DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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 § 102
2. 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.
3. Claim 10 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anquetil (US 2021/0319718 A1).
Regarding claim 10, Anquetil discloses a training device, comprising: a housing (102) having a tissue-engaging surface (see Fig. 1); a motor (e.g. rotary motor 126); and a controller (141) coupled to the motor, wherein the controller is configured to: receive an indication that the tissue-engaging surface is positioned in contact with a user or synthetic injection surface (Par. 28); cause, in response to the indication, the motor to be driven in a first direction for a predetermined period of time; and without requiring any intervention by a user after the predetermined period of time, automatically cause the motor to be driven in a second direction without causing any component to move from inside the housing to outside the housing (see Par’s. 77-79 – in training mode, motor operates in a suitable manner to provide a simulation consistent with operation of an auto-injector during actual injection, which includes piercing, injection, and retraction; furthermore, the training cartridge is a needle free cartridge and therefor the motor operates without causing any component, i.e. a needle, to move from inside to outside).
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baker et al. (US 2015/0100024 A1) (hereinafter Baker ‘024).
Regarding claim 16, Baker ‘024 discloses a training device, comprising: a housing (10, 12 – see Fig. 1) having a tissue-engaging surface; a motor (50 – Fig. 6A); and a controller (processor) coupled to the motor, wherein the controller is configured to: receive a first indication that the tissue-engaging surface is positioned in contact with a user or synthetic injection surface; cause, in response to the indication, the motor to be driven in a first direction; receive a second indication that the tissue-engaging surface has been removed from contact with the user or synthetic injection surface within a predetermined period of time; and cause, in response to the second indication, the motor to be driven in a second direction (see Par. 112 – contact sensor detects contact between sensor and patient and sends signal to processor; upon contact, processor causes motor to move in order to initiate injection; upon removal from contact, processor and stopper act to stop the motor or reverse direction of the motor).
Claim Rejections - 35 USC § 103
4. 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.
5. Claims 1, 6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Anquetil (US 2021/0319718 A1) in view of Baker et al. (US 2014/0276414 A1) (hereinafter Baker ‘414).
Regarding claim 1, Anquetil discloses a training device, comprising: a housing (102) having a tissue-engaging surface (see Fig. 1); a touch sensor disposed on the tissue-engaging surface and configured to detect contact with skin or synthetic injection surface (Par. 28); a motor (126); and a controller (141) coupled to the motor,
wherein the controller is configured to: receive an indication that the touch sensor has detected contact with skin or synthetic injection surface; and cause, in response to the first indication and the second indication, the motor to be driven for a predetermined period of time without causing any component to move from inside the housing to outside the housing (Par. 28 – operates in response to contact detected; Par’s. 77-79 - in training mode, motor operates in a suitable manner to provide a simulation consistent with operation of an auto-injector during actual injection, and the training cartridge is a needle free cartridge and therefor the motor operates without causing any component to move from inside to outside) (as per claim 1)
To the extent that Anquetil does not explicitly disclose an activating switch configured to be moved from a deactivated configuration to an activated configuration, wherein receive a first indication that the activating switch has been moved from the deactivated configuration to the activated configuration, and the controller acts based on this indication, Baker ‘414 discloses activation of a switch to signal an auto-injector to perform injection functions (see e.g. Par 44). Accordingly, it would have been obvious to one skilled in the art before the effective filing date of the invention to modify the teachings of Anquetil by including this activation switch of Baker ‘014. Such a modification would involve combining prior art elements according to known methods to yield predictable results.
Regarding claims 6 and 9, Anquetil further discloses a piston (120) configured to move within a vial; wherein the motor is configured to drive the piston (see Fig. 1) (as per claim 6), and a vial containing a fluid; wherein the motor is configured to be driven without dispensing the fluid (in training mode – Par’s. 77-79) (as per claim 9).
6. Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Anquetil (US 2021/0319718 A1) in view of Leimbach et al. (US 2022/0218344 A1).
Regarding claims 11-13, Anquetil does not appear to explicitly disclose the controller is further configured to: receive an activation signal indicating that the training device has been removed from a tray; and cause, in response to the activation signal, the training device to transition from a sleep mode to an active mode (as per claim 11), the controller is further configured to: cause, after the predetermined period of time, the training device to transition from the active mode to the sleep mode (as per claim 12), and the controller is further configured to: cause, after the predetermined period of time, an audible or visual alert to be emitted from the training device (as per claim 13). However, Leimbach discloses (see e.g. Par. 466) these features of activating a surgical device when removed from a surface from sleep mode to active mode, transition from active to sleep after a period of time, and causing an audible alert from the device (e.g. by dimming and then turning off background). Accordingly, it would have been obvious to one skilled in the art before the effective filing date of the invention to modify the teachings of Anquetil by including these features of Leimbach. Such a modificiation would involve applying a known technique to a known device ready for improvement to yield predictable results.
7. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Anquetil (US 2021/0319718 A1) in view of Armes (US 2014/0142507 A1).
Regarding claim 15, Anquetil does not appear to disclose, but Armes does disclose a piston disposed within a vial; wherein the motor is decoupled from the piston such that the piston remains stationary when the motor is driven (actuator no load – motor moves but not pushing against plunger - Par. 187). Accordingly, it would have been obvious to one skilled in the art before the effective filing date of the invention to modify the teachings of Anquetil by utilizing this arrangement of Armes, to obtain a more realistic simulated auto-injector.
8. Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. (US 2015/0100024 A1) (hereinafter Baker ‘024) in view of Leimbach et al. (US 2022/0218344 A1).
Regarding claims 17-19, Baker ‘024 does not appear to explicitly disclose the controller is further configured to: receive an activation signal indicating that the training device has been removed from a tray; and cause, in response to the activation signal, the training device to transition from a sleep mode to an active mode (as per claim 17), the controller is further configured to: cause, after the predetermined period of time, the training device to transition from the active mode to the sleep mode (as per claim 18), and the controller is further configured to: cause, after the predetermined period of time, an audible or visual alert to be emitted from the training device (as per claim 19). However, Leimbach discloses (see e.g. Par. 466) these features of activating a surgical device when removed from a surface from sleep mode to active mode, transition from active to sleep after a period of time, and causing an audible alert from the device (e.g. by dimming and then turning off background). Accordingly, it would have been obvious to one skilled in the art before the effective filing date of the invention to modify the teachings of Baker ‘024 by including these features of Leimbach. Such a modification would involve applying a known technique to a known device ready for improvement to yield predictable results.
Allowable Subject Matter
9. Claims 2-5, 7, 8, 14 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Anquetil, Baker ‘414, Baker ‘024, Leimbach, Armes, and the other prior art of record disclose various arrangements of training syringes and auto-injectors, but do not explicitly disclose, in combination with their respective independent claims, the arrangements recited in claims 2, 3, 14 and 20, including a piston within a vial, and a needle, wherein the piston remains stationary when the motor is driven, in claim 2, and a needle within the housing, wherein the motor is decoupled from the needle such that the needle remains stationary when the motor is driven, in claims 3, 14 and 20.
Conclusion
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER EGLOFF whose telephone number is (571) 270-3548. The examiner can normally be reached 9:00 AM – 5:00 PM, Monday through Friday Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Peter R Egloff/
Primary Examiner, Art Unit 3715
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