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
Applicant's election with traverse of Group I, species 10 (Fig. 9) in the reply filed on 02/13/26 is acknowledged. The traversal is on the ground(s) that: when making a lack of unity requirement, the examiner must (1) list the different group of claims and (2) explain why each group lacks unity with each other group (i.e. why there is no single general inventive concept) specifically describing the unique special technical feature in each group”.
This is not found persuasive because: on page 4, 4th paragraph of Requirement for Restriction/Election 12/12/25, Examiner clearly pointed out the distinguish in two different groups I & II.
For example: Group I (claim 1) requires the method of measuring at least one administration parameter; and when the operation of the dispensing mechanism is determined to be complete, comparing the at least one administration parameter with acceptable administration parameters in order to confirm whether the administration was successful. These limitations do not include in the Group II.
Group II (claim 23) requires the method of determining at least one physiological parameter of a user based on the at least one dispensing mechanism parameter; and when the operation of the dispensing mechanism is determined to be complete, comparing the at least one physiological parameter with acceptable physiological parameters in order to confirm whether the administration was successful. These limitations do not include in the Group I.
Although the Inventions I & II of these groups require the technical feature of using a drug administration device, however, this technical feature is not a special feature as it does not contribute over the prior art in view of Taylor et al. (US 2016/0030683). Taylor discloses a method of confirming administration from a drug administration device including steps: measuring at least one dispensing mechanism parameter (measuring flow rate of drug), ... when the operation of the dispensing mechanism is determined to be complete, comparing the at least one administration parameter with acceptable administration parameters in order to confirm whether the administration was successful, see para [0076].
Although Taylor discloses a method of determining at least one physiological parameter, blood glucose level of a user based recommending insulin dosing (dispensing mechanism parameter), para [0054]; however, Taylor fails to disclose the step of comparing the at least one physiological parameter with acceptable physiological parameters in order to confirm whether the administration was successful, as required in claim 23 of Group II.
In addition, Examiner states on page 5 of Requirement for Restriction/Election 12/17/25 that:
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Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 16 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.
It is unclear to Examiner that the claim 16 is being referred back to claim 1, 8 or 14. See below.
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Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5-6, 8, 11-14 & 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor et al. (US 2016/0030683).
Regarding claim 1, Taylor discloses a method for confirming administration from a drug administration device 2 (Figs. 1-2) or 102 (Figs 9-11), the method comprising:
operating a dispensing mechanism (e.g. plunger or drive mechanism located inside the injection pen 2) of the drug administration device;
measuring at least one dispensing mechanism parameter (para [0054], recording actual dosing information, e.g., as confirmed by a flow or other type of sensor 20 provided in a pen needle adapter and configured to accurately detect amount of drug actually delivered);
determining whether the operation of the dispensing mechanism is complete based on the at least one dispensing mechanism parameter (e.g., the amount, dose of drug to be delivered by the device, also see para [0054] as discussed in the above);
measuring at least one administration parameter (para [0057], a sensor 20 is sensing flow to confirm total dose actually delivery; para [0074], the smart sensor 20, 180 is configured to measure at least one parameter related to fluid delivery and/or the drug being delivered) and
when the operation of the dispensing mechanism is determined to be complete, comparing the at least one administration parameter with acceptable administration parameters in order to confirm whether the administration was successful (e.g., para [0076], ... Flow data can be used to accurately determine completed dose (e.g., a comparison of dosage input with actual amount detected as being delivered based on flow data from sensor 20, 180). The flow data can also be used by a processor to determine if a leak or an occlusion has occurred. An indication (e.g., confirmation of complete dose delivery, or warning of incomplete dose, or status indicating leak or occlusion) can be generated on a display).
Regarding claim 2, further comprising: modifying further operation of the drug administration device based on the at least one dispensing mechanism parameter and/or the at least one administration parameter (para [0051], the biosensor is configured to provide a feedback mechanism to a drug delivery system and, as such, adjustments to drug delivery can be made without any human interaction... it can adjust the dose and any changes to the flow rate or dose can be confirmed by the fluid detection sensor 20).
Regarding claim 5, wherein modifying the further operation of the drug administration device comprises: preventing the further operation of the drug administration device when the successful administration was not confirmed (para [0050] states that: ... the sensor 20 can signal the pump to stop the injection or create a visual or audible display for the patient or clinician to alert them of a complication (e.g., occlusion, leak, incorrect dose or drug, expiry or contamination). It is noted that an occlusion, leak or incorrection dose are equivalent to the claimed limitation, i.e., the successfully administration was not confirmed.
Regarding claim 6, the claim includes “and/or” conjunction. It is reasonable to interpret the claim to mean the later. Only one of four limitations in the claim 6 is needed to teach the claim due to the or limitation. In this case, Taylor discloses that wherein modifying the further operation of the drug administration device comprises: modifying a dosage volume to be administered during further operation of the drug administration device; and/or modifying a rate with which a drug is administered by the drug administration device (e.g., para [0051], the biosensor is configured to provide a feedback mechanism to a drug delivery system and, as such, adjustments to drug delivery can be made without any human interaction... it can adjust the dose and any changes to the flow rate or dose can be confirmed by the fluid detection sensor 20.
Regarding claim 8, wherein operating the dispensing mechanism of the drug administration device comprises: displacing a displaceable component (needle 21) from a first position (before injection) of the displaceable component.
Regarding claim 11, wherein measuring the at least one dispensing mechanism parameter or the at least one administration parameter comprises: measuring a flow rate of a drug administered by the drug administration device (see abstract, smart sensors are employed to determine one or more of drug identification, dose, flow rate, also see para [0016]).
Regarding claim 12, Taylor discloses in para [0049] that: the fluid detection sensor 20 is in contact with the fluid so that it can identify important characteristics of the drug. The sensor 20 provided in a pen needle adapter (adjacent to the injection site) and configured to accurately detect amount of drug actually delivered, para [0060], also see para [0079]. Therefore, the sensor 20 is capable of detecting or determining an amount of liquid present in a vicinity of an injection site.
Regarding claim 13, wherein measuring the at least one administration parameter comprises: measuring a physiological parameter (e.g., blood glucose level, para [0047, 0054]), of a user of the drug administration device, associated with successful administration.
Regarding claim 14, further comprising: assessing/evaluating an operational status of the drug administration device before and/or during operation of the dispensing mechanism (e.g., para [0050], for example, the sensor 20 can signal the pump to stop the injection or create a visual or audible display for the patient or clinician to alert them of a complication (e.g., occlusion, leak, incorrect dose or drug, expiry or contamination). ... Since it has a flow rate detector, the sensor 20 can also provide a feedback mechanism to the pump to ensure the correct flow rate. If there was an occlusion or leak, or the connection to the patient was compromised, or the pump has stopped, the sensor 20 can detect these conditions and operate in conjunction with the user interface 22 to generate an alert to the pump user to check the infusion line. In all embodiments of the present invention, drug administration, and any errors that occur during drug administration...).
Regarding claims 17-18, further comprising: notifying a user whether the administration was successful (para [0076], ... Flow data can be used to accurately determine completed dose (e.g., a comparison of dosage input with actual amount detected as being delivered based on flow data from sensor 20, 180); wherein notifying the user whether the administration was successful comprises one or more of a visual feedback, an auditory feedback, and a tactile feedback ( para [0076], .... An indication (e.g., confirmation of complete dose delivery, or warning of incomplete dose, or status indicating leak or occlusion) can be generated on a display).
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 3-4 & 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2016/0030683).
Regarding claims 3-4, Taylor states in para [0051] that: ... This biosensor can be configured to provide a feedback mechanism to a drug delivery system and, as such, adjustments to drug delivery can be made without any human interactions..., and then it can adjust the dose and any changes to the flow rate or dose can be confirmed by the fluid detection sensor 20. The para [0058] states: With reference to FIG. 4B, the pen 2 has a smart sensor 20 in an adapter 18 or in a cartridge, connectivity with a user interface 22 such as a smartphone or laptop or PDM... Therefore, a person skilled in the art would recognize that the biosensor is provide feedback (or a notification to a user) of adjustment to drug delivery via visual feedback (user interface 22). In other words, Taylor discloses a method notifying a user that the further operation of the drug administration device has been modified; wherein notifying the user that the further operation of the drug administration device has been modified comprises one or more of visual feedback.
Regarding claims 20-21, as mentioned in the claim 1 above, Taylor discloses that when the operation of the dispensing mechanism is determined to be complete, comparing the at least one administration parameter with acceptable administration parameters in order to confirm whether the administration was successful (e.g., para [0076], ... Flow data can be used to accurately determine completed dose (e.g., a comparison of dosage input with actual amount detected as being delivered based on flow data from sensor 20, 180). The flow data can also be used by a processor to determine if a leak or an occlusion has occurred. An indication (e.g., confirmation of complete dose delivery, or warning of incomplete dose, or status indicating leak or occlusion) can be generated on a display);
Wherein the acceptable administration parameters include a predefined threshold value (any number can be defined as a predefined threshold value). Taylor discloses a method of comparing the administration parameter. Although Taylor does not directly state or name a specific detail such as the measured at least one administration parameter is below the predefined threshold value; however, Taylor discloses that the sensor detects an incomplete dose or leak or occlusion, para [0076]. Therefore, a person skilled in the art would recognize that the administration parameter is below the predefined threshold value (or the acceptable administration parameter). In addition, Taylor discloses in para [0051] that: a biosensor (e.g., a blood glucose meter (BGM) or continuous blood glucose (CGM) meter wirelessly connected to a pen 2 or pump 102 or patch pump 90) can also be employed to monitor the blood glucose levels or other physiologic conditions to ensure that the optimal dose was given to the patient. This biosensor can be configured to provide a feedback mechanism to a drug delivery system and, as such, adjustments to drug delivery can be made without any human interactions.
Taylor also states in para [0054] that: ... the pen 2 can also communicate (e.g., wirelessly) with a BGM or CGM or other automated blood glucose testing device to improve glucose control by recommending insulin dosing with greater accuracy (e.g., using feedback information from glucose testing provided by the BGM/CGM), recording actual dosing information (e.g., as confirmed by a flow or other type of sensor 20 provided in a pen needle adapter and configured to accurately detect amount of drug actually delivered), ... Such automated sensing, feedback and adjustments to recommended insulin dosing eliminates manual blood glucose control regimens ... With a smart drug delivery device 2, patients spend significantly more time within their recommended range for glucose control, which can result in HbA1c improvement.
Having said in the para [0054] above, a person skilled in the art would recognize that the administration parameter can be obtain above the predefined threshold value by adjusting the insulin dose (when the blood glucose value is higher than the target value; a person skilled in the art would recognize that the administration parameter should be provided higher (or increase the infusion rate) to bring the blood glucose value down to the target value), also see para [0060].
In addition, Taylor states in the abstract that: pen injector systems or drug delivery cartridges to improve tracking of drug self-administration and stop medication errors that occur primarily through self or automated injection (e.g., due to incorrect or incomplete dosing, excessive dose or rate...). In other words, the administration parameter is above the predefined threshold value (when the injection is excessive dose).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2016/0030683) in view of Moberg et al. (US 9,033,925).
Regarding claim 7, Taylor discloses the claimed invention except for the limitation that wherein measuring the at least one dispensing mechanism parameter or measuring the at least one administration parameter comprises: measuring a speed of a motor of the drug administration device and/or a duration of operation of the motor.
Morberg discloses a drug administration device and method of delivering a drug comprising:
measuring the at least one dispensing mechanism parameter or measuring the at least one administration parameter comprises: measuring a speed of a motor of the drug administration device and/or a duration of operation of the motor (e.g., the occlusion detector measures increased reservoir pressure indirectly by monitoring one or more motor parameter (Note: equivalent to the claimed “speed of motor”), such as voltage, current, running time, or rotational or linear displacement, col. 16, lines 26-40; measure a torque applied to a drive system component (Note: equivalent to the claimed “speed of motor”) as in indication of the fluid pressure within a reservoir, col. 24, line42-45;
In addition, Morberg also states that: There are many variables occlusion detection approach. Examples of such variables are properties and/or parameter of the system, pump and/or motor, such as force, drive current, drive voltage, drive time of the motor, coast time of the motor, energy of the delivery pulse, and variables from the closed loop delivery algorithm, such as drive count, coast count, and delta encode count..., col. 30, line 63-col. 32, line 32). It is noted that the parameters of motor as mentioned the above that are equivalent or related to parameters of the speed of a motor of the drug delivery device during of operation of the motor to determine a condition of delivery rate whether normal or occlusion. It is further noticed that a person skilled in the art would recognize that the dispensing mechanism parameter, i.e. flow rate of the fluid or the administration parameter, i.e. amount of fluid delivery is reduced and the measured value is lower than expected value when occlusion happened.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the drug administration device and method of Taylor with including a method of measuring a speed of motor of the drug administration device during of operation of the motor, as taught by Moberg, in order to detect an occlusion in a medication during delivering drug into a patient.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2016/0030683) in view of Nyholm et al. (US 7,993,300).
Regarding claim 7, Taylor discloses the claimed invention except for the limitation that wherein measuring the at least one dispensing mechanism parameter or measuring the at least one administration parameter comprises: measuring a speed of a motor of the drug administration device and/or a duration of operation of the motor.
Note: a person skilled in the art would recognize that the device 2 in Taylor can be used as an injector including a battery driven electrical motor.
Nyholm discloses a method for ensuring administration from a drug administration device comprising a step of measuring the at least one dispensing mechanism parameter or measuring the at least one administration parameter comprises: measuring a speed of a motor of the drug administration device and/or a duration of operation of the motor (e.g., the determining of the speed of the piston rod comprises the step of measuring the speed of the motor using some sort of encoder unit and an associated electronic detect circuit, col. 2, lines 61-66. A person skilled in the art would recognize that the motor-driven piston of the syringe pump is powered with a defined speed which determines the flow rate. In other words, determining value of the speed of the piston rod is equivalent to the determining of flow rate or amount of fluid being dispensed).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the drug administration device and method of Taylor with including a method of measuring a speed of motor of the drug administration device during of operation of the motor, as taught by Moberg, in order to ensure a constant target speed of a battery driven electrical motor to move a piston in the injection device so as to inject a set dose of medicine from the injector device more accuracy.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2016/0030683) and further in view of Searle et al. (US 2016/0074587).
Regarding claims 9 & 10, Taylor discloses the claimed invention except for the limitation that: measuring the displacement of the displaceable component; wherein measuring the displacement of the displaceable component comprises using a Hall effect sensor.
Searle discloses a drug delivery device and method in Fig. 14 comprising: operating the dispensing mechanism of the drug delivery device comprises: displacing a displaceable component 1404 (e.g., piston and plunger rod) from a first position of the displaceable component, see Fig. 14; wherein a syringe sleeve 1400 includes a plurality of magnetic position sensors 1402; the syringe 1404 has RFID chip 1406 and a magnet 1408 that is sensed by the Hall-effect sensors 1402 to determine a dose amount, para [0061]. Therefore, Searle discloses a method of measuring the at least one dispensing mechanism parameter or the at least one administration parameter (dose amount) comprises: measuring the displacement of the displaceable component 1404.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the drug administration device and method of Taylor with providing a plurality of magnetic position sensor and a magnet being located at/on displaceable component and providing Hall-effector sensor being located on a housing, as taught by Searle, in order to determine the dose amount
Claims 9-10 & 22 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2016/0030683) and further in view of Bohm (US 2008/0152507).
Regarding claim 9, Taylor discloses the claimed invention except for the limitation that: measuring the displacement of the displaceable component.
Bohm discloses an injection device and method comprising: displacing a displaceable component, i.e. position sensor 307, capacitive displacement position sensor 307 from a first position of the displaceable component, paras [0054-0055]; wherein measuring the at least one dispensing mechanism parameter (e.g., rate of displacement of the infusion liquid from a reservoir, the rate at the solution is pumped from the reservoir, para [0039]) or the at least one administration parameter comprises: measuring the displacement of the displaceable component (e.g., the displacement position of the movable partition 124).
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the drug administration device and method of Taylor with providing a position sensor, capacitive displacement position sensor in the device, as taught by Bohm, in order to determine the dispensing state (e.g., the displacement position of the movable partition/piston, the rate of displacement of the infusion).
Regarding claim 10, it is very well-known and standard industry practice to use Hall effect sensor for position sensing.
Regarding claim 22, Taylor discloses the claimed invention except for wherein the drug comprises at least one of infliximab, golimumab, ustekinumab, daratumumab, guselkumab, epoetin alfa, risperidone, esketamine, ketamine, and paliperidone palmitate. Given that the Taylor device is designed for insulin delivery and incorporates methods for confirmation drug administration, a person skilled in the art would recognize that its broader utility. The mechanical and monitoring principles of the Taylor injection pen are inherently adaptable for the delivery of various other therapeutic agents (as listed in the claim 22) based on specific treatment requirements.
In addition, Bohm teaches that the delivery device system used of insulin can also be used for other drug such as ketamine, para [0028].
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device and method of Taylor with using drug, i.e. ketamine, as taught by Bohm, in order to able to deliver of variety of medically useful drugs for various treatment such as diabetes and anesthesia.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor et al. (US 2016/0030683) in view of McCullough et al. (US 2017/0098058).
Regarding claims 15-16, Taylor discloses the claimed invention except for the limitation that wherein assessing the operational status of the drug administration device comprises at least one of:
analyzing a power source of the drug administration device to verify that the power source has sufficient charge for successful administration; and
sensing an angular orientation of the drug administration device relative to a user of the drug administration device and determining whether the sensed angular orientation is a proper angular orientation.
McCullough discloses a drug delivery device system and method for use with drug delivery device, in Figs. 4-10, comprising: a drug administration device 302; a skin sensor 362 and an orientation sensor 314 are engaged to the drug administration device 302; the method comprising: assessing an operational status of the drug administration device before operation of the dispensing mechanism, paras [0032-0034, 0117], also see Fig. 9; sensing an angular orientation (via the skin sensor 362 and orientation sensor 314) of the drug administration device relative to a user of the drug administration device and determining whether the sensed angular orientation is a proper angular orientation, para [0123]; wherein assessing the operational status of the drug administration device comprises: moving the displaceable component (needle or a distal portion of the drug administration device 302) of the drug administration device a predefined distance, paras [0123, 0145], also see Fig. 9.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the drug administration device and method of Taylor with providing a skin sensor and orientation sensor being attached to a distal portion of the drug administration device, as taught by McCullough, in order to make sure the drug administration device to be positioned on the skin such that the needle will enter the skin at a right angle or orthogonally to the skin.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
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