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(s) 21-24 is/are 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(s) 21-24, these claims create confusion as to the required, collected articles for the system. Specifically, these claims recite the “injector system” (see in reference to amended Claim 1) to comprise articles including an “auto-injector”, a “needle-free injector”, a “needle-based injector”, and a “jet injector” without actually integrating these various “injectors” into the system. Claim 1, as presented, already requires “a needle-free injector” as part of the “system” the “needle-free injector” being integrated with the “a sensor system” and “a processor” to define the “injector system” (which was originally presented as a “needle-free injector” system. As understood by the specification the “needle-free injector” (recited in Claim 1) is understood to be a specific genus (i.e. needle-based or needle-free) of injectors within a broader family (see Par. 5), while also defining a genus in which various species of injectors reside (see e.g. a needle-free “auto-injector, jet injector, or the like”). There does not appear to be any configurations which integrate together in an “injector system” a plurality of injectors (see e.g. Fig. 1).
It is unclear if Applicant is claiming the same injector twice or if Applicant is trying to assert that in order to infringe upon Claims 21-24 at least two “injectors” are required, a first injector which is the needle-free injector of Claim 1 and a second injector which is one of an “auto-injector”, a “needle-free injector”, a “needle-based injector”, or a “jet injector”.
If the injectors recited in Claims 21-24 are not the same “needle-free injector” already integrated into the system of Claim 1 it is unclear as to what degree of integration into the “system” these new injectors require for infringement to occur. Specifically, without any exposition in the claim requiring integration of these second injectors does infringement require them to be provided together in a single package? Collected together as part of a single instrument tray? Retained together in a storage room? Used together to perform a combined treatment procedure? Again, there are no specific embodiments discussed in the specification that integrated together multiple injectors.
Separately, if the “injector” of Claim 1 is to be satisfied by the injectors respectively recited in Claims 21-24 it is unclear how an injector can be simultaneously “need-free” or “needle-based” as required by Claim 23.
For the sake of prosecution it will be presumed that the newly recited “injectors” of Claims 21-24 are the same “injector” as the “needle-free injector” of Claim 1, whereby Claims 21 and 24 further limit the previously claimed “needle-free injector”, Claim 23 recites an impossible configuration by attempting to require to mutually opposed configurations for the same injector, and Claim 22 fails to further limit Claim 1 and is therefore separately rejected under 35 USC 112(d).
Examiner is reminded that the originally filed claims where directed, explicitly, to a “needle-free injector system”. While “auto-injector” and “jet injector” are held to be potential species within the genus of “needle-free injector”, a “needle-based injector” is an entirely different genus which will be held as restricted from prosecution by original presentation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 22 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1, on which Claim 22 depends, already requires the “needle-free injector” with the same level of specificity such that Claim 22 is not found to further limit the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-16 and 21-24 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 Claims 1 and 22, 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).
Regarding Claims 21 and 24, while the reference patent fails to identify the “needle-free injector” claimed as either of an “auto-injector” or “jet injector”, Examiner submits that such species are known, obvious species of need-free injection systems (see Baym – Par. 50 which describes a “jet” type auto-injector within the needle-less injector genus) and therefore fail to define and distinguish over the issued claims of the reference patent.
With respect to Claim 23, here, presuming that the “needle-based injector” is intended to replace the needleless injector previously claimed it is submitted that such species are obvious variants which make no contribution over one another.
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, 21, 22, and 24 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, 5, 21, 22, and 24, Baym discloses a needle-free injector system (110 – Par. 50) comprising:
A needle-free injector which can be embodied as a jet-type auto-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, 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 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, 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.
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 9) that “Monitoring at least one operational step for use of the agent-dispensing device in the training mode… with at least one of an accelerometer [or] gyroscopes, “as described in Baym, is different than ‘determining whether the injection even was a treatment event including a successful delivery of the dose to the patient based on the one or more signals from the gyroscope, the accelerometer, and the contact sensor during the injection event’ as required in independent claim 1…” However, this is not persuasive.
The invention of Baym is directed toward a jet-type needleless auto-injector which utilizes a sensor suite to monitor and evaluate the usage of the injector device to determine whether or not the device is used properly and that usage is authorized (Par. 91), whereby the indication of proper use is therefore indicative of successful treatment event including successful delivery of the dose as evaluated and determined by the injector. Specifically, the use sensors (410) include various sensors which provide data to the verification module that analyzes the sensor data to ensure that the received data sufficiently corresponds with the data associated with proper usage of the injector and therefore a properly conducted treatment even with delivery of the dose (see Par. 92). Baym uses this use sensor data to provide a performance score analysis (Par. 123) in order to create a test score on the patient’s use of the device where reports are collected, logged, and analyzed over a period of time to ensure maintained competency (Par. 123). The sensor system of Baym is not only used for initial training, but is incorporated into an actual “agent-dispensing device 110” (Par. 129) to “monitor proper or improper use of the agent-dispensing device 110 while the device is in at least one of the dispensing mode or the training mode”. Here “proper” use will clearly be understood as being used in a manner necessary to affect the performing of an actual treatment event in accordance with the prescribed treatment protocol.
Further modification to the invention of Baym is obviated in view of Slate which provides a similar injection device which also uses sensor arrangements (Par. 15, 48, 50 – e.g. light sensing switches to sense plunger position, vacuum sensors to confirm fluid flow, and/or current sensors to monitor motor operation) used to monitor the proper use of the injector device which includes additional, specific data analysis used especially to “determine compliance” to confirm usage of the system determine whether the injection is “valid” or “invalid” and determine “compliance” with system usage and dosing volume (Abstract; Par. 2, 6, 7, 9, 10, 11, 15, 27, 47, 50, 51). As such, 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 monitor continued competency AND compliance with the prescribed injection system utilizing various combinations of sensors known in the art (inclusive, but not necessarily exclusive to, the accelerometer and gyroscope of Baym, as well as an obvious contact sensor in view of Nimrod), to ensure that the user is operating the injector appropriately and delivering “valid” (re: successful) injections at the prescribed dosage (i.e. ensuring that the right dose is successfully determined) in a competent manner as judge by the processor. In other words, it would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize, at the minimum, the accelerometer and gyroscope of Baym and a contact sensor, as disclosed by Nimrod, to log and rate usage of the device to analyze how the injection was performed, consider to what extent this use data corresponds to proper and competent usage, how this use data corresponds to a prescribed treatment protocol (including dosing and timing) and therefore correlates this information into the determination as to whether an injection was “valid” (i.e. successful delivery of the appropriately prescribed dose in accordance with the prescribed protocol) or “invalid” (e.g. provided in a manner wherein the sensor data deviates from the expected values which would be associated with a successful delivery and therefore is considered to be demonstrative by the system of an unsuccessful injection attempt). Without providing any additional direction into the claims as to any specific algorithms or specific implementations by the system categorizes, analyzes, and evaluates the claimed sensor data the instant claims fail to define and distinguish over competency and validity data as gathered and logged by modified Baym.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 07/01/2026
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