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 .
Election/Restrictions
Applicant’s election without traverse of claims 22-30 in the reply filed on 03 April 2026 is acknowledged. Claims 31-38 have been withdrawn.
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.
Claim 28 is 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.
The term “substantially” in claim 28 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what it means for the membrane to be “disposed substantially” upon the one or more active areas. A membrane is either disposed entirely, partially, or not disposed on the one or more active areas. The disclosure also does not provide a clear definition for the term “substantially.” Clarification is requested.
Claim Rejections - 35 USC § 102
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.
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.
Claims 22, 23, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Feldman et al. ‘592 (US Pub No. 2020/0060592 – cited by Applicant).
Regarding claim 22, Feldman et al. ‘592 teaches an analyte sensor (Fig. 1A pH sensor and [0026]) comprising:
a first working electrode (Fig. 1 working electrode 104 and [0026]);
one or more first active areas disposed upon the first working electrode, the one or more first active areas being responsive to a first analyte (Fig. 1A active portion 110 and [0026]); and
a first photopolymerized mass transport limiting membrane formed directly upon the first working electrode and overcoating at least the one or more first active areas (Fig. 1A membrane 140 and [0027]).
Regarding claim 23, Feldman et al. ‘592 teaches wherein the first photopolymerized mass transport limiting membrane comprises an acrylate polymer or copolymer, a thiol-ene copolymer, or any combination thereof ([0027], [0034]).
Regarding claim 26, Feldman et al. ‘592 teaches wherein the first photopolymerized mass transport limiting membrane is crosslinked ([0036]).
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 24, 25, 29, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. ‘592 in view of Thomas ‘507 (International Pub No. WO 2010/099507 – cited by Applicant).
Regarding claim 24, Feldman et al. ‘592 teaches a second working electrode (Fig. 1A working electrode 106 and [0026]);
one or more second active areas disposed upon the second working electrode (Fig. 1A active portion 112 and [0026]); and
a second mass transport limiting membrane overcoating at least the one or more second active areas and differing in composition from the first photopolymerized mass transport limiting membrane (Fig. 1A membrane 140 and [0027]; “The thickness of membrane 140 may vary or remain constant along the length of the sensor.” The thickness of the membrane can be a difference in composition.).
Feldman et al. ‘592 teaches all of the elements of the current invention as mentioned above except for the one or more second active areas being responsive to a second analyte different from the first analyte.
Thomas ‘507 teaches that one or more analytes may be monitored, such as glucose, ketones, lactate, and the like, in a body fluid ([0057]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more second active areas of Feldman et al. ‘592 to being responsive to a second analyte different from the first analyte as Thomas ‘507 teaches that one or more analytes may be monitored ([0057]) as this would be simple substitution of one known element (monitoring more than one analytes) for another (monitoring one analyte) to obtain predictable results (monitoring analyte(s)).
Regarding claim 25, Feldman et al. ‘592 teaches wherein the second mass transport limiting membrane is a second photopolymerized mass transport limiting membrane differing in composition from the first photopolymerized mass transport limiting membrane (Fig. 1A membrane 140 and [0027]; “The thickness of membrane 140 may vary or remain constant along the length of the sensor.” The thickness of the membrane can be a difference in composition. This indicates that the portion of the membrane 140 that covers active portion 110 may have a different thickness to the portion of the membrane 140 that covers active portion 112.).
Regarding claim 29, Feldman et al. ‘592 teaches all of the elements of the current invention as mentioned above except for wherein the one or more first active areas comprise one or more analyte-responsive enzymes.
Thomas ‘507 teaches wherein the one or more first active areas comprise one or more analyte-responsive enzymes (Fig. 3A sensing layer 112 and [0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one or more first active areas of Feldman et al. ‘592 to include one or more analyte-responsive enzymes as Thomas ‘507 teaches that this will aid in detecting the analyte ([0074]).
Regarding claim 30, Feldman et al. ‘592 teaches all of the elements of the current invention as mentioned above except for wherein the first working electrode is disposed upon a sensor tail configured for insertion in a tissue.
Thomas et al. ‘507 teaches wherein the first working electrode is disposed upon a sensor tail configured for insertion in a tissue (Figs. 1, 3A distal section 120 and [0068], [0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first working electrode of Feldman et al. ‘592 to include being disposed upon a sensor tail configured for insertion in a tissue as Thomas et al. ‘507 teaches that this will aid in transcutaneous positioning through a skin surface of a user ([0068]).
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Feldman et al. ‘592 in view of Ouyang et al. ‘277 (US Pub No. 2020/0237277, provisional application 28 January 2019).
Regarding claim 27, Feldman et al. ‘592 teaches all of the elements of the current invention as mentioned above except for wherein the first photopolymerized mass transport limiting membrane is discontinuous.
Ouyang et al. ‘277 teaches a membrane may not be continuous (i.e., are discontiguous), but separately overcoat active areas without departing from the scope of the present disclosure ([0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first photopolymerized mass transport limiting membrane of Feldman et al. ‘592 to be discontinuous as Ouyang et al. ‘277 teaches that a membrane may be continuous or discontiguous as both types of membrane would not depart from the scope of the invention.
Regarding claim 28, Feldman et al. ‘592 teaches wherein the first photopolymerized mass transport limiting membrane is disposed substantially upon the one or more active areas (Fig. 1A membrane 140 and [0027]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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, Alexander Valvis can be reached at (571) 272-4233. 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.
/AURELIE H TU/ Primary Examiner, Art Unit 3791
Prosecution Insights