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 1-15 are 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. Claims that depend directly or indirectly from claims 1 and 15 are also rejected due to said dependency.
In regard to claim 1, the claim recites “ wherein the second sensing section extends along 30% to 100% of a total periphery of the first sensing section to enable the interference eliminating range contacting a surrounding of the first working electrode and at least partially overlapping with the measurement range to directly consume the interferant for reducing a generation of an interfering current signal at the first working electrode.” The claim contains conditional/ optional language of “enable” which do not positively claim the limitations recited after enable (“Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation”, see MPEP 2103 C and 2111.04). The conditional/ optional limitations are not given patentable weight. It is unclear whether the function(s) recited after “enable” is/are performed or not. It is suggested that “configured to cause” or similar language should be set forth in order to more positively claim the functions.
In regard to claim 15, the claim recites “the gap between the first sensing section and the second sensing section enables the interference eliminating range at least partially overlapping with the measurement range, and cause the second conductive material to directly consume the interferant for reducing a generation of an interfering current signal at the first working electrode.” The claim contains conditional/ optional language of “enable” which do not positively claim the limitations recited after enable (“Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation”, see MPEP 2103 C and 2111.04). The conditional/ optional limitations are not given patentable weight. It is unclear whether the function(s) recited after “enable” is/are performed or not. It is suggested that “configured to cause” or similar language should be set forth in order to more positively claim the functions.
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.
Claims 1-2, 4-8, and 10-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,950,502. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-15 of ‘502 anticipate or recite similar limitations as claims 1-2, 4-8, and 10-15 of present application.
Claims 11-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 9, 12, 14-17, and 19-20 of copending Application No. 16/944,458 in view of Simpson et al. (USPGPUB 2013/0131478 – applicant cited). In regard to claims 11-15, claims 1, 7, 9, 12, 14-17, and 19-20 of ‘458 recite all the claimed limitations except providing a micro biosensor for “implantation under a skin to perform a measurement of a physiological parameter of the target analyte”. Simpson teaches a method for providing a micro biosensor for implantation under a skin to perform a measurement of a physiological parameter of the target analyte (implanted, abstract and [0110]; glucose, [0006]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (claims 1, 7, 9, 12, 14-17, and 19-20 of ‘458) to incorporate the implantation of the sensor under the skin as taught by Simpson, since both methods are for analyte/ target sensing in biofluids and one of ordinary skill in the art would have recognized implantation of the sensor under the skin facilitate in vivo/ internal target analyte sensing (see Simpson). The rationale would have been to provide in vivo/ under the skin target analyte sensing.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 1-15 would be allowable if overcome the 35 USC 112(b) rejections and the double patenting rejections.
The following is a statement of reasons for the indication of allowable subject matter: In regard to claims 1 and 11, Simpson teaches a micro biosensor for implantation under a skin to perform a measurement of a physiological parameter of a target analyte in a biofluid and reduce an interference of at least one interferant in the biofluid on the measurement ([0002]; [0138]; [0173]), and the micro biosensor comprises: a substrate having a first surface and a second surface which are oppositely configured ([0150]); a first working electrode including a first sensing section configured on the first surface of the substrate, wherein the first sensing section includes a first conductive material ([0154]); a chemical reagent covered on at least a portion of the first conductive material of the first sensing section for reacting with the target analyte in the biofluid to produce a resultant ([0071]; [0073]); and at least one second working electrode configured on the first surface of the substrate, and including a second sensing section, wherein the second sensing section is configured adjacent to at least one side of the first sensing section ([0172]), when the first working electrode is driven by a first working voltage to cause the first sensing section to have a first sensitivity to the resultant and produce a measurement range, the first conductive material reacts with the resultant to produce a physiological signal corresponding to the physiological parameter of the target analyte ([0071]; [0150]; [0410]); and when the second working electrode is driven by a second working voltage, the second sensing section has a second sensitivity smaller than the first sensitivity to the resultant ([0214]). Wang et al. (USPGPUB 2022/0095968 – applicant cited) teaches an implantable glucose sensor comprises a second conductive material different from the first conductive material ([0409-0410]; different materials, [0477]). Say et al. (USPGPUB 2010/0324400 – applicant cited) teaches an implantable glucose sensor comprises a second sensing section produce an interference eliminating range contacting a surrounding of the first working electrode and at least partially overlapping with the measurement range to directly consume the interferant for reducing a generation of an interfering current signal at the first working electrode ([0128]) and performing an interference eliminating action, wherein the interference eliminating action is to drive the second working electrode by a second working voltage to cause the second conductive material to produce an interference eliminating range and cause the second conductive material to directly consume the interferant for reducing a generation of an interfering current signal at the first working electrode ([0128]). However, the prior art of record does not teach or suggest “wherein the second sensing section extends along 30% to 100% of a total periphery of the first sensing section to enable the interference eliminating range contacting a surrounding of the first working electrode and at least partially overlapping with the measurement range to directly consume the interferant for reducing a generation of an interfering current signal at the first working electrode (when overcomes the 35 USC 112(b) rejection above)” and “wherein the second sensing section is configured adjacent to at least one side of the first sensing section with a gap no larger than 0.2 mm… and the gap between the first sensing section and the second sensing section enables the interference eliminating range at least partially overlapping with the measurement range, and cause the second conductive material to directly consume the interferant for reducing a generation of an interfering current signal at the first working electrode (when overcomes the 35 USC 112(b) rejection above)”, in combination with the other claimed elements/ steps.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHU CHUAN LIU whose telephone number is (571)270-5507. The examiner can normally be reached M-Th (6am-6pm).
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.
/CHU CHUAN LIU/Primary Examiner, Art Unit 3791