DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. According to the Preliminary Amendment, filed 12 September 2024, the status of the claims is as follows:
Claims 21-40 are new; and
Claims 1-20 are cancelled.
Claim Interpretation
3. 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.
4. 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:
“a continuous analyte monitor” in claim 21, which corresponds to the structure “analyte sensor system 102” in the original disclosure, filed 25 April 2024, para. [0275].
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 § 101
5. 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.
6. Claims 21-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, i.e. abstract idea, without significantly more.
Step 1 of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.03):
Claims 21-33 are directed to a “system”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine. Claims 34-39 are directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e. a process. Claims 21-33 are directed to a “computer-program product comprising a non-transitory computer-usable medium”, which describes one of the four statutory categories of patentable subject matter, i.e. a machine.
Step 2A of the Revised Patent Subject Matter Eligibility Guidance (see MPEP 2106.04):
Claim(s) 21-40, recite the following mental process:
process the monitored sensor data of the first type to determine a monitoring scheme for the continuous analyte monitor, the monitoring scheme comprising a parameter related to operation of a user interface, the processing comprising evaluating user interface preferences of the patient based on at least one of the following:
the patient's frequency of interaction with a device over the first time period;
the patient's responsiveness to alerts based on the monitored sensor data of the first type over the first time period; or
the patient's frequency of interaction with an application associated with the monitored sensor data of the first type over the first time period; and
monitor, over a second time period, the sensor data of the second type according to the determined monitoring scheme.
Based on broadest reasonable interpretation, these limitations are directed to receiving data and performing a mathematical operation, which can be done mentally or using pen and paper.
This judicial exception is not integrated into a practical application because the additional limitations of “a sensor configured to collect sensor data of a first type for a patient” and “a continuous analyte monitor configured to collect sensor data of a second type for the patient” in claim 1, “monitoring, over a first time period, sensor data of a first type for the patient” in claim 34, “wherein the monitoring the sensor data of the first type comprises utilization of a low-fidelity monitoring technique” in claim 24, “wherein the low-fidelity monitoring technique comprises at least one of single point analyte monitoring, blinded continuous analyte monitoring, or an optical monitoring technique” in claim 25, “wherein the sensor comprises an activity sensor comprises an activity sensor” in claim 26, “wherein the sensor comprises a blood glucose meter” in claim 27, “wherein the continuous analyte monitor comprises a continuous glucose monitor” in claim 28, add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the mental process. Furthermore, “a processor in communication with the sensor and the continuous analyte monitor, wherein the process or is configured to:” in claim 1, and “A computer-program product comprising a non-transitory computer-usable medium having computer-readable program code embodied therein, the computer-readable program code adapted to be executed to implement a method comprising:” in claim 40, are merely parts of a computer to be used as a tool to perform the mental process.
Step 2B of the Patent Subject Matter Eligibility Guidance (see MPEP 2106.05):
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional claim limitations individually, the additional limitations that are not directed to the mental process are “a sensor configured to collect sensor data of a first type for a patient” and “a continuous analyte monitor configured to collect sensor data of a second type for the patient” in claim 1, “monitoring, over a first time period, sensor data of a first type for the patient” in claim 34, “wherein the monitoring the sensor data of the first type comprises utilization of a low-fidelity monitoring technique” in claim 24, “wherein the low-fidelity monitoring technique comprises at least one of single point analyte monitoring, blinded continuous analyte monitoring, or an optical monitoring technique” in claim 25, “wherein the sensor comprises an activity sensor comprises an activity sensor” in claim 26, “wherein the sensor comprises a blood glucose meter” in claim 27, “wherein the continuous analyte monitor comprises a continuous glucose monitor” in claim 28. Such limitations are conventional and routine in the art, and add insignificant pre-solution activity to the abstract idea that merely collects data to be used by the abstract idea.
The additional limitations “a processor in communication with the sensor and the continuous analyte monitor, wherein the process or is configured to:” in claim 1, and “A computer-program product comprising a non-transitory computer-usable medium having computer-readable program code embodied therein, the computer-readable program code adapted to be executed to implement a method comprising:” in claim 40, are merely parts of a computer to be used as a tool to perform the mental process.
The additional limitations of dependent claims 22, 23, 29-33, and 35-39 are merely directed to and further narrow the scope of the mental process.
Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide computer implementation of the abstract idea using collected data without: improvement to the functioning of a computer or to any other technology or technical field; applying the mental process with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; applying or using the mental process in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment; or adding a specific limitation other than what is well-understood, routine, conventional activity in the field.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 21-40 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 21 recites the limitations “monitor, over a first time period, the sensor data of the first type” and “monitor, over a second time period, the sensor data of the second type according to the determined monitoring scheme”, “determine a monitoring scheme for the continuous analyte monitor”, and “evaluating user interface preferences of the patient…” Claims 34 and 40 recite the limitations “monitoring over, a time period, sensor data of a first type for the patient” and “monitoring, over a second time period, sensor data of a second type for the patient with the continuous analyte monitor according to the determined monitoring scheme”, “determine a monitoring scheme for the continuous analyte monitor”, and “evaluating user interface preferences of the patient…”. It is unclear as to what steps are required to carry out either of these steps. Although it is clear that both the first data type and the second data type are monitored, it is unclear as to what exactly that means or how it is performed. Additionally, it is not clear as to what the monitoring scheme is exactly. The claims indicate it comprises a parameter “related to” operation of a user interface. However, it is unclear as to what defines the "related to" or how the parameter influences or determines the operation of the user interface. Furthermore, it is unclear as to how the parameter is determined that is then seemingly used to determine the monitoring scheme. Moreover, it is unclear as to the user interface preferences are evaluated "based on" the listed data options. It is unclear as to what occurs in the step of evaluating or to what degree the evaluation is influenced or determined "based on" the listed data options.
Claims 22-33 and 35-39 are rejected due to their dependencies, either directly or indirectly to base claims 21 and 33, respectively.
Allowable Subject Matter
9. Claims 21-40 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office Action.
10. Claims 21-40 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112, set forth in this Office Action.
11. The following is a statement of reasons for the indication of allowable subject matter:
Taub et al., U.S. Patent Application No. 2009/0143661 A1 (“Taub”), teaches the following:
A monitoring system (“analyte monitoring system”) 100 (see “Referring to FIG. 1, the analyte monitoring system 100 includes …” in para. [0032], and fig. 1) comprising:
a sensor (“second sensor”, not labeled) configured to collect sensor data of a first type (“more than one analyte, the analytes may be monitored at the same or different times”) for a patient (see “However, it will be appreciated by one of ordinary skill in the art that the analyte monitoring system 100 may include more than one sensor 101, and/or more than one data processing unit 102, and/or more than one data processing terminal 105. Multiple sensors may be positioned in a patient for analyte monitoring at the same or different times. In certain embodiments, analyte information obtained by a first positioned sensor may be employed as a comparison to analyte information obtained by a second sensor. This may be useful to confirm or validate analyte information obtained from one or both of the sensors. Such redundancy may be useful if analyte information is contemplated in critical therapy-related decisions. In certain embodiments, a first sensor may be used to calibrate a second sensor, or vice-versa.” in para. [0034]; and see “Analytes that may be monitored include, but are not limited to, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB), creatine, creatinine, DNA, fructosamine, glucose, glutamine, growth hormones, hormones, ketone bodies, lactate, peroxide, prostate-specific antigen, prothrombin, RNA, thyroid stimulating hormone, and troponin. The concentration of drugs, such as, for example, antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs of abuse, theophylline, and warfarin, may also be monitored. In those exemplary embodiments that monitor more than one analyte, the analytes may be monitored at the same or different times.” in para. [0030]);
a continuous analyte monitor (“sensor”) 101 configured to collect sensor data of a second type for the patient (see “Referring to FIG. 1, the analyte monitoring system 100 includes a sensor 101, …” in para. [0032]; and see “In certain embodiments, the sensor 101 is physically positioned in or on the body of a user whose analyte level is being monitored. The sensor 101 may be configured to at least periodically sample the analyte level of the user and convert the sampled analyte level into a corresponding signal for transmission by the data processing unit 102.” in para. [0036]); and
a processor (“data processing unit”) 102 in communication with the sensor and the continuous analyte monitor 101 (see “The data processing unit 102 performs data processing functions, where such functions may include but are not limited to, filtering and encoding of data signals, each of which corresponds to a sampled analyte level of the user, for transmission to a receiver unit (104 or 106) via the communication link 103.” in para. [0036]), wherein the processor 102 is configured to:
monitor, over a first time period, the sensor data of the first type (see “In those exemplary embodiments that monitor more than one analyte, the analytes may be monitored at the same or different times.” in para. [0030]);
…
the patient's frequency of interaction (“user's frequency of interaction”) with a device (“receiver units”) 104and/or 106 over the first time period (see “In this way, receiver units 104 and 106 can monitor the frequency of interaction between the user and the receiver units 104 and 106.” in para. [0048]; and see “Other examples of graphs may include graphs of the user's frequency of interaction with the receiver unit (104 or 106), or units (104 and 106), over a period of time, …” in para. [0051]);
…
As to Claims 21-33, neither Taub nor the prior art of record teaches the monitoring system of base claim 21, including the following, in combination with all other limitations of the base claim:
process the monitored sensor data of the first type to determine a monitoring scheme for the continuous analyte monitor, the monitoring scheme comprising a parameter related to operation of a user interface, the processing comprising evaluating user interface preferences of the patient based on at least one of the following:
the patient's frequency of interaction with a device over the first time period;
the patient's responsiveness to alerts based on the monitored sensor data of the first type over the first time period; or
the patient's frequency of interaction with an application associated with the monitored sensor data of the first type over the first time period; and
monitor, over a second time period, the sensor data of the second type according to the determined monitoring scheme.
As to Claims 34-39, neither Taub nor the prior art of record teaches the method of monitoring a patient of base claim 34, including the following, in combination with all other limitations of the base claim:
processing the monitored sensor data of the first type to determine a monitoring scheme for a continuous analyte monitor, the monitoring scheme comprising a parameter related to operation of a user interface, the processing comprising evaluating user interface preferences of the patient based on at least one of the following:
the patient's frequency of interaction with a device over the first time period;
the patient's responsiveness to alerts based on the monitored sensor data of the first
type over the first time period; or
the patient's frequency of interaction with an application associated with the monitored sensor data of the first type over the first time period; and
monitoring, over a second time period, sensor data of a second type for the patient with the continuous analyte monitor according to the determined monitoring scheme.
As to Claim 40, neither Taub nor the prior art of record teaches the computer-program product of base claim 40, including the following, in combination with all other limitations of the base claim:
processing the monitored sensor data of the first type to determine a monitoring scheme for a continuous analyte monitor, the monitoring scheme comprising a parameter related to operation of a user interface, the processing comprising evaluating user interface preferences of the patient based on at least one of the following:
the patient's frequency of interaction with a device over the first time period;
the patient's responsiveness to alerts based on the monitored sensor data of the first type over the first time period; or
the patient's frequency of interaction with an application associated with the monitored sensor data of the first type over the first time period; and
monitoring, over a second time period, sensor data of a second type for the patient with the continuous analyte monitor according to the determined monitoring scheme.
Conclusion
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 03/23/2026