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
2. This action is responsive to the amendments filed 6/3/2026. Claims 1, 17, and 20 have been amended. No claims were newly added or have been canceled.
Response to Arguments
3. Applicant’s arguments filed on 6/3/2026 with respect to the art rejections have been fully considered but they are not persuasive. In substance, applicant argues that A) Rainey fails to disclose or suggest “electrically coupled electrodes” because “each electrode is electrically isolated from another electrode” and B) Rainey fails to disclose or suggest “configured to deliver tumor treating fields to the subject’s body” as recited in claim 1.
4. In response to A), the examiner respectfully disagrees.
At the onset, it is important to note the scope of the claims. Electrical coupling is the transfer or sharing of electrical signals, energy, or current between two or more electrical components, circuits, cells, systems, etc., such that activity in one influences activity in another. The claims merely require that the electrodes need to be electrically coupled in some manner and do not define the element that they are electrically coupled to. Rainey discloses electrical coupling in at least paragraph 0126. The connectors 1952, 1954, 1956 and 1958 provide electrical signals to the electrodes 1942, 1944, 1946 and 1948 respectively, when connected to an electrical generator and therefore the electrodes are electrically coupled. Thus, Rainey teaches the scope of the limitations as currently claimed.
5. In response to B), the examiner respectfully disagrees.
At the onset, it is important to note the scope of the claims. Claim 1 only recites a transducer with an electrode array. Device claims cover what a device is, not what the device does. Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). So long as the device is capable of performing a function, the metes and bounds of the claims have been met. With regards to the limitation of “configured to deliver tumor treating fields to the subject’s body”, the Examiner notes that there is no pulse generator currently recited in the claims. Thus, the electrode array of the transducer apparatus needs to only be capable of having such a signal applied to it. Electrodes can apply a variety of different signals (including tumor treating fields) and it is the Examiner’s position that Rainey is capable of delivering tumor treating fields because electrical currents can be used to treat tumors as evidenced by Schaefer (NPL Reference, “Efficacy of Direct Electrical Current Therapy and Laser-Induced Interstitial Thermotherapy in Local Treatment of Hepatic Colorectal Metastases”, published 2/26/2007; see pg. 230 – Background heading) as a non-limiting example. The device of Rainey delivers electrical stimulation, therefore it is capable of supplying a tumor treating field. Thus, Rainey meets the scope of the limitations as currently claimed.
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.
Claims 1-5, 7-8, 10-11, and 20 are rejected under 35 U.S.C 103 as being unpatentable over Rainey et al. (US Pub.: 2008/0215128 A1, – Previously Cited).
Regarding claim 1, Rainey teaches a transducer apparatus for delivering tumor treating fields to a subject's body (e.g. paragraph 0126, – electrical stimulation; Examiner notes that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (See MPEP 2111.02(II)), the transducer apparatus (e.g. Fig. 13. – electrode arrangement 1900) comprising:
an array of electrically coupled electrodes (e.g. Fig. 13; electrodes 1942, 1944, 1946, 1948; paragraph 0126, – the electrodes are electrically coupled), the array configured to be positioned over the subject's body with a face of the array facing the subject's body and configured to deliver tumor treating fields to the subject’s body (e.g. abstract; paragraphs 0126-0127, – electrodes applying electrical stimulation; Examiner notes that this limitation contains functional language and it is the Examiner’s position that Rainey’s electrodes are capable of delivering tumor treating fields. Please see response to arguments above);
a substrate (e.g. Fig 13. – element 5 in annotated figure below), wherein:
the array of electrically coupled electrodes (1942, 1944, 1946, 1948) is disposed entirely on a first side of the substrate (5), the face of the array faces away from the substrate (5);
and wherein, when viewed from a direction perpendicular to the face of the array, a non-adhesive region (e.g. Fig. 13 – element 6 in annotated figure below), where no adhesive layer is present, is located between a pair of adjacent electrically coupled electrodes of the array (e.g. Fig 13. – electrodes 1942 and 1944), wherein the non-adhesive region spans at least 25% of a total distance between the pair of adjacent electrically coupled electrodes for at least one measurement as measured along a straight line between the pair of adjacent electrically coupled electrodes (e.g. Fig 13. – dashed arrow and element 6 in annotated figure below. The dashed arrow illustrates the distance between adjacent electrode pairs 1942 and 1944. There is no adhesive between the electrode pairs.).
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However, Rainey does not explicitly teach the substrate comprising an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array.
Rainey, in another embodiment, discloses a substrate comprising an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array (e.g. paragraph 0089, – adhesive sealing gel 231).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rainey to include an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array, as taught and suggested by another embodiment of Rainey, in order to provide the predictable results of enhancing patient comfort by maintaining the electrodes in the proper position when applied to the skin during therapy.
Regarding claim 2, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein the non-adhesive region spans at least 50% of the total distance between the pair of adjacent electrodes (e.g. Fig 13. – dashed arrow and element 6 in annotated figure above).
Regarding claim 3, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein the non-adhesive region spans at least 100% of the total distance between the pair of adjacent electrodes (e.g. Fig 13. – dashed arrow and element 6 in annotated figure above).
Regarding claim 4, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein, when viewed from the direction perpendicular to the face of the array, an external perimeter of the adhesive layer has at least one concave portion (1920); and the non-adhesive region (6) is bounded by a concave portion of the at least one concave portion of the external perimeter (1920).
Regarding claim 5, Rainey teaches the transducer apparatus of claim 4 as discussed above, and Rainey further teaches wherein, when viewed from the direction perpendicular to the face of the array, a second non-adhesive region, where no adhesive layer is present, is located between a second pair of adjacent electrodes of the array (e.g. Fig. 13 – area between electrode 1946 and electrode 1948), wherein the second non-adhesive region spans at least 25% of a total distance between the second pair of adjacent electrodes for at least one measurement as measured along a straight line between the second pair of adjacent electrodes (e.g. Fig. 13 – distance between electrode 1946 and electrode 1948); and the second non-adhesive region is also bounded by the concave portion of the at least one concave portion of the external perimeter (1920).
Regarding claim 7, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein when viewed in the direction perpendicular to the face of the array, an opening is present within the adhesive layer (e.g. Fig. 13 – aperture 1970), the opening (1970) having a perimeter surrounded on all sides by the adhesive layer (1920); and the non-adhesive region (6) is located within the perimeter of the opening (1970).
Regarding claim 8, Rainey teaches the transducer apparatus of claim 7 as discussed above, and Rainey further teaches wherein, when viewed from the direction perpendicular to the face of the array, a second non-adhesive region, where no adhesive layer is present, is located between a second pair of adjacent electrodes of the array (e.g. Fig. 13 – area between electrode 1946 and electrode 1948), wherein the second non-adhesive region spans at least 25% of a total distance between the second pair of adjacent electrodes for at least one measurement as measured along a straight line between the second pair of adjacent electrodes (e.g. Fig. 13 – distance between electrode 1946 and electrode 1948); and the second non-adhesive region is also located within the perimeter of the opening (1970).
Regarding claim 10, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein when viewed from the direction perpendicular to the face of the array, the substrate (5) has at least two separate adhesive layers spaced apart from each other by the non-adhesive region (e.g. Fig. 13; adhesive layers are separated by the non-adhesive region).
Regarding claim 11, Rainey teaches the transducer apparatus of claim 1 as discussed above, and Rainey further teaches wherein the non-adhesive region is a space where no portion of the substrate is located (e.g. Fig. 13 – aperture 1970).
Regarding claim 20, Rainey teaches a transducer apparatus for delivering tumor treating fields to a subject's body (e.g. paragraph 0126, – electrical stimulation; Examiner notes that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (See MPEP 2111.02(II)), the transducer apparatus comprising:
an array of electrically coupled electrodes (e.g. Fig. 13; electrodes 1942, 1944, 1946, 1948; paragraph 0126, – the electrodes are electrically coupled), the array configured to be positioned over the subject's body with a face of the array facing the subject's body and configured to deliver tumor treating fields to the subject’s body (e.g. abstract; paragraphs 0126-0127, – electrodes applying electrical stimulation; Examiner notes that this limitation contains functional language and it is the Examiner’s position that Rainey’s electrodes are capable of delivering tumor treating fields);
a substrate (e.g. Fig 13. – element 5 in annotated figure above as used in claim 1).
However, Rainey does not explicitly teach a substrate with at least one adhesive region thereon for attaching the transducer apparatus to the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, a ratio Sa/Se of a surface area of the at least one adhesive region (Sa) to a surface area of the array of electrically coupled electrodes (Se) is less than 1.5, wherein the surface area of the at least one adhesive region (Sa) is defined as all adhesive portions of the transducer apparatus that touch the subject's skin upon application of the transducer apparatus to the subjects body, and excludes any areas of the adhesive region overlapping the electrically coupled electrodes of the array.
Rainey, in another embodiment, discloses a substrate with at least one adhesive region thereon for attaching the transducer apparatus to the subject's body (e.g. paragraph 0089, – adhesive sealing gel 231); wherein, when viewed from a direction perpendicular to the face of the array, a ratio Sa/Se of a surface area of the at least one adhesive region (Sa) to a surface area of the array of electrically electrodes (Se) is less than 1.5, wherein the surface area of the at least one adhesive region (Sa) is defined as all adhesive portions of the transducer apparatus that touch the subject's skin upon application of the transducer apparatus to the subjects body (e.g. paragraph 0089), and excludes any areas of the adhesive region overlapping the electrically coupled electrodes of the array (e.g. paragraph 0089).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rainey to incorporate at least one adhesive region thereon for attaching the transducer apparatus to the subject's body; wherein, when viewed from a direction perpendicular to the face of the array, a ratio Sa/Se of a surface area of the at least one adhesive region (Sa) to a surface area of the array of electrically coupled electrodes (Se) is less than 1.5, wherein the surface area of the at least one adhesive region (Sa) is defined as all adhesive portions of the transducer apparatus that touch the subject's skin upon application of the transducer apparatus to the subjects body, and excludes any areas of the adhesive region overlapping the electrically coupled electrodes of the array, as taught and suggested by another embodiment of Rainey, in order to provide the predictable results of enhancing patient comfort by maintaining the electrodes in the proper position when applied to the skin during therapy and making it easier to remove from the skin once therapy is concluded.
Claim 14 is rejected under 35 U.S.C 103 as being unpatentable over Rainey and further in view of Palero et al. (US Pub.: 2017/0189704 A1, – Previously Cited).
Regarding claim 14, Rainey teaches the transducer apparatus of claim 1 as
discussed above. However, Rainey does not explicitly teach wherein one or more of the electrodes of the array have a triangular shape, a substantially triangular shape with rounded corners, a truncated triangular shape, a substantially truncated triangular shape with rounded corners, a wedge shape, a substantially wedge shape with rounded corners, a truncated wedge shape, or a substantially truncated wedge shape with rounded corners.
Palero, in a same field of endeavor of electrical stimulation, discloses wherein one or more of the electrodes of the array have a triangular shape, a substantially triangular shape with rounded corners, a truncated triangular shape, a substantially truncated triangular shape with rounded corners, a wedge shape, a substantially wedge shape with rounded corners, a truncated wedge shape, or a substantially truncated wedge shape with rounded corners (e.g. paragraph 0030, – triangular electrode).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transducer of Rainey to include wherein one or more of the electrodes of the array have a triangular shape, as taught and suggested by Palero, because it is a simple substitution of one known electrode shape for another in order to obtain the predictable results of effective electrical stimulation performed on the skin.
Claim 15 is rejected under 35 U.S.C 103 as being unpatentable over Rainey and further in view of Rubinson et al. (US Pub.: 2013/0001090 A1, – Previously Cited).
Regarding claim 15, Rainey teaches the transducer apparatus of claim 1 as discussed above. However, Rainey does not explicitly teach wherein the electrodes in the array comprise polymer films.
Rubinson, in a same field of endeavor of electrical stimulation, discloses wherein the electrodes in the array comprise polymer films (e.g. paragraphs 0009, 0098).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transducer of Rainey to incorporate wherein the electrodes in the array comprise polymer films, as taught and suggested by Rubinson, in order to improve/enhance the flexibility of the electrodes as well as to lower electrical impedance (Rubinson, paragraph 0098).
Claims 17-18 are rejected under 35 U.S.C 103 as being unpatentable over Rainey and further in view of Palti et al. (US Pub.: 2013/0178820 A1).
Regarding claim 17, Rainey teaches a method of applying tumor treating fields to a subject's body (e.g. paragraph 0126, – electrical stimulation; Examiner notes that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (See MPEP 2111.02(II)), the method comprising:
locating a first transducer in a first position on the subject's body (e.g. paragraph 0016), the first transducer (e.g. Fig. 13 – electrode arrangement 1900) comprising:
an array of electrically coupled electrodes (e.g. Fig. 13; electrodes 1942, 1944, 1946, 1948; paragraph 0126, – the electrodes are electrically coupled), the array configured to be positioned over the subject's body with a face of the array facing the subject's body (e.g. abstract; paragraph 0127);
a substrate (e.g. Fig 13. – element 5 in annotated figure above as applied in claim 1), wherein:
the array of electrically coupled electrodes (1942, 1944, 1946, 1948) is disposed entirely on a first side of the substrate, the face of the array faces away from the substrate (5);
and wherein, when viewed from a direction perpendicular to the face of the array, a non-adhesive region, where no adhesive layer is present, is located between a pair of electrically coupled adjacent electrodes of the array (e.g. Fig 13. – element 6 in annotated figure above as applied in claim 1), wherein the non-adhesive region spans at least 25% of a total distance between the pair of adjacent electrically coupled electrodes for at least one measurement as measured along a straight line between the pair of adjacent electrically coupled electrodes (e.g. Fig 13. – element 6 in annotated figure above); inducing an electric field between the first transducer and a second transducer located on the subject's body (e.g. paragraphs 0126-0127, – electrodes applying electrical stimulation). However, Rainey does not explicitly teach a substrate comprising an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array; inducing an electric field between the first transducer and a second transducer located on the subject's body to apply tumor treating fields to the subject’s body.
Rainey, in another embodiment, discloses a substrate comprising an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array (e.g. paragraph 0089, – adhesive sealing gel 231).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rainey to include an adhesive layer for attaching the transducer apparatus to the subject's body and the adhesive layer is on the first side of the substrate facing the same direction as the face of the array, as taught and suggested by another embodiment of Rainey, in order to provide the predictable results of enhancing patient comfort by maintaining the electrodes in the proper position when applied to the skin during therapy.
However, Rainey does not explicitly teach inducing an electric field between the first transducer and a second transducer located on the subject's body to apply tumor treating fields to the subject’s body.
Palti, in a same field of endeavor of electrical stimulation, discloses inducing an electric field between the first transducer and a second transducer located on the subject's body to apply tumor treating fields to the subject’s body (e.g. Fig. 11; paragraphs 0043, 0081, 0106).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rainey to incorporate inducing an electric field between the first transducer and a second transducer located on the subject's body to apply tumor treating fields to the subject’s body, as taught and suggested by Palti, for the purpose of being able to provide additional treatments to a patient such as treating tumors associated with lung cancer (Palti, paragraph 0043).
Regarding claim 18, Rainey in view of Palti teaches the method of claim 17 as discussed above, and Rainey further teaches wherein, when viewed from the direction perpendicular to the face of the array, an external perimeter of the adhesive layer has at least one concave portion (1920); and the non-adhesive region (6) is bounded by a concave portion of the at least one concave portion of the external perimeter (1920).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL TEHRANI whose telephone number is (571)270-0697. The examiner can normally be reached 9:00am-5:00pm.
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, 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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/D.T./Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792
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