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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 29 April 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed 29 April 2026. As directed by the amendment claims 101-121 and 123-130 remain pending in this application.
Response to Arguments
Applicant’s arguments, see pages 6-9, filed 29 April 2026, with respect to the rejection(s) of claim(s) 101-116 and 123-130 under 35 USC §102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yodfat et al. (US 2012/0277667) in view of Voskanyan et al. (US 2012/0046533).
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) 101-116 and 123-130 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al. (US 2012/0277667) in view of Voskanyan et al. (US 2012/0046533).
Regarding claim 101, Yodfat teaches a device configured to perform simultaneous sensing of a concentration of an analyte and administration of a therapeutic fluid (Abstract, Figs. 1-52) comprising:
a body comprising an upper housing (Fig. 3, 10), a lower housing (Fig. 3, 20), and a bottom, skin-contacting base (¶[0156], where the cradle has a bottom portion that adheres to the skin of a patient), wherein the upper housing comprises a port configured to reversibly attach to a fluid delivery device configured for delivery of a fluid via insertion of a needle (Fig. 4, 204), wherein the port comprises a self-sealing septum (¶[0170]) in contact with the lower housing thereby forming an internal cavity (¶[0170], where the self-sealing septum is on the proximal end and forms a cavity);
a sensing cannula (Fig. 6a, 300) comprising a proximal end (where the proximal end is , a distal end (where the tip 300 has a distal end inserted into the patient), an external surface (Fig. 6a, where the structure has a surface that contacts the patient), an internal lumen (where 300 has an internal area that houses multiple parts including electrodes and dispensing channel), at least one hollow channel within the internal lumen extending from the proximal end of the sensing cannula to the distal end of the sensing cannula configured for the administration of the therapeutic fluid (¶[0170], where the cannula 305 is internal and is meant for dispensing therapeutic fluid), at least one indicating electrode on the external surface configured to sense the concentration of the analyte (¶[0017], [0157], where the device has one or more electrodes for sensing analyte within the body) and a conductor on the external surface extending from the proximal end of the sensing cannula to the at least one indicating electrode (¶[0043], [0181], [0185]), wherein the proximal end of the sensing cannula is retained within the body (¶[0156], where 300 is within the patient’s body during operation), and wherein the distal end of the sensing cannula extends from the skin-contacting base (Fig. 6a, where 300 extends from the base of the device into the patient); and
a channel within the body in fluid communication with the internal cavity formed by the self-sealing septum and the proximal end of the combined sensing cannula (¶[0170], where the device has a channel in which fluid flows and has a septum at a proximal end of 300 which helps to form said channel).
Yodfat does not specifically teach wherein the upper housing and the lower housing are configured to receive a single hollow inserter needle partially enclosing the sensing cannula for insertion into a skin surface of a mammal, wherein the single hollow inserter needle is configured to facilitate simultaneous sensing of the concentration of the analyte and fluid delivery of the therapeutic fluid.
Voskanyan teaches an embodiment (Figs. 6A-6F) of a medical device comprising: a base (see annotated Fig. 6C on next page), a first insertable member (“sensor lumen” – Fig. 6D) secured to the base and including a sensor member (“Sensor”), and a second insertable member (“Infusion lumen” – Fig. 6D) configured to be secured to the base and including an infusion cannula; and further teaches: the first insertable member (sensor lumen) and the second insertable member (infusion lumen) are arranged adjacent each other (as shown in Fig. 6D) for insertion together in a single insertion location (Figs. 6C and 6F show them as a “dual lumen tube” that is inserted together in a single location) with a needle to facilitate the function of both of these parts of the device (Fig. 6D where the needle surrounds at least part of the infusion lumen and facilitates functions of sensing and fluid delivery.
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Yodfat such that the first insertable member and the second insertable member are arranged adjacent each other for insertion together in a single insertion location, in order to allow the sensor and infusion catheter to be built into a single set with a needle to facilitate both sensing and fluid delivery, which greatly improves comfort and convenience for the patient by reducing both the amount of hardware the patient has to wear on their body and the number of needle sticks required for use, as taught by Voskanyan (¶[0061], lines 5-10).
Regarding claim 102, the combined device of Yodfat and Voskanyan teaches the device of claim 101, Yodfat further teaches wherein the upper housing comprises a top face comprising the port (Fig. 7, where the upper housing 10 has a face that has a port 204).
Regarding claim 103, the combined device of Yodfat and Voskanyan teaches the device of claim 101, wherein the port comprises a visible opening comprising the self-sealing septum (Fig. 7, where there is an opening in the port and the self-sealing septum is located proximal on 300 which allows for the self-sealing septum to be in the opening of 204).
Regarding claim 104, the combined device of Yodfat and Voskanyan teaches the device of claim 101, Yodfat further teaches further comprising a signal processing module configured to receive an electrical current from the sensing cannula (¶[0063], [0184]-[0186]).
Regarding claim 105, the combined device of Yodfat and Voskanyan teaches he device of claim 104, Yodfat further teaches wherein the signal processing module is configured to provide an electrical potential to the sensing cannula (¶[0184]-[0186]).
Regarding claim 106, the combined device of Yodfat and Voskanyan teaches the device of claim 105, Yodfat further teaches wherein the signal processing module comprises a second body comprising an upper face, a lower face, and a vertical surface between the upper face and the lower face (Fig. 3, where the processing module is a separate unit that has at least an upper face, lower face, and a vertical surface as it is a 3D object which could be a PCB or other processor, ¶[0152]).
Regarding claim 107, the combined device of Yodfat and Voskanyan teaches the device of claim 106, Yodfat further teaches wherein the vertical surface provides the electrical potential to the sensing cannula and receives the electrical current from the sensing cannula via a set of electrical contacts on the vertical surface (¶[0183]).
Regarding claim 108, the combined device of Yodfat and Voskanyan teaches the device of claim 107, Yodfat further teaches wherein the second body comprises a set of arms in contact with the upper housing, and wherein the lower face is in contact with the skin- contacting base (¶[0183], where the wires and connectors link the processor to the base).
Regarding claim 109, the combined device of Yodfat and Voskanyan teaches the device of claim 104, Yodfat further teaches further comprising an interface circuit configured to convey current signals from the sensing cannula to the signal processing module (Fig. 3, where the sensing apparatus conveys signals to the signal processing unit, ¶[0163], [0170]).
Regarding claim 110, the combined device of Yodfat and Voskanyan teaches the device of claim 109, Yodfat further teaches wherein the interface circuit comprises a proximal end and a distal end (Fig. 3, where the circuit transfers from a proximal end near the processor to a distal end that is a part of 300 and completes the circuit).
Regarding claim 111, the combined device of Yodfat and Voskanyan teaches the device of claim 110, Yodfat further teaches wherein the interface circuit comprises one or more conductors configured to convey the current signals from the sensing cannula to the signal processing module (¶[0179] & [0181]).
Regarding claim 112, the combined device of Yodfat and Voskanyan teaches the device of claim 101, Yodfat further teaches wherein the fluid delivery device comprises a syringe (¶[0020]).
Regarding claim 113, the combined device of Yodfat and Voskanyan teaches the device of claim 101, Yodfat further teaches wherein the fluid delivery device comprises a pen (Fig. 3, 300, where the inserted portion is a pen-like structure that allows for fluid delivery).
Regarding claim 114, the combined device of Yodfat and Voskanyan teaches the device of claim 101, Yodfat further teaches wherein the at least one indicating electrode comprises an enzyme layer overlaying a conductive surface (¶[0011] & [0042]).
Regarding claim 115, the combined device of Yodfat and Voskanyan teaches the device of claim 114, Yodfat further teaches wherein the enzyme layer is covered with a semi- permeable membrane (¶[0011] & [0042], where the semi-permeable nature of the enzymes is known element in the art when using redox enzymes for a device such as the one in Yodfat).
Regarding claim 116, the combined device of Yodfat and Voskanyan teaches the device of claim 114, Yodfat further teaches wherein the enzyme layer comprises glucose oxidase (¶[0011]-[0013], where the oxidase based sensing method is known in the art).
Regarding claim 123, the combined device of Yodfat and Voskanyan teaches the device of claim 101, Yodfat further teaches wherein the sensing cannula comprises a stiffness sufficient for insertion into a skin surface of a mammal without using an inserter needle (¶[0034], [0156], where the insertion does not need a needle to be inserted into the skin of a patient).
Regarding claim 124, the combined device of Yodfat and Voskanyan teaches the device of claim 101, Yodfat further teaches wherein the skin-contacting base comprises an adhesive surface configured to attach to a skin surface of a subject (¶[0096]).
Regarding claim 125, the combined device of Yodfat and Voskanyan teaches the device of claim 101, Yodfat further teaches wherein the analyte is selected from the group consisting of: glucose (¶[0018]).
Regarding claim 126, the combined device of Yodfat and Voskanyan teaches the device of claim 125, Yodfat further teaches wherein the analyte is glucose (¶[0018]).
Regarding claim 127, the combined device of Yodfat and Voskanyan teaches the device of claim 101, Yodfat further teaches wherein the therapeutic fluid is selected from the group consisting of: an insulin (¶[0157]).
Regarding claim 128, the combined device of Yodfat and Voskanyan teaches the device of claim 127, Yodfat further teaches wherein the therapeutic fluid is the insulin (¶[0157]).
Regarding claim 129, the combined device of Yodfat and Voskanyan teaches the device of claim 128, Yodfat further teaches wherein the insulin or the insulin analog formulation comprises an excipient comprising a phenol or cresol.
Regarding claim 130, Yodfat teaches a device configured to perform simultaneous sensing of a concentration of an analyte and administration of a therapeutic fluid (Abstract, Figs. 1-52), comprising:
a body comprising an upper housing (Fig. 3, 10), a lower housing (Fig. 3, 20), and a bottom, skin-contacting base (¶[0156], where the cradle has a bottom portion that adheres to the skin of a patient), and an infusion tubing extending outward from the body configured to connect to a source of the therapeutic fluid (Fig. 3, 300, where the cylindrical structure connects to the dispensing area which contains a therapeutic fluid);
a sensing cannula (Fig. 6a, 300) comprising a proximal end (where the proximal end is , a distal end (where the tip 300 has a distal end inserted into the patient), an external surface (Fig. 6a, where the structure has a surface that contacts the patient), an internal lumen (where 300 has an internal area that houses multiple parts including electrodes and dispensing channel), at least one hollow channel within the internal lumen extending from the proximal end of the sensing cannula to the distal end of the sensing cannula configured for the administration of the therapeutic fluid (¶[0170], where the cannula 305 is internal and is meant for dispensing therapeutic fluid), at least one indicating electrode on the external surface configured to sense the concentration of the analyte (¶[0017], [0157], where the device has one or more electrodes for sensing analyte within the body) and a conductor on the external surface extending from the proximal end of the sensing cannula to the at least one indicating electrode (¶[0043], [0181], [0185]), wherein the proximal end of the sensing cannula is retained within the body (¶[0156], where 300 is within the patient’s body during operation), and wherein the distal end of the sensing cannula extends from the skin-contacting base (Fig. 6a, where 300 extends from the base of the device into the patient); and
a channel within the body in fluid communication with the internal cavity formed by the self-sealing septum and the proximal end of the combined sensing cannula (¶[0170], where the device has a channel in which fluid flows and has a septum at a proximal end of 300 which helps to form said channel).
Yodfat does not specifically teach wherein the upper housing and the lower housing are configured to receive a single hollow inserter needle partially enclosing the sensing cannula for insertion into a skin surface of a mammal, wherein the single hollow inserter needle is configured to facilitate simultaneous sensing of the concentration of the analyte and fluid delivery of the therapeutic fluid.
Voskanyan teaches an embodiment (Figs. 6A-6F) of a medical device comprising: a base (see annotated Fig. 6C on next page), a first insertable member (“sensor lumen” – Fig. 6D) secured to the base and including a sensor member (“Sensor”), and a second insertable member (“Infusion lumen” – Fig. 6D) configured to be secured to the base and including an infusion cannula; and further teaches: the first insertable member (sensor lumen) and the second insertable member (infusion lumen) are arranged adjacent each other (as shown in Fig. 6D) for insertion together in a single insertion location (Figs. 6C and 6F show them as a “dual lumen tube” that is inserted together in a single location) with a needle to facilitate the function of both of these parts of the device (Fig. 6D where the needle surrounds at least part of the infusion lumen and facilitates functions of sensing and fluid delivery.
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Yodfat such that the first insertable member and the second insertable member are arranged adjacent each other for insertion together in a single insertion location, in order to allow the sensor and infusion catheter to be built into a single set with a needle to facilitate both sensing and fluid delivery, which greatly improves comfort and convenience for the patient by reducing both the amount of hardware the patient has to wear on their body and the number of needle sticks required for use, as taught by Voskanyan (¶[0061], lines 5-10).
Claim(s) 117-121 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat et al. (US 2012/0277667) in view of Voskanyan et al. (US 2012/0046533), and further in view of Ward et al. (US 2016/0354542).
Regarding claim 117, the combined device of Yodfat and Voskanyan teaches the device of claim 114, however, Yodfat and Voskanyan do not specifically disclose wherein the enzyme layer comprises an osmium-based redox mediator.
Ward teaches an insulin delivery device that utilizes reactions with enzyme based elements to delivery insulin while measuring glucose levels. Ward teaches an osmium-based redox mediator for the enzyme layer in the reaction for the device (¶[0017]). By modifying the device of Yodfat to use an osmium-based redox mediator, the device will allow for electrons to transfer from glucose to an electrode without interference from the insulin preservatives (¶[0017] from Ward).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Yodfat to use an enzyme layer that comprises an osmium-based redox mediator (¶[0017] from Ward).
Regarding claim 118, Yodfat, Voskanyan and Ward teach the device of claim 117, Ward further teaches wherein the osmium-based redox mediator comprises osmium dimethyl bipyridine (¶[0023] & [0035]).
Regarding claim 119, the combined device of Yodfat and Voskanyan teaches the device of claim 114, however, Yodfat and Voskanyan do not specifically disclose wherein the enzyme layer comprises polyvinylimidazole.
Ward teaches an enzyme later that comprises polyvinylimidazole (¶[0017], [0037]). By modifying the device of Yodfat to have an enzyme layer that comprises polyvinylimidazole it would allow for glucose permeation when the device is being used to monitor glucose (¶[0037] from Ward).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Yodfat to have an enzyme layer that comprises polyvinylimidazole (¶[0037] from Ward).
Regarding claim 120, the combined device of Yodfat and Voskanyan teaches the device of claim 101, however, Yodfat and Voskanyan do not specifically disclose wherein the sensing cannula comprises a reference electrode comprising silver/silver chloride (Ag/AgCl).
Ward teaches a reference electrode comprising silver/silver chloride (¶[0009], [0015], where the use of silver/silver chloride is known in the art). By modifying the device of Yodfat to use a reverence electrode comprising silver/silver chloride, it would allow the device to more specifically detect analyte glucose when monitoring (¶[0009] from Ward).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Yodfat to use a reference electrode comprising silver/silver chloride (¶[0009] from Ward).
Regarding claim 121, the combined device of Yodfat and Voskanyan teaches the device of claim 101, however, Yodfat and Voskanyan do not specifically disclose wherein the signal processing module provides a bias potential to the sensing cannula of less than 250 millivolts (mV) relative to a reference potential.
Ward teaches a low bias potential when using PVI-OsDiMeBPY, specifically 180 mV (¶[0041]). By utilizing a low bias potential with the specific combination of enzymes and polymers such as in Ward, the device of Yodfat would be able to measure glucose with little or no interference from insulin preservatives (¶[0041] from Ward).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Yodfat to have a bias potential of less than 250 millivolts (mV) (¶[0041] from Ward).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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