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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 11th 2025 has been entered.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 18-22, 24-29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Opolski (US 2004/0176797).
Regarding claims 18 and 26, Opolski discloses a delivery tool (Figures 5C-5D) capable of deploying a fiducial (¶[0035]) within a patient, the delivery tool comprising: a catheter including a housing (511; in view of ¶[0026] of Applicant’s specification, the catheter being a housing is readable by this limitation) defining a longitudinally-extending passageway (8) having a proximal portion and a distal portion, the distal portion of the longitudinally-extending passageway configured to removably receive a fiducial (a fiducial of similar size and structure to implant 550 could be designed for use with the tool as claimed);
Opolski fails to disclose for the Figures 5C-5D embodiment a pusher rod movable through a restraining member and magnet as claimed.
Opolski discloses for a different embodiment (Figures 4B-5B) a permanent magnet (on/in 420; ¶[0036], [0053], [0055]; Figure 4B) axially restrained by an axial restraining member 411 (axial restraint of member 411, and therefore the magnet, would be required to push the implant off the magnet using member 501 - ¶[0056] [0057]; also see ¶[0039]); and a pusher rod (501) axially movable through the permanent magnet and the axial restraining member and configured to exert a threshold, distally-oriented force on the implant to overcome the magnetic attraction between the permanent magnet and the implant, thereby deploying the implant from the delivery tool (¶[0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the axial restraining member (411), magnet (420) and pusher rod (501) of Figures 4B-5B in place of the sleeve (505) and pusher rod (540) of Figures 5C-5D as a simple substitution of one known implant release mechanism for another in order to obtain predictable results (MPEP 2143 (I)(B)). With this modification to Figures 5C-5D, a magnetic attraction between the permanent magnet and the implant would maintain the implant within the distal portion of the longitudinally-extending passageway during insertion of the delivery tool into a patient (Applicant’s proximal portion is located at a distal half of the passageway as evident from Figure 1, therefore the distal and proximal portions of Opolski’s passageway can be arbitrarily designated - the portion in which the magnet resides can be considered as the proximal portion and the portion in which the implant resides can be considered as the distal portion) and the pusher rod of Figures 5A-5B would be movable through the delivery tool housing (511).
Regarding claim 19, the magnet is a permanent magnet (¶[0036]).
Regarding claim 20, as evident from Figure 1A, the delivery tool is capable of being grasped or otherwise held by some form of a robot arm of a robotic surgical system for manipulation of the delivery tool by the robot arm.
Regarding claim 21, the tool is capable of deploying a fiducial including a chemical configured to be released from the fiducial for localizing a target within the patient (a fiducial is not structurally required by the claims).
Regarding claim 22, the tool is capable of deploying a fiducial including indocyanine green configured to be released from the fiducial for localizing a target within the patient (a fiducial is not structurally required by the claims).
Regarding claim 24, the delivery tool is capable of deploying the fiducial within a lung of the patient (as evidenced by ¶[0068]).
Regarding claim 25, the pusher rod is configured to be moved through the delivery tool by a robot arm of a robotic surgical system (as evident from Figure 1A, the handle 110 of the rod could be manipulated by some form of robotic arm to deploy the fiducial as claimed).
Regarding claim 27, as evident from Figure 1A, the delivery tool is capable of being grasped or otherwise held by some form of a robot arm of a robotic surgical system for manipulation of the delivery tool by the robot arm.
Regarding claim 28, the tool is capable of deploying a fiducial including a chemical configured to be released from the fiducial for localizing a target within the patient (a fiducial is not structurally required by the claims).
Regarding claim 29, the tool is capable of deploying a fiducial including indocyanine green configured to be released from the fiducial for localizing a target within the patient (a fiducial is not structurally required by the claims).
Regarding claim 31, the delivery tool is capable of deploying the fiducial within a lung of the patient (as evidenced by ¶[0068]).
Claims 23 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Opolski (US 2004/0176797) in view of Stigall et al. (US 2014/0228943).
Regarding claims 23 and 30, Opolski fails to disclose the outer diameter of the housing as claimed. However, Opolski disclose that the tool is intended to deliver a variety of implants including stents, valves and filters (¶[0035]).
Stigall et al. teach that a catheter for delivery for stents, valves and filters (Abstract; ¶[0013]) should have an outer diameter of 3-9 French (1-3mm; ¶[0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Stigall et al. to have made the housing with a diameter of about 1-2 mm since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. Both Opolski and Stigall et al. being in Applicant’s field of detachably delivering small implantable devices within the vasculature.
Allowable Subject Matter
Claims 12-17 are allowed.
Response to Arguments
Applicant’s arguments with respect to claims 18 and 26 are not persuasive. Applicant has argued that Opolski does not disclose an axial restraining member as claimed. The sleeve (411), when placed within the catheter (511), would restrain the magnet (420) from axial movement. The pusher rod (501) would be moveable through these structures to release a fiducial from the magnet.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thomas McEvoy whose telephone number is (571) 270-5034 and direct fax number is (571) 270-6034. The examiner can normally be reached on Monday-Friday, 9:00 am – 6:00 pm.
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771