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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 4-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 4 defines the adhesion pad as comprising a first medical tape and a second medical tape; claim 1 defines the device as comprising an adhesive on each layer of the adhesion pad. As presented, this would result in a the device of claim 4 comprising an additional adhesive on top of the adhesive which is inherently present in any “medical tap” as defined in the disclosure of the instant application – that is, two layers of adhesive on each layer of the adhesive pad. There is no disclosure of an additional adhesive being present on top of the adhesive inherently already part of “medical tape”, such that the disclosure does not reasonably convey possession of a device with layers of adhesives in addition to those already present in medical tapes at the time the invention was filed.
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 14 and 15 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 14 recites “the peripheral region of the adhesion pad”; there is insufficient antecedent basis for this limitation in the claim, as no peripheral region is defined in claims 1 or 14. It appears the claim should refer to one or both of the layers of the adhesion pad, but it is not clear which. Clarification is required.
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 8-11 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 8 defines the devices as “further” including “an adhesion layer”, but the “adhesion layer” merely includes “the first adhesive and the second adhesive” which are already present in the device, such that nothing “further” has been defined. 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.
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, 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 sweat patch, comprising:
a collection pad configured to contact a dermal layer of a subject and, when in contact with the dermal layer of the subject, absorb and retain body fluid from the dermal layer (element 40); and
an adhesion pad overlying the collection pad and configured, when applied to the dermal layer of the subject, to secure the collection pad in contact with the dermal layer (figure 5),
the adhesion pad comprising a first layer and a second layer (elements 10, 50),
wherein the first layer forms a central portion of the adhesion pad and includes a contact area contacting the collection pad (element 50; figure 5; column 7, lines 45-48),
wherein the second layer forms a peripheral portion of the adhesion pad (column 7, lines 45-48; element 10, figure 5) and is hollow (see figure 5, “having an unfilled or hollowed-out space within” https://www.merriam-webster.com/dictionary/hollow; “a cavity, gap, or space” https://www.ahdictionary.com/word/search.html?q=hollow), and
wherein the first layer and the second layer overlap in an “overlap region” spaced apart from the contact area of the first layer (figure 5, the total areas where the layers overlap includes the region “spaced apart” from the contact area; the Examiner notes that, as presented, the area of overlap is not limited to only the overlap region),
wherein a first adhesive on the first layer is configured to secure a portion of the first layer that surrounds the contact area of the first layer to the dermal layer, and wherein a second adhesive on the second layer is configured to secure a portion of the second layer outside the overlap region to the dermal layer (figure 5).
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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 as the first layer and a second medical tape as the second layer (column 7, lines 45-48).
Regarding claim 14, Kidwell further discloses at least one anti-tampering feature within a 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) 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 a 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) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee (US 2016/0058380) in view of Saita (US 6063029).
Regarding claim 1, Lee discloses a sweat patch, comprising:
a collection pad configured to contact a dermal layer of a subject and, when in contact with the dermal layer of the subject, absorb and retain body fluid from the dermal layer (“absorbent layer”, paragraph [0158]); and
an adhesion pad overlying the collection pad and configured, when applied to the dermal layer of the subject to secure the collection pad in contact with the dermal layer (figures 2, 3),
the adhesion pad comprising a first layer and a second layer (figures 2, 3),
wherein the first layer forms a central portion of the adhesion pad and includes a contact area contacting the collection pad (element 204),
wherein the second layer forms a peripheral portion of the adhesion pad and is hollow (element 206 – see figure 2, showing the hollow area 216)
and wherein the first layer and the second layer overlap in an overlap region (figures 2, 3)
wherein a first adhesive on the first layer is configured to secure a portion of the first layer that surrounds the contact area of the first layer to the dermal layer (element 204), and
wherein a second adhesive on the second layer is configured to secure a portion of the second layer outside the overlap region to the dermal layer (figures 2, 3).
Lee does not disclose the overlap region being spaced apart from the contact area between the first layer and the collection pad; Lee is not specific as to the relative amount of element 204 which is absorbent and serving as a collection pad that would in turn define the boundaries of the contact area and its relationship to the overlap region.
Saita teaches a patch comprising a collection pad configured to contact a dermal layer of a subject and, when in contact with the dermal layer of the subject, absorb and retain body fluid from the dermal layer (element 5), and an layer overlying the collection pad and configured, when applied to the dermal layer, to secure the collection pad in contact with the dermal layer (element 2), where the layer includes a contact area contacting the collection pad in its central portion (figures 1a-c) and a surrounding region spaced apart from the contact area which is configured to be secured to the dermal layer by means of an adhesive on the layer (element 2; figures 1a-c).
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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 the contact area between collection pad and first layer being less than the area of the entire first layer, resulting in a surrounding portion of the layer in contact with the dermal layer, as taught by Saita, in order to ensure that the first layer is securely adhered to the dermal layer.
Regarding claim 2, 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” as the first layer and a second “medical tape” as the second layer (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” on portions of the adhesion pad, the adhesion layer including the adhesives (paragraphs [0233]-[0235]).
Regarding claim 9, Lee further discloses that the adhesives are medical grade adhesives (paragraphs [0233]-[0234]).
Regarding claim 10, Lee further discloses that the second adhesive has a same shape as the second layer (paragraphs [0233]-[0235]; figures 2, 3, 27).
Regarding claim 11, Lee further discloses that the adhesives of the adhesion layer are the adhesives of the “medical tape” (paragraphs [0233]-[0234]).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee, as modified by Saita above, and further in view of Schoendorfer (US 5465713).
Lee, as modified, does not disclose at least one anti-tampering feature within a 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, as modified by Saita, with anti-tampering slits in a 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.
Response to Arguments
Applicant's arguments filed 13 May 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) Lee have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant addresses only Lee’s figure 26, not any other cited teaching, addressing whether Lee teaches the newly added limitations directed to the contact area between collection pad and first layer of the adhesive pad being less than the entirety of the first layer of the adhesive pad; as this is taught by Saita as modifying Lee above, these remarks are moot.
The Examiner notes that Applicant’s remarks do not address any other reference applied in the previous Office Action, in particular failing to discuss any of the disclosures of Kidwell or Schoendorfer, both of which are applied again above, beyond a general allegation of patentability and “deficiencies” in these references without actually identifying these supposed deficiencies, such that these general assertions are moot.
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 KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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/KAREN E TOTH/Examiner, Art Unit 3791
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