DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 13/127,247, filed on 05/03/2011.
Specification
The disclosure is objected to because of the following informalities:
The first sentence of paragraph [0709] should be rewritten. Phrases such as “the reservoir delivery the insulin to catheter” and “a position opposite to the catheter delivery the insulin to subcutaneous” are unclear.
Appropriate correction is required.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claims 1 and 9 are objected to because of the following informalities:
In claim 1, line 5, “the tilt angle” should be changed to “a tilt angle” for further clarification.
In claim 9, the acronym “MET” should be written out for at least the initial recitation.
Appropriate correction is required.
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 8-9 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.
Claim 8 recites estimating the quantity of insulin being delivered, however it is unclear why the quantity of insulin needs to be estimated when the quantity of insulin is usually already set by the program or the user. It is also unclear how the quantity of insulin can be estimated when it is unclear if any insulin is actually being delivered by virtue of the claim language. Furthermore, it would be helpful to know the purpose of this estimation, for example, is this estimation to be compared to a programmed quantity or is it merely a means of calculating volume with a rate that has been set by the programming or user. Lastly, it is noted the pending claims are drawn to an insulin infusion device and that all the limitations should be in proper form for a device claim and should not include limitations that can be interpreted as methods, as having subject matter from two different statutory classes is improper. Clarification of the limitations of claim 8 is requested.
Claim 9 is rejected by virtue of being dependent on a rejected base 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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-4 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by U.S. Patent Publication No. 2008/0125701 to Moberg et al. (“Moberg”).
Regarding claim 1, Moberg teaches an insulin infusion device (Fig. 1/3) comprising a cannula (needle of infusion set 438, also shown in Fig. 1 under 206) for infusing insulin under the skin, an insulin infusion section (434) for storing therein insulin to be delivered to the cannula, a motion measurement section (414) that measures the tilt angle or rotation angle of a center axis of the insulin infusion section from a neutral position thereof or vibration applied to the insulin infusion section (Fig. 6, when 804 is in a neutral state), to output a measured value as motion information of living activity ([0070]), and a controlling section (418) that controls, based on the motion information, a process of notifying a user of the timing or recommended direction of priming of the insulin infusion section ([0071]).
Regarding claim 2, Moberg teaches the insulin infusion device according to claim 1 as shown above, Moberg further teaching a recording section (422, [0079]) that records therein the motion information.
Regarding claim 3, Moberg teaches the insulin infusion device according to claim 2 as shown above, Moberg further teaching a communication section (428, [0082]) that transmits the motion information recorded in the recording section.
Regarding claim 4, Moberg teaches the insulin infusion device according to claim 2, further comprising a display section (428, [0082]) that displays thereon the motion information recorded in the recording section.
Claims 5-7 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by U.S. Patent Publication No. 2008/0125701 to Moberg et al. (“Moberg”) as evidenced by U.S. Patent No. 6,248,067 to Causey, III et al. (“Causey”).
Regarding claim 5, Moberg teaches the insulin infusion device according to claim 1, Moberg further teaching a recording section that records therein the motion information and the characteristic amount with the motion information and the characteristic amount associated with each other ([0036], information may be downloaded from a glucose monitor). Although Moberg does not specify details of the glucose monitor, examples of continuous glucose monitoring devices were incorporated by reference ([0041]) including that of Causey.
Causey teaches a biosensor (10) which selectively responds to a specific analyte in a biological fluid for detecting the presence or concentration of the analyte in the biological fluid and an analyte measurement section that measures a characteristic amount of the analyte with the biosensor (100).
Regarding claim 6, Moberg as evidenced by Causey teach the insulin infusion device according to claim 5 as shown above, Causey further teaching the biosensor is a continuous glucose monitoring sensor (column 3, lines 23-26) to be inserted under the skin (Figs. 1-2).
Regarding claim 7, Moberg as evidenced by Causey teach the insulin infusion device according to claim 5, Causey further teaching the biosensor is a blood glucose sensor for measuring blood glucose level (column 3, lines 29-31).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 8 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moberg in view of U.S. Patent Publication No. 2010/0017141 to Campbell et al. (“Campbell”).
Regarding claim 8, Moberg teaches the insulin infusion device according to claim 1 as shown above, Moberg further teaching a pump section (432) for delivering insulin stored in the insulin infusion section to the cannula but does not show the details of the controlling section.
Campbell teaches estimating ([0011]), based the operation time (subsequent time period) of the pump section, the quantity of the last bolus that is still active in the body (insulin on board), and records the estimated quantity in the recording section ([0022]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Moberg to estimate and store insulin on board as taught by Campbell to yield the predictable result of providing a proper dose of insulin to the patient. As is known in the art, insulin on board is an important factor to consider to avoid the provision of too much insulin ([0003]) that may harm the patient.
Claim 9 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moberg in view of U.S. Patent Publication No. 2009/0069720 to Beck et al. (“Beck”).
Regarding claim 9, Moberg teaches the insulin infusion device according to claim 1, Moberg further teaching a living activity calculation section (418) that calculates, based on the motion information, living activity level (from the acceleration sensor) but does not mention metabolic equivalents.
Beck teaches calculating motion information in terms of METs ([0003]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used METs as the units of motion in Moberg as taught by Beck to yield the predictable result of providing motion information. Moberg already teaches the implementation of motion information to inform treatment, Beck merely shows an example of known units that are used to express motion information used in similar types of sensors.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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