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
Receipt is acknowledged or paper submitted under 35 U.S.C. 119(a)-(d), which papers have been places of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/02/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were submitted on 03/02/2023. These drawings are reviewed and accepted by the examiner.
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 1-17 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.
Claims 1, 16, and 17 recite the limitation "acquire a sentence corresponding to the measurement value" in the second limitation, which is preceded by “acquire a plurality of measurement values.” There is insufficient antecedent basis for “the measurement value” in the claim because it is unclear which, out of the plurality of values, measurement value is being referred to.
Claims 2-17 depend on claim 1 and are therefore also rejected as being indefinite.
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) steps for measurement data gathering and selection. This judicial exception is not integrated into a practical application because nothing in the claims precludes the steps from practically being performed in the mind. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the processor, which is recited at a high level of generality, provides conventional computer functions that do not add meaningful limits to practicing the abstract idea.
Claims 1, 16, and 17 recites, in part, acquiring measurement values, acquiring a sentence, and selecting values based on a phrase in the sentence. The first and second steps are merely data gathering, pre-solutional activity. The last step of selecting measurement values based on a phrase can be done in the human mind by selecting values based on a verbal request. The processor is recited at a high level of generality and is recited as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. Therefore, the claims as a whole do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 2-15 are rejected under the same rationale. In summary, the dependent claims recite different ways of selecting measurement values and creating diagrams, all of which do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
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.
Claim(s) 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lefkowsky et al. (US 20200335187 A1).
Regarding claims 1, 16, and 17, Lefkowsky et al. (US 20200335187 A1) teaches:
“acquire a plurality of measurement values measured from the same subject at a plurality of different points in time” (par. 0336; ‘The determination of what medication resulted in an optimal outcome for an identified cohort of individuals may be determined by comparing the outcome information stored in database 18 for those individuals with the medications that were prescribed or administered to them; dividing the cohort into sub-cohorts; analyzing, for each sub-cohort, measures of outcome such as progression-free survival, overall survival, quality of survival, or so forth; and returning one or more measures that indicate the optimal outcome(s).’; Fig. 9, item 212);
“acquire a sentence corresponding to the measurement value” (par. 0330; ‘For instance, extracted parameters from the phrase “How many male patients 45 years or older have had pancreatic cancer?” may include “pancreatic”, “male” and “45 years”.’; par. 0332; ‘As another example, in the case of the voice message “What type of medication should I prescribe for John Doe,” operation module 64 structures a database query to search for a medication (e.g., the intent) of a cohort of patients who are clinically similar to the patient John Doe, where such medication resulted in an optimal outcome for the cohort.’) and
“select at least some of the plurality of measurement values based on a phrase related to the measurement value included in the sentence” (par. 0338; ‘In another example, the data operation module 64 may select all or a subset of records from patients in the database 18. From those records, the module 64 may then select records from a first cohort of patients with a genomic biomarker similar to the queried patient.’; Fig. 9, item 212).
Regarding claim 2 (dep. on claim 1), Lefkowsky further teaches:
“wherein the at least one processor is configured to select at least some of the plurality of measurement values based on a phrase that expresses a change over time in the measurement value included in the sentence” (par. 0341; ‘“How many ovarian cancer patients in the last 48 months have had a p85 PIK3CA mutation?”, “What percentage of basal cell carcinoma patients in the last 18 months have had cryosurgery?”).
Regarding claim 3 (dep. on claim 1), Lefkowsky further teaches:
“time information indicating a point in time of measurement is added to the measurement value” (Fig. 9, item 212; Patient and Date Diagnosed), and the at least one processor is configured to:
“create a plot diagram including the at least some selected measurement values using the measurement value and the time information as variables” (par. 0379; ‘In an alternative, the application may open a collaborator window 210 as shown in FIG. 9 in which to present visual response files. In FIG. 9, an exemplary visual response representation is shown at 212.’); and
“cause a display to display the plot diagram” (par. 0379; ‘In an alternative, the application may open a collaborator window 210 as shown in FIG. 9 in which to present visual response files. In FIG. 9, an exemplary visual response representation is shown at 212.’).
Regarding claim 4 (dep. on claim 3), Lefkowsky further teaches:
“wherein the at least one processor is configured to, in a case where an instruction is received: create the plot diagram including all of the plurality of acquired measurement values” (par. 0372; ‘Where visual files are generated and presented to a user, collaboration server 12 may store all visual representations as part of the ongoing collaboration record for subsequent access.’; par. 0373; ‘Oncologist 150 responds with a first query to “Select patients with pancreatic cancer.”’); and
“cause the display to display the plot diagram” (par. 0379; ‘In an alternative, the application may open a collaborator window 210 as shown in FIG. 9 in which to present visual response files. In FIG. 9, an exemplary visual response representation is shown at 212.’).
Regarding claim 5 (dep. on claim 1), Lefkowsky further teaches:
“time information indicating a point in time of measurement is added to the measurement value, and the at least one processor is configured to select the measurement value to which the time information indicating the point in time of measurement determined based on the phrase related to the measurement value is added” (par. 0341; ‘“How many ovarian cancer patients in the last 48 months have had a p85 PIK3CA mutation?”, “What percentage of basal cell carcinoma patients in the last 18 months have had cryosurgery?”).
Regarding claim 6 (dep. on claim 1), Lefkowsky further teaches:
“wherein the at least one processor is configured to select at least some of the plurality of measurement values according to the number of measurement values determined based on the phrase related to the measurement value” (par. 0341; ‘“How many ovarian cancer patients in the last 48 months have had a p85 PIK3CA mutation?”, “What percentage of basal cell carcinoma patients in the last 18 months have had cryosurgery?”).
Regarding claim 7 (dep. on claim 1), Lefkowsky further teaches:
“wherein the at least one processor is configured to select at least some of the plurality of measurement values based on a phrase that expresses a disease name included in the sentence” (par. 0341; ‘“How many ovarian cancer patients in the last 48 months have had a p85 PIK3CA mutation?”, “What percentage of basal cell carcinoma patients in the last 18 months have had cryosurgery?”).
Regarding claim 8 (dep. on claim 1), Lefkowsky further teaches:
“wherein the at least one processor is configured to select at least some of the plurality of measurement values based on a phrase that expresses a purpose of examination included in the sentence” (par. 0434; ‘For example, if a doctor asks device 20 to “give me the results of my patient, Dwayne Holder's, sequencing report” and then asks a subsequent question “what are the best clinical trial options”, the system determines that these questions are in a dialog path and answers the clinical trial question based on the clinical trial recommendations that have been provided on Dwayne Holder's clinical report (e.g., the system recommends clinical trials on sequencing reports and the system access all the data in each of those reports).’).
Regarding claim 9 (dep. on claim 1), Lefkowsky further teaches:
“wherein the at least one processor is configured to determine whether to select the measurement value based on a result of comparison between the measurement value included in the sentence and a predetermined threshold value” (par. 0330; ‘Referring again to FIG. 1, parameter extraction module 74 extracts important parameters from the user's uttered voice message. For instance, extracted parameters from the phrase “How many male patients 45 years or older have had pancreatic cancer?” may include “pancreatic”, “male” and “45 years”.’ The parameters are used to select measurement values by doing comparisons against threshold values.).
Regarding claim 10 (dep. on claim 1), Lefkowsky further teaches:
“wherein the at least one processor is configured to determine whether to select at least two measurement values included in the sentence based on a result of comparison between a difference between the at least two measurement values and a predetermined threshold value” (par. 0340; ‘For instance, one intent may be to generate a database data subset (e.g., patients that meet qualifying query parameters). As another instance, another intent may be to return a number (e.g., number of patients that meet qualifying parameters).’).
Regarding claim 11 (dep. on claim 1), Lefkowsky further teaches:
“wherein the at least one processor is configured to select the measurement value that satisfies a predetermined condition from among the plurality of measurement values” (par. 0340; ‘For instance, one intent may be to generate a database data subset (e.g., patients that meet qualifying query parameters). As another instance, another intent may be to return a number (e.g., number of patients that meet qualifying parameters).’).
Regarding claim 12 (dep. on claim 1), Lefkowsky further teaches:
“wherein the at least one processor is configured to, in a case where a difference between at least two measurement values included in the plurality of measurement values satisfies a predetermined condition, select the at least two measurement values” (par. 0340; ‘For instance, one intent may be to generate a database data subset (e.g., patients that meet qualifying query parameters). As another instance, another intent may be to return a number (e.g., number of patients that meet qualifying parameters).’).
Regarding claim 13 (dep. on claim 1), Lefkowsky further teaches:
“wherein: time information indicating a point in time of measurement is added to the measurement value, and the at least one processor is configured to select at least some of the plurality of measurement values that are continuous in time series order” (par. 0054; ‘In at least some cases the at least one data operations includes an operation to query for a clinical history data, the first set of data comprises a therapy, and the associating step comprises adjusting the operation to query for the clinical history data element based on the therapy.’ Clinical history provides values that are continuous in time series order.).
Regarding claim 14 (dep. on claim 1), Lefkowsky further teaches:
“wherein: time information indicating a point in time of measurement is added to the measurement value, and the at least one processor is configured to select at least some of the plurality of measurement values that are discrete in time series order” (par. 0059; ‘In at least some cases the second set of data comprises outcomes information comprising one or more of Response to Therapy (e.g. CR, PR, SD, PD), RECIST score, Date of Outcome, date of observation, date of progression, date of recurrence, adverse event to therapy, adverse event date of presentation, adverse event grade, date of death, date of last follow-up, and disease status at last follow up.’).
Regarding claim 15 (dep. on claim 1), Lefkowsky further teaches:
“wherein the measurement value is at least one of a size of a lesion or a signal value at a part of the lesion in a medical image obtained by imaging the lesion” (par. 0058; ‘In at least some cases the second set of data comprises treatment information comprising one or more of drug name, drug start date, drug end date, drug dosage, drug units, drug number of cycles, surgical procedure type, date of surgical procedure, radiation site, radiation modality, radiation start date, radiation end date, radiation total dose delivered, and radiation total fractions delivered.’).
Conclusion
Other pertinent prior art are cited in the PTO-892 for the applicant's consideration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK VILLENA whose telephone number is (571)270-3191. The examiner can normally be reached 10 am - 6pm EST Monday through Friday.
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MARK . VILLENA
Examiner
Art Unit 2658
/MARK VILLENA/Examiner, Art Unit 2658
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