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 .
Election/Restriction
Applicant’s election without traverse of Invention I (Claims 1-12) in the reply filed on 12/02/25 is acknowledged. Invention II (Claims 13-20) has been withdrawn.
Information Disclosure Statement
No information disclosure statements (IDS) was submitted.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a method of determining the plasma concentration of acetaminophen. Thus, the claim is directed to a process, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“measuring the effect of the acetaminophen's distortion of blood glucose readings, comprising (a) an accurate, non-distorted reading of the plasma glucose concentration, and (b) a continuous glucose monitor (CGM) with a consistent and observable distortion due to acetaminophen interference, and (c) a computer algorithm that utilizes the values and difference in values measured from (a) and (b) as inputs to determine the concentration of acetaminophen present in the patient's blood plasma”
These limitations describe a mental process as the skilled artisan is capable of performing the judicial exception mentally, or using pen and paper. Furthermore, nothing from the claims or applicant’s accompanying specification shows that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“continuous analyte sensors; a continuous glucose monitor (CGM)”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity e.g., mere generic sensors and glucose device, receiving data, outputting data.
Furthermore, the additional limitations recite well-known structural limitations (generically recited sensors, glucose device, etc.) and as such, do not amount to significantly more than the identified judicial exception. Examiner takes official notice that the additional limitations are conventional components in prior analyte monitoring systems. Jacks (applied in this office action) teaches these additional elements, showing these additional elements are well known and conventional [par. 1].
Claims 2, 11 and 12 recite the additional limitations:
“glucose meter; multiple continuous glucose monitors; multiple continuous analyte sensors”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity e.g., mere generic glucose devices, and sensors.
Furthermore, the additional limitations recite well-known structural limitations (generically recited sensor and glucose sensor components, etc.) and as such, do not amount to significantly more than the identified judicial exception. Examiner takes official notice that the additional limitations are conventional components in prior analyte monitoring systems.
Dependent claims 3-10 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-12 are not patent eligible under 35 USC 101.
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 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, 2 and 4-10 are rejected under 35 U.S.C. 103 as being
anticipated by Jacks (U.S. Patent Application Publication 2022/0125348 A1)
Regarding claim 1, Jacks teaches a method of determining the plasma concentration of acetaminophen by measuring the effect of the acetaminophen's distortion of blood glucose readings through continuous analyte sensors [par. 1, 70], comprising (a) an accurate, non-distorted reading of the plasma glucose concentration [fig. 7, element 72; par. 68], and (b) a continuous glucose monitor (CGM) with a consistent and observable distortion due to acetaminophen interference [fig. 7, element 74; par. 68].
Although Jacks does not explicitly teach (c) a computer algorithm that utilizes the values and difference in values measured from (a) and (b) as inputs to determine the concentration of acetaminophen present in the patient's blood plasma, this would be obvious to a person having ordinary skill in the art when the invention was filed since Jacks also suggests measuring an actual plasma glucose level and measured glucose level, and showing the effect of acetaminophen on the measured sensor glucose level [par. 68]. Additionally, Jacks teaches calculating a sensor signal rate of change to determine interferent concentration [par. 41] Therefore, incorporating a computer algorithm that utilizes the values and difference in values measured from (a) and (b) as inputs to determine the concentration of acetaminophen would involve only routine skill in the art.
Regarding claim 2, Jacks further teaches the non-distorted reading of the plasma glucose in (a) is measured with a glucose meter [par. 79]
Regarding claim 4, Jacks further teaches the non-distorted reading of the plasma glucose in (a) is measured with a Continuous Glucose Monitor with a known and modeled distortion dependent upon the plasma concentration of acetaminophen [par. 70, 76]
Regarding claim 5, Jacks further teaches detection of multiple interferents [par. 98]
Although Jacks does not explicitly teach the plasma concentration of medications that include acetaminophen as an ingredient are determined with a conversion algorithm from the determined plasma acetaminophen concentration, this would be obvious to a person having ordinary skill in the art when the invention was filed since Jacks also suggests using a single model or a plurality of models specific to the interferent [par. 98]. Additionally, Jacks suggests determining the concentration of acetaminophen [par. 41, 97]. Examiner notes that the remaining interferents may be determined once acetaminophen is detected based on the other interferent specific models. Therefore, incorporating determining the plasma concentration of medications with a conversion algorithm from the determined plasma acetaminophen concentration would involve only routine skill in the art.
Regarding claim 6, Jacks further teaches detection of multiple interferents [par. 98]
Although Jacks does not explicitly teach the plasma concentration of medications that are coadministered with acetaminophen are determined with a conversion algorithm from the determined plasma acetaminophen concentration, this would be obvious to a person having ordinary skill in the art when the invention was filed since Jacks also suggests using a single model or a plurality of models specific to the interferent [par. 98]. Additionally, Jacks suggests determining the concentration of acetaminophen [par. 41, 97]. Examiner notes that the remaining interferents may be determined once acetaminophen is detected based on the other interferent specific models. Therefore, incorporating determining the plasma concentration of medications that are coadministered with acetaminophen with a conversion algorithm from the determined plasma acetaminophen concentration would involve only routine skill in the art.
Regarding claim 7, Jacks further teaches the presence of acetaminophen in a patient is detected through the determination of the existence of the distortion effect of acetaminophen on a continuous analyte sensor [fig. 7; par. 68, 103]
Regarding claim 8, Jacks further teaches the presence of medications coadministered with acetaminophen is detected through the determination of the existence of the distortion effect of acetaminophen on a continuous analyte sensor [par. 84 “the information associated with the presence of an interferent in the body fluid (i.e., indication that interferent was ingested, indication that interferent was ingested and time of ingestion and/or size of dose) is ascertained through analysis of relevant signals such as … sensor glucose (SG) rate of change”].
Regarding claim 9, Jacks further teaches the presence of acetaminophen in a patient is detected through the measurement of the distortion effect of acetaminophen on a continuous analyte sensor [par. 41]
Regarding claim 10, Jacks further teaches the presence of medications coadministered with acetaminophen is detected through the measurement of the distortion effect of acetaminophen on a continuous analyte sensor [par. 84 “the information associated with the presence of an interferent in the body fluid (i.e., indication that interferent was ingested, indication that interferent was ingested and time of ingestion and/or size of dose) is ascertained through analysis of relevant signals such as … sensor glucose (SG) rate of change”]
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being
anticipated by Jacks and in further view of Bohm (U.S. Patent Application Publication 2025/0302349 A1)
Regarding claim 3, Jacks teaches a method of determining the plasma concentration of acetaminophen, as disclosed above.
However, Jacks does not teach the non-distorted reading of the plasma glucose in (a) is measured with a Continuous Glucose Monitor without significant distortion
Bohm teaches the non-distorted reading of the plasma glucose in (a) is measured with a Continuous Glucose Monitor without significant distortion [par. 461]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Jacks to incorporate the non-distorted reading of the plasma glucose in (a) is measured with a Continuous Glucose Monitor without significant distortion, for determining sensor sensitivity, as evidence by Bohm [par. 460]
Regarding claim 12, Bohm further teaches multiple continuous analyte sensors are used to determine the acetaminophen concentration [par. 377, 389]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Jacks to incorporate multiple continuous analyte sensors are used to determine the acetaminophen concentration, for determining a response to a second stimulus signal, as evidence by Bohm [par. 181]
Claim 11 is rejected under 35 U.S.C. 103 as being anticipated by Jacks and
in further view of Bergmann (U.S. Patent Application Publication 2021/0370088 A1)
Regarding claim 11, Jacks teaches a method of determining the plasma concentration of acetaminophen, as disclosed above, and the use of a continuous glucose monitor are used to determine the acetaminophen concentration [par. 1, 12].
However, Jacks does not teach multiple continuous glucose monitors
Bergmann teaches multiple continuous glucose monitors [par. 69]
Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to modify Jacks to incorporate multiple continuous glucose monitors, to explore the effect of FBRs on continuous glucose monitors (CGMs), as evidence by Bergmann [par. 69]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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GRACE L ROZANSKI/
Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791