DETAILED ACTION
Response to Amendment
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/29/2026 has been entered.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In regard to claims 10 and 14, the claims are rendered indefinite because the infusion unit and the control unit are recited as detachable from one another but claim 1 establishes that infusion unit comprises the control unit. It is unclear how the infusion unit and the control unit can be detachable from one another if the control unit is part of the infusion unit.
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, 6-7, 9, 11-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over DiIanni et al. (US 2005/0238507; hereafter Delanni) in view of Welsch et al. (US 2016/0228633; hereafter Welsch).
In regard to claim 1, DiIanni 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]).
DiIanni 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 sensing unit is integrated in the infusion unit, and the sensing unit and the infusion unit are discarded after a single use OR the sensing unit is integrated in the control unit, and the sensing unit and the control unit are reuseable.
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) and wherein the sensing unit (30a, 30b, 30, etc including touchless interface 50 and touchless control module 120) is integrated in the infusion unit (infusion unit is regarded as “infusion pump 10”), and the sensing unit and the infusion unit are discarded after a single use (these limitations are functional which fail to structurally distinguish over the prior art; the DiIianni device with the incorporated sensing unit can be discarded after single use if desired; no further structural requirements are needed) OR the sensing unit (30a, 30b, 30, etc including touchless interface 50 and touchless control module 120) is integrated in the control unit (“pump control system 110”) (see Fig. 2 and par. [0051]), and the sensing unit and the control unit are reuseable )the DiIianni device with the incorporated sensing unit can be discarded after single use if desired; no further structural requirements are needed).
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 DiIanni 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, Welsch teaches 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 DiIanni 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 the fixed time period, 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 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 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 Delanni).
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).
Claim(s) 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over DiIanni and Welsch in further view of Estes et al. (US 2007/0124002; hereafter Estes).
In regard to claims 10 and 14, the combination fails to teach wherein, the infusion unit and the control unit are detachable from each other.
In a similar art, Estes discloses the control unit 1102 may be included as a portion of the pump unit 1104. In other implementations, the control unit 1102 may be a separate, detachable entity from the pump unit 1104. Regardless of whether or not the control unit 1102 and the pump unit 1104 are separate entities, in operation, system processing may occur in the control unit 1102, in the pump unit 1104, or may occur in a combination of both. (see par. [0130]).
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 combination with the detachable control unit of Estes in order to provide a modular configuration to the system.
Response to Arguments
Applicant's arguments filed 4/29/2026 have been fully considered but they are not persuasive.
In response to the applicant’s argument that Welsch fails to disclose a sensing unit wherein the sensing unit is integrated in the infusion unit, and the sensing unit and the infusion unit are discarded after a single use OR the sensing unit is integrated in the control unit, and the sensing unit and the control unit are reuseable, the examiner respectfully disagrees. The applicant argues that Welsch does not teach that the touchless operator input mechanism (30a-30) is not integrated in the pump control system 110 of Welsch. This argument is not persuasive. The applicant is ignoring the claim language and the interpretation of the art of Welsch. The sensing unit is regarded as (30a, 30b, 30, etc including touchless interface 50 and touchless control module 120) as opposed to just 30a, 30b, and 30 as alleged by applicant in the remarks. Furthermore, the claim language recites that the sensing unit is integrated in the infusion unit and not the pumping mechanism as alleged by applicant in the remarks. The examiner maintains that Figure 2 of Welsch clearly shows the identified sensing unit integrated into the infusion unit (“infusion pump 10”). The applicant further argues that there is no disclosure in Welsch about being discarded together after a single use. First, the applicant is ignoring the combination of DiIanni and Welsch. Arguments against the teaching reference alone are improper since Welsch is not being relied upon for teaching this specific limitation. As articulated in the rejection, the sensing unit of Welsch incorporated into the system of DiIanni results in a system that can be discarded after a single use as this limitation is functional and requires no further structural requirements not taught by the combination.
In response to the applicant’s argument that Welsch fails to disclose the sensing unit is integrated in the control unit, and the sensing unit and the control unit are reuseable, the examiner respectfully disagrees. The applicant is again reminded that the sensing unit is regarded as (30a, 30b, 30, etc including touchless interface 50 and touchless control module 120) as opposed to just 30a, 30b, and 30 as alleged by applicant in the remarks. The identified sensing unit is integrated into the identified control system 110 as clearly shown in Figure 2 and par. [0051]. The units work together and are broadly integrated in the same broader unit 10. The applicant appears to be of the position that since the modules 120 and 110 are not shown within the same box in Figure 2 but does not explain further how they are not integrated. There is no specific definition of integrated in the applicant’s specification nor a discussion in the Remarks of how the limitation of “integrated” is not met beyond a reference to Figure 2. The applicant further argues that there is no disclosure in Welsch about being reusable. First, the applicant is ignoring the combination of DiIanni and Welsch. Arguments against the teaching reference alone are improper since Welsch is not being relied upon for teaching this specific limitation. As articulated in the rejection, the sensing unit of Welsch incorporated into the system of DiIanni results in a system that can be reused as this limitation is functional and requires no further structural requirements not taught by the combination.
Conclusion
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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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
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