DETAILED ACTION
Note: 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
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1-9, drawn to a method for assessing blood pressure stability in a living subject.
Group II, claims 10-17, drawn to a method for classifying a living subject.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of “defining a target blood pressure range, said range including a blood pressure target value centered within the target blood pressure range; calculating a total deviation of data points from the blood pressure target value; defining a plurality of expanded blood pressure ranges; plotting a cumulative distribution curve based on the data points and the plurality of expanded blood pressure ranges… determining a plurality of outcome measures, the plurality of outcome measures including the total deviation and at least one of an x-intercept of the exponential cumulative function, a y-intercept of the exponential cumulative function, λ, In(λ), and a fitting error calculated from said fitting”, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Wu (CN 109350025 A). See prior art rejection below for more detail.
During a telephone conversation with Brian Chellgren on November 10, 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-9. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10-17 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed application (PRO 63/175371 filed on April 15, 2021) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 29, 2024 (two submissions) have been considered by the examiner.
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 1-9 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 method for assessing blood pressure stability in a living subject. 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:
“A method for assessing blood pressure stability in a living subject, the method comprising the steps of: …defining a target blood pressure range, said range including a blood pressure target value centered within the target blood pressure range; calculating a total deviation of data points from the blood pressure target value; defining a plurality of expanded blood pressure ranges; plotting a cumulative distribution curve based on the data points and the plurality of expanded blood pressure ranges; fitting an exponential cumulative function to the cumulative distribution curve; determining a plurality of outcome measures, the plurality of outcome measures including the total deviation and at least one of an x-intercept of the exponential cumulative function, a y-intercept of the exponential cumulative function, λ, In(λ), and a fitting error calculated from said fitting; and assessing blood pressure stability of the living subject based on the plurality of outcome measures.”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/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:
“…measuring a blood pressure of a living subject over a period of time, said measuring including collecting a plurality of data points…”
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 extra-solution activity, i.e., mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they relate to widely-understood, routine, and conventional techniques for obtaining blood pressure. Examiner adds that the measuring limitations is recited at a high level of generality such that it does not amount to significantly more.
Dependent claims 2-9 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-9 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 102(a)(1)
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 1, 2, and 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu et al. (CN 109350025 A) (hereinafter “Wu”).
English Translation of Wu relied upon for claim mapping below.
With respect to claim 1, Wu teaches a method for assessing blood pressure stability in a living subject (see abstract), the method comprising the steps of: measuring a blood pressure of a living subject over a period of time (abstract “measuring the blood pressure value of a user on different days”), said measuring including collecting a plurality of data points (abstract); defining a target blood pressure range, said range including a blood pressure target value centered within the target blood pressure range (pg. 4, #10 “compared to a preset value” suggests a target blood pressure range including a blood pressure target value); calculating a total deviation of data points from the blood pressure target value (pg. 4, # 15 “Then, first deviation (SD) and second deviation (DD) are analyzed according to preset threshold”); defining a plurality of expanded blood pressure ranges; plotting a cumulative distribution curve based on the data points and the plurality of expanded blood pressure ranges; fitting an exponential cumulative function to the cumulative distribution curve (pg. 3, #1 “the fit approach includes fitting of a polynomial, exponential function fitting, Gauss curve fitting”); determining a plurality of outcome measures, the plurality of outcome measures including the total deviation (pg. 4, # 15 “Then, first deviation (SD) and second deviation”) and at least one of an x-intercept of the exponential cumulative function, a y-intercept of the exponential cumulative function, λ, In(λ), and a fitting error calculated from said fitting (pg. 4, #15 - #18 “first deviation… second deviation… absolute value… judges the fluctuation… a positive value or negative value… compared when two deviations are negative with [respect to]… preset threshold”); and assessing blood pressure stability of the living subject based on the plurality of outcome measures (abstract “performing curve fitting… it is determined that the current blood pressure value is abnormal; if both the current systolic blood pressure and the current diastolic blood pressure match their corresponding functions, the current blood pressure value is determined to be normal”).
With respect to claim 2, Wu teaches wherein the measured blood pressure is a systolic blood pressure, wherein the blood pressure target range is a systolic blood pressure target range, wherein the blood pressure target value is a systolic blood pressure target value; and wherein the plurality of data points are a plurality of systolic blood pressure values collected over time (abstract)
With respect to claim 6, Wu teaches wherein the exponential cumulative function is fitted to the cumulative distribution curve using the equation
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(pg. 3, #1 “the fit approach includes fitting of a polynomial, exponential function fitting, Gauss curve fitting”; pg. 3, #6 “Y = f(x) is fitted).
With respect to claim 7, Wu teaches further comprising classifying the living subject as one of as one of hypotensive, hypertensive, unstable, or normal based on the assessment of blood pressure stability (pg. 2, background “user can be warned… hypertension”; pg. 4, #18 “It is judged as normal if in threshold interval, if being judged as abnormal outside threshold interval, and can be by intensity of anomaly It is hierarchical”).
With respect to claim 8, Wu teaches further comprising classifying the living subject as having stable or unstable blood pressure based on the assessment of blood pressure stability (pg. 4, #18 “It is judged as normal if in threshold interval, if being judged as abnormal outside threshold interval, and can be by intensity of anomaly It is hierarchical”).
With respect to claim 9, Wu teaches wherein the plurality of expanded blood pressure ranges vary by a predetermined expansion rate (pg. 4, #15 “first deviation… second deviation… the fluctuation of blood pressure information… preset threshold”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Park (US PG Pub. No. 2016/0029970 A1).
With respect to claims 3 and 4, Wu teaches a method for assessing blood pressure stability in a living subject, as established above.
However, Wu does not teach the limitations further recited in claims 3 and 4.
Regarding claim 3, Park teaches target blood pressure ranges based on particular user (par.0059). Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to incorporate target blood pressure ranges based on a particular user’s age, height, and body weight for the purpose of determining the validity of biological data of a user, as suggested by Park (par.0002). Although Wu and Park do not expressly teach the target blood pressure range is 110 mmHg to 120 mmHg, and wherein the blood pressure target value is 115 mmHg, further modification to include this range and target value would have been prima facie obvious to person having ordinary skill in the art when the invention was filed since (1) it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233; and (2) it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
With respect to claim 4, Park teaches prior to calculating the total deviation of data points, omitting a first portion of data points above the target blood pressure range and omitting a second portion of data points below the target blood pressure range (par.0016 “may further include eliminating a first valid section from the valid range when the biological data is not acquired during the validity period set for the first valid section”; see also par.0064, 68). Therefore, it would have been prima facie obvious to person having ordinary skill in the art when the invention was filed to incorporate omitting/eliminating a portion(s) of data above/below the target blood pressure range(s) in order to primarily determine the biological data as invalid even when the biological data belonging to the very valid section is acquired at a later time, as evidence by Park (par.0064, 68).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wu in view of Becker (US PG Pub. No. 2004/0267570 A1).
With respect to claim 5, Wu teaches a method for assessing blood pressure stability in a living subject, as established above.
However, Wu does not teach the limitations further recited in claim 5.
Regarding claim 5, Becker teaches calculating an area under the curve (AUC) for the cumulative distribution curve, and wherein said plurality of outcome measures include the AUC (par.0118 “a curve of blood pressure can be plotted and the area under the curve calculated as an expression of total body exposure to blood pressure”).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Wu to incorporate calculating AUC, in the manner recited, for the purpose of producing a scalar summary statistic of excess exposure to blood pressure, as evidence by Becker (par.0118).
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791