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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 5, 7-16 and 21-24 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “skin at the … body”, and the claim also recites “skin at the skull” and “skin at the … scalp” which are increasingly narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In this case, skin of the “body” is broader and encompasses both the skin of the skull and skin of the scalp, since both the skull and scalp are parts of the body. Similarly, skin at the scalp is a subset of all the skin present around the skull. As such, these are not three alternatives to each other, but rather three partially overlapping limitations of varying breadth which renders the claim indefinite because it is unclear whether the “skull” and/or “scalp” limitations are required at all.
For the same reason, the recitation of “a transducer-scalp or a transducer-skin interface” in claims 1 and 14 also renders the claim indefinite.
For the same reason, the recitation of “a transducer-scalp … or … a transducer-skin interface” in claim 8 also renders the claim indefinite. These limitations are also in improper antecedent form because claim 1 already recites these limitations; thus, they should be introduced as “the” or “said” instead of “a.”
For the same reason, the recitation of “skull, scalp or skin interface” in claims 1, 3 and 16 also renders the claims indefinite.
For the same reason, “body” and “brain” in claim 21 renders the claim indefinite. The brain is a narrower limitation encompassed by the broader recitation of the body overall.
Claims 1 and 16 also recite the limitation "the skull … interface" (in lines 9-10 of claim 1, and in line 2 of claim 16). There is insufficient antecedent basis for this limitation in the claim. The claims only previously recited the scalp and skin interfaces.
The remaining claims not specifically discussed above are rejected by virtue of depending (directly or indirectly) on a rejected claim, and thus incorporating the indefinite subject matter.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14-16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 recites “further comprising step (1) of claim 1 is not executed and in place of step (1), the following step (1b) is executed …”. This is improper because it attempts to remove a limitation from claim 1. Dependent claims must include all of the limitations of the claim upon which it depends, and thus cannot remove or replace a limitation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claims 15-16 are rejected by virtue of dependence on claim 14 and thus similarly fail to incorporate all of the limitations of claim 1 from which they indirectly depend.
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.
Claims 1, 5, 7, 11, 13 and 21-24 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2021/0346693 A1 to Deslauriers (hereinafter “Deslauriers”).
Regarding Claim 1, Deslauriers teaches a method for modulating tumor treating fields (TTFields) for the treatment of a cancer in a subject in need thereof (see e.g. Para. 81: “The therapeutic effect may include, for example but not by way of limitation, preventing, inhibiting, or reducing the occurrence of at least one tumor and/or cancer.”; Para. 87: “the TTFields described above that have been found to advantageously destroy tumor cells”), the method comprising the steps of:
(1) obtaining a topical agent disposed between a TTField transducer and the subject's skin at the skull, scalp or body of the subject; the agent configured to provide a transducer-scalp or a transducer-skin interface between the transducer, agent, and/or the skin , wherein the agent at the interface is configured to provide a conductivity between the transducer and the skin (see e.g. Para. 103: “a semi-solid conductive gel for application to a patient's skin and for placement between the patient's skin and at least one insulated electrode that generates an alternating electric field within a patient”; Para. 102: “which dramatically enhances the electrical and/or thermal conductivity of the semi-solid conductive gel”; Para. 127: “to optimize conductivity and minimize resistance of the composition”; ; and
(2) optimizing the conductivity of the agent to increase a penetrating dose of TTFields to the cancer and/or to minimize one or more hotspots or a toxicity at the skull, scalp, or skin interface, wherein the optimizing is executed by adding an ingredient to the agent and/or by changing at least a portion of the agent to a different agent with a different conductivity; and wherein the optimizing minimizes the TTField's penetrating dose intensity or charge carrier density on the skull, scalp, or skin while maximizing the TTField's field or dose intensity or charge carrier density on the cancer or on a tumor (see e.g. Paras. 102-103 and 107 describing the addition of a bulk electron transport agent, Paras. 118-121 describing the addition of a free salt, Para. 127 describing the addition of a scrim “selected to optimize conductivity and minimize resistance of the composition,” Para. 138 listing “one or more dermatological therapeutic agents that may enhance the hydrogel/skin interface, enhance skin conductivity, enhance adhesiveness, and/or reduce or prevent the occurrence of dAEs (such as, but not limited to, an anti-microbial agent, an antibiotic, an anti-viral agent, an anti-fungal agent, an anti-inflammatory agent, an anesthetic, an emollient, a cleansing agent, an astringent, and combinations thereof, and the like)” and Para. 146 describing various modifications to the gel for optimization and Para. 95 describing how the TTfields are configured so as to only treat the treatment area).
Regarding Claims 5 and 7, Deslauriers teaches wherein the agent comprises a composition, wherein the composition includes a hydrogel, organogel, suspension, cream, emollient, paste, lotion, lipid, micro or nanoparticles, or a combination thereof (see e.g. Para. 111: hydrogel); and wherein the agent is configured to be removably affixed to the TTField transducer; wherein the agent is configured to be peeled off of the TTField transducer by a healthcare provider such that a different agent can be applied to the transducer (see e.g. Paras. 138, 152 discussing removability of the gel).
Regarding Claim 11, Deslauriers teaches after executing step (2).the optimized agent is in place for a time period in the range from about 18 hours or more per day, continuously (see e.g. Paras. 5-6, 151 and 196).
Regarding Claim 13, wherein the agent comprises a conductive agent comprising titanium dioxide, zinc oxide, and/or a hydrogel, organogel, suspension, cream, emollient, paste, lotion, micro or nanoparticles, poly (vinyl alcohol)/polyethylene glycol/graphene oxide, hyaluronic acid, dimethyl sulfoxide, PEO (Polyethylene-Oxide)/PVP (polyvinylpyrrolidone), polysaccharide (natural), gum karaya (natural), polyacrylamide (synthetic polymer), alginate, menthyl anthranilate, octocrylene, octyl salicylate, oxybenzone, padimate O, ecamsule, cinoxate, dimethyl sulfoxide, phenylbenzimidazole, sulisobenzone, homosalate, dioxybenzone, avobenzone, a dye, an ultraviolet absorbing agent, or a combination thereof (see e.g. Para. 111: hydrogel; see e.g. Paras. 102-103 and 107 describing the addition of a bulk electron transport agent, Paras. 118-121 describing the addition of a free salt; see e.g. Paras. 113, 138, 145, 146, 219 discussing various other additives in the gel).
Regarding Claim 21, Deslauriers further teaches various frequency values and ranges significantly overlapping with or falling within Applicant’s ranges here (see e.g. Paras. 85-86, 89, 130, 149; search “kHz” throughout Deslauriers).
Regarding Claim 22, Deslauriers teaches wherein the method is used in combination with a surgical procedure, radiotherapy, chemotherapy, targeted therapy, and/or immunotherapy (the TTFields are a targeted therapy, and thus the method of modulating the TTFields using the hydrogel is combined with the actual delivery of the TTFields).
Regarding Claim 23, Deslauriers teaches wherein the method is used in combination with an antibiotic, anti-inflammatory, corticosteroid, anti-allergen or hypoallergenic composition, a skin barrier, or a combination thereof (see e.g. Para. 138: “(v) one or more dermatological therapeutic agents that may enhance the hydrogel/skin interface, enhance skin conductivity, enhance adhesiveness, and/or reduce or prevent the occurrence of dAEs (such as, but not limited to, an anti-microbial agent, an antibiotic, an anti-viral agent, an anti-fungal agent, an anti-inflammatory agent, an anesthetic, an emollient, a cleansing agent, an astringent, and combinations thereof, and the like).”)
Regarding Claim 24, Deslauriers further teaches the step of (3) designing and/or changing a cancer treatment for the subject after the optimization in step (2) (see e.g. Paras. 152-153).
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 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Deslauriers.
Regarding Claims 8 and 12, Deslauriers teaches optimizing the conductivity of the agent and wherein the topical agent is operative to penetrate at least a portion of the skin to enhance skin conductivity (see e.g. Paras. 113, 138, 145, 146, 219 discussing various additives in the gel and the enhancement of skin conductivity in Para. 138), but fails to specify exact conductivities falling within the claimed ranges here. However, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal conductivity of the agent based on whatever conductivity produces the most optimal treatment results. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Deslauriers in view of US 2020/0023179 A1 to Bomzon et al. (hereinafter “Bomzon”).
Regarding Claim 3, Deslauriers teaches the method of claim 1 discussed above but fails to specifically teach measuring a dose of TTFields at the skull, scalp, or skin interface and/or at the tumor; and wherein the measuring is performed before or after step 2. Another reference, Bomzon, teaches a method of measuring the dose of TTfields to enhance the therapeutic result (see e.g. the title, abstract and Para. 67). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Deslauriers to measure the dose of the TTfields before and/or after step 2 because it would predictably help ensure that the proper, intended dose is actually being delivered to the tumor.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Deslauriers in view of US 2021/0038584 A1 to Voloshin-Sela (hereinafter “Voloshin-Sela”).
Regarding Claims 9-10, Deslauriers teaches the method of claim 1 as discussed above but fails to specifically teach applying a vascular endothelial growth factor (VEGF) inhibitor at or under the interface; wherein the inhibitor comprises, bevacizumab or a biosimilar of bevacizumab, a VEGF tyrosine kinase small molecule inhibitor, sunitinib, sorafenib, vandetanib, or a combination thereof. Another reference, Voloshin-Sela teaches combining one or more of these inhibitors to enhance TTFields treatment of tumors (see e.g. Paras. 3, 13, 20, 37, 41-42, 44, 50, 70, claims 8 and 16). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Deslauriers to further include applying one or more of these inhibitors because Voloshin-Sela teaches that it is known to enhance the therapeutic outcome of TTFields treatment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2021/0220640 A1: see title and abstract (generally relevant)
US 2021/0138233 A1: see title and abstract (generally relevant)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at (571)-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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