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 .
This office action is in response to applicant’s communication of 12/09/2024. Currently claims 20-39 are pending and rejected below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/09/2024 is being considered by the examiner.
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) 20-22, 24-39 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Reisenhus (US 2019/0298932 A1).
Reisenhus discloses a user equipment comprising: an electronic control unit (Reisenhu “external control device”); an equipment signaling unit (see para [0010], [0060]); and a wireless communication unit (Reisenhu “communication means”) operatively connected to the electronic control unit,wherein the electronic control unit is configured to:control an operation of the wireless communication unit(see para [0010], the wireless communication unit being configured to determine at least one characteristic associated with at least one component of a drug delivery device,evaluate the determined at least one characteristic, and based on a result of evaluating the determined at least one characteristic, issue, or determine whether to issue, one or more control unit commands(see para [0016]-[0017]), wherein the one or more control unit commands comprise commands configured to:cause the equipment signaling unit to present information relating to the drug delivery device to a user, the information being based on the determined at least one characteristic, and/or cause the wireless communication unit to send a system command to the drug delivery device (see para [0025]).
Concerning claim 21 and user equipment of the user equipment of wherein the electronic control unit is configured to determine, based on the result of evaluating the determined at least one characteristic (see para [0010]), whether the wireless communication unit should send at least one unlock command as the system command to the electronic system to unlock at least one usability function of the drug delivery device, andwherein the user equipment is configured to send the at least one unlock command when the result of the evaluation is that the determined at least one characteristic meets at least one predetermined criterion (see para [0016]-[0017]).
Concerning claim 22 and the user equipment is a wearable device (see para [0061]),.
Concerning claim 24 and the determined at least one characteristic comprises a distance between, or a proximity of, the at least one component of the drug delivery device and the user equipment (see para [0015]).
Concerning claim 25 and evaluating the determined at least one characteristic comprises determining whether the component or the entire drug delivery device is within a predetermined distance of the user equipment, andwherein, only when the component or the drug delivery device is within the predetermined distance, an unlock command is sent as the system command to unlock at least one usability function of the drug delivery device (see para [0015]-[0017]).
Concerning claim 26 and the user equipment is configured to use an ultra-wide band (UWB) distance measurement to determine the distance between the at least one component of the drug delivery device and the user equipment or the proximity of the drug delivery device and the user equipment (see para [0061] and use of app and smartphone technologies with examiner is of the position is a form of ultra wide band).
Concerning claim 27 and the determined at least one characteristic comprises identifiers of at least two components of the drug delivery device,wherein evaluating the determined at least one characteristic comprises determining whether the at least two components of the drug delivery device are compatible with one another, andwherein the user equipment is configured to send the unlock command only when the components are compatible with one another (again see para [0015]-[0017]).
Concerning claim 28 and the user equipment is configured to determine a first identifier of a first component and a second identifier of a second component of the device in one relative position with respect to the drug delivery device (see para [0015]-[0017] and visual status pairing or initial set up procedures).
Concerning claim 29 and the equipment signaling unit is operatively connected to the electronic control unit and, on instruction by the electronic control unit, configured to indicate at least one of the following:a device identification to indicate a drug delivery device which the user should use for an upcoming medicament administration,information on a compatibility of components of the drug delivery device,a ready state of the drug delivery device, especially a state after having sent the unlock command, or a dose amount to be set in the drug delivery device for a dose delivery operation (see para [0020]-[0022]).
Concerning claim 30 and the electronic control unit is configured to issue a ready command to cause a system signaling unit, in response to the ready command, to indicate to the user that the drug delivery device is ready for commencing a dosing operation (see para [0020]-[0024]).
Concerning claim 31 Reisenhus discloses a drug delivery device, comprising a container component, the container component (113) comprising or being configured to retain a container with drug; anda mechanism component (101), the mechanism component comprising a drive mechanism for setting a dose of medicament to be delivered from the container and delivering the set dose, wherein the container component and the mechanism component are configured to releasably connect to one another, wherein the container component comprises an identifier (300/400) for being communicated to a wireless communication unit of a user equipment, and wherein the mechanism component comprises an identifier for being communicated to the wireless communication unit of the user equipment, and an electronic system comprising:a system wireless communication unit configured to wirelessly receive an unlock command from a user equipment; and a system electronic control unit operatively connected to the system wireless communication unit and configured to, in response to the unlock command,issue an activation command to activate at least one usability function of the drug delivery device (see para [0020]-[0027]).
Concerning claim 32 and activating the at least one usability function comprises switching on or revealing a dose display of the drug delivery device (see display 441).
Concerning claim 33 and activating the at least one usability function comprises unlocking a dose member of the drug delivery device, wherein the drug delivery device is configured such that the dose member, in response to the activation command, is moved relative to a housing of the drug delivery device (see add on dial member 480/490 for example).
Concerning claim 34 and the drug delivery device is configured such that the dose member, in response to the activation command, is moved axially relative to a housing of the drug delivery device from a locked or non-operating position into an operating position (see dose button 490).
Concerning claim 35 Reisenhus discloses a method for dispensing a drug to a user with the drug delivery device according to claim 31, the method comprising preparing the drug delivery device for a dosing operation by wirelessly determining at least one characteristic of at least one component of the drug delivery device and activating at least one usability function of the drug delivery device when the at least one determined characteristic meets a predefined criterion (see para [0020]-[0024]).
Concerning claim 36 and the step of activating the at least one usability function comprises switching on or revealing a dose display of the drug delivery device (see 441 display and functions).
Concerning claim 37 and dispensing the drug to the user from the container component (again see para [0020]-[0024]).
Concerning claim 38 Reisenhus discloses the step of wirelessly determining at least one characteristic of at least one component of the drug delivery device is performed by a user equipment comprising an electronic control unit (Reisenhu “external control device”);an equipment signaling unit(see para [0010], [0060]);; and a wireless communication unit (Reisenhu “communication means”) operatively connected to the electronic control unit,wherein the electronic control unit is configured to:control an operation of the wireless communication unit, the wireless communication unit being configured to determine at least one characteristic associated with at least one component of a drug delivery device, evaluate the determined at least one characteristic, and based on a result of evaluating the determined at least one characteristic, issue or determine whether to issue one or more control unit commands, wherein the one or more control unit commands comprise commands configured to: cause an equipment signaling unit of the user equipment to present information relating to the drug delivery device to a user, the information being based on the determined at least one characteristic, and/or cause the wireless communication unit to send a system command to an electronic system of or for the drug delivery device (again see para [0020]-[0024]).
Concerning claim 39 Reisenhus discloses one or more non-transitory computer readable storage media storing machine- readable code (see paras [0010], [0019] that, when executed by an electronic control unit of a user equipment that comprises an electronic control unit (Reisenhu “external control device”); and a wireless communication unit (Reisenhu “communication means”) operatively connected to the electronic control unit, causes the electronic control unit to perform the following operations:controlling an operation of the wireless communication unit, the wireless communication unit being configured to determine at least one characteristic associated with at least one component of a drug delivery device;evaluating the determined at least one characteristic; andbased on a result of evaluating the determined at least one characteristic, issuing or determining whether to issue one or more control unit commands, wherein the one or more control unit commands comprise commands configured to:cause an equipment signaling unit of the user equipment to present information relating to the drug delivery device to a user, the information being based on the determined at least one characteristic, and/or cause the wireless communication unit to send a system command to an electronic system of or for the drug delivery device (again see para [0020]-[0024]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reisenhus (US 2019/0298932 A1).
Reisenhus discloses the claimed invention except the wearable device is a smart watch. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the wearable device a smart watch since it was known in the art that smartwatches and smartphones are often carried by the user on the body and on the wrist via a strap or band. They also both share app and functionality with one another. It is examiner’s position that a PHOSITA would know that the display and control may be any wearable computing device such as a smartwatch similar to a smartphone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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