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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 11-18 are directed to a method (i.e., a process), claims 1-10 are directed to a system (i.e., a machine), and claims 19 & 20 are directed to a non-transitory machine-readable medium (i.e., a machine). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Step 2A - Prong One:
Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts.
Representative independent claim 11 includes limitations that recite at least one abstract idea. Specifically, independent claim 11 recites:
11. A machine-implemented method for automatic transferring infusion parameters between infusion devices, comprising, under the control of one or more electronic devices: identifying that a new infusion device moved into a predetermined area associated with an active infusion device based on signals transmitted between the new and active infusion devices, the active infusion device currently performing an ongoing infusion of a medication to a patient; determining, responsive to identifying the new infusion device moving into the predetermined area with the active infusion device, that an orientation of the new infusion device is indicative of the new infusion device arriving to replace or supplement the active infusion device; responsive to determining the orientation, automatically programming the new infusion device with settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient, without user input of the settings; and activating the new infusion device to initiate a new infusion or to continue the ongoing infusion of the medication based on the automatically programmed settings.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity” because identifying that a new infusion device moved into a predetermined area associated with an active infusion device; performing an ongoing infusion of a medication to a patient; determining, responsive to identifying the new infusion device moving into the predetermined area with the active infusion device, that an orientation of the new infusion device is indicative of the new infusion device arriving to replace or supplement the active infusion device; responsive to determining the orientation, programming the new infusion device with settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient; and activating the new infusion device to initiate a new infusion or to continue the ongoing infusion of the medication based on the settings amount to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions), at the currently claimed high level of generality.
Accordingly, the claim recites at least one abstract idea.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 11, and 19, as drafted, is a process that, under its broadest reasonable interpretation, covers certain methods of organizing human activity but for the recitation of generic computer components. That is, other than reciting one or more electronic devices, infusion devices, one or more processors, a non-transitory machine-readable medium, and an electronic device to perform the limitations, nothing in the claim elements precludes the steps from practically being certain methods of organizing human activity. If a claim limitation, under its broadest reasonable interpretation, covers certain methods of organizing human activity but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the one or more electronic devices, infusion devices, one or more processors, non-transitory machine-readable medium, and an electronic device are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of transmitting signals, identifying data, determining data, programming, and activating) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05). Their collective functions merely provide conventional computer implementation.
Claims 2-10, 12-18, and 20 are ultimately dependent from Claim(s) 1, 11, and 19 and include all the limitations of Claim(s) 1, 11, and 19. Therefore, claim(s) 2-10, 12-18, and 20 recite the same abstract idea. Claims 2-10, 12-18, and 20 describe further limitations regarding identify the new care area for the new infusion device; determine infusion pump parameters associated with the new care area; program the new infusion device with the infusion pump parameters associated with the new care area responsive to determining the orientation; wherein the infusion pump parameters include one or more hard or soft limits on one or more infusion settings corresponding to the settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient; determine that the new infusion device is authorized for the new care area; determine that one or more parameters associated with the new infusion device are restricted from being used in the new care area; providing a request to confirm override of on the restriction; receiving a confirmation to override the restriction; programming, responsive to receiving the confirmation, the new infusion device administer the medication in the new care area according to the one or more parameters without the restriction; detecting a distance and a motion; matching the distance and motion to a predetermined pattern; identify a third infusion device in the predetermined area; determining the distance and motion is more aligned with replacing or supplementing the active infusion device than the third infusion device; confirmation to program the new infusion device with parameters for the patient; wherein the settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient are automatically transferred; and identify the new and active infusion devices in the predetermined area and configured to determine the orientation of the new infusion device. These are all just further describing the abstract idea recited in claims 1, 11, and 19, without adding significantly more. In particular, the user interface, locator device, server, and memory are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of displaying data, prompting, identifying/determining data, and transferring data) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, independent claims 1, 11, and 19 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitations directed to signals transmitted between devices, all of which the Examiner submits merely add insignificant extra-solution activity to the abstract idea or are claimed in a merely generic manner (e.g., at a high level of generality), the Examiner further submits that such steps are not unconventional as they merely consist of receiving and transmitting data over a network. See MPEP 2106.05(d)(II).
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
Therefore, claims 1-20 are ineligible under 35 USC §101.
Claim Objections
Claim 11 is objected to because of the following informalities: change “the control” to “control” at line 2. Appropriate correction is required.
Claims 8 and 18 are objected to because of the following informalities: change “parameters for the patient” to “the parameters for the patient” in the last line of the claims. Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 9, 10, 11, and 19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bazargan et al. (WO 2021/262475 A1).
(A) Referring to claim 1, Bazargan discloses A system comprising: one or more processors configured to (see abstract of Bazargan):
identify that a new infusion device moved into a predetermined area associated with an active infusion device based on signals transmitted between the new and active infusion devices, the active infusion device currently performing an ongoing infusion of a medication to a patient (para. 108, 114, 59, and 23 of Bazargan; prior to establishing the communication link (e.g., concurrently with task 92, task 94, or task 95), the one or more processors may obtain third biometric data derived from the one or more sensor signals generated by the one or more sensors of the first device. For increased security, the third biometric data may be different from the first biometric data (e.g., the first and third biometric data may correspond to different time periods, different features of the one or more sensor signals, and/or different sensors altogether). Furthermore, upon determining (e.g., automatically) that the first device is being removed from service, the one or more processors may advertise the third biometric data to any nearby devices (e.g., any devices in a predetermined area local to the one or more processors). For instance, upon being placed into service, the replacement medical device (e.g., an insulin delivery device or a continuous glucose monitoring device) may generate biometric data. The replacement medical device may advertise (e.g., based on a short-range wireless transmission capable of being received by any nearby devices) the biometric data, which can be compared with biometric data generated by the in-use medical device to determine whether the in-use medical device and the replacement medical device are/were associated with (e.g., attached to or otherwise worn by) the same patient. If so, a wireless network connection may be automatically established, for example, to transfer patient-specific configuration data from the in-use medical device to the replacement medical device.);
determine, responsive to identifying the new infusion device moving into the predetermined area with the active infusion device, that an orientation of the new infusion device is indicative of the new infusion device arriving to replace or supplement the active infusion device (para. 23, 59, and 63 of Bazargan; upon being placed into service, the replacement medical device (e.g., an insulin delivery device or a continuous glucose monitoring device) may generate biometric data. Examples of biometric data include movement data (e.g., from an inertial measurement sensor such as an accelerometer or a gyroscope), glucose level readings (e.g., from a glucose sensor), skin temperature data (e.g., from a skin temperature sensor), and/or other measurement data obtained from one or more sensors. The replacement medical device may advertise (e.g., based on a short-range wireless transmission capable of being received by any nearby devices) the biometric data, which can be compared with biometric data generated by the in-use medical device to determine whether the in-use medical device and the replacement medical device are/were associated with (e.g., attached to or otherwise worn by) the same patient. If so, a wireless network connection may be automatically established, for example, to transfer patient-specific configuration data from the in-use medical device to the replacement medical device. The replacement device may determine it is being placed into service based on accelerometer data indicative of placement on the body of a user. For example, durable portion 32 may include an accelerometer configured to generate signals that can be processed to determine movement that is consistent with walking and/or to synthesize a biometric profile (e.g., based on a user’s gait).);
responsive to determining the orientation, automatically program the new infusion device with settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient, without user input of the settings (para. 23 of Bazargan; upon being placed into service, the replacement medical device (e.g., an insulin delivery device or a continuous glucose monitoring device) may generate biometric data. Examples of biometric data include movement data (e.g., from an inertial measurement sensor such as an accelerometer or a gyroscope), glucose level readings (e.g., from a glucose sensor), skin temperature data (e.g., from a skin temperature sensor), and/or other measurement data obtained from one or more sensors. The replacement medical device may advertise (e.g., based on a short-range wireless transmission capable of being received by any nearby devices) the biometric data, which can be compared with biometric data generated by the in-use medical device to determine whether the in-use medical device and the replacement medical device are/were associated with (e.g., attached to or otherwise worn by) the same patient. If so, a wireless network connection may be automatically established, for example, to transfer patient-specific configuration data from the in-use medical device to the replacement medical device.); and
activate the new infusion device to initiate a new infusion or to continue the ongoing infusion of the medication based on the automatically programmed settings (para. 23, 33, and 42 of Bazargan; insulin pump 14 may be configured to operate in accordance with user-specific configuration data to delivery insulin to patient 12.).
(B) Referring to claim 9, Bazargan discloses further comprising the new infusion device and the active infusion device, wherein the signals are transmitted between the new and active infusion devices, and wherein the settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient are automatically transferred from a memory of the active infusion device to a memory of the new infusion device (para. 58 & 59 of Bazargan).
(C) Referring to claim 10, Bazargan discloses wherein the one or more processors comprise a server located remote from the new and active infusion devices, the system further comprising: a locator device configured to identify the new and active infusion devices in the predetermined area and configured to determine the orientation of the new infusion device (Fig. 1, para. 47, 104, 108, 59, and 63 of Bazargan).
(D) Claims 11 and 19 differ from claim 1 by reciting “A machine-implemented method for automatic transferring infusion parameters between infusion devices, comprising, under the control of one or more electronic devices…“ (para. 23 & 24 of Bazargan; a wireless network connection may be automatically established, for example, to transfer patient-specific configuration data from the in-use medical device to the replacement medical device) and “A non-transitory machine-readable medium having instructions stored thereon that, when executed by an electronic device, causes the electronic device to perform a method comprising…“ (para. 131 of Bazargan; the functions may be stored on, as one or more instructions or code, a computer- readable medium and executed by a hardware-based processing unit. Computer-readable media may include computer-readable storage media forming a tangible, non-transitory medium. Instructions may be executed by one or more processors).
The remainder of claims 11 and 19 recite substantially the same limitations as claim 1, and are therefore rejected for the same reasons given above.
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) 2-4, 12-14, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bazargan et al. (WO 2021/262475 A1) in view of Borges et al. (US 2014/0278458 A1).
(A) Referring to claim 2 and similar claim 12, Bazargan does not disclose wherein the predetermined area is at least part of a new care area different than a care area in which the new infusion device was last programmed, wherein the one or more processors are further configured to: identify the new care area for the new infusion device; determine infusion pump parameters associated with the new care area; and automatically program the new infusion device with the infusion pump parameters associated with the new care area responsive to determining the orientation.
Borges discloses wherein the predetermined area is at least part of a new care area different than a care area in which the new infusion device was last programmed, wherein the one or more processors are further configured to: identify the new care area for the new infusion device (para. 15-20 of Borges); determine infusion pump parameters associated with the new care area (para. 12, 19, and 20 of Borges); and automatically program the new infusion device with the infusion pump parameters associated with the new care area responsive to determining the orientation (para. 39-44 of Borges).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Borges within Bazargan. The motivation for doing so would have been to improve management of infusions of drugs, fluids, and the like as a patient is transitioned between different care areas (para. 1 of Borges).
(B) Referring to claims 3 and 13, Bazargan does not disclose wherein the infusion pump parameters include one or more hard or soft limits on one or more infusion settings corresponding to the settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient.
Borges discloses wherein the infusion pump parameters include one or more hard or soft limits on one or more infusion settings corresponding to the settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient (para. 3 & 4 of Borges).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Borges within Bazargan. The motivation for doing so would have been for improvement in the safety and clinical utility of infusing intravenous drugs and fluids (para. 3 of Borges).
(C) Referring to claim 4 and similar claim 14, Bazargan discloses wherein the one or more processors are further configured to: determine that the new infusion device is authorized for the new care area before automatically programming the new infusion device (para. 104-108 of Bazargan).
(D) Referring to claim 20, Bazargan does not disclose wherein the predetermined area is at least part of a new care area different than a care area in which the new infusion device was last programmed, wherein the method further comprises: identify the new care area for the new infusion device; determine infusion pump parameters associated with the new care area, wherein the infusion pump parameters include one or more hard or soft limits on one or more infusion settings corresponding to the settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient; and automatically program the new infusion device with the infusion pump parameters associated with the new care area responsive to determining the orientation.
Borges discloses wherein the predetermined area is at least part of a new care area different than a care area in which the new infusion device was last programmed, wherein the method further comprises: identify the new care area for the new infusion device (para. 15-20 of Borges); determine infusion pump parameters associated with the new care area (para. 12, 19, and 20 of Borges), wherein the infusion pump parameters include one or more hard or soft limits on one or more infusion settings corresponding to the settings currently being used by the active infusion device in the ongoing infusion of the medication to the patient (para. 3 & 4 of Borges); and automatically program the new infusion device with the infusion pump parameters associated with the new care area responsive to determining the orientation (para. 39-44 of Borges).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Borges within Bazargan. The motivation for doing so would have been to improve management of infusions of drugs, fluids, and the like as a patient is transitioned between different care areas (para. 1 of Borges).
Claim(s) 5 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bazargan et al. (WO 2021/262475 A1) in view of Borges et al. (US 2014/0278458 A1), and further in view of Kamen et al. (US 2021/0365849 A1).
(A) Referring to claim 5 and similar claim 15, Bazargan and Borges do not expressly disclose wherein the one or more processors are further configured to: determine that one or more parameters associated with the new infusion device are restricted from being used in the new care area; and providing, for display on the new infusion device, a request to confirm override of on the restriction; receiving a confirmation to override the restriction; and programming, responsive to receiving the confirmation, the new infusion device administer the medication in the new care area according to the one or more parameters without the restriction.
Kamen discloses wherein the one or more processors are further configured to: determine that one or more parameters associated with the new infusion device are restricted from being used in the new care area (para. 549, 439, 461, 427, 495, and 507 of Kamen); and providing, for display on the new infusion device, a request to confirm override of on the restriction (para. 461 of Kamen); receiving a confirmation to override the restriction (para. 461 of Kamen); and programming, responsive to receiving the confirmation, the new infusion device administer the medication in the new care area according to the one or more parameters without the restriction (para. 461-464 of Kamen).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Kamen within Bazargan and Borges. The motivation for doing so would have been to help to ensure that correct information is entered (para. 787 of Kamen).
Free of Prior Art
Dependent claims 6 and 16 are free of prior art. As such, claims 7, 8, 17, and 18 are also free of prior art, through dependency.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches a syringe for delivering medications to implanted drug delivery systems and methods for use thereof (US 2019/0117883 A1); wirelessly configurable medical device for a broadcast network system (US 2010/0234708 A1); and automatic device configuration via a network service (US 2022/0036992 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENA NAJARIAN whose telephone number is (571)272-7072. The examiner can normally be reached Monday - Friday 9:30 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687