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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 4-5, there is insufficient description defining what a ray is supposed to be. For example, is it an arbitrary mathematical ray or is it a physical ray?
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 4-5 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.
Regarding claims 4-5, it is unclear what a ray is supposed to be. For example, is it an arbitrary mathematical ray or is it a physical ray? Further clarification is required.
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.
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(s) 1-6, 8-9, 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirson (US 11441776 A1).
Regarding claims 1 and 13, Kirson discloses A method of applying alternating electric fields to a target region in a subject's body, the body having an anterior surface, a posterior surface, a left surface, and a right surface (eg. multiple embodiments Fig. 1-5, electrode arrays on multiple sides, and respective paragraphs), the method comprising: (a) applying an alternating voltage at a frequency between 50 kHz and 1 MHz (eg. Abstract, Col. 2, Ln. 18- Col. 3, Ln. 67, Col. 4, Ln. 58 – Col. 5, Ln. 51) between a first set of one or more electrode elements positioned on a first region of the anterior surface and a second set of one or more electrode elements positioned on a second region of the posterior surface during a plurality of first portions of a first interval of time (eg. Fig. 4A-B and Col. 10, Ln. 13 – Ln. 22), and applying an alternating voltage at a frequency between 50 kHz and 1 MHz (eg. Abstract, Col. 2, Ln. 18- Col. 3, Ln. 67, Col. 4, Ln. 58 – Col. 5, Ln. 51) between a third set of one or more electrode elements positioned on a third region of the left surface and a fourth set of one or more electrode elements positioned on a fourth region of the right surface (eg. Fig. 4C-D 5A-D, Col. 10, Ln. 22 – Ln. 30) during a plurality of second portions of the first interval of time (eg. Fig. 5A-D, Col. 10, Ln. 66 – Col. 11, Ln. 22); and (b) applying an alternating voltage at a frequency between 50 kHz and 1 MHz between a fifth set of one or more electrode elements positioned on a fifth region of the anterior surface and a sixth set of one or more electrode elements positioned on a sixth region of the posterior surface during a plurality of first portions of a second interval of time (eg. Fig. 5A-D, Col. 10, Ln. 66 – Col. 11, Ln. 56 separate regions such as Fig 5C-D arrays 55/57 and 56-58), and applying an alternating voltage at a frequency between 50 kHz and 1 MHz between a seventh set of one or more electrode elements positioned on a seventh region of the left surface and a eighth set of one or more electrode elements positioned on a eighth region of the right surface during a plurality of second portions of the second interval of time (eg. Fig. 3-5, electrode array 31-32 combined with other side electrodes 51 and 52), wherein the first interval of time and the second interval of time are nonoverlapping (eg. Col. 3, Ln. 25-Col. 4, Ln. 6, Col. 10, Ln. 66- Col. 11, Ln. 22), wherein less than 20% of the fifth region overlaps the first region (eg. Fig. 1 and 3-5, separate regions (eg. Fig. 1 and 3-5, separate regions such as Fig 5C-D arrays 55/57 and 56-58), wherein less than 20% of the sixth region overlaps the second region (eg. Fig. 1 and 3-5, separate regions such as Fig 5C-D arrays 55/57 and 56-58), wherein less than 20% of the seventh region overlaps the third region, and wherein less than 20% of the eighth region overlaps the fourth region (eg. Fig. 3-5, electrode array 31-32 combined with other side electrodes 51 and 52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the embodiments (Eg. Fig. 1, and 3-5) to have multiple electrodes in various configurations as needed to treat a wide variety of anatomical locations (eg. Col. 11, Ln. 50-56).
Regarding claims 2 and 14, Kirson discloses no part of the fifth region overlaps the first region, wherein no part of the sixth region overlaps the second region, wherein no part of the seventh region overlaps the third region, wherein no part of the eighth region overlaps the fourth region (eg. Fig. 1 and 3-5, separate regions (eg. Fig. 1 and 3-5, separate regions such as Fig 5C-D arrays 55/57 and 56-58).
Regarding claims 3 and 15 Kirson discloses repeating steps (a) and (b) in an alternating sequence at least ten times. (eg. Col. 3, Ln. 25-Col. 4, Ln. 6, Col. 10, Ln. 66- Col. 11, Ln. 22).
Regarding claim 4, Kirson discloses the target region comprises a tumor, the tumor having a centroid, wherein a ray projected directly anterior from the centroid does not intersect the first region, wherein a ray projected directly posterior from the centroid does not intersect the second region, wherein a ray projected directly anterior from the centroid does not intersect the fifth region, and wherein a ray projected directly posterior from the centroid does not intersect the sixth region (Eg. Abstract, Fig. 3-5, Col. 1, Ln. 10-30, Col. 8, Ln. 3 – Col. 11, Ln. 63, it is unclear what the ray is defined since it can mean any geometric ray can come out of a center point and not hit a portion of a region or electrode).
Regarding claim 5, Kirson discloses the target region comprises a tumor, the tumor having a centroid, wherein a ray projected directly anterior from the centroid does not intersect at least one of the first region and the fifth region, wherein a ray projected directly posterior from the centroid does not intersect at least one of the second region and the sixth region, wherein a ray projected directly to the left from the centroid does not intersect at least one of the third region and the seventh region, and wherein a ray projected directly to the right from the centroid does not intersect at least one of the fourth region and the eighth region (Eg. Abstract, Fig. 3-5, Col. 1, Ln. 10-30, Col. 8, Ln. 3 – Col. 11, Ln. 63, it is unclear what the ray is defined since it can mean any geometric ray can come out of a center point and not hit a portion of a region or electrode).
Regarding claims 6 and 16, Kirson discloses the second interval of time is separated from the first interval of time by less than 48 hours (eg. Col. 9, Ln. 32 – Col. 10, Ln. 12, Col. 10, Ln. 66 – Col. 11, Ln. 22).
Regarding claim 8, Kirson discloses each of the alternating voltages has a sinusoidal waveform (eg. Col. 12, Ln. 25-34, Col. 13, Ln. 32 – Col. 14, Ln. 4, AC signals are commonly sinusoidal).
Regarding claims 9 Kirson discloses each of the first, second, third, fourth, fifth, sixth,seventh, and eighth regions are located on the subject's abdomen (Eg. Abstract, Fig. 3-5, Col. 1, Ln. 10-30, Col. 8, Ln. 3 – Col. 11, Ln. 63, can have various types of configurations based on anatomy).
Claim(s) 7, 10-12, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kirson (US 11441776 A1) in view of Travers (US 2021/0177492 A1).
Regarding claims 7 and 17, Kirson discloses the invention of claim 1, but does not disclose the first interval of time is at least 12 hours and the second interval of time is at least 12 hours.
Travers teaches a control device for TTF therapy that varies the firing configurations and sequencies by hours and days (eg. Para. 48).
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 invention of Kirson to vary the firing configurations and sequences as taught by Travers to optimize treating various tumors in between periods while letting the electrodes cool down (eg. Travers, Para. 48).
Regarding claims 10 and 18, the combined invention of Kirson and Travers discloses (c) prior to the first interval of time, positioning the first, second, third, and fourth sets of one or more electrode elements on the first, second, third, and fourth regions, respectively; (d) after the first interval of time, removing the first, second, third, and fourth sets of one or more electrode elements from the subject's body; (e) prior to the second interval of time, positioning the fifth, sixth, seventh, and eighth sets of one or more electrode elements on the fifth, sixth, seventh, and eighth regions, respectively; and (f) after the second interval of time, removing the fifth, sixth, seventh, and eighth sets of one or more electrode elements from the subject's body (Eg. Kirson, Abstract, Fig. 3-5, Col. 1, Ln. 10-30, Col. 8, Ln. 3 – Col. 11, Ln. 63, the switching of the electrode firing configuration and sequencies between different regions is equivalent to taking the non-firing electrodes off since they won’t be firing anyway).
Regarding claims 11 and 19, the combined invention of Kirson and Travers discloses repeating steps (a) and (b) in an alternating sequence at least ten times. (eg. Kirson, Col. 3, Ln. 25-Col. 4, Ln. 6, Col. 10, Ln. 66- Col. 11, Ln. 22).
Regarding claims 12 and 20, the combined invention of Kirson and Travers discloses each of the primary regions and each of the secondary regions are located on the subject's abdomen (Eg. Kirson, Abstract, Fig. 3-5, Col. 1, Ln. 10-30, Col. 8, Ln. 3 – Col. 11, Ln. 63, can have various types of configurations based on anatomy).
Conclusion
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/MICHAEL J LAU/Examiner, Art Unit 3796