Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Summary
This is the Non-Final Office action based on the RCE 17/466741, DIV of 14/731045 application, RCE filed 05/19/2025.
Claims 21-23, 26-36, 38, & 40-41 are pending and have fully been considered.
Claims 1-20, 24-25, 37, & 39 have been cancelled.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/19/2025 has been entered.
Claim Interpretation
Independent Claims 21, 35, & 38 all require the device components including a holder, a detector, an interface/memory, and a processor. They do not require the test element mentioned in the instant claims. As claimed it is only that the detector has to be configured to measure using the test element and that the holder has to be configured to receive the test element. As claimed- the test element is not claimed as a separate element like the holder, detector, interface, and processor instantly claimed, but instead the test element is only claimed as something which the claimed holder and detector are “configured to,” interact with.
As claimed, both the holder and detector are claimed very broadly and generally in that it is, “an electrochemical-based detector or a photometric detector.”
Further, as instantly claimed, the processor seems to only be performing a general simple comparison of one number to another number, and making an adjusting the measured hematocrit value based on a deviation (difference in the values).
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 21, 35, 38, and those dependent therefrom including Claims 22-23, 26-34, 36 & 40-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Through 101, inquiry analysis:
Step 1-Is the claim directed to a statutory category of invention?
Yes, the independent claims 21, 35, & 38 are drawn towards a statutory category of a device/machine.
Step 2A, Prong 1-Do the claims involve a Judicial Exception?
Yes. The independent claims 21, 35, & 38 involve/recites the judicial exceptions of an abstract idea which is the mathematical comparison between the hematocrit reference value and a measured blood glucose value, that is claimed to be programmed/configured into the instant processor. The processor is also configured to, “adjusts,” / modifies the measured glucose value to an “adjusted glucose value,” based on the deviation/difference between the hematocrit reference value and the measured blood glucose value.
The instant processor is claimed as configured to determine hematocrit correction based on simple comparison to a hematocrit correction value, and then to adjust the measured glucose value based on the deviation found during the comparison. This is all simple math or simple mental processes which are abstract ideas, which as claimed are automated/performed on a generic computer/ processor. See MPEP 2106.04(a)(2) abstract idea groups, III- Mental processes: “claim that requires a computer may still recite a mental process.”
Step 2A, Prong 2— Is the judicial exception practically applied?
The claims do not integrate the abstract idea into a practical application.
The claimed holder, detector which is electrochemical or photometric, interface with memory storing a reference value, and processor in Claims 21, 35, & 38 are generic. All of these device parts are claimed very generally and without specificity or particularity of structure. Therefore, as instantly claimed- these claimed structures do not provide meaningful limitation to integrate the judicial exception into a practical application.
With respect to the claim limitation of outputting/displaying the adjusted glucose value on the glucose meter. This is considered extra-solution activity or stating to “apply it,” with respect to the judicial exception, so does not practically apply. See MPEP 2106.05 (f).
Further with respect to the claimed configuration of the processor, to determine hematocrit correction based on comparison to a hematocrit correction value, and then to adjust the measured glucose value based on the deviation (difference) found during the comparison, this is all simple math or simple mental processes which are automated and performed on a computer. Further, as claimed this processor is considered a general-purpose/generic computer. See MPEP 2106.04(a)(2) (C): “performing mental process on a generic computer.”
Step 2B— Do the claims include significantly more than the judicial exceptions?
The additional elements claimed a “holder,” “a detector,” “a memory,”, in some claims, “and interface,” in some claims, and also “a reference instrument,” are well understood routine and conventional (WURC) for hematocrit detection, especially at the level of generality claimed. See MPEP 2106.05(d) which deals with what is considered “Well-Understood, Routine and Conventional”. Things that are WURC are not considered to add significantly more.
The dependent claims are analyzed the same way as the claims above.
Claim 22, specifies that the processor only corrects the hematocrit correction “if,” both values are received and Claim 29 specifies that no measurement happens if no value is received, and Claims 34 & 41, “if” values are received within certain periods of time. This again is merely automating a simple mental process and does not move the claims to be an application of the judicial exception.
Claim 23, specifies that the meter is handheld. These types of meters are routine and conventional in the art so this does not change matters.
Claim 26, specifies that the detector is a photometric detector. Photometric detectors are routine and conventional in the art- so this does not move the claim to be a practical application of the judicial exception.
Claim 27, specifies that the test element, which is not instantly positively claimed as actually a required part of the independent claims for the meter is “positionable,” in the optical path. This means, it is able to be positioned/optional- and even if it weren’t optional- positioning of a test element would not integrate the judicial exception into a practical application.
Claims 28 & 30 specifies further configuration of the processor to display user identification and to display other information. This is routine and conventional in the art so therefore does not change matters.
Claim 31 does not change the matters above as it specifies that the comparison is performed with respect to a lookup table, and therefore the processor merely is automating a simple mental process and is a general-purpose computer.
Claims 32-33 does not change matters. Use of RFID chips is routine and conventional in the art, so by itself does not integrate the judicial exception into a practical application.
Claim 36 does not change matters, as it only adds a “laboratory analyzer.” These are routine and conventional in the art.
Claim 40 does not change matters as it only adds that the interface is configured for wireless communication, which is routine and conventional in the art.
Claim Rejections - 35 USC § 103
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 patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, 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 negatived by the manner in which the invention was made.
Claims 21-23, 26-36, 38, & 40-41 are rejected under 35 U.S.C. 103 (a) as being obvious over McCOLL in US 20110073494 in view of COSENTINO in US 20070231209 and further in view of HAYTER in US 20070270672.
With respect to Claim 21-22 & 38, MCCOLL teach of a multianalyte measurement system having a meter and a test strip(abstract). The device provides hematocrit measurements by applying a test voltage between a reference electrode and a first working electrode; measuring a first test current, a second test current and a third test current at the working electrode with the meter after a blood sample containing an analyte is applied to the test strip; and estimating a hematocrit-corrected analyte concentration from the first, second and third test currents; and displaying the hematocrit-corrected analyte concentration(abstract).
More specifically, McCOLL et al. teach of a holder/strip port (110) (paragraph 0057) configured to receive a disposable test element/test strip, an electronic component for measuring test currents, which can read on the claimed “electrochemical detector,” (paragraphs 0057-0058) which is configured to provide a measured glucose value (paragraph 0071, 0089), an interface (108), and a processor (122), and a display (104) and a memory (120) (paragraph 0057).
McCOLL et al. also teach of the processor making hematocrit corrected glucose measurements with equations (paragraph 0010-0018, 0024-0030, 0082-0109 among others), and of repeating process steps which includes repeating measurements (paragraph 0130, 0123, 0126). McCOLL teaches of recognizing hematocrit bias (paragraph 0005) and making corrections/adjustments based on differences from these bias (paragraph 0027-0032 & 0083).
McCOLL et al. also teaches of all of the instantly claimed “configurations,” as broadly claimed. As broadly claimed, the device is not required to have a blood sample and reference sample that are different from each other as this is a methodical limitation or and sample worked upon and not part of the claimed device. However, since McCOLL does not clearly call out comparison to a predetermined reference value stored in memory as claimed-CONSTENTINO is used to remedy this.
CONSENTINO et al. teach of a device for detecting glucose using a test strip. The test strip includes an insertion portion and an exposed portion. The exposed portion of the test strip is arranged to accept a blood sample from a patient. The test strip includes a calibration identifier accessible to a calibration identifier access device in a glucose meter via an interface residing at least partially within the insertion portion. The calibration identifier includes a calibration code for calibrating the glucose meter to the test strip (abstract).
CONSENTINO et al also teach of the device being wireless (paragraph 0005), of using software outside the glucose meter (paragraph 0073, 0215, 0245), of using an RFID (machine readable) means (paragraph 0083). CONSENTINO et al. also teach of connecting with an external database with a user/calibration identifier (abstract and paragraph 0006). CONSENTINO et al. further teach of the device being an optical detection device (paragraph 0245, Claim 2). CONSENTINO et al. further teach of coordinated listen and detect module for the glucose meter (paragraph 0170) which reads on the instantly broadly claimed repeated conduction and correction of detected glucose measurements with hematocrit (paragraph 0170).
CONSTENTINO further teach of storing test results and reference values (look up table values) in a memory database or storage (the memory can be considered an interface and any value can be considered “predetermined,” as claimed if it is stored )(paragraph 0150, 0087-0088, 0108, 0130). (Consistent with instant application Claim 31—the hematocrit reference value can be from a look-up table.)
This memory in CONSTENTINO is considered to be, “configured to store said predetermined hematocrit reference value, said predetermined hematocrit reference value being determined by an external reference instrument, wherein the fresh blood sample and the reference blood sample are distinct from each other,” since no external reference instrument is actively determining a reference value within the bounds of these claims. This also applies to the processor since it depends on these limitations. This is because—the device a memory in CONSTENTINO is capable of/configured to receive input/predetermined values, particularly of the look up table type (as applicant instantly claimed in Claim 31 that the hematocrit correction values can be).
It would have been obvious to one of ordinary skill in the art and one would have had reasonable expectation of success to compare use the lookup table/predetermined values stored in memory of CONSTENTINO that are stored in memory with the device of McCOLL due to the needs for improvements on glucose meters and the need for more frequent communication/testing when it comes to glucose measurements (CONSENTINO, paragraph 0006-0009) and due to the advantage memory storage has for showing trends and past results and due to the advantage stored look up tables have to help determine accurate blood glucose concentrations (CONSENTINO, paragraph 0108, 0116, 0150).
McCOLL and CONSENTINO do not call out that the detector is specifically “electrochemical,” or “photometric,” based.
HAYTER is used to remedy this and more specifically teach of a wearable sensor system(abstract). HAYTER et al. further teach of the device being able to sense/detect glucose (paragraph 0017, 0033, 0036), and further of the detector being a photometric or a photodiode (paragraph 0034, 0081, 0135, abstract). It would have been obvious to one of ordinary skill in the art and one would have had reasonable expectation of success to use the photometric sensor of HAYTER as or in place of the sensor in McCOLL or CONSENTINO due to the advantage the offer with offering many detectable characteristic such as opacity, transparency, fluorescence, absorptivity among others (McCOLL, paragraph 0034).
With respect to Claim 23, CONSTENTINO et al. teach of a portable (can be hand-held) device the Cardiocom.RTM. Commander device (paragraph 0065). Also, McCOLL teach of the device being hand held (Figure 1).
With respect to Claims 25 & 40, CONSTENTINO et al. teach of wireless communication (paragraph 0050, 0078, 0094). Also, McCOLL et al. teach of wireless transmission of data (paragraph 0058).
With respect to Claim 26-27, McCOLL teaches that photometric/irradiating with light/optical detection is obvious (paragraph 0006). HAYTER teach of the detector being a photometric or a photodiode (paragraph 0034, 0081, 0135, abstract).
With respect to Claim 28, McCOLL et al. teach of displaying identification information (paragraph 0151). CONSTENTINO also teach of including identification information (paragraph 0089).
With respect to Claims 29-30, McCOLL et al. teach of determination of uncorrected data and of them being displayed in a chart (paragraph 0131-0138). CONSENTINO et al. also teach of determination of failure conditions and indications to not measure if conditions aren’t satisfied (paragraph 0221).
With respect to Claim 31, CONSENTINO et al. teach of using a look up table (paragraph 0150).
With respect to Claims 32-33, CONSTENTINO et al. teach of using an RFID (machine readable) means (paragraph 0083, 0086, 0087).
With respect to Claims 34 & 41, CONSTENTINO et al. teach of determining if the received request was received in the predetermined period of time (paragraph 0161).
With respect to Claims 35-36, See claim 21 rejection. Also, McCOLL et al. teach of using a reference instrument (clinical analyzer) (paragraph 0131-0133).
Response to Arguments
Applicant's arguments filed 05/19/2025 have been fully considered but they are not persuasive.
With respect to the Claim Interpretation section, applicant states that they have amended the claims to add additional clarity. The examiner agrees that amendments dated 05/19/2025 add additional clarity, however the claim interpretation section of this office action is maintained for clarity of the record. This is not a rejection.
Though the amendments dated 05/19/2025 have helped add clarity, the amended claims do not overcome either the 101 or the 103 rejections.
With respect to the 101 rejection, the examiner consulted with their SPE on 11/15/2025 with respect to these claims and the examiner’s SPE agreed the examiner should maintain the 101 rejection.
With respect to the 101 rejection, applicant argues that the instant claims include that the processor is configured to adjust the measured blood glucose value using hematocrit correction value to obtain adjusted glucose value accounting for hematocrit bias. With respect to this, the examiner notes--- that as claimed this claimed correction is only done by a general comparison to a reference value and the correction is performed based on the deviation/difference. As claimed, this is simple math or a simple mental process that is performed on a generic computer. Especially at the level of generality claimed, this does not turn the claimed processor into a specially programmed processor or make it more than a generic computer.
Applicant further argues with respect to the 101 rejection that the function of the claimed glucose meter itself is improved because this adjustment improves accuracy and the glucose measurement is more accurate. With respect to this, this is not seen as “improvement to the functioning of a computer,” as what is claimed is general math/general comparisons. This is not something that improves the functioning of a computer, but instead is a generic computer which is performing simple math/mental process comparisons.
Therefore, the 101 rejection is maintained.
Applicant does not make any substantive arguments about the prior art. Applicant states that in interview dated 02/14/2025 that it was preliminarily agreed that the claim amendments which overcome the 101 rejection would overcome the 103 rejection. The examiner agrees that, if the 101 rejection were overcome, applicant would likely have better luck with the prior art since 3 references were used. However, the 101 was not overcome after consultation with the examiner’s SPE. Unfortunately what is claimed in the instant specification for how, to determine hematocrit detection in paragraph 0045 seems only simple math and the other claimed device parts are generic. Therefore- the examiner is unable to offer a helpful direction to which to amend the claims at this time. Appeal is always an option if applicant decides to try that avenue, but of course this is only a Non-Final action, so applicant is also welcome to file additional amendments in response to this action.
All claims remain rejected as shown above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758