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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 1 is objected to because of the following informalities:
in claim 1, line 9: the period should be a semicolon.
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.
Claims 6 and 9 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.
Claim 6 recites “electrodermal activity” in line 2, but it is not clear if this recitation is the same as, related to, or different from “electrodermal activity” in claim 2, line 2. If they are the same, “electrodermal activity” in claim 6 should be “the electrodermal activity”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 9 recites “the time duration” in line 3 and “the time duration” in lines 4-5, but it is not clear if these recitations are the same as, related to, or different from “a duration” of claim 1, line 8. If they are the same, “the time duration” in claim 9, line 3 and in claim 9, lines 4-5 should be “the duration”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other. Also, if they are different, there is insufficient antecedent basis for “the time duration” in claim 9.
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.
Claims 1-2, 4, 8-9, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2019/0328565 (Perez)(previously cited).
With respect to claim 1, Perez teaches a neurological stimulation device comprising:
an intra-epidermal skin electrode array (the microneedle electrodes 199 of Perez; paragraph 0253 of Perez; FIG. 1H of Perez) adapted to be placed against skin of a patient;
an electrical switch (the controller of Perez; paragraphs 0033, 0047-0048, 0068-0069, 0081, 0083, 0207, 0215, 0232, 0235-0242, 0255, 0278, 0383, 0387-0388, 0394 of Perez) providing an activation signal; and
an electrical energy source (the pulse generator of Perez; paragraphs 0033, 0036, 0047-0048, 0081, 0083, 0206-0207, 0215, 0232, 0235-0241, 0255, 0383, 0387-0388, and 0394 of Perez) communicating with the electrode array and the electrical switch and responding to the activation signal to provide a metered discharge of electricity to the electrode array to produce an intra-epidermal electrical stimulation concentrated in an epidermis of the skin with a duration of less than one second (paragraphs 0037 and 0402-0430 of Perez) at greater than 4 mA (paragraphs 0037 and 0402-0430 of Perez),
wherein the intra-epidermal skin electrode array provides a set of needle electrodes (the microneedle electrodes 199 of Perez) extending from a stop surface (the base 138 of Perez) to penetrate the epidermis to a depth stopping above a dermis layer of the skin (the ranges of paragraph 0253 of Perez are sufficiently specific to anticipate the claimed distance) and adapted to selectively activate the fast pain nociceptors (this capability of the electrode array does not further limit the physical structure of the claimed device or physically distinguished the claimed device from the device of Perez).
With respect to claim 2, Perez teaches a monitoring circuit monitoring electrodermal activity of the skin to provide an output indicating the electrodermal activity in response to the metered discharge of electricity (the GSR monitoring portion in paragraphs 0218, 0322, and 0361 and Table 1 of Perez).
With respect to claim 4, Perez teaches that the needle electrodes are less than 1.5 mm in length from the stop surface (the ranges of paragraph 0253 of Perez are sufficiently specific to anticipate the claimed range).
With respect to claim 8, Perez teaches that the electrical energy source is a current source providing a variable voltage to produce a constant current through the epidermis (paragraphs 0308 and 0402-0430 of Perez).
With respect to claim 9, Perez teaches a timing circuit controlling the time duration and locking out the metered discharge of electricity for a second predetermined time after the time duration (paragraphs 0308, 0402-0430, 0483-0484, 0504, 0506-0507, and 0512 of Perez).
With respect to claim 11, Perez teaches a user interface (the companion control device of Perez) allowing a setting of the electrical energy source to provide a current intensity of the intra-epidermal electrical stimulation at multiple levels greater than 4 mA (paragraphs 0029, 0037 and 0402-0430 of Perez).
With respect to claim 12, Perez teaches a user interface (the companion control device of Perez) allowing a setting of the electrical energy source to limit the duration to between 0.5 to 100 ms (paragraphs 0029, 0037 and 0402-0430 of Perez).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Perez, in view of U.S. Patent Application Publication No. 2010/0274327 (Carroll)(previously cited).
Perez teaches a neurological stimulation device comprising an intra-epidermal skin electrode array (the microneedle electrodes 199 of Perez; paragraph 0253 of Perez; FIG. 1H of Perez) adapted to be placed against the skin of a patient and a metered discharge of electricity to the electrode array to produce an intra-epidermal electrical stimulation concentrated in the epidermis of the skin with a duration of less than one second (paragraphs 0037 and 0402-0430 of Perez) at greater than 4 mA (paragraphs 0037 and 0402-0430 of Perez). Carroll teaches that one or more of the microneedle electrodes of a plurality of microneedle electrodes on an electrode patch may be used as electrical returns (paragraph 0033 of Carroll). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use one or more of the microneedle electrodes of the plurality of microneedle electrodes as the return path for the current since it controls the flow of current into a predetermined path.
With respect to claim 5, the combination teaches or suggest that the needle electrodes include electrodes receiving the metered discharge of electricity (the microneedle electrodes 199 of Perez; paragraph 0253 of Perez; FIG. 1H of Perez) and electrodes providing an electrical return to the electrical energy source (one or more of the microneedle electrodes of the plurality of microneedle electrodes as the return path as suggested by Carroll).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Perez, in view of U.S. Patent Application Publication No. 2004/0039254 (Stivoric)(previously cited).
Perez teaches a sensor for measuring GSR (paragraphs 0218, 0322, and 0361 and Table 1 of Perez). Stivoric teaches that GSR sensors that come into contact with the skin may be provided with a plurality of microneedles for, among other things, enhancing electrical contact with the skin and providing real time access to interstitial fluid in and below the epidermis, which access may be used to measure various parameters such as pH level of the skin through electrochemical, impedance based or other well-known methods (paragraph 0138 of Stivoric). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the GSR sensor of Stivoric with its plurality of microneedles as the GSR sensor of Perez since (1) it enhances electrical contact with the skin, (2) it provides real time access to interstitial fluid in and below the epidermis, which access may be used to measure various parameters such as pH level of the skin through electrochemical, impedance based or other well-known methods, (3) Perez teaches a GSR sensor and Stivoric teaches one such sensor, and/or (4) it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 6, the combination teaches or suggests that the monitoring circuit monitors electrodermal activity (the GSR monitoring portion in paragraphs 0218, 0322, and 0361 and Table 1 of Perez) using a monitoring electrode array different from the intra-epidermal skin electrode array (the GSR sensor of Stivoric with its plurality of microneedles).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Perez.
Perez teaches that the electrodes and the rest of the device within a housing 320 may be detachable from each other (paragraphs 0231, 0241, 0269, 0271, and 0299 of Perez). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a detachable connector between the electrodes and the rest of the electronics within a housing since it permits the housed components to be reused and the electrodes to be disposable (paragraphs 0231, 0241, 0269, 0271, and 0299 of Perez).
With respect to claim 7, Perez teaches or suggests that a releasable electrical connector communicating between the intra-epidermal skin electrode array and a housing holding the electrical switch and the electrical energy source (the housing and connector of Perez; paragraphs 0231, 0241, 0269, 0271, and 0299 of Perez).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Perez, in view of U.S. Patent Application Publication No. 2015/0360030 (Cartledge)(previously cited).
Perez teaches the use of any energy providing device, including a lithium-ion battery, a betavoltaic battery, a solar cell, nickel-cadmium battery, a fuel cell, a mobile phone, or remote charging station, as the power source (paragraph 0205 of Perez). Cartledge teaches that a rechargeable battery is also a suitable power source and an alternative to a non-rechargeable battery (paragraph 0337 of Cartledge). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a rechargeable battery as the power source in Perez since it is a simple substitution of one known element for another to obtain predictable results and/or it permits use of a battery that is low in power.
With respect to claim 10, the combination teaches or suggests that the intra-epidermal skin electrode array (the microneedle electrodes 199 of Perez; paragraph 0253 of Perez; FIG. 1H of Perez), electrical switch (the controller of Perez; paragraphs 0033, 0047-0048, 0068-0069, 0081, 0083, 0207, 0215, 0232, 0235-0242, 0255, 0278, 0383, 0387-0388, 0394 of Perez) and electrical energy source (the pulse generator of Perez; paragraphs 0033, 0036, 0047-0048, 0081, 0083, 0206-0207, 0215, 0232, 0235-0241, 0255, 0383, 0387-0388, and 0394 of Perez) are integrated with a single handheld housing (the housing 111 of Perez) providing a rechargeable battery (the rechargeable battery of Cartledge) providing energy to the electrical energy source (the housing 111 shown in FIG. 1A of Perez with the battery disclosed to be the power management module 120; paragraph 0215 of Perez).
Response to Arguments
The Applicant’s arguments filed on 12/19/2025 have been fully considered.
Claim objections
In view of the claim amendments filed on 12/19/2025, the previous claim objections have been withdrawn.
There are new claim objections that have been necessitated by the claim amendments filed on 12/19/2025.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 12/19/2025, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, have been withdrawn.
There are new claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that have been necessitated by the claim amendments filed on 12/19/2025.
Prior art rejections
The Applicant asserts:
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370
990
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This argument is not persuasive. Perez teaches all the features of claim 1. Even though the device of Perez and the device of claim 1 have different intended uses, the structural elements are still the same, as outlined above.
The Applicant asserts:
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530
999
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…
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228
1007
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This argument is not persuasive. In paragraph 0253, Perez teaches that the depth of insertion or penetration of the micro-needle electrodes 199 ranges from 0.1 mm to 4 mm. Such a disclosed range clearly contemplates depth values from 0.1 mm to 1.4 mm. For example, in paragraph 0391, Perez teaches specific distances from “0.1 mm to 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4…or any increment therein”. As agreed by the Applicant, the epidermis ranges from 1.5 mm or less. As such, with this 0.1-1.4 mm depth contemplated by Perez, the microneedle electrodes 199 of Perez are clearly disclosed as extending from the base 138 of Perez to penetrate the epidermis to a depth stopping above a dermis layer of the skin. The fact that there are other contemplated embodiments and/or other-contemplated ranges for the microneedle lengths does not negate the fact that Perez still teaches the claimed microneedle lengths.
The Applicant asserts:
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48
1007
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86
968
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This argument is not persuasive. First, Perez does not disparage the use of micro-needle electrodes that terminate in the epidermis. As such, Perez does not teach away from such microneedle lengths. Second, in paragraph 0253, Perez teaches that the depth of insertion or penetration of the micro-needle electrodes 199 ranges from 0.1 mm to 4 mm. Such a disclosed range clearly contemplates depth values from 0.1 mm to 1.4 mm. As agreed by the Applicant, the epidermis ranges from 1.5 mm or less. As such, with this 0.1-1.4 mm depth contemplated by Perez, the microneedle electrodes 199 of Perez are clearly disclosed as extending from the base 138 of Perez to penetrate the epidermis to a depth stopping above a dermis layer of the skin.
The Applicant asserts:
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475
1009
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This argument is not persuasive. First, in paragraph 0253, Perez teaches that the depth of insertion or penetration of the micro-needle electrodes 199 ranges from 0.1 mm to 4 mm. Such a disclosed range clearly contemplates depth values from 0.1 mm to 1.4 mm. At the very minimum, Perez contemplates a length of 0.1 mm. Further, in paragraph 0391, Perez teaches specific distances from “0.1 mm to 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4…or any increment therein”. Paragraph 0458 of Perez discloses this as well. Thus, the idea that Perez is disclosing a genus that does not necessarily anticipate the claimed species is not persuasive. Quite the opposite, Peres is disclosing the claimed species explicitly.
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791