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 (IDS) submitted on 10/10/2024 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7, drawn to an adhesive patch for detecting sweat on a subject, classified in A61B5/4266.
II. Claims 8-13, drawn to a method of making an adhesive patch for detecting sweat on a subject, classified in A61B5/6833.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the product as claimed can be made by another materially different process.
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 have acquired a separate status in the art in view of their different classification; the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and the inventions require a different field of search (e.g., searching different classes /subclasses or electronic resources, or employing different search strategies or search queries).
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.
During a telephone conversation with Peter Paredes on 1/21/2026 a provisional election was made without traverse to prosecute the invention of group I, claims 1-7. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-13 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 1-7 are objected to because of the following informalities:
Claim 1 recites the limitation “the test window changes color from transparent to indicate sweating” is recited in the active voice but as the claim is directed to an apparatus/product, it should refer to what the apparatus/product is configured to do. As such, the limitation should read as “the test window is configured to change color from transparent to indicate sweating” or similar. Claims 2-7 are objected to for being dependent on claim 1.
Claims 3-5, specifically claim 3 is objected to as it should recite “hydrochromic” instead of “hydrochomic”.
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 4 and 5 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.
The term “generally translucent and yellowish” in claims 4 and 5 is a relative term which renders the claim indefinite. The term “generally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Essentially, the addition of the term generally make the claim indefinite as it is metes and bounds of when something is “generally translucent” or “generally yellowish” are unclear (i.e. is it considered generally translucent if one can see through it when backlit, or does it need to be translucent in natural light; is something generally yellowish when there is any yellow light reflected by the material, or is there a specific amount of yellow light that defines generally yellowish; etc…).
For the purpose of advancing prosecution, the examiner with interpret the claim as if the term generally is not present.
Claim Rejections - 35 USC § 102/103
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 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.
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, 3, 5, 6 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Zakrzewski (US 2008/0081964 A1).
Regarding claims 1, 3, 4, 6 and 7; Zakrzewski discloses an adhesive patch (figures 1 and 2) for detecting sweat on a subject, comprising:
an adhesive dressing (element 20) surrounding a test window (window of flexible sheet, element 12, defined by moisture indicating substance, element 18), wherein the test window is transparent (wherein the examiner notes that while not explicitly stated, the disclosure notes that changes in color are observed to identify areas of where wetness is indicated and paragraphs [0033] discloses and figure 12 depicts marking the outline of the darkened areas using a marking instrument that wherein the darkened area is viewed through the flexible sheet, which indicates that the sheet is transparent in order to allow the user to make the outline of the area stained by the moisture indicating substance; paragraphs [0019],[0020],[0033]; figures 1, 2 and 12);
the test window includes a reactive chemical mixture (element 18) which changes color in the presence of moisture (moisture indicating substance changes color to indicate it was moistened; paragraphs [0019],[0020],[0033]; figures 1, 2 and 12); and
the test window changes color from transparent to indicate sweating (changes to a staining color; paragraphs [0019],[0020],[0033]; figures 1, 2 and 12).
In the alternative, if one were to determine that Zakrzewski does not disclose the test window is transparent; it would have been obvious to one of ordinary skill in the art at the time of filing to make the flexible sheet (element 12) transparent in order to view/identify the areas where the reactive chemical mixture changes color while applied to the skin to identify and mark the hyperhidrosis zones for treatment.
Further regarding claim 3; Zakrzewski discloses the reactive chemical mixture is selected from the group consisting of: iodine, starch, or a hydrochromic material (wherein Zakrzewski discloses the color indicating substance, element 18, is preferably a starch-iodine mixture; paragraph [0019]).
Further regarding claim 4; Zakrzewski discloses the use of iodine and starch as the reactive chemical mixture. The examiner notes that Zakrzewski does not indicate a color of the starch and iodine but contends that the mixture would be also be generally translucent and yellowish as claimed as Zakrzewski does not disclose any alteration to the materials and furthermore the applicant’s specification does not mention/disclose any alteration to the materials to make them generally translucent and yellowish. Therefore, if Zakrzewski discloses the same materials as claimed and not alterations are disclosed, then they would inherently be the same color and transparency as the claimed materials. In the alternative, while Zakrzewski is silent to the colors of the iodine and starch, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the iodine and starch to be any color as a matter of design choice since the color of the chemical reactive material is a mere aesthetic design choice (see MPEP 2144.04 I), wherein one could modify the starch and iodine to be any different colors and still provide the same functionality of identify the presence of moisture.
Regarding claims 6 and 7; the examiner notes that the limitations of claims 6 and 7 further define one of the alternative options recited in the Markush group from claim 3 to which claims 6 and 7 are dependent upon; however, since claim 3 is recited in the alternative (by reciting that the group consists of “iodine, starch, or a hydrochromic material”) and claims 6 and 7 only further define one of the alternative options recited, then Zakrzewski’s disclosure of the iodine and starch as the reactive chemical mixture as recited in the rejection of claim 3 meets the BRI of the claims 6 and 7 merely further define one of the alternatives which and is not required by claim 3. Therefore, any disclosure that would read on claim 3 would also read on the BRI of claims 6 and 7.
Examiner’s Note: For the purpose of practicing compact prosecution, the examiner will further address claims 6 and 7 below in the alternative; however, the examiner encourages the applicant to amend claims 4 and 6 to include the limitations: “wherein the reactive chemical mixture is iodine and starch” for claim 4, and “wherein the reactive chemical mixture is a hydrochromic material” in claim 6 before the other limitations recited those claims in order to clearly set forth claims where the specific reactive chemical mixture is required to avoid such an interpretation as provided in the rejection of claims 6 and 7 above.
Claim Rejections - 35 USC § 103
Claim 2 are rejected under 35 U.S.C. 103 as being unpatentable over Zakrzewski.
Zakrzewski is described in the rejection of claim 1 above; however, Zakrzeski does not explicitly disclose the test window includes a surface of about 1.5 sq. in.
Regarding claim 2; there is no evidence of record that establishes that changing the size of the test window to include a surface of about 1.5 sq. in. would result in a difference in function of the device of Zakrzewski. Further, a person of ordinary skill in the art at the time of filing, being faced with modifying the size of the window of Zakrzewski would have a reasonable expectation of success in making such a modification and it appears that device would function as intended being given the claimed window size. Lastly, the applicant has not disclosed that he claimed window size solves any stated problem, merely indicating that the window may be about 1.5 sq. in., and therefore appear to place no criticality to the range as claimed that it produces an unexpected result.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the window size of Zakrzewski to be 1.5 sq. in. as a matter of design choice within the skill of the art.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zakrzewski as applied to claims 1 and 3 above, and further in view of Joseph et al (US 2014/0088533 A1).
Examiner’s Note: As noted above, the additional 103 rejection of claims 6 and 7 are being provided in the alternative in order to promote compact prosecution. Therefore the claims are still rejected under 35 USC 102/103 as applied above; and the following 35 USC 103 rejection are provided in the alternative to advance prosecution as follows.
Regarding claims 6 and 7; Zakrzewski is described in the rejection of claims 1 and 3 above; Zakrzewski further discloses that the reactive chemical mixture can be iodine and starch or other suitable substances.
Joseph teaches hydrochromic liquid activated formulation with permanent colorant which is optically active chemical that change color in response to moisture content, wherein the hydrochromic material comprises a pigment, a dye, a resin and a solvent (wherein Joseph discloses the colorants as dyes and pigments with examples thereof in paragraphs [0018]-[0024], resins and solvents as binding agents and examples thereof in paragraphs [0025]-[0043], and additional ingredients of solvents in paragraphs [0050]-[0063]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use Joseph hydrochromic material comprises a pigment, a dye, a resin and a solvent as the reactive chemical mixture which changes color in the presence of moisture. This is suggested by Zakrzewski teaching use using other suitable substances. Furthermore, it is simple substitution of one known element for another to yield a predictable result (substituting Zakrzewski iodine/starch reactive chemical mixture with Joseph hydrochromic material comprising a pigment, a dye, a resin, and a solvent).
Further regarding claim 7; Joseph further discloses the hydrochromic material wherein the pigment can include cationic surfactants, anionic surfactants, nonionic surfactants, amphoteric surfactants, polyester surfactants, or polyamine surfactants (paragraphs [0018]-[0024]); the dye includes benzofuran, lactone, fluorane, or aniline compounds (paragraphs [0018]-[0024]; the resin includes a mixture of a ketonic compound and a cellulose compound (paragraphs [0025]-[0043]); and the solvent includes alcohols, ketones, acetates, or ethoxyacetyl chloride (paragraphs [0025]-[0043], specifically [0040]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 4,846,182 to Fogt et al; discloses a method of preparing a fluid absorbent quantitative test device.
US 2023/0055053 A1 to Yi et al; discloses a perspiration mapping patch.
US 2022/0079476 A1 to Ziaie et al; discloses a multichannel hydration management sensor.
US 2021/0007655 A1 to Barlow et al; discloses a sweat mapping method.
US 2014/0275862 A1 to Kennedy; discloses system and methods for assessing sweat gland output.
US 2017/0095233 A1 to Heikenfeld; discloses device with reduced sweat volumes between sensors and sweat glands.
US 2017/0296114 A1 to Ghaffari et al; discloses method and system for measuring perspiration.
JP 2005-179314 A to Yokoi; discloses a patch preparation for skin testing.
JP 2010-46196 A to Yokoi; discloses a perspiration amount measuring method and perspiration amount measuring patch.
WO 2016/025468 A2 to Rogers et al; discloses device and related methods for epidermal characterization of biofluids.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791