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 without traverse of Group I, Clm. 1-18 in the reply filed on 14 November 2025 is acknowledged.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim(s) 1-18 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-6 of U.S. Patent No. U.S. Patent No. 11,896,805.. Although the claims at issue are not identical, they are not patentably distinct from each other in further view of U.S. Publication No. 2014/0322683 (“Baym”).
Regarding Claim 1, the reference patent (US 11,86,805) claims (see Clm. 1)a needle-free injector system comprising:
A needle-free injector configured to deploy a dose of treatment to a patient as an injection event;
A sensor system including a gyroscope and a contact sensor; and
A processor configured to perform steps of:
Detecting an actuation of the needle-free injector to deploy the dose in the injection event;
Monitoring one or more signals from the sensor during the injection event;
Determining whether the injection event was a treatment event including a successful delivery of the dose to the patient based on the one or more signals from the sensor during the injection event, and
Transmitting information regarding the injection even to a server. In the instant case the reference patent fails to explicitly claim what “information” is transmitted. However, to the extent that the device particularly claims that the processor determines information including whether a treatment event includes the successful delivery of the dose, it would have been obvious for one having ordinary skill in the art at the time the invention was made to transmit this information to the server inasmuch as it presents one specific and particularly claimed selection of information the device is intended to generate, whereby it would have been obvious to transmit ANY and ALL information generated by the system in satisfaction of the broad recitation of transmitting “information regarding the injection event to the server”.
The primary distinction between the instant claims and the claims of the reference patent is that the claimed invention of the reference patent only particularly includes a gyroscope and contact sensor (in Claim 1). No specific claim requires EACH of the gyroscope, contact sensor, AND accelerometer. However, further inclusion of an accelerometer into the claimed sensor system of the reference patent would have been obvious. Specifically, the prior art, see Baym, discloses:
A needle-free injector (120 – Par. 50) configured to deploy a dose of treatment to a patient as an injection event;
A sensor system comprising a gyroscope (Par. 92, 207) and (see “at least one of..”) an accelerometer (Par. 92, 192, 147, 207); and
A processor (250) configured to perform the steps of:
Detecting an actuation of the needle-free injector to deploy the dose in the injection event, monitoring the signals from the sensor system during the injection event, determining whether the injection event was a treatment event including a successful delivery of the dose to the patient based on the signals from the sensor system during the injection event (Par. 7, 91, 92, 128, 129, 147, 166, 172, 173 207), and
Transmitting information regarding the injection event to a server (150), including at least whether the injection event was the treatment event including the successful delivery of the dose to the patient (Par. 92, 121, 123, 169, 181).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to further include an accelerometer as part of the sensor system of the claims of the reference patent, as disclosed by Baym, in order to provide additional sensor data which can be used to analyze and verify proper utilization of the injection device in order to confirm that the user is properly utilizing the device in compliance with their prescribed treatment protocol.
The dependent claims (see Claims 2-18) present additional features which have not been found to define and distinguish over the claims of the reference patent, said limitations either being expressly reflected in the dependent claims (see Clm. 2-6) OR obvious in light of the prior art (as enumerated below whereby modification to the claimed invention of the reference patent would have been obvious for the same reasons, using the same art, as applied for modification to Baym).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 3-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0322683 (“Baym”) in view of WO 2013/065055 (“Nimrod”) and U.S. Publication No. 2002/0188419 (“Slate”).
Regarding Claims 1 and 5, Baym discloses a needle-free injector system (110 – Par. 50) comprising:
A needle-free injector (120 – Par. 50) configured to deploy a dose of treatment to a patient as an injection event;
A sensor system comprising a gyroscope (Par. 92, 207) and (see “at least one of..”) an accelerometer (Par. 92, 192, 147, 207); and
A processor (250) configured to perform the steps of:
Detecting an actuation of the needle-free injector to deploy the dose in the injection event, monitoring the signals from the sensor system during the injection event, determining whether the injection event was a treatment event including a successful delivery of the dose to the patient based on the signals from the sensor system during the injection event (Par. 7, 91, 92, 128, 129, 147, 166, 172, 173 207), and
Transmitting information regarding the injection event to a server (150), including at least whether the injection event was the treatment event including the successful delivery of the dose to the patient (Par. 92, 121, 123, 169, 181).
Baym discloses the invention substantially as claimed except that that the sensor system further includes a “contact sensor”. However, the presence of such sensors is notoriously well-known in the art. For example, Nimrod discloses a related injection device (107) which includes a sensor suite configured to determine whether the invention is being properly used including orientation sensors (131), skin contact sensors (130), among other sensors (135). Specifically, Nimrod includes a contact sensor (130) which is used to determine whether the injector system is “correctly oriented at a patient injection site” (Clm. 2; Pg. 6-7).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Baym to incorporate a contact sensor, as disclosed by Nimrod, in order to monitor contact of the device with a patient skin in order to determine proper operation of the device for purposes of treatment compliance and competency logging.
Should Examiner’s arguments that Baym is suggestive in continued monitoring of compliance and competency in the dispensing mode (not just training) is not explicit (see Par. 7) the following is presented. Slate discloses a needleless injector (30) which includes various sensor arrangements (Par. 15, 48, 50) for monitoring proper use of the device, wherein the system is provided with a comm link (20) to communicate use data to a server (22), wherein the server determines compliance and dose monitoring data (Par. 2, 6, 7, 42) to determine whether an injection was valid or invalid and allow a clinician to provide for continued monitoring of treatment and confirm that the patient is using the device properly and in compliance with the prescribed treatment regimen, wherein compliance can be monitored and determined both remotely at the server and locally at the injector’s processor (Par. 27).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the system of Baym to provide for continued competency and compliance monitoring after training, using both locally and remotely analysis, as disclosed by Slate, in order to ensure that the user is continuing to perform proper and compliant successful injections thereby allowing both self-evaluation of the treatment regimen while also allowing a clinician to monitor the continued treatment to ensure safe and efficacious self-administration of drugs as prescribed.
Regarding Claim 3, Baym discloses that the system is configured to determine continued competency and protocol adherence even after training (see Par. 7 – see also modifications in view of Slate as applied above), and utilizes the processor to determine a likelihood that the dose of the treatment was successfully delivered to the patient and transmit this likelihood to the server (i.e. the device of Baym monitors the sensor suite to determine whether the device was used properly and therefore the use is indicative of a successful treatment event — see Abstract; Par. 92, 123, 126) — whereby the “test score’ is considered to be indicative of a “likelihood” in accordance with the claims wherein a higher grade indicates a stronger likelihood that treatment is being completed in a successful and compliant manner).
Regarding Claim 4, Examiner first notes that the server is NOT positively recited as part of the claimed workpiece. Rather all recitation of the server MUST be understood to be merely functional in nature illustrating an intended use of the information transmitted from the processor of the injector. As such, these claim limitations can be afforded very little patentable weight, where positive recognition of the specific utilities of the server is immaterial to the needlefree injector itself.
Furthermore, Baym, (see also Slate as applied above to provide for complete continued compliance monitoring and analysis), discloses the server comprises a second processor configured to perform steps of:
receiving, at the server, information for a plurality of treatment events for the patient over a period of time, determining a compliance rate for a treatment regimen of the patient for the plurality of treatment events, and communicating, to a device associated with the patient, a message regarding an administration of at least one of the plurality of treatment events (Par. 123, 126 – Baym; Abstract, Par. 6, 7 - Slate).
Regarding Claims 6, Baym discloses that the processor is configured to determine a likelihood that the dose of the treatment was successfully delivered to the patient based on signals from the sensor suite during the injection event (re: a “test score” – Par. 92, 123, 126), wherein the sensor may comprise an “ambient sensor” (e.g. moisture sensor, gas sensors, optical sensors, temperature sensors…etc. – Par. 92).
Regarding Claim 7, Baym, see also Slate, transmitting information to the server includes transmitting an indication of whether the injection event was a treatment event for the patient based on the successful delivery of the dose to the patient (Par. 132 – Baym; Abstract, Par. 6, 7 – Slate).
Regarding Claim 8, Baym discloses the server is configured to receive, for a plurality of treatment events over a period of time, a degree to which the patient has successfully administered the plurality of treatment events, to determine a compliance rate for a treatment regimen of the patient for the plurality of treatment events, and to communicate, to a device associated with the patient, a message regarding an administration of at least one of the plurality of treatment events (Par. 123, 126 – Baym; Abstract, Par. 6, 7 - Slate).
Regarding Claim 9, Baym discloses the server is configured to allow, disallow, or modify a current or future treatment based on the compliance rate (Par. 7).
Regarding Claim 10, Baym discloses the at least one ambient sensor includes a thermometer (Par. 92).
Claim(s) 2 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0322683 (“Baym”) in view of WO 2013/065055 (“Nimrod”) and U.S. Publication No. 2002/0188419 (“Slate”) as applied above, and further in view of CN 103269737 (“Hemond”).
Regarding Claims 2 and 12, Baym, as modified by Nimrod, discloses detecting the successful delivery of the dose to the patient based on at least:
an orientation of the needle-free injector system detected with the gyroscope (Par. 92, 207),
a motion of the needle-free injector system detected with the accelerometer (Par. 92, 207), and
a contact with the patient detected with the contact sensor (see Nimrod – Pg. 6-7; Clm. 2).
Should Applicant argue that the utility of the gyroscope is not immediately evident from the disclosure of Baym the following is presented. Hemond discloses a related injector (100) which likewise uses a gyroscope (re: “gyro tester” and “gyro instrument”) to monitor the operation of the device to determine if an injection event has been provided in the proper “delivery location/orientation prior to and during delivery” (Par. 81).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize the gyroscope of Baym to explicitly determine orientation of the injection device to determine proper and appropriate orientation, as disclosed by Hemond, in order to ensure that the device is being used as directed to determine user competency and help ensure that the device is used in a safe and efficacious manner.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0322683 (“Baym”) in view of WO 2013/065055 (“Nimrod”), U.S. Publication No. 2002/0188419 (“Slate”), and CN 103269737 (“Hemond”) as applied above, and further in view of WO 2015/171964 (“Fouche”)
Regarding Claims 16 and 17, Baym, as modified in view of Hemand (see above), discloses the invention substantially as claimed except that the proper orientation of the injector is a “vertical orientation” with the gyroscope being used to determine whether the injection is made horizontal or vertical and thereby determine that a horizontal orientation is indicative of an improper injection and a vertical orientation is indicative of a proper injection. Specifically, while Baym, in view of Heman, establishes that it is known to be useful and obvious to use a gyroscope to determine proper orientation of the device during use it does not explicitly indicate what this proper orientation actually is.
However, Fouche discloses a related needleless injector (Fig. 2), wherein proper operation of such an injector requires the user to “hold it stationary and normal to the skin” (Par. 77). As such, it would have been obvious for a person having ordinary skill in the art at the time the invention was made to configure the gyroscope of the modified invention of Baym to differentiate between a vertical (i.e. normal to the skin) and horizontal (i.e. not normal to the skin) orientation, as disclosed by Fouche, in order to ensure that the device is held in the correct orientation with respect to the skin to confirm a proper versus improper injection technique using the supplied gyroscope to determine a stationary and normal/vertical orientation during injection.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0322683 (“Baym”) in view of WO 2013/065055 (“Nimrod”) and U.S. Publication No. 2002/0188419 (“Slate”) as applied above, and further in view of U.S. Publication No. 2010/0174225 (“Pesach”)
Regarding Claim 11, Baym discloses the invention substantially as claimed except that the processor is configured to detect the successful delivery of the dose to the patient based on a change, detected with the thermometer, in a skin temperature of the patient from before the injection event to after the injection event. However, Pesach discloses a drug delivery device (100) which is provided with a sensor for continuously monitoring skin temperature before, during, and after an injection event (Par. 31, 89, 91, and 93) and detect, based on the change in temperature at the skin of the injection site that an injection event has occurred (i.e. the change in temperature is correlated to vasodilation and local blood perfusion — see Par. 10, 12, 16, 22, 93). It would have been obvious for a person having ordinary skill in the art at the time the invention was made to configure the device of Baym to apply a temperature conditioning step as part of the injection event and provide a continuous temperature sensor to monitor the skin temperature prior to, during, and after the injection, as disclosed by Pesach, and monitor the change in skin temperature to determine proper compliance with the injection protocols to control/enhance the pharmacokinetic profile of specific therapeutics.
Specifically, both Baym and Pesach describe the delivery of insulin, therefore there is a clear expectation of benefits for the pharmacological enhancements described by Pesach and therefore clear motivation to monitor the effect of such enhancement in order to determine that a proper treatment event has occurred.
Claim(s) 13 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0322683 (“Baym”) in view of WO 2013/065055 (“Nimrod”) and U.S. Publication No. 2002/0188419 (“Slate”) as applied above, and further in view of WO 2015/171964 (“Fouche”).
Regarding Claims 13 and 18, Baym discloses the invention substantially as claimed except that the processor is configured to disallow the injection event unless the injector is “substantially motionless”/”detecting an absence of motion” based upon the signal from the accelerometer. However, Fouche discloses a related needleless injector (Fig. 2), wherein proper operation of such an injector requires the user to “hold it stationary and normal to the skin” (Par. 77). It would have been obvious for a person having ordinary skill in the art at the time the invention was made to utilize the accelerometer to determine that the user is properly holding the device of Baym in a stationary manner against the skin, as disclosed by Fouche, prior to unlocking the device to ensure that the injector is being properly operated in the prescribed manner to inject medicament into the skin and is not accidentally moved prior to or during injection which would lead to less effective injection.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2014/0322683 (“Baym”) in view of WO 2013/065055 (“Nimrod”) and U.S. Publication No. 2002/0188419 (“Slate”) as applied above, and further in view of U.S. Publication No. 2017/0266370 (“Cerman’).
Regarding Claim 14 and 15, Baym, as modified, discloses the invention substantially as claimed except that the contact sensor includes a capacitive sensor which is configured to detect a successful delivery of the dose to the patient based upon a change in skin capacitance from before the injection event to after the injection event. However, the prior art describes injection devices (100) which include capacitive sensors configured to detect changes in skin capacitance responsive to an injection event (Par. 39, 67-69, 85) in order to determine a successful rejection based upon retention/migration of the medication. It would have been obvious for a person having ordinary skill in the art at the time the invention was made to configure the device of Baym to implement a capacitance sensor, as disclosed by Cerman, in order to monitor skin capacitance and determine when an injection event has successfully occurred based upon medicament migration/retention (see Cerman, Par. 15, 27, 38, 51) thereby utilizing a specific type of known contact sensor recognized by the prior art to be useful and efficacious for determining apposition between the injection device and the skin in a known and predictable manner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 12/31/2025