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 statements (IDS) submitted on 05/30/24 and 03//04/24 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on April 10, 2026, amended claims 1, 3, 4, and 6 have been entered. Claims 2 and 10-20 have been cancelled. New claim 21 has been added.
Response to Arguments
Applicant's remarks and amendments with respect to the objections have been fully considered and were persuasive. Therefore, these objections have been withdrawn.
Applicant’s arguments with respect to Vaddiraju were considered but were not persuasive. Applicant argues that Vaddiraju does not teach the use of an analyte modulating layer that comprises an acrylate hydrogel, and instead teaches a protective layer that comprises an acrylate hydrogel. Examiner notes that Vaddiraju teaches the protection layer has diffusion properties [par. 56], which is the function of an analyte modulating layer. Therefore, this equates to an analyte modulating layer that comprises an acrylate hydrogel, when taking into consideration broadest reasonable interpretation.
Applicant’s remaining arguments filed with respect to the 103 rejections raised in the previous office action were fully considered, but 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 (Somasuntharam, Garcia and Akbari references), and updated obviousness rationale.
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 and 3-9 are rejected under 35 U.S.C. 103 as being obvious under Somasuntharam (U.S. Patent Application Publication 2021/0076993 A1) in view of Vaddiraju (U.S. Patent Application Publication 2018/0328877 A1) and Garcia (U.S. Patent Application Publication 2022/0313124 A1)
Somasuntharam was applied in Applicant’s IDS filed on 03/04/24 and previous office action
Vaddiraju and Garcia were applied in the previous office action
Regarding claim 1, Somasuntharam teaches an amperometric analyte sensor [par. 5] comprising: a working electrode comprising: a base layer [fig. 2A, element 102; par. 68]; a conductive layer [fig. 2A, element 104] disposed over the base layer [par. 68]; an analyte sensing layer [fig. 2A, element 110] disposed over the conductive layer [par. 70]; and an analyte modulating layer [fig. 2A, element 112] disposed over the analyte sensing layer [par. 6, 72], wherein: the analyte modulating layer permselectively modulates the diffusion of glucose and oxygen therethrough such that the diffusion of glucose is limited relative to oxygen [par. 52 “an analyte modulating layer that functions to both release an immunosuppressant agent as well as in analyte diffusion control (e.g. to modulate the amounts of glucose and oxygen exposed to the analyte sensing layer)”, par. 53 “the analyte modulating layer is formed to exhibit a first permeability to glucose and a second permeability to O.sub.2, and the permeability to O.sub.2 is greater than the permeability to glucose”]; and the analyte modulating layer comprises a hydrogel [par. 72 “glucose limiting membranes can be made from a wide variety of materials known to be suitable for such purposes, e.g. … hydrogels”] having a polymer reversibly coupled to a bioactive agent such that the bioactive agent is uncoupled from the polymer in response to a stimuli [par. 8, 30, 37 “the polymeric material used to make the analyte modulating layer and/or sublayers, the amount of and/or thickness of the sublayers, and the concentration of the immunosuppressant agent in the sublayers is precisely controlled so to create one or more specific release profiles for the immunosuppressant agent”, 52].
Although Somasuntharam does not explicitly teach the analyte modulating layer exhibits a permeability to glucose and oxygen that is altered by less than 10% following release of the bioactive agent from the analyte modulating layer, this would be obvious to a person having ordinary skill in the art when the invention was filed since Somasuntharam also suggests a sensor flex assembly that can be coated with an immunosuppressant agent layer without interfering with analyte modulating membrane functionality [par. 20]. Additionally, Somasuntharam teaches “the polymeric material used to make the immunosuppressant releasing layer and/or sublayers, the amount of and/or thickness of the sublayers, and the concentration of the immunosuppressant agent in the sublayers is controlled so to create one or more specific release profiles for the immunosuppressant agent” [par. 8]. Further, Somasuntharam suggests the analyte modulating layer is made from materials that determine analyte diffusion [par. 57, 66]. Therefore, the modulating layer exhibiting a permeability by less than 10% following release of the bioactive agent from the analyte modulating layer would involve only routine skill in the art.
However, Somasuntharam does not teach a layer comprising an acrylate hydrogel
Vaddiraju teaches a layer comprising an acrylate hydrogel [par. 56]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Somasuntharam to incorporate a layer comprising an acrylate hydrogel, to improve adhesion, as evidence by Vaddiraju [par. 56]
However, Somasuntharam does not teach the bioactive agent is at least one of: an antibacterial agent and an anticoagulant agent
Garcia teaches the bioactive agent is at least one of: an antibacterial agent and an anticoagulant agent [par. 280]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Somasuntharam to incorporate the bioactive agent is at least one of: an antibacterial agent and an anticoagulant agent, for promoting fluid influx or efflux, as evidence by Garcia [par. 279]
Regarding claim 3, Somasuntharam further teaches the bioactive agent comprises at least one of a dexamethasone, a heparin or a fluoroquinolone [par. 43]
Regarding claim 4, Somasuntharam further teaches the bioactive agent is noncovalently entrapped within the polymer; and/or the bioactive agent is covalently coupled to the polymer; and/or the bioactive agent is coupled to the polymer by an acrylate moiety disposed on the bioactive agent [par. 55, 97 “the various layers (e.g. the analyte sensing layer) of the sensors can have one or more bioactive and/or inert materials incorporated therein. The term “incorporated” as used herein is meant to describe any state or condition by which the material incorporated is held on the outer surface of or within a solid phase or supporting matrix of the layer. Thus, the material “incorporated” may, for example, be immobilized, physically entrapped, attached covalently to functional groups of the matrix layer(s)”]
Regarding claim 5, Somasuntharam further teaches the analyte modulating layer comprises at least one of: a Poly(2-hydroxyethyl methacrylate), a polyurethane and a chain extender [par. 55, 63]
Regarding claim 6, Somasuntharam further teaches the bioactive agent is uncoupled from the polymer in response to: exposure to aqueous media; exposure to endogenous stimuli present in the environment in which the sensor is disclosed; an alteration in the pH of the environment in which the amperometric analyte sensor is disposed; an alteration in the temperature of the environment in which the amperometric analyte sensor is disposed; and/or an electrochemical stimuli selected from: a voltage applied to the amperometric analyte sensor; and/or a current within the amperometric analyte sensor [Examiner notes the agent is released after implantation]
Regarding claim 7, Garcia further teaches the bioactive agent is uncoupled from the polymer in response to: active oxygen species including hydrogen peroxide [par. 253]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Somasuntharam and Vaddiraju, to incorporate uncoupling the bioactive agent from the polymer in response to: active oxygen species including hydrogen peroxide, to bind-up or substantially inactivate interferants, as evidence by Garcia [par. 253]
Regarding claim 8, Somasuntharam further teaches the amperometric analyte sensor consists of a single sensor flex assembly comprising a flexible planar element having a longitudinal member comprising a first side and a second side [fig. 7A; par. 31]
Regarding claim 9, Somasuntharam further teaches the bioactive agent is coupled to an external surface of the analyte modulating layer [par. 31 “the immunosuppressant agent is coupled to or disposed within a primary analyte sensing component that functions in analyte sensing, for example the analyte modulating layer… the shaded regions on the longitudinal arm of the sensor flex assembly shown in these figures indicate different illustrative regions and ways in which a composition comprising an immunosuppressant agent can be disposed in an analyte sensor (e.g. in dots on top of an analyte modulating layer”]
Claim 21 is rejected under 35 U.S.C. 103 as being obvious under Somasuntharam in view of Vaddiraju and Akbari (U.S. Patent Application Publication 2020/0188180 A1)
Regarding claim 21, Somasuntharam teaches an amperometric analyte sensor [par. 5] comprising: a working electrode comprising: a base layer [fig. 2A, element 102; par. 68]; a conductive layer [fig. 2A, element 104] disposed over the base layer [par. 68]; an analyte sensing layer [fig. 2A, element 110] disposed over the conductive layer [par. 70]; and an analyte modulating layer [fig. 2A, element 112] disposed over the analyte sensing layer [par. 6, 72], wherein: the analyte modulating layer permselectively modulates the diffusion of glucose and oxygen therethrough such that the diffusion of glucose is limited relative to oxygen [par. 52 “an analyte modulating layer that functions to both release an immunosuppressant agent as well as in analyte diffusion control (e.g. to modulate the amounts of glucose and oxygen exposed to the analyte sensing layer)”, par. 53 “the analyte modulating layer is formed to exhibit a first permeability to glucose and a second permeability to O.sub.2, and the permeability to O.sub.2 is greater than the permeability to glucose”]; and the analyte modulating layer comprises a hydrogel [par. 72 “glucose limiting membranes can be made from a wide variety of materials known to be suitable for such purposes, e.g. … hydrogels”] having a polymer reversibly coupled to a bioactive agent such that the bioactive agent is uncoupled from the polymer in response to a stimuli [par. 8, 30, 37 “the polymeric material used to make the analyte modulating layer and/or sublayers, the amount of and/or thickness of the sublayers, and the concentration of the immunosuppressant agent in the sublayers is precisely controlled so to create one or more specific release profiles for the immunosuppressant agent”, 52],
However, Somasuntharam does not teach a layer comprising an acrylate hydrogel
Vaddiraju teaches a layer comprising an acrylate hydrogel [par. 56]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Somasuntharam to incorporate a layer comprising an acrylate hydrogel, to improve adhesion, as evidence by Vaddiraju [par. 56]
However, Somasuntharam does not teach wherein the bioactive agent is uncoupled from the polymer in response to: an alteration in the pH of the environment in which the amperometric analyte sensor is disposed; an alteration in the temperature of the environment in which the amperometric analyte sensor is disposed; and/or an electrochemical stimuli selected from: a voltage applied to the amperometric analyte sensor; and/or a current within the amperometric analyte sensor
Akbari teaches the bioactive agent is uncoupled from the polymer in response to: an alteration in the pH of the environment in which the amperometric analyte sensor is disposed [par. 117]; an alteration in the temperature of the environment in which the amperometric analyte sensor is disposed [par. 124]; and/or an electrochemical stimuli selected from: a voltage applied to the amperometric analyte sensor; and/or a current within the amperometric analyte sensor [par. 125]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Somasuntharam to incorporate the bioactive agent is uncoupled from the polymer in response to: an alteration in the pH of the environment in which the amperometric analyte sensor is disposed; an alteration in the temperature of the environment in which the amperometric analyte sensor is disposed; and/or an electrochemical stimuli selected from: a voltage applied to the amperometric analyte sensor; and/or a current within the amperometric analyte sensor, for releasing therapeutic agents in response to change in the wound environment, as evidence by Akbari [par. 124]
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000
GRACE L ROZANSKI/
Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights