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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/08/21, 01/25/22, 04/08/22, 06/22/22, 10/26/22, 02/10/23, 05/10/23, 08/02/23, 10/03/23, 01/29/24, 05/13/24, 07/24/24, 12/11/24, 04/29/25, 07/29/25 and 02/06/26 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on February 6, 2026, amended claim 1 has been entered. New claim 31 has been added.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action regarding claim 1 were fully considered are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Haselby reference), and updated obviousness rationale.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action Regarding claims 21 and 30 were fully considered and were persuasive. Examiner has cited new reference (Haselby reference). Please see prior art section below for more detail, updated citations (Haselby reference), and updated obviousness rationale.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action Regarding claim 31 was fully considered but was not persuasive. While Examiner agrees Neuenfeldt does not teach the separate zones are laterally adjacent, Neuenfeldt does teach the separate zones have different fiber sizes [par. 73.]. Therefore, this equates to the first zone and the second zone have a different fiber size or fiber composition from one another, when taking into consideration broadest reasonable interpretation.
Claim Rejections - 35 USC § 103
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 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8, 12 and 25-27 are rejected under 35 U.S.C.103 as being unpatentable over Neuenfeldt (US Patent Application Publication 2021/0401564 A1) and in further view of Kane (US Patent Application Publication 2019/0059792 A1), Ghosh (US Patent Application Publication 2020/0069949 A1) and Haselby (US Patent Number 10154918 B2).
Neuenfeldt, Kane and Ghosh were applied in the previous office action
Regarding claim 1, Neuenfeldt teaches an implantable medical device comprising [par. 21]: a housing [par. 42]; an optical chemical sensing element [par. 42], wherein the optical chemical sensing element is disposed along the housing [par. 42, 82]; and a fibrous electrospun cover layer [fig. 5, element 32; par. 80 “the vascularizing structure 32 and the immuno-protective barrier 34 are contemplated as being provided by the membrane 2”; par. 72, Examiner notes the membrane 2 has electropsun fibers] par. 21, 72], wherein the fibrous electrospun cover layer is disposed over the optical chemical sensing element [par. 42, 80, Examiner notes that since the sensor is located within the housing, it is covered by cover layer] wherein the fibrous electrospun cover layer comprises a plurality of zones, the plurality of zones comprising at least a first zone and a second zone [par. 21; Examiner notes a first range of thickness of the electrospun membrane is considered the first zone and a second range of thickness of the electrospun membrane is considered the second zone], wherein the first zone and the second zone have a different thickness, fiber density, fiber size, or fiber composition from one another [par. 9];
However, Neuenfeldt does not teach the first zone is in contact with at least a portion of a surface of the optical chemical sensing element and the second zone covers at least a portion of a surface of only the housing.
Kane teaches the first zone is in contact with at least a portion of a surface of the optical chemical sensing element and the second zone covers at least a portion of a surface of the housing [fig. 4, elements 308, 410; par. 53; Examiner notes the outer barrier layer 410 lines the surface of the housing 412].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate the first zone is in contact with at least a portion of a surface of the optical chemical sensing element and the second zone covers at least a portion of a surface of the housing, for providing a barrier between the sensing element and housing and for providing an analyte permeable zone, as evidence by Kane [par. 53].
Ghosh teaches the second zone covers at least a portion of a surface of only the housing [par. 49, 87; Examiner notes the sensor in fig. 9, element 724, is not covered by the biocompatible polymer covering the housing]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt and Kane, to incorporate the second zone covers at least a portion of a surface of only the housing, for leaving the electrode exposed, as evidence by Ghosh [par. 49].
However, Neuenfeldt does not teach wherein the first zone is positioned laterally adjacent to the second zone along an exterior surface of the implantable medical device
Haselby teaches wherein the first zone is positioned laterally adjacent to the second zone along an exterior surface of the implantable medical device [fig. 11, elements 130A, 130B; col. 15: lines 13-34, col. 16: lines 4-22]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate wherein the first zone is positioned laterally adjacent to the second zone along an exterior surface of the implantable medical device, for aiding in maintaining alignment of the support structure, as evidence by Haselby [col. 16: lines 4-22].
Regarding claim 2, Neuenfeldt further teaches the fibrous electrospun cover layer is from 10 microns to 2 millimeters thick [par. 21].
Regarding claim 3, Neuenfeldt further teaches the fibrous electrospun cover layer is disposed over the optical chemical sensing element and the housing [fig. 5, element 32, par. 80; Examiner notes that since the sensor is located within the housing, it is covered by cover layer].
However, Neuenfeldt does not teach the first zone is disposed over the optical chemical sensing element and the second zone is disposed over the housing.
Kane teaches the first zone is disposed over the optical chemical sensing element and the second zone is disposed over the housing [fig. 4, elements 308, 410; par. 53; Examiner notes the outer barrier layer 410 lines the surface of the housing 412]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate the first zone is disposed over the optical chemical sensing element and the second zone is disposed over the housing, for providing a barrier between the sensing element and housing and for providing an analyte permeable zone, as evidence by Kane [par. 53].
Regarding claim 4, Neuenfeldt further teaches the fibrous electrospun cover layer encapsulates the housing [fig. 5, element 32, par. 80].
Regarding claim 5, Kane further teaches the membrane is permeable to one or more physiological chemical elements [par. 53].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate the membrane is permeable to one or more physiological chemical elements, for allowing the analyte of interest to reach the sensor, as evidence by Kane [par. 53].
Regarding claim 6, Neuenfeldt in view of Kane of claim 5 teaches the membrane is permeable to potassium and sodium [par. 59].
Regarding claim 7, Kane further teaches the fibrous electrospun cover layer comprising polyethylene glycol [par. 121].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate the fibrous electrospun cover layer comprising polyethylene glycol, as these are suitable polymers for ion-permeable polymeric matrix material, as evidence by Kane [par. 121].
Regarding claim 8, Kane further teaches the fibrous electrospun cover layer comprising a copolymer comprising polyethylene glycol subunits [par. 121]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate the fibrous electrospun cover layer comprising a copolymer comprising polyethylene glycol subunits, as these are suitable polymers for ion-permeable polymeric matrix material, as evidence by Kane [par. 121].
Regarding claim 12, Neuenfeldt further teaches a frame, wherein the frame is disposed between the housing and the fibrous electrospun cover layer [fig. 5, element 34; par. 80].
Regarding claim 25, Kane further teaches the first zone is in contact only with the surface of the optical chemical sensing element [fig. 4, element 308]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate the first zone is in contact only with the surface of the optical chemical sensing element, for providing permeability to ions, as evidence by Kane [par. 53]
However, Neuenfeldt and Kane do not teach the second zone covers only the surface of the housing
Ghosh teaches the second zone covers only the surface of the housing [par. 49, 87; Examiner notes the sensor in fig. 9, element 724, is not covered by the biocompatible polymer covering the housing]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt and Kane, to incorporate the second zone covers only the surface of the housing, for leaving the electrode exposed, as evidence by Ghosh [par. 49].
Regarding claim 26, Kane further teaches the housing is formed from a biostable metal [par. 71].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate the housing is formed from a biostable metal, as is a well-known material used for implantable devices, as evidence by Kane [par. 71].
Regarding claim 27, Kane further teaches the plurality of zones is permeable to one or more analytes [par. 53]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate the plurality of zones is permeable to one or more analytes, for allowing ions to reach the sensing device from all sides, as evidence by Kane [par. 53].
Regarding claim 31, Neuenfeldt further teaches the first zone and the second zone have a different fiber size or fiber composition from one another [par. 73, Examiner notes the membrane has different sized fibers].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Neuenfeldt, Kane, Ghosh and Haselby and in further view of Hansen (US Patent Number 7144474 B1).
Hansen was applied in the previous office action
Regarding claim 9, Neuenfeldt, Kane, Ghosh and Haselby teach an implantable medical device, as disclosed above, and a fibrous electrospun cover layer.
However, Neuenfeldt, Kane, Ghosh and Haselby do not teach the fibrous electrospun cover layer comprising polyethylene glycol.
Hansen teaches the fibrous electrospun cover layer comprising polyethylene glycol molecules, wherein the polyethylene glycol molecules are covalently bonded to the thermoplastic fibers [col. 54: lines 57-67].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, Kane, Ghosh and Haselby, to incorporate he fibrous electrospun cover layer comprising polyethylene glycol molecules, wherein the polyethylene glycol molecules are covalently bonded to the thermoplastic fibers, to securely adhere the molecules to the fibers, as evidence by Hansen [col. 54: lines 57-67].
Claims 21 and 30 are rejected under 35 U.S.C.103 as being unpatentable over Neuenfeldt and in further view of Li (EP 3409203 A1) and Haselby.
Li was applied in the previous office action
Regarding claim 21, Neuenfeldt teaches an implantable medical device comprising [par. 21]: a housing [par. 42]; an optical chemical sensing element [par. 42], wherein the optical chemical sensing element is disposed along the housing [par. 42, 82]; and a fibrous electrospun cover layer [fig. 5, element 32; par. 80 “the vascularizing structure 32 and the immuno-protective barrier 34 are contemplated as being provided by the membrane 2”; par. 72, Examiner notes the membrane 2 is has electropsun fibers] par. 21, 72]; wherein the fibrous electrospun cover layer is disposed over the optical chemical sensing element [par. 42, 80, Examiner notes that since the sensor is located within the housing, it is covered by cover layer]; wherein the fibrous electrospun cover layer comprises a plurality of zones, the plurality of zones comprising at least a first zone and a second zone [par. 21; Examiner notes a first range of thickness of the electrospun membrane is considered the first zone and a second range of thickness of the electrospun membrane is considered the second zone], wherein the first zone and the second zone have a different thickness, fiber density, fiber size, or fiber composition from one another [par. 9, 73];
However, Neuenfeldt does not teach wherein the exterior surface of the optical chemical sensing element is flush with an exterior surface of the housing.
Li teaches wherein the exterior surface of the optical chemical sensing element is flush with an exterior surface of the housing [fig. 13, element 202, 102]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate, wherein the exterior surface of the optical chemical sensing element is flush with an exterior surface of the housing, to allow for a cover to be places over the recesses pan to keep aqueous solution 1204 within recessed pan 316 such that the sensing element 202 can be constantly bathed in aqueous solution 1204 prior to implant, as evidence by Li [par. 54].
However, Neuenfeldt does not teach wherein the first zone and the second zone are not stacked upon one another in a cross- section of the implantable medical device
Haselby teaches wherein wherein the first zone and the second zone are not stacked upon one another in a cross- section of the implantable medical device [fig. 11, elements 130A, 130B; col. 15: lines 13-34, col. 16: lines 4-22]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate wherein the first zone and the second zone are not stacked upon one another in a cross- section of the implantable medical device, for aiding in maintaining alignment of the support structure, as evidence by Haselby [col. 16: lines 4-22].
Regrading claim 30, Neuenfeldt teaches an implantable medical device [par. 21] comprising: a housing [par. 42]; an optical chemical sensing element [par. 42], wherein the optical chemical sensing element is disposed along the housing [par. 42, 82]; and a fibrous electrospun cover layer [fig. 5, element 32; par. 80 “the vascularizing structure 32 and the immuno-protective barrier 34 are contemplated as being provided by the membrane 2”; par. 72, Examiner notes the membrane 2 is has electropsun fibers; par. 21, 72], wherein the fibrous electrospun cover layer is disposed over the optical chemical sensing element [par. 42, 80, Examiner notes that since the sensor is located within the housing, it is covered by cover layer], wherein the fibrous electrospun cover layer comprises a plurality of zones, the plurality of zones comprising at least a first zone and a second zone [par. 21; Examiner notes a first range of thickness of the electrospun membrane is considered the first zone and a second range of thickness of the electrospun membrane is considered the second zone], wherein the first zone and the second zone have a different thickness, fiber density, fiber size, or fiber composition from one another [par. 9]
However, Neuenfeldt does not teach wherein an exterior of the housing and the optical chemical sensing element form a planar exterior surface
Li teaches wherein an exterior of the housing and the optical chemical sensing element form a planar exterior surface [fig. 13, element 202, 102]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate, an exterior of the housing and the optical chemical sensing element form a planar exterior surface, to allow for a cover to be places over the recesses pan to keep aqueous solution 1204 within recessed pan 316 such that the sensing element 202 can be constantly bathed in aqueous solution 1204 prior to implant, as evidence by Li [par. 54].
However, Neuenfeldt does not teach and wherein the first zone and the second zone cover different portions of the exterior planar surface
Haselby teaches and wherein the first zone and the second zone cover different portions of the exterior planar surface [fig. 11, elements 130A, 130B; col. 15: lines 13-34, col. 16: lines 4-22]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, to incorporate wherein the first zone and the second zone cover different portions of the exterior planar surface, for aiding in maintaining alignment of the support structure, as evidence by Haselby [col. 16: lines 4-22].
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Neuenfeldt, Li and Haselby and in further view of Kane
Regarding claim 23, Neuenfeldt, Li and Haselby teach an implantable medical device, as disclosed above, and a fibrous electrospun cover layer.
However, Neuenfeldt, Li and Haselby not teach cover layer protrudes outwards from the exterior surface of the optical chemical sensing element
Kane teaches cover layer protrudes outwards from the exterior surface of the optical chemical sensing element [fig. 4, element 310; par. 52]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, Li and Haselby, to incorporate cover layer protrudes outwards from the exterior surface of the optical chemical sensing element, for providing protection to the masking layer 310 from accidental removal by frictional forces during implantation, as evidence by Kane [par. 52].
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Neuenfeldt, Li, Haselby and Kane and in further view of Schmitz (US Patent Number 9320618 B2).
Schmitz was applied in the previous office action
Regarding claim 24, Neuenfeldt, Li, Haselby and Kane teach an implantable medical device, as disclosed above, and a fibrous electrospun cover layer
However, Neuenfeldt, Li, Haselby and Kane do not teach the cover layer that protrudes outwards exhibits rounded edges.
Schmitz teaches the cover layer that protrudes outwards exhibits rounded edges [col. 129: lines 65-67; col. 130: lines 1-4]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, Li, Haselby and Kane, to incorporate the cover layer that protrudes outwards exhibits rounded edges, for preventing trauma to tissue during placement, as evidence by Schmitz [col. 129: lines 65-67; col. 130: lines 1-4].
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Neuenfeldt, Kane, Ghosh and Haselby and in further view of Roberts (US Patent Application 2018/0364207 A1).
Roberts was applied in the previous office action
Regarding claim 28, Neuenfeldt, Kane, Ghosh and Haselby teach an implantable medical device, as disclosed above, and a fibrous electrospun cover layer
However, Neuenfeldt, Kane, Ghosh and Haselby do not teach the fibrous electrospun cover layer comprises electrospun fibers having a diameter of 500 nanometers to 1 micron.
Roberts teaches the fibrous electrospun cover layer comprises electrospun fibers having a diameter of 500 nanometers to 1 micron [par. 46]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, Kane, Ghosh and Haselby, to incorporate the fibrous electrospun cover layer comprises electrospun fibers having a diameter of 500 nanometers to 1 micron, to meet the challenge of miniaturization allowing sensors to easily become wearable or adapted to space-restricted mobile applications, as evidence by Roberts [par. 9].
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Neuenfeldt, Kane, Ghosh and Haselby and in further view of Li.
Regarding claim 29, Neuenfeldt, Kane, Ghosh and Haselby teach an implantable medical device, as disclosed above, and a fibrous electrospun cover layer
However, Neuenfeldt, Kane, Ghosh and Haselby do not teach the fibrous electrospun cover layer comprises one or more pigments.
Li teaches the fibrous electrospun cover layer comprises one or more pigments [par. 53]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Neuenfeldt, Kane, Ghosh and Haselby, to incorporate the fibrous electrospun cover layer comprises one or more pigments, for providing optical isolation, as evidence by Li [par. 53].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791