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 Objections
Claim 17 is objected to because of the following informalities: in line 6, “angels” should read --angles--. 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.
Claims 2, 7 and 12-14 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.
The term “optimal duty cycle” in claims 2, 7 and 12 is a relative term which renders the claims indefinite. The term “optimal duty cycle” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The only discussion of an “optimal duty cycle” that the examiner was able to locate is in par. 0052 of the original disclosure, noting “a random selection of angles at optimal duty cycles determined by the electric field generator 102, such as a 50 ms duty cycle and/or a or temperature-limited duty cycle, may optimize the average therapeutic dose delivered to a target ROI (e.g., tumor, etc.).” However, besides an example of a 50 ms duty cycle, the discussion lacks any indication of how to derive and how to establish an “optimal duty cycle” versus a non-optimal duty cycle. The scope of a duty cycle that is optimal in relation to a duty cycle that is not optimal is not knowable from the guidance provided by the original disclosure.
In regards to claims 13 and 14, the phrase “wherein selectively deactivating is based on selection of angles that are one or more of: most distant from previous angles used within a current duty cycle, and orthogonal relative to a geometric center of the region of interest and a temperature associated deactivation state of one or more electrodes” is unclear. It is unclear how a selection of angles can be “orthogonal relative to a geometric center of the region of interest and a temperature associated deactivation state of one or more electrodes” because, while an angle can be “orthogonal relative to a geometric center of the region of interest,” it is unclear how an angle can be “a temperature associated deactivation state of one or more electrodes.” It appears that the claim is lacking language drawn to a step of using a temperature associated deactivation state of one or more electrodes. Also, it is unclear whether the “and a temperature associated deactivation state of one or more electrodes” is referring to both the angles that are one or more of “most distant from previous angles used within a current duty cycle” and “orthogonal relative to a geometric center of the region of interest” or only “orthogonal relative to a geometric center of the region of interest.”
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Palti (US 2006/0167499, hereinafter “Palti”).
In regards to claim 1, Palti discloses a method comprising:
causing cyclical application of a first electric field via a first transducer array in a first direction and a second electric field via a second transducer array in a second direction, opposite the first direction (par. 0118, “applying the AC signal…would result in a field in a front-to-back direction”), to a region of interest, wherein the first transducer array comprises a first plurality of electrodes and the second transducer array comprises a second plurality of electrodes (Fig. 28, pars. 0117-0121; the first array comprising electrodes A1-A9 and second array comprising electrodes N1-N9); and
during the cyclical application,
selectively deactivating, one or more electrodes of the first plurality of electrodes or one or more electrodes of the second plurality of electrodes, to adjust an angle at which the first electric field or the second electric field is applied to the region of interest (par. 0119).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Palti. Palti discloses the essential features of the claimed invention except for wherein selectively deactivating is based on selection of angles that are one or more of: most distant from previous angles used within a current duty cycle, and orthogonal relative to a geometric center of the region of interest; or wherein selectively deactivating is based on selection of angles that are one or more of: most distant from previous angles used within a current duty cycle, and orthogonal relative to pairs of cathode electrodes and anode electrodes that are orthogonal to each other.
However, Palti teaches another embodiment including electrodes positioned orthogonal to each other (Fig. 32A) that appears to be combinable with the embodiment of Fig. 28 (par. 0164) that would result in selectively deactivating based on selection of angles that are orthogonal relative to a geometric center of the region of interest; and selectively deactivating based on selection of angles that are orthogonal relative to pairs of cathode electrodes and anode electrodes that are orthogonal to each other (par. 0164, Figs. 13 and 32B -- anode and cathode relationship in Fig. 13 and all electrodes are both anodes and cathodes due to the AC signal applied in Fig. 32B) to provide the predictable results of, as the field undergoes 90 degrees of rotation, the dipole will also undergo the same amount of rotation, and the force generating the rotation momentum remains maximal and constant (par. 0164).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Palti by selectively deactivating based on selection of angles that are orthogonal relative to a geometric center of the region of interest; and selectively deactivating based on selection of angles that are orthogonal relative to pairs of cathode electrodes and anode electrodes that are orthogonal to each other to provide the predictable results of, as the field undergoes 90 degrees of rotation, the dipole will also undergo the same amount of rotation, and the force generating the rotation momentum remains maximal and constant.
Allowable Subject Matter
Claims 2, 3 and 6-17 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 and resolving the section 112 issues set forth above.
The following is a statement of reasons for the indication of allowable subject matter: although Palti describes adjusting an angle of first and second electric fields, Palti, alone or in combination with the remaining prior art, fails to disclose or fairly render unpatentable the combination of elements recited in the claims, including providing a random selection of angles (the angles of Palti are “swept” to provide a rotation of the field around the region of interest) or selecting angles based on a temperature-limited duty cycle. The concept of deactivating electrodes based on temperature is generally known (see, e.g., US 2006/0149341 also to Palti at par. 0047), but the prior art lacks teaching and proper motivation to select angles of field application based on such temperature feedback.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571)270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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