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 .
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. 17/935094, filed on 9/24/2022.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 11-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,147,332. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variant of each other.
Instant Application
U.S. Patent No. 12,147,332
Claim 11:
A method for storing measurement data detected by a sensor and indicative of an analyte in a sample of a body fluid, comprising, in a system having a processor and a memory:
providing a first measurement data set comprising a first measurement value for an analyte in a sample of a body fluid measured by a sensor;
providing second measurement data set comprising a second measurement value for the analyte in the sample of the body fluid measured by the sensor;
wherein the first measurement data set and/or the second measurement data set further comprise a value selected from the group consisting of: orientation of the sensor, median of a current flowing into the sensor, a standard deviation, a sensor voltage median, a battery voltage, temperature of the device, and an event flag;
determining a relative measurement data set comprising a value difference between the measurement values in the first and second measurement data sets;
storing the first measurement data set in the memory;
storing the relative measurement data set in the memory in the memory, wherein the first measurement data set occupies a larger area in the memory than the relative measurement data set; and
storing an indicator assigned to the relative measurement data set in the memory and indicative of a characteristic of the relative measurement data set
Claim 1:
A method for storing measurement data detected by a sensor and indicative of an analyte in a sample of a body fluid, comprising, in a system having a processor and a memory:
dividing the memory into at least two pages, wherein a size of the at least two pages matches a page size of a flash or EEPROM memory;
providing first measurement data indicative of a first measurement value for an analyte in a sample of a body fluid measured by a sensor, wherein each of the at least two pages in the memory comprises a header having the first measurement data, whereby each of the at least two pages is configured to be decoded independently;
providing second measurement data indicative of a second measurement value for the analyte in the sample of the body fluid measured by the sensor;
determining a relative measurement value by the processor, the relative measurement value being indicative of a value difference between the first measurement value and the second measurement value;
providing first measurement storage data in the memory, comprising storing the first measurement value in a first storage area having a first storage size in the memory;
providing relative measurement storage data in the memory, comprising storing the relative measurement value in the memory, the relative measurement storage data stored in a second storage area having a second storage size in the memory which is smaller than the first storage size; and
storing an indicator in the memory, the indicator being assigned to the relative measurement storage data in the memory and indicative of a characteristic of the relative measurement storage data.
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are substantially similar in scope and they use the same limitations. It would have been obvious to a person of ordinary skill in the art at the time the invention was made to add “wherein the first measurement data set and/or the second measurement data set further comprise a value selected from the group consisting of: orientation of the sensor, median of a current flowing into the sensor, a standard deviation, a sensor voltage median, a battery voltage, temperature of the device, and an event flag”, which is a common way within the art to design sensors with a medical monitoring device, and omit the additional elements "dividing the memory into at least two pages, wherein a size of the at least two pages matches a page size of a flash or EEPROM memory; wherein each of the at least two pages in the memory comprises a header having the first measurement data, whereby each of the at least two pages is configured to be decoded independently" of claims 1-12 of U.S. Patent No. 12,147,332 to arrive at the claims 11-19 of the instant application because the person would have realized that the remaining element would perform the same functions as before. "Omission of element and its function in combination is obvious expedient if the remaining elements perform same functions as before." See In re Karlson (CCPA) 136 USPQ 184, decide Jan 16, 1963, Appl. No. 6857, U. S. Court of Customs and Patent Appeals.
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.
Claims 11-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
As to independent claims 11 and 19:
At Step 1:
The claims are directed to a “method” and “system” and thus directed to a statutory category
At Step 2A, Prong One:
The claims recite the following limitations directed to an abstract idea:
“providing a first measurement data set comprising a first measurement value for an analyte in a sample of a body fluid measured by a sensor” as drafted this recites generating (i.e. collecting) data - certain methods of organizing human activity
“providing second measurement data set comprising a second measurement value for the analyte in the sample of the body fluid measured by the sensor” - as drafted this recites generating (i.e. collecting) data - certain methods of organizing human activity
“wherein the first measurement data set and/or the second measurement data set further comprise a value selected from the group consisting of: orientation of the sensor, median of a current flowing into the sensor, a standard deviation, a sensor voltage median, a battery voltage, temperature of the device, and an event flag” - as drafted this recites generating (i.e. collecting) data - certain methods of organizing human activity
“determining a relative measurement data set comprising a value difference between the measurement values in the first and second measurement data sets” as drafted this recites analyzing and providing data – a mental process of evaluating data that can be performed in the human mind or using a pen and paper
“storing the first measurement data set in the memory” as drafted this recites generating (i.e. collecting) data - certain methods of organizing human activity
“storing the relative measurement data set in the memory in the memory, wherein the first measurement data set occupies a larger area in the memory than the relative measurement data set” as drafted this recites generating (i.e. collecting) data - certain methods of organizing human activity
“storing an indicator assigned to the relative measurement data set in the memory and indicative of a characteristic of the relative measurement data set” as drafted this recites generating (i.e. collecting) data - certain methods of organizing human activity
The mere nominal recitation of a generic computing device does not take the claim out of the “certain methods of organizing human activity” or “a mental process of evaluating data” groupings. Thus, the claim recites an abstract idea.
At Step 2A, Prong Two:
This judicial exception is not integrated into a practical application because the claim as a whole merely describes how to generally “apply” the concept of collecting, analyzing, and providing data in a computer environment. The claimed “a computing system including at least one processor” are each recited at a high level of generality and are merely invoked as tools to perform an existing data retrieval process. Even considered in combination, simply implementing the abstract idea on a generic computer recited at a high level of generality is not a practical application of the abstract idea.
At Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because as noted previously, the “a computing system including at least one processor” individually and in combination merely describe how to generally “apply” the concept of collecting, analyzing, and providing data in a computer environment. The same applies here. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea. The claim is ineligible.
As to dependent claims 22-38:
At Step 1:
The claims are directed to a “method” and thus directed to a statutory category
At Step 2A, Prong One:
The claims recite the following limitations directed to an abstract idea:
“storing an additional indicator assigned to the first measurement data set in the memory and indicative of a characteristic of the first measurement data set” as drafted this recites obtaining (i.e. collecting) data - certain methods of organizing human activity
“the first measurement value is stored as an absolute value of the first measurement value” as drafted this recites analyzing data – mathematical concept
“storing the first measurement value, the relative measurement value, and the indicator bit by bit in a consecutive order of data bits” - as drafted this recites obtaining (i.e. collecting) data - certain methods of organizing human activity
“the relative measurement value storage size is smaller by one or more bits than the first measurement value storage size” as drafted this recites insignificant activity
“the indicator assigned to the relative measurement data set is indicative of a number of data bits assigned to the relative measurement data set in the memory” as drafted this recites analyzing and providing data – a mental process of evaluating data that can be performed in the human mind or using a pen and paper
“the indicator assigned to the relative measurement data set is indicative of a data compression characteristic of the relative measurement data set” as drafted this recites analyzing and providing data – a mental process of evaluating data that can be performed in the human mind or using a pen and paper
“the indicator is provided in a header information in the memory” as drafted this recites analyzing and providing data – a mental process of evaluating data that can be performed in the human mind or using a pen and paper
The mere nominal recitation of a generic computing device does not take the claim out of the “certain methods of organizing human activity” or “a mental process of evaluating data” groupings. Thus, the claim recites an abstract idea.
At Step 2A, Prong Two:
This judicial exception is not integrated into a practical application because the claim as a whole merely describes how to generally “apply” the concept of collecting, analyzing, and providing data in a computer environment. The claimed “computing device” are each recited at a high level of generality and are merely invoked as tools to perform an existing data retrieval process. Even considered in combination, simply implementing the abstract idea on a generic computer recited at a high level of generality is not a practical application of the abstract idea.
At Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because as noted previously, the “computing device” individually and in combination merely describe how to generally “apply” the concept of collecting, analyzing, and providing data in a computer environment. The same applies here. Thus, even when viewed as a whole, nothing in the claim adds significantly more (i.e., an inventive concept) to the abstract idea. The claim is ineligible.
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.
Claim(s) 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muhlenberg et al (US 5,836,982) in view of Pankalla et al (US 2020/0217814 A1).
As to claims 11 and 19, Muhlenberg teaches a method for storing measurement data detected by a sensor
(Please see column 2 line 28-33 disclosing a system for compressing and storing measurements of battery powered sensor devices. Muhelnberg refers generally to sensors for physiological signals and exemplarily to sensors for cardiac signals and does not disclose that the data measured by the sensor device are indicative of an analyte in a sample of bodily fluid.)
providing first measurement data indicative of a first measurement value
(Please see column 4 line 39-42 disclosing storing individual samples. As already mentioned, the measured data of Muhelnberg is not specific for analytes ina sample of bodily fluid.)
providing second measurement data indicative of a second measurement value
(Please see column 4 line 39-42 disclosing storing successive individual samples, i.e. a second measurement data. As already mentioned, the measured data of Muhelnberg is not specific for analytes in a sample of bodily fluid.)
determining a relative measurement value by the processor, the relative measurement value being indicative of a value difference between the first measurement value and the second measurement value;
(Please see column 4 line 39-42 disclosing storing the deltas (i.e. the value differences) between successive individual samples.)
storing the first measurement value in the memory (Muhlenberg gathers samples as analog signals and converts them to digital signals. Then the digital signals are stored in memory. See column 4, lines 13-32);
storing the relative measurement value in the memory, wherein the first measurement data set occupies a larger area in the memory than the relative measurement data set; and
(Please see column 4 line 39-42 disclosing storing the number of significant bits corresponding to the first sample and the deltas (i.e. the value differences) between successive second samples, with a minimum number of bits, implicitly in a second storage area, implicitly with smaller size, writing only the corresponding least significant bits.)
storing an indicator assigned to the relative measurement data set in the memory and indicative of a characteristic of the relative measurement data set.
(Please see column 4 lines 63 to column 5 lines 6, disclosing storing the number of significant bits (i.e. the indicator) in a block header and then writing all assembled deltas by writing only the NBits least significant bits (i.e. relative measurement storage data) plus one sign bit indicating a positive or negative delta (i.e. indicative of a characteristic of the relative measurement storage data), relative to the periodic individual samples (i.e. "first measurement data"). )
Muhlenberg fails to teach storing measurement data detected by a sensor and indicative of an analyte in a sample of a body fluid; and wherein the first measurement data set and/or the second measurement data set further comprise a value selected from the group consisting of: orientation of the sensor, median of a current flowing into the sensor, a standard deviation, a sensor voltage median, a battery voltage, temperature of the device, and an event flag.
However, Pankalla teaches storing measurement data detected by a sensor and indicative of an analyte in a sample of a body fluid (Please see paragraph [0015]); and wherein the first measurement data set and/or the second measurement data set further comprise a value selected from the group consisting of: orientation of the sensor, median of a current flowing into the sensor, a standard deviation, a sensor voltage median, a battery voltage, temperature of the device, and an event flag (Pankalla discloses the electrochemical sensor may be adapted to generate at least one electrical measurement signal which may directly or indirectly indicate a presence and/or an extent of the electrochemical detection reaction, such as at least one current signal and/or at least one voltage signal. See [0020]).
Before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art, to modify the teachings of Muhlenberg to incorporate the sensor system adapted for adapted for detecting at least one analyte in a sample of a body fluid as taught by Pankalla for the purpose of prevention and treatment of various diseases by evaluating the electrical measurement.
As to claim 12, Muhlenberg teaches storing an additional indicator assigned to the first measurement data set in the memory and indicative of a characteristic of the first measurement data set (Please see column 7, lines 1-7 for Adding the marker channel data to the compressed signal results in a slight decrease in the compression ratio due to the addition of the record indicator, which is the price paid for adding the additional marker channel data.).
As to claim 13, Muhlenberg teaches the first measurement value is stored as an absolute value of the first measurement value (Muhlenberg discloses storing of a measurement, e.g. lastSample in Fig. 2 point 42).
As to claim 14, Muhlenberg teaches storing the first measurement value, the relative measurement value, and the indicator bit by bit in a consecutive order of data bits (Muhlenberg discloses storing bitwise the sample, the delta and any "indicators" consecutively, e.g. fig 3. The particular and arbitrary order of storing of the header, value, delta, sign, etc. is straightforward to implement for a skilled artisan).
As to claim 15, Muhlenberg teaches the second storage size is smaller by one or more bits than the first storage size (Muhlenberg discloses storing of only the least significant bits for the relative values (deltas), hence storage size being smaller. Column 4 line 36 discloses a 2:1 compression ratio.).
As to claim 16, Muhlenberg teaches the indicator assigned to the relative measurement data set is indicative of a number of data bits assigned to the relative measurement data set in the memory (Muhlenberg discloses in Figure 4 determination and use of a number of bits allocated to the sample and the deltas, saved in a header block.).
As to claim 17, Muhlenberg teaches the indicator assigned to the relative measurement data set is indicative of a data compression characteristic of the relative measurement data set (Muhlenberg discloses determination of NBits used for encoding the value or deltas, which is a "data compression characteristic". Column 5, line 47 through column 6, line 21.).
As to claim 18, Muhlenberg teaches the indicator is provided in a header information in the memory (Muhlenberg discloses storage of the indicators in the headers of a memory block column 5 line 4.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Haase et al (US 20210137430 A1) - A fully implantable sensor for detecting an analyte in a body fluid sample is disclosed. The sensor includes a chamber plate that receives the body fluid sample. The chamber plate has a biocompatible polymer membrane having a molecular weight cutoff of at least 15 kDa. The sensor also includes a quantum cascade laser illumination source that generates an illumination light beam in a spectral range and transmits the light beam to the chamber plate. In response to the illumination light beam at least partially illuminating the chamber plate, the chamber plate generates a reflection light beam that at least partially illuminates the body fluid sample within the chamber plate. The sensor has an optical detector that detects at least one property of the reflection light beam and generates a sensor signal that correlates to the presence of the analyte. The sensor includes a controller to evaluate the sensor signal.
Chen et al (US 20170235911 A1) - A system for measuring health data includes a measurement device. The measurement device includes at least one measurement interface to receive a first fluid sample, a processor to measure one or more first characteristics of the first fluid sample, and at least one memory device to store first data. The processor reads the first data and measures the one or more first characteristics of the first fluid sample according to the first data. The at least one memory device also stores second data. The processor reads the second data instead of the first data to reconfigure the measurement device and measures one or more second characteristics of a second fluid sample according to the second data. An external processing device may be communicatively coupled to the measurement device and may execute a healthcare application that communicates with the measurement device and may be employed to reconfigure the measurement device.
Hayter (US 20070270672 A1) - A system for determining the level of an analyte in a physiological fluid of a live individual is described. A wearable sensor periodically obtains data representative of the level of the analyte and has a passive RFID tag that stores the data. A receiver wirelessly interrogates the sensor with an RF interrogation signal. The RFID tag modulates or otherwise modifies the wireless interrogation signal using the data and the receiver receives back the modulated or otherwise modified interrogation signal and extracts the data from it. The receiver then determines, from the data, the level of the analyte in the fluid. The sensor may be a photometric or colorimetric sensor or an electrochemical sensor. The receiver may be, or be incorporated into, a hand-held device, a portable device, a PDA, a mobile telephone, or a laptop computer. The resulting system is more versatile and consumes less power than conventional systems.
Hall et al (US 20060189926 A1) - An apparatus is provided for monitoring a predetermined parameter of a patient's body fluid while infusing an infusion fluid into the patient. The apparatus comprises an infusion line and a catheter configured for insertion into a blood vessel of the patient, and a reversible infusion pump connected between a source of an infusion fluid and the infusion line and catheter. The apparatus further comprises a body fluid sensor assembly mounted in fluid communication with the infusion line and which includes a first sensor and a sample cell. The first sensor provides a signal indicative of a predetermined parameter of any fluid present in the infusion line. The sample cell is substantially transmissive to light comprising a wavelength B. The apparatus further comprises a controller that is configured to operate the infusion pump in a forward direction so as to pump the infusion fluid through the infusion line and catheter for infusion into the patient. The controller is configured to intermittently interrupt its operating of the infusion pump in the forward direction to operate the infusion pump in a rearward direction so as to draw a body fluid sample from the patient through the catheter and infusion line. The body fluid sample drawn from the patient is disposed such that a first portion of the body fluid sample is in sensing contact with the first sensor of the body fluid sensor assembly, and a second portion of the body fluid sample is disposed within the sample cell of the body fluid sensor assembly. The controller further is configured to monitor the signal provided by the first sensor of the body fluid sensor assembly and to detect a change in the signal indicative of the arrival of the body fluid sample at the first sensor. The controller, in response to detecting the arrival of the body fluid sample at the first sensor, is configured to cease its operating of the infusion pump in the rearward direction. The signal produced by the first sensor provides an indication of a predetermined parameter of the patient's body fluid when the body fluid sample is in sensing contact with the first sensor.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED M BIBBEE whose telephone number is (571)270-1054. The examiner can normally be reached Monday-Thursday 8AM-6PM.
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/JARED M BIBBEE/Primary Examiner, Art Unit 2161