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 .
Election/Restrictions
Applicant’s election with traverse of Group II drawn to claims 9-15 in the response filed on 5/19/2025 has been considered by the Examiner. Claims 1-8 and 16-20 are directed to a nonelected group. The Applicant sets forth on page 2 of the Remarks, ‘The restriction requirement is not reasonable despite the lack of unity raised by the Examiner. In particular, the application contains only three independent claims …Moreover, there should be no serious burden on the Examiner to search for the remaining features recited in the independent claims in addition to the alleged “same or corresponding special technical features.”’
The Examiner however respectfully disagrees. Each independent claim was examined for unity:
Claim 1 technical features include an energy delivery device, lumens for circulating fluid, a temperature sensor, and a protrusion at the distal most tip of the device that includes the temperature sensor.
Claim 9 technical features include an energy delivery device, lumens for circulating fluid, a temperature sensor, a protrusion at the distal most tip of the device that includes the temperature sensor, and a step of simultaneously circulating cooling fluid while delivering energy.
Claim 16 technical features include an energy delivery device, lumens for circulating fluid, and a temperature sensor.
The common technical features were the temperature sensor, lumens for circulating fluid, and a conductive energy delivery device and unity was present a priori.
Unity lacks a posteriori when the common technical features are anticipated or obvious over prior. A restriction requirement is therefore reasonable when the remaining features between the inventions are different and not minimal. The remaining features such as protrusion at the distal most tip of the device which includes the temperature sensor and the step of simultaneously delivering cooling fluid and energy are not trivial features that require minimal search effort.
Drawing
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 418. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/25/2020 and 07/22/2021 has been considered by the examiner.
Claim Status
A complete action on the merits of claims 9-15 follows below.
Claim Objections
Claim 9 objected to because of the following informalities:
In claim 9 line 8 “an protrusion” should recite –a protrusion.—
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.
Claim 15 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 15 is dependent on itself and it is unclear which claim it should depend on.
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 9-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leung (2008/0065062) in view of Cosman (9,956,032), and in further view of Lefler (2009/0054962).
Regarding claim 9, Leung teaches a method of treating tissue of a patient’s body ([Abstract] a method of treating a spinal tissue of a patient’s body), the method comprising:
providing an energy source (RF generator 102) coupled to at least one probe assembly, the at least one probe assembly (106) comprising an elongate member with a distal region (190) and a proximal region (184), said distal region comprising an electrically non-conductive outer circumferential portion (184 manufactured out of polyimide- electrical insulation [0071]);
an electrically-conductive energy delivery device extending distally from said electrically non-conductive outer circumferential portion for delivering one of the electrical and radiofrequency energy to the patient’s body (192 exposed conductive tip [0015]), said energy delivery device comprising a conductive outer circumferential surface and one or more internal lumens configured for circulating a cooling fluid to a distal end of said energy delivery device (hypotubes 302, 304 are made of conductive material [0068]);
a protrusion extending from said distal end of said energy delivery device (protrusion at distal most tip , Fig. 4), said protrusion being electrically coupled to said energy delivery device ([0072] thermocouple junction made by joining a stainless steel hypotube 406 to a constantan wire 410), said protrusion comprising a temperature sensing element extending from a distal end of the energy delivery device (402), the temperature sensing element comprising at least one optical fiber extending therethrough (optical fluorescent sensors);
inserting the energy deliver device of the at least one probe assembly into the patient’s body ([Abstract] inserting the energy delivery devices of the first and second internally-cooled probe assemblies into spaced-apart treatment sites for the spinal tissue);
actively controlling energy delivered to the tissue by controlling an amount of energy delivered through the energy delivery device and by controlling a flow rate of the pump assembly ([0057]).
Leung does not teach that a distal-most end of the at least one optical fiber is exposed to define a temperature sensing face.
However, Cosman teaches a device within the same field of invention (an internally cooled RF electrode [Abstract]) and provides for an exposed temperature sensing face (131 fiber optic temperature sensor . Fig. 1 C illustrates 131 to be exposed with respect to coating 133 or electrically insulating shaft 103…Col. 19 lines 66-67 electrical insulation 133 …covering all by the distal point 131 of the tube 132).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal-most end of the optical fiber to provide for an exposed portion as an obvious design choice for the purposes of enhancing thermal responsiveness absent evidence of unexpected results.
Leung is silent about specifically teaching simultaneously circulating the cooling fluid through the one or more internal lumens via at least one pump assembly and delivering energy from the energy source to the tissue through the energy delivery device.
However, Lefler teaches a device within the same field of invention (cooling an energy delivery portion) wherein the step of delivering energy to the tissue is ….performed at least partially concurrently with, a step of cooling the energy delivery portion of the electrosurgical device [0096].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide for the step of simultaneously delivering cooling fluid through the lumens and delivering energy through the energy delivery device for the purpose of achieving a desired lesion size since Lefler provides cooling an electrosurgical probe may change the size, shape, and location of formation lesion [0096].
Regarding claim 10, Leung in view of Cosman, and Lefler teaches the limitations of claim 9 as previously rejected above. Cosman teaches further comprising measuring an actual temperature of the tissue using a temperature sensing face positioned at a distal end of the at least one optical fiber of the temperature sensing element (temperature monitoring of the target tissue by a temperature sensor in the electrode can control the process; Col. 1 lines 51-52).
Regarding claim 11, Leung in view of Cosman, and Lefler teaches the limitations of claim 9 as previously rejected above. Cosman further teaches comprising adjusting a length that the at least one optical fiber protrudes from the distal end of the energy delivery device to provide lesions of different sizes in the tissue (Col 19 lines 51-52 the distance T can be adjustable by the user if the extension tip 120 is configured to slide relative to the active tip).
Regarding claim 12, Leung in view of Cosman, and Lefler teaches the limitations of claim 11 as previously rejected above. Cosman further teaches wherein the length that the at least one optical fiber protrudes from the distal end of the energy delivery device is less than about 1 millimeter (mm) (Col 19 line 27 the distance between the extension tip temperature sensor 131 and the distal end of active tip 181A bea value in the range of 0.1 mm to 10 mm).
Regarding claim 13, Leung in view of Cosman, and Lefler teaches the limitations of claim 9 as previously rejected above. Cosman further teaches wherein the temperature sensing element further comprises a sheath position over at least a portion of the at least one optical fiber (electrical insulation tube 133, Fig. 1C).
Regarding claim 14, Leung in view of Cosman, and Lefler teaches the limitations of claim 13 as previously rejected above. Cosman further teaches wherein the sheath is secured to the energy delivery device via an adhesive (Col. 13 lines 31-33 Each of the electrical insulations 103 and 133 can be tapered and/or adhered to its respective shaft 102 or 132 at the distal end of the insulation).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tehrani (2016/0338679) teaches an optical fiber that is exposed ( [0181] The tip of the OBN contains the single exposed fiber as an optical sensor 1302 for light source and detection , Fig. 30)
Ellingsen (US 7,048,732) teaches the sheath constricted of rigid biocompatible insulative material (an optical sensor 1 and sheath tube 2 …the materials in which the tube 2 and the tip 3 is made may be chosen within a wide range of different materials having sufficiently low magnetic susceptibility and being capable of withstanding a large range of temperatures. Also, the material should be biocompatible, according to a USP Class VI approval or similar, thus having ability to appropriately interact with the host biological organism into which it has been inserted, not generating any reactions from the organism… The tube material is thus preferably made from low susceptibility material like, but not limited to, polyimide, polytetrafluorethylene (Teflon), polyetheretherketone (PEEK)).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M. Hoffman can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Y.E/Examiner, Art Unit 3794
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794