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
Applicant’s election without traverse of Species 3A-3E in the reply filed on March 16 2026 is acknowledged. Claims 1-20 are pending.
Claims 8, 16, and 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.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 March 16 2026.
Examiner notes the applicant included claims 19 and 20 as part of the election of Species to Figs. 3A-3E however, it appears claims 19 and 20 are directed to Species 5 - Figure 5 and a vascular access with a catheter assembly and a connector with a blunt cannula or male lure and have been withdrawn accordingly. Prosecution will proceed on claims 1-7,9-15, and 17-18.
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.
Claim(s) 1,2,7, 11, 12,13, 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al.( US 20060020192) hereinafter Brister et al. in view of Kujawa et al.( US 11197980) hereinafter Kujawa et al.
Brister et al. teaches a transcutaneous analyte sensor is provided, the sensor comprising: an in vivo portion adapted for at least partial insertion through a skin of a host, wherein the in vivo portion comprises an anchoring mechanism adapted for maintaining the in vivo portion of the sensor in a stable position within the host.
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Regarding claims 1 and 12, Brister et al. teaches an introducer needle, comprising a sharp distal tip, a proximal end opposite the sharp distal tip, and an introducer needle lumen extending through the sharp distal tip and the proximal end of the introducer needle; and a sensing probe slidably disposed within the introducer needle lumen, wherein a distal end of the sensing probe is disposed within the introducer needle lumen in an initial configuration of the vascular access system.
Note figs 7A-7D , annotated above, paragraphs [0176] – [0185] set forth the introducer needle and the sensing probe within the needle and the subsequent insertion of the needle and sensor and retraction of the needle once the sensor is in place.
Brister et al. further teaches [0181] Figs. 7A through 7D are schematic side cross-sectional views that illustrate the applicator components and their cooperating relationships at various stages of sensor insertion. Fig. 7A illustrates the needle and sensor loaded prior to sensor insertion. Fig. 7B illustrates the needle and sensor after sensor insertion. Fig. 7C illustrates the sensor and needle during needle retraction. Fig. 7D illustrates the sensor remaining within the contact subassembly after needle retraction. Although the embodiments described herein suggest manual insertion and/or retraction of the various components, automation of one or more of the stages can also be employed. For example, spring-loaded mechanisms that can be triggered to automatically insert and/or retract the sensor, needle, or other cooperative applicator components can be implemented.
However Brister et al. does not specifically teach wherein the introducer needle is configured to retract in response to the distal end of the sensing probe being advanced beyond the sharp distal tip.
Kujawa et al. teaches in the same field of endeavor a catheter ( interpreted as a probe) insertion system includes a housing extending along a longitudinal axis. A needle extends distally from a distal end of the housing. The needle has a longitudinal passage coaxially aligned with the housing. A catheter has a length and is sized and shaped to be advanced from a retracted position within the longitudinal passage of the needle to an extended position with at least a portion of the catheter length extending beyond a distal tip of the needle. The needle is typically configured to be retracted back into the housing after the catheter has been advanced, thus providing an integrated catheter and catheter insertion apparatus. After needle retraction, the housing may be taped to the patient's skin while the needle remains protected within the housing. A lure on the catheter may then be connected to a fluid or other source in an otherwise conventional manner. Paragraph [7], The catheter will typically be configured (typically having a suitable length, diameter, and shaped) to allow the catheter to be advanced from a retracted position within the longitudinal passage in the needle to an extended position beyond a distal tip of the needle, typically having from 25% to 90%, usually from 50% to 75%, of the catheter length extending beyond the distal end of the needle when the catheter is in its extended position. The needle will be configured to be retracted back into the housing after the catheter has been distally advanced through the needle. In this way, the needle can be safely sequestered within the housing, and the housing can be secured to the patient, typically being taped or otherwise secured to a location on the patient's skin adjacent the catheter entry location.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Brister et al. to include an automatic needle retraction mechanism in which the needle is retracted back into the housing after the catheter( probe) has been distally advanced through the needle as taught by Kujawa et al. as an obvious substitution of one known retraction method and system for another with a reasonable expectation for yielding a functioning vascular access system as part of the system of Brister et al.
Regarding claim 2, Brister et al. teaches a housing comprising a longitudinal passage, wherein the introducer needle is slidably disposed within the longitudinal passage of the housing, wherein the introducer needle extends from a distal end of the housing in the initial configuration of the vascular access system. Note Figures 6 and 7A-7D, and paragraph [0177] The guide tube subassembly 20 includes a guide tube carrier 64 and a guide tube 66. In some embodiments, the guide tube is a cannula. The guide tube carrier 64 slides along the applicator body 18 (housing) and maintains the appropriate relative position of the guide tube 66 during insertion and subsequent retraction. For example, prior to and during insertion of the sensor, the guide tube 66 ( longitudinal passage) extends through the contact subassembly 26 to maintain an opening that enables easy insertion of the needle there through (see Figs. 7A to 7D). During retraction of the sensor, the guide tube subassembly 20 is pulled back, engaging with and causing the needle and associated moving components to retract back into the applicator 12 (See Figs. 7C and 7D).
Regarding claims 7,13, 14, Brister et al. teaches wherein the sensor is configured to measure a hemodynamic parameter. Note paragraph [0053] sets forth an extensive list of potential analytes that could be measured that are considered to be at least related to a hemodynamic parameter. [0211] Figs. 12A to 12C are perspective and side views of a sensor system including the mounting unit 14 and electronics unit 16 attached thereto. After sensor insertion, the transcutaneous analyte sensor system 10 measures a concentration of an analyte or a substance indicative of the concentration or presence of the analyte as described above. Although the examples are directed to a glucose sensor, the analyte sensor can be a sensor capable of determining the level of any suitable analyte in the body, for example, oxygen, lactase, insulin, hormones, cholesterol, medicaments, viruses, or the like. Once the electronics unit 16 is connected to the mounting unit 14, the sensor 32 is able to measure levels of the analyte in the host.
Regarding claim 11, Brister et al. teaches wherein the introducer needle is held in place in the initial configuration by a releasable latch, wherein the sensing probe is configured to release the releasable latch to allow the introducer needle to retract. Note paragraph [0188] the applicator is designed for manual insertion and/or retraction, automated insertion and/or retraction of the sensor/needle, for example, using spring-loaded components, can alternatively be employed and [0189] The preferred embodiments advantageously provide a system and method for easy insertion of the sensor and subsequent retraction of the needle in a single push-pull motion. Because of the mechanical latching system of the applicator, the user provides a continuous force on the plunger cap 82 and guide tube carrier 64 that inserts and retracts the needle in a continuous motion.
However Brister et al. does not specifically teach wherein the introducer needle is configured to retract in response to the distal end of the sensing probe being advanced beyond the sharp distal tip.
Kujawa et al. teaches in the same field of endeavor a catheter ( interpreted as a probe) insertion system includes a housing extending along a longitudinal axis. A needle extends distally from a distal end of the housing. The needle has a longitudinal passage coaxially aligned with the housing. A catheter has a length and is sized and shaped to be advanced from a retracted position within the longitudinal passage of the needle to an extended position with at least a portion of the catheter length extending beyond a distal tip of the needle. The needle is typically configured to be retracted back into the housing after the catheter has been advanced, thus providing an integrated catheter and catheter insertion apparatus. After needle retraction, the housing may be taped to the patient's skin while the needle remains protected within the housing. A luer on the catheter may then be connected to a fluid or other source in an otherwise conventional manner. Paragraph [7], The catheter will typically be configured (typically having a suitable length, diameter, and shaped) to allow the catheter to be advanced from a retracted position within the longitudinal passage in the needle to an extended position beyond a distal tip of the needle, typically having from 25% to 90%, usually from 50% to 75%, of the catheter length extending beyond the distal end of the needle when the catheter is in its extended position. The needle will be configured to be retracted back into the housing after the catheter has been distally advanced through the needle. In this way, the needle can be safely sequestered within the housing, and the housing can be secured to the patient, typically being taped or otherwise secured to a location on the patient's skin adjacent the catheter entry location.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Brister et al. to include an automatic needle retraction mechanism in which the needle is retracted back into the housing after the catheter( probe) has been distally advanced through the needle as taught by Kujawa et al. as an obvious substitution of one known retraction method and system for another with a reasonable expectation for yielding a functioning vascular access system as part of the system of Brister et al.
Claim(s) 9 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al.( US 20060020192) hereinafter Brister et al. in view of Kujawa et al.( US 11197980) hereinafter Kujawa et al. and further in view of Peterson et al.( US 20160058474) hereinafter Peterson et al.
Brister et al. in view of Kujawa et al. teach the claimed invention as set forth above including a sensing probe hub, wherein the sensing probe extends distally from the sensing probe hub. Note Brister et al. paragraphs [0088] Fig. 1 is a perspective view of a transcutaneous analyte sensor system 10. In the preferred embodiment of a system as depicted in Fig. 1, the sensor includes an applicator 12, a mounting unit 14, and an electronics unit 16. The system can further include a receiver 158, such as is described in more detail with reference to Fig. 14. [0089] The mounting unit 14 includes a base 24 adapted for mounting on the skin of a host, a sensor adapted for transdermal insertion through the skin of a host (see Fig. 4), and one or more contacts 28 configured to provide secure electrical contact between the sensor and the electronics unit 16. The mounting unit 14 is designed to maintain the integrity of the sensor in the host so as to reduce or eliminate translation of motion between the mounting unit, the host, and/or the sensor.
However, Brister et al. in view of Kujawa et al. do not specifically teach a protective tube extending from the sensing probe hub, wherein the sensing probe is disposed within the protective tube and spaced apart from the protective tube such that fluid may flow between the protective tube and the sensing probe.
Peterson et al. teaches in the same field of endeavor an inserter assembly for continuous glucose monitoring with medication delivery capability where the assembly has a deployment button containing a needle deployment mechanism having a sharp held in a pre-release position, a housing body in which the deployment button is movably received within a top end of the housing body, the housing body having a sensor deployment assembly containing a lumen and a sensor disposed within the lumen and extending out of the lumen to a circuit board that is part of the sensor deployment assembly, the sensor deployment assembly matingly connected to the sharp where the sharp extends beyond the sensor deployment assembly and contains the sensor not fixedly attached to the sharp, and a sensor housing releasably received within a lower end of the housing body, the sharp extending into a sensor deployment assembly recess within the sensor housing and directly above a sensor opening in a bottom of the sensor housing. Note Figs 24, 24A, [0144] and[ 0145} a sensor carrier 270a with a single lumen tube 973 fixedly attached to sensor carrier 270a, and a sensor board 280. Continuous monitoring sensor 120 and single lumen tube 973 extend through a sensor opening 250 in bottom 252 of sensor housing 206′.
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Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the modified system of Brister et al. in view of Kujawa et al. a protective tube extending from the sensing probe hub, wherein the sensing probe is disposed within the protective tube and spaced apart from the protective tube such that fluid may flow between the protective tube and the sensing probe as taught by Peterson et al. as an obvious substitution of one known sensor deployment arrangement for another with a reasonable expectation for yielding a functioning vascular access system as part of the modified system of Brister et al. in view of Kujawa et al.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brister et al.( US 20060020192) hereinafter Brister et al. in view of Kujawa et al.( US 11197980) hereinafter Kujawa et al. and further in view of Lee et al. (EP 3822625) hereinafter Lee et al.
Brister et al. in view of Kujawa et al. teach the claimed invention as set forth above including [0235] An RF module 148 is operably connected to the processor 138 and transmits the sensor data from the sensor to a receiver within a wireless transmission 150 via antenna 152.
Brister et al. in view of Kujawa et al. do not specifically teach wherein the parameter is determined using artificial intelligence.
Lee et al. teaches an analyte concentration measurement method using artificial intelligence deep learning, and more particularly, to an analyte concentration measurement method using artificial intelligence deep learning, which recognizes an area corresponding to an analyte by converting a signal obtained from a sensor by applying deep learning-based artificial neural network techniques, and predicts a most suitable type and concentration of the analyte by extracting each element necessary for determining type or concentration of the analyte in the area.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the system of Brister et al. as modified by Kujawa et al. the use of AI to analyze the analyte parameters as taught by Lee et al. to obtain more accurate and faster results.
Allowable Subject Matter
Claims 3-6,10, and 18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record teaches the subject matter of the independent claims including a subcutaneous analyte sensor with an introducer needle and a sensing probe in which the Needle is retracted upon advancement of the sensing probe beyond the end of the needle.
The prior art of record does not reasonably teach alone or in combination a vascular access system where the introducer needle is fully retractable within the sensing probe hub and the housing when the sensing probe hub is fully advanced with respect to the housing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yee et al.( US 20200397357) teaches [0006] Sensor assemblies that include a medical device, such as an analyte sensor (e.g., a glucose sensor) and/or an infusion device, and a device to position at least a portion of the medical device beneath a skin surface of a user are provided, as well as methods of positioning at least a portion of a medical device such as an analyte sensor (e.g., a glucose sensor) and/or an infusion device beneath a skin surface of a user, and methods of analyte testing.
Gottlieb et al.( US 20090299301) teaches An introducer is provided for introducing a sensor into the body of a patient. The introducer connects to a sensor hub. When the sensor hub and introducer are connected, the introducer needle is exposed. When the sensor hub and introducer are disconnected, a needle cover and the needle move with respect to each other so that the needle cover substantially covers the needle, protecting a user from being injured by the needle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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