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 25 is 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 claim 25, it requires that: any two of the detection modules. According to the Figs. 1, 7-8 & 10, there is only one detection module 100. The para [0346] states that the detection module 100 is a continuous glucose monitor (Continuous Glucose Monitoring. CGM). Beside the CGM 100 as mentioned, it is unclear to Examiner that which element is a second detection module?
The term “the third module” is vague. It is unclear to Examiner that which element is considered as “a third module”?
Claim 25 recites the limitation "the third module" in line 5. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kovatchev et al. (US 6,923,763).
Regarding claim 1, Kovatchev discloses a closed-loop artificial pancreas insulin infusion control system comprising:
detection module, i.e. blood glucose (BG) monitoring, configured to detect a current blood glucose level G continuously, (col. 14, line 9 & col. 19, lines 20-24);
a program module, configured to preset with an rMPC algorithm (risk model predictive control, e.g., to estimate or predict BG in the near future and to estimate of the risk of hypoglycemia, see abstract) that converts an asymmetric blood glucose in an original physical space (e.g., Fig. 4, the scale is nt symmetric as hypoglycemia, col. 14, lines 14-20) to an approximately symmetric blood glucose risk in a risk space (e.g., Fig. 5, col. 14, lines 21-28) and a target blood glucose level GB (col. 14, line 28), and to calculate insulin infusion instructions based on a blood glucose risk by the rMPC algorithm, col. 5, lines 11-14, 53-58; co;. 6, lines 6-12 & also see Figs. 10 & 13-14; and
an infusion module (insulin infusion unit, insulin pump, col. 5, line 32, 63-65), connected to the program module, and configured to infuse insulin, controlled by the program module, according to corresponding output instructions calculated by the rMPC algorithm (e.g., insulin infusion rates can be instructed to reduce if the onset of hypoglycemia is predicted, col. 5, lines 53-58, col. 6, lines 43-52.
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.
Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kovatchev et al. (US 6,923,763) in view of Yodfat et al. (US 8,148,446).
Kovatchev discloses all the claimed subject matter as required. As best as understood, the sensor module, the program module and infusion module are connected to each other so that the device system can detect or predict the future BG and adjusting the insulin infusion rate. Kovatchev does not disclose that these modules are formed a single part whose attached position on a skin is different from a third module.
Yodfat discloses an infusion pump comprising: any two of the detection module, i.e., sensing apparatus 147, position detector 900 or indication means 145, a program module/CPU 140, an infusion module 146 are connected to each other, and are configured to form a single part whose attached position on a skin is different from a third module, i.e. needle, see Figs. 7 & 13.
It would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device system of Kovatchev with obtaining any two-detection module, a program module, an infusion module being connected to each other and formed a single part, as taught by Yodfat, in order to reuse the single part unit for saving cost.
Allowable Subject Matter
Claims 2-7, 10-11, 14-16, 19-20, 23-24 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.
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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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights