DETAILED ACTION
This action is in reference to the communication filed on 7 JAN 2025.
Claims 1-15 appear to be previously canceled, claims 16-30 have been added.
Claims 16-30 are present and have been examined.
Claim Rejections - 35 USC § 101
Claim 26 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319 (Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. § 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation “non-transitory” to the claim. Cf. Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation “non-human” to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. § 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998). 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)(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.
Claim(s) 16-19, 21-25 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Brukalo et al (US 20140113553 A1, hereinafter Brukalo).
In reference to claim 16, 27:
Brukalo teaches: A method of a receiver of associating a designated user with a medicament delivery device configured to communicate a medicament delivery event wirelessly to the receiver (at least [fig 1, 2 and related text], comprising:
and a receiver configured toa associate a designated user with a medicament delivery device configured to communicate a medicament delivery event wireless to the receiver, the receiver comprising a processing unit and a memory (at least [fig 1, 2 and related text] , said memory containing instructions operable by said processing unit whereby the receiver is operative to:
receiving a wireless signal identifying a medicament delivery device communicating a medicament delivery event (at least [0064] “Remote controller 200 can send commands to infusion pump 300 to dispense a fluid or medication for a pre-determined time period, rate, and/or volume. In one exemplary embodiment, a user may select from a menu of basal programs that have been programmed on infusion pump 300. In another embodiment, the user may more specifically set a basal rate, a bolus dose, and a combination thereof may be programmed as commands to infusion pump 300 from remote controller 200. Remote controller 200 can receive data from infusion pump 300 such as the status of the dispensing of medication (e.g. the dispense rate, amount of medication remaining in infusion pump 300, or the proportion of medication delivered based on the amount programmed).”);
acquiring information indicating whether or not at least one neighbouring receiver also has received a wireless signal identifying said medicament delivery device communicating the medicament delivery event (at least [fig 12 and related text including [0074] “Confirm 642 is a command that allows the user to confirm RF connection between infusion pump 300 and a paired device, such as remote controller 200. If a pairing search is under way, confirm 642 displays a cancel command, in case the user wants to cancel the pairing search. If confirm 642 displays a confirm command, and it is not executed by the user, the pairing between infusion pump 300 and remote controller 200 is rejected. This allows a user to reject pairing with the wrong device, such as someone else's infusion pump.” i.e. ); and if not:
determining that the identified medicament delivery device was used by the designated user for causing the medicament delivery event (at least [0062] “Both remote controller 200 and infusion pump 300 have a unique identification code embedded in their respective first RF module 218 and second RF module 322. This is desirable because under certain conditions, a second user with a second infusion pump 300 may be in close proximity to the first user. It would be undesirable for the first user's remote controller 200 to communicate with the second user's infusion pump 300. In order to avoid such a scenario, a user must initiate a pairing protocol before using infusion pump 300 for the first time.”).
In reference to claim 17, 28:
Brukalo further teaches: wherein if the acquired information indicates that a wireless signal identifying said medicament delivery device has been received at said at least one neighboring receiver, the method further comprises:
requesting a confirmation from the designated user indicating whether or not the user triggered the medicament delivery event, wherein it is determined that the identified medicament delivery device was used by the designated user for causing the medicament delivery event if a confirmation is received from the user in response to the request (at least [fig 7 and related text] “Once a device is found, remote setup screen 634 is displayed, the channel over which RF communication occurs is displayed in channel 638, and the user is prompted to confirm paired remote 640 using confirm 642. Once paired remote 640 is confirmed using confirm 642, remote setup screen 644 is displayed. Remote setup screen 644 includes paired remote 646 and next 648. By highlighting next 648 and pressing second OK button 314, display 316 displays local infusion pump home screen 650.”).
In reference to claim 18 29:
Brukalo further teaches: wherein the requesting and receiving of the confirmation is effected over a user interface of the receiver (at least [fig 7 and related text] “Once a device is found, remote setup screen 634 is displayed, the channel over which RF communication occurs is displayed in channel 638, and the user is prompted to confirm paired remote 640 using confirm 642. Once paired remote 640 is confirmed using confirm 642, remote setup screen 644 is displayed. Remote setup screen 644 includes paired remote 646 and next 648. By highlighting next 648 and pressing second OK button 314, display 316 displays local infusion pump home screen 650.”)
In reference to claim 19:
Brukalo the received confirmation further comprising an identifier of the medicament delivery device for which the designated user triggered the medicament delivery event (at least [fig 7 and related text] “Once paired remote 640 is confirmed using confirm 642, remote setup screen 644 is displayed. Remote setup screen 644 includes paired remote 646 and next 648. By highlighting next 648 and pressing second OK button 314, display 316 displays local infusion pump home screen 650. Since infusion pump 300 is now paired with remote controller 200, remote control icon 652 is displayed. When remote control icon 652 is displayed, it indicates that RF is enabled, infusion pump 300 is paired with remote controller 200, and that infusion pump 300 is ready to receive commands from remote controller 200. “ – paired remote 646 includes the identifier/serial of the device, see also fig 1 and related text where elements 200/300 show a verification pairing with the numerical serial identifier)
In reference to claim 21:
Brukalo further teaches: if the acquired information indicates that a wireless signal identifying said medicament delivery device has been received at said at least one neighbouring receiver: informing the neighbouring device of the received confirmation (at least [fig 12 and related text including [074] “Confirm 642 is a command that allows the user to confirm RF connection between infusion pump 300 and a paired device, such as remote controller 200. If a pairing search is under way, confirm 642 displays a cancel command, in case the user wants to cancel the pairing search. If confirm 642 displays a confirm command, and it is not executed by the user, the pairing between infusion pump 300 and remote controller 200 is rejected. This allows a user to reject pairing with the wrong device, such as someone else's infusion pump.” i.e. notification).
In reference to claim 22 30:
Brukalo teaches: A method of a receiver of associating a designated user with a medicament delivery device configured to communicate a medicament delivery event wirelessly to the receiver (at least [figs 1, 2, and related text], comprising:
and a receiver configured toa associate a designated user with a medicament delivery device configured to communicate a medicament delivery event wireless to the receiver, the receiver comprising a processing unit and a memory (at least [fig 1, 2 and related text] , said memory containing instructions operable by said processing unit whereby the receiver is operative to:
receiving a wireless signal identifying a medicament delivery device communicating a medicament delivery event (at least [0064] “Remote controller 200 can send commands to infusion pump 300 to dispense a fluid or medication for a pre-determined time period, rate, and/or volume. In one exemplary embodiment, a user may select from a menu of basal programs that have been programmed on infusion pump 300. In another embodiment, the user may more specifically set a basal rate, a bolus dose, and a combination thereof may be programmed as commands to infusion pump 300 from remote controller 200. Remote controller 200 can receive data from infusion pump 300 such as the status of the dispensing of medication (e.g. the dispense rate, amount of medication remaining in infusion pump 300, or the proportion of medication delivered based on the amount programmed).”);
determining whether or not the identification of the medicament delivery device complies with a predetermined identification number pattern (at least [fig 6 and related text] “Paired infusion pump 552 includes the serial number of the paired infusion pump. After verifying that paired infusion pump 552 is correct, accept command 554 is highlighted and selected.” At [0062] “. When initiating the pairing protocol, remote controller 200 and infusion pump 300 exchange their unique identification code (e.g. serial number). In all subsequent wireless communications, the correct unique identification code must be established before exchanging data.” At [068] “ Device "pairing" is a process in which a master (remote controller 200) learns who its slave is (an infusion pump) and in which the slave (infusion pump) learns who its master (remote controller) is. All devices utilize suitable information identification, such as, for example, a fixed device-type serial number address, sound, or optical identifier. Preferably, the remote controller 200 holds one serial number of the infusion pump 300 that is paired with the controller 200; the infusion pump 300 stores one single master remote controller's serial number from which it will accept commands; and only one remote controller 200 and one infusion pump 300 may be paired at a time.”); and if so:
determining that the identified medicament delivery device was used by the designated user for causing the medicament delivery event (at least [0062] “Both remote controller 200 and infusion pump 300 have a unique identification code embedded in their respective first RF module 218 and second RF module 322. This is desirable because under certain conditions, a second user with a second infusion pump 300 may be in close proximity to the first user. It would be undesirable for the first user's remote controller 200 to communicate with the second user's infusion pump 300. In order to avoid such a scenario, a user must initiate a pairing protocol before using infusion pump 300 for the first time.”).
In reference to claim 23:
Brukalo further teaches: the identification of the medicament delivery device being determined to comply with a predetermined identification number pattern if the identification of the medicament delivery device follows a predetermined identification number series (at least [068] “ Device "pairing" is a process in which a master (remote controller 200) learns who its slave is (an infusion pump) and in which the slave (infusion pump) learns who its master (remote controller) is. All devices utilize suitable information identification, such as, for example, a fixed device-type serial number address, sound, or optical identifier. Preferably, the remote controller 200 holds one serial number of the infusion pump 300 that is paired with the controller 200; the infusion pump 300 stores one single master remote controller's serial number from which it will accept commands; and only one remote controller 200 and one infusion pump 300 may be paired at a time. “ at [fig 10 and related text] “ Remote infusion pump home screen 558 includes remote infusion pump home screen 586, indicating the serial number or friendly name of infusion pump 300 with which remote controller 200 is paired. By default, remote infusion pump home screen 586 includes the serial number of infusion pump 300 with which remote controller 200 is paired. The serial number displayed on remote infusion pump home screen 586 can be checked against the serial number printed on the back of infusion pump 300.”).
In reference to claim 24:
Brukalo further teaches: the identification of the medicament delivery device being determined to comply with a predetermined identification number pattern if said identification has been pre-registered with the receiver (at least [068] “ Device "pairing" is a process in which a master (remote controller 200) learns who its slave is (an infusion pump) and in which the slave (infusion pump) learns who its master (remote controller) is. All devices utilize suitable information identification, such as, for example, a fixed device-type serial number address, sound, or optical identifier. Preferably, the remote controller 200 holds one serial number of the infusion pump 300 that is paired with the controller 200; the infusion pump 300 stores one single master remote controller's serial number from which it will accept commands; and only one remote controller 200 and one infusion pump 300 may be paired at a time. “)
In reference to claim 25:
Brukalo further teaches: A computer program comprising computer-executable instructions for causing a receiver to perform steps recited in claim 16 when the computer-executable instructions are executed on a processing unit included in the receiver (at least [fig 5 and related text] “Remote controller 200 is schematically shown in FIG. 5 to further include the following functional components such as a first display (DIS) 202, a first navigational buttons (NAV) 216, a first radio frequency module (RF) 218, a blood glucose measurement (BGM) module 220, a first battery (BAT) 222, a wired communication port (COM) 224, a first alarm (AL) 226, a first microprocessor (MP) 228, a memory portion (MEM) 230, and a memory chip port (MCP) 232 as shown in FIG. 5. “).
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.
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) 20, 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brukalo in view of Finney (US 20210377726 A1).
In reference to claim 20:
Brukalo teaches all the limitations above. However, Brukalo does not specifically teach changing delivery schedules. Finney further teaches: if wireless signals are received identifying a plurality of medicament delivery devices communicating a medicament delivery event:
providing a recommendation to the designated user to change medicament delivery schedule (at least [0109, 0122] “For example, the use of time-varying broadcasts and cryptographic signatures helps reduce the risk of a patient's device associating with the wrong device. This also protects against a malicious actor trying to force a patient's non-medical device 606 to associate with another device instead of the medical device 602/604. An attacker not possessing advance knowledge of the secret keys within the medical device 602/604 cannot generate false messages that would be accepted by the patient's device. (An attacker could retransmit valid messages received via eavesdropping at a later time; the use of timestamps referenced to a shared time reference, such as an absolute clock, protects against this).” – i.e. “time varying broadcasts” would prevent the issue). Brukalo and Finney are analogous references directed at improving the connections between receiver devices and medical devices. As such, the solution of time-varying broadcasts as taught by Finney would have been an obvious one to combat the problems of cross pairing as identified as common to such medical devices as identified in both Brukalo and Finney. The time varying taught by Finney would not change the functioning of the pairing process in Brukalo, and would merely provide the option to improve said transmissions vital to provide medication delivery effectively.
In reference to claim 26:
Finney teaches: A computer program product comprising a computer readable medium, the computer readable medium having the computer program according to claim 25 embodied thereon (at least [0027, 066]). One of ordinary skill in the art would have found the computer program product taught by Finney to be an equivalent substation for the computer program product taught by Brukalo as a means to execute the claimed steps.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2021/0150462, to Leitermann discloses communications between neighboring receiving devices associated with devices associated with inventory items.
US 20210201642, to Wicks, discloses using RFID tags associated with merchandise and in communication with more than one receiver in a retail environment.
US 20210085868 to Lim discloses a means of pairing a plurality of devices for diabetes management to a plurality of other devices.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687