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 with traverse of claims 8-20 in the reply filed on 01/13/2026 is acknowledged. The traversal is on the ground(s) that the subject matter of each of the claim groups in linked by a common inventive concept. This is not found persuasive because Group I is directed towards method of making the sensor and group II is directed towards the sensor.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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.
Claim(s) 8,11,13,15,16,18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated Yang et al. (USPN 2017/0311858).
Regarding claim 8, Yang et al. discloses a sensor apparatus for implantation within a mammal comprising: a base layer (figure 2A [0070], [0078], layer 102); a conductive layer disposed on the base layer, wherein the conductive layer includes a working electrode (figure 2A working electrode layer 104, [0069], [0079]); an interference rejection membrane disposed over the working electrode, wherein the interference rejection membrane comprises a polymeric silicon-oxygen composition ([0051]-[0052], [0058], [0128], poly(vinyl alcohol) includes silicon functionality); an analyte sensing layer disposed over the interference rejection membrane, wherein the analyte sensing layer includes an oxidoreductase (figure 2A layer 110 with interference rejection membrane 120, [0071]-[0073]); and an analyte modulating layer disposed over the analyte sensing layer ([0064], [0071]), wherein the analyte modulating layer includes a composition that modulates the diffusion of the analyte therethrough ([0094], [0104], analyte modulating layer comprises a composition that modulates the diffusion of an analyte diffusing through the layer).
Regarding claims 11 and 18, the interference rejection membrane comprises a (SiO3)n composition ([0046], [0092], membrane made with coupling agent which is an species of SiO3).
Regarding claim 13, the interference rejection membrane comprises a Polydimethylsiloxane (PDMS) composition ([0093], [0096], [0133]).
Regarding claim 15, a method of estimating the concentrations of glucose in vivo, the method comprising: disposing a sensor apparatus of claim 1 into an in vivo environment of a subject (as discussed in rejection of claim 1), wherein the environment comprises glucose; and estimating the concentration of glucose ([0095], [0099]); so that the concentrations of glucose vivo are estimated ([0095], [0099]).
Regarding claim 16, the working electrode is formed from a platinum black composition; the interference rejection membrane is in direct contact with the platinum black composition ([0036], [0046], [0072]); and the interference rejection membrane is formed to comprise adhesive properties that facilitate adhesion with the platinum black composition ([0036], [0046], [0072]).
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) 9-10, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. as applied to claims 8 and 16 above, and further in view of Martens et al. (USPN 2014/0206832-Cited by the Applicant).
Regarding claim 9, Yang et al. discloses that the Interference rejection membrane comprises a polymeric silicon composition (para [0056]-[0058]); but does not specifically disclose a Si4O11 composition having a hexagonal polymeric structure. However, Martens et al. discloses a silicon oxide composition for use in sensors (para [0010], [0381]), comprising a Si4O11 composition (para [0417]). It would have been obvious to one having ordinary skill in the art at the time of the invention before the effective filing dated of the claimed invention, to substitute the silicon composition as taught by Martens for use in the method of making a sensor apparatus for implantation within a mammal as taught by Yang et al, in order to provide flexible and Inert anti-fouling coatings (Martens: para [0008], [0010]), since Yang et al. and Martens et al. are both directed towards sensors comprising silicon oxide compositions.
Regarding claims 10 and 17, Yang et al. discloses the interference rejection membrane comprises a silicon oxide composition (para [0046], [0092]); but does not specifically disclose a (Si4O11)n composition. However, Martens et al. discloses a silicon oxide composition for use in sensors (para [0010], [0381]), comprising a (Si4O11)n composition (para [0355], siloxane bridge. It would have been obvious to one having ordinary skill in the art at the time of the invention before the effective filing dated of the claimed invention to substitute the polymer comprising the silicon oxide composition as taught by Martens et al. for use in the method of making a sensor apparatus for implantation within a mammal of Yang et al. in order to provide flexible and inert anti-fouling coatings (Martens: para [0008], [0010]), since both Yang et al. and Martens et al. are directed towards sensors comprising silicon oxide compositions.
Claim(s) 12 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. as applied to claims 8 and 16 above, and further in view of Zaltsman et al. (USPN 2019/0062528-Cited by the Applicant).
Regarding claims 12 and 19, Yang et al. discloses the interference rejection membrane comprises a polymeric silicon composition (para [0056]-[0058]), However, it fails to disclose a cationic polyhedral oligomeric silsesquioxane (POSS) composition. However, Zaltsman et al. discloses an implant in a mammal (para [0220]) comprising a cationic polyhedral oligomeric silsesquioxane (POSS) composition (para [0024], [0103], [0151], quatemary ammonium group with polyhedral oligomeric silsesquioxane). It would have been obvious to one having ordinary skill in the art at the time of the invention before the effective filing dated of the claimed invention to substitute the polymeric composition as taught by Zaltsman et al. for use in the method of making a sensor apparatus as in Yang et al. in order to provide anti-microbial surface properties ( [0010]), since both Yang et al. and Zaltsman et al. are directed towards implants comprising polymeric silicon.
Claim(s) 14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. as applied to claims 8 and 16 above, and further in view of Ohno et al. (USPN 2005/0288468).
Regarding claims 14, 20, Yang et al. discloses that the Interference rejection membrane comprises a polymeric silicon composition (para [0056]-[0058]); but does not specifically disclose a Polydimethyisiloxane-8-poly(heptasthyl octasilsesquioxane methyl mathacrylate) composition. However, Ohno discloses a polymeric silicon composition comprising polydimethylsiloxane and poly(heptaethyl octasilsesquioxane (para [0083]-[0084], [0096], [0174], highly branched polymer comprising polydimethylsiloxane and polymerizable monomer heptaethyl octasilsesquicxane.). It would have been obvious to one having ordinary skill in the art at the time of the invention before the effective filing dated of the claimed invention to substitute the polymer as taught by Ohno for use in the method of making a sensor apparatus as in Yang et al. in order to provide control of the polymeric sillcon structure for desired properties (Ohno: para [0002]) such as a protective biocompatible silicon layer (Yang et al. para [0070]), because Ohno and Yang et al. are directed towards polymeric silicon
coatings. Further, regarding the methyl methacrylate composition, Yang et al. discloses methacrylate (para [0051]) and Ohno discloses polymerizing methyl methacrylate (para [0083]. [0088]. methyl meth(acrylate).). Therefore, varying substitutions on the silicon polymer would have been obvious through routine experimentation in order to optimize protective biocompatible.
Conclusion
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/MARJAN FARDANESH/Primary Examiner, Art Unit 3791
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