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 .
Claims Accounting
Applicant' s arguments, filed 04/02/2025, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 04/02/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-4, 7, and 9 have been amended.
Claims 1-10 are the current claims hereby under examination.
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.
Claim 4 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.
Regarding claim 4, the claim recites “a thickness of the protective film is 0.001~100um” in lines 2-3. The symbol “~” is interpreted to mean “about in the range”. This defines a relative term which renders the claim indefinite. The symbol “~” 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. Therefore, the range of the thicknesses the protective film is considered to be indefinite. Clarification is requested.
For the purposes of examination, the claim is interpreted as “a thickness of the protective film is 0.01-100um”.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2016/0058380 by Lee et al. – previously cited, hereinafter “Lee” in view of US Patent Publication 2014/0188398 by Cohen et al. – previously cited, hereinafter “Cohen”.
Regarding claims 1-2 and 7, Figs. 10-13 of Lee teaches a body fluid analyte detection device (Figs. 12-13; adhesive sensor system 320), comprising: an analyte detection module, configured to detect analyte parameter information ([0200]; Figs. 10-13 describe an adhesive sensor system that accommodates a sensor not shown. The sensor housing unit housing 352 is configured to mount a sensor electronics unit such as sensor electronics unit 202 of Fig. 2), the analyte detection module comprises a transmitter unit, a sensor unit ([0127], the sensor system may be the DexCom G4® Platinum glucose sensor and transmitter), and a bottom case (Figs. 12-13, sensor electronics unit housing 352); a pasting module, comprising a tape (Fig. 10, inner liner 324) and a protective film (Fig. 10, outer liner 330), wherein a first side of the tape is fixedly connected with the analyte detection module (Figs. 10 and 13 show the sensor housing unit housing 352 is secured to inner liner 324 via layer 326), and a second side of the tape opposite to the first side is coated with a paste material ([0201] “An undersurface 338 of the inner liner 324 may include an adhesive material to facilitate securing the adhesive sensor system 320 to the host's skin), the protective film is fixed around an outer edge of the first side of the tape ([0206], The underside 344 of 330 contains an adhesive that fixes the outer liner to the inner liner (via 328 and 326)), an outer edge of the protective film is conformal to the outer edge of the first side of the tape (The outer edges of outer liner 330 and inner liner 324 are conformal as seen in Fig. 11.).
Lee does not teach wherein a rockwell hardness of the protective film is greater than a rockwell hardness of the tape, or wherein the rockwell hardness of the protective film is 80-100 HRM.
However, where the general conditions of a claim are disclosed in the prior art (Par. [0230] of Lee discloses that the layers of the adhesive pad may be formed of different materials and be configured to perform a different function and therefore may require different mechanical properties (e.g. rockwell hardness), it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the claimed rockwell hardness of the protective film or the claimed rockwell hardness of the tape. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum rockwell hardness of the tape and of the protective film taught by Lee.
Modified Lee does not teach wherein the analyte detection module comprises a power supply and the sensor unit comprises an internal part and an external part.
Figs. 2C and 5 of Cohen teaches components of a DexCom G4® Platinum glucose sensor system ([0187]), including battery 234 and continuous analyte sensor 10. Cohen further teaches that continuous analyte sensor 10 may be transcutaneous, requiring that sensor penetrates the skin ([0097]). The portion of the sensor electronics external to the skin can be considered the external part and the portion of the sensor that extends through and under the skin can be considered the internal part.
It is therefore understood that the analyte detection module of Lee also comprises a power supply and the sensor unit comprises an internal part and an external part, as these are components of the DexCom G4® Platinum glucose sensor system as taught by Lee and Cohen.
Regarding claim 3, Lee in view of Coh4en teaches the body fluid analyte detection device of claim 1, but does not teach wherein the tape comprises one of polyethylene, polypropylene, non-woven cloth or pure cotton.
Lee teaches that the inner liner (i.e., tape) is comprised of a flexible and resilient material ([0200]). Lee further teaches another embodiment wherein examples of materials that are considered flexible and resilient include polyethylene and cotton ([0157]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the tape taught by Lee in view of Cohen such that the tape comprises one of polyethylene, polypropylene, non-woven cloth or pure cotton, as taught by Lee. This combination would be obvious to try, as the material is selected from a finite number of identified, predictable solutions, with a reasonable expectation of success. See MPEP 2143.I.E.
Regarding claim 4, Lee in view of Cohen teaches the body fluid analyte detection device of claim 1, but does not teach wherein a thickness of the tape is 0.001-1 μm, and a thickness of the protective film is 0.01~100 μm.
However, where the general conditions of a claim are disclosed in the prior art (Par. [0200, 0202] of Lee discloses that the inner liner 324 (i.e., tape) and outer liner 330 (i.e., protective film) are preferably thin), it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Furthermore, as Applicant has failed to provide details of criticality or unexpected results with regard to the claimed thickness of the protective film or the claimed thickness of the tape. Therefore, it would have been obvious to a person of ordinary skill in the art, through routine optimization, to determine an optimum thickness of the tape and of the protective film taught by Lee in view of Cohen.
Regarding claim 5, Lee in view of Cohen teaches the body fluid analyte detection device of claim 1, but does not teach wherein the protective film is one of polycarbonate, polyamide, polyformaldehyde, polyphenyl ether, polyester, polyphenylene sulfide or polyaryl ester.
Lee teaches that the outer liner (i.e., protective film) is comprised of a flexible and resilient material ([0202]). Lee further teaches another embodiment wherein examples of materials that are considered flexible and resilient include polyester ([0157]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the tape taught by Lee in view of Cohen such that the protective film is one of polycarbonate, polyamide, polyformaldehyde, polyphenyl ether, polyester, polyphenylene sulfide or polyaryl ester, as taught by Lee. This combination would be obvious to try, as the material is selected from a finite number of identified, predictable solutions, with a reasonable expectation of success. See MPEP 2143.I.E.
Regarding claim 6, Lee in view of Cohen teaches the body fluid analyte detection device of claim 1, wherein the protective film has a ring structure (Lee, Fig. 10, outer liner 330 is considered to have a ring structure as its edge is shaped as an oval ring).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lee, in view of Cohen, as applied to claim 7, in view of US Patent Publication 2014/0288402 by Brister et al. – previously cited, hereinafter “Brister”.
Regarding claim 8, Lee in view of Cohen teaches the body fluid analyte detection device of claim 7, wherein the tape is provided with a first through hole (Lee, Fig. 10, opening 332 accommodates the sensor), but does not teach wherein the internal part passes through the first through hole.
Brister teaches an implementation of a transcutaneous sensor very similar to that taught by Lee and Cohen, wherein an adhesive pad 8 comprises an opening (See Fig. 3) and wherein the internal part (sensor 32) extends through the adhesive pad and into the skin (See Figs. 9 and 11B).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the body fluid analyte detection device as taught by Lee in view of Cohen such that the internal part passes through the first through hole, to provide the transcutaneous sensor a path through the adhesive layer. This combination would merely comprise combining prior art elements according to known methods to yield predictable results. See MPEP 2143.I.A.
Regarding claim 9, the combination of Lee, Cohen, and Brister teaches the body fluid analyte detection device of claim 8, but does not teach wherein, the second side surface of the tape is covered with at least one layer of a release paper.
Fig. 46 of Lee further teaches an embodiment that includes a liner system (i.e., release paper comprising a bottom covering liner 461 and bottom folding liner 463. The bottom covering liner has a circumference and surface area that substantially covers the bottom surface of the adhesive sensor system. The liners are configured to be peeled off prior to use ([0197]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the body fluid analyte detection device as taught by the combination of Lee, Cohen, and Brister such that the second side surface of the tape is covered with at least one layer of a release paper. The liner system (i.e., release paper) taught by Lee protects the adhesive from contaminants that may compromise the adhesion prior to use.
It is noted that the release paper taught by the combination of Lee, Cohen, and Brister is capable and intended to be removed prior to pasting on a surface (Lee, [0197]).
Regarding claim 10, the combination of Lee, Cohen, and Brister teaches the body fluid analyte detection device of claim 9, wherein the release paper is provided with a second through hole (See Lee, Fig. 46A, bottom liner 461 comprises an opening), but does not teach wherein a position of the second through hole corresponds to the first through hole, so that the internal part passes through the second through hole.
Fig. 10 of Lee shows an exploded view of the multilayer adhesive system, wherein the openings 340, 342, 334, and 334 are in alignment. The openings of the layers being in alignment allows for the sensor to pass through ([0200, 0202]). Fig. 46A of Lee depicting the bottom liner also shows an opening in the liner.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the release paper taught by the combination of Lee, Cohen, and Brister such that a position of the second through hole corresponds to the first through hole, so that the internal part passes through the second through hole, to accommodate the sensor, as taught by Lee ([0200, 0202]).
Response to Arguments
Applicant’s arguments, filed 04/02/2025 have been fully considered.
The amendments to claims 2 and 3 overcome the objections of record, and the amendments to the specification overcome the objection of record.
The amendments to the claims overcome the rejections under 35 U.S.C. 112(b) of claims 2 and 9. The amendments to the claims do not overcome the rejections under 35 U.S.C. 112(b) of claim 4.
The amendments to the claim do not invoke claim interpretation under 35 U.S.C. 112(f) for any claim limitations.
Applicant’s arguments regarding the rejection of claim 1 under 35 U.S.C. 103 is acknowledged. Applicant argues that Lee teaches that differing thicknesses and contour of the adhesive pad may be designed to provide comfort to the wearer. Applicant argues that this teaches that Lee prevents adhesive pad 322 from warping by adjusting the thickness ratio between periphery and the interior of the adhesive pad, rather than by adjusting the hardness of the adhesive pad. This argument is not found persuasive. This argument assumes that Lee only teaches one method of adjusting the properties of the adhesive pad to achieve desired outcomes.
The Office action mailed on 01/12/2026 and this Office action rely on the teachings of par. [0230] of Lee, wherein Lee teaches that the layers of the adhesive pad may be formed of different materials and be configured to perform a different function and therefore may require different mechanical properties. Rockwell Hardness is a mechanical property of the adhesive pad (as all solid materials have a Rockwell Hardness level), and therefore the materials of the different layers of the adhesive pad may require different Rockwell Hardnesses. The Office actions assert that since Rockwell Hardness is a mechanical property of the layers, it would be obvious to optimize the Rockwell Hardness of each layer.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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