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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 22, 2026 has been entered. By this amendment, claims 1 and 12 are amended, claim 5 is cancelled, and claims 1-4 and 6-20 are now pending in the application, with claims 12-20 withdrawn from further consideration as being drawn to a non-elected invention.
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.
Claims 1-4 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lanchava (DE 202020106283) in view of Freeman (U.S. 2022/0370788, previously cited). Regarding claim 1, Lanchava discloses a garment (hat 200, vest 400, bra 500, shorts 600), comprising: a support layer (201-205 of hat 200, 401-403 of vest 400, 501 of bra 500, and 601-603 of shorts 600) sized and dimensioned to cover at least some of a treatment area of a target region (hat 200 is sized and dimensioned to cover at least some of a treatment area of a head, vest 400 is sized and dimensioned to cover at least some of a treatment area of a torso, bra 500 is sized and dimensioned to cover at least some of a treatment area of a chest, and shorts 600 are sized and dimensioned to cover at least some of a treatment area of a bottom); a first anchor point associated with the support layer and a first position on a patient (see exemplary annotated Figure 7 below, where each of the embodiments includes a first anchor point, which is considered merely a point of connection between the support layer and a first position on a patient); a second anchor point associated with the support layer and a second position on the patient different from the first position (see exemplary annotated Figure 7 below, where each of the embodiments includes a second anchor point, which is considered merely a point of connection between the support layer and a second position on a patient); a transducer array 300 operable to deliver a TTField having a frequency between 50 kHz and 1 MHz (“The field energy electrode patch in the hat is used to treat intracranial Tumors used, the frequency of the electric field being 170-230KHz, wherein the field energy electrode patch within the vest is used to treat tumors comprising: the colon tumor, the frequency of the electric field being 30-70 KHz; small cell lung cancer, where the frequency of the electric field is 170-230 KHz; non-small cell lung cancer, where the frequency of the electric field is 120-170 KHz; and wherein the field energy electrode patch in the brassiere is used for treating breast cancer, the frequency of the electric field being 100-180 KHz; wherein the field energy electrode patch within the shorts is used to treat tumors which include: bladder cancer, where the frequency of the electric field is 100-180 KHz; ovarian cancer, the frequency of the electric field being 170-230 KHz; The field energy electrode patch in the hat is used to treat intracranial tumors, the frequency of the electric field being 200KHz; wherein the field energy electrode patch within the vest is used to treat the tumors comprising: the colon tumor, the frequency of the electric field being 50 KHz; small cell lung cancer, where the frequency of the electric field is 200 KHz; non-small cell lung cancer, where the frequency of the electric field is 150 KHz; and wherein the field energy electrode patch in the brassiere is used for treating breast cancer, the frequency of the electric field being 120-150 KHz; wherein the field energy electrode patch within the shorts is used to treat the tumors comprising: bladder cancer, wherein the frequency of the electric field is 130-150 KHz; ovarian cancer, where the frequency of the electric field is 200 KHz.”, see translation page 2, line 38-page 3, line 13), the transducer array having a skin facing surface and an opposed support layer surface, the transducer array further comprising a complementary array fastener positioned on the opposed support layer surface, and an attaching component positioned on the skin facing surface (“For the substrate 302 A rag can be used with a pressure-sensitive adhesive on both sides, with one side of the rag attached to the Inside of the portable device and the other side on the electrode sheet body 301 is glued”, page 5, lines 32-34, where the pressure-sensitive adhesive on both sides is considered the claimed “complementary array fastener positioned on the opposed support layer surface” and the claimed “attaching component positioned on the skin facing surface”); and one or more transducer array fastener connected to the support layer, and configured to attach to the complementary array fastener of the transducer array so as to support the transducer array within at least a portion of the treatment area (“The portable device is made of elastic fabric and can be wrapped on the human body, making the field energy electrode patch 300 fit closely to the human body.”, page 6, lines 8-9).
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However, Lanchava fails to disclose the transducer array fastener and the complementary array fastener being separable with a first force, the transducer array having the attaching component that when attached to the patient is separable from the patient with a second force greater than the first force, whereby application of the first force to the transducer array in a direction away from the patient does not cause separation of the transducer array from the patient. Freeman teaches a garment 100/100A-F, comprising: a support layer 51/53/51A/51B sized and dimensioned to cover at least some of a treatment area of a target region (see Figures 6A-D and 7); a first anchor point associated with the support layer and a first position on a patient (the area shown as 107 in Figures 6B and 6D); a second anchor point associated with the support layer and a second position on the patient different from the first position (the area shown as 102 in Figures 6B and 6D); a transducer array 107/102 operable to deliver a TTField (array 107/102 is considered “operable”, i.e. capable, of delivering a TTField because the electrodes would be capable of performing the function, and “the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus”, see MPEP 2114), the transducer array having a skin facing surface and an opposed support layer surface (see Figure 3), the transducer array further comprising a complementary array fastener positioned on the opposed support layer surface (“the fastener can engage with a corresponding mating portion disposed on or integrated with the housing 120 that is coupled to one of the at least two pads.”, paragraph [0141], where the “corresponding mating portion” is considered the “complementary array fastener positioned on the opposed support layer surface” as claimed), and an attaching component (adhesive layer 138, see Figure 3) positioned on the skin facing surface; and one or more transducer array fastener connected to the support layer (“the removable garment can include a retention feature”, paragraph [0140], and “the retention feature can include a fastener including at least one of hook and loop fastener strip, a tie, a snap, a button, or a combination of one or more of the foregoing. For example, the fastener can engage with a corresponding mating portion disposed on or integrated with the housing 120 that is coupled to one of the at least two pads.”, paragraph [0141]), and configured to attach to the complementary array fastener of the transducer array so as to support the transducer array within at least a portion of the treatment area (“the retention feature can include a fastener including at least one of hook and loop fastener strip, a tie, a snap, a button, or a combination of one or more of the foregoing. For example, the fastener can engage with a corresponding mating portion disposed on or integrated with the housing 120 that is coupled to one of the at least two pads.”, paragraph [0141]), the transducer array fastener and the complementary array fastener being separable with a first force (“ the interlock can be engaged by an application of hand force pressing the interlock on a mating portion and can disengage by an application of hand force pulling the interlock free of the engagement portion.”, paragraph [0141]), the transducer array having the attaching component that when attached to the patient is separable from the patient with a second force greater than the first force (“peel strength of the adhesive”, paragraph [0141]), whereby application of the first force to the transducer array in a direction away from the patient does not cause separation of the transducer array from the patient (“The disengagement hand force can be less than the peel strength of the adhesive such that removal of the removable garment does not peel the adhesive layer of the one of the at least two pads from the torso of the patient.”, paragraph [0141]). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Lanchava to make the transducer array fastener and the complementary array fastener being separable with a first force, the transducer array having the attaching component that when attached to the patient is separable from the patient with a second force greater than the first force, whereby application of the first force to the transducer array in a direction away from the patient does not cause separation of the transducer array from the patient, as taught by Freeman, in order to ensure that the transducer array can remain in place while the support structure is re-positioned, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 2, Lanchava discloses a first connection point associated with the support layer, the first connection point disposed at a first vertical position and a first horizontal position of the support layer (see annotated Figure 8 below); a second connection point associated with the support layer, the second connection point disposed at a second vertical position and a second horizontal position of the support layer, the second vertical position being vertically displaced from the first vertical position (see annotated Figure 8 below), the second horizontal position being horizontally displaced from the first horizontal position (see annotated Figure 8 below); and an adjustment assembly (the zipper shown in annotated Figure 7 below) adjustably secured to the support layer at the first connection point and the second connection point such that adjustment of the adjustment assembly varies spacing between the first connection point and the second connection point; the adjustment assembly adjustable between a first position and a second position; wherein the adjustment assembly in the first position exerts a force in a direction extending from the second connection point to the first connection point; wherein the adjustment assembly is associated with one of the first anchor point or the second anchor point (see annotated Figures 7 and 8 below).
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Regarding claim 3, Lanchava discloses that the adjustment assembly is one or more of a waist strap, a chest strap, a neck strap, and a shoulder strap (the zipper which zips up the vest is considered a waist strap and chest strap because it tightens the vest in the waist and chest areas).
Regarding claim 4, Lanchava discloses multiple transducer arrays 300 in the hat, vest, and shorts embodiments (see Figures 3, 8, 9, 13, and 14) and, thus, Lanchava discloses that the transducer array is a first transducer array, the portion is a first portion, the one or more transducer array fastener is one or more first transducer array fastener, and the complementary array fastener is a first complementary array fastener, further comprising: one or more second transducer array fastener configured to receive a second complementary array fastener of a second transducer array positioned within at least a second portion of the treatment area, the one or more second transducer array fastener receiving the second complementary array fastener. However, Lanchava fails to disclose the second transducer array fastener and the second complementary array fastener being separable by a third force, the second transducer array having an attaching component that when attached to the patient is separable from the patient with a fourth force greater than the third force. Freeman teaches a garment 100/100A-F, comprising: a support layer 51/53/51A/51B sized and dimensioned to cover at least some of a treatment area of a target region (see Figures 6A-D and 7); a first anchor point associated with the support layer and a first position on a patient (the area shown as 107 in Figures 6B and 6D); a second anchor point associated with the support layer and a second position on the patient different from the first position (the area shown as 102 in Figures 6B and 6D); a transducer array 107/102 operable to deliver a TTField (array 107/102 is considered “operable”, i.e. capable, of delivering a TTField because the electrodes would be capable of performing the function, and “the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus”, see MPEP 2114), the transducer array having a skin facing surface and an opposed support layer surface (see Figure 3), the transducer array further comprising a complementary array fastener positioned on the opposed support layer surface (“the fastener can engage with a corresponding mating portion disposed on or integrated with the housing 120 that is coupled to one of the at least two pads.”, paragraph [0141], where the “corresponding mating portion” is considered the “complementary array fastener positioned on the opposed support layer surface” as claimed), and an attaching component (adhesive layer 138, see Figure 3) positioned on the skin facing surface; and one or more transducer array fastener connected to the support layer (“the removable garment can include a retention feature”, paragraph [0140], and “the retention feature can include a fastener including at least one of hook and loop fastener strip, a tie, a snap, a button, or a combination of one or more of the foregoing. For example, the fastener can engage with a corresponding mating portion disposed on or integrated with the housing 120 that is coupled to one of the at least two pads.”, paragraph [0141]), and configured to attach to the complementary array fastener of the transducer array so as to support the transducer array within at least a portion of the treatment area (“the retention feature can include a fastener including at least one of hook and loop fastener strip, a tie, a snap, a button, or a combination of one or more of the foregoing. For example, the fastener can engage with a corresponding mating portion disposed on or integrated with the housing 120 that is coupled to one of the at least two pads.”, paragraph [0141]), the transducer array fastener and the complementary array fastener being separable with a first force (“ the interlock can be engaged by an application of hand force pressing the interlock on a mating portion and can disengage by an application of hand force pulling the interlock free of the engagement portion.”, paragraph [0141]), the transducer array having the attaching component that when attached to the patient is separable from the patient with a second force greater than the first force (“peel strength of the adhesive”, paragraph [0141]), whereby application of the first force to the transducer array in a direction away from the patient does not cause separation of the transducer array from the patient (“The disengagement hand force can be less than the peel strength of the adhesive such that removal of the removable garment does not peel the adhesive layer of the one of the at least two pads from the torso of the patient.”, paragraph [0141]). It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the invention of Lanchava to make second transducer array fastener and the second complementary array fastener being separable by a third force, the second transducer array having an attaching component that when attached to the patient is separable from the patient with a fourth force greater than the third force, as taught by Freeman, in order to ensure that the transducer array can remain in place while the support structure is re-positioned, and as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 6, Lanchava discloses that the first portion of the treatment area overlaps with at least a portion of the second portion of the treatment area (see Annotated Figure 8 below). It is respectfully submitted that the recitations of a “first portion of the treatment area” and a “second portion of the treatment area” are arbitrary designations that can be defined arbitrarily. If Applicant intends for the first transducer array to overlap the second transducer array, then it is recommended by Applicant claim such. Claim 1 broadly requires “a support layer sized and dimensioned to cover at least some of a treatment area of a target region” and “to support the transducer array within at least a portion of the treatment area” and claim 4 broadly requires that “the portion is a first portion” and “a second transducer array positioned within at least a second portion of the treatment area”. As is shown below, the first portion may be considered the top portion of the torso, while the second portion may be considered the bottom portion of the torso and satisfy the claim limitations. Applicant is recommended to further define these “portions”.
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Regarding claim 7, Lanchava discloses that the one or more second transducer array fastener includes multiple spatially disposed second transducer array fasteners configured to be positioned adjacent to the treatment area (there are multiple second transducer arrays and, therefore, would be multiple second transducer array fasteners, one corresponding to each transducer array).
Regarding claim 8, Lanchava discloses that the one or more transducer array fastener is selectably associated with the support layer (“For the substrate 302 A rag can be used with a pressure-sensitive adhesive on both sides, with one side of the rag attached to the Inside of the portable device and the other side on the electrode sheet body 301 is glued”, page 5, lines 32-34).
Regarding claim 9, Lanchava discloses that the transducer array is attached to the support layer via the complementary array fastener engaging the transducer array fastener (“For the substrate 302 A rag can be used with a pressure-sensitive adhesive on both sides, with one side of the rag attached to the Inside of the portable device and the other side on the electrode sheet body 301 is glued”, page 5, lines 32-34), the transducer array further operable to receive a TTField signal and generate a TTField based on the TTField signal (“Device for treating tumors of several organs based on an electric field”, Abstract).
Regarding claim 10, Lanchava discloses the invention substantially as claimed, but fails to disclose that the transducer array fastener and the complementary array fastener comprise a snap fastener having a snap member and a receiving member configured to receive the snap member. Freeman teaches that a retention feature for attaching transducer arrays to the support structure may comprise that the transducer array fastener and the complementary array fastener comprise a snap fastener having a snap member and a receiving member configured to receive the snap member (“In implementations, the retention feature can include a fastener including at least one of hook and loop fastener strip, a tie, a snap, a button, or a combination of one or more of the foregoing.”, paragraph [0141]). 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 invention of Lanchava such that the transducer array fastener and the complementary array fastener comprise a snap fastener having a snap member and a receiving member configured to receive the snap member, as taught by Freeman, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Regarding claim 11, Lanchava discloses the invention substantially as claimed, but fails to disclose that the transducer array fastener and the complementary array fastener comprise a hook and loop fastener having a hook member and a loop member configured to engage the hook member. Freeman teaches that a retention feature for attaching transducer arrays to the support structure may comprise that the transducer array fastener and the complementary array fastener comprise a hook and loop fastener having a hook member and a loop member configured to engage the hook member (“In implementations, the retention feature can include a fastener including at least one of hook and loop fastener strip, a tie, a snap, a button, or a combination of one or more of the foregoing.”, paragraph [0141]). 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 invention of Lanchava such that the transducer array fastener and the complementary array fastener comprise a hook and loop fastener having a hook member and a loop member configured to engage the hook member, as taught by Freeman, as it has been held that combining prior art elements according to known methods to yield predictable results requires only routine skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Response to Arguments
Applicant’s arguments with respect to claims 1-4 and 6-11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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