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 .
Election/Restrictions
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 4/15/2026.
Claim Objections
Claims 11, 13, 17, 18 are objected to because of the following informalities:
Claim 11 recites in line 9 of the claim, "a proximal end and distal end". This phrase lacks an article before "distal end" and is grammatically incorrect. It should be amended to "a proximal end and a distal end".
Claim 13 recites in line 2 of the claim, "defines insertion depth". This phrase lacks an article and should be amended to "defines an insertion depth" or "defines the insertion depth".
Claim 17 recites in lines 2 and 3 of the claim, "each of the first element and the second element having their own discrete proximal end and distal end". The phrase "having their own" is grammatically incorrect as it refers to the singular "each". It should be amended to "having its own".
Claim 18 recites "and pseudoreference electrode". This phrase lacks an article and should be amended to "and a pseudoreference electrode".
Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 11, 12, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Van Antwerp et al. (US 2009/0062767A1; hereinafter “Van Antwerp”) in view of Frey et al. (US 20190231238A1; hereinafter “Frey”).
Independent claim 11 recites a combined infusion set and sensor for placement within tissue, comprising:
a housing having a base plate that includes a base opening;
a circuit board having a board opening, the board opening being partially aligned with the base opening;
a cannula being terminated at a cannula opening, the cannula further having a hollow;
a sharp being at least partially within the hollow; and
a sensor having a proximal end and distal end, the proximal end being in electrical contact with the circuit board and a distal end being retained by a portion of the cannula, the sensor further including sensor slack,
wherein the cannula, the sharp and the sensor transition from a first position to a second position, during the transition the sharp protruding through the cannula opening and the transition to the second position eliminating the sensor slack, the second position having the cannula and sensor placed within the tissue via a single point of insertion.
In relation to independent claim 11, Van Antwerp discloses Van Antwerp discloses a combined infusion set and sensor for placement within tissue. Specifically, Van Antwerp discloses at paragraph [0045]:
"[a]n illustrative embodiment of the invention is an apparatus for supplying a fluid to a body of a patient (e.g. insulin) and for monitoring a body characteristic of the patient (e.g. blood glucose), the apparatus comprising a base adapted to secure the apparatus to the skin of a patient, a first piercing member coupled to and extending from the base, wherein the first piercing member is operatively coupled to at least one cannula for infusing a fluid to an infusion site, a second piercing member coupled to and extending from the base and operatively coupled to an electrochemical sensor having a sensor electrode for determining at least one body characteristic of the patient at a sensor placement site."
The teachings of paragraph [0045] disclose the claimed housing having a base plate (the base), a cannula for infusing fluid (the first piercing member operatively coupled to at least one cannula), and a sensor (the electrochemical sensor).
Van Antwerp further discloses at paragraph [0052]:
"[o]ne embodiment of the invention is an apparatus comprising a dual insertion set for supplying a fluid to the body of a patient and for monitoring a body characteristic of the patient. The dual insertion set includes a base, an infusion portion, and a sensor portion. The base may be used to secure the dual insertion set to the skin of a patient. The infusion portion typically has at least one cannula for supplying the fluid to an infusion placement site, which is coupled to and extends from the base. The at least one cannula has at least one lumen with a distal end for fluid communication with the placement site and at least one port structure formed near another end of the at least one lumen opposite the distal end."
The teachings of paragraph [0052] disclose the cannula having a hollow (the lumen), a cannula opening (the distal end for fluid communication), and a base plate (the base).
Van Antwerp further discloses at paragraph [0054]:
"One embodiment of the invention is a dual insertion set for supplying a fluid to a body of a patient and for monitoring a body characteristic of the patient which includes a base, an infusion portion, a sensor portion and at least two piercing members. The base is used to secure the dual insertion set to the skin of a patient. The infusion portion includes at least one cannula for supplying a fluid to an infusion placement site, which is coupled to and extends from the base. The at least one cannula has at least one lumen with a distal end for fluid communication with the placement site and at least one port structure formed near another end of the at least one lumen opposite the distal end. The sensor portion includes at least one sensor having at least one sensor electrode formed on a substrate. The at least one sensor is for determining at least one body characteristic of the patient at a sensor placement site. The piercing members are coupled to and extends from the base to facilitate insertion of the at least one cannula and the at least one sensor."
The teachings of paragraph [0054] disclose the sharp (the piercing member) being at least partially within the hollow of the cannula and facilitating insertion.
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Van Antwerp further discloses at paragraph [0056]:
"as illustrated in FIG. 3, an apparatus comprising a dual insertion set 10 in accordance with an embodiment of the present invention includes a sensor portion 20, an infusion portion 30, a base 40, a sensor 22, a cannula 33, and piercing members 24 and 34."
The teachings of paragraph [0056] disclose the sensor having a proximal end in electrical contact with a circuit board (the sensor portion 20 connected to the base 40) and a distal end retained by a portion of the cannula.
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Van Antwerp further discloses at paragraph [0061]:
"One exemplary embodiment of an apparatus of the invention is shown in FIG. 4. In this embodiment, the sensor and sensor connector are built toward one edge of the assembly, while the cannula is positioned toward the center; both are at a 90° angle to the skin surface. For insertion, a hub with two needles attached is engaged with the assembly (see, e.g. FIG. 4A). The set is then inserted into the subcutaneous tissue, either manually or with an automatic insertion device. The hub with needles is then removed and discarded (see, e.g. FIG. 4B). The infusion catheter can then be the attached and the sensor is plugged into a cable or transmitter (see, e.g. FIG. 4C and 4D)."
The teachings of paragraph [0061] disclose the cannula, sharp, and sensor transitioning from a first position (pre-insertion) to a second position (inserted into tissue), with the second position having the cannula and sensor placed within the tissue via a single point of insertion.
Van Antwerp further discloses at paragraph [0063]:
"Yet another embodiment of the invention is a combination subcutaneous sensor and infusion set using a dual lumen tube. This embodiment of the invention incorporates tubing with two independent lumens to allow a sensor and infusion catheter to share a single site. The sensor is housed in one lumen of the tubing, while the second lumen can be used for infusion. This allows the sensor to be isolated from direct contact with the drug being infused. Typically, the set combines a sensor with an infusion catheter and includes a dual lumen tube that houses the sensor in one lumen while providing a channel for drug infusion through the second lumen. The set can be inserted with a single needle."
The teachings of paragraph [0063] disclose the second position having the cannula and sensor placed within the tissue via a single point of insertion.
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Van Antwerp further discloses at paragraph [0064]:
"FIGS. 6A-6F shown an embodiment of the invention having a dual lumen tube with external needle. In this embodiment, the needle, which has one side ground away to form a 'C'-shaped cross-section, is external to the dual lumen tube. The needle is used to insert the device, then withdrawn and discarded."
The teachings of paragraph [0064] disclose the sharp (needle) being at least partially within the hollow of the cannula (the dual lumen tube), and the sharp protruding through the cannula opening during the transition to the second position. Van Antwerp does not explicitly disclose the sensor including sensor slack, wherein the transition to the second position eliminates the sensor slack. However, Frey discloses a medical device comprising an analyte sensor with a reserve loop (sensor slack). Specifically, Frey discloses at paragraph [0082] (Embodiment 1):
"A medical device for detecting at least one analyte in a body fluid, the medical device comprising: at least one analyte sensor having an insertable portion adapted for at least partially being inserted into a body tissue of a user, at least one electronics unit, wherein the analyte sensor is operably connected to the electronics unit, wherein the electronics unit comprises at least one interconnect device with at least one electronic component attached thereto; at least one insertion cannula, wherein the analyte sensor partially is placed inside the insertion cannula; wherein the insertion cannula is movable in between at least one extended position and at least one retracted position, wherein the electronics unit remains in a fixed position when the insertion cannula is moved from the extended position to the retracted position or vice a versa; wherein the analyte sensor comprises at least one active portion having at least one sensor electrode for sensing the analyte thereon; wherein the analyte sensor further comprises at least one passive portion electrically connected to the electronics unit in at least one connector portion; wherein the passive portion provides, in between the connector portion and the active portion, at least one reserve loop configured for compensating for an insertion path during movement from the retracted position into the extended position or vice versa."
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Frey further discloses at paragraph [0173]:
"When the insertion cannula 114 is in the retracted position 222, as illustrated in FIG. 3B, the passive portion 152 forms in between the connector portion 206 and the active portion 148, the at least one reserve loop 150 configured for compensating for an insertion path during movement from the retracted position 222 into the extended position 224. The reserve loop 150 may be at least to a large extent received within the insertion cannula compartment 132."
Frey further discloses at paragraph [0174]:
"When the insertion cannula 114 is in the extended position, as illustrated in FIG. 3C, the insertable portion 160 of the analyte sensor 122 may be extended through the opening 166 and may be received in the body tissue (not shown) of the user or the patient. The reserve loop 150 may be diminished. Thus, a portion of the analyte sensor 122, which contributes to the reserve loop 150 may be decreased."
The teachings above disclose the transition to the second (extended) position eliminating (diminishing) the sensor slack (reserve loop).
Based on the above comments, it would have been obvious to a person of ordinary skill in the art at the time of filing to modify the combined infusion set and sensor of Van Antwerp to incorporate the reserve loop (sensor slack) of Frey. Both Van Antwerp and Frey are in the same field of
transcutaneous analyte monitoring devices that combine a sensor with an insertion mechanism. The motivation to combine is that the reserve loop of Frey solves the known problem of accommodating the difference in path length between the retracted and extended positions of the sensor during insertion, ensuring that the sensor is not placed under tension or compression during insertion, which could damage the sensor or cause inaccurate readings. A person of ordinary skill in the art would have been motivated to incorporate the reserve loop of Frey into the combined infusion set of Van Antwerp to
improve the reliability and accuracy of sensor insertion, with a reasonable expectation of success given that both references involve flexible electrochemical sensors inserted transcutaneously using a cannula and needle.
In relation to claim 12, Van Antwerp in view of Frey discloses the combined infusion set and sensor of claim 11, as set forth above. Van Antwerp further discloses at paragraph [0061]:
"The set is then inserted into the subcutaneous tissue, either manually or with an automatic insertion device. The hub with needles is then removed and discarded (see, e.g. FIG. 4B)."
Van Antwerp further discloses at paragraph [0064]:
"The needle is used to insert the device, then withdrawn and discarded."
The teachings above disclose the sharp transitioning to a third position, the third position having the sharp withdrawn from the tissue. In view of the conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the combined infusion set and sensor.
In relation to claim 13, Van Antwerp in view of Frey discloses the combined infusion set and sensor of claim 11, as set forth above. Frey further discloses at paragraph [0089]:
"at least one reserve loop configured for compensating for an insertion path during movement from the retracted position into the extended position or vice versa."
The reserve loop compensates for the insertion path, meaning the length of the reserve loop corresponds to and thereby defines the depth to which the insertion cannula and sensor are inserted into the tissue. This corresponds to the claimed sensor slack defining the insertion depth of the cannula. The motivation to combine is as set forth above for claim 11.
In relation to claim 16, Van Antwerp in view of Frey discloses the combined infusion set and sensor of claim 11, as set forth above. Frey further discloses at paragraph [0114] (Embodiment 24):
"the medical device comprises at least one housing, wherein the housing comprises at least one
electronics unit compartment and at least one insertion cannula compartment, wherein the electronics unit is at least to a large extend received in the electronics unit compartment, wherein the insertion cannula is at least to a large extend received in the insertion cannula compartment when the insertion cannula is in the retracted position."
Frey further discloses at paragraph [0173]:
"The reserve loop 150 may be at least to a large extent received within the insertion cannula compartment 132."
This discloses the sensor slack (reserve loop) being contained within the housing (the insertion cannula compartment of the housing). The motivation to combine is as set forth above for claim 11.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Van Antwerp et al. (US 2009/0062767A1; hereinafter “Van Antwerp”) in view of Frey et al. (US 2019/0231238A1; hereinafter “Frey”), as discussed above, and in further view of Little et al. (US 9,493,807; hereinafter “Shah”).
In relation to claim 14, Van Antwerp in view of Frey discloses the combined infusion set and sensor of claim 11, as set forth above. However, the combination of Van Antwerp and Frey does not explicitly disclose that the sensor slack is unfurled against the cannula to reinforce the cannula and minimize buckling or kinking of the cannula during the transition between the first position and the second position.
Little discloses a folded analyte sensor apparatus in which the sensor is disposed within a needle during insertion, and the folded configuration imparts mechanical stability. Specifically, Little discloses:
"In another embodiment of the invention having electrodes only on one side of a fixed bend, the base substrate can be folded so as to impart mechanical stability to the sensor when the sensor is implanted in vivo." (Little; col. 9, line 66 to col. 10, line 3)
Little further discloses:
"In alternative embodiments of the invention the apparatus does not comprise a housing that surrounds the sensor (e.g. the tubeless assembly shown in FIG. 6B). In these embodiments, the sensor is disposed within a needle adapted to pierce a tissue and implant the apparatus in vivo. Typically, in such embodiments, the needle is adapted to be removed from the tissue following implantation of the analyte sensor apparatus." (Little; col. 3, lines 13-21)
Little further discloses at claim 11:
"further comprising disposing the base substrate within a needle, wherein: the needle is adapted to pierce a tissue and implant the analyte sensor apparatus in vivo; and the needle is adapted to be removed from the tissue following implantation of the analyte sensor apparatus."
Based on the above comments, it would have been obvious to a person of ordinary skill in the art to modify the assembly of Van Antwerp and Frey such that the sensor slack (reserve loop) is unfurled against the cannula during insertion, as taught by Little. Little expressly teaches that a flexible sensor substrate can be folded and disposed within a needle to impart mechanical stability during insertion. The motivation to combine would be to increase the structural rigidity of the cannula-sensor assembly during the insertion transition, thereby preventing buckling or kinking of the cannula and ensuring reliable placement of the cannula and sensor within the tissue, as Little teaches that folding the sensor base substrate against the needle imparts mechanical stability to the sensor during implantation.
In relation to claim 15, Van Antwerp in view of Frey and Shah discloses the combined infusion set and sensor of claim 14, as set forth above. Little further discloses that the sensor is disposed within a
needle that receives the sensor. Specifically, Little discloses:
"in some embodiments, the sensor is disposed within a housing (e.g. a tube) and adapted to be implanted in vivo (e.g. the tubed assembly embodiment shown in FIG. 6A). Typically, in such embodiments, the housing comprises an aperture adapted to allow an aqueous medium in which the apparatus is disposed to contact a working electrode." (Little; col. 3, lines 8-13)
Little further discloses:
"In these embodiments, the sensor is disposed within a needle adapted to pierce a tissue and implant the apparatus in vivo." (Little; col. 3, lines 16-18)
The needle or tube receiving the sensor corresponds to a channel on the cannula into which the sensor slack is unfurled, as claimed. The motivation to combine is as set forth above for claim 14.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Van Antwerp et al. (US 2009/0062767A1; hereinafter “Van Antwerp”) in view of Frey et al. (US 2019/0231238A1; hereinafter “Frey”), as discussed above, and in further view of Shah et al. (US 2019/0246962A1; hereinafter 'Shah 962”).
In relation to claim 17, Van Antwerp in view of Frey discloses the combined infusion set and sensor of claim 11, as set forth above. However, the combination of Van Antwerp and Frey does not explicitly disclose the sensor comprising a first element and a second element, each having their own
discrete proximal end and distal end.
Shah '962 discloses an analyte sensor comprising two discrete elements — an A-side and a B-side — each having its own proximal end (contact pads and electrode traces) and distal end (working electrodes). Specifically, Shah '962 discloses at paragraph [0017]:
"In varying embodiments, the sensor array 101 includes the analyte sensor 101 a having an A-side 200 a and a B-side 200 b that enables continuous detection of glucose and at least a second analyte."
Shah '962 further discloses at paragraph [0030]:
"working electrodes for analyte sensors can be formed on A-side 200a while counter/reference electrodes are formed on B-side 200b. While the various electrodes may be separated on distinct A-side and B-side, in many embodiments the sensor array 101 having the plurality of working electrodes is inserted into the subcutaneous tissue via a single point of insertion."
The A-side 200a and B-side 200b of the analyte sensor 101a of Shah '962 each constitute a discrete element having its own proximal end (contact pads/electrode traces at the proximal end) and distal end (working electrodes at the distal end), corresponding to the claimed first element and second element each having their own discrete proximal end and distal end.
Based on the above comments, it would have been obvious to a person of ordinary skill in the art to modify the sensor of Van Antwerp and Frey to comprise a first element and a second element as taught by Shah '962. Shah '962 expressly provides the motivation at paragraph [0015]:
"The ability to measure multiple biochemical signals via a single probe, combined with optional physical
sensors in the same package results in a system that reduces burden on the subject rather than requiring mindfulness of multiple sensor insertions and separate physical sensors."
The motivation to incorporate the multi-element sensor architecture of Shah '962 into the combined infusion set of Van Antwerp and Frey would have been to enable simultaneous monitoring of multiple analytes (e.g., glucose and a second analyte such as lactate or oxygen) using a single insertion, thereby reducing patient discomfort and the burden of wearing multiple devices.
In relation to claim 18, Van Antwerp in view of Frey and Shah '962 discloses the combined infusion set and sensor of claim 17, as set forth above. Shah '962 further discloses that the first element (A-side 200a) includes working electrodes, and the corresponding pseudo-reference electrodes on
the B-side 200b are operably associated with the A-side working electrodes. Specifically, Shah '962 discloses at paragraph [0018]:
"FIG. 2A is a view of the A-side 200a that includes first working electrodes 202 and second working electrodes 206 along with corresponding first electrode trace 204 and second electrode trace 208. In many embodiments the first working electrodes 202 are transducers configured to detect, or measure, glucose concentration. The second working electrodes 206 can be configured to measure the concentration of a second analytes such as, but not limited to lactate, oxygen, ROS, ketones or the like. FIG. 2B is a view of the B-side 200b that includes a plurality of combination counter-reference electrodes 214 and 218 formed on electrode traces 216 and 220 respectively. In preferred embodiments a two-electrode system consisting of the first and second working electrodes with corresponding combined counter-reference electrodes, or pseudo-reference electrodes, are used to detect concentrations of the various analytes."
The A-side 200a of Shah '962 includes working electrodes 202 and 206, and the corresponding pseudo-reference electrodes 214 and 218 on the B-side 200b are operably associated with the A-side working electrodes, corresponding to the claimed first element including a working electrode and a pseudoreference electrode. The motivation to combine is as set forth above for claim 17.
In relation to claim 19, Van Antwerp in view of Frey and Shah '962 discloses the combined infusion set and sensor of claim 18, as set forth above. Shah '962 further discloses that the second element (B-side 200b) also includes its own combination counter-reference (pseudo-reference) electrodes. Specifically, Shah '962 discloses at paragraph [0018]:
"FIG. 2B is a view of the B-side 200b that includes a plurality of combination counter-reference electrodes 214 and 218 formed on electrode traces 216 and 220 respectively. In preferred embodiments a two-electrode system consisting of the first and second working electrodes with corresponding combined counter-reference electrodes, or pseudo-reference electrodes, are used to detect concentrations of the various analytes."
Shah '962 further discloses at paragraph [0030]:
"In some embodiments each working electrode has a corresponding counter electrode while in other embodiments multiple working electrodes share a counter electrode. In still other embodiments, two working electrodes share a counter electrode while the third working electrode has a dedicated discrete counter electrode. Furthermore, the various embodiments of working electrodes and counter electrodes can be distributed among separate and discrete substrates."
The teachings above establish that the second element (B-side 200b) of Shah '962 includes its own combination counter-reference (pseudo-reference) electrodes 214 and 218, and that the second element can be configured with its own working electrode and pseudoreference electrode, corresponding to the claimed second element including a working electrode and a pseudoreference electrode. The motivation to combine is as set forth above for claim 17.
In relation to claim 20, Van Antwerp in view of Frey and Shah '962 discloses the combined infusion set and sensor of claim 17, as set forth above. Shah '962 further discloses a configuration where a first element has working electrodes and a second element has pseudoreference electrodes. Specifically, Shah '962 discloses at paragraph [0018]:
"FIG. 2A is a view of the A-side 200a that includes first working electrodes 202 and second working electrodes 206" and "FIG. 2B is a view of the B-side 200b that includes a plurality of combination counter-reference electrodes 214 and 218."
Shah '962 further discloses at paragraph [0030]:
"working electrodes for analyte sensors can be formed on A-side 200a while counter/reference
electrodes are formed on B-side 200b."
The above teachings disclose a configuration where the first element (A-side 200a) carries the working electrodes and the second element (B-side 200b) carries the pseudoreference/counter-reference electrodes, corresponding to the claimed first element having a working electrode and the second element having a pseudoreference electrode. The motivation to combine is as set forth above for claim 17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANUEL A MENDEZ whose telephone number is (571)272-4962. The examiner can normally be reached Mon-Fri 7:00 AM-5:00 PM.
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783
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