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 .
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Godara et al. (US Pat. Pub. 2007/0027449 A1), and further in view of Chandran et al. (US Pat. Pub. 2005/0159797 A1) and Coonahan et al. (US Pat. Pub. 2009/0227893 A1).
Regarding claim 1, Godara provides for a system for improving location accuracy of a radiofrequency ablation procedure performed on a target nerve of a patient, the system comprising:
a probe having an outer diameter, a proximal end, and a distal end (probe 100), the probe comprising an electrically insulated portion located at the proximal end (116) and an exposed conductive portion for delivering energy to a target nerve located at the distal end (118).
an introducer for facilitating insertion of the distal end of the probe into the patient adjacent the target nerve (604), the introducer having an inner diameter, a proximal end, and a distal end, wherein the exposed conductive portion of the probe is configured to extend past the distal end of the introducer during energy delivery to the target nerve (see [0081] providing for the device to extend through the cannula for treatment at the target nerve), wherein the inner diameter of the introducer defines a lumen (via the with 604),
a pharmacological agent for blocking nerve signal transmission along the target nerve (see [0066]), and
a fiducial marker configured for placement adjacent the target nerve (see the marker in [0051] or [0064]; these markers are part of the probe 100 and capable of placement near a target nerve).
While Godara provides for various arrangements of the fiducial marker on the probe (see the citation of the features disclosed in US Pat. App. No. 11/079318), Godara fails to specifically provide that the fiducial marker is disposed on an outer surface of the introducer. Chandran disclose the use of a similar marker on a probe inserted through a cannula, and further provides for the inclusion of a fiducial marker on an introducer (see the band 108 placed on the cannula 100). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have provided the fiducial marker on the outer surface of the introducer of probe 100 of Godara in view of the teaching in Chandran to provide for an additional measure of visualization when advancing the introducer in the body and near nerve tissue. Chandran, itself, is already cited and incorporated-by-reference by Godara, and one of ordinary skill would be reasonably motivated in view of the combined teaching to provide the redundant visualization to achieve enhanced safety in/around nerve tissue.
Chandran fails to provide that this arrangement on the outer surface of the introducer is configured to be deployed from the introducer. Coonahan provides for an alternative manner of providing a marker on an outer surface of a shaft of a device wherein the marker is configured to be delivered adjacent to target tissue (see figures 9A-C providing for the exteriorly placed marker 70 and its ability to be placed as in figure 9A3 and 9C) and to remain in place in the tissue after removal of the shaft of the device (via 70 being detachable from the shaft; see also figures 9A-C with the vias tips/hooks at 62A-E/64A-E).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have rendered the combined marker of Godara and Chandran as a deployable fiducial marker in view of the teaching in Coonahan. Such would provide for a known alternative manner of providing a marking to a target site within the body that can be repeatedly identified during treatment and then during follow-up checks and treatments. The Examiner notes that the “configured to be deployed” and “configured to grasp” language is interpreted as a functional recitations of the intended use of the claimed system. The Examiner is of the position that the combined fiducial marker of Godara/Chandran/Coonahan is readily capable of functioning as claimed thereby resulting in the claimed subject matter failing to structurally distinguish the claimed arrangement from the prior art combination.
Regarding claim 2, Godara provides for an obturator for facilitating insertion of the introducer into the patient (606).
Regarding claim 3, the Examiner is of the position that the probe of Godara is functionally capable treating a target nerve including those set forth in claim 3. See further [0124] and [0127] of Godara disclosing nerve-treating capability.
Regarding claim 4, in view of the combination with Chandran in the rejection of claim 1 above, the combined marker would be at least one of sonopaque, radiopaque, and fluorescent (see at least [0051] and [0064] of Godara).
Regarding claim 5, Godara further provides that the introducer is configured to deliver the pharmacological agent to the target nerve (such is provided via the delivery of the agent through the introducer when the probe 100 is inserted therethrough).
Regarding claim 6, in view of the combination in the rejection of claim 1 above, Chandran, the combined arrangement provides that the introducer is configured for storage of the fiducial marker until it is delivered to the target nerve (via the marker being placed on the probe, and the introducer capable of containing the probe/marker therein until the marker is delivered to a target nerve).
Regarding claim 7, in view of the combination with Chandran in claim 1 above, the combination provides that the fiducial marker is formed from a solid material (see [0038]-[0040] of Chandran providing for various solid materials and construction for the band 108).
Regarding claim 8, in view of the combination in the rejection of claim 1 above, Coonahan specifically provides in the relied upon embodiment in figures 9A-9C, the combined fiducial marker includes one or more appendages, wherein the appendages are configured to anchor the fiducial marker to the target nerve or tissue adjacent the target nerve (see figures 9A-C with the vias tips/hooks at 62A-E/64A-E).
Regarding claims 9 and 10, in view of the combination with Chandran in claim 1 above, the combination provides that the fiducial marker is non-degradable in the form of a metal (see [0038]-[0040] providing for non-degradable metals such as gold, silver and platinum).
Regarding claim 11, while Godara and Chandran fails to provide for a material of construction that is degradable, Coonahan further provides for the utilization of a material for the fiducial marker is degradable (see [0096] providing for biodegradable iron). The Examiner is, therefore, of the position tht it would have been obvious to have utilized the alternative material as contemplated in Coonahan for the combined marker per the combination of claim 1. Coonahan readily provides for various alternative materials that overlap with those in Godara, and further provides that such would function equally as well as other similar materials to provide for the requisite visualization within the body.
Regarding claim 13, Godara provides for a system for improving location accuracy of a radiofrequency ablation procedure performed on a target nerve of a patient, the system comprising:
a probe having an outer diameter, a proximal end, and a distal end (probe 100), the probe comprising an electrically insulated portion located at the proximal end (116) and a conductive portion for delivering energy to a target nerve located at the distal end (118),
an introducer for facilitating insertion of the distal end of the probe into the patient adjacent the target nerve (604), the introducer comprises an outer surface, a proximal end and a distal end (see the structure of 604 as in figure 6).
While Godara provides for various arrangements of the fiducial marker on the probe (see the citation of the features disclosed in US Pat. App. No. 11/079318), Godara fails to specifically provide that the fiducial marker is disposed on an outer surface of the introducer. Chandran disclose the use of a similar marker on a probe inserted through a cannula, and further provides for the inclusion of a fiducial marker on an introducer (see the band 108 placed on the cannula 100). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have provided the fiducial marker on the outer surface of the introducer of probe 100 of Godara in view of the teaching in Chandran to provide for an additional measure of visualization when advancing the introducer in the body and near nerve tissue. Chandran, itself, is already cited and incorporated-by-reference by Godara, and one of ordinary skill would be reasonably motivated in view of the combined teaching to provide the redundant visualization to achieve enhanced safety in/around nerve tissue.
Chandran fails to provide that this arrangement on the outer surface of the introducer is configured to be deployed from the introducer such that the fiducial marker is positioned adjacent the nerve. Coonahan provides for an alternative manner of providing a marker on an outer surface of a shaft of a device wherein the marker is configured to be delivered adjacent to target tissue (see figures 9A-C providing for the exteriorly placed marker 70 and its ability to be placed as in figure 9A3 and 9C). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have rendered the combined marker of Godara and Chandran as a deployable fiducial marker in view of the teaching in Coonahan. Such would provide for a known alternative manner of providing a marking to a target site within the body that can be repeatedly identified during treatment and then during follow-up checks and treatments.
Regarding claim 14, in view of the combination in the rejection of claim 13 above, the combined arrangement results in the introducer being configured for storage of the fiducial marker until the distal end of the introducer positioned adjacent the target nerve. Such is in view of the disclosure in at least [0094] of Coonahan provides for the device to be introduced into tissue with the marker in place and then for the subsequent deployment.
Regarding claim 15, in view of the combination in the rejection of claim 13 above, Coonahan provides for an alternative arrangement of a fiducial marker on an outer surface of a shaft wherein the fiducial marker has a helical shape (see figures 10A/B with the helical marker 80). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the helical embodiment as in Coonahan instead of the blossom arrangement (70) to provide for an alternative manner of utilizing a helical-shaped deployable marker with the system.
Regarding claim 16, in view of the combination in the rejection of claim 13 above, Coonahan specifically provides in the relied upon embodiment in figures 9A-9C, the combined fiducial marker includes one or more appendages, wherein the appendages are configured to anchor the fiducial marker to the target nerve or tissue adjacent the target nerve (see figures 9A-C with the vias tips/hooks at 62A-E/64A-E).
Regarding claim 17, in view of the combination in the rejection of claim 13 above, the fiducial marker is configured to be deployed from the introducer as the distal end of the introducer comes into contact with the target nerve. The Examiner notes that the “configured to be deployed” language is interpreted as a functional recitation of the intended use of the claimed system. The Examiner is of the position that the combined fiducial marker of Godara/Chandran/Coonahan is readily capable of functioning as claimed thereby resulting in the claimed subject matter failing to structurally distinguish the claimed arrangement from the prior art combination. The Examiner further finds that the combined marker is indeed configured to grasp onto the target nerve and remain in place to mark the target nerve after removal of the introducer (see figures 9A-C with the vias tips/hooks at 62A-E/64A-E).
Regarding claim 18, Godara provides for a system for improving location accuracy of a radiofrequency ablation procedure performed on a target nerve of a patient, the system comprising:
a probe having an outer diameter, a proximal end, and a distal end (probe 100), the probe comprising an electrically insulated portion located at the proximal end (116) and a conductive portion for delivering energy to a target nerve located at the distal end (118),
an introducer for facilitating insertion of the distal end of the probe into the patient adjacent the target nerve (604), the introducer comprising an outer surface, a proximal end and a distal end (see the structure of 604 as in figure 6).
While Godara provides for various arrangements of the fiducial marker on the probe (see the citation of the features disclosed in US Pat. App. No. 11/079318), Godara fails to specifically provide that the fiducial marker is disposed on an outer surface of the introducer. Chandran disclose the use of a similar marker on a probe inserted through a cannula, and further provides for the inclusion of a fiducial marker on an introducer (see the band 108 placed on the cannula 100). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have provided the fiducial marker on the outer surface of the introducer of probe 100 of Godara in view of the teaching in Chandran to provide for an additional measure of visualization when advancing the introducer in the body and near nerve tissue. Chandran, itself, is already cited and incorporated-by-reference by Godara, and one of ordinary skill would be reasonably motivated in view of the combined teaching to provide the redundant visualization to achieve enhanced safety in/around nerve tissue.
Chandran fails to provide that this arrangement on the outer surface of the introducer is configured to be deployed from the introducer as the distal end comes into contact with the nerve such that the fiducial marker is configured to grasp onto the target nerve and remain in place to mark the target nerve after removal of the introducer. Coonahan provides for an alternative manner of providing a marker on an outer surface of a shaft of a device wherein the marker is configured to be delivered adjacent to target tissue (see figures 9A-C providing for the exteriorly placed marker 70 and its ability to be placed as in figure 9A3 and 9C) and to remain in place in the tissue after removal of the shaft of the device (via 70 being detachable from the shaft; see also figures 9A-C with the vias tips/hooks at 62A-E/64A-E).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have rendered the combined marker of Godara and Chandran as a deployable fiducial marker in view of the teaching in Coonahan. Such would provide for a known alternative manner of providing a marking to a target site within the body that can be repeatedly identified during treatment and then during follow-up checks and treatments. The Examiner notes that the “configured to be deployed” and “configured to grasp” language is interpreted as a functional recitations of the intended use of the claimed system. The Examiner is of the position that the combined fiducial marker of Godara/Chandran/Coonahan is readily capable of functioning as claimed thereby resulting in the claimed subject matter failing to structurally distinguish the claimed arrangement from the prior art combination.
Regarding claim 19, in view of the combination in the rejection of claim 13 above, the combined arrangement results in the introducer being configured for storage of the fiducial marker until the distal end of the introducer positioned adjacent the target nerve. Such is in view of the disclosure in at least [0094] of Coonahan provides for the device to be introduced into tissue with the marker in place and then for the subsequent deployment.
Regarding claim 20, in view of the combination in the rejection of claim 18 above, Coonahan specifically provides in the relied upon embodiment in figures 9A-9C, the combined fiducial marker includes one or more appendages, wherein the appendages are configured to anchor the fiducial marker to the target nerve or tissue adjacent the target nerve (see figures 9A-C with the vias tips/hooks at 62A-E/64A-E).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Godara et al. (US Pat. Pub. 2007/0027449 A1) in view of Chandran et al. (US Pat. Pub. 2005/0159797 A1) and Coonahan et al. (US Pat. Pub. 2009/0227893 A1) as applied to claim 1 above, and further in view of Meyer (US Pat. No. 6,298,256 B1).
Regarding claim 12, none of Godara, Chandran or Coonahan provides for the inclusion of a syringe, wherein the pharmacological agent is configured for storage in the syringe, wherein the introducer is configured to receive the syringe to facilitate delivery of the pharmacological agent to the target nerve. Meyer provides for an exemplary manner for the delivery of a anesthetic wherein the anesthetic is stored in a syringe and an introducer is configured to receive the syringe to facilitate the delivery of the agent (See figure 1 with the hub 18 configured to receive the syringe as in col. 6; 23-28). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the hub/syringe arrangement as in Meyer with the structure of the introducer of Godara to provide for an exemplary manner of delivering the disclosed anesthetic in Godara to a location within the body. The Examiner further notes that a syringe is a well-known and commonly-utilized manner of containing a pharmacological agent, with Meyer readily establishing that such is used for delivery of such an agent as already required in Godara.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
Prosecution Insights