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 09/08/21 has been considered by the examiner.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on January 12, 2026 has been entered.
Amendment Entered
In response to the amendment filed on January 12, 2026, amended claims 1 and 11 have been entered. New claim 21 has been entered.
Response to Arguments
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered and 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 (Grosman and Scharf 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, 5-7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Franano (U.S. Patent Application Publication 2021/0275187 A1) and in further view of Scharf (U.S. Patent Application Publication 2016/0151639 A1), Grosman (U.S. Patent Application Publication 2016/0256629 A1) and Koide (U.S. Patent Application Publication 2014/0224671 A1).
Franano, Scharf and Koide were applied in the previous office action.
Regarding claim 1, Franano teaches electrolysis apparatus for oxidation of ions in the blood stream [par. 258], comprising: a catheter which is inserted into a bloodstream of said body of the associated user, the catheter having: an anode located at a distal end of said catheter [fig. 29H, I, element 1014; par. 259], and a medium provided between said anode and said cathode to transfer ions [fig. 29H, element 1020; par. 258, "the potential and current flowing to the working electrode (anode) causes oxidation of ions in the bloodstream"; par. 259 "constant current is provided between anode and cathode"; Examiner notes the medium is the wire between the anode and cathode]; and a cathode connected to said anode by a wire located within said catheter [fig. 29H, I, element 1028; par. 259]; a cover on said anode to exclude molecules from said catheter [par. 258]; and an electrical source external to said body of the associated user connected to said wire forward on a surface of the anode [par. 215, 216, 263].
However, Franano does not teach a glucose electrolysis apparatus for reducing osmolality of blood of a body of an associated user, and to perform functions from the following group before being removed from the bloodstream of the body of the associated user at a time determined by a healthcare provider based on clinical improvement and/or improvement of the associated user's blood chemistry []: decrease blood osmolality decrease blood glucose levels; modify blood chemistry; modify blood pH levels; modify blood immunologic function; and improve patient's neurological status.
Scharf teaches a glucose electrolysis apparatus for reducing glucose of blood of a body of an associated user [par. 78, 80], and to perform functions from the following group before being removed from the bloodstream of the body of the associated user at a time determined by a healthcare provider based on clinical improvement and/or improvement of the associated user's blood chemistry [par. 160, 223, 323]: decrease blood glucose levels [par. 78]; modify blood chemistry [par. 78]; modify blood pH levels [par. 78]; modify blood immunologic function [par. 78]; and improve patient's neurological status [par. 78; Examiner notes the modification in oxygen release from hemoglobin can improve neurological status]
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 Franano, to incorporate a glucose electrolysis apparatus for reducing glucose of blood of a body of an associated user, and to perform functions from the following group before being removed from the bloodstream of the body of the associated user at a time determined by a healthcare provider based on clinical improvement and/or improvement of the associated user's blood chemistry: decrease blood glucose levels; modify blood chemistry; modify blood pH levels; modify blood immunologic function; and improve patient's neurological status, for reducing and/or preventing infection, as evidence by Scharf [par. 323].
Although Scharf does not explicitly teach a glucose electrolysis apparatus for reducing osmolality of blood of a body of an associated user and to perform functions from the following group before being removed from the bloodstream of the body of the associated user at a time determined by a healthcare provider based on clinical improvement and/or improvement of the associated user's blood chemistry including: decrease blood osmolality, this would be obvious to a person having ordinary skill in the art when the invention was filed, since Scarf also suggests decreasing blood glucose levels [par. 78] and the use of electrolysis for the oxidation of glucose [par. 11]. Examiner notes that when glucose is broken down into CO2 and water, this reduces blood osmolality. Therefore, incorporating the step of reducing osmolality of blood of a body of an associated user would involve only routine skill in the art.
Additionally, Grosman teaches glucose is commonly reduced to CO2 and water [par. 356]
However, Franano does not teach electricity from said external electrical source and not from the body of the associated user is used to forward drive an oxidation reaction of glucose to occur to reduce osmolality of the blood.
Koide teaches electricity from said external electrical source and not from the body of the associated user is used to forward drive an oxidation reaction of glucose to occur to reduce osmolality of the blood [par. 67; Examiner notes the oxidation of glucose is the breaking down of glucose, therefore reducing osmolality].
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 Franano, to incorporate electricity from said external electrical source and not from the body of the associated user is used to forward drive an oxidation reaction of glucose to occur to reduce osmolality of the blood, to cause a change to gluconolactone and a generation of hydrogen peroxide, as evidence by Koide [par. 67].
Regarding claim 5, Franano further teaches said cathode comprises one or more of the following: silver, silver chloride, platinum, and lithium [par. 257, 259, Examiner notes the cathode is considered a conductor].
Regarding claim 6, Franano further teaches a conductor is provided to allow a conduit to be completed between said anode and said cathode [par. 263].
Regarding claim 7, Franano further teaches said conductor comprises one or more of the following: copper, aluminum, silver, steel, iron, gold, or a combination thereof [par. 257].
Regarding claim 10, Franano does not teach oxidation of glucose occurs according to a reaction as follows: 602(g) + Glucose (aq) [Wingdings font/0xDF][Wingdings font/0xE0] 6C02(g) + 6H20(l) AG° = ~ 2870 kJ/ mol9
Grosman teaches oxidation of glucose occurs according to a reaction as follows: 602(g) + Glucose (aq) [Wingdings font/0xDF][Wingdings font/0xE0] 6C02(g) + 6H20(l) AG° = ~ 2870 kJ/ mol9 [par. 356; Examiner notes that this is the basic formula for glucose oxidation].
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 Franano, to incorporate oxidation of glucose occurs according to a reaction as follows: 602(g) + Glucose (aq) [Wingdings font/0xDF][Wingdings font/0xE0] 6C02(g) + 6H20(l) AG° = ~ 2870 kJ/ mol9, for reducing H2O2 and causing an electrical current flow, as evidence by Grosman [par.356].
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Franano, Scharf, Grosman and Koide and in further view of Rohde (U.S. Patent Application Publication 2009/0082653 A1).
Regarding claim 2, Franano, Scharf, Grosman and Koide teach a glucose electrolysis apparatus for reducing osmolality of blood, as disclosed above
However, Franano, Scharf, Grosman and Koide do not teach said anode comprises a bio enzyme cascade.
Rohde teaches said anode comprises a bio enzyme cascade [par. 23-25, 34].
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 Franano, Scharf, Grosman and Koide, to incorporate anode comprises a bio enzyme cascade, for oxidizing blood glucose, as evidence by Rohde [par. 24].
Regarding claim 3, Rohde further teaches said bio enzyme cascade comprises multiple enzymes on a surface of said anode to drive said reduction reaction forward and to oxidize blood glucose to carbon dioxide and water [par. 21, 23-25, 34].
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 Franano, Scharf, Grosman and Koide, to incorporate said bio enzyme cascade comprises multiple enzymes on a surface of said anode to drive said reduction reaction forward and to oxidize blood glucose to carbon dioxide and water, for reducing oxygen, as evidence by Rohde [par. 21].
Regarding claim 4, Rhode further teaches said enzymes comprise one or more of the following: pyrroloquinoline quinone (PQQ) dependent glucose dehydrogenase, PQQ- dependent 2-gluconate dehydrogenase, aldolase, PQQ-dependent alcohol dehydrogenase, PQQ-dependent aldehyde dehydrogenase, and oxalate oxidase [par. 27].
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 Franano, Scharf, Grosman and Koide, to incorporate said enzymes comprise one or more of the following: pyrroloquinoline quinone (PQQ) dependent glucose dehydrogenase, PQQ- dependent 2-gluconate dehydrogenase, aldolase, PQQ-dependent alcohol dehydrogenase, PQQ-dependent aldehyde dehydrogenase, and oxalate oxidase, as these are known enzymes for glucose oxidation to be used with redox polymers, as evidence by Rohde [par. 23-27].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Franano, Scharf, Grosman and Koide and in further view of Karren (U.S. Patent Application Publication 2019/0263691 A1).
Karren was applied in the previous office action.
Regarding claim 9, Franano, Scharf, Grosman and Koide teach a glucose electrolysis apparatus for reducing osmolality of blood, as disclosed above.
However, Franano, Scharf, Grosman and Koide do not teach said medium comprises one of a salt bridge, a semi-permeable membrane, and a semi-porous material.
Karren teaches said medium comprises one of a salt bridge, a semi-permeable membrane, and a semi-porous material [par. 107].
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 Franano, Scharf, Grosman and Koide, to incorporate said medium comprises one of a salt bridge, a semi-permeable membrane, and a semi-porous material, for transferring specified ions from the anode to the cathode and to separate the solutions in the anode and cathode compartments, as evidence by Karren [par. 107].
Claims 11-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Franano and in further view of Rhode, Wang (U.S. Patent Application Publication 2013/0274737 A1), Koide, Scharf and Grosman.
Wang was applied in the previous office action.
Regarding claim 11, Franano teaches a method of oxidation in a fluid [par. 254] comprising: providing a catheter; providing an anode at a distal end of said catheter [fig. 29H, I, element 1014; par. 259]; connecting a cathode to said anode by a reduction wire located within said catheter [fig. 29H, I, element 1028; par. 259]; covering said anode with a cover to exclude molecules from entering said catheter [par. 258]; providing a medium between said anode and said cathode to transfer ions [fig. 29H, element 1020; par. 258, "the potential and current flowing to the working electrode (anode) causes oxidation of ions in the bloodstream"; par. 259 "constant current is provided between anode and cathode"; Examiner notes the medium is the wire between the anode and cathode]; connecting an electrical source external to said body of the associated user to said anode and said cathode; [par. 215, 216, 263]; and inserting said catheter into said bloodstream to break down ions of a fluid [par. 254, 259].
However, Franano does not teach a method of oxidation of glucose in blood; covering an outer portion anode to exclude molecules from said catheter
Rohde teaches a method of oxidation of glucose in blood [par. 24]; a coating on said anode to exclude molecules from said catheter [par. 35, 36]
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 Franano, to incorporate a method of oxidation of glucose in blood, and a coating on said anode to exclude molecules from said catheter, for facilitating the transport of a species that are reduced, such as oxygen in hemoglobin and blood, and to keep out undesirable macromolecular materials and help to insure the long life of the sensor as evidence by Rhode [par. 24, 35].
Wang teaches a mesh covers an outer portion of said anode [fig. 5, elements 26, 40; Examiner notes the mesh 34 covers the tip of the catheter and the electrode; par. 44]
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 Franano, to incorporate a mesh covers an outer portion of said anode, for fully covering the electrode and catheter, as evidence by Wang [par. 44].
However, Franano does not teach electricity from said external electrical source and not from the associated user's body is used to facilitate drive an oxidation reaction of glucose to occur to break down glucose and reduce osmolality of the blood.
Koide teaches electricity from said external electrical source and not from the associated user's body is used to facilitate drive an oxidation reaction of glucose to occur to break down glucose and reduce osmolality of the blood [par. 67; Examiner notes the oxidation of glucose is the breaking down of glucose, therefore reducing osmolality].
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 Franano, to incorporate electricity from said external electrical source and not from the associated user's body is used to facilitate drive an oxidation reaction of glucose to occur to break down glucose and reduce osmolality of the blood, to cause a change to gluconolactone, as evidence by Koide [par. 67].
However, Franano does not teach to perform functions from the following group before being removed from the bloodstream of the body of the associated user at a time determined by a healthcare provider based on clinical improvement and/or improvement of the associated user's blood chemistry: decrease blood osmolality; decrease blood glucose levels; modify blood chemistry; modify blood pH levels; modify blood immunologic function; and improve patient's neurological status.
Scharf teaches to perform functions from the following group before being removed from the bloodstream of the body of the associated user at a time determined by a healthcare provider based on clinical improvement and/or improvement of the associated user's blood chemistry [par. 160, 223, 323]: decrease blood glucose levels [par. 78]; modify blood chemistry [par. 78]; modify blood pH levels [par. 78]; modify blood immunologic function [par. 78]; and improve patient's neurological status [par. 78; Examiner notes the modification in oxygen release from hemoglobin can improve neurological status]
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 Franano, to incorporate to perform functions from the following group before being removed from the bloodstream of the body of the associated user at a time determined by a healthcare provider based on clinical improvement and/or improvement of the associated user's blood chemistry: decrease blood glucose levels; modify blood chemistry; modify blood pH levels; modify blood immunologic function; and improve patient's neurological status, for reducing and/or preventing infection, as evidence by Scharf [par. 323].
Although Scharf does not explicitly teach to perform functions from the following group before being removed from the bloodstream of the body of the associated user at a time determined by a healthcare provider based on clinical improvement and/or improvement of the associated user's blood chemistry including: decrease blood osmolality, this would be obvious to a person having ordinary skill in the art when the invention was filed, since Scarf also suggests decreasing blood glucose levels [par. 78] and the use of electrolysis for the oxidation of glucose [par. 11]. Examiner notes that when glucose is broken down into CO2 and water, this reduces blood osmolality. Therefore, incorporating the step of reducing osmolality of blood of a body of an associated user would involve only routine skill in the art.
Additionally, Grosman teaches glucose is commonly reduced to CO2 and water [par. 356]
Regarding claim 12, Rohde further teaches said anode comprises a bio enzyme cascade [par. 23-25, 34].
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 Franano, to incorporate anode comprises a bio enzyme cascade, for oxidizing blood glucose, as evidence by Rohde [par. 24].
Regarding claim 13, Rohde further teaches said bio enzyme cascade comprises multiple enzymes on a surface of said anode to drive said reduction reaction forward and to oxidize blood glucose to carbon dioxide and water [par. 21, 23-25, 34].
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 Franano, to incorporate said bio enzyme cascade comprises multiple enzymes on a surface of said anode to drive said reduction reaction forward and to oxidize blood glucose to carbon dioxide and water, for reducing oxygen, as evidence by Rohde [par. 21].
Regarding claim 14, Rhode further teaches said enzymes comprise one or more of the following: pyrroloquinoline quinone (PQQ) dependent glucose dehydrogenase, PQQ- dependent 2-gluconate dehydrogenase, aldolase, PQQ-dependent alcohol dehydrogenase, PQQ-dependent aldehyde dehydrogenase, and oxalate oxidase [par. 27].
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 Franano, to incorporate said enzymes comprise one or more of the following: pyrroloquinoline quinone (PQQ) dependent glucose dehydrogenase, PQQ- dependent 2-gluconate dehydrogenase, aldolase, PQQ-dependent alcohol dehydrogenase, PQQ-dependent aldehyde dehydrogenase, and oxalate oxidase, as these are known enzymes for glucose oxidation to be used with redox polymers, as evidence by Rohde [par. 23-27].
Regarding claim 15, Franano further teaches said cathode comprises one or more of the following: silver, silver chloride, platinum, and lithium [par. 257, 259, Examiner notes the cathode is considered a conductor].
Regarding claim 16, Franano further teaches a conductor is provided to allow a conduit to be completed between said anode and said cathode [par. 263].
Regarding claim 17, Franano further teaches said conductor comprises one or more of the following: copper, aluminum, silver, steel, iron, gold, or a combination thereof [par. 257].
Regarding claim 20, Grosman futher teaches oxidation of glucose occurs according to a reaction as follows: 602(g) + Glucose (aq) [Wingdings font/0xDF][Wingdings font/0xE0] 6C02(g) + 6H20(l) AG° = ~ 2870 kJ/ mol9 [par. 356; Examiner notes that this is the basic formula for glucose oxidation].
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 Franano, to incorporate oxidation of glucose occurs according to a reaction as follows: 602(g) + Glucose (aq) [Wingdings font/0xDF][Wingdings font/0xE0] 6C02(g) + 6H20(l) AG° = ~ 2870 kJ/ mol9, for reducing H2O2 and causing an electrical current flow, as evidence by Grosman [par.356].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Franano, Rhode, Wang, Koide, Sharf and Grosman and in further view of Karren (U.S. Patent Application Publication 2019/0263691 A1).
Regarding claim 19, Franano, Rhode, Wang, Koide, Sharf and Grosman teach a method of oxidation in a fluid as disclosed above.
However, Franano, Rhode, Wang, Koide, Sharf and Grosman do not teach said medium comprises one of a salt bridge, a semi-permeable membrane, and a semi-porous material.
Karren teaches said medium comprises one of a salt bridge, a semi-permeable membrane, and a semi-porous material [par. 107].
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 Franano, Rhode, Wang, Koide, Sharf and Grosman, to incorporate said medium comprises one of a salt bridge, a semi-permeable membrane, and a semi-porous material, for transferring specified ions from the anode to the cathode and to separate the solutions in the anode and cathode compartments, as evidence by Karren [par. 107].
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Franano, Scharf, Grosman and Koide and in further view of Wang.
Regarding claim 21, Franano, Scharf, Grosman and Koide teach a glucose electrolysis apparatus for reducing osmolality of blood, as disclosed above
However, Franano, Scharf, Grosman and Koide do not teach a glucose electrolysis apparatus for reducing osmolality of blood, as disclosed above
Wang teaches the distal end of the catheter includes a mesh covering [fig. 3, element 34; par. 40]
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 Franano, Scharf, Grosman and Koide, to incorporate the distal end of the catheter includes a mesh covering, for fully covering the electrode and catheter, as evidence by Wang [par. 44].
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