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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/04/2026 has been entered.
Claims Accounting
Applicant's arguments, filed 08/04/2026, 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 08/04/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1 and 4 have been amended.
Claims 1-10 are the current claims hereby under examination.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “an analyte detection module, configured to detect analyte parameter information the analyte detection module comprises” in lines 2-3. This should read “an analyte detection module configured to detect analyte parameter information, wherein the analyte detection module comprises”.
Claim 1 recites “the sensor unit becomes part of the bottom case, the sensor unit is in directly contact with the tape” in line 13. This should read “the sensor unit becomes part of the bottom case and the sensor unit is in direct contact with the tape.”
Appropriate correction is required.
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 1-10 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.
Regarding claim 1, the claim recites “after the sensor unit is assembled, the sensor unit becomes part of the bottom case, the sensor unit is in directly contact with the tape” in lines 12-13. There is insufficient support in the written description for the limitation of “the sensor unit is in directly contact with the tape”, and therefore this limitation constitutes new matter. The specification contains recitations of direct contact with regard to tape 131 being in direct contact with the skin of the host in par. [0038]. Applicant identified pars. [0036-0038] and [0076-0078] and Figs. 1 and 2 as support for the claim amendments.
The recitations of pars. [0036-0038] that are directed toward the sensor unit teach that the bottom case 10 is used to assemble the transmitter unit 12 and the sensor unit 11 and that sensor unit 11 comprises an internal part 1131 and an external part 1132, the external part 1132 is bent relative to the internal part 1131. The recitations of pars. [0076-0078] that are directed toward the sensor unit teach that the bottom board of the bottom case 10 is further provided with a window 106 where a sensor unit 11 is assembled and the edge contour shape of the sensor unit 11 matches that of the window 106. Pars. [0076-0078] further teaches that the sensor unit 11 is assembled on the bottom case 10 and becomes a part of the bottom case. The recitations of pars. [0036-0038] and [0076-0078] do not describe the relationship of the sensor unit 11 and the tape when assembled.
Fig. 1 shows an assembled view of the body fluid analyte detection device, wherein the sensor unit 11 is not visible in relation to the tape. Fig. 2 depicts the sensor unit 11 and the window 106. The edge contour shapes of the window unit are visible, however, Fig. 2 does not depict the tape, or the relationship of the sensor unit 11 to the tape when assembled.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(a) are rejected by virtue of their dependency on a rejected base claim.
Examiner’s Note
The following is a statement of reasons for the lack of prior art rejections of claims 1-10:
No prior art rejections are applicable based on prior art found in the search for amended claim 1 because no prior art, either alone or in combination teaches the limitation of “the sensor unit is in directly contact with the tape” in combination with the other claimed elements.
Any amendments to the claims to overcome the rejections under 35 U.S.C. 112(a) may require further search and consideration due to changes in the scope of the claim resulting from amendments, and could result in the application of prior art rejections in future Office actions.
Response to Arguments
Applicant’s arguments, filed 08/04/2026, have been fully considered.
The amendments to the claims overcome the rejections under 35 U.S.C. 112(b) of claim 4.
Applicant’s arguments regarding the rejection of claim 1 under 35 U.S.C. 103 is acknowledged. Applicant argues that Lee fails to disclose the technical points of mitigating the edge of the tape from warping though specific hardness differences and that Lee fails to teach the new limitations of amended claim 1. These arguments are moot as amendments to the claims result in rejections on new grounds under 35 U.S.C. 112(a) as stated above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2019/0216397 by Yavorsky et al. – cited by Applicant, teaches a thin rigid layer (i.e., shim) disposed over an adhesive layer with a contour matching that of the adhesive layer in order to resist an uncoupling of the adhesive patch from the anatomy of the wearer.
US Patent 10,161,082 by Chapman teaches that a rigid portion can be any rigid material having a Rockwell hardness greater than a threshold, thereby teaching that Rockwell hardness correlates to rigidity.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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