fig. 5; para. [0049]) securing the torquer to the adaptor body; the torquer being movable with the adaptor body along and about a longitudinal axis of the adaptor body (para. [0034]).
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Regarding claim 2, McArthur discloses the torquer including a torquer body (158) and a nut (152) rotatable relative to the torquer body, the nut being snap fit into the cavity of the receptacle portion (para. [0040]).
Regarding claim 3, McArthur discloses wherein the engagement member includes at least one tab having a portion that snap fit over the nut (annotated Fig. 5 below).
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Regarding claim 4, McArthur discloses wherein the adaptor body includes a grip portion (annotated Fig. 4B below) extending along a longitudinal axis of the adaptor body in a direction away from the receptacle portion and the opening of the cavity.
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Regarding claim 5, McArthur discloses the torquer including a torquer body (158), wherein the adaptor body (140) and a nut (152) is rotatable relative to the torquer body to releasably pinch an elongated medical device extending through the torquer and the pathway by rotating the grip portion relative to the torquer body (such as when the snap-fit mating interface maintains relative rotational position between compression nut (140) and torque nut (152); para. [0035]).
Regarding claim 6, McArthur discloses wherein the adaptor body includes a driven member intermediate the opening of the cavity and the grip portion (annotated Fig. 4B below).
Regarding claim 7, McArthur discloses wherein the driven member is a gear (annotated Fig. 4B above; gripping elements (144; Fig. 2) define teeth along the external surface of the tubular compression nut (140), thus the intermediate portion of the compression nut including the gripping elements constitutes a gear).
Regarding claim 8, McArthur discloses wherein the adaptor body includes an extension member portion (130) extending from the grip portion in a direction away from the opening of the cavity (annotated Fig. 4B above), the extension member portion having a free end (distal end of body (130); Fig. 4A; para. [0043]) defining a second end of the adaptor opposite the first end.
Regarding claim 9, McArthur discloses wherein an outer diameter of the grip portion is greater than an outer diameter of the extension member portion (annotated Fig. 4B above).
Regarding claim 10, McArthur discloses wherein the adaptor body includes an outer bearing portion (144) intermediate the first end and a second end of the adaptor body (Fig. 2).
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.
Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wenderow et al. (U.S. Patent No. 9095681; hereinafter “Wenderow”) in view of McArthur.
Regarding claim 11, Wenderow discloses a robotic drive system (300) for a catheter procedure (Figs. 15-16) comprising:
a device module (326; Figs. 23A-23B) including a drive member (520);
an adaptor (512) including an adaptor body having a pathway therethrough and a receptacle portion defining a cavity having an opening at a first end of the adaptor body (shaft (512) defines a lumen receiving a guidewire therethrough; Figs. 23A-23B; col. 24, ll. 35-37)
the adaptor body including a driven member (518) operatively connected to the drive member to rotate the adaptor body about a longitudinal axis of the adaptor (col. 24, ll. 43-46).
Wenderow discloses the invention substantially as claimed, except for the receptacle portion removably receiving a torquer within the cavity.
McArthur, a reference in the torquer field of endeavor, teaches configuring an adaptor body (140) to have a pathway therethrough including a receptacle portion (annotated Fig. 4A below; para. [0040])) defining a cavity having an opening at a first end of the adaptor body (Figs. 4A-4B) receiving a torquer (150) within the cavity through the opening (Figs. 4A-4B; para. [0040]); and the receptacle portion including an engagement member (143; Fig. 5; para. [0049]) securing the torquer to the adaptor body; the torquer being movable with the adaptor body along and about a longitudinal axis of the adaptor body (para. [0034]).
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McArthur teaches that such a configuration provides great rotational control over a guidewire extending through the adaptor body (para. [0028]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the adaptor of Wenderow such that the receptacle portion removably receives a torquer within the cavity; the receptacle portion including an engagement mechanism securing the torquer to the adaptor body; a portion of the torquer being movable with the adaptor body along and about a longitudinal axis of the adaptor body; and configure the driven member to rotate the adaptor body and torquer about a longitudinal axis of the adaptor, in view of McArthur, in order to provide greater rotational control over a guidewire during a procedure to facilitate navigation of the guidewire within a patient.
Regarding claim 12, the modified device discloses the torquer including a torquer body (158) and a nut (152) rotatable relative to the torquer body, the nut being snap fit into the cavity of receptacle portion (McArthur Fig. 4A, para. [0040]), wherein the portion of the torquer being movable with the adaptor body is the nut (McArthur paras. [0034]-[0035]).
Regarding claim 13, the modified device discloses wherein the receptacle portion includes at least one tab having a portion that snap fit over the nut (annotated McArthur Fig. 5 below).
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Regarding claim 14, the modified device discloses wherein the adaptor body (512) includes an outer bearing portion rotatably received to a device module bearing surface (494; Wenderow col. 24, ll. 23-28).
Regarding claim 15, the modified device discloses wherein the adaptor body (512) includes a grip portion (portion of shaft (512) rigidly coupled to bevel gear (518); Wenderow col. 24, ll. 39-41) extending along a longitudinal axis of the adaptor body in a direction away from the receptacle portion and the opening of the cavity (Wenderow Fig. 23A).
Regarding claim 16, the modified device discloses wherein the adaptor body (140) is rotatable relative to a nut (152) to releasably pinch an elongated medical device extending through the torquer and the pathway by rotating the grip portion relative to the adaptor body (para. [0035]).
Regarding claim 17, the modified device disclose wherein the adaptor body (512) includes an extension member portion (portion of shaft (512) received within collar (494); Wenderow Fig. 23A; col. 24, ll. 24-28) extending from the grip portion in a direction away from the opening of the cavity, the extension member portion having a free end defining a second end of the adaptor opposite the first end of the adaptor (Wenderow Figs. 17 and 23A, the free end of the extension member portion being closely adjacent to a flexible track (defined along rollers (418, 430); Wenderow Figs. 19-22; col. 23, ln. 15 – col. 24, ln. 37).
Regarding claim 18, the modified device discloses wherein an outer diameter of the grip portion is greater than an outer diameter of the extension member portion (Wenderow Fig. 23A).
Regarding claim 19, Wenderow discloses a method for a robotic drive system (300) for a catheter procedure (Figs. 15-16) comprising:
providing a device module (326; Figs. 23A-23B) including a drive member (520);
providing an adaptor (512) including an adaptor body having a pathway extending therethrough and a receptacle portion defining a cavity having an opening at a first end of the adaptor body (shaft (512) defines a lumen receiving a guidewire therethrough; Figs. 23A-23B; col. 24, ll. 35-37);
securing an elongated medical device (301) extending through the pathway (Figs. 23A-23B); and
placing the elongated medical device and adaptor within the device module (Fig. 23A).
The method of Wenderow is not explicitly disclosed with securing a torquer to a robotic drive system.
McArthur, a reference in the torquer field of endeavor, teaches attaching a torquer (150) to an adaptor (140) by inserting a nut (152) of the torquer into the cavity of the adaptor through the opening at the first end of the adaptor body, while a portion of the torquer is located outside of the adaptor (Fig. 4A), wherein the nut is fixed to and movable with the adaptor body along and about a longitudinal axis of the adaptor body (para. [0034]); and securing an elongated medical device (102) within the torquer and extending through the pathway (Fig. 4A).
McArthur teaches that attaching the torquer and adaptor in this manner provides great rotational control over a guidewire extending through the adaptor (para. [0028]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wenderow for securing a torquer to a robotic drive system for a catheter procedure comprising:
attaching a torquer to the adaptor by inserting a nut of the torquer into the cavity of the adaptor through the opening at the first end of the adaptor body, while a portion of the torquer is located outside of the adaptor, wherein the nut is fixed to and movable with the adaptor body along and about a longitudinal axis of the adaptor body;
securing an elongated medical device within the torquer and extending through the pathway; and
placing the elongated medical device, adaptor and torquer within the device module
in view of McArthur, in order to provide greater rotational control over a guidewire during a procedure to facilitate navigation of the guidewire within a patient.
Regarding claim 20, the modified method discloses wherein the adaptor (512) includes a driven member (518; Wenderow Figs. 23A-23B); and further including robotically controlling a drive member (520; Wenderow col. 24, ll. 38-46; col. 10, ll. 47-56) in the device module to operatively rotate driven member, adaptor, torquer and elongated medical device together.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Blacker (U.S. Patent Application Publication No. 20140066900) disclosing a system including rotary control of a guide catheter (Figs. 1 and 14-22);
Opie et al. (U.S. Patent Application Publication No. 20040236214) disclosing a guide wire torque device (Figs. 1-3);
Stevens (U.S. Patent No. 6193735) disclosing a rotary control for a guide wire (Fig. 2);
Von Malmborg et al. (U.S. Patent Application Publication No. 20080294030) disclosing a torque device for a guide wire (Figs. 2-3); and
Sherts et al. (U.S. Patent No. 6533772) disclosing a guidewire torque device (Figs. 9a-9c).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771