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 .
Election/Restrictions
Applicant's election with traverse of invention I in the reply filed on 12 January 2026 is acknowledged. The traversal is on the ground(s) that the requirement for restriction “focuses on the terms” in the preamble and “contains no analysis of the body of the claims. This is not found persuasive because the requirement clearly sets forth analysis of the body of the claims:
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Applicant’s assertion that a patch comprising a pad with adhesives thereon overlying a collection pad overlaps with a patch comprising a plurality of medical tapes overlying a collection pad, where apparently a plurality of medical tapes are considered analogous to a single pad, is entirely unpersuasive, particularly on top of the assertion that the bodies of the claims were not considered in analysis of the differences between the claims.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12, 13, 16, and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12 January 2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/379086, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. 63/379086 has no disclosure of a third medical tape overlaying an adhesion pad comprising first and second adhesives and first and second medical tapes, or an additional adhesion layer over an adhesion pad comprising first and second adhesives. As such the effective filing date for claims 5-11 is that of the filing of the instant invention, 5 October 2023.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, an adhesion pad which itself comprises medical tapes must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The illustrated embodiments only show medical tapes that are considered in combination to be a “pad” without identifying what element is the element that comprises these tapes. A “pad” is generally “anything made of or stuffed with soft material to fill out a shape, protect against friction, pressure, jarring, or blows, etc.; cushion; a piece of folded gauze, compressed cotton, etc. used as a dressing or protection on a wound, etc.” https://www.collinsdictionary.com/dictionary/english/pad; “a piece of usually folded absorbent material (such as gauze) used as a surgical dressing or protective covering” https://www.merriam-webster.com/dictionary/pad; further, a “tape” is “a narrow flexible strip or band” https://www.merriam-webster.com/dictionary/tape, “a long, narrow strip of material that is sometimes sticky on one side” https://dictionary.cambridge.org/dictionary/english/tape, “a continuous narrow, flexible strip of cloth, metal, paper, or plastic, such as adhesive tape, magnetic tape, or ticker tape” https://www.ahdictionary.com/word/search.html?q=tape. The drawings only show medical bandages without any accompanying pad or any singular strips which might be considered “tape”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-11, 14, and 15 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Limitations in the claims positively reciting the human body include:
“when applied to skin of a subject”
“securing the collection pad in contact with the skin”
“secures a central region of the adhesion pad… to the skin”
Each of these should be amended to not positively recite the human body – for example, “configured to be applied to skin of a subject”, “configured to secure the collection pad in contact with the skin”, “configured to secure a central region… to the skin”.
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.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lenigk (US 2020/0107758).
Regarding claim 1, Lenigk discloses a sweat patch, comprising:
a collection pad (element 322); and
an adhesion pad overlying the collection pad configured to be applied to skin of a subject, when applied to skin of a subject, the adhesion pad configured to secure the collection pad in contact with the skin (paragraph [0057]-[0058]),
wherein a first adhesive is configured to secure a central region of the adhesion pad surrounding the collection pad to the skin (element 1002), and
wherein a second adhesive is configured to secure a peripheral region of the adhesion pad surrounding the central region to the skin (element 1008).
Regarding claim 3, as the adhesives are used for a medical purpose they are inherently medical adhesives.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (US 2016/0058380).
Regarding claim 1, Lee discloses a sweat patch, comprising:
a collection pad (“absorbent layer”, paragraph [0158]); and
an adhesion pad overlying the collection pad configured to be applied to skin of a subject, when applied to skin of a subject, the adhesion pad configured to secure the collection pad in contact with the skin (figures 2, 3),
wherein a first adhesive is configured to secure a central region of the adhesion pad surrounding the collection pad to the skin (element 204), and
wherein a second adhesive is configured to secure a peripheral region of the adhesion pad surrounding the central region to the skin (element 206).
Regarding claim 3, Lee further discloses that the second adhesive is more durable than the first adhesive (paragraph [0174]).
Regarding claim 3, as the adhesives are used for a medical purpose they are inherently medical adhesives.
Regarding claim 4, Lee further discloses that the adhesion pad comprises a first “medical tape” within the central region and a second “medical tape” within the peripheral region and overlapping an outer edge of the first medical tape (figures 2, 3).
Regarding claim 5, Lee further discloses a third “medical tape” over the second medical tape, the third medical tape having a same shape as the second “medical tape” (paragraphs [0233]-[0235]; figures 27, all are the same shape, oval).
Regarding claim 6, Lee further discloses that the third medical tape is a medical tape different from the first medical tape and the second medical tape (paragraphs [0233], [0234]).
Regarding claim 7, Lee further discloses that the third medical tape may be more durable than the first medical tape (paragraph [0233]).
Regarding claim 8, Lee further discloses an “adhesion layer” over the adhesion pad (paragraphs [0233]-[0235]).
Regarding claim 9, Lee further discloses that the adhesion layer is a medical grade adhesive (paragraphs [0233]-[0234]).
Regarding claim 10, Lee further discloses that the adhesion layer has a same shape as the second adhesive (paragraphs [0233]-[0235]; figures 27, all are the same shape, oval).
Regarding claim 11, Lee further discloses that the adhesion layer is a “medical tape” (paragraphs [0233]-[0234]).
Claim(s) 1, 3, 4, 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kidwell (US 6443892).
Regarding claim 1, Kidwell discloses a sweat patch, comprising:
a collection pad (element 40); and
an adhesion pad overlying the collection pad and, when applied to skin of a subject, securing the collection pad in contact with the skin (figure 5),
wherein a first adhesive secures a central region of the adhesion pad surrounding the collection pad to the skin (column 7, lines 45-48; element 50, figure 5), and
wherein a second adhesive secures a peripheral region of the adhesion pad surrounding the central region to the skin (column 7, lines 45-48; element 10, figure 5).
Regarding claim 3, Kidwell further discloses that the first and second adhesives are medical grade adhesives (column 7, lines 45-48)
Regarding claim 4, Kidwell further discloses that the adhesion pad comprises a first medical tape within the central region and a second medical tape within the peripheral region and overlapping an outer edge of the first medical tape (figure 5).
Regarding claim 14, Kidwell further discloses at least one anti-tampering feature within the peripheral region of the adhesion pad (column 8, lines 54-67).
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) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Schoendorfer (US 5465713).
Lee does not disclose at least one anti-tampering feature within the peripheral region of the adhesion pad, particularly the at least one anti-tampering feature comprising a plurality of slits. Schoendorfer teaches a sweat patch with an adhesion pad comprising an adhesive configured to secure a peripheral region of the pad to skin (column 4, lines 11-25), with at least one anti-tampering feature comprising a plurality of slits within the peripheral region of the adhesion pad (column 28 line 52 to column 29 line 24). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Lee with anti-tampering slits in the periphery of the adhesion pad, as taught by Schoendorfer, in order to prevent the subject from removing and replacing the pad to alter the sweat being collected.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kidwell in view of Schoendorfer (US 5465713).
Kidwell does not disclose the at least one anti-tampering feature comprising a plurality of slits. Schoendorfer teaches a sweat patch with an adhesion pad comprising an adhesive configured to secure a peripheral region of the pad to skin (column 4, lines 11-25), with at least one anti-tampering feature comprising a plurality of slits within the peripheral region of the adhesion pad (column 28 line 52 to column 29 line 24). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Kidwell with anti-tampering slits in the periphery of the adhesion pad, as taught by Schoendorfer, in order to prevent the subject from removing and replacing the pad to alter the sweat being collected.
Conclusion
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/KAREN E TOTH/ Examiner, Art Unit 3791