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.
Response to Amendment
The Response filed June 10, 2026 has been entered. Claims 1-20 are pending in the application. The previous rejections of claims under 35 U.S.C. 112(b) (pre-AIA ), second paragraph are withdrawn in light of Applicant’s amendments to the claims. Response to applicant's arguments can be found at the end of this Office action.
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 19-20 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 19, recites “within the device module to engage the driven member” in lines 17-18. There is insufficient antecedent basis for the device module and riven member recitations, because such elements are not previously positively recited in the claim. The limitation “driven member configured to be driven by a drive member of a device module,” recited in line 7 of claim 19, does not positively recite the provision or presence of a drive member or drive module in the claimed method. For examination purposes, claim 19 is interpreted as including a step of providing a device module including a drive member.
Claim 20 is rejected as being dependent upon rejected claim 19 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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blacker (U.S. Patent No. 10307570).
Regarding claim 1, Blacker discloses an adaptor (180; Figs. 19-21) configured to engage a torquer (170), the adaptor comprising:
an adaptor body having a pathway therethrough (bore of outer piece (180) receiving inner piece (170) and connector (48); annotated Fig. 21 below) and comprising:
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a receptacle portion defining a cavity (receiving inner piece (170) and connector (48); annotated Fig. 21) having an opening (receiving connector (48)) at a first end of the adaptor body,
wherein the receptacle portion includes an engagement member (inner surface frictionally engaging inner piece (170); col. 9, ll. 44-46) configured to secure the torquer to the adaptor body while a portion of the torquer is configured to be fixed to an elongated medical device disposed in the pathway and the adaptor is not fixed to the elongated medical device (outer piece (180) is sized and shaped to secure inner portion (170) while the inner portion is capable to be fixed to guide catheter (122) and outer piece (180) is not fixed to the guide catheter); and
a driven member (160) configured to rotate the adaptor body and the torquer while a portion of the torquer is fixed to the elongated medical device and the adaptor is not fixed to the elongated medical device (col. 9, ll. 31-36).
Regarding claim 2, Examiner notes that the additional features of the torquer recited in claim 2 are interpreted as functional limitations because the torquer is merely functionally recited in the claims.
The adaptor, outer member (180) of Blacker, is sized and shaped to be capable of engaging a torquer having the same outer dimensions as inner member (170) and including a torquer body and a nut rotatable relative to the torquer body, the nut configured to snap fit into the cavity of the receptacle portion.
Regarding claim 3, Blacker discloses wherein the engagement member includes at least one tab (annotated Fig. 21 below) having a portion configured to snap fit over the nut (e.g., the indicated tab is capable of snap fitting over a nut having dimensions allowing fit into the bore of outer member (180)).
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Regarding claim 4, Blacker discloses wherein the adaptor body includes a grip portion extending along a longitudinal axis of the adaptor body in a direction away from the receptacle portion and the opening of the cavity (annotated Fig. 21 below).
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Regarding claim 5, Examiner notes that the additional features of the torquer recited in claim 5 are interpreted as functional limitations because the torquer is merely functionally recited in the claims.
The adaptor, outer member (180) of Blacker, is sized and shaped to be capable of engaging a torquer having the same outer dimensions as inner member (170) and including a torquer body, wherein the adaptor body and a nut are rotatable relative to the torquer body to releasably pinch the elongated medical device when the elongated medical device extends through the torquer and the pathway by rotating the grip portion relative to the torquer body.
Regarding claim 6, Blacker discloses wherein driven member (160) is disposed intermediate the opening of the cavity and the grip portion (annotated Fig. 21 above).
Regarding claim 7, Blacker discloses wherein the driven member is a gear (col. 9, ll. 31-36).
Regarding claim 8, Blacker discloses wherein the adaptor body includes an extension member portion 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 (annotated Fig. 21 above).
Regarding claim 9, Blacker discloses wherein an outer diameter of the grip portion is greater than an outer diameter of the extension member portion (annotated Fig. 21 above).
Regarding claim 10, Blacker discloses wherein the adaptor body includes an outer bearing portion intermediate the first end and a second end of the adaptor body (annotated Fig. 21 above).
Regarding claim 11, Blacker discloses a robotic drive system (Figs. 19-21) for a catheter procedure comprising:
a device module (32) including a drive member (58); and
an adaptor (180) comprising:
an adaptor body having a pathway (bore of outer piece (180) receiving inner piece (170) and connector (48); annotated Fig. 21 below) therethrough and comprising:
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a receptacle portion defining a cavity (receiving inner piece (170) and connector (48); annotated Fig. 21) having an opening (receiving connector (48)) at a first end of the adaptor body and configured to secure a torquer (170) within the cavity while a portion of the torquer is fixed to an elongated medical device disposed in the pathway and the adaptor is not fixed to the elongated medical device (outer piece (180) is sized and shaped to secure inner portion (170) while the inner portion is fixed to guide catheter (122) and outer piece (180) is not fixed to the guide catheter); and
a driven member (160) operatively connected to the drive member and configured to be driven by the drive member to rotate the adaptor body and the torquer about a longitudinal axis of the adaptor body while the portion of the torquer is fixed to the elongated medical device and the adaptor is not fixed to the elongated medical device (col. 9, ll. 31-36).
Regarding claim 12, Examiner notes that the additional features of the torquer recited in claim 12 are interpreted as functional limitations because the torquer is merely functionally recited in the claims.
The adaptor, outer member (180) of Blacker, is sized and shaped to be capable of engaging a torquer having the same outer dimensions as inner member (170) and including a torquer body and a nut rotatable relative to the torquer body, the nut configured to snap fit into the cavity of the receptacle portion.
Regarding claim 13, Blacker discloses wherein the engagement member includes at least one tab (annotated Fig. 21 below) having a portion configured to snap fit over the nut (e.g., the indicated tab is capable of snap fitting over a nut having dimensions allowing fit into the bore of outer member (180)).
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Regarding claim 14, Blacker discloses wherein the adaptor body includes an outer bearing portion (182) configured to be rotatably received by a device module bearing surface (Figs. 19-20; col. 9, ll. 20-22).
Regarding claim 15, Blacker discloses wherein the adaptor body includes a grip portion extending along the longitudinal axis of the adaptor body in a direction away from the receptacle portion and the opening of the cavity (annotated Fig. 21 below).
Regarding claim 16, Blacker discloses wherein the adaptor body is rotatable relative to a nut (170) to releasably pinch (e.g., between threads of inner piece (170)) the elongated medical device disposed in the pathway (Fig. 21).
Regarding claim 17, Blacker discloses wherein the adaptor body includes an extension member portion 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 (annotated Fig. 21 above), the free end of the extension member portion being adjacent to a flexible track (col. 9, ll. 27-31).
Regarding claim 18, Blacker discloses wherein an outer diameter of the grip portion is greater than an outer diameter of the extension member portion (annotated Fig. 21).
Regarding claim 19, Blacker discloses a method for incorporating a torquer into a robotic drive system for a catheter procedure (Figs. 19-21; col. 9, ll. 11-61), the method comprising:
providing an adaptor (180) including:
an adaptor body having a pathway extending therethrough (bore of outer piece (180) receiving inner piece (170) and connector (48); annotated Fig. 21 below);
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a receptacle portion defining a cavity (receiving inner piece (170) and connector (48); annotated Fig. 21) having an opening at a first end of the adaptor body;
a driven member (160) configured to be driven by a drive member (58) of a device module (32) to rotate the adaptor body and the torquer about a longitudinal axis of the adaptor body while the portion of the torquer is fixed to the elongated medical device and the adaptor is not fixed to the elongated medical device (col. 9, ll. 47-50);
attaching a torquer (170) to the adaptor by inserting a nut (172) of the torquer into the cavity of the adaptor through the opening at the first end of the adaptor body (Fig.20), while a portion of the torquer is located outside of the adaptor (Fig. 21), wherein the nut is fixed to and movable with the adaptor body along and about a longitudinal axis of the adaptor body (col. 9, ll. 47-50);
securing an elongated medical device (122) within the torquer and extending through the pathway while the elongated medical device is not secured to the adaptor (Fig. 21); and
placing the elongated medical device, the adaptor and the torquer within the device module to engage the driven member with the drive member while the elongated medical device is secured within the torquer and is not secured to the adaptor (Figs. 19-20; col. 9, ll. 13-19).
Regarding claim 20, Blacker discloses the method further including robotically controlling the drive member to simultaneously rotate the driven member, the adaptor, the torquer and the elongated medical device (col. 8, ll. 1-5).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN A HOLLM/Examiner, Art Unit 3771
