DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The amendment and Request for Continued Examination (RCE) filed on 06/15/26 have been entered in the case. Claims 21, 23, 25-29, 31-37, 39-42 are pending for examination and claims 22, 24, 30, 38 are cancelled.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21, 23, 25-29, 31-37, 39-42 are rejected under pre-AIA 35 U.S.C. 102 (e) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Bazargan et al. (US 8,181,849).
Regarding claim 21, Bazargan discloses an apparatus 201 comprising:
a housing 202 with a mating unit (an interior space is accommodating and attaching a reservoir 10, in addition, a mating unit includes multiple components, i.e., #231, 207, or screw ..., col. 8, lines 22-46); wherein the mating unit is configured for releasably attaching to a medical device 10 for ejecting a medicament contained in the medical device 10;
one or more sensor 32 disposed within the housing for determining information related to the medical device. Note: the sensor 32 is color sensor relies on optical (light source 30). Therefore, it is fair enough to call as an optical sensor. Alternatively, a person skilled in the art would recognize that the color sensor 32 can be used as an optical sensor.
wherein the one or more optical sensor 32 comprises at least one optical/color sensor 32 configured to capture information representative of a color 12 of at least a part of the medical device, and the apparatus is configured to recognize the color of at least the part of the medical device 10 from the captured information and to determine a type of medical device (e.g., type of insulin, col. 5, lines 25-34) or a type of medicament contained in the medical device based on the recognized color of the part of the medical device (e.g., type of insulin, reservoir size, reservoir material, col. 10, lines 7-40).
Regarding claim 23, wherein the at least one optical sensor is a camera unit or a photometer (e.g., photodiode, see #3020 & 3030 in Fig. 3).
Regarding claim 25, wherein the at least one optical sensor 32 is configured to capture the information representative of the color, and the apparatus is configured to further process the captured information (via microprocessor 222), col. 9, lines 59-67, also see Fig. 3.
Regarding claim 26, wherein the at least one optical sensor 32 is configured to capture the information representative of the color, and the apparatus is configured to store the captured information (via memory), col. 3, lines 15-18, col. 10, lines 41-46.
Regarding claim 27, wherein the at least one optical sensor 32 is configured to capture the information representative of the color, and the apparatus is configured to provide the captured information to another device (e.g., remote device, external source, or other device such as a controller, or bedside monitor, col. 3, lines 51-62, col. 10, lines 32-59).
Regarding claim 28, comprising a processor 222.
Regarding claim 29, wherein the processor 222/3050 is configured to control light sources 30 comprising white and/or colored LEDs (#3020, see Fig. 3).
Regarding claim 31, wherein the processor 222/3050 is configured to control a photometer (photodiode #3020 & 3030 in Fig. 3) that is configured to determine an optical property associated with the medical device.
Regarding claim 32, wherein the optical property (marking color 12/12A-G) associated with the medical device comprises optical data indicated by a housing of the medical device, see Figs. 1-2A.
Regarding claim 33, as mentioned in the rejection of claim 21 above, wherein the processor is configured to determine the type of medical device or the type of medicament contained in the medical device based on the captured information.
Regarding claim 34, further comprising a light source which provides light of a certain wavelength or spectrum (#3030 in Fig. 3, see abstract, col. 3, lines 5-14; 27-30, 62-65, col. 9, lines 22-28, col. 10, lines 25-31.
Regarding claim 35, further comprising a wireless unit which is configured to transmit information to another device (remote device, external source, or other device such as a controller, or bedside monitor, col. 3, lines 51-62, col. 10, lines 32-59) in a wireless fashion (col. 6,lines 25-29).
Regarding claim 36, further comprising an interface configured to provide the captured information to another device via a wired or wireless connection, col. 6, lines 25-29.
Regarding claim 37, wherein the apparatus is configured to optically capture information corresponding to color codes or colors that are characteristics of different types of injection devices (e.g., type of insulin or different medications, different concentration, different size of insulin, col. 10, lines 7-17).
Regarding claims 39-40, the claims 39-40 include all claimed subject matter as required in the claims 21 & 23. Therefore, the claims 39-40 are rejected using the same analysis as noted above with regard to claims 21 & 23.
Regarding claim 41, wherein the apparatus is configured to detect a rotatable member (e.g., small motor i.e., DC, stepper, solenoid, piezoelectric, piston drive, peristaltic pump, shape memory alloy driven or other type and drive train components such as gears, screws, and levers that act in concert to convert rotational motor motion to translational displacement of a piston in a fluid reservoir, col. 6, lines 37-42)
configured to rotate relative to a housing of the medical device (e.g., convert rotational motor motion to translational displacement of a piston in a fluid reservoir, col. 6, lines 37-42; a programable controls for regulating the motor (e.g., Examiner note: the motor being rotated), as well as for setting desired dosage internal over a certain period of time, col. 6, lines 52-55; as the drive shaft 232 of the motor 203 rotates, the drive screw 204 drives the plunger slide 205 directly to obtain the axial displacement against the reservoir piston 207 to deliver the predetermined amount of medication or fluid. A gear box 250 couples the drive screw 204 to the drive shaft 232 of the motor 203. When using a DC or stepper motor, the motor can be rapidly rewound when the reservoir is emptied or as programmed by the user, col. 8, lines 47-55).
Regarding claim 42, similar to the analysis as noted in the claim 41 above, wherein the apparatus is configured to detect a rotation of the rotatable member relative to the housing of the medical device.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21, 23, 25-29, 31-37, 39-42 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on 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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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights