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 § 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 30-31 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 31-30 depend on a cancelled claim 25. The scope of the claims is unclear and indefinite.
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.
Claim 1, 3, 6, 9, 11, 12, 18, 21, 30 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Pfannenstiel et al. (US 2020/0367966) in view of BEN-HAIM (US 2015/0320492).
Regarding claim 1, Pfannenstiel discloses a method of ablating tissue using a microwave ablation system comprising a plurality of applicators (one or more devices 10), said method comprising the steps of: (a) having the applicators inserted into the tissue and located in and/or adjacent a target tissue section [0095];(b) having the system perform an ablation cycle by activating at least one of the applicators so that the at least one applicator emits electromagnetic radiation that is sufficiently strong to cause ablation of the target tissue section [0095], said at least one applicator comprising a directional applicator that emits radiation to define an angular radiation pattern (fig.22), step (a) including the step of orienting the directional applicator so that the angular radiation pattern extends from the directional applicator toward the target tissue section [0095]; and (c) having the system perform a sensing cycle that includes the step of using one or more of the applicators to take a measurement associated with impedance [0069]. Pfannenstiel does not specifically teach the measurement of impedance being directly associated with dielectric property of the tissue.
BEN-HAIM teaches system may include deploying at least two transmission points of a multi point probe to a proximity with the treatment location in the body. A transmission pattern may be selected that defines, for each of the transmission points, a respective signal of a plurality of transmission signals. BEN-HAIM specifically teaching the method of creating a map of a dielectric property in at least a part of the treatment location according to an analysis of the intercepted energy. The system detects the changes in n a dielectric property of the treatment location or of data received by a receiving point and an adjustment of the delivering according to the detecting [0010] and [0014]. BEN-HAIM further teaches the anatomical map may be represented as one or more 3D matrices of coefficients each indicative of a value of certain dielectric property. This combination is optionally presented to a user, allowing the user to specify a location of a target area (e.g., tissue) as well as indicating by the selection characteristics of the target area. The system also teaches having different duty cycles and may be set to generate transmission signals that form one or both treatment signals and/or test signals, optionally interchangeably and/or simultaneously and/or concurrently and/or at different times from different transmission points. The one or more EM energy sources may include one or more feedback receivers or sensors that measure input power, reflected power and/or temperature and/or impedance of one or more of the points, for example antennas [0065]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the system of Pfannenstiel with perform a sensing cycle that includes the step of using one or more of the applicators to take a measurement associated with a dielectric property of the tissue. as taught by BEN-HAIM for the purpose of providing enhanced feedback regarding the treatment area for having the desired treatment.
Regarding claim 3, Pfannenstiel/ BEN-HAIM teaches the method as claimed in claim 1, step (b) including the step of activating multiple ones of the applicators so that the multiple applicators each emit electromagnetic radiation for causing ablation of the target tissue section each of said applicators comprising a directional applicator that emits radiation to define the angular radiation pattern [0095], step (a) including the step of orienting the directional applicators so that each angular radiation pattern extends from the respective directional applicator toward at least another one of the directional applicators (fig.22, see also [0095] of Pfannenstiel).
Regarding claim 6, Pfannenstiel/ BEN-HAIM teaches the method as claimed in claim 1, step (a) including the step of orienting the directional applicator based upon the measurement to maximize a signal transmission level between the applicators, said orienting step including (i) the step of rotating the directional applicator relative to the tissue about an applicator axis, and/or (ii) the step of inserting or retracting the directional applicator relative to the tissue along the applicator axis ([0095] of Pfannenstiel).
Regarding claim 9, Pfannenstiel/ BEN-HAIM teaches the method as claimed in claim 1, further comprising the step of:(d) having the system switch itself between step (b) and step (c) to have the ablation and sensing cycles performed at different times, said microwave ablation system including a switching device that performs step (d) ([0095] of Pfannenstiel).
Regarding claim 11, Pfannenstiel/ BEN-HAIM teaches the method as claimed in claim 1, further comprising the step of:(d) having the system perform step (b) and step (c) simultaneously, with one of the applicators being activated to emit electromagnetic radiation for causing ablation of the target tissue section, and another one of the applicators being used to take the measurement ([0095] of Pfannenstiel).
Regarding claim 12, Pfannenstiel/ BEN-HAIM teaches the method as claimed in claim 1, step (b) including the step of activating multiple ones of the applicators so that the multiple applicators each emit electromagnetic radiation for causing ablation of the target tissue section, each of said applicators comprising a directional applicator that emits radiation to define the angular radiation pattern (fig.22, see also [0095] of Pfannenstiel), step (a) including the step of orienting the directional applicators so that each angular radiation pattern extends from the respective directional applicator toward at least another one of the directional applicators (fig.22, see also [0095] of Pfannenstiel).
Regarding claim 18, Pfannenstiel/ BEN-HAIM teaches the method as claimed in claim 1, step (c) being performed prior to step (b) in order to sense a baseline measurement ([0065] of BEN-HAIM).
Regarding claim 21, Pfannenstiel/ BEN-HAIM teaches the method as claimed in claim 18, further comprising the steps of:(d) having the system perform another sensing cycle after step (b) so that the ablation cycle and the another sensing cycle cooperatively provide a treatment iteration, with the another sensing cycle including the step of using the at least one applicator to take another measurement associated with the dielectric property of the tissue; and (e) having the system switch itself from step (b) to step (d) ([0065] of BEN-HAIM).
Regarding claim 30, Pfannenstiel/ BEN-HAIM teaches the method as claimed in claim 25, further comprising the step of:(f) terminating the ablation procedure based upon the comparison of step (e) ([0090] of BEN-HAIM).
Regarding claim 39, Pfannenstiel discloses a microwave ablation system (fig.20; collectively 112) configured to ablate tissue, said microwave ablation system comprising: at least one microwave source [0089]; a plurality of applicators (fig.22; operable to be inserted into the tissue and located in and/or adjacent a target tissue section [0095], at least one of said applicators configured to receive power from the microwave source during an ablation cycle and emit electromagnetic radiation that is sufficiently strong to cause ablation of the target tissue section (fig.22, see also [0095]), said at least one applicator comprising a directional applicator that emits radiation to define an angular radiation pattern, with the directional applicator configured to be oriented so that the angular radiation pattern extends from the directional applicator toward the target tissue section (fig.22, see also [0095]); and a meter1ing device configured to receive a signal from at least one of the applicators during a sensing cycle to take a measurement associated with impedance [0069]. Pfannenstiel does not specifically teach the measurement of impedance being directly associated with dielectric property of the tissue.
BEN-HAIM teaches system may include deploying at least two transmission points of a multi point probe to a proximity with the treatment location in the body. A transmission pattern may be selected that defines, for each of the transmission points, a respective signal of a plurality of transmission signals. BEN-HAIM specifically teaching the method of creating a map of a dielectric property in at least a part of the treatment location according to an analysis of the intercepted energy. The system detects the changes in n a dielectric property of the treatment location or of data received by a receiving point and an adjustment of the delivering according to the detecting [0010] and [0014]. BEN-HAIM further teaches the anatomical map may be represented as one or more 3D matrices of coefficients each indicative of a value of certain dielectric property. This combination is optionally presented to a user, allowing the user to specify a location of a target area (e.g., tissue) as well as indicating by the selection characteristics of the target area. The system also teaches having different duty cycles and may be set to generate transmission signals that form one or both treatment signals and/or test signals, optionally interchangeably and/or simultaneously and/or concurrently and/or at different times from different transmission points. The one or more EM energy sources may include one or more feedback receivers or sensors that measure input power, reflected power and/or temperature and/or impedance of one or more of the points, for example antennas [0065]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the application was effectively filed to modify the system of Pfannenstiel with perform a sensing cycle that includes the step of using one or more of the applicators to take a measurement associated with a dielectric property of the tissue. as taught by BEN-HAIM for the purpose of providing enhanced feedback regarding the treatment area for having the desired treatment.
Allowable Subject Matter
Claim 15-17, 20, 23-24, 26-28, 35 and 38 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Pfannenstiel does not teach any measurement that includes a transmission coefficient of the tissue.
BEN-HAIM teaches as one or more 3D matrices of coefficients each indicative of a value of certain dielectric property and transmission pattern is optionally a set of instructions calculated to instruct feeding the transmission points with of a plurality of transmission signal ([0085]-[0086]). However, BEN-HAIM is silent regarding the measurement including a transmission coefficient of the tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794