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 .
DETAILED ACTION
1. Applicant’s response filed on October 28, 2025 is acknowledged. Claims 18-20 have been amended. Claims 28-34 have been canceled. Claims 52-61 have been added. A call was made on October 6, 2025 to discuss a telephonic election for a proposed restriction requirement. In the filing of 10/28/25, Applicant elected Group I. While all other claims that make up the additional inventions have been canceled, the restriction requirement as it would have pertained to those claims is set forth below.
Election/Restriction
2. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 18-27, drawn to a method of reducing electrosensation and/or skin irritation, classified in A61K 2121/00.
II. Claims 28-31, drawn to a polymerized hydrogel, classified in A61K47/6903.
III. Claims 32-34, drawn to an AEE-generating transducer array, classified in A61N 1/0476.
The inventions are independent or distinct, each from the other because:
Inventions I and Inventions II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case Invention II can be used for tissue engineering or environmental cleanup.
Inventions I and Inventions III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case Invention III can be used in diagnostics.
Inventions II and III are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions are different in that Invention II is drawn to a hydrogel and Invention III to an AEE-generating transducer array.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions above are patentably distinct. The search for each of the above inventions would not be co-extensive in scope particularly with regard to the literature search. Burden consists not only of specific searching of Cooperative Patent Classification, classes and subclasses, but also of searching multiple databases for foreign references and literature searches. Burden also resides in the examination of independent claim sets for clarity, enablement, and double patenting issues. Further, a reference that would anticipate the invention of one group would not necessarily anticipate or even make obvious another group. Finally, the consideration for patentability is different in each case. Thus, it would be an undue burden to examine all of the above inventions in one application and the restriction for examination purposes as indicated above is deemed proper.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
As noted above, with the recent filing, Applicant elected without traverse to prosecute the invention of Group I, claims 18-27 and newly added claims 52-61.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claims 18-27 and 52-61 are currently under examination.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on February 26, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. An initialed copy is attached hereto.
Claim Objections
4. Claim 22 is objected to because of the following informalities: said claim comprises extra spaces, particularly in line four. Appropriate correction is required.
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.
5. Claim 21 is 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.
Said claim is rendered vague and indefinite by the use of parenthesis. Parenthesis are viewed in the same manner as ‘such as’, which is exemplary language and is not permitted in a claim. The ambiguity of scope is not clear as the Office does not know clearly what is included and what is to be excluded. As written, it is impossible to determine the metes and bounds of the claimed invention.
6. Claim 26 recites the limitation "portion of the cancer cells" in line 5. There is insufficient antecedent basis for this limitation in the claim.
7. Claim 53 recites the limitation "and at least one hyperhidrosis agent" in line 2. There is insufficient antecedent basis for this limitation in the claim.
8. Claim 59 recites the limitation "and at least one hyperhidrosis agent" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
The following rejections are made in view of the 112(b)’s as identified above.
9. Claim(s) 18, 21-27, 52, and 55-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Deslauriers, US 2021/0220640 A1; Published: 7/22/21.
Independent claim 18 is drawn to a method of reducing electrosensation and/or skin irritation in a subject caused by application of an alternating electric field to the subject, the method comprising the step of: 1) administering at least one composition to at least a portion of a target region of the subject, wherein the at least one composition comprises at least one active agent selected from at least one localized numbing agent, at least one anti-hyperhidrosis agent, and combinations thereof; and 2) applying an alternating electric field to the target region of the subject.
Deslauriers discloses an assembly for use in a TTField-generating system that includes at least one electrode in combination with a polymerized conductive hydrogel and a liquid conductive hydrogel disposed on at least a portion of the polymerized hydrogel (see abstract). Further, Deslauriers discloses a method that includes: (1) applying any of the assemblies or transducer arrays disclosed or otherwise contemplated herein to a skin of a patient; and (2) generating an alternating electric field having a frequency in a range of from about 50 kHz to about 500 kHz for a period of time (see paragraph 106; meets a limitation of claim 18, 26 and 55). The Office takes the position that ‘a period of time’ does not exclude or preclude “at least about 24 hours”; particularly in view of paragraph 0046, which discloses that an effective amount of a treatment protocol (i.e., an alternating electric field), is sufficient to exhibit a detectable therapeutic effect without undue adverse side effects (such as (but not limited to) toxicity, irritation, and allergic response) commensurate with a reasonable benefit/risk ratio when used in the manner of the inventive concept(s). The steps of (1) and (2) can be performed two or more times (see illustrative embodiments as described in paragraphs 0152-0167; meets claim 27).
In addition, as it pertains to the polymerized hydrogel, it may have at least one dermatological therapeutic agent disposed therein and known in the art that may enhance the hydrogel/skin interface, enhance skin conductivity, and/or reduce or prevent the occurrence of dAEs. Non-limiting examples of dermatological therapeutic agents that fall within the scope of the present disclosure include an anesthetic (see paragraph 0081; meets claim 18, 55, 58).
Each of the polymerized conductive hydrogel and the liquid hydrogel may be in any form and are sterile (see paragraph 0056; meets claims 21, 56). The polymerized hydrogel is semi-solid (0057). The polymerized hydrogel may be formed of any hydrophilic polymer, for example, the hydrogel may be a polyacrylic acid gel, a povidone gel, or a cellulose gel (meets claim 21). In addition, the hydrogel may comprise at least one of chitosan, alginate, agarose, methylcellulose, hyaluronan, collagen, laminin, matrigel, fibronectin, vitronectin, poly-1-lysine, proteoglycans, fibrin glue, gels made by decellularization of engineered and/or natural tissues, as well as any combinations thereof (meets claims 22 and 56). Further, the gel may comprise at least one of polyglycolic acid (PGA), polylactic acid (PLA), poly-caprolactone (PCL), polyvinyl alcohol (PVA), polyethylene glycol (PEG), methyl methacrylate, poly(methyl methacrylate) (PMMA), poly(2-hydroxyethyl methacrylate) (PolyHEMA), poly(glycerol sebacate), polyurethanes, poly(isopropylacrylamide), poly(N-isopropylacrylamide), or any combination thereof (see paragraph 0058, meets claims 21 and 56).
All routes of administration known in the art are considered, including but not limited to, oral, topical, transdermal (encompasses microneedling-reading upon claim 25), parenteral, subcutaneous, intranasal, mucosal, intramuscular, intraperitoneal, intravitreal, and intravenous routes, and including both local and systemic applications (see paragraph 0048; meets claims 23-24). The polymerized hydrogel may be provided with any pH that does not damage the skin of a patient or cause chemical irritation of the skin upon prolonged exposure to the gel; for example a pH of a range of from about 6.5 to about 7.5 (see paragraph 0061; meets claim 56).
The polymerized hydrogel may be provided with any thickness (i.e., a range of from about 10 mil to about 50 mil, etc.) (see paragraph 0063; meets claim 56). The polymerized hydrogel may be provided with a skin adhesion rate of the gel being at least about 120 g/inch (see paragraph 0064; meets claim 56). In certain non-limiting embodiments, the compositions of the invention has a shelf life of at least about six months (see paragraph 0105; meets claim 56). In certain particular embodiments, step (1) includes the application of at least two pairs of transducer arrays, each along with polymerized hydrogel and liquid hydrogel disposed upon the electrodes thereof, to the patient's skin (see paragraph 0107; meets claim 57). Deslauries discloses that TTFields are low intensity (e.g., 1-3 V/cm) (see paragraph 0003; meets claim 26). The method steps of the prior art are identical to those that are claimed, the numbing agent and/or anti-hyperhidrosis agent, recited in claim 52, is necessarily effective for at least about two weeks, absent evidence to the contrary.
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.
10. Claim(s) 18-25, 52-53, 55-57, and 60-61 are rejected under 35 U.S.C. 103 as being unpatentable over Deslauriers, US 2021/0220640 A1; Published: 7/22/21, as applied to claims 18, 21-25, 52, and 55-57 above, and further in view of Modi, US 2008/0220021 A1; Published: 9/11/08.
Independent claim 18 is drawn to a method of reducing electrosensation and/or skin irritation in a subject caused by application of an alternating electric field to the subject, the method comprising the step of: 1) administering at least one composition to at least a portion of a target region of the subject, wherein the at least one composition comprises at least one active agent selected from at least one localized numbing agent, at least one anti-hyperhidrosis agent, and combinations thereof; and 2) applying an alternating electric field to the target region of the subject.
Deslauriers teaches the limitations as set forth supra.
Deslauriers do not specifically teach a method comprising botulinum toxin as either an anti-hyperhidrosis agent, as recited in claim 19 and 53 or as a numbing agent, as recited in claim 19-20, 53, and 60-61.
Modi teaches a method of treating hyperhidrosis comprising topical or transdermal administration of an effective amount of a botulinum toxin composition to the skin of a patient, wherein the botulinum toxin composition comprises botulinum toxin encapsulated in phospholipid micelles, one or more primary stabilizers, and one or more skin penetration enhancers (see paragraph 0015 and 30). Said composition may be used to efficiently deliver other active ingredients to the skin, such as muscle paralyzing agents, hormones, growth factors, vaccine agents, drugs, therapeutic proteins, small molecules and antiperspirant agents. The methods described herein can also be used to formulate compositions for the treatment of pain, comprising an analgesic as the active ingredient (see paragraph 0060).
Compositions containing botulinum toxin and one or more skin penetration enhancers can be used to successfully treat several types of disorders associated with neurotransmitter release when applied to a person's skin, like neurogenic inflammation (skin irritation involved in psoriasis) and hyperhidrosis (symptoms include redness and cracking in affected areas) (see paragraph 0061). Moreover, suitable active ingredients for inclusion in the composition include Botulinum toxin Type A, Type B, Type C, Type D, Type E, Type F, and Type G (see paragraph 0032).
It would have been obvious before the effective filing date of the presently claimed invention to employ an anti-hyperhidrosis agent and/or a numbing agent in methods to treat a skin irritation and/or electrosensation as suggested by Deslauriers with a reasonable expectation of success. This modification may be viewed as the substitution of particular agent which were known and suggested in the art for the treatment of a disorder amenable to treatment by botulinum toxin, like hyperhidrosis or other skin irritation in a subject as generally suggested by the combined teachings of Deslauriers. The skilled artisan would have been motivated to make this modification because Modi suggests these particular genera of agent to solve the problem with which the methods suggested by Deslauriers were concerned with solving and because Modi suggests this particular agent can be relied on, is cost effective to prepare, and simple to use. Rather than one single large dose being delivered once to a single site, the composition can be used to administer the active ingredient at a low dose, daily, to provide an effective treatment with enhanced safety and reduced side effects. The skilled artisan would have had a reasonable expectation of success because each of the documents teach methods for treating skin irritation with a numbing agent or hyperhidrosis agent, namely BTX-A.
Accordingly, the subject matter of the rejected claims would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
11. Claim(s) 18, 53-54, and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Deslauriers, US 2021/0220640 A1; Published: 7/22/21, in view of Modi, US 2008/0220021 A1; Published: 9/11/08, as applied to claims 18-25, 52-53, 55-57, and 60-61 above, and further in view of Vadoud-Seyedi et al., British Journal of Dermatology, 2007; 156: 986-989.
Independent claim 18 is drawn to a method of reducing electrosensation and/or skin irritation in a subject caused by application of an alternating electric field to the subject, the method comprising the step of: 1) administering at least one composition to at least a portion of a target region of the subject, wherein the at least one composition comprises at least one active agent selected from at least one localized numbing agent, at least one anti-hyperhidrosis agent, and combinations thereof; and 2) applying an alternating electric field to the target region of the subject.
Deslauriers teaches the limitations as set forth supra.
Modi teaches the limitations as set forth supra.
The combination of Deslauriers and Modi do not specifically teach that the composition comprises at least one localized numbing agent and at least one hyperhidrosis agent, as recited in claim 53; that the hyperhidrosis agent comprises Botulinum toxin, and an additional localized numbing agent, for example lidocaine, as recited in claim 54 and 59; nor do they teach that the method comprises the steps of administering, either simultaneously or wholly or partially sequentially, at least two compositions to at least a portion of a target region of the subject, wherein a first composition comprises at least one localized numbing agent, and a second composition comprises at least one anti-hyperhidrosis agent; and apply an alternating electric field to the target region of the subject.
Vadoud-Seqedi teaches that Botulinum toxin type A represents a safe and effective treatment for primary axillary hyperhidrosis. It further notes that one of the most troublesome disadvantages associated with this therapy is pain at the injection sites. Thus, the prior art teaches that reconstitution of botulinum toxin A in a solution of lidocaine could be an easy alternative procedure to reduce the discomfort associated with those injections. A randomized, side by side, double-blind study was performed to test the treatment of hyperhidrosis with botulinum toxin type A reconstituted in lidocaine or in normal saline.
Based on the results it is concluded that reconstitution of botulinum toxin A in lidocaine jeopardizes neither the short-term nor the long-term results achieved with botulinum toxin in the treatment of axillary hyperhidrosis. However, reconstitution of botulinum toxin A in lidocaine was associated with significantly reduced pain during the injections, suggesting that lidocaine can be added to botulinum toxin.
It would have been obvious before the effective filing date of the presently claimed invention to employ an anti-hyperhidrosis agent in combination with a numbing agent in methods to treat a skin irritation and/or electrosensation, for example hyperhidrosis as suggested by Deslauriers and Modi with a reasonable expectation of success. All the claimed elements were known in the prior art and the concept of reconstituting botulinum toxin A in lidocaine was associated with significantly reduced pain during the injections, suggesting that lidocaine can be added to botulinum toxin. One skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. See the recent Board decision Ex parte Smith,--USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396).
Accordingly, the subject matter of the rejected claims would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
12. No claim is allowed.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAKIA J JACKSON-TONGUE whose telephone number is (571)272-2921. The examiner can normally be reached Monday-Friday 930AM-530PM.
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/LAKIA J JACKSON-TONGUE/Examiner, Art Unit 1645 January 10, 2026
/BRIAN GANGLE/Primary Examiner, Art Unit 1645