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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 17, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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) 1-6, 8-14, and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yuds (US 20210187189 A1) in view of Schiller (US 6546787 B1).
Regarding claim 1, Yuds teaches a device for transcutaneous insertion (wearable device/pump patch 100), comprising: a flexible insertion piece configured for transcutaneous insertion ([0086] “The needle deployment mechanism can comprise a needle carriage and a cannula carriage initially engaged with each other for driving a flexible cannula into the user using an insertion needle, and a spring member for withdrawing the insertion needle from the user upon insertion of the flexible cannula into the user”). However, Yuds fails to disclose a deformation sensor on the insertion piece.
Schiller teaches systems employ a strain gage mounted on the wall of the needle and a strain monitor providing feedback to a user. Schiller discloses and a deformation sensor configured for detecting one or more deformation signals (Col 5, lines 25-28, “the strain signal may be communicated from the strain gage 60 proximally along the length of the needle using at least one, and preferably two more leads 64 and 66;” Fig. 5, strain gage 60).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Yuds to include a deformation sensor as disclosed in Schiller to provide a user with feedback regarding the strain on the insertion piece, allowing the delivery of a particular therapeutic agent to the tissue structure of interest with a fairly high degree of precision (Schiller Col 3, lines 17-18 and Col 13, line 67 – Col 14 lines 1-2).
Regarding claim 2, the combination of Yuds/Schiller discloses the device of claim 1, wherein the deformation sensor comprises a strain sensor configured for detecting a bending of the insertion piece (Yuds: [0086] “a flexible cannula into the user;” Schiller: Col 5, lines 57-59 “the strain gage is intended to measure the strain (e.g., the axial shortening or elongation) of the needle wall [cannula wall per Yuds].”).
Regarding claim 3, the combination of Yuds/Schiller discloses the device of claim 2, wherein upon bending and unbending the strain sensor reverts to its original properties (Schiller: Col 5, lines 53-64 “FIG. 2 is intended to schematically illustrate that the substrate 62 of the strain gage 60 is connected to the wall 56 of the needle at a minimum of two spaced-apart locations. As discussed below, the strain gage is intended to measure the strain (e.g., the axial shortening or elongation) of the needle wall. The substrate 62 can just as easily be connected to the wall 56 of the needle by a single adhesive or other bond that extends between two spaced-apart locations on the needle wall. It is sufficient that the adhesive, however applied, serves to induce compression or elongation of the substrate 62 proportionate to the displacement of two or more spaced-apart locations along the needle wall.”).
Regarding claim 4, the combination of Yuds/Schiller discloses the device of claim 2, wherein the strain sensor is configured for continuous measurement (Schiller: Col 9, lines 34-39 “The needle 50 can either be advanced manually by the operator or b; means of a motor. If the needle is to be manually advanced, the needle system can provide the operator with some visual feedback (e.g., a graph on a computer screen) showing, in real time, the strain on the needle.”).
Regarding claim 5, the combination of Yuds/Schiller discloses the device of claim 2, wherein the strain sensor comprises an electronic strain sensor (Schiller: Col 4, lines 49-54 “The communication cable 80 is useful in delivering this strain signal to a signal processor 85. The following detailed discussion focuses on the use of an electrical strain signal, in which case the communication cable is typified as a pair or bundle of electrical wires.”).
Regarding claim 6, the combination of Yuds/Schiller discloses the device of claim 1, wherein the deformation sensor comprises at least two strain sensors (Schiller: Col 7, lines 25-40 “a plurality of strain gages are carried by the needle. FIG. 4 is a schematic end view of one such needle, illustrating four strain gages positioned equiangularly about the internal surface of the needle wall 56… Other arrangements of multiple strain gages on the needle 50 could also be selected to achieve any particular design objectives.”).
Regarding claim 8, the combination of Yuds/Schiller discloses the device of claim 6, wherein the at least two strain sensors are arranged at different angles (ᵦ,ᵧ) around a longitudinal axis (L1) of the flexible insertion piece (Yuds: [0086] “flexible cannula into the user”; Schiller: strain gage sensors 60; Fig. 4, Fig. 5; Col 7, lines 25-40 “a plurality of strain gages are carried by the needle [flexible cannula per Yuds]. FIG. 4 is a schematic end view of one such needle, illustrating four strain gages positioned equiangularly about the internal surface of the needle wall 56… If so desired, each of these strain gages maybe positioned at about the same point along the length of the needle. In certain embodiments, though, it may be advantageous to stagger the positions of the strain gages at different locations along the length of the needle to get a more informative profile of the stress on the wall of the needle at different locations… Other arrangements of multiple strain gages on the needle 50 could also be selected to achieve any particular design objectives.”).
Regarding claim 9, the combination of Yuds/Schiller discloses the device of claim 1, wherein an axis of the deformation sensor is oriented along a longitudinal axis (L1) of the flexible insertion piece (Schiller: Fig. 2, strain gage 60) and/or wherein wiring attached to the deformation sensor is oriented along the longitudinal axis (L1) (Schiller: Fig. 5; Col 6, lines 44-47 “the electrical leads 64, 66 simply extend proximally along the entire length of the needle [flexible cannula per Yuds] for direct electrical connection to the signal processor, such as through the communication cable 80”).
Regarding claim 10, the combination of Yuds/Schiller discloses the device of claim 1, wherein the deformation sensor is arranged on the outside of the flexible insertion piece or is arranged on the inside of the flexible insertion piece off-centered (Schiller: Col 6, lines 59-62 “The primary difference between the needle 50' of FIG. 3 and the needle 50 [flexible cannula per Yuds] of FIG. 2 is that the strain gage 60 in FIG. 3 is carried by the exterior surface of the needle wall 56 rather than within the lumen 58, as in FIG. 2.”).
Regarding claim 11, the combination of Yuds/Schiller discloses the device of claim 1, wherein the device for transcutaneous insertion is a continuous analyte measurement sensor comprising a transcutaneous analyte sensor (Yuds: [0022] “The device can be wearable and can continuously monitor a patient's blood oxygenation, partial O.sub.2 saturation, hematocrit, and hemoglobin.” [0086] “The pump patch can also comprise a mechanism for manually actuating a bolus dose by applying a force to a specific area on the upper portion of the housing, and a mechanism for deploying a transcutaneous analyte sensor for the purpose of determining a physiological indicator.”).
Regarding claim 12, the combination of Yuds/Schiller discloses the device of claim 1, wherein the flexible insertion piece is a flexible cannula for drug delivery (Yuds: [0086] “a flexible cannula into the user… The pump patch can also comprise a mechanism for manually actuating a bolus dose by applying a force to a specific area on the upper portion of the housing”).
Regarding claim 13, the combination of Yuds/Schiller discloses a transcutaneous insertion system (Yuds: [0022] “erythropoietin delivery system that interfaces with a prescribed patch and wirelessly connects to the patient's nephrologist. In some embodiments, the delivery system can also deliver an iron supplement.”), comprising:
a device for transcutaneous insertion according to claim 1 (Yuds: pump patch 100); and
a memory comprising instructions that, when executed, cause one or more processors (Schiller: Col 4, lines 63-64 “the signal processor 85 is typified as a programmable computer”) to:
receive one or more signals from the deformation sensor (Schiller: Col 5, lines 25-28, “the strain signal may be communicated from the strain gage 60;” Col 4, lines 49-51 “The communication cable 80 is useful in delivering this strain signal to a signal processor 85.”); and
determine a deformation value of the flexible insertion piece from the one or more signals (Schiller: Col 9, lines 36-38 “the needle system can provide the operator with some visual feedback (e.g., a graph on a computer screen) showing, in real time, the strain on the needle”).
Regarding claim 14, the combination of Yuds/Schiller discloses the transcutaneous insertion system of claim 13, further comprising a display, where the memory includes instructions that, when executed, cause the one or more processors to transmit a notification to the display (Schiller: Col 9, lines 36-38 “the needle system can provide the operator with some visual feedback (e.g., a graph on a computer screen) showing, in real time, the strain on the needle.” Yuds: [0107] “The user interface can be used for transmitting information to the user (such as an LCD display, a speaker or a vibrating alarm).”).
Regarding claim 16, the combination of Yuds/Schiller discloses the transcutaneous insertion system according to claim 13, wherein the device and the memory are disposed in a housing adapted for placement adjacent to skin of a user (Yuds: [0087] “the upper and lower covers make up an external shell or housing for pump patch 100… The lower cover is preferably affixed to the patient's skin via any well known, long-lasting adhesive layer 210 that is safe for skin contact with the user.” Fig. 5, pump patch 100, controller 116, pump 114, needle deployment mechanism 108; [0102] “Controller 116 can comprise an ultra-low-power (ULP) programmable controller”).
Regarding claim 17, the combination of Yuds/Schiller discloses a method of detecting deformation of at least a part of the insertion piece according to claim 1 (Schiller: Col 9, lines 44-45 “the current strain level monitored by the strain gage 60”), the method comprising:
receiving one or more signals from the deformation sensor (Schiller: Col 5, lines 25-28, “the strain signal may be communicated from the strain gage 60;” Col 4, lines 49-51 “The communication cable 80 is useful in delivering this strain signal to a signal processor 85.”);
determining a deformation value of the flexible insertion piece from the one or more signals; and optionally transmitting a notification to a display (Schiller: Col 9, lines 36-38 “the needle system can provide the operator with some visual feedback (e.g., a graph on a computer screen) showing, in real time, the strain on the needle.” Yuds: [0107] “The user interface can be used for transmitting information to the user (such as an LCD display, a speaker or a vibrating alarm).”).
Claim(s) 7, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yuds (US 20210187189 A1) in view of Schiller (US 6546787 B1), and in further view of Hibner (US 20150209573 A1).
Regarding claim 7, the combination of Yuds/Schiller discloses the device of claim 6. However, the combination of Yuds/Schiller fails to particularly disclose the strain sensors being connected in parallel or in series.
Hibner teaches various surgical devices and methods for monitoring and regulating tissue compression. Hibner discloses wherein the at least two strain sensors are connected in parallel or in series ([0037] “The first strain gauge can be positioned on the first jaw and the second strain gauge is positioned on the second jaw. The first and second gauges can be wired in parallel;” [0037] “Multiple strain gauges can be wired to separate power sources, for example two strain gauges can be wired to two separate power sources, or preferably wired in parallel to the same power source.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Yuds/Schiller to include the at least two strain sensors being connected in parallel as disclosed in Hibner so that if one strain gauge fails, the device is still configured to measure a strain (Hibner [0006]).
Regarding claim 15, the combination of Yuds/Schiller discloses the transcutaneous insertion system of claim 13, wherein the memory further comprises instructions that, when executed, cause the one or more processors (Schiller: Col 4, lines 63-64 “the signal processor 85 is typified as a programmable computer”) to:
compare the determined deformation value with a reference value; and when the determined deformation value fulfills a predetermined condition with regard to the reference value, conduct at least one of: b) issue an alarm which is transmitted to the display (Schiller: Col 9, lines 42-47 “Of course, other forms of feedback may be used either instead of or in addition to such a graphical display on a computer screen. For example, the current strain level monitored by the strain gage 60 may be used to generate an audible tone, the volume or pitch of which can be varied in proportion to the measured strain [each change in volume or pitch is indicative of the deformation value fulfilling a predetermined condition of meeting or exceeding a reference deformation value].” Yuds: [0107] “The user interface can be used for transmitting information to the user (such as an LCD display, a speaker or a vibrating alarm).”).
However, the combination of Yuds/Schiller fails to disclose an alarm detectable on the device for transcutaneous insertion or deactivating the device.
Hibner discloses compare the determined deformation value with a reference value; and when the determined deformation value fulfills a predetermined condition with regard to the reference value ([0005] “A controller can be configured to determine when the force exceeds a predetermined threshold and, if the force is in excess of the predetermined threshold, to cause a notification signal to be issued to a user.” [0007] “The notification signal can vary in any number of ways.”), conduct at least one of:
a) issue an alarm which is detectable on the device for transcutaneous insertion ([0007] “For example, the notification signal can include an audible signal. In certain aspects, the notification signal can activate a visual indicator disposed on the handle portion. In other aspects, the notification signal can be configured to provide a tactile sensation to a user. For another example, the notification signal can include a vibration.”);
c) deactivate the device for transcutaneous insertion ([0008] “the actuator can be configured to automatically fix a relative position of the first and second jaws.” [0049] “When the alert is received by a user, the closure grip 20 can optionally automatically lock in the current position or alternatively a user can engage one or more locking features configured to fix a position of the closure actuator relative to the stationary grip 22.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Yuds/Schiller to include an alarm detectable on the device for transcutaneous insertion or deactivating the device as disclosed in Hibner to provide a variety of ways of notifying the user and adjust operational characteristics based on the feedback (Hibner [0007, 0027]).
Regarding claim 18, the combination of Yuds/Schiller discloses the method of detecting deformation according to claim 17, further comprising:
comparing the determined deformation value with a reference value; and when the determined deformation value fulfills a predetermined condition with regard to the reference value, conducting at least one of: b) issue an alarm which is transmitted to the display device (Schiller: Col 9, lines 42-47 “Of course, other forms of feedback may be used either instead of or in addition to such a graphical display on a computer screen. For example, the current strain level monitored by the strain gage 60 may be used to generate an audible tone, the volume or pitch of which can be varied in proportion to the measured strain [each change in volume or pitch is indicative of the deformation value fulfilling a predetermined condition of meeting or exceeding a reference value].” Yuds: [0107] “The user interface can be used for transmitting information to the user (such as an LCD display, a speaker or a vibrating alarm).”).
However, the combination of Yuds/Schiller fails to disclose an alarm detectable on the device for transcutaneous insertion or deactivating the device.
Hibner discloses comparing the determined deformation value with a reference value; and when the determined deformation value fulfills a predetermined condition with regard to the reference value ([0005] “A controller can be configured to determine when the force exceeds a predetermined threshold and, if the force is in excess of the predetermined threshold, to cause a notification signal to be issued to a user.” [0007] “The notification signal can vary in any number of ways.”), conduct at least one of:
a) issue an alarm which is detectable on the device for transcutaneous insertion ([0007] “For example, the notification signal can include an audible signal. In certain aspects, the notification signal can activate a visual indicator disposed on the handle portion. In other aspects, the notification signal can be configured to provide a tactile sensation to a user. For another example, the notification signal can include a vibration.”);
c) deactivate the device for transcutaneous insertion ([0008] “the actuator can be configured to automatically fix a relative position of the first and second jaws.” [0049] “When the alert is received by a user, the closure grip 20 can optionally automatically lock in the current position or alternatively a user can engage one or more locking features configured to fix a position of the closure actuator relative to the stationary grip 22.”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Yuds/Schiller to include an alarm detectable on the device for transcutaneous insertion or deactivating the device as disclosed in Hibner to provide a variety of ways of notifying the user and adjust operational characteristics based on the feedback (Hibner [0007, 0027]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOLLY HALPRIN whose telephone number is (703)756-1520. The examiner can normally be reached 12PM-8PM ET.
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/M.H./Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791