DETAILED ACTION
Election/Restrictions
Newly submitted claims directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: The added claims of 27-39 recite two patentably distinct species of the second layer, said second layer comprising an ion-exchange polymer or a polymer having a positive or negative charge. These species are independent or distinct as they recite properties that are not inherent of a polyvinylpyridine or a copolymer thereof or a polyvinylimidazole or a copolymer thereof.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: The species are independent or distinct because the claims to the different species recite the mutually exclusive characteristics of such species. In addition, these species are not obvious variants of each other based on the current record. The species require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search queries); and or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 USC 101 and/or 35 USC 112, first paragraph.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 27-39 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Claim(s) 1-4, 24, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2019/0320947), in view of Silver (US 2006/0079740), Zhang (US 2013/0126349) and Liu et al. (US 2009/0099434).
As to claim 1, Chen teaches an analyte sensor and corresponding method comprising: a sensor comprising at least a first working electrode ([0039]); an analyte-responsive active area (218) disposed upon a surface of the first working electrode (214) ([0045]), wherein the analyte-responsive active area comprises an enzyme ([0060]) and an electron transfer agent ([0066]); and a multi-layer mass transport limiting membrane ([0072]) permeable to the analyte that overcoats at least a portion of the analyte-responsive active area ([0069]). Chen fails to teach a multi-layered with the recited materials.
Silver teaches an analyte sensor for detecting glutamate in vivo ([0333]), the sensor comprising:(i) at least a first working electrode ([0316]); (ii) a glutamate-responsive active area disposed upon a surface of the first working electrode ([0091] – sensing surface), wherein the glutamate-responsive active area comprises a glutamate oxidase ([0334]) and an electron transfer agent ([0190] – mediators of the electron transfer process). It would have been obvious to modify Chen with Silver to allow for the detection of glutamate, to enable the measurement of other physiological parameters.
The above combination does not teach a first layer comprising a copolymer of polyurethane and a second polymer, the second polymer being selected from the group consisting of a polyether, a polyester, a polyalkene, a polyamine,and a polyalkylene oxide, and wherein the second layer comprises: polyvinylpyridine or a copolymer thereof; or polyvinylimidazole or a copolymer thereof.
Zhang teaches selectively permeable membranes for biosensors including that is a polyether-based thermoplastic polyurethane copolymer ([0066]). Liu teaches a mass transport limiting membrane composed of polymers such as polyvinylpyridine and polyvinylimidazole ([0147]). As such, it would have been obvious to modify Chen with Silver, Zhang, and Liu to utilize materials known for being permeable and/or functioning as mass transport limiting membranes comprising the recited materials.
As to claim 2, Chen teaches the active area further comprises a polymer, wherein the enzyme is crosslinked with the polymer ([0071]).
As to claims 3-4, Chen teaches the use of albumin as a stabilizer for the enzyme, and incorporated into the active area ([0044]).
As to claim 24, Chen teaches the layer comprises a crosslinker ([0271]).
As to claim 25, Chen teaches the second layer comprises polyvinylpyridine-co-styrene ([0137]).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2019/0320947), Silver (US 2006/0079740), Zhang (US 2013/0126349) and Liu et al. (US 2009/0099434), and further in view of Tapsak et al. (US 2003/0217966).
As to claim 23, the above combination does not recite that the first layer is capable of absorbing about 30% to about 70% of its weight in water. Tapsak teaches that hydrophilic polyurethanes, used as flux controlling membranes, can be synthesized with the ability to absorb up to 50% of its dry weight of water ([0006]). Accordingly it would have been obvious to modify the above combination with Tapsak to ensure that the resulting membrane is sufficiently capable of absorbing enough water to allow the passage of analytes through the system.
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 2019/0320947), Silver (US 2006/0079740), Zhang (US 2013/0126349) and Liu et al. (US 2009/0099434), and further in view of Pestice et al. (US 2009/0143658).
As to claim 26, while Chen teaches that the active area (618) may be up to about 10 µm ([0067]), along with a bilayer membrane (Fig. 14 – 621a and 621b) which appears to be roughly double the thickness of the active area, it does not necessarily teach that layers are within the recited thickness. Pestice teaches electrochemical sensors with multiple membrane layers, including an interference layer which may be around 20 microns ([0072]) as well as flux limiting membranes which can also be around 20 microns ([0084]). Accordingly, it would have been obvious to modify the above combination with Pestice to explicitly use layers of the recited thickness as it would have been obvious to try in view of what has been taught within Chen as well as explicitly disclosed within Pestice.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. It is noted that arguments pertaining to Silver are moot because Silver is not relied upon for its membranes, but rather just its glutamate sensor.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 1/13/26