DETAILED ACTION
Status of Claims
This action is in reply to the application filed on 26 April, 2024.
Claims 1 - 17 have been cancelled, and Claims 18 – 36 have been added by a preliminary amendment filed on 13 May, 2024.
Claims 18 – 36 are currently pending and have been examined.
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 Interpretation
Claims 18 – 31, represented by independent claims 18 and 27, recite limitations that encompass an abstract mental process including determining if a user is authorized to operate a drug delivery device based on a prescription of
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.
Claims 18 – 31 and 34 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 18, 27, 30 and 34 determine whether a user is authorized based on information indicative of a prescription of a drug to a patient. It is unclear that the user and the patient are the same person – any patient will do. Here, Examiner recognizes that the user may NOT be the patient, for example a healthcare provider may be the user administering a drug to a patient using the dispensing device. Nonetheless, the claims imply, and Claim 33 expressly recites that the drug delivery device is “for self-administration”. For purposes of this examination, Examiner assumes that the user is the patient. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 18 – 21, 23, 27, 28 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Valentine: (US PGPUB 2021/0093515 A1)
CLAIMS 1, 27 and 30
Valentine discloses a drug dispensing device that includes the following limitations:
A method performable with an electronic device in order to communicate with a drug delivery device, (Valentine Abstract, 0006, 0033), the method comprising:
determining whether a user of the electronic device is authorized to operate the drug delivery device based on first information and second information, wherein: the first information is indicative of a prescription of a drug to a patient, and the second information is indicative of the drug the drug delivery device is foreseen to dispense; (Valentine 0005, 0009, 0026, 0053); and
generating an output signal to be communicated to the drug delivery device in order to enable changing an operational state of the drug delivery device if the user is determined to be authorized to use the drug delivery device; (Valentine 0002, 0010, 0011, 0022, 0037, 0053, 0059).
Valentine discloses a method performed on an electronic device – an app controlled drug dispenser interface – that is resident on an interface device such as a smartphone, computer, tablet, etc. The app is used for authorizing the use of a separate, communicatively connected, drug dispensing device, based on information about the prescription and information about the particular drug contained in the delivery device. A drug dispensing algorithm determines if the user is authorized, and if authorized, the electronic device outputs a signal to the dispensing device to enable dispensing.
With respect to Claims 27 and 30, Valentine further discloses the following limitations:
An electronic device comprising one or more processors and one or more non- transitory computer readable media comprising instructions that, when executed by the one or more processors, cause the one or more processors to perform operations; (Valentine 0006, 0015, 0026, 0033, 0052, 0106);
One or more non-transitory computer readable media storing instructions that, when executed by an electronic device, cause the electronic device to perform the method according to claim 18; (Valentine 0026, 0052).
CLAIMS 19 – 21, 23 and 28
Valentine the limitations above relative to Claim 18. Additionally, Valentine discloses the following limitations:
the first information is extracted from a first signal transmitted from an external device to the electronic device, and the second information is extracted from a second signal transmitted from the drug delivery device to the electronic device; (Valentine 0005, 0037, 0053, 0106).
at least one of the first signal or the second signal is authenticated before generating the output signal, and/or at least one of the first signal or the second signal is cryptographically secured, wherein extracting the first information and/or second information comprises decrypting at least one of the first signal or the second signal; (Valentine 0026).
at least one of the first signal or the second signal is a wirelessly transmitted signal; (Valentine 0033, 0109);
the first signal is a Long Range Communication signal and/or is transmitted via a cloud service; (Valentine 0033);
Valentine discloses receiving prescription information from the pharmacy system and drug delivery device information from the device itself, including authentication techniques. Valentine uses Bluetooth (i.e. wireless) communication or other close proximity communication (i.e. NFC), or communication over the Internet (i.e. long-range communication). Valentine controls power to the dispenser, configured to hold drug packages.
Claims 32, 33, 35 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bureau at al.: (US PGPUB 2015/0201880 A1).
CLAIM 32
Bureau discloses a drug injection system that includes the following limitations:
A drug delivery device comprising: a mechanism unit configured to be operatively coupled with a drug reservoir unit, wherein: the mechanism unit is configured to enable a dispense process for dispensing a drug; (Bureau Abstract, 0058, 0070, 0073, 0075, 0083);
the mechanism unit comprises an arrangement for changing an operational state of the mechanism unit, the mechanism unit comprises a communication component for receiving an output signal transmitted from an electronic device to the drug delivery device, and the mechanism unit is configured such that operation of the arrangement in order to change the operational state of the mechanism unit is prevented unless an output signal from the electronic device is received via the communication component; (Bureau 0014, 0021, 0091).
Bureau discloses an integrated injection system that includes a drug delivery device configured to enable a dispense process for dispensing a drug. The drug delivery device comprises a pump operatively coupled to a drug reservoir. Bureau teaches an activator for engaging a drive mechanism that is triggered by receiving a signal from an external smartphone, (i.e. an output signal transmitted from an electronic device to the drug delivery device). Dispensing is prevented by a mechanical stopper that is broken by force of the fluid being dispensed after activation.
CLAIM 33
Bureau discloses the limitations above relative to Claim 32. Additionally, Bureau discloses the following limitations:
wherein the drug delivery device is a device for self-administration; (Bureau 0070);
the arrangement comprises an electromechanical actuator, and operation of the arrangement for changing the operational state comprises operation of the electromechanical actuator; (Bureau 0014, 0021, 0091).
Bureau discloses injection devices where the user performs the injection (i.e. self-administration). Bureau teaches an activator for engaging a drive mechanism (i.e. an electromechanical actuator), that is triggered by receiving a signal from an external smartphone. Dispensing is prevented by a mechanical stopper that is broken by force of the fluid being dispensed after activation.
CLAIM 35
Bureau discloses the limitations above relative to Claim 32. Additionally, Bureau discloses the following limitations:
wherein the drug delivery device is configured to retain a drug container with a drug or comprising a drug container with a drug; (Bureau 0012, 0021, 0075).
Bureau teaches an integrated injection device system that includes a drug delivery device in the form of an injection device that houses a drug reservoir.
CLAIM 36
Bureau discloses the limitations above relative to Claim 32. Additionally, Bureau discloses the following limitations:
wherein the mechanism unit comprises a dispense mechanism for dispensing a drug dose, wherein the dispense mechanism comprises an energy member, wherein the energy member is configured to provide energy for moving a plunger rod in distal direction; (Bureau 0075).
Bureau teaches an integrated injection device system that includes a plunger type part that pushes the liquid from a drug reservoir.
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.
Claims 22, 24 – 26, 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Valentine: (US PGPUB 2021/0093515 A1) in view of Bureau et al.: (US PGPUB 2015/0201880 A1)
CLAIMS 22, 24 and 26
Valentine the limitations above relative to Claim 18. With respect to the following limitations:
the second signal is a Near Field Communication signal; (Bureau 0058, 0061);
generating a power signal in order transfer energy to the drug delivery device via induction; (Bureau 0058, 0060, 0061)
wherein the drug delivery device is an injection device; (Bureau 0009, 0011.
Valentine discloses a drug delivery device, but does not expressly disclose an injection device. Valentine discloses Bluetooth or similar close proximity communication protocols (@ Claim 15), but does not expressly disclose NFC communication. Similarly, Valentine discloses generating a power signal for activating the device, (Valentine 0025), but does not disclose energy transfer via induction. Initially, Examiner asserts that each of these recited features are well-known; nonetheless, Examiner relies on Bureau. Bureau teaches an integrated injection device system that includes a drug delivery device in the form of an injection device, in electronic communication with a communication device such as a smartphone. Communication maybe via NFC. Bureau teaches that power to the injection device may be provided by the smartphone via magnetic induction. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the drug delivery device of Valentine so as to have included injection devices, NFC communication and inductive charging in accordance with the teaching of Bureau, in order to allow for control the activation of a drug injection device.
CLAIM 29
Valentine the limitations above relative to Claim 27. Additionally, Valentine discloses the following limitation:
at least one Long Range Communication component; (Valentine 0033).
Valentine discloses an application resident on a smartphone that provides communication over the Internet (i.e. long-range communication).
With respect to the following limitations:
at least one Near Field Communication component; (Bureau 0058, 0061);
an inductive charging component; (Bureau 0058, 0060, 0061).
Valentine discloses Bluetooth or similar close proximity communication protocols (@ Claim 15), but does not expressly disclose NFC communication. Similarly, Valentine discloses generating a power signal for activating the device, (Valentine 0025), but does not disclose energy transfer via induction. Initially, Examiner asserts that each of these recited features are well-known. Nonetheless, Bureau teaches an integrated injection device system that includes a drug delivery device in the form of an injection device, in electronic communication with a communication device such as a smartphone. Communication maybe via NFC. Bureau teaches that power to the injection device may be provided by the smartphone via magnetic induction. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the drug delivery device of Valentine so as to have included injection devices, NFC communication and inductive charging, in accordance with the teaching of Bureau, in order to allow for control the activation of a drug injection device.
CLAIM 31
Valentine the limitations above relative to Claim 30. With respect to the following limitation:
wherein the drug delivery device is configured to retain a drug container with a drug or comprising a drug container with a drug; (Bureau 0012, 0021, 0075).
Valentine discloses a dispenser that dispenses liquid medications on a dose-by-dose basis (@ 0007), but does not expressly disclose retaining a drug container. Bureau teaches an integrated injection device system that includes a drug delivery device in the form of an injection device that houses a drug reservoir. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the drug delivery device of Valentine so as to have included a drug reservoir, in accordance with the teaching of Bureau, in order to allow for refills.
CLAIM 25
Valentine the limitations above relative to Claim 18. With respect to the following limitation:
the change of the operational state is associated with a mechanical change in a mechanism unit of the drug delivery device, and the change of the operational state is a change between a state where setting a drug dose and/or dispensing a drug dose is prevented and a state where setting a drug dose and/or dispensing a drug dose is enabled; (Bureau 0014, 0021, 0091).
Valentine discloses that the dispenser may be “Locked” until the application unlocks it, (@ 0011, 0034), but does not expressly disclose a mechanical mechanism. Bureau teaches an integrated injection device system that includes a drug delivery device in the form of an injection device including an activator for engaging a drive mechanism (i.e. a mechanical mechanism), that is triggered by a signal from the external smartphone. Dispensing is prevented by a mechanical stopper that is broken by force of the fluid being dispensed after activation. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the drug delivery device of Valentine so as to have included a mechanical lock, in accordance with the teaching of Bureau, in order to prevent unauthorized dispensing.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Bureau et al.: (US PGPUB 2015/0201880 A1) in view of Valentine: (US PGPUB 2021/0093515 A1)
CLAIM 34
Bureau discloses the limitations above relative to Claim 32. With respect to the following limitations:
determining whether a user of the electronic device is authorized to operate the drug delivery device based on first information and second information, wherein: the first information is indicative of a prescription of a drug to a patient, and the second information is indicative of the drug the drug delivery device is foreseen to dispense; (Valentine 0005, 0006, 0009, 0026, 0033, 0053); and
generating an output signal to be communicated to the drug delivery device in order to enable changing an operational state of the drug delivery device if the user is authorized to use the drug delivery device; (Valentine 0002, 0010, 0011, 0022, 0037, 0053, 0059).
Bureau discloses activating a drug delivery device based on a signal for an electronic communication device (@ 0014, 0021), but does not expressly disclose generating a signal to activate the drug delivery device based on the user being authorized. Valentine discloses a method performed on an electronic device – an app controlled drug dispenser interface – that is resident on an interface device such as a smartphone, computer, tablet, etc. The app is used for authorizing the use of a separate, communicatively connected, drug dispensing device, based on information about the prescription and information about the particular drug contained in the delivery device. A drug dispensing algorithm determines if the user is authorized, and if authorized, the electronic device outputs a signal to the dispensing device to enable dispensing. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the injection system of Bureau so as to have included generating an activation signal only if the user is authorized, in accordance with the teaching of Valentine, in order to allow for control the activation of a drug injection device.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PGPUB 2020/0030531 A1 to Day et al. discloses a drug delivery device including an electro-mechanical lockout mechanism.
US PGPUB 2020/0224964 A1 to Alexander et al. discloses an injection device into which a drug container can be inserted. Power for charging a battery may be provided by induction.
US PGPUB 2021/0313838 A1 to Spinella discloses an injection device including power for charging a battery may be provided by induction.
US PGPUB 2022/0016339 A1 to Calasso et al. discloses a drug delivery device comprising an injection device that is activated by energy transfer using induction.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
Official replies to this Office action may now be submitted electronically by registered users of the EFS-Web system. Information on EFS-Web tools is available on the Internet at: http://www.uspto.gov/patents/process/file/efs/guidance/index.jsp. An EFS-Web Quick-Start Guide is available at: http://www.uspto.gov/ebc/portal/efs/quick-start.pdf.
Alternatively, official replies to this Office action may still be submitted by any one of fax, mail, or hand delivery. Faxed replies should be directed to the central fax at (571) 273-8300. Mailed replies should be addressed to “Commissioner for Patents, PO Box 1450, Alexandria, VA 22313-1450.” Hand delivered replies should be delivered to the “Customer Service Window, Randolph Building, 401 Dulany Street, Alexandria, VA 22314.”
/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date: 3 September, 2026
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