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 .
Response to Amendment
Claims 22-38 are currently pending. Claims 31-38 remain withdrawn. Claim 28 has been amended to overcome the 35 U.S.C. 112(b) rejection set forth in the Non-Final Office Action mailed on 24 April 2026.
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 – previously cited).
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 – previously cited).
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 – previously cited).
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 upon the one or more active areas (Fig. 1A membrane 140 and [0027]).
Response to Arguments
Applicant argues that Feldman et al. ‘592 does not teach the photopolymerized mass transport limiting membrane. Examiner respectfully disagrees, as Feldman et al. ‘592 teaches that the membrane 140 comprises a polymer having biocompatibilizing properties and/or an ability to limit the flux of analyte (i.e., protons) to active portions 110 and 112 ([0027]). [0122]-[0123] of the PGPUB of the current application teaches that the photopolymerized mass transport limiting membrane may be an acrylate polymer. [0035] of the PGPUB of the current application also mentions that the membrane 220 has the capability of limiting analyte flux. [0037] of the PGPUB of the current application mentions that membrane 220 is a photopolymerized mass transport limiting membrane. Thus, the membrane 140 of Feldman et al. ‘592 reads on the photopolymerized mass transport limiting membrane of claim 1 as both comprise a polymer and have the ability of limit the flux of an analyte. As such, Applicant’s arguments are not persuasive and the 35 U.S.C. 102(a)(1) rejection has been maintained.
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 AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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