CTNF 18/669,801 CTNF 90279 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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 (i.e., changing from AIA to pre-AIA) 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 08-25-01 AIA Applicant’s election without traverse of Invention II, drawn to a chemical sensor system of claims 7-12 in the reply filed on 5/11/26 is acknowledged. 08-06 AIA Claim (s) 1-6 and 13-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/11/26 . 08-23-02 AIA Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). 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, the “wherein the temperature sensor is disposed over or in at least part of each of the chambers,” in claim 12 must be shown or the feature(s) canceled from the claim(s). Fig. 15 instead shows an individual temperature sensor (i.e., 1502, 1504, 1506) disposed over or in a respective chamber, such that all the temperature sensors together are in each chamber (i.e., no single temperature sensor is in all chambers). No new matter should be entered. 06-22 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 Objections 07-29-01 AIA Claim 7 is objected to because of the following informalities: “wherein the seal is disposed separates” (line 6) appears that it should be “wherein the seal separates.” Appropriate correction is required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15-aia AIA Claim(s) 7 and 9-11 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by U.S. Patent Application Publication No. 2009/0277242 to Crane et al. (hereinafter “Crane”) . For claim 7, Crane discloses a chemical sensor system (Abstract) comprising: a package (Examiner’s Note: made up of the elements it comprises), the package comprising a first chamber (101) (Fig. 3) (para [0052]); a second chamber (102) (Fig. 3) (para [0052]); and a seal (11) (Fig. 3) (para [0052]); wherein the seal is disposed separates the first chamber and the second chamber (as can be seen in Fig. 3); wherein the seal is frangible (para [0052], [0057], [0062], and/or [0065]); an implantable monitor device (1/2/3) (Figs. 1-2) (para [0047]), the implantable monitor device comprising an optical chemical sensor (4) (Fig. 2) (para [0047]); wherein the implantable monitor device is disposed within the first chamber (para [0054]); a first aqueous solution (“aqueous solution,” para [0022]), the first aqueous solution comprising a solute (para [0070], “exposing the analyte 12 to the aqueous solution”); and wherein the first aqueous solution is disposed within the second chamber (para [0070], “exposing the analyte 12 to the aqueous solution,” the analyte 12 being in the second chamber, see Fig. 3). For claim 9, Crane further discloses wherein the first aqueous solution has a pH of 7.0 to 7.8 (“water,” para [0022], water having a pH of 7.0). For claim 10, Crane further discloses the package further comprising: a third chamber (103); and a second seal (11a), wherein the second seal is frangible (para [0067]); and the chemical sensor system further comprising a second aqueous solution (“third calibration solution,” para [0077]), wherein the second aqueous solution is disposed within the third chamber (para [0077]), the second aqueous solution comprising a solute (para [0077]), wherein the solute of the second aqueous solution is at a different concentration than in the first aqueous solution (para [0077]). For claim 11, Crane further discloses a temperature sensor (5), wherein the temperature sensor is disposed on or in the package (para [0054]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crane in view of U.S. Patent Application Publication No. 2022/0133234 to Li et al. (hereinafter “Li”) . For claim 8, Crane does not expressly disclose wherein the package is hermetically sealed. However, Li teaches wherein a package is hermetically sealed (para [0011] and [0051]). It would have been obvious to a skilled artisan to modify Crane wherein the package is hermetically sealed, in view of the teachings of Li, for the obvious advantage of ensuring that the aqueous solution and analyte of Crane don’t mix before the seal is broken . 07-21-aia AIA Claim (s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crane . For claim 12, Crane does not expressly disclose wherein the temperature sensor is disposed over or in at least part of each of the chambers. However, Crane does teach a heating element (14) disposed over or in at least part of each of the chambers (as can be seen in Fig. 3a) and that that heating element is used to provide an increase in temperature to each chamber so that the temperature sensor can measure temperature during calibration (para [0063]). It would have been obvious to a skilled artisan to modify Crane wherein the temperature sensor is disposed over or in at least part of each of the chambers, in view of the teachings of Crane, for the obvious advantage of being able to sense that increase in temperature in each of the chambers that Crane talks about at para [0063]). Otherwise, Crane wouldn’t be able to sense the function/effect of the heating element. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DANIEL L CERIONI/Primary Examiner, Art Unit 3791 Application/Control Number: 18/669,801 Page 2 Art Unit: 3791 Application/Control Number: 18/669,801 Page 3 Art Unit: 3791 Application/Control Number: 18/669,801 Page 4 Art Unit: 3791 Application/Control Number: 18/669,801 Page 5 Art Unit: 3791 Application/Control Number: 18/669,801 Page 6 Art Unit: 3791 Application/Control Number: 18/669,801 Page 7 Art Unit: 3791
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