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 (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.
Notice of Amendment
In response to the amendment(s) filed on 8/28/26, amended claim(s) 7 and 11-12, canceled claim(s) 3-4 and 6, and new claim(s) 21-23 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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 each of the plurality of temperature sensors 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, but each individual temperature sensor is not disposed over or in each chamber. No new matter should be entered.
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 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) 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 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
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.
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.
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.
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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crane in view of U.S. Patent Application Publication No. 2012/0316415 to Gilbert.
For claim 21, Crane does not expressly disclose a temperature sensing strip, wherein the temperature sensing strip is disposed over at least part of each of the chambers.
However, Gilbert teaches a temperature sensing strip (“a strip of temperature-indicating film,” para [0362]), wherein the temperature sensing strip is formed of the “correct size and shape” and is disposed at a “preferred location and orientation” (para [0339]) (also see para [0362] which equates the “indicator media” to the “strip of temperature-indicating film”).
It would have been obvious to a skilled artisan to modify Crane to include a temperature sensing strip, in view of the teachings of Gilbert, because such a modification would be the simple substitution of one temperature sensor structure for another temperature sensor structure that would lead to the predictable result of being able to detecto temperature in and/or around the device.
It would also have been obvious to a skilled artisan to optimize Crane wherein the temperature sensing strip is disposed over at least part of each of the chambers given that Gilbert recognizes that size, shape, location, and orientation of the temperature sensing structure are all result-effective variables that may be optimized based on what is “correct” and “preferred” (i.e., correct/preferred being the result). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crane in view of U.S. Patent Application Publication No. 2013/0018353 to Chung et al. (hereinafter “Chung”).
For claim 22, Crane does not expressly disclose wherein the first aqueous solution comprises the solute within the second chamber when the seal is intact.
However, Chung teaches wherein the first aqueous solution (“Solution A” or “Solution B,” see Fig. 1) comprises the solute (para [0037]-[0038]) within the second chamber (12 or 14, see Fig. 1) when the seal is intact (i.e., 18 and/or 20, see Fig. 1).
It would have been obvious to a skilled artisan to modify Crane wherein the first aqueous solution comprises the solute within the second chamber when the seal is intact, in view of the teachings of Chung, for the obvious advantage of mixing multiple components together after breaking the seal.
For claim 23, Crane does not expressly disclose wherein breaking the frangible seal causes the first aqueous solution comprising the solute to flow into the first chamber from the second chamber.
However, Chung teaches wherein breaking a frangible seal (i.e., 18 and/or 20, see Fig. 1) causes a first aqueous solution (“Solution A” or “Solution B,” see Fig. 1) comprising a solute (para [0037]-[0038]) to flow into a first chamber (16, and/or one of 12 or 14) from a second chamber (the other 12 or 14, see Fig. 1).
It would have been obvious to a skilled artisan to modify Crane wherein breaking the frangible seal causes the first aqueous solution comprising the solute to flow into the first chamber from the second chamber, in view of the teachings of Chung, for the obvious advantage of mixing multiple components together after breaking the seal.
Response to Arguments
Applicant’s arguments filed 8/28/26 have been fully considered.
With respect to the objection(s) to the drawings, the newly amended claim language has similar issues for the reasons stated above.
With respect to the claim objection, Applicant’s amendments and arguments are persuasive and thus the objection is withdrawn.
With respect to the 102 rejection(s), Applicant’s arguments will be treated in the order they were presented. With respect to the first argument, claim 7 does not recite that the first aqueous solution comprises a solute, both of which are disposed within the second chamber when the seal is intact. Instead, claim 7 recites “a first aqueous solution, the first aqueous solution comprising a solute; and wherein the first aqueous solution is disposed within the second chamber.” Instead, claim 22 recites “wherein the first aqueous solution comprises the solute within the second chamber when the seal is intact.” With respect to the second argument, claim 7 recites “wherein the implantable monitor device is disposed within the first chamber.” The claim does not recite that the implantable monitor device is entirely within the first chamber. Therefore, if part of the implantable monitor device of Crane is disposed inside the chamber, then Crane reads on “the implantable monitor device is disposed within the first chamber.” With respect to the third argument, Crane explicitly discloses “[t]he sensor 1 comprises an insertable tip 2 which is adapted for insertion into a patient” (see para [0047] of Crane). If something is insertable, it’s not clear how it would not be “implantable” as required by claim 7. The term “implantable” is being construed as meaning “able to be implanted.” Does Applicant have a different construction? Alternatively, is Applicant relying on some extrinsic evidence that structures that are invasively inserted into a patient can’t be implanted? If so, then the examiner respectfully requests such evidence be made of record so that the Examiner may evaluate such a claim.
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.
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
Prosecution Insights