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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 03/18/2026. Claims 94-123 are currently pending and being examined.
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.
Election/Restrictions
Claim 120 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/18/2026.
Claim Objections
Claim 100 is objected to because of the following informalities: Claim 100 recites “the one or more of the plurality of conductors” in line 1. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “one or more of the plurality of conductors”. Appropriate correction is required.
Claim 108 is objected to because of the following informalities: Claim 108 recites “an analyte” in line 2. However, “an analyte concentration” has already been instantiated in claim 1. Examiner suggests reciting “the analyte concentration”. Appropriate correction is required.
Claim 111 is objected to because of the following informalities: Claim 11 recites “the electrode layer” in line 3. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the electrode”. Appropriate correction is required.
Claim 113 is objected to because of the following informalities: Claim 113 recites “the analyte” in line 1. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “the analyte concentration”. Appropriate correction is required.
Claim 121 is objected to because of the following informalities: Claim 121 recites “sensing analyte concentration” in line 1. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “sensing an analyte concentration”. Appropriate correction is required.
Claim 121 is objected to because of the following abnormalities: Claim 121 recites “an analyte concentration” in line 3. However, “an analyte concentration” has already been instantiated in line 1. Examiner suggests reciting “the analyte concentration”. Appropriate correction is required.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 94-97, 99-117, 119, and 121-123 are rejected under 35 U.S.C. 103 as being unpatentable over Neta (USPAP 2013/0237955) in view of Ward (USPAP2016/0354542).
In reference to independent claim 94, Neta discloses a device (10, fig 4) for sensing an analyte concentration and delivering a composition (para 0121 discloses “a device 10 for delivering therapeutic fluid into the body and for monitoring analyte levels within the body”) into a subcutaneous space (para 0127 discloses “The tip 300 can be inserted through a cradle opening into the subcutaneous tissue 6.”), comprising:
a. a sensing cannula (300, fig 4; fig 4; para 0127 discloses “tip 300 may include a cannula for fluid delivery and optionally a probe for analyte sensing”) comprising an probe for detecting the analyte concentration in the subcutaneous space (para 0011 discloses “In an embodiment of our invention, the outer wall, which is not in contact with a drug and which is bathed with glucose-containing subcutaneous interstitial fluid, is the optimal location for the sensing elements.” disclosed above para 0127 above an analyte is sensed),
b. a signal processing module (130, fig 3) operably coupled to the sensing cannula (300) through a plurality of conductors (arrows in fig 3 and all the wiring between 300 and 1888, including all the wiring in, and connected to, the PCB 131 which is a part of the processor 130); and
c. a fluid reservoir (para 0128 discloses “The dispensing apparatus 1888 in particular can include a drive mechanism with gear and a reservoir.”) configured to deliver the composition through the sensing cannula (300) into the subcutaneous space (para 0127 discloses “The tip 300 can be inserted through a cradle opening into the subcutaneous tissue 6.”) upon receiving a signal from the signal processing module (130), however
Neta is silent to wherein the electrode comprises a redox-catalytic layer.
Ward, a similar sensing cannula for use with pumps, teaches a sensing cannula comprising an electrode for detecting the analyte concentration in the subcutaneous space, wherein the electrode comprises a redox-catalytic layer (claim 1 discloses “A combined drug delivery cannula and continuous glucose sensor that measures glucose without interference from the drug excipient, said cannula being a hollow tube, the outer wall of which includes: an electrode layer with at least one indicating electrode, said layer underlying a redox-catalytic layer that includes an osmium compound bound to a ligand, and either glucose oxidase or glucose dehydrogenase.” The redox-catalytic layer is interpreted to be part of the electrode).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sensing structure taught in Ward in the device of Neta to create a “durable sensing catheter design” para 0047; Ward. To be clear, the sensing cannula surface layer and its complimentary pharmacological compounds taught in Ward is are used in the device of Neta.
In reference to independent claim 121, Neta discloses a device (10, fig 4) for sensing analyte concentration and delivering a composition (para 0121 discloses “a device 10 for delivering therapeutic fluid into the body and for monitoring analyte levels within the body”) into a subcutaneous space (para 0127 discloses “The tip 300 can be inserted through a cradle opening into the subcutaneous tissue 6.”), the device comprising:
a. a sensing cannula (300, fig 4; para 0127 discloses “tip 300 may include a cannula for fluid delivery and optionally a probe for analyte sensing”) comprising an probe for detecting an analyte concentration in the subcutaneous space (para 0011 discloses “In an embodiment of our invention, the outer wall, which is not in contact with a drug and which is bathed with glucose-containing subcutaneous interstitial fluid, is the optimal location for the sensing elements.” disclosed above para 0127 above an analyte is sensed);
b. a signal processing module (130, fig 3) operably coupled to the sensing cannula (300) through a plurality of conductors (arrows in fig 3 and all the wiring between 300 and 1888, including all the wiring in, and connected to, the PCB 131 which is a part of the processor 130); and
c. an electronic pump(1888, fig 3) configured to depress a syringe (para 0141 discloses “disposable part 200 can include a plunger/piston 240 slideable within the reservoir 222 and can force fluid 3 to be expelled from the reservoir 222 into the delivery tube 230 and from the delivery tube 230 to an exit port 213. A drive screw 234 can serve as plunger/piston rod. Clockwise or counterclockwise rotation of drive screw 234 can be converted by nut 233 to forward or backward linear motion”) fluidically connected to a fluid reservoir (222) upon receiving a signal from the signal processing module (130, fig 3), wherein depressing the syringe (moving the piston 240 inside the reservoir) delivers the composition through the sensing cannula (300) into the subcutaneous space (para 0127 discloses “The tip 300 can be inserted through a cradle opening into the subcutaneous tissue 6.”, the processor 130 instructs the dispensing apparatus 1888 to move the plunger 240 in the syringe/reservoir to move fluid out of the delivery tube 230 and into the cannula 300).
Neta is silent to wherein the probe comprises an electrode.
Ward, a similar sensing cannula for use with pumps, teaches a sensing cannula comprising an electrode for detecting the analyte concentration in the subcutaneous space (claim 1 discloses “A combined drug delivery cannula and continuous glucose sensor that measures glucose without interference from the drug excipient, said cannula being a hollow tube, the outer wall of which includes: an electrode layer with at least one indicating electrode, said layer underlying a redox-catalytic layer that includes an osmium compound bound to a ligand, and either glucose oxidase or glucose dehydrogenase.” The redox-catalytic layer is interpreted to be part of the electrode).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sensing structure taught in Ward in the device of Neta to create a “durable sensing catheter design” para 0047; Ward. To be clear, the sensing cannula surface layer and its complimentary pharmacological compounds taught in Ward is are used in the device of Neta.
In reference to independent claim 122, Neta discloses a device capable of the method for sensing an analyte concentration and delivering a composition (para 0121 discloses “a device 10 for delivering therapeutic fluid into the body and for monitoring analyte levels within the body”) into a subcutaneous space (para 0127 discloses “The tip 300 can be inserted through a cradle opening into the subcutaneous tissue 6.”), comprising:
a. providing a sensing cannula (300, fig 4; para 0127 discloses “tip 300 may include a cannula for fluid delivery and optionally a probe for analyte sensing”), for detecting the analyte concentration in the subcutaneous space (para 0127 discloses “The tip 300 can be inserted through a cradle opening into the subcutaneous tissue 6.” disclosed above para 0127 above an analyte is detected);
b. inserting the sensing cannula (300) into the subcutaneous space (para 0127 discloses “The tip 300 can be inserted through a cradle opening into the subcutaneous tissue 6.”);
c. monitoring, by the sensing cannula (300), the analyte concentration in the subcutaneous space (para 0127 discloses “tip 300 may include a cannula for fluid delivery and optionally a probe for analyte sensing”); and
d. delivering a sufficient amount of the composition through the sensing cannula (300, fig 3) into the subcutaneous space based at least in part on the monitoring of the analyte concentration (para 0131 discloses “the processor 130 can receive glucose readings from sensing apparatus 1777 and can automatically control insulin delivery from the dispensing apparatus 1888 based, at least in part, on the received glucose readings”), however
Neta is silent to the sensing cannula comprises an electrode for detecting the analyte concentration in the subcutaneous space, wherein the electrode comprises a redox-catalytic layer;
Ward, a similar sensing cannula for use with pumps, teaches a sensing cannula (underlined below) comprises an electrode for detecting the analyte concentration (glucose) in the subcutaneous space, wherein the electrode comprises a redox-catalytic layer (claim 1 discloses “A combined drug delivery cannula and continuous glucose sensor that measures glucose without interference from the drug excipient, said cannula being a hollow tube, the outer wall of which includes: an electrode layer with at least one indicating electrode, said layer underlying a redox-catalytic layer that includes an osmium compound bound to a ligand, and either glucose oxidase or glucose dehydrogenase.” The redox-catalytic layer is interpreted to be part of the electrode).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the sensing structure taught in Ward in the device of Neta to create a “durable sensing catheter design” para 0047; Ward. To be clear, the sensing cannula surface layer and its complimentary pharmacological compounds taught in Ward is are used in the device of Neta.
In reference to dependent claim 95, Neta in view of Ward discloses the device of claim 94, Neta further discloses a device further comprising a housing (housing of 10, fig 4) having a top surface (to of 10), a base (20), and one or more vertical walls (vertical walls of 10).
In reference to dependent claim 96, Neta in view of Ward discloses the device of claim 95, Neta further discloses a device (10) wherein the housing (housing of 10, fig 4) further comprises one or more electrical contacts on the one or more vertical walls (contacts linked to the button 15, fig 2 that is on the vertical wall of 10).
In reference to dependent claim 97, Neta in view of Ward discloses the device of claim 95, wherein one or more of the plurality of conductors (arrows in fig 3 and all the wiring between 300 and 1888, including all the wiring in, and connected to, the PCB 131 which is a part of the processor 130) is contained in the housing (all of the conductors as interpreted are in the housing).
In reference to dependent claim 99, Neta in view of Ward discloses the device of claim 94, Ward further discloses a device wherein the sensing cannula further comprises one or more electrical contacts (claim 8 discloses “a reference electrode is also disposed on the outer cannula wall.”).
In reference to dependent claim 100, Neta in view of Ward discloses the device of claim 99, Neta further discloses a device wherein the one or more of the plurality of conductors (arrows in fig 3 and all the wiring between 300 and 1888, including the wiring in the PCB 131 which is a part of the processor 130) is in contact with the one or more electrical contacts (Neta is silent to contacts on the sensing cannula, however Ward, combined above, discloses contacts called electrodes for sensing the glucose, see claim 8) on the sensing cannula (para 0129 discloses “Tip 300 can be inserted through passageway in cradle 20 into the subcutaneous tissue 6. Processor 130 can be provided for one or more of the following tasks: 1) to receive analyte readings from the sensing apparatus 1777, 2) to control operation of the sensing apparatus 1888, 3) to communicate with remote control unit 40, and 4) to process received internal or external data. In some embodiments, the fluid can be insulin and the analyte can be glucose.”).
In reference to dependent claim 101, Neta in view of Ward discloses the device of claim 99, Ward further discloses a device wherein one or more of the plurality of conductors is disposed on an exterior surface of the sensing cannula (claim 8 discloses “a reference electrode is also disposed on the outer cannula wall.”).
In reference to dependent claim 102, Neta in view of Ward discloses the device of claim 94, Neta further discloses a device wherein one or more of the plurality of conductors (arrows in fig 3) is operably coupled to the electrode (fig 3 shows the conductors attached to the sensing catheter 300, Neta is silent to electrodes however Ward, combined above, discloses in claim 8 discloses “a reference electrode is also disposed on the outer cannula wall.”).
In reference to dependent claim 103, Neta in view of Ward discloses the device of claim 94, Neta further discloses a device wherein one or more of the plurality of conductors (arrows in fig 3 and all the wiring between 300 and 1888, including the wiring in the PCB 131 which is a part of the processor 130) is held in contact with the sensing cannula (300) through a connector (connector in 25 has to be present in order to work).
In reference to dependent claim 104, Neta in view of Ward discloses the device of claim 94, Neta further discloses a device further comprising a fluid path (230, fig 7a) connecting the fluid reservoir (222) and the sensing cannula (300).
In reference to dependent claim 105, Neta in view of Ward discloses the device of claim 94, Ward further discloses a device wherein the redox-catalytic layer comprises a redox mediator and an enzyme (para 0090 discloses “Combine 40 uL of the redox mediator solution and 10 uL glucose oxidase [ an enzyme as disclosed by applicant in claim 107 ] solution. When dispensed manually, one can draw up this mixture into 1 mL plastic syringe with 30 gauge needle and carefully position tip of needle over center of each of the three electrodes”).
In reference to dependent claim 106, Neta in view of Ward discloses the device of claim 105, Ward further discloses a device wherein the redox mediator comprises a metal in a platinum group (osmium is a platinum group metal) that is covalently bound to a pyridine-based or imidazole-based ligand (para 0035 discloses “Those skilled in the art will understand that electron donating groups such as methyl, methoxy or amino, when bound to the pyridine or imidazole ligands, will allow the osmium to transfer electrons at a lower polarizing bias. The term for the osmium and the pyridine or imidazole ligand complex is redox mediator”).
In reference to dependent claim 107, Neta in view of Ward discloses the device of claim 105, Ward further discloses a device wherein the enzyme comprises glucose oxidase or glucose dehydrogenase (claim 1 discloses “a redox-catalytic layer that includes an osmium compound bound to a ligand, and either glucose oxidase or glucose dehydrogenase”).
In reference to dependent claim 108, Neta in view of Ward discloses the device of claims 105, Ward further discloses a device wherein the redox mediator and the enzyme allow electron transfer (para 0017 discloses “if one utilizes certain systems such as osmium-based redox mediators that operate at a low bias potential, electrons can be transferred from glucose to an indicating electrode without interference from the insulin preservatives”) from an analyte in the subcutaneous space to the electrode (para 0090 discloses “Combine 40 uL of the redox mediator solution and 10 uL glucose oxidase solution. When dispensed manually, one can draw up this mixture into 1 mL plastic syringe with 30 gauge needle and carefully position tip of needle over center of each of the three electrodes”).
In reference to dependent claim 109, Neta in view of Ward discloses the device of claim 108, Ward further discloses a device wherein the electron transfer is sufficient to cause a response to an applied bias potential to the electrode of no more than +250 millivolts (mV) relative to a reference electrode (reference electrode is disclosed in claim 8; para 0033 discloses “responses to the phenolics are very dependent upon the magnitude of the bias potential. In particular, as the potential is raised to high potentials such as those over 350 mV, there is a very large oxidative response. In contrast, as the bias is lowered, particularly below 250”).
In reference to dependent claim 110, Neta in view of Ward discloses the device of claim 109, Ward discloses a device wherein the response comprises a current (para 0018 discloses the sensor is “the amperometric sensor” meaning the sensors response to the analyte is a current signal).
In reference to dependent claim 111, Neta in view of Ward discloses the device of claim 109, Ward further discloses a device wherein the applied bias potential to the electrode of no more than +250 mV relative to the reference electrode allows the electrode layer to undergo substantially no electropolymerization of an excipient of the composition during continuous operation of the electrode (para 0096 discloses “a potential bias of 180 mV is suitable. A low bias such as this largely avoids the signal artifact resulting from oxidation of insulin preservatives (phenol, m-cresol) that would be seen if a higher bias were used. A low bias also avoids the problem of electropolymerization that is routinely seen with the use of higher bias potentials”), thereby maintaining a sensitivity of the electrode to analyte in the presence of the composition (preceding limitation is functional in nature and accomplished by operating at 180mV as disclosed in Ward).
In reference to dependent claim 112, Neta in view of Ward discloses the device of claim 94, Ward discloses a device wherein the electrode comprises an amperometric glucose sensor (para 0018 discloses the sensor is “the amperometric sensor”).
In reference to dependent claim 113, Neta in view of Ward discloses the device of claim 94, Neta further discloses a device (10) wherein the analyte comprises glucose (para 0127 discloses “A tip 300 can be provided to deliver fluid (e.g., insulin) into the body and/or to monitor analytes (e.g., glucose) within the body.”).
In reference to dependent claim 114, Neta in view of Ward discloses the device of claim 94, Neta further discloses a device (10) wherein the composition comprises insulin or an insulin analog (para 0127 discloses “A tip 300 can be provided to deliver fluid (e.g., insulin) into the body and/or to monitor analytes (e.g., glucose) within the body.”).
In reference to dependent claim 115, Neta in view of Ward discloses the device of claim 94, Ward further discloses a device wherein the composition further comprises a pharmaceutical acceptable excipient (claim 7 discloses “the excipient is phenol and/or m-cresol”).
In reference to dependent claim 116, Neta in view of Ward discloses the device of claim 115, Ward further discloses a device wherein the pharmaceutical acceptable excipient comprises phenol, cresol (claim 7 discloses “the excipient is phenol and/or m-cresol”), a salt, a stabilizing agent, or any combination thereof.
In reference to dependent claim 117, Neta in view of Ward discloses the device of claim 94, Neta further discloses a device (10) wherein the plurality of conductors comprises a conductive metal or alloy (para 0214 discloses “as determined, e.g., by surrounding housing components, further electronic components, and copper-based conductive paths”).
In reference to dependent claim 119, Neta in view of Ward discloses the device of claim 94, Neta further discloses a device (10) wherein the plurality of conductors comprises a flexible electronic circuit (para 170 discloses “FIG. 14 shows the folded PCB 131 and electronic components. The PCB 131 can be a rigid/flexible type with extensions to relevant components.”).
In reference to dependent claim 123, Neta in view of Ward discloses the device of claim 94, Neta further discloses a device (10) wherein the device does not comprise a spring configured to drive the sensing cannula (300, fig 3) into the subcutaneous space (para 0127 discloses “The tip 300 can be inserted through a cradle opening into the subcutaneous tissue 6.”, fig 6 and the specification do not show a spring to drive the cannula into the subcutaneous tissue).
Claim 98 is rejected under 35 U.S.C. 103 as being unpatentable over Neta (USPAP 2013/0237955) in view of Ward (USPAP2016/0354542) further in view of Amirouche (USPAP 2018/0214636).
In reference to dependent claim 98, Neta in view of Ward discloses the device of claim 95, however
Neta and Ward are silent to one or more of the plurality of conductors is disposed on an external surface of the one or more vertical walls of the housing.
Amirouche, a similar diabetic treatment design, teaches one or more of the plurality of conductors (USB port 925) is disposed on an external surface of the one or more vertical walls of the housing (the USB port is on the external vertical wall of the housing of 900, fig 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a USB port of Amirouche in the device of Neta in view of Ward to “allow for a transfer of data from the master control unit to an external device, such as a smartphone, memory stick, or computing device” para 0075; Amirouche.
Claim 118 is rejected under 35 U.S.C. 103 as being unpatentable over Neta (USPAP 2013/0237955) in view of Ward (USPAP2016/0354542) further in view of List (USPAP 2019/0298916).
In reference to dependent claim 118, Neta in view of Ward discloses the device of claim 94, however
Neta and Ward are silent to the plurality of conductors comprises a compressible conductive rubber.
List, a similar insulin pump, teaches plurality of conductors comprises a compressible conductive rubber (para 0031 discloses “conductive rubber element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an elastomeric element having electrically conductive properties. The term further specifically may refer, without limitation, to an arbitrary material or a composition of materials adapted to allow a flow of an electrical current in one or more directions and further adapted to be elastically deformable” rubber is known to be compressible, furthermore the presence of “one or more” indicates a plurality).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use rubber of List in the device of Neta in view of Ward because “ the use of the conductive rubber foam may be advantageous in cases where high contact forces are difficult to support” para 0031, List.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Varsavsky (USPAP 2019/0175082) discloses a sensor & cannula device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783
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