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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“measurement unit” first recited in claim 1, whose corresponding structure is understood to be an invasive glucose monitor as per Applicant’s description of the invention at Page 3 and 12;
“control unit” first recited in claim 1, whose corresponding structure is understood to be the processing components of a blood glucose monitoring device as shown at Fig. 1 and described at page 11;
“storage unit” first recited in claim 1, whose corresponding structure is understood to be the memory or data storage components of a blood glucose monitoring device as shown at Fig. 1 and described at page 13;
“communication unit” first recited in claim 5, whose corresponding structure is understood to “include an infrared communication module, an NFC (Near Field Communication) module, a Bluetooth module, a WiFi (Wireless Fidelity) module, an LTE module, etc.” as described at page 15.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 4, 8, 12, and 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Re. Claims 4 and 12: Claims 4 and 12 each recite “the file size corresponding to the remaining portion of the blood glucose measurement data.” There is insufficient antecedent basis for this limitation in the claim.
Claims 4 and 12 each recite “the file size of the second verification data from the position where transmission was stopped.” There is insufficient antecedent basis for this limitation in the claim.
Re. Claims 8 and 16: Claims 8 and 16 recite the term “CRC value;” however, Applicant’s Specification and claims fail to provide a definition for this term. For purposes of examination, the phrase “CRC value” is interpreted as “cyclic redundancy check value.”
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 5-11, and 13-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Cole et al. (US 20250098959 A1) (hereinafter – Cole).
Re. Claims 1 and 9: Cole teaches a blood glucose measurement device (Figs. 1, 2, 6A-6C, 10, 12, 13: sensor 110; alternatively or additionally, a blood glucose measurement device may further comprise receiving devices 120, 130 and components thereof)
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 (Paragraph 0078: “As embodied herein, the sensing hardware 260 can include an analyte sensor transcutaneously or subcutaneously positioned in contact with a bodily fluid of a subject;” Fig. 2: sensor hardware 260 as described in Paragraph 0181: “…data gathered by the sensor 110 (e.g., through the sensor hardware 260)”);
a control unit that generates blood glucose measurement data by converting the blood glucose measurement signal into digital data (Paragraph 0098: “As an example, and not limitation, the data can include raw data from one or more components of the sensing hardware 260 (e.g., a signal value read from an analog-to-digital converter), data used to process raw data from the components of the sensing hardware 260 (e.g., a temperature level, noise level, etc.), data that has been processed by the analyte sensor 110 into another usable format (e.g., human-readable data), etc. The data can further include derivative values calculated from the sensor data, such as calculated rates of changes, trending values, projected values, etc.;” Paragraph 0177: “The operating system 213 can comprise various application programs for collecting and analyzing biological signals such as analyte levels;” additionally or alternatively, controllers of receiving devices 120, 130 may be considered further comprising a claimed control unit); and
a storage unit that stores the blood glucose measurement data (Paragraph 0103: “At 505, the analyte sensor 110 can collect analyte data from a subject… In particular embodiments, the sensing hardware can include an analyte sensor for measuring the levels of an analyte (e.g., glucose… The analyte sensor 110 can receive input from the sensing hardware (e.g., analyte sensor, temperature sensor, etc.)… the input from the sensing hardware can be processed by the analyte sensor. The input can be temporarily stored into a memory of the analyte sensor 110 (e.g., a volatile memory or RAM of an ASIC or other control unit).”),
wherein the control unit stores preset first verification data in the storage unit, and stores the blood glucose measurement data in the storage unit continuously to the first verification data (Fig. 4: any one of packet header, payload header, connection data, and/or integrity check value).
Claim 9 recites limitations of claim 1 mutatis mutandis as a method claim, and is rejected analogously to claim 1.
Re. Claims 2 and 10: Cole teaches the invention according to claims 1 and 9. Cole further teaches the invention wherein if a preset predetermined condition is satisfied, the control unit stores second verification data continuously to the blood glucose measurement data (Fig. 4: any other of the header, payload header, connection data, and/or integrity check value).
Re. Claims 3 and 11: Cole teaches the invention according to claims 2 and 10. Cole further teaches the invention wherein if storage of the blood glucose measurement data is completed without the occurrence of a specific event during the storage of the blood glucose measurement data, the control unit stores the second verification data continuously to the blood glucose measurement data (Fig. 4; Examiner notes that storage of the values for header, payload header, connection data, and/or integrity check value each occur without the occurrence of a non-specified “specific event”).
Re. Claims 5 and 13: Cole teaches the invention according to claims 2 and 10. Cole further teaches the invention further comprising a communication unit that transmits the stored blood glucose measurement data based on the control of the control unit (Abstract: “The analyte sensor may also include a communication module. A first receiver device may be wirelessly coupled to the communication module of the analyte sensor and configured to receive analyte data from the analyte sensor;” alternatively or additionally, Fig. 1: see communication between receiving devices and user device 140 or remote server 150).
Re. Claims 6 and 14: Cole teaches the invention according to claims 5 and 13. Cole further teaches the invention wherein the control unit compares at least one of the first verification data and the second verification data with a specific value corresponding to each of them;
if at least one of the first verification data and the second verification data and the specific value corresponding to each of them match each other, transmits the blood glucose measurement data to an external device through the communication unit; and
if at least one of the first verification data and the second verification data and the specific value corresponding to each of them do not match each other, transmits flag data and the blood glucose measurement data to the external device through the communication unit, wherein the flag data is data indicating the occurrence of an error for the blood glucose measurement data
(Paragraph 0099: “In particular embodiments, when a receiving device receives the packet 400 (and decrypts the payload 410, if the integrity check value 430 is stored in the payload 410), the receiving device can compare to the value of the integrity check value 430 to a counterpart check value 430. If the received integrity check value 430 does not correspond to the counterpart check value 430, the receiving device can disregard the payload 410 or inform the analyte sensor 110, subject, or user of the receiving device of a possible error. In particular embodiments, the counterpart check value can include a value calculated by the received device after receiving the packet 400 using the same algorithm or formula and input data as would have been used by the analyte sensor 110 in preparing the integrity check value 430 prior to transmission”).
Re. Claims 7 and 15: Cole teaches the invention according to claims 2 and 10. Cole further teaches the invention wherein at least one of the first verification data and the second verification data has a file size of at least 1 byte (Paragraph 0206: “As an example, as embodied herein, an appropriately-sized error detection code for the length of the message (e.g., a 16-bit CRC) can be used”).
Re. Claims 8 and 16: Cole teaches the invention according to claims 2 and 10. Cole further teaches the invention wherein at least one of the first verification data and the second verification data includes at least one of a CRC value or a parity bit (Paragraph 0206: “As an example, as embodied herein, an appropriately-sized error detection code for the length of the message (e.g., a 16-bit CRC) can be used”).
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.
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over:
Cole et al. (US 20250098959 A1) (hereinafter – Cole) in view of
Oh (US 20200233739 A1) (hereinafter – Oh).
Re. Claims 4 and 12: Cole teaches the invention according to claims 2 and 10, btu does not teach the invention wherein if storage of the blood glucose measurement data is stopped due to the occurrence of a specific event during the storage of the blood glucose measurement data, the control unit stores dummy data by the file size corresponding to the remaining portion of the blood glucose measurement data and the file size of the second verification data from the position where transmission was stopped.
Oh teaches analogous art in the technology of data validation for memory devices when specific events have occurred (Abstract). Oh further teaches the invention wherein if storage of the blood glucose measurement data is stopped due to the occurrence of a specific event during the storage of the blood glucose measurement data, the control unit stores dummy data by the file size corresponding to the remaining portion of the blood glucose measurement data and the file size of the second verification data from the position where transmission was stopped (Paragraph 0044: “Referring to FIGS. 1 and 2, it is assumed that an SPO has occurred during a program operation for data DT_3 in a fourth page PG3 of a first memory block. A general storage device (e.g., non-volatile memory device 200) allocates a new memory block without using the corresponding memory block any more when a specific event occurs during a program operation, stores user data in a newly allocated memory block and performs an erase operation on the previous memory block, thereby increasing the number (“quantity”) of unnecessary erase operations due to the occurrence of a specific event. In some example embodiments, dummy data is stored in a page in which no data is stored among the plurality of pages included in the memory block in which the program operation is interrupted due to the SPO, or a memory block in which the SPO has occurred is set as a closed block to block the program operation to the remaining pages”).
It would have been obvious to one having ordinary skill in the art before the effective filing date to have modified Cole to utilize the data-preserving features of Oh, the motivation being that doing so enables data preservation during a sudden power off event (Paragraphs 0007-0008).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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