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 .
Information Disclosure Statement
The information disclosure statement(s) filed 05/03/2024, 06/07/2024, 07/31/2024, 08/13/2024, 09/26/2024, 01/08/2025, 07/09/2025, 09/22/2025, 01/26/2026, and 02/27/2026 has/have been considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities:
CROSS-REFERENCE TO RELATED APPLICATIONS should reference the issued U.S. Patent 12,268,863 B2 for U.S. Patent Application No. 18/432,933. Appropriate correction is required.
Election/Restrictions
The application contained claims directed to the following patentably distinct species:
Invention I: claims 1-9, directed to a transducer apparatus.
Invention II: claims 10-24, directed to a transducer apparatus.
Invention III: claims 25-26, directed to a transducer apparatus.
Applicant's election with traverse of claims 1-9 in the reply filed on 03/23/2026 is acknowledged. The traversal is on the ground(s) that the inventions are not mutually exclusive, are obvious variants, and no search burden is present. This is not found persuasive because:
Although the specification teaches that the features of the claims may be combined in a single apparatus, the claims are directed to transducer apparatuses with elements of which are mutually exclusive from one another, thereby creating distinct species with no generic claims which in turn creates undue search burden on the Examiner and necessitate an election of species. It is important to note that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Mutually exclusive elements in the claims include invention II’s graphite anisotropic layer absent in inventions I and III, and invention II-III’s plurality of slits or cuts in the layer of anisotropic material absent in invention I. Invention II also includes “one or more cutouts have a closed shape so that the one or more cutouts are surrounded by the polymeric material layer when viewed from a direction perpendicular to the face of the array” absent in inventions I and III. Invention I also require the polymeric material layer having a thickness of less than or equal to 250 µm, absent in inventions II-III. Therefore, since the claims are directed to distinct species with mutually exclusive elements, the divergent subject matter of the inventions are not considered by the Examiner to be obvious variants, creating undue search burden for the Examiner and thus a restriction via election of species was required.
In regards to the assertion that no search burden exists, the claims incorporate divergent subject matter in each of the inventions which require extensive searching in differing subclasses. Applicant asserts that the search would be in the same class, namely A61N 1/0476, however the claims and their divergent subject matter in defining the structural elements would require searching in at least the entirety of A61N Electrotherapy CPC class to search and apply art to teach electrode elements that are present in one invention and absent others. As discussed above, the species themselves are directed to mutually exclusive elements, specifically inventions II-III containing mutually exclusive elements from the elected invention I. There is no significant overlap in the inventions that completely eliminate or even significantly reduce Examiner search burden due to the diverging and additional mutually exclusive elements in the inventions/species in the present claims, despite the specification and Applicant’s assertation of the features being combinable. Therefore, due to the number of claims (now 27 total claims), the divergent subject matter of the inventions, and the requirement of different fields of search to search and apply art for these divergent subject matters, it is considered by the Examiner that there is a serious search and/or examination burden for the claims.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 5-6 and 9 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Schmidt (US 20190117971 A1 – hereinafter Schmidt).
Re. claim 1, Schmidt teaches transducer apparatus for delivering tumor treating fields to a subject's body (paragraph 0002 – “Embodiments herein relate to medical devices including volume filling leads and methods for using the same to treat cancerous tumors within a bodily tissue. More specifically, embodiments herein relate to using volume filling leads and electrodes configured to generate therapeutic electric fields at the site of a cancerous tumor”; figures 8-9),
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the transducer apparatus comprising:
an array of electrodes (figures 8-9, electrode array 812), the array configured to be positioned over the subject's body with a face of the array facing the subject's body (paragraph 0084 – “The lead 802 can include two or more electrodes 812 disposed on an outer surface of the expandable lead head 81”),
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the array comprising:
electrode elements positioned in substantially symmetrical positions arranged around a centroid of the array (figure 9 shows the electrodes 812 are positioned symmetrically);
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a void space located between at least one pair of adjacent electrodes of the array (figure 9 shows voice spaces between the electrodes 812);
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and a polymeric material layer overlaying the array of electrodes and located on a side of the array facing away from the subject's body (figures 8-9, expandable head 810 overlaying the electrodes 812 can be made of a polymer; paragraph 0085 – “Referring now to FIG. 9, volume-filling lead 802 is shown where head 810 is depicted as an expandable balloon in a second expanded position in accordance with the embodiments herein…the expandable balloon can be formed from an elastomeric material including but not limited to polytetrafluoroethylene (ePTFE), polyethylene-co-tetrafluoroethene (ETFE), polyurethanes, silicones, poly(p-xylylene) polymers such as parylene polymers, polyether block amides such as PEBAX®, nylons, or derivatives thereof”).
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Re. claim 2, Schmidt further teaches wherein the polymeric material layer comprises polyurethane (figures 8-9, expandable head 810 overlaying the electrodes 812 can be made of a polymer; paragraph 0085 – “Referring now to FIG. 9, volume-filling lead 802 is shown where head 810 is depicted as an expandable balloon in a second expanded position in accordance with the embodiments herein…the expandable balloon can be formed from an elastomeric material including but not limited to polytetrafluoroethylene (ePTFE), polyethylene-co-tetrafluoroethene (ETFE), polyurethanes, silicones, poly(p-xylylene) polymers such as parylene polymers, polyether block amides such as PEBAX®, nylons, or derivatives thereof”).
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Re. claim 5, Schmidt further teaches wherein the array of electrodes has point symmetry (figure 9, midpoint of the middle electrode has point symmetry to match the electrodes in opposing directions).
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Re. claim 6, Schmidt further teaches wherein the polymeric material layer is disposed over the array of electrodes such that the polymeric material layer covers the array of electrodes and the void space in the array (figure 8 shows the polymeric expandable head 810 which cover the void spaces between the electrodes 812).
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Re. claim 9, Schmidt further teaches wherein the apparatus is capable of stretching such that the void space located between at least one pair of adjacent electrodes of the array is increased in size due to movement of one or more electrodes of at least one pair of adjacent electrodes of the array in a direction away from one another (figures 8-9 show the void spaces between electrodes 812 of the expandable polymer balloon head 810 increasing from a first non-expanded position in figure 8, to a second expanded position in figure 9; paragraph 0084 – “The expandable lead head 810 can be configured to be expanded between a first non-expanded position, as shown in FIG. 8, and a second expanded position, as shown in FIG. 9, in order to fill an intracorporeal void”).
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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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 20190117971 A1 – hereinafter Schmidt) in view of Freeman (US 20160256676 A1 – hereinafter Freeman).
Re. claim 3, Schmidt teaches the claimed invention of claim 1, including the polymeric material layer as stated above, but does not explicitly teach wherein the polymeric material layer comprises a polyurethane polymer film or bandage.
Freeman teaches an electrode device comprising a polymeric material layer (figure 4, top layer 22) overlaying current dispersing elements (paragraph 0058 – “In one example, the current dispersing elements 24a, 24b can be positioned between the flexible, water vapor-permeable, conductive adhesive layer 26 and a non-conductive, flexible, water vapor-permeable, electrically-insulating top layer 22…”), and further teaches wherein the polymeric material layer comprises a polyurethane polymer film or bandage (paragraph 0060 – “The top layer 22 is generally non-conductive, flexible, water vapor-permeable, electrically-insulating, and optionally at least substantially liquid-impermeable or waterproof. The non-conductive flexible, water-vapor permeable, electrically-insulating top layer 22 may comprise or consist of polyurethane, such as Tegaderm™ polyurethane film (available from 3M), Opsite™ polyurethane film (available from Smith & Nephew), or Hydrofilm™ polyurethane film (available from Hartman USA)”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric material layer of Schmidt, to incorporate the polyurethane polymer film as taught by Freeman, since such modification would still predictably result in, for example, provide electrical protection from collateral current spreading.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 20190117971 A1 – hereinafter Schmidt) in view of Deslauriers (US 20210346693 A1 – hereinafter Deslauriers).
Re. claim 4, Schmidt teaches the claimed invention of claim 1, including the polymeric material layer as stated above, but does not explicitly teach wherein the polymeric material layer has a thickness of less than or equal to 250 µm.
Deslauriers teaches a similar system for delivering tumor treating fields (abstract – “A conductive pad having a topcoat layer, an electrode element and a conductive gel element is described. The electrode element is connected to the topcoat layer, and configured to receive an electrical signal from a generator producing an electric signal as a TTField”). Deslauriers further teaches a pad (figure 28, pad 696), comprising a polymer layer (figure 28, polymer layer 28),
and wherein the polymeric material layer has a thickness of less than or equal to 250 µm (paragraph 0476 – “…the flexible polymer layer 700 is preferably as thin as possible (e.g., less than 10 μm or less than 5 μm)”).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric material layer of Schmidt, to incorporate polymeric layer with the thickness of less than or equal to 250 µm as taught by Deslauriers, since such modification would still predictably result in the polymer layer functioning as an electrical insulator to prevent unwanted electrical spreading (Deslauriers paragraph 0476).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schmidt (US 20190117971 A1 – hereinafter Schmidt) in view of Fiorina (US 20070088419 A1 - Fiorina).
Re. claim 7, Schmidt further teaches wherein the polymeric material layer substantially covers the array of electrodes (figure 8 shows the polymeric expandable head 810 covering the void spaces AND the electrodes 812).
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Schmidt does not explicitly teach wherein the polymeric material layer has one or more cutouts formed therein, at least one of the one or more cutouts being coincident with at least a portion of the void space located between at least one pair of adjacent electrodes in the array.
Fiorina teaches a pad electrode array device (abstract – “A pad assembly according to the invention is used for mounting a current generator for applying a therapeutic electrical current to an area of human skin. Such an assembly includes a pad comprising a thin, flexible, stretchable plastic film that conforms to human skin…”), and further teaches the pad (figure 6, electrode pad device 200),
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comprising a polymeric material layer (Pads in figures 1-6 contain plastic film shown in figures 3-4 as plastic film 31, which can be made of known polymers polypropylene and/or polyethylene, plastic film also present in the pad device 200 of figure 6; paragraph 0021 – “A base layer 31 of pad 12 is a plastic film that is flexible, stretchable, and printable, and conforms to human skin…Films made of vinyl, rubbers, nylon, polyester, polypropylene and polyethylene can be used”; paragraph 0027 – “FIG. 6 illustrates a four electrode version of a device 200 according to the invention. The construction is substantially the same as described for FIGS. 1-5, except that the number of inner contacts 246 and the corresponding connections is at least four, one for each wing 217”).
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Fiorina further teaches the polymeric material layer has one or more cutouts formed therein (figure 6 shows a cutout of the device 200 with four electrode wings 217; paragraph 0027 – “The current generator may, for example, be configured to create positive electrodes at wings 217A and negative electrodes at each of wings 217B”),
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And at least one of the one or more cutouts being coincident with at least a portion of the void space located between at least one pair of adjacent electrodes in the array (figure 6, cutout are coincident with the void spaces between the electrodes at wings 217).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric material layer of Schmidt, to incorporate the polymeric material cutout configuration as taught by Fiorina, since such modification would still predictably result in maximizing surface area and improving patient-interface contact.
Re. claim 8, Fiorina of the combined invention further teaches wherein the one or more cutouts have an open shape so that the one or more cutouts define one or more concave portions along an outer edge of the polymeric material layer when viewed from a direction perpendicular to the face of the array (Fiorina teaches the cutout in figure 6, which would define opened concave/inward portions along the outer edge of the polymeric film when looked at from the side).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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, CARL LAYNO can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796
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