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 .
Claim Objections
Claims 1 and 10 objected to because of the following informalities:
In claim 1, “providing the patient indicators” should read “providing the set of patient indicators.”
In claims 1 and 10, “via the stenosis analytical model” should read “via the percentage stenosis analytical model.”
Appropriate correction is required.
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.
In Claims 1 and 17, the claim limitation “likely percentage of arterial stenosis” renders the claim indefinite because the limitation is unclear. It is unclear because the claim does not define how “likely percentage” is measured or determined. For purposes of examination, the claim limitation is interpreted as the probability for arterial stenosis.
In Claim 4, the claim limitation “the patient physical exam indications” renders the claim indefinite because the limitation is unclear. It is unclear whether “the patient physical exam indications” defines the characteristics for only the first patient physical exam indications, the second physical exam indications, or both. For purposes of examination, the claim limitation is interpreted as “the first and second patient physical exam indications.”
In Claim 5, the claim limitation “the indication of patient hypertension” renders the claim indefinite because the limitation is unclear. It is unclear whether “the indication of patient hypertension” defines the characteristics for only the first indication of patient hypertension, the second indication of patient hypertension, or both. For purposes of examination, the claim limitation is interpreted as “the first and second indications of patient hypertension.”
In Claim 10, the claim limitation “new data and original data” renders the claim indefinite because the limitation is unclear. It is unclear what new data and original data are referring to. For example, does new data and original data encompass previously collected set of patient indicators and newly collected set of patient indicators? Does new data and original data encompass previously collected patient biographic indications and currently collected patient biographic indications [Examiner’s note, this question also applies to patient physical exam indications, indication of patient hypertension, or plurality of cardiovascular dimensions]? For purposes of examination, the claim limitation is interpreted as newly collected set of patient indicators and previously collected set of patient indicators.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 1-17 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1-17 recites at least one step or instruction for determining the percentage of stenosis in the arteries of the user’s heart, which is grouped as a mental process under the 2019 PEG or a certain method of organizing human activity under the 2019 PEG. Accordingly, each of Claims 1-17 recites an abstract idea.
Specifically, Claims 1 and 17 recite [Examiner’s note, underlined text represents abstract ideas, bolded text represents additional elements]:
Claim 1 | “A method for determining a percentage of stenosis in arteries of a heart, the method comprising:
receiving a set of patient indicators, the set comprising: a patient's biographic indications, a first set of patient physical exam indications, a first indication of patient hypertension, and a plurality of cardiovascular dimensions from patient scan data (Observation);
providing the patient indicators to a percentage stenosis analytical model (Judgement);
via the stenosis analytical model, generating a first result comprising a likely percentage of arterial stenosis for the patient and a confidence interval (Mathematical Concept);
providing an alert to a user based on an upper bound of the confidence interval, wherein the alert to a medical provider is transmitted if the confidence interval encompasses a percentage of arterial stenosis equal to or greater than 70% (Judgement), and
providing a behavioral recommendation to the patient to lower the likely percentage of arterial stenosis if the likely percentage of arterial stenosis is greater than 50% (Evaluation/Opinion).”
Claim 17 | “A method for determining a percentage of stenosis in arteries of a heart, the method consisting of:
receiving a set of patient indicators, the set consisting of: a patient's biographic indications, a first set of patient physical exam indications, a first indication of patient hypertension, and a first plurality of cardiovascular dimensions from patient scan data (Observation);
providing the patient indicators to a percentage stenosis analytical model (Judgement);
wherein the percentage stenosis analytical model incorporates a measurement of minimal lumen diameter, an interaction between the minimal lumen diameter and a proximal reference lumen diameter, an interaction between a calculated percentage of a right coronary artery and distal reference lumen diameter, an interaction between a calculated percentage of the right coronary artery and a proximal reference lumen diameter, an age of the patient, an indication of body surface area, an interaction between age and an indication of body mass index, a distance to ostium from minimal lumen diameter, and the first indication of patient hypertension (Mathematical Concept),
via the stenosis analytical model, generating a first result comprising a likely percentage of arterial stenosis for the patient and a confidence interval (Mathematical Concept);
providing an alert to a user based on an upper bound of the confidence interval, wherein the alert to a medical provider is transmitted if the confidence interval encompasses a percentage of arterial stenosis equal to or greater than 70% (Judgement), and
providing a behavioral recommendation to the patient to lower the likely percentage of arterial stenosis if the likely percentage of arterial stenosis is greater than 50% (Evaluation/Opinion).”
Regarding the dependent claims, the following dependent claims are directed to steps that are also abstract or organizing human activity:
Claims 2, 5, 6, 10-16 include steps that are also abstract as a mental process through additional data gathering or analysis and utilizes mathematical concepts.
Claims 3, 4 includes steps that are also abstract as a mental process through collection of patient biographic and physical exam data.
Claims 7-9 includes steps that are also abstract as a mathematical concept.
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrowing idea is still an abstract idea and an abstract idea with additional well-known equipment/functions are not significantly more than the abstract idea.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2a, Prong 2
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claims 1-17 fails to recite any additional elements that integrate the judicial exception into a practical application. The abstract ideas alone do not provide an improvement to a technological field, the method does not affect a particular treatment or effect a particular change based on the abstract idea, nor does the method use a particular machine to perform the Abstract Idea.
Step 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
There are no additional elements recited in the claims beyond the claimed subject matter that encompasses abstract ideas and therefore no claimed subject matter can qualify as “significantly more” under step 2B of the Alice/Mayo framework.
Claim Rejections - 35 USC § 103
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, 3, 4, 6, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Min et al. (US 20220392065 A1) in view of Lee et al. (“Deep learning-based prediction for significant coronary artery stenosis on coronary computed tomography angiography in asymptomatic populations,” 21 JUN 2023, reference U on PTO-892) and Brodnick et al. (US 20160089048 A1).
Regarding Claim 1, Min discloses a method for determining a percentage of stenosis in arteries of a heart (Min | Paragraph 0014; [Examiner’s note, the risk for coronary artery disease (CAD) primarily involves arterial stenosis. Therefore, one skilled in the art can determine the CAD risk scores taught in Min is the same as determining the percentage of arterial stenosis.]), the method comprising:
receiving a set of patient indicators (Min | Paragraphs 0928, 0941, 0943; [Examiner’s note, following elements stores a set of patient indicators from the respective paragraphs: patient medical information storage component (1708), patient information (1860), data structures (1880).]), the set comprising:
a patient's biographic indications, a first set of patient physical exam indications, a first indication of patient hypertension (Min | Paragraph 0928, The images may be archived in a patient medical information storage component 1708, which stores other types of patient data (for example, previously generated images, patient test results, patient specific information that can include age, gender, race, BMI, medication, blood pressure, heart rate, weight, height, body habitus, smoking, diabetes, hypertension, prior CAD, family history, lab test results, and the like).; [Examiner’s note, the Patient Medical Information Storage Component receives and stores the patient’s biographic indications (age and gender), physical exam (diabetes, BMI, smoking) and patient hypertension.]); and
a plurality of cardiovascular dimensions from patient scan data (Min | Patient Medical Information Storage Component – element 1708; Figures 7AK, 8A, and 8B; Paragraphs 0379, 0436, 0928, 1486, 1667; [Examiner’s note, Claim 6 goes into further detail on the breakdown of the cited references regarding the plurality of cardiovascular dimensions from patient scan data.]);
providing the patient indicators to a percentage stenosis analytical model (Min | Paragraph 0278, 1243);
via the stenosis analytical model, generating a first result comprising a likely percentage of arterial stenosis for the patient (Min | Paragraphs 0282, 1021); and
providing a behavioral recommendation to the patient to lower the likely percentage of arterial stenosis if the likely percentage of arterial stenosis is greater than 50% (Min | Paragraphs 0199-0201, 0442-0443; Figures 9K-L; [Examiner’s note, the patient receives recommendations through the management portion on reducing their risk of plaque buildup.]).
Min does not explicitly disclose the algorithm generating a confidence interval; providing an alert to a user based on an upper bound of the confidence interval, wherein the alert to a medical provider is transmitted if the confidence interval encompasses a percentage of arterial stenosis equal to or greater than 70%;
Lee teaches the algorithm generating a confidence interval; the confidence interval encompasses a percentage of arterial stenosis equal to or greater than 70% (Lee | Figure 4; Page 5 under paragraph “3.3 Comparison of predication models for coronary artery stenosis”; [Examiner’s note, the x-axis within Figure 4 is the confidence interval and the orange bars represent ≥70% stenosis.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min to incorporate the teachings of an algorithm generating a confidence interval because it provides an accurate probability regarding the degree of stenosis the patient may have and allow for the physician to provide appropriate treatment to reduce their risk (Lee | Page 10 under paragraph “5. Conclusion”).
Additionally, Brodnick teaches alerting user and medical provider when confidence interval is above set percentage (Brodnick | Figure 1 – Step 30; Paragraph 0182). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Lee to incorporate the teachings of an alert from Brodnick because the alert allows for adequate warning to the physician when the user is experiencing any cardiac fluctuations and or abnormalities (Brodnick | Paragraph 0118-0119).
Regarding Claim 3, Min in view of Lee and Brodnick teaches the method of claim 1, wherein the patient biographic indications comprises: an age of the patient, and an indication of gender of the patient (Min | Patient Medical Information Storage Component – element 1708; Paragraph 0014, the one or more clinical parameters comprise one or more of percentile health condition for age or percentile health condition for gender; Paragraphs 0239-0240, 0928).
Regarding Claim 4, Min in view of Lee and Brodnick teaches the method of claim 1, wherein the patient physical exam indications comprise at least one of: an indication of an indication of diabetes, an indication of body mass index (BMI), an indication of smoking history (Min | Patient Medical Information Storage Component – element 1708; Paragraph 0928, patient medical information storage component 1708, which stores other types of patient data (for example, previously generated images, patient test results, patient specific information that can include age, gender, race, BMI, medication, blood pressure, heart rate, weight, height, body habitus, smoking, diabetes, hypertension, prior CAD, family history, lab test results, and the like)), an indication of hyperlipidemia, and an indication of body surface area (BSA) [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
Regarding Claim 6, Min in view of Lee and Brodnick teaches the method of claim 1, wherein the plurality of cardiovascular dimensions from patient scan data comprises at least one of: lesion length (Min | Paragraph 0379), calculated percentage of right coronary artery, calculated percentage of left circumflex artery, calculated percentage of left anterior descending artery (Min | Figures 7AK, 8A, and 8B; Paragraph 0436; [Examiner’s note, the user can select various artery territories on the user interface and see the calculated percentage of the chosen territories stenosis]), fractional flow reserve (Min | Paragraph 1486), minimum lumen diameter (Min | Paragraph 1667), distal reference lumen diameter, proximal reference lumen diameter, maximal lumen diameter within left main coronary artery segment, and distance between a ostium to the narrowest side [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
Regarding Claim 14, Min in view of Lee and Brodnick teaches the method of claim 1, further comprising a recommendation to the patient to adopt the behavioral recommendation and recalculate the likely percentage of arterial stenosis within four months if the first result of percentage of arterial stenosis is greater than 70% (Min | Paragraph 0941; Figures 9K-L).
Claims 2, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Lee, Brodnick, Kroll et al. (US 20100079291 A1), and Flack et al. (US 20030125983 A1).
Regarding Claim 2, Min in view of Lee and Brodnick teaches the method of claim 1, and generating a percentage of arterial stenosis for the patient (Min | Paragraphs 0282, 1021);
Min in view of Brodnick does not explicitly teach the algorithm generating a confidence interval; the algorithm generating a new result; receiving a second set of patient physical exam indications, wherein if the first set and second set of patient physical exam indications are equal, only one set of indications will be used in a calculation of percentage stenosis, wherein if the first and second set of patient physical exam indications are different, the second set of patient physical exam indications are used in an updated calculation of the algorithm; and receiving a second indication of patient hypertension, wherein if the first set and second indications of patient hypertension are equal, only one set of indications will be used in the updated calculation of percentage stenosis, wherein if the first set and second indications of patient hypertension are different, the second indication of patient hypertension is used in the calculation of the algorithm; generating a second result of arterial stenosis comprising a likely percentage of arterial stenosis for the patient, wherein the second result is generated if the second set of patient physical exam indications is different from the first set of patient physical exam indications, or if the second indication of patient hypertension is different from the first indication of patient hypertension;
Lee teaches the algorithm generating a confidence interval (Lee | Figure 4). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Brodnick to incorporate the teachings of an algorithm generating a confidence interval because it provides an accurate probability regarding the degree of stenosis the patient may have and allow for the physician to provide appropriate treatment to reduce their risk (Lee | Page 10 under paragraph “5. Conclusion”).
Additionally, Kroll teaches receiving a second set of patient physical exam indications, wherein if the first set and second set of patient physical exam indications are equal, only one set of indications will be used in a calculation of percentage stenosis, wherein if the first and second set of patient physical exam indications are different, the second set of patient physical exam indications are used in an updated calculation of the algorithm (Kroll | Paragraph 0041; [Examiner’s note, when first set and second set are equal, either data set is selected. Thus, the second set will be chosen for this condition. The next condition states when first set is not equal to the second set, the second set will be chosen. Therefore, both conditions will pick the second data set to update the algorithm.]); generating a second result from the algorithm, wherein the second result is generated if the second set of patient physical exam indications is different from the first set of patient physical exam indications (Kroll | Paragraph 0041), or if the second indication of patient hypertension is different from the first indication of patient hypertension [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.].
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Lee and Brodnick to incorporate the teachings of the weight management system from Kroll because the visual BMI tracking encourages the user to break unhealthy habits and adopt healthy routines to improve their health (Kroll | Paragraphs 0040-0041).
Lastly, Flack teaches receiving a second indication of patient hypertension, wherein if the first set and second indications of patient hypertension are equal, only one set of indications will be used in the updated calculation of percentage stenosis, wherein if the first set and second indications of patient hypertension are different, the second indication of patient hypertension is used in the calculation of the algorithm (Flack | Figure 22; Paragraphs 0102-0103; [Examiner’s note, when first set and second set are equal, either data set is selected. Thus, the second set will be chosen for this condition. The next condition states when first set is not equal to the second set, the second set will be chosen. Therefore, both conditions will pick the second data set to update the algorithm.]).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Lee, Brodnick, and Kroll to incorporate the teachings of a hypertension treatment algorithm from Flack because the algorithm aids the physician to confirm whether the patient has a particular medical condition (Flack | Paragraph 0102).
Regarding Claim 15, Min in view of Lee, Brodnick, Kroll, and Flack teach the method of claim 2, provide potential health outcomes and interventions needed to reduce the percentage of arterial stenosis to the patient (Min | Paragraphs 1007-1008).
Min in view of Lee, Brodnick, and Flack does not explicitly teach the second set of patient physical exam indications are significantly worse than the first set of patient physical exam indications, or if the second indications of patient hypertension are significantly worse than the first indication of patient hypertension, a warning is provided to the patient;
Kroll teaches the second set of patient physical exam indications are significantly worse than the first set of patient physical exam indications (Kroll | Paragraphs 0081-0082), or if the second indications of patient hypertension are significantly worse than the first indication of patient hypertension [Examiner’s note, the claim comprises multiple limitations; however, only one of the alternatives needs to be supported by the prior art.], a warning is provided to the patient (Kroll | Paragraphs 0081-0082).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the system of Min in view of Lee, Brodnick, and Flack to incorporate the teachings of a warning system from Kroll because the warning is used to prevent and encourage the user to break unhealthy habits and adopt healthy routines to improve their health (Kroll | Paragraphs 0040-0041; 0081).
Regarding Claim 16, Min in view of Lee, Brodnick, Kroll, and Flack teach the method of claim 15, further comprising providing the patient a communication encouraging the patient how the percentage of arterial stenosis can decrease with appropriate interventions (Min | Figures 9K-L; [Examiner’s note, based on the degree of maximal coronary stenosis, the patient is provided appropriate interventions within the management section.]; Paragraphs 1007-1008).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Lee, Brodnick, and Selvaraj et al. (US 20240321447 A1).
Regarding Claim 5, Min in view of Lee and Brodnick teaches the method of Claim 1 and the indication of patient hypertension (Min | Patient Medical Information Storage Component – element 1708; Paragraph 0928). However, Min does not explicitly teach a binary system which indicates whether a patient does or does not have high blood pressure;
Selvaraj teaches the indication of patient hypertension comprises a numerical value of 0 or 1, wherein a value of 0 indicates the patient does not have high blood pressure, wherein a value of 1 indicates the patient does have high blood pressure (Selvaraj | Table 2). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Lee and Brodnick to incorporate the teachings of a binary blood pressure determination from Selvaraj. Doing so would allow for the binary system to act as an initial filter, and categorizing previous patient data to the most appropriate pretrained predictive model. Thus, comparing a patient's historical information against their current medical data. As a result, this model serves as an early detection system to prevent the likelihood and probability of the individual developing a specific medical event, such as sepsis (Selvaraj | Table 2; Figures 4-5; Paragraphs 0123 and 127).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Lee, Brodnick, Yocca et al. (US 20220202373 A1), and Olesen et al. (US 20230130840 A1).
Regarding Claim 10, Min in view of Lee and Brodnick teaches the method of claim 1, and receiving a set of patient indicators (Min | Paragraphs 0928, 0941, 0943), providing the patient indicators to a percentage stenosis analytical model (Min | Paragraph 0278, 1243), via the stenosis analytical model, generating a result comprising a likely percentage of arterial stenosis for the patient (Min | Paragraphs 0282, 1021).
Min in view of Lee and Brodnick does not explicitly teach monitoring to determine whether new data is available wherein if new data is available, determining whether the data is suitable for use in recalculating the likely percentage of arterial stenosis by evaluating a length of time between a collection of new data and original data, whereby if the length of time is more than four months, the new data is used in recalculating the algorithm; and providing a second result to the patient;
Yocca teaches monitoring to determine whether new data is available wherein if new data is available, determining whether the data is suitable for use, the new data is used in recalculating the algorithm; and providing a second result to the patient (Yocca | Paragraph 0137). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Lee and Brodnick to incorporate the teachings of continuous monitoring from Yocca because continuous patient monitoring enables the early detection of medical episodes and the timely administration of treatments to mitigate them (Yocca | Paragraph 0137).
Lastly, Olesen teaches recalculating the algorithm by evaluating a length of time between a collection of new data and original data, whereby if the length of time is more than four months (Olesen | Paragraph 0029). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Lee, Brodnick, and Yocca to incorporate the teachings of recalculating the algorithm by evaluating a length of time between a collection of new data and original data from Olsen because this approach facilitates longitudinal tracking, which minimizes data collection errors (Olesen | Paragraph 0029).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Lee, Brodnick, and Kroll et al. (US 20100079291 A1).
Regarding Claim 11, Min in view of Lee and Brodnick teaches the method of claim 4, the indication of body mass index (BMI) (Min | Patient Medical Information Storage Component – element 1708; Paragraph 0928); calculating the likely percentage of arterial stenosis via the stenosis analytical model (Min | Paragraphs 0282, 1021).
Min in view of Lee and Brodnick does not explicitly teach new data, indicator for BMI or body surface area, determining whether the data is suitable for use in recalculating the algorithm by evaluating if the indication of body mass index or the indication of body surface area has a 5% or greater change for the patient, whereby if the change of body mass index or the indication of body surface area has changed by 5% or more, the indication of body mass index and the indication of body surface area obtained more recently is used in recalculating the algorithm; and providing a second result to the patient;
Kroll teaches new data, indicator for BMI or body surface area, determining whether the data is suitable for use in recalculating the algorithm by evaluating if the indication of body mass index or the indication of body surface area has a 5% or greater change for the patient (Kroll | Paragraphs 0080-0082), whereby if the change of body mass index or the indication of body surface area has changed by 5% or more, the indication of body mass index and the indication of body surface area obtained more recently is used in recalculating the algorithm (Kroll | Paragraphs 0041, 0080-0082); and providing a second result to the patient (Kroll | Paragraphs 0041, 0080-0082).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Lee and Brodnick to incorporate the teachings of recalculating the algorithm from Kroll because the updated results, based on the user's new BMI data, accurately shows if they are on track to achieving their health goals (Kroll | Paragraphs 0080-0082).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Lee, Brodnick, Kline et al. (US 20230016673 A1), and Olesen et al. (US 20230130840 A1).
Regarding Claim 12, Min in view of Lee and Brodnick teaches the method of claim 3, and calculating the percentage of arterial stenosis (Min | Min | Paragraphs 0282, 1021). Min in view of Lee and Brodnick does not explicitly teach recalculating the algorithm using an updated age of the patient if the age of the patient has increased by at least one year;
Kline teaches recalculating the algorithm using an updated age of the patient if the age of the patient has increased by a length of time (Kline | Paragraph 0014, eliminating at least one of the separate sets of equal length segments; (m) recalculating stenosis after eliminating at least of the separate sets).
Additionally, Olesen teaches recalculating the algorithm by evaluating a length of time between a collection of new data and original data, whereby if the length of time a year (Olesen | Paragraph 0029).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify Min to incorporate the teachings of recalculating the algorithm using an updated age of the patient if the age of the patient has increased by at least one year from Kline and Olesen, for the obvious advantage of providing longitudinal tracking, which enables long-term monitoring for the early detection and treatment of patients at risk of stroke (see para [0012] of Kline).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Min in view of Lee, Brodnick, Kroll, Flack, and Fathieh et al. (US 20210212582 A1).
Regarding Claim 13, Min in view of Lee, Brodnick, Kroll, and Flack teaches the method of claim 2. Min in view of Lee, Brodnick, and Kroll does not explicitly teach rejecting the second result if the second set of patient physical exam indications or the second indication of hypertension have greater than a twenty percent change within six months of obtaining the first set of patient physical exam indications or the first indication of hypertension;
Flack teaches the second set of patient physical exam indications or the second indication of hypertension have greater than a twenty percent change within six months of obtaining the first set of patient physical exam indications or the first indication of hypertension (Flack | Figure 22; Paragraphs 0102-0103; [Examiner’s note, Flack teaches the receiving the updated hypertension data.]). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Lee, Brodnick, and Kroll to incorporate the teachings of a hypertension treatment algorithm from Flack because the algorithm aids the physician to confirm whether the patient has a particular medical condition (Flack | Paragraph 0102).
Lastly, Fathieh teaches rejecting the second result if the second set of patient physical exam indications or the second indication of hypertension have a percent change within of obtaining the first set of patient physical exam indications or the first indication of hypertension (Fathieh | Paragraphs 0059-0060). One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the method of Min in view of Lee, Brodnick, Kroll, and Flack to incorporate the teachings of the signal rejection from Fathieh because it removes anomalies during data collection (Fathieh | Paragraphs 0289-0291).
Allowable Subject Matter
Claims 7-9, and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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