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 .
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.
Claim(s) 3-9 is/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.
Regarding claim 3, the phrase "two actuators" renders the claim indefinite because it is unclear. Claim 3 depends on claim 1 wherein claim 1 recites “an actuator”. It is unclear whether “an actuator” of claim 1 is one of the “two actuators” of claim 3, or the “two actuators” of claim 3 are additionally introduced to the claim.
Claims 4-9 are rejected by virtue of depending on claim 3.
Regarding claim 4, the phrase "the actuator" renders the claim indefinite because it is unclear if “the actuator” of claim 4 refers to “an actuator” of claim 1 or “two actuators” of claim 3.
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)(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.
(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) 1-2, 10-13, 16-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN111939371 (Examiner notes: CN111939371 is cited in the IDS 06/29/2023. See the attached NPL for its translation)
Regarding claim 1, CN111939371 discloses
An interlocking drug infusion device (figs. 1-5 – the first embodiment, see lines 181-377 of the translation), comprising:
a drug reservoir (100, fig. 2), used for accommodating a drug to be infused (see lines 221-227 of the translation), provided with a piston (120, fig. 2) and a screw (130, fig. 2);
a driving wheel (140, fig. 2), connected with the screw (130, fig. 2), driving the screw (130) to push the piston (120) forward by rotation (see lines 231-234 of the translation);
a driving unit (150), the driving unit (150) moved in a driving direction (counterclockwise direction) to drive the driving wheel (140) to rotate (see lines 240-247 and 249-250 of the translation);
an actuator (180), electrically connected to the driving unit (150), used to provide power for the driving unit (150) in the driving direction after energized (see lines 240-247 of the translation);
a program module (101, figs. 1a-1b), electrically connected to the actuator (180, see lines 189-192 of the translation), the program module (101) providing a first driving instruction (first driving instrusion to perform a first infusion rate when the drug is first infused, lines 307-308) for controlling the actuator to perform periodic power output (see lines 324-327 for 101 with the time controller to control the force output of 180 to control the rotation of 150, and see lines 307-308 for rotation of 150 to perform an infusion rate when the drug is first infused to the patient); and
a position detection module (190, fig. 2), used to determine a periodic drug infusion amount (lines 348-370 of the translation), wherein when the periodic drug infusion amount reaches a preset threshold (lines 308-311 of the translation for the threshold being close to completing the infusion), the position detection module and/or the program module (101) provide the actuator (180) with a second driving instruction (see lines 324-327 for 101 with the time controller to control the force output of 180 to control the rotation of 150, and see lines 308-311 for rotation of 150 to perform a different infusion rate when the infusion is close to completion).
Regarding claim 2, CN111939371 discloses
The interlocking drug infusion device of claim 1, further comprising an elastic member (170, fig. 2) that applies an elastic force (FR, fig. 2) to the driving unit (150) to reset the driving unit (lines 265-276 of the translation).
Regarding claim 10, CN111939371 discloses
The interlocking drug infusion device of claim 1, wherein the position detection module (190, fig. 2) includes a position detection element (110, fig. 2 and lines 348-370 of the translation), and the position detection element (110) detects a position through a non-contact detection (see fig. 2 and lines 348-370 of the translation).
Regarding claim 11, CN111939371 discloses
The interlocking drug infusion device of claim 10, wherein the position detection element is a magnetic element (see lines 351-352 of the translation).
Regarding claim 12, CN111939371 discloses
The interlocking drug infusion device of claim 11, wherein the position detection element (110) is arranged in the piston (120, see fig. 2) or the screw or a junction of the screw and the piston (Examiner notes: claim 12 uses the words “or”, which makes only one limitation positively recited in claim 12. Since CN111939371 discloses 110 arranged in 120, CN111939371 read on claim 12).
Regarding claim 13, CN111939371 discloses
The interlocking drug infusion device of claim 12, wherein the position detection element (110) is provided in the piston (120), and the piston is provided with at least one recess for accommodating the position detection element (see fig. 2 and lines 349-350, 351-354, 372-374 of the translation for 110 being in the piston 120).
Regarding claim 16, CN111939371 discloses
The interlocking drug infusion device of claim 1, further comprising an infusion mechanism module (100/140/150/180) and a control mechanism module (101/190), the drug reservoir (100), the drive wheel (140), the driving unit (150), and the actuator (180) are provided on the infusion mechanism module (see figs. 1-5), the program module (101) and the position detection module (190) are provided on the control mechanism module (see figs. 1-5).
Regarding claim 17, CN111939371 discloses
The interlocking drug infusion device of claim 16, wherein the infusion mechanism module (100/140/150/180) and the control mechanism module (101/190) are detachable to each other designed separately (see figs. 1a-1b), and the control mechanism module is reusable (see lines 197-201 of the translation)
Regarding claim 18, CN111939371 discloses
The interlocking drug infusion device of claim 16, wherein the infusion mechanism module (100/140/150/180) and the control mechanism module (101/190) are disposed in one housing (see figs. 1a-1b), discarded together after a single-use (Examiner notes: the entire device can be discarded after a single-use).
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.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN111939371 in view of Anderson et al. (US 2013/0006194).
Regarding claim 14, CN111939371 discloses the interlocking drug infusion device of claim 13, as set forth above, except for wherein the recess is provided with a plurality of projects, for fixing the position detection element.
However, Anderson teaches a first element (60, fig. 5) provided with at least one recess (see fig. 5) for accommodating a second element (80, fig. 5) wherein the recess is provided with a plurality of projects (100, fig. 5), for fixing the second element (see fig. 6).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify CN111939371 by adding the recess of the CN111939371 piston with a plurality of projects, as taught by Anderson, for the purpose of providing sufficient structure to engage the position detection element with the piston to lock the position detection element in place (par. 0144 of Anderson).
Regarding claim 15, CN111939371 in view of Anderson discloses the interlocking drug infusion device of claim 14,
Anderson further teaches wherein the recess (see fig. 5) also provides a positioning part (109) for further fixing the second element (see figs. 5-6 and pars. 0144-0145).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to further modify CN111939371 by adding a positioning part, as taught by Anderson, for the purpose of holding the position detection element to prevent or resist inadvertent dropping the position detection element from the piston (par. 0145 of Anderson).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN111939371 in view of Madugula et al. (US 2020/0238099).
Regarding claim 19, CN111939371 discloses
An artificial pancreas, comprising: the interlocking drug infusion device of claim 16 (see claim 16 above)
CN111939371 only discloses the infusion device configured to infuse different types of drugs (lines 225-227 of the translation) but is silent about a detection mechanism module, configured to detect blood glucose continuously, connected or integrated with the control mechanism module and the infusion mechanism module of the interlocking drug infusion device.
However, Madugula teaches an infusion device comprising a detection mechanism module (18, fig. 1), configured to detect blood glucose continuously (fig. 3 and par. 0033), connected or integrated with the control mechanism module and the infusion mechanism module of the interlocking drug infusion device (see figs. 1 and 3, par. 0033).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify CN111939371 by adding a detection mechanism, as taught by Madugula, for the purpose of monitoring the glucose levels of the patient and providing that information to doctors (par. 0023 of Madugula) to protect the patient from overdose.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Examiner, Art Unit 3783