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 .
Response to Arguments
In order to present a different prior art rejection Examiner has made this rejection a Non-Final rejection.
Applicant's arguments filed 1/20/25 have been fully considered but they are not persuasive and/or moot in view of the new rejection.
With regards to the restriction, Examiner is maintaining the restriction. While the specifically recited CPC’s stated in the original restriction were searched does not negate that the previous Examiner determined there to be a search burden. Per MPEP 803, “For purposes of the initial requirement, a serious search burden on the examiner may be prima facie shown by appropriate explanation of separate classification, or separate status in the art, or a different field of search as defined in MPEP § 808.02. Similarly, a serious examination burden, for example, may be prima facie shown by appropriate explanation of non-prior art issues under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph, and/or 35 U.S.C. 112(a) relevant to one invention that are not relevant to the other invention.” Examiner notes that each of the independent claims required elements which are not required by the other. Additionally, as the restriction included a apparatus and method of use, Examiner notes that rejoinder will be considered upon the determination of an allowable claim matter.
Applicants arguments are directed to the combination of the Wasserman and Wong, as Wong is not currently applied the arguments are moot. Regardless, Examiner notes that if you could not apply a secondary reference for an element that may achieve the same goal as that in the primary reference, it would seemingly negate several of the KSR rationales such as simple substitution. The PTAB decisions Applicant points to were fact specific to the claimed elements as well as the discussion in the those rejections and the current claims do not have the same elements, as such they are not analogous.
Drawings
Figure 2A-D should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
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 1-13 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 1 recites “the first pad having a conductive foam and a first conductive gel element”, “the conductive foam having a solid continuous phase material being at least one of constructed of a conductive material or having the conductive material attached, absorbed, or adsorbed to the solid continuous phase material” and “the first conductive gel element being attached, absorbed, or adsorbed to the conductive foam”. The issue here is it is unclear what is required by this. Can the hydrogel be both “having the conductive material attached, absorbed, or adsorbed to the solid continuous phase material” and “the first conductive gel element being attached, absorbed, or adsorbed to the conductive foam” or not? It creates confusion on what is required and what the distinct elements are. For the above reasons the claims do not clearly define the metes and bounds and the claim is rejected. The claims depending from this claim share this issue and are likewise rejected.
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.
Claim(s) 1, 3-6, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200155835 to Wasserman et al. (hereinafter Wasserman – Cited in a prior 892) in view of US 20200171297 to Kirson et al. (hereinafter Kirson).
Regarding Claim 1, an interpretation of Wasserman discloses a system for delivering TTFields to a body of a subject (abstract), the system comprising:
an electric field generator ([0039], Fig. 3) configured to generate an electrical signal having an alternating current waveform at a frequency in a range from 50 kHz to 500 kHz ([0001], [0039] including “200 khz” , Fig. 3);
a first conductive lead electrically coupled to the electric field generator ([0039], Fig. 3), the first conductive lead configured to carry the electrical signal ([0039], Fig. 3);
a first pad coupled to the first conductive lead ([0039]-[0040], Figs. 3-4);
a second conductive lead electrically coupled to the electric field generator ([0039], Fig. 3), the second conductive lead configured to carry the electrical signal ([0039], Fig. 3); and
a second pad coupled to the second conductive lead ([0039]-[0040], Figs. 3-4), the second pad having a second electrode element and receiving the electrical signal from the second conductive lead ([0039]-[0040], Figs. 3-4), the second electrode element connected to a second conductive gel element ([0039]-[0041], Figs. 3-4).
An interpretation of Wasserman may not explicitly disclose the first pad having a conductive foam and a first conductive gel element, the conductive foam receiving the electrical signal from the first conductive lead, the conductive foam having a solid continuous phase material being at least one of constructed of a conductive material or having the conductive material attached, absorbed, or adsorbed to the solid continuous phase material, and defining a plurality of pockets interspersed throughout the solid continuous phase material, the first conductive gel element being attached, absorbed, or adsorbed to the conductive foam;
However, in the same field of endeavor (medical devices), Kirson teaches the pad having a conductive foam and a first conductive gel element ([0042], [0044]-[0046], Fig. 1; Discloses foam and hydrogel), the conductive foam receiving the electrical signal from the first conductive lead ([0042], [0044]-[0046], Figs. 1, 13; Discloses foam and hydrogel), the conductive foam having a solid continuous phase material being at least one of having the conductive material attached, absorbed, or adsorbed to the solid continuous phase material ([0044]-[0047], Figs. 1, 13; The foam is a “solid” phase material The conductive hydrogel is “attached, absorbed, or adsorbed” to the foam thus fulfilling the definition of a “conductive foam” as claimed), and defining a plurality of pockets interspersed throughout the solid continuous phase material ([0046]-[0047], Figs. 1, 13; ring shaped regions/pockets interspersed throughout the layer), the first conductive gel element being attached, absorbed, or adsorbed to the conductive foam ([0044]-[0047], Figs. 1, 13; The conductive hydrogel is “attached, absorbed, or adsorbed” to the foam thus fulfilling the definition of a both the claimed “conductive foam” and “first conductive gel element” as claimed).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pads of electrode array of Wasserman to include the specific layout configuration as recited by Kirson because Kirson provides a particular known layout configuration of the layers and describes their interactions in more detail, and combining the elements of Wasserman with those described by Kirson is Combining prior art elements according to known methods to yield predictable results of applying therapy to the body.
Regarding Claim 3, an interpretation of Wasserman further discloses an electrode layer and a dielectric layer ([0005] including “each of the electrode elements having a dielectric layer”; there’s an electrode layer and a dielectric layer on the electrode).
Wasserman may not explicitly disclose further discloses wherein the first pad further comprises the dielectric layer positioned between the at least one electrode layer and the conductive foam.
However, in the same field of endeavor (medical devices), Kirson teaches an electrode layer and a dielectric layer wherein the first pad further comprises the dielectric layer positioned between the at least one electrode layer and the conductive foam ([0042], [0046]-[0047], Figs. 1, 13-14; dielectric layer on electrodes is between electrodes and foam).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pads of electrode array of Wasserman to include the specific layout configuration as recited by Kirson because Kirson provides a particular known layout configuration of the layers and describes their interactions in more detail, and combining the elements of Wasserman with those described by Kirson is Combining prior art elements according to known methods to yield predictable results of applying therapy to the body.
Regarding Claim 4, an interpretation of Wasserman further discloses wherein the electrode layer comprises a plurality of spatially disposed electrode elements ([0001]-[0002], [0052], [0058], Figs. 3-4).
Regarding Claim 5, an interpretation of Wasserman further discloses wherein the dielectric layer comprises a plurality of spatially disposed dielectric elements ([0002] including “Each electrode element includes a ceramic disk”, [0005] including “each of the electrode elements having a dielectric layer; and a support configured to hold the plurality of electrode elements so that the dielectric layer of the electrode elements can be positioned in contact with the subject's body”, [0052], [0058], Figs. 3-4; there is a dielectric layer associated with each of the electrodes).
Regarding Claim 6, an interpretation of Wasserman further discloses wherein the dielectric elements include a ceramic material ([0002] including “Each electrode element includes a ceramic disk”, [0005] including “each of the electrode elements having a dielectric layer; and a support configured to hold the plurality of electrode elements so that the dielectric layer of the electrode elements can be positioned in contact with the subject's body”, [0052], [0058], Figs. 3-4; there is a dielectric layer associated with each of the electrodes).
Regarding Claim 10, an interpretation of Wasserman further discloses one or more temperature sensor configured to measure a temperature of the first pad ([0043]-[0044], Fig. 3-4).
Regarding Claim 11, an interpretation of Wasserman discloses a control box configured to monitor the one or more temperature sensor and turn off the electric field generator if the temperature exceeds a comfortability threshold (Abstract including “A controller input signals from the temperature sensors to determine the temperature at each of the electrode elements, and controls the state of the control input of each of the electrically controlled switches to selectively switch off the current or adjusted the duty cycle at any electrode element that is overheating.”, [0060]).
Regarding Claim 12, an interpretation of Wasserman may not explicitly disclose wherein the first conductive gel element is positioned within at least some of the pockets.
However, in the same field of endeavor (medical devices), Kirson teaches wherein the first conductive gel element is positioned within at least some of the pockets ([0044]-[0047], Figs. 1, 13;).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the pads of electrode array of Wasserman to include the specific layout configuration as recited by Kirson because Kirson provides a particular known layout configuration of the layers and describes their interactions in more detail, and combining the elements of Wasserman with those described by Kirson is Combining prior art elements according to known methods to yield predictable results of applying therapy to the body.
Claim Rejections - 35 USC § 103
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wasserman in view of Kirson in further view of US 5218973 to Weaver et al. (hereinafter Weaver).
Regarding Claim 7, an interpretation of Wasserman may not explicitly disclose at least one electrode layer electrically coupled with the conductive foam without a dielectric material positioned between the electrode layer and the conductive foam.
However, in the same field of endeavor (medical devices), Weaver teaches at least one electrode layer electrically coupled with the conductive foam without a dielectric material positioned between the electrode layer and the conductive foam (Col 4:60-Col 5:7, Col 6:9-35, Figs. 4-5; Electrode layer is in direct contact with “sponge like” foam layer).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the capacitive electrodes dielectric layer as recited by Wasserman to be a non-capacitive electrode by using a different configuration of layers which is the simple substitution for the electrode with dielectric layer as recited by Wasserman for the configuration of layers without the dielectric layer as recited by Weaver, which is the simple substitution of one known element for another to obtain predictable results.
Regarding Claim 8, an interpretation of Wasserman may not explicitly disclose wherein the electrode layer includes an electrode element in contact with the conductive foam.
However, in the same field of endeavor (medical devices), Weaver teaches wherein the electrode layer includes an electrode element in contact with the conductive foam (Col 4:60-Col 5:7, Col 6:9-35, Figs. 4-5; Electrode layer is in direct contact with “sponge like” foam layer).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the capacitive electrodes dielectric layer as recited by Wasserman to be a non-capacitive electrode by using a different configuration of layers which is the simple substitution for the electrode with dielectric layer as recited by Wasserman for the configuration of layers without the dielectric layer as recited by Weaver, which is the simple substitution of one known element for another to obtain predictable results.
Regarding Claim 13, an interpretation of Wasserman may not explicitly disclose wherein the conductive foam has a skin facing surface, and wherein the first conductive gel element is attached, absorbed, or adsorbed on the skin facing surface of the conductive foam.
However, in the same field of endeavor (medical devices), Weaver teaches wherein the conductive foam has a skin facing surface (Col 6:9-35, Figs. 4-5), and wherein the first conductive gel element is attached, absorbed, or adsorbed on the skin facing surface of the conductive foam (Col 6:9-35, Figs. 4-5; sheets 41 and 43 are disclosed as being “sponge like” layers such as foam with hydrogel layer 45 between the foam and skin).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the layout of layers of the electrode elements as recited by Wasserman in view of Kirson with the configuration of the layers as recited by Weaver because it is merely rearranging the layers as recited while still achieving the predicable result of applying signal to the body; or phrased differently the simple substitution of one known element for another to obtain predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20130190847 see Figs. 2-3, 5
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES R MOSS whose telephone number is (571)272-3506. The examiner can normally be reached Monday - Friday (9:30 am - 5:30 pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571)272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/James Moss/Examiner, Art Unit 3792
