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 .
Status of Claims
This office action is responsive to the amendment filed 10 February 2026.
Claims 1-126, 135, and 143 are canceled.
Claims 142 and 144-147 are withdrawn.
Claims 127 and 142 are amended.
Claims 127-134 and 136-141 are presently pending in this application.
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 127, 129-134, 136-138, 140, and 141 rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US Patent Publication No. 20170188916 A1), hereinafter Wang, in view of Yang et al (US Patent No. 8512731 B2), hereinafter Yang.
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Regarding claim 127, Wang discloses a device (Wang: Fig. 1, sensor system 100) for measurement of a concentration an analyte (system 100 provides an output signal indicative of a concentration of an analyte; para. 0146), the device (Fig. 1, system 100) comprising: a sensor substrate (Fig. 3B, comprises core 410 and first layer 412) comprising a distal end (Fig. 3A above, distal end A) separated from a proximal end (Fig. 3A above, proximal end B), and at least one sensor portion (Fig. 3A, window 406) positioned between the distal end (Fig. 3A above, distal end A) and the proximal end (Fig. 3A above, window 406 is positions between distal end A and proximal end B), the sensor portion (Fig. 3A, window 406) configured to generate a signal associated with the concentration of the analyte (A working electrode is located in window 406, which provides an output signal indicative of a concentration of an analyte; para. 0146 and 0165); and a bioactive releasing membrane (Fig. 3A, membrane 408) adjacent the sensor substrate (Fig. 3A and 3B, membrane 408 is adjacent to core 410), the bioactive releasing membrane (Fig. 3A, membrane 408) comprising at least one first bioactive agent (membrane 408 may contain bioactive agents; para. 0175 and 0413) capable of modifying a tissue response of a subject (bioactive agents include anti-inflammatory agents to reduce inflammation; para. 0420); the bioactive releasing membrane (Fig. 3A, membrane 408) directly adjacent: a resistance membrane; an electrode membrane, or an interference membrane (Fig. 3A, first layer 412 comprises a working electrode, which is adjacent to membrane 408; para. 0165), the bioactive releasing membrane (Fig. 3A, membrane 408) comprises at least one polymer segment (membrane 408 can comprise one or more hard or soft copolymer segments; para. 0175 and 0250), wherein the at least one polymer segment (membrane 408 can comprise one or more hard or soft copolymer segments; para. 0175 and 0250) is selected from the group consisting of epoxides, polyolefins, polysiloxanes, polyamides, polystyrenes, polyacrylates, polyethers, polypyridines, polyesters, polyalkylesters, polyalkylcarbonates, polycarbonates, polyethylene vinyl acetate, polyvinyl alcohol, repeating zwitterionic groups, and copolymers thereof (the at least one polymer segment can comprise epoxides; para. 0051).
Wang does not expressly disclose the at least one bioactive agent is selected from dexamethasone acetate, a combination of dexamethasone and dexamethasone acetate, or a combination of a dexamethasone salt and dexamethasone acetate.
Yang teaches at least one bioactive agent is selected from dexamethasone acetate, a combination of dexamethasone and dexamethasone acetate, or a combination of a dexamethasone salt and dexamethasone acetate (dexamethasone acetate is used as a bioactive agent; col 5, ln 11-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Wang such that the at least one bioactive agent is selected from dexamethasone acetate, a combination of dexamethasone and dexamethasone acetate, or a combination of a dexamethasone salt and dexamethasone acetate as taught by Yang in order to modulate an individual’s physiological response to an implanted device and inhibit inflammation (col 5, ln 11-19).
Regarding claim 129, Wang in view of Yang discloses the device above, wherein the bioactive releasing membrane (Fig. 3A, membrane 408) comprises at least one polymer segment (membrane 408 can comprise one or more hard or soft copolymer segments; para. 0175 and 0250), wherein the at least one polymer segment (membrane 408 can comprise one or more hard or soft copolymer segments; para. 0175 and 0250) selected from the group consisting of epoxides, polyolefins, polysiloxanes, polyamides, polystyrenes, polyacrylates, polyethers, polyurethanes, polyurethane ureas, polypyridines, polyesters, polyalkylesters, polyalkylcarbonates, polycarbonates, polyethylene vinyl acetate, polyvinyl alcohol, and copolymers thereof (the at least one polymer segment can comprise epoxides; para. 0051).
Regarding claim 130, Wang in view of Yang discloses the device above, wherein the bioactive releasing membrane comprises a soft segment (membrane 408 can comprise soft hydrophilic segments; para. 0175 and 0233-0234) and a hard segment (membrane 408 can comprise hard hydrophobic segments; para. 0175 and 0233-0234) comprising urethane groups, urea groups, or a combination of urethane groups and urea groups (polymer membranes can comprise polyurethane; para. 0051).
Regarding claim 131, Wang in view of Yang discloses the device above, wherein the bioactive releasing membrane (Fig. 3A, membrane 408) comprises a multicomponent soft segment (membrane 408 can comprise one or more hard or soft copolymer segments; para. 0175 and 0250) comprising two or more different polymer segments (membrane 408 can comprise one or more hard or soft copolymer segments; para. 0175 and 0250).
Regarding claim 133, Wang in view of Yang discloses the device above, wherein the soft segment membrane 408 can comprise one or more hard or soft copolymer segments; para. 0175 and 0250) comprises a combination of one or more of polysiloxane, polyalkylether, polyalkylester, polyalkylcarbonate, polycarbonate , and polysiloxane-polyalkylether segmented blocks (membrane 408 can comprise one or mor soft copolymer segments comprising polysiloxanes; para. 0260) and wherein the hard segment (membrane 408 can comprise one or more hard or soft copolymer segments; para. 0175 and 0250) comprises at least one of norbornane diisocyanate (NBDI), isophorone diisocynate (IPDI), tolylene diisocynate (TDI), 1,3-phenylene diisocyanate (MPDI), trans-1,3- bis(isocynatomethyl) cyclohexane (1,3-H6XDI), bicyclohexylmethane-4,4'-diisocynate(HMDI), 4,4'-Diphenylmethane diisocynate (MDI), trans-1,4-bis(isocynatomethyl) cyclohexane (1,4- H6XDI), 1,4-cyclohexyl diisocynate (CHDI), 1,4-phenylene diisocynate (PPDI), 3,3'-Dimethyl-4,4'- biphenyldiisocyanate (TODI), and 1,6-hexamethylene diisocyanate (HDI) (the polymer can comprise IPDI; para. 0480).
Regarding claim 134, Wang in view of Yang discloses the device above, wherein the weight/weight ratio of the at least one first bioactive agent (membrane 408 may contain bioactive agents; para. 0175 and 0413) to the bioactive releasing membrane (Fig. 3A, membrane 408) is from about 0.1 to about 2 (the membrane can contain 0.1 to 50 wt. % bioactive agents; para. 0445).
Regarding claim 136, Wang in view of Yang discloses the device above, further comprising a dissolvable coating (biointerface layer coatings; para. 0160) adjacent the bioactive releasing membrane (biointerface layer coatings are coated upon the biointerface layer; para. 0160) comprising a second releasable bioactive agent (membrane 408 may contain bioactive agents; para. 0175 and 0413), wherein the first releasable bioactive agent is the same or different from the second releasable bioactive agent (membrane 408 may contain any variety bioactive agents alone or in combination; para. 0413 and 0428).
Regarding claim 137, Wang in view of Yang discloses the device above, further comprising a diffusion adjustment membrane (membrane 408 can comprise an enzyme layer; para. 0175) adjacent the bioactive releasing membrane (membrane 408 can comprise a biointerface layer; para. 0135), wherein diffusion adjustment membrane (membrane 408 can comprise an enzyme layer; para. 0175) is different from the bioactive releasing membrane (membrane 408 can comprise a biointerface layer, which is different than the enzyme layer; para. 0135, 0160, and 0163).
Regarding claim 138, Wang in view of Yang discloses the device above, further comprising an electrically insulating end-cap (Fig. 3A, second layer 404 defines the boundaries of the working electrode; para. 0170) adjacent the distal end (Fig. 3A shown above, second layer 404 is disposed over, and, therefore, is adjacent to the distal end A).
Regarding claim 140, Wang in view of Yang discloses the device above, wherein the electrically insulating end-cap (Fig. 3A, second layer 404 defines the boundaries of the working electrode; para. 0170) extends longitudinally or circumferentially from the distal end (Fig. 3A shown above, second layer 404 is disposed over, and, therefore, extends both longitudinally and circumferentially from the distal end A).
Regarding claim 141, Wang in view of Yang discloses the device above, wherein the electrically insulating end-cap (Fig. 3A, second layer 404 defines the boundaries of the working electrode; para. 0170) extends from the distal end (Fig. 3A above, distal end A) up to the sensor portion (Fig. 3A shown above, second layer 404 is disposed over the distal end A and extend up to the window 406).
Claim 128 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Yang, in further view of Huffstetler et al. (US Patent Publication No. 20200375511 A1), hereinafter Huffstetler.
Regarding claim 128, Wang in view of Yang discloses the device above.
Wang does not expressly disclose the bioactive releasing membrane is positioned only at the distal end.
Huffstetler teaches a bioactive releasing membrane (Huffstetler: Fig. 4, drug-eluting polymer matrix 828) is positioned only at a distal end (Fig. 4, matrix 828 only covers the distal end of sensor housing 102; para. 0056).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the bioactive releasing membrane of Wang in view of Yang such that the bioactive releasing membrane is positioned only at the distal end as taught by Huffstetler in order to cover only a portion of the sensor housing via dip coating and reduce deterioration of the analyte sensor (Huffstetler: para. 0010 and 0056).
Claim 132 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Yang, in further view of an alternative embodiment of Huffstetler.
Regarding claim 132, Wang in view of Yang discloses the device above, wherein the multicomponent soft segment (membrane 408 can comprise one or more hard or soft copolymer segments; para. 0175 and 0250) comprises a hydrophobic block (membrane 408 can comprise hydrophobic segments; para. 0175 and 0233-0234) and a hydrophilic block (membrane 408 can comprise hydrophilic segments; para. 0175 and 0233-0234) comprising at least one of a polysiloxane, a polyalkylcarbonate, and a polycarbonate (membrane 408 can comprise polysiloxanes; para. 0260).
Wang does not expressly disclose the multicomponent soft segment comprising of a combination of at least one of a polysiloxane, a polyalkylcarbonate, and a polycarbonate with a polyalkylether, a polyalkylester.
Huffstetler teaches a multicomponent soft segment (Huffstetler: Fig. 5E, membrane 934) comprising of a combination of at least one of a polysiloxane, a polyalkylcarbonate (membrane 934 can comprise polycarbonate), and a polycarbonate with a polyalkylether, a polyalkylester (the drug eluting material comprises an additive, which is polyalkylene oxide; para. 0044).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the bioactive releasing membrane of Wang in view of Yang such that the multicomponent soft segment comprising of a combination of at least one of a polysiloxane, a polyalkylcarbonate, and a polycarbonate with a polyalkylether, a polyalkylester as taught by Huffstetler in order to allow for tailored elution of one or more therapeutic agents (Huffstetler: para. 0044).
Claim 139 is rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Yang, in further view of Vaddiraju, et al. (US Patent Publication No. 20180328877 A1), hereinafter Vaddiraju.
Regarding claim 139, Wang in view of Yang discloses the device above.
Wang does not expressly disclose the electrically insulating end-cap is non-permeable to electrochemically active species or to the analyte. Vaddiraju teaches and electrically insulating end-cap (Vaddiraju: Fig. 1, dielectric layer 30 is an external-most layer) is non-permeable to electrochemically active species or to the analyte (layer 30 is impermeable to solvents, water, and other electrochemically active constituents; para. 0045).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the electrically insulating end-cap of Wang in view of Yang such that the electrically insulating end-cap is non-permeable to electrochemically active species or to the analyte as taught by Vaddiraju in order to prevent diffusion of the electrochemically active species to the electrode’s surface to accurately control the electrode signal level (Vaddiraju: para. 0045).
Response to Arguments
Applicant’s arguments, see page 7, filed 10 February 2026, with respect to the objection to the drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see page 7-9, filed 10 February 2026, with respect to the rejections of claims 127-134 and 136-141 under 35 USC 102 and 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Wang in view of Yang cited above.
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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/LEI GONZALEZ/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
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