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 § 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.
Claims 21-25, 28, and 30-38 are rejected under 35 U.S.C. 102(a)(1) and (2) as being anticipated by Wasserman et al. (US 2018/0050200, hereinafter “Wasserman”).
In regards to claim 21, Wasserman discloses a system comprising:
a plurality of transducer arrays (Figs. 1, 6A and 6B; element 50) each comprising a substrate supporting a plurality of electrode elements (Figs. 6A and 6B, element 59, “substrate”) configured for placement on the body of a patient (par. 0007) and at least one temperature sensor (Figs. 6A and 6B, element 54, “temperature sensors”), the electrode elements configured to provide TTFields (par. 0040, abstract);
at least one distal circuit operable to receive a temperature signal from the at least one temperature sensor of the plurality of transducer arrays and operable to output a DATA signal (Figs. 6A and 6B, element 40, “DATA”); and
an electric field generator electrically coupled to the at least one distal circuit and operable to receive one or more DATA signal and output one or more TTField Signal (Fig. 1, element 20, pars. 0039, 0042).
In regards to claim 22, at least one electrode element is associated with a temperature sensor (Figs. 6A and 6B, see temperature sensor 54 associated with electrode 52).
In regards to claim 23, at least one distal circuit is integrated into each of the transducer arrays (Fig. 6B see distal circuit 40 integrated with transducer array 50).
In regards to claim 24, the at least one distal circuit is integrated with the electric field generator (pars. 0039 and 0042, electrically integrated and indirectly physically integrated).
In regards to claim 25, the at least one distal circuit includes a distal circuit associated with each transducer array and the electric field generator is electrically coupled to each distal circuit (Figs. 1 and 6B).
In regards to claim 28, the at least one distal circuit is located on a wearable patch which, optionally, may be adhered or affixed to the body of the patient (par. 0062, 0068; “configured to hold the plurality of electrode elements 52 against the subject's body”, “affixed in their desired positions”).
In regards to claim 30, the system further comprises a hub (Fig. 2) electrically connected to each of the plurality of transducer arrays and which hub comprises one of the at least one distal circuit (Fig. 2, the hub also includes a “distal circuit” per claim 21 because it receives temperature signals from each of the arrays and outputs a data signal; e.g., par. 0042).
In regards to claim 31, the system comprises multiple transducer arrays, each of which has a distal circuit operable to receive a temperature signal from each of the associated temperature sensors of the electrode elements for each transducer array (Fig. 1), and wherein each distal circuit is operable to receive DATA signals (pars. 0038-0040).
In regards to claim 32, Wasserman discloses a system comprising:
a first transducer array (Fig. 1, top left element 50) comprising a first substrate supporting a plurality of first electrode elements configured for placement on the body of a patient (Fig. 6A and 6B) and at least one first temperature sensor (elements 54), the first electrode elements configured to provide TTFields (Fig. 1, top left element 50);
a junction electrically coupled to the first transducer array and operable to receive a first temperature signal from the at least one first temperature sensor of the first transducer array and operable to output the first temperature signal, and to receive a first TTField signal (Fig. 6A, element 42); and
a second transducer array comprising a second substrate supporting a plurality of second electrode elements configured for placement on the body of the patient and at least one second temperature sensor, the second electrode elements configured to provide TTFields (Fig. 1, top right element 50 with similar elements as the first transducer array);
a distal circuit (Fig. 2, elements 32 and 33) operable to receive the first temperature signal from the at least one first temperature sensor of the first transducer array from the junction and to receive a second temperature signal from the at least one second temperature sensor of the second transducer array (Fig. 2, via P1, P2, N1, N2) and operable to output a first DATA signal and a second DATA signal (via elements 32 and 33, par. 0042), wherein the distal circuit communicates with the junction (Figs. 1 and 6A); and
an electric field generator electrically coupled to the distal circuit and operable to receive the first DATA signal and the second DATA signal and output a first TTField signal and a second TTField signal (Fig. 1, element 20, pars. 0039, 0042).
In regards to claim 33, at least one first electrode element and at least one second electrode element is associated with a temperature sensor (Fig. 6A, elements 52 and 54).
In regards to claim 34, the system further comprises a hub electrically connected to the first transducer array and the second transducer array and which hub comprises the distal circuit (Fig. 2, element 30).
In regards to claim 35, Wasserman discloses a system comprising:
a first transducer array comprising a first substrate supporting a plurality of first electrode elements configured for placement on the body of a patient and at least one first temperature sensor, the first electrode elements configured to provide TTFields (Figs. 1, 6A, 6B; top left element 50 of Fig. 1 with similar elements as set forth above);
a first distal circuit operable to receive a first temperature signal from the at least one first temperature sensor of the first transducer array and operable to output a first DATA signal and to receive a first TTField Signal (Figs. 6A, 6B, element 40);
a second transducer array comprising a second substrate supporting a plurality of second electrode elements configured for placement on the body of the patient and at least one second temperature sensor, the second electrode elements configured to provide TTFields (Figs. 1, 6A, 6B; top right element 50 of Fig. 1 with similar elements as set forth above);
a second distal circuit operable to receive a second temperature signal from the at least one second temperature sensor of the second transducer array and operable to output a second DATA signal and to receive a second TTField Signal (Figs. 6A, 6B, element 40);
a cable comprising a first set of wires electrically coupled to the first transducer array and a second set of wires electrically coupled to the second transducer array (Fig. 1, elements 35 and/or 25); and
an electric field generator electrically coupled to the cable and operable to receive the first and second DATA signal and output the first TTField Signal and the second TTField Signal (Fig. 1, element 20, pars. 0039, 0042).
In regards to claim 36, at least one first electrode element and at least one second electrode element is associated with a temperature sensor (Figs. 6A and 6B, elements 52 and 54).
In regards to claim 37, Wasserman discloses a system comprising:
a first transducer array comprising a first substrate supporting a plurality of first electrode elements configured for placement on the body of a patient and at least one first temperature sensor, the first electrode elements configured to provide TTFields (Figs. 1, 6A, 6B; top left element 50 of Fig. 1 with similar elements as set forth above);
a second transducer array comprising a second substrate supporting a plurality of second electrode elements configured for placement on the body of the patient and at least one second temperature sensor, the second electrode elements configured to provide TTFields (Figs. 1, 6A, 6B; top right element 50 of Fig. 1 with similar elements as set forth above);
a distal circuit (Fig. 2, elements 32 and 33) operable to receive the first temperature signal from the at least one first temperature sensor of the first transducer array and to receive a second temperature signal from the at least one second temperature sensor of the second transducer array (Fig. 2, via P1, P2, N1, N2) and operable to output a DATA signal and receive a TTField signal (via elements 31, 32 and 33, par. 0042);
a cable comprising a first set of wires electrically coupled to the first transducer array and a second set of wires electrically coupled to the second transducer array (Fig. 1, elements 35 and/or 25); and
an electric field generator electrically coupled to the cable and operable to receive the first and second DATA signal and output the first TTField Signal and the second TTField Signal (Fig. 1, element 20, pars. 0039, 0042).
In regards to claim 38, at least one first electrode element and at least one second electrode element is associated with a temperature sensor (Figs. 6A and 6B, elements 52 and 54).
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 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Wasserman in view of Lin et al. (US 2021/0104310, hereinafter “Lin”).
Wasserman discloses the essential features of the claimed invention, including a system comprising:
a plurality of transducer arrays (Fig. 1, elements 50), each transducer array having a substrate supporting a plurality of electrode elements (Figs. 6B, element 59, “substrate”) configured for placement on the body of a patient (par. 0007) and at least one temperature sensor (Figs. 6B, element 54, “temperature sensors”), the electrode elements configured to provide TTFields (par. 0040, abstract); each transducer array having a first side of a connector (Fig. 4B, element 38), and each transducer array comprising a distal circuit electrically coupled to the transducer array and operable to receive a temperature signal from the at least one temperature sensor and the distal circuit being operable to at least output a DATA signal and to receive a TTField Signal (Fig. 4B, element 40) via a cable (Fig. 4B, element connecting 40 and 38), the distal circuit being either supported by the substrate, or integrated into the first side of the connector (Figs. 4B and 6B), or both;
the cable having four conductors (Fig. 4B, element connecting 40 and 38; note the 4 connector pins corresponding to the 4 conductors of Fig. 6B), each conductor having a first end electrically coupled to the distal circuit and a second end electrically coupled to the connector (Fig. 4B);
a hub comprising a plurality of connectors configured to mate with the first side of the connector and operable to electrically couple each of the plurality of transducer arrays to the hub (Fig. 4B, elements 30 and 38); and
an electric field generator electrically coupled to the hub and operable to receive one or more DATA signal and output one or more TTField Signal (Fig. 1, element 20, pars. 0039, 0042).
Wasserman does not expressly disclose that the connector comprises a first side having a TRRS plug and a second side having a TRRS socket. However, Lin in the same field of endeavor of connecting electrical stimulation pads (par. 0403) teaches providing connection to electrical stimulation pads via a connector comprising a first side having a TRRS plug and a second side having a TRRS socket (par. 0451, Figs. 15C and 15B) to provide the predictable results of a connector that is commercially available off the shelf to provide the desired signals to electrical stimulation pads (par. 0451). 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 Wasserman by providing connection to the electrical stimulation pads via a connector comprising a first side having a TRRS plug and a second side having a TRRS socket to provide the predictable results of a connector that is commercially available off the shelf to provide the desired signals to electrical stimulation pads.
In regards to claim 40, Wasserman discloses that at least one electrode element is associated with a temperature sensor (Figs. 6A and 6B, elements 52 and 54).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Wasserman in view of Hartman et al. (US 8,676,333, hereinafter “Hartman”). Wasserman discloses the essential features of the claimed invention except for wherein the plurality of transducer arrays are linked together in a chain and each transducer array has a distal circuit associated with it. However, Hartman in the same field of endeavor of electrical stimulation teaches providing transducer arrays that are linked together in a chain (Fig. 1b) and each transducer array has a distal circuit associated with it (Fig. 3; col. 5, lines 8-19) to provide the predictable results of reducing the number of wires that must be managed, simplifying setup and reduction for the potential for damage (col. 5, lines 20-29). 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 Wasserman by providing transducer arrays that are linked together in a chain and each transducer array has a distal circuit associated with it to provide the predictable results of reducing the number of wires that must be managed, simplifying setup and reduction for the potential for damage.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Wasserman in view of Bly et al. (US 2009/0076363, hereinafter “Bly”). Wasserman discloses the essential features of the claimed invention, including that the distal circuit can be positioned on the substrate (par. 0064), but does not expressly disclose wherein the at least one distal circuit is located on a patch adhered or affixed to the substrate. However, Bly in the same field of endeavor of wearable electrodes teaches providing a substrate wherein the at least one distal circuit is located on a patch adhered or affixed to the substrate (par. 0100) to provide the predictable results of allowing the electrode to move with the body and thus remain adhered to the skin for an extended time (par. 0100). 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 Wasserman by providing a substrate wherein the at least one distal circuit is located on a patch adhered or affixed to the substrate to provide the predictable results of allowing the electrode to move with the body and thus remain adhered to the skin for an extended time.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-25, 30, 31, and 35-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 12,083,332. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 21-25, 30, 31 are broader than (I.e., “anticipated by”) the claims of the issued patent. Claims 35-40 likewise are broader than the claims of the issued patent, except for the inclusion of cables for connecting the components and the inclusion of a TRRS connector for the connections (claims 39 and 40). However, as set forth above, provision of cables and TRRS connections for surface electrode applications are well known in the art and would have been obvious expedients. 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 the ‘332 patent by including these features to provide no more than predictable results.
Allowable Subject Matter
Claim 27 is 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. Although the prior art teaches providing a plurality of transducer arrays that are linked together in a chain (see above), the prior art, taken alone or in combination, fails to provide a teaching of the concept of providing a plurality of transducer arrays consisting of n transducer arrays linked together in a chain and there are fewer than n distal circuits present. Further, the prior art does not provide an adequate teaching for providing fewer distal circuits than transducer arrays, in combination with the remaining claim limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Hrdlicka et al. (US 6,687,538) is another example of connection means for stimulation electrodes, but fails to teach electrodes for placement on a body for TTField stimulation or the distal circuit as recited in the claims.
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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