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 Amendment
This Office Action is responsive to the amendment filed on 29 Jun 2026. As directed by the amendment: claims 18 and 20 have been amended, claim 19 has been canceled, claims 14-18 and 20 have been withdrawn, and no claims have been added. Thus, claims 1-13 are presently pending examination.
Claim Rejections - 35 USC § 112
Claims 12 and 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.
The term “approximately equidistant” in claims 12 and 13 is a relative term which renders the claim indefinite. The term “approximately equidistant” 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. It is unclear as to how differently the distances between hub ports can differ and still be considered “approximately equidistant”.
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.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wasserman et al. (US 20220096819 A1), hereinafter Wasserman, in view of Palti (US 7565205 B2).
Regarding claim 1, Wasserman discloses a transducer array (Fig. 1, paragraph [0043], system 10), comprising:
a hub (Fig. 1, paragraph [0048], hub 30; Fig. 6, paragraph [0106], hub 30a) comprising a housing having a housing peripheral edge having a boundary (Fig. 10, paragraph [0113], housing 350), and a hub port supported by the housing, the hub port positioned within the boundary of the housing peripheral edge (Fig. 10, paragraph [014], port 358); and
a transducer subarray (Fig. 1, paragraph [0043], transducer array 50) comprising an electrode (Fig. 3, paragraph [0043], electrode element 52), a subarray port (Fig. 8, paragraph [0108], second portion 142a of a USB-C port), and a support layer having a support layer peripheral edge and supporting the electrode and the subarray port (Fig. 4C, paragraphs [0072], [0075], [0089]-[0090], substrate 59),
the subarray port coupling the hub port and the electrode (paragraph [0075], "The first portion 140 of the connector 42a mates with the second portion 142 of the connector 42a such that electrical signals are configured to pass through the connector 42a from the transducer array 50 to the distal circuit 40 and then the hub 30. ... The AC current signal 110a may continue through appropriate wiring on the substrate 59 such that the one or more electrode elements 52 may be electrically connected to a corresponding conductor of the cable 35"),
the electrode receiving an alternating current waveform from the hub via the subarray port (paragraph [0071], "ten signals 110 may traverse the connector 42 with one signal 110a for the AC current to the one or more electrode elements 52"; paragraph [0073], "The cable 35 may include (i) a conductor 51 that permits current (e.g., AC current) to flow between the first end 120 of the cable 35 and the second end 122 of the cable 35"; paragraph [0075], "The AC current signal 110a may continue through appropriate wiring on the substrate 59 such that the one or more electrode elements 52 may be electrically connected to a corresponding conductor of the cable 35").
Wasserman does not explicitly disclose that the alternating current waveform has a frequency in a range between 50 kHz-1 MHz.
However, Palti teaches methods of selective destruction of rapidly dividing cells in a localized area (column 1, lines 38-39), wherein an electrode (Fig. 2A, electrodes 28 and 32) receives an alternating current waveform having a frequency in a range between 50 kHz-1 MHz (column 11, lines 40-43, "the electric fields that are used are alternating fields having frequencies that are in the range from about 50 KHz to about 500 KHz, and preferably from about 100 KHz to about 300 KHz").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wasserman with the teachings of Palti so that the alternating current waveform has a frequency in a range between 50 kHz-1 MHz, because doing so increases the probability of breaking the cell membrane and disrupt cell structures (Palti, column 7, lines 1-14) of actively dividing cells without damaging normal cells (Palti, column 5, lines 50-53).
Regarding claim 2, the transducer array of claim 1 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that
the hub further comprises a hub lead connector port supported by the housing (Fig. 6, paragraph [0106], signal connector 21), and
the transducer array further comprises: a conductive lead electrically coupled to the hub lead connector port (Fig. 6, paragraph [0106], "system 10a includes a signal connector 21 as an electric field generator connector operable to connect the cable 25 to the electric field generator 20. As shown in FIG. 6, the cable 25 may be an 8-conductor cable electrically coupled to a hub 30a").
Regarding claim 3, the transducer array of claim 1 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that the subarray port of the transducer subarray is disposed at least partially within the support layer peripheral edge (paragraph [0075], "second portion 142 of the connector 42a may be provided at or on the substrate 59"; Fig. 8 depicts second portion 142a between electrodes 52).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to place the subarray port within the support layer peripheral edge, for the purpose of optimizing the device's durability, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 4, the transducer array of claim 1 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that the electrode is a first electrode (Fig. 1 depicts four transducer arrays 50), the hub port is a first hub port (Fig. 10 depicts four ports 358),
wherein the hub further comprises a second hub port supported by the housing, the second hub port positioned within the boundary of the housing peripheral edge (Fig. 10 depicts four ports 358),
wherein the transducer subarray is a first transducer subarray, the subarray port is a first subarray port, the support layer is a first support layer, and the support layer peripheral edge is a first support layer peripheral edge (Fig. 1 depicts four transducer arrays 50), and
further comprising a second transducer subarray, the second transducer subarray comprising a second electrode, a second subarray port, a second support layer, having a second support layer peripheral edge and supporting the second electrode and the second subarray port (Fig. 1 depicts four transducer arrays 50),
the second subarray port coupling the second hub port and the second electrode (paragraph [0075], "The first portion 140 of the connector 42a mates with the second portion 142 of the connector 42a such that electrical signals are configured to pass through the connector 42a from the transducer array 50 to the distal circuit 40 and then the hub 30. ... The AC current signal 110a may continue through appropriate wiring on the substrate 59 such that the one or more electrode elements 52 may be electrically connected to a corresponding conductor of the cable 35"),
the second electrode receiving the alternating current waveform from the hub via the second subarray port (paragraph [0071], "ten signals 110 may traverse the connector 42 with one signal 110a for the AC current to the one or more electrode elements 52"; paragraph [0073], "The cable 35 may include (i) a conductor 51 that permits current (e.g., AC current) to flow between the first end 120 of the cable 35 and the second end 122 of the cable 35"; paragraph [0075], "The AC current signal 110a may continue through appropriate wiring on the substrate 59 such that the one or more electrode elements 52 may be electrically connected to a corresponding conductor of the cable 35").
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a second hub port and second transducer array, for the purpose of increasing the device's area of effect, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 5, the transducer array of claim 4 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that the first support layer peripheral edge of the first transducer subarray has a first shape and the second support layer peripheral edge of the second transducer subarray has a second shape different from the first shape (paragraph [0045], "In the event that a transducer array may be too large, or of an unsuitable shape to conveniently conform to the desired location of the body (for example, an array to be positioned on the side of the head where the ears partially block the desired location of the array), the array may be cut to a more convenient size and/or shape").
Furthermore, it would have been an obvious matter of design choice to make the second transducer subarray with a second shape different from the first shape, for the purpose of fitting the transducer subarray to a different part of the body than the first transducer subarray, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 6, the transducer array of claim 4 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that the first support layer peripheral edge of the first transducer subarray has a first shape and the second support layer peripheral edge of the second transducer subarray has a second shape congruent with the first shape (paragraph [0045], "In the event that a transducer array may be too large, or of an unsuitable shape to conveniently conform to the desired location of the body (for example, an array to be positioned on the side of the head where the ears partially block the desired location of the array), the array may be cut to a more convenient size and/or shape").
Furthermore, it would have been an obvious matter of design choice to make the second transducer subarray with a second shape congruent with the first shape, for the purpose of ensuring that similar amounts of stimulation are delivered to different parts of the body, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 7, the transducer array of claim 4 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that the first support layer of the first transducer subarray has a first area and the second support layer of the second transducer subarray has a second area different from the first area (paragraph [0045], "In the event that a transducer array may be too large, or of an unsuitable shape to conveniently conform to the desired location of the body (for example, an array to be positioned on the side of the head where the ears partially block the desired location of the array), the array may be cut to a more convenient size and/or shape").
Furthermore, it would have been an obvious matter of design choice to make the second transducer subarray with a second area different from the first area, for the purpose of fitting the transducer subarray to a different part of the body than the first transducer subarray, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 8, the transducer array of claim 4 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that the first support layer of the first transducer subarray has a first area and the second support layer of the second transducer subarray has a second area congruent with the first area (paragraph [0045], "In the event that a transducer array may be too large, or of an unsuitable shape to conveniently conform to the desired location of the body (for example, an array to be positioned on the side of the head where the ears partially block the desired location of the array), the array may be cut to a more convenient size and/or shape").
Furthermore, it would have been an obvious matter of design choice to make the second transducer subarray with a second area congruent with the first area, for the purpose of ensuring that similar amounts of stimulation are delivered to different parts of the body, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 9, the transducer array of claim 2 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that the conductive lead comprises a first end (Fig. 6, signal connector 21) and a second end (end of cable 25 connected to hub 30a), the second end of the conductive lead being operable to be selectively coupled to the hub lead connector port (paragraphs [0115]-[0116], "cable 366 is used in place of the cable 25 shown in FIG. 1. ... cable 366 is a USB-C cable and is connected to the hub 30a via a USB-C connection").
Regarding claim 10, the transducer array of claim 1 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that the transducer subarray comprises more than one electrode (Fig. 3, paragraph [0027], one or more electrode elements 52), each electrode being configured to receive the alternating current waveform (paragraph [0075], "The AC current signal 110a may continue through appropriate wiring on the substrate 59 such that the one or more electrode elements 52 may be electrically connected to a corresponding conductor of the cable 35").
Regarding claim 11, the transducer array of claim 1 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that the housing of the hub further comprises a first surface and a second surface, the hub further comprising an additional electrode disposed on at least a first portion of the first surface of the housing and being configured to receive the alternating current waveform (paragraphs [0117]-[0122], "housing 350 of the hub 30a may further include an attaching member 368. The attaching member 368 may be attached to the housing 350 ... In one embodiment, the attaching member 368 is a hook and loop fastener. ... One of the hook component and the loop component may be attached to the housing 350 ... the other of the hook component and the loop component may be attached to...a particular electrode array 50").
Regarding claim 12, the transducer array of claim 1 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that a number of hub ports, n, are distributed around the housing peripheral edge equidistant or approximately equidistant from each other (Fig. 10 depicts n=4 ports 358 distributed around peripheral edge of hub 30a approximately equidistant from each other), and
n transducer subarrays are each coupled to a respective one of the n hub ports via a respective subarray port (Fig. 10 depicts n=4 array connectors 354, which allow connections to n subarrays; paragraph [0115]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to distribute the hub ports approximately equidistant from each other, for the purpose of optimizing the user's comfort, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 13, the transducer array of claim 1 is obvious over Wasserman and Palti, as explained above. Wasserman further discloses that a number of hub ports, n, are distributed around the housing peripheral edge equidistant or approximately equidistant from each other (Fig. 6 depicts n=5 hub ports distributed around peripheral edge of hub 30a approximately equidistant from each other), and
n-1 or n-2 transducer subarrays are each coupled to a respective one of the n hub ports via a respective subarray port (Fig. 6 depicts n-1=4 connectors 42a-1 to 42a-4, which allow connections to n-1 subarrays; paragraph [0110]).
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to distribute the hub ports approximately equidistant from each other, for the purpose of optimizing the user's comfort, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Southwell et al. (US 20180289955 A1) discloses an electrode connector assembly for the use in transcutaneous electrical stimulation comprising a flexible web extending in a plane; first, second, third and fourth electrode connectors carried by the web and spaced from each other about the web in the plane; an electrical connector; and first, second, third and fourth conductors electrically coupling the respective first, second, third and fourth electrode connectors to the electrical connector.
Matsushita (US 20220203086 A1) discloses electrical stimulation fitness wear comprising multiple electrical cables 36 respectively connect the multiple electrode parts 30 to a connection part of a control unit electrically.
Shen et al. (CN 114099957 A) discloses a tumour electric field treatment system, comprising electrode arrays configured to connect to a hub (Figs. 21-30).
Sun et al. (CN 114099956 A) discloses a tumour electric field treatment system and electrode patch assembly, comprising electrode arrays configured to connect to a hub (Figs. 4-6).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE SISON whose telephone number is (703)756-4661. The examiner can normally be reached 8 am - 5 pm PT, Mon - Fri.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINE SISON/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
Prosecution Insights