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 . 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 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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 101-105) in the reply filed on 03/11/2026 is acknowledged.
Claims 106-110 and 161-166 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Accordingly, claims 101-105 are currently under consideration.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 101-105 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2009/0187091 (“Say”).
Regarding claim 101, Say teaches [a] medical device system (Fig. 14) comprising: a housing configured to be worn on skin of a host and including a distal surface for facing towards the skin and a proximal surface facing opposite the distal surface (Fig. 14, on-skin sensor control unit 44 includes a housing 45, ¶¶s 0188-0190); an elongate analyte sensor coupled to the housing and configured to extend distally from the housing and be positioned in the skin of the host (Fig. 14, sensor 42); and an elongate insertion element including a shaft having a channel that a portion of the elongate analyte sensor is positioned in, the shaft configured to be inserted into the skin to guide the portion of the elongate analyte sensor into the skin (Fig. 12, insertion device 120, ¶ 0178), and the shaft having a diametrical clearance from the portion of the elongate analyte sensor of at least 0.07 millimeters (¶ 0083, the thickness of the substrate 50, and therefore sensor 42, ranges from 50 to 500 µm; ¶ 0179, a typical cross-section of the insertion device 120 is 1 mm or less; although Say is not explicit about diametrical clearance, Fig. 13B shows one configuration in which the diametrical clearance (if taking the inner diameter of device 120 as e.g. half of the 1 mm outer diameter and the outer diameter of sensor 42 as 50 µm) is ~ 0.45 mm. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use these dimensions for the sensor and insertion device, since they are known options as identified in Say. Further, these dimensions are results-effective variables that can be changed as desired to achieve particular insertion properties/characteristics. It would have been obvious to achieve a diametrical clearance as claimed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 102, Say teaches all the features with respect to claim 101, as outlined above. Say further teaches wherein the diametrical clearance is at least 0.10 millimeters (as above, ~ 0.45 mm).
Regarding claim 103, Say teaches all the features with respect to claim 101, as outlined above. Say further teaches wherein the elongate insertion element comprises a needle (Fig. 12, see e.g. tip 121, ¶ 0178).
Regarding claim 104, Say teaches all the features with respect to claim 101, as outlined above. Say further teaches wherein the channel has a C-shaped cross-section (Fig. 13B).
Regarding claim 105, Say teaches all the features with respect to claim 101, as outlined above. Say further teaches wherein the elongate analyte sensor has a first portion coupled to the housing and a second portion extending distally from the distal surface of the housing and positioned within the channel (as shown in Fig. 14 – also see ¶¶s 0178, 0179, etc.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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