DETAILED ACTION
Response to Amendment
Terminal Disclaimer
The terminal disclaimer filed on 1/30/206 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 12,102,792 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
Claim(s) 1-4 and 6-15 are rejected under 35 U.S.C. 103 as being unpatentable over DiIanni et al. (US 2005/0238507; hereafter DeIanni) in view of Welsch et al. (US 2016/0228633; hereafter Welsch).
In regard to claim 1, DeIanni discloses a bilaterally driven drug infusion system (200), comprising: an infusion unit comprising: a drug storage unit (230); a piston (236) and a driving wheel (256) which are connected with a screw (252), wherein the driving wheel (256), provided with wheel teeth (258a/258b), drives the screw to rotate (see par. [0036] and [0038]), the piston is arranged in the drug storage unit (see par. [0032]), the screw advances the piston to move (see par. [0032]); a driving unit (linear actuator including 262, 260a/b; see par. [0034] and [0038]), cooperated with the driving wheel (256); a power unit (control circuitry applying current to 260a/260b; see par. [0038]), connected to the driving unit; a control unit (290), controlling the driving unit to output forces in two different directions on the driving unit (see directions 20 and 22 in Fig. 5 and par. [0038]-[0039]);
DeIanni fails to disclose a sensing unit, operatively connected to the control unit and used to sense or recognize body movements, wherein the body movements which are different represent different functional instructions, and according to the body movement sensed or recognized by the sensing unit, the control unit controls the infusion unit to execute a corresponding functional instruction of the functional instructions, wherein the body movement sensed or recognized by the sensing unit within a fixed period t is recognized as a valid body movement, and beyond the fixed time period t, the body movement is recognized as an invalid body movement.
In a similar art, Welsch discloses an insulin pump (10a, 10b, etc) comprising a sensing unit (30a, 30b, 30, etc including touchless interface 50 and touchless control module 120), operatively connected to the control unit (110) and used to sense or recognize body movements (see par. [0043]-[0080]; see Figs. 3a-3c), wherein the body movements which are different represent different functional instructions (see par. [0055] for a finger gesture forming the letter “A” to request an adjustment to the infusion rate, see par. [0056] for flicking motions for adjusting the infusion rate, and par. [0057] for thumbs up gesture to confirm the change), and according to the body movement sensed or recognized by the sensing unit, the control unit controls the infusion unit to execute a corresponding functional instruction of the functional instructions (see various disclosures cited above; Welsch discloses various gesture based control of pump functions), wherein the body movement sensed or recognized by the sensing unit within a fixed period t is recognized as a valid body movement, and beyond the fixed time period t, the body movement is recognized as an invalid body movement (Welsch explicitly discloses a 2 second period of time in par. [0080]; the examiner also notes that any gesture based recognition is time-based because the module has to detect the beginning and end of the gesture).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of DeIanni with the sensing unit of Welsch in order to provide an infusion pump with reliable touchless control which can provide safe and reliable drug delivery to a patient (see par. [0006]-[0016] of Welsch), especially a patient in need of ICU care (see par. [0078]).
In regard to claim 2, the combination teaches wherein, the functional instructions include infusing drug or stopping infusing drug, priming an infusion needle, puncturing or retracting the infusion needle, adjusting an infusion speed or an infusion mode, adjusting an amount of drug infusion, turning on or off an alarm, connecting or disconnecting a remote device, switching a physical state, or starting an event (see highlighted portions of Welsch although the entire disclosure is of interest).
In regard to claim 3, the combination teaches wherein, the sensing unit is provided with one or more of an acceleration sensor, an inclination sensor, a vibration sensor and a rotation sensor (see par. [0044]-[0048] of Welsch; the disclosed sensors can detect the listed movements).
In regard to claim 4, the combination teaches wherein, the body movements include one or a combination of jumping, squatting, leg movements, arm movements, taps on the sensing unit, bending over, torso twist, special way of walking (see at least par. [0055]-[0057] and Figs. 3a-3c of Welsch; the detected movements can include all of these movements).
In regard to claims 6-7, the combination does not teach this particular time period but these limitations are deemed to be design considerations which fail to distinguish over the cited art. The period of time could be chosen by the ordinary skilled artisan to best match the intended gesture to detect.
In regard to claim 8, the combination teaches wherein, the sensing unit is integrated in the infusion unit or the control unit (see at least Fig. 2 of Welsch).
In regard to claim 9, the combination teaches, wherein, the sensing unit, the control unit and the infusion unit are arranged in one device (see at least Fig. 2 of Welsch).
In regard to claim 10, the combination teaches wherein, the infusion unit and the control unit are designed separately, and the control mechanism module is reusable (see at least par. [0045] for peripheral device controller embodiments that are separate from the pump).
In regard to claim 11, the combination teaches wherein, the infusion unit and the control unit are disposed in one housing, discarded together after a single use (see at least Fig. 2 and 3a-3c of Welsch; “discarded after a single use” is a functional limitation; anything can be thrown away).
In regard to claim 12, the combination teaches wherein, further comprising a body movement verification unit which is connected to the sensing unit (120 and 30 of Welsch can be considered separately as a body movement verification unit and a sensing unit).
In regard to claim 13, the combination teaches wherein, the driving unit have a variety of different operating modes, thereby making the bilaterally driven drug infusion system have various different infusion increments or infusion rates (see at least par. [0028] of DeIanni).
In regard to claim 14, the combination, wherein, the infusion unit and the control unit are designed separately, and the control mechanism module is reusable (see at least par. [0045] of Welsch for peripheral device controller embodiments that are separate from the pump); “reusable” is a functional limitation).
In regard to claim 15, the combination, wherein, the infusion unit and the control unit are disposed in one housing, discarded together after a single use ((see at least Fig. 2 and 3a-3c of Welsch; “discarded after a single use” is a functional limitation; anything can be thrown away).
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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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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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783