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 . Claims 30 and 36-48 are currently pending. The previous 101 rejection and drawing objections have been withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 30, 36-40, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Vadgama et al. GB 2,332,278 (hereinafter Vadgama) in view of Lee et al. KR Publication 2004-0032429 (hereinafter Lee).
Regarding claim 30, Vadgama discloses an electrochemical measurement system adapted for use with an external fluid environment (Figure 1), the electrochemical measurement system comprising: a silver - silver chloride reference electrode (electrode 4-6, column 3 lines 18-21, abstract), a working electrode (electrode 2, 3, see also abstract), an electrolyte in contact with the silver - silver chloride reference electrode and the working electrode (electrolyte 7), and an ion selective membrane between the electrolyte and the external fluid environment (membrane 8).
Vadgama is silent on the specifics of the ion selective membrane. Lee teaches an electrochemical sensing device that includes electrodes within an ion selective membrane that includes an aromatic epoxy polymer made from one or more monomers having at least one epoxide group ([0082][0083] which details a bisphenol A based epoxy resin that can be crosslinked with glycidyls), and a chloride salt physically trapped in the aromatic epoxy polymer ([0086] which details the use of chloride salts), wherein when hydrated, the aromatic epoxy polymer forms a network of channels for ion exchange (the above combination would have performed the claimed functional language given the resultant structure is identical, also the channels would have been required for the ions to pass through it at all). Therefore it would have been obvious to the skilled artisan before the effective filing date to utilize the aromatic polymeric epoxy as the membrane as taught by Lee in lieu of the membrane of Vadgama in order to increase sensitivity, reduce shrinkage during curing, and the ability to further tune analyte diffusion.
Regarding claim 36, Vadgama is silent on the additional membrane specifics.
Lee teaches that the one or more monomers have at least one epoxide group from which the aromatic epoxy polymer is made are bis-phenyl monomers (Claim 2, Table 1). It would have been obvious to the skilled artisan before the effective filing date to utilize the ion selective membrane as taught by Lee with the device of Vadgama in order to increase sensitivity, reduce shrinkage during curing, and the ability to further tune analyte diffusion.
Regarding claim 37, Vadgama is silent on the additional membrane specifics.
Lee teaches that the bis-phenyl monomers have the general formula ([0082] which details several examples of diglycidyl bisphenol A diglycidyl ether which is a subset under the larger DGEBA structures that the Applicant is broadly claiming). It would have been obvious to the skilled artisan before the effective filing date to utilize the ion selective membrane as taught by Lee with the device of Vadgama in order to increase sensitivity, reduce shrinkage during curing, and the ability to further tune analyte diffusion.
Regarding claims 38-39, Vadgama is silent on the additional membrane specifics. Lee teaches that the aromatic epoxy polymer is made by reacting the one or more monomers with an amine hardener Claim 1, Table [0100][0110][0129]). It would have been obvious to the skilled artisan before the effective filing date to utilize the ion selective membrane as taught by Lee with the device of Vadgama in order to increase sensitivity, reduce shrinkage during curing, and the ability to further tune analyte diffusion.
Regarding claim 40, Vadgama is silent on the claimed formula II. Lee is also silent on the exact formula however, Lee does expressly teach polyethylene polyamine epoxy curing agents including diethylenetriamine, triethylenetetramine, and tetraethylenepentamine ([0083]). These compounds possess the same repeating ethyleneamine backbone structure recited in Applicant’s Formula II and differ primarily in the degree of terminal amine substitution (primary versus substituted/tertiary terminal amines). It would have been obvious to the skilled artisan before the effective filing date to utilize substituted amine variants of the expressly disclosed polyethylene polyamine curing agents as they are art recognized equivalents as epoxy curing agents, terminal substitution predictably alters curing rate, viscosity, steric effects, and crosslink density, and modification of terminal amine substitution constituted routine optimization of known epoxy hardener systems.
Regarding claim 48, Vadgama discloses that the silver - silver chloride reference electrode comprises a wire, rod, pellet, or a micro-fabricated electrode (Figure 1 and page 14, paragraph 2, which details that the substrate can be 0.5mm and the thickness of the reference electrode is about half of that based on Figure 1 making it about 250microns which would be considered a micro-fabricated electrode). Given it is a relative estimate based on the figures, the skilled artisan would have had to have made a short leap for the overall sizing. The Applicant includes no criticality on the actual sizing, and by extension the skilled artisan before the effective filing date would have found utilizing an electrode (on the micron scale) to be an obvious matter of design choice. Further, the other claimed forms of a rod, wire, and pellet were also well-known before the effective filing date as industry standards for electrode design.
Claims 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Vadgama in view of Lee, or in the alternate, in further view of Yandrasits et al. US Publication 2021/0032378 (hereinafter Yandrasits).
Regarding claims 41-43, Vadgama as modified by Lee does not explicitly disclose the exact sizing of the pores (1 micron, 500nm, and 100nm), however given that they are made of the same material and used in the same applications, it would have been obvious to the skilled artisan before the effective filing date to utilize the claimed sizing as a matter of design choice. The recited channel diameters constitute routine optimization of result-effective variables relating to ionic transport, selectivity, hydration behavior, and membrane strength. Additionally, Applicant has not disclosed any criticality for the above claimed ranges in the original disclosure.
Yandrasits teaches an ion permeable membrane for electrochemical device that includes channel sizes of less than 100nm ([0124] which details it can be as low as 20 nanometers). Therefore it would have been obvious to the skilled artisan before the effective filing date to utilize the channel size as taught by Yandrasits with the combination of Vadgama and Lee as a matter of design choice given the lack of criticality detailed above.
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Vadgama in view of Lee, and in further view of D’Orazio et al. US Patent 5,773,270 (hereinafter D’Orazio).
Regarding claim 44, Vadgama is silent on the thickness of the membrane, even though the figures suggest it should be approximately 250 microns on its own with the thickness being about half of the substrate’s thickness. D’Orazio teaches an electrochemical sensor for glucose sensing that include an ion selective membrane having a thickness between 10 microns and 2mm (abstract, 90 microns is disclosed). Therefore, it would have been obvious to the skilled artisan before the effective filing date, given the lack of criticality for the claimed range, to utilize the membrane thickness of D’Orazio with the device of Vadgama and Lee as predictable results would have ensued (having a minimal functional thickness to afford permeability of the desired material while preventing potentially interfering substances).
Claims 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over Vadgama in view of Lee, and in further view of Uematsu EP 0289753 (hereinafter Uematsu).
Regarding claims 45-47, Vadgama as modified by Lee does not detail the exact ratio of polymer to salt ratio (pre-polymerized) weight is less than 5:1 through 1:1. Uematsu teaches an ion permeable membrane for testing blood/urine that includes a membrane with the above ratios of polymer to salt (page 3, lines 26-34 and 49-56, see also claims 2-3). Uematsu additionally teaches the thickness of 10microns to 2mm (see page 4 lines 19-21). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the polymer to salt ratio as taught by Uematsu with the device of Vadgama in order to have greater control over the ion-exchange rate and selectivity. The thickness is obvious as it leads to the easiest adhesion of the membrane to the electrode body (see Uematsu’s explicitly criticality, page 4 lines 20-21).
Response to Arguments
Applicant’s arguments with respect to claim 30 have been considered but are moot in view of the new ground(s) of rejection. New art has been applied above to remedy any deficiencies in the prior rejection of record.
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.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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