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 Objections
Claims 1, 4-5, 9, and 13 are objected to because of the following informalities: Claim 1 recites “the validity” in line 10, but instead should be --a validity--. Claim 1 recites “the determination” in the last line, but instead should be --the validity determination--. Claim 4 recites “the first storage area” in line 2, but instead should be --a first storage area--. Claim 4 recites “the second storage area” in line 4, but instead should be --a second storage area--. Claim 5 recites --the first storage area and the second storage area-- in lines 2-3, but instead should be --a first storage area and a second storage area--. Claim 9 recites “the validity” in line 8, but instead should be --a validity--. Claim 9 recites “the determination” in the last line, but instead should be --the validity determination--. Claim 13 recites --the first storage area and the second storage area-- in line 3, but instead should be --a first storage area and a second storage area--. 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 6-8 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.
Claim 6 recites “wherein the first storage space and the second storage space of the first storage area correspond to the first storage space and the second storage space of the second storage area” in line 7-9, but is indefinite. There is no previously recited second storage space of the first storage area or first storage space of the second storage area. Therefore, it is unclear how the limitation is intended to be interpreted because it is not known what data is stored in each of those spaces. Same issue applies to claim 14.
Claim 6 recites “and the first storge space and the second storage spare are continuous” in the last two lines, but is indefinite because the limitation is ambiguous. Which storage spaces are being referenced? Between the two area? Within either or both of the two areas? For examination purposes, any of the interpretations are reasonable as a basis for rejection. Same issue applies to claim 14.
Claims not listed are rejected by virtue of claim dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites the limitation “a measurement unit that is partially inserted into the body of a subject and generates a blood glucose measurement signal” in lines 2-3, which incorporates a human organism and has been construed by the examiner that a human body surface is a component of the device. It is suggested that Applicant amend claim 1 to recite -- a measurement unit that is configured to be partially inserted into the body of a subject and generate a blood glucose measurement signal-- in order to remove the recitation of human
tissue.
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.
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.
Claims 1-5, 7-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Taub et al. (US 20140275898), hereinafter Taub, in view of Lashgari et al. (US 20250032801), hereinafter Lashgari.
Regarding claims 1 and 9, Taub teaches a blood glucose measurement (abstract and ¶[0006]) comprising:
a measurement unit that is partially inserted into the body of a subject and generates a blood glucose measurement signal by measuring a blood glucose concentration of the subject (¶[0048] and fig. 1, “insertion device 150 that, when operated, transcutaneously positions a portion of analyte sensor 101 through a skin surface and in fluid contact”);
a control unit that generates blood glucose measurement data by converting the blood glucose measurement signal into digital data (¶[0092], “Data processing or control unit may be programmed to perform signal processing such as, for example, but not limited to, current to frequency conversion of the raw sensor signals, analog to digital conversion, signal filtering, storage, data transmission and reception”);
a storage unit that includes a plurality of storage areas and stores the blood glucose measurement data in the plurality of storage areas (¶[0095] and fig. 5, memory 560,570); and
a communication unit that transmits the blood glucose measurement data stored in at least one of the plurality of storage areas to an external device (¶[0095], “transmitting data packets and/or signals corresponding to measured analyte levels”),
wherein the control unit determines the validity of the blood glucose measurement data stored in the plurality of storage areas (¶[0121], “where when an error condition associated with operation of the glucose sensor is detected by the processing unit, the processing unit is configured to store data associated with the first predetermined type of data in a subset of the second plurality of memory locations of the memory unit”), and controls the communication unit to transmit the blood glucose measurement data stored in at least one of the plurality of storage areas to the external device (fig. 1, data is transmitted from sensor 101 to external devices 120,170), but fails to teach that the transmission is based on a result of the determination.
Lashgari teaches a medical monitoring device (abstract and ¶[0102,0106], “physiological data acquired from patient 208 such as DCA data” (emphasis added)). The physiological data is retained in multiple memory devices and designated in valid and invalid subsets before being transmitted to an external device (¶[0098, 0248], “The external device 154 facilitates access by physicians to patient data as well as permitting the physician to review” and “the DCA data sets, valid subsets, and/or invalid subsets, can be retained in a memory by the IMD and/or external device until they are transmitted to a healthcare provider for review”(emphasis added)).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Taub, such that the transmission to the external device is based on a result of the validity determination, to facilitate access by physicians to patient data and permit review of the data, to aid in quickly address medical issues, and/or to reduce the burden of reviewing all potential events (¶[0098,0125,0248]).
Regarding claims 2 and 10, Taub teaches wherein the storage unit stores the blood glucose measurement data in a first storage area included in the plurality of storage areas (¶[0121], “a first plurality of memory locations configured to store a first predetermined type of data” (emphasis added)), and
stores the blood glucose measurement data in a second storage area included in the plurality of storage areas (¶[0121], “a second plurality of memory locations configured to store a second predetermined type of data”),
wherein the blood glucose measurement data stored in the first storage area match with the blood glucose measurement data stored in the second storage area (¶[0121], “ where the first predetermined type of data includes error data, the second predetermined type of data includes monitored physiological condition data, where when an error condition associated with operation of the glucose sensor is detected by the processing unit, the processing unit is configured to store data associated with the first predetermined type of data in a subset of the second plurality of memory locations of the memory unit.” Therefore, the first and second plurality of data in both areas match).
Regarding claims 3 and 11, Taub fails to teach wherein the communication unit transmits the blood glucose measurement data stored in the first storage area to the external device if the blood glucose measurement data stored in the first storage area is determined to be valid; and transmits the blood glucose measurement data stored in the second storage area to the external device if the blood glucose measurement data stored in the first storage area is determined to be invalid.
Lashgari teaches that the valid and invalid subsets are an option, therefore a condition e.g. if/then, before being transmitted to the external device (¶[0248], “optionally the DCA data sets, valid subsets, and/or invalid subsets, can be retained in a memory by the IMD and/or external device until they are transmitted to a healthcare provider for review” (emphasis added). Moreover, the data can be on two separate memory devices i.e. IMD, external device in addition to transmitting to another external device).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Taub-Lashgari, such that blood glucose data is transmitted to an external device if the data stored in the storage area is determined to be valid or invalid, as taught by Lashgari, to aid in quickly addressing medical issues and/or changes with the patient (¶[0248]).
Regarding claims 4 and 12, Taub teaches wherein the storage unit stores the blood glucose measurement data in the first storage area included in the plurality of storage areas (¶[0121], “ a memory unit having a first plurality of memory locations configured to store a first predetermined type of data”); and
stores the blood glucose measurement data in the second storage area included in the plurality of storage areas if a preset error event is determined to have occurred in the first storage area (¶[0121], “where the first predetermined type of data includes error data, the second predetermined type of data includes monitored physiological condition data, where when an error condition associated with operation of the glucose sensor is detected by the processing unit, the processing unit is configured to store data associated with the first predetermined type of data in a subset of the second plurality of memory locations of the memory unit”).
Regarding claims 5 and 13, Taub teaches wherein the storage unit stores the blood glucose measurement data by crossing the first storage area and the second storage area included in the plurality of storage areas (¶[0121], “where the first predetermined type of data includes error data, the second predetermined type of data includes monitored physiological condition data, where when an error condition associated with operation of the glucose sensor is detected by the processing unit, the processing unit is configured to store data associated with the first predetermined type of data in a subset of the second plurality of memory locations of the memory unit.” That is, error data is crossed from the first memory area of a first plurality of memory locations associated with the first predetermined type of data to a memory area associated with the second plurality of memory locations and second predetermined type of data).
Regarding claims 7 and 15, Taub teaches wherein the storage unit stores the first blood glucose measurement data in the first storage space of the first storage area (¶[0121], “ a first plurality of memory locations configured to store a first predetermined type of data”); and stores the second blood glucose measurement data in the first storage space of the second storage area (¶0121], “a second plurality of memory locations configured to store a second predetermined type of data”), wherein the first storage space of the first storage area corresponds to the first storage space of the second storage area (¶[0121], “where the first predetermined type of data includes error data, the second predetermined type of data includes monitored physiological condition data, where when an error condition associated with operation of the glucose sensor is detected by the processing unit, the processing unit is configured to store data associated with the first predetermined type of data in a subset of the second plurality of memory locations of the memory unit”(emphasis added) indicating that the first storage space comprising the first predetermined type of data is duplicated in the second storage area).
Regarding claims 8 and 16, Taub-Lashgari teach wherein the control unit checks the validity of the blood glucose measurement data stored in the first storage area and the second storage area (¶[0092] of Taub, the control unit is configured to store data); and the communication unit includes a step of transmitting blood glucose measurement data determined to be valid among the blood glucose measurement data stored in the first storage area and the second storage area to the external device (fig. 1 of Taub and [0248]).
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Taub in view of Lashgari, as applied to claim 5, and further in view of Gill et al. (US 20240298969), hereinafter Gill.
Regarding claims 6 and 14, Taub teaches wherein the storage unit stores first blood glucose measurement data in a first storage space of the first storage area (¶[0121], “a memory unit having a first plurality of memory locations configured to store a first predetermined type of data”); and
stores second blood glucose measurement data in a second storage space of the second storage area (¶[0121], “a second plurality of memory locations configured to store a second predetermined type of data”),
wherein the first storage space and the second storage space of the first storage area correspond to the first storage space and the second storage space of the second storage area (¶[0121], “where when an error condition associated with operation of the glucose sensor is detected by the processing unit, the processing unit is configured to store data associated with the first predetermined type of data in a subset of the second plurality of memory locations of the memory unit” indicates that the two storage areas mirror each other), but fails to teach the first storage space and the second storage space are continuous with each other.
Gill teaches a medical device configured to sensor physiological characteristics and generated physiological data indicative of the characteristics (abstract). The device is configured to index continuously across memory areas to aid in unnecessarily consuming battery power, assisting with data stitching of multiple data units into a continuous section(s) of data, and identifying gaps in the data (¶[0151-65]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Taub-Lashgari, such that the first storage space and the second storage space are continuous with each other, as taught by Gill, to aid in unnecessarily consuming battery power, assisting with data stitching of multiple data units into a continuous section(s) of data, and identifying gaps in the data.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ballantyne teaches activating the agent module to transmit a request to the remote server via the enabled communications link; receive files from the remote server, and store the received files from the remote server in the predetermined memory locations accessible by the agent module; validating the downloaded files, with the data management module, prior to transferring the downloaded files stored within the predetermining memory locations into an internal memory accessible by the medical device control software. US 20160058933
McLane teaches transmitting, by the device, the error corrected collected biological signals as encrypted data over a secure connection to a cloud system. US 12262973
Suzuki teaches error log information automatically stored and accumulated in a certain storage area of the PDA 8 as described later is transmitted to the server system together with the ending notification. US 20050240441
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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