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 .
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.
Claims 2-4, 6-11, 15-16, 18, and 21-26 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.
As to claim 26, this claim recites in the preamble, a device for detecting an analyte and later recites a controller configured to receive a training signal from the sensor system related to detecting at least one analyte in a training sample associated with a user. It is not clear if these refer to the same analyte, rendering the claims indefinite.
Claim 26 is also indefinite for another reason. The claim recites:
“…match the test result to the determined presence, amount, or concentration of the at least one analyte in the training sample; and
adjust at least one value based on the matched test result, wherein said at least one value is used for determining the physiological status of the user.”
It is unclear whether the adjustment itself is based on the matched test result or if it can be any adjustment to a value that is the result of a match. To elaborate, the matched result may indicate 100 mg/dl of an analyte. In the first scenario, there may be a rule that says any matched result more than 90 mg/dl is adjusted to be increased by 5%. It is based on the matched result because 100 mg/dl is more than 90 mg/dl. In the second, the 100 mg/dl match test result was conducted at an ambient temperature that was 10 degrees below the standard measurement environment, which then needs to be adjusted to compensate for this temperature difference. It is still based on the matched result because the adjustment is still predicated on 100 mg/dl being a base value that must be subsequently adjusted. Because claim 26 is amenable to two or more plausible claim constructions with materially different scope, the claims must be rejected as indefinite. For purposes of examination, the claim will be understood to include any adjustment of the matched value.
As to claim 27, it is unclear if the “adjusted value” is the same as the controller configured to “adjust at least one value based on the matched test result, wherein said at least one value is used for determining the physiological status of the user.” Examiner notes that the claims is only to a processor that is configured to perform certain actions. The “adjusted value” is assumed to exist, but it is not clear that the value actually has been adjusted, rendering the claim indefinite.
As to claims 2-4, 6-11, 15-16, 18, and 21, these claims recite “wearable device,” whereas independent claim 26 only recites “a device.” The claims must be amended to achieve congruency in the claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,036,020 B2 in view of US 2013/0158376 A1 to Hayter et al.
The only portion of the claims that is different from reference claim 1 is the inclusion of the controller that is configured to adjust at least one value based on the matched test result, wherein said at least one value is used for determining the physiological status of the user. This is supplied by Hayter, which teaches adjusting a matched result (see [0074]-[0076]). Such adjustments would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in order to provide the predictable result of correcting environmental factors that affect electrochemical processes.
Allowable Subject Matter
Claims 2-4, 6-11, 15-16, 18, and 21-26 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph. The claims would also be allowable if rewritten or amended to overcome the double patenting rejection set forth in this Office action, or upon the filing of a terminal disclaimer to remove the double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-Tu, 8:30 am - 5 pm.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
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