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/Restrictions
Applicant’s election without traverse of Group II, drawn to a process of measuring arterial blood pressure and detecting auscultatory gap, in the reply filed on 7/31/25 is acknowledged.
Regarding the Election of Species, the examiner respectfully acknowledges and appreciates Applicant’s remarks, clarifications and proposals regarding the outstanding Election of Species in lieu of Applicant’s election of Group II. In view of thereof, the examiner hereby withdraws the Election of Species Requirement set forth along with the Restriction Requirement in the Office Action mailed 5/8/25. Thus, the withdrawn Election of Species requirement is moot.
Claims 1-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/31/25.
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).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
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.
Claim Objections
Claim 7 is objected to because of the following informalities: the positive recitation of “more natural and easy to produce” should apparently read “more natural and easier to produce”, or the like. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: there appears to be a missing “and” between the last two “optional” limitations., or the like. 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 7-8 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.
The term “typically 85 percent or more” in claim 7 is a relative term which renders the claim indefinite. The term “typically 85 percent or more” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the scope of the invention are indeterminate with respect to the explicitly, implicitly, or inherently required predetermined value relating to the correspondence of -- performing self-validation of the more precise measurement by establishing correspondence between values obtained by the two distinct machine learning-based modalities with said correspondence being no less than a predetermined value, typically 85 percent or more--. In the interest of compact prosecution, the examiner respectfully recommends reciting “85% of more” instead of “typically 85% or more”, which would appear to obviate the instant rejection.
The term “string-like vibrations” in claim 8 is a relative term which renders the claim indefinite. The term “string-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the scope of the invention are indeterminate with respect to what may and/or may not be required or excluded by the recitation of “string-like” and/or how “string-like” the vibrations must necessarily be to be considered “string-like”. In the interest of compact prosecution, the examiner respectfully recommends deleting the “string-like vibrations” recitation because a range of corresponding frequencies is recited, arguably rendering the indefinite recitation unnecessary and/or redundant.
The term “cylinder/pipe-like vibrations” in claim 8 is a relative term which renders the claim indefinite. The term “cylinder/pipe-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of the scope of the invention are indeterminate with respect to what may and/or may not be required or excluded by the recitation of “cylinder/pipe-like” and/or how “cylinder/pipe-like” the vibrations must necessarily be to be considered “cylinder/pipe-like”. In the interest of compact prosecution, the examiner respectfully recommends deleting the “cylinder/pipe-like vibrations” recitation because a range of corresponding frequencies is recited, arguably rendering the indefinite recitation unnecessary and/or redundant.
Allowable Subject Matter
Claims 7 and 8 would be allowable over prior art if rewritten to overcome the indefiniteness rejections hereinabove because the prior art does not disclose, teach, and/or fairly suggest, alone or in combination, an improvement in the field of arterial blood pressure measurement with detection of auscultatory gap including the combination of elements comprising:
using finger applied applanation pressure in which blood pressure is measured and the presence of the auscultatory gap is detected to generate biophysical phenomena known as Korotkoff events (KE);
compression of one pre-selected arterial segment without the interruption of blood flow through collateral blood vessels;
active participation of the user in the process of measurement to reduce white coat hypertension;
provisioning and modification in real-time instructions to the user how and when to apply applanation pressure, change its magnitude and the direction of the vector of the applanation pressure with said instructions selected from a group consisting of voice- based, sound-based, text-based, and image-based directives;
utilization of pulsatile application of applanation pressure;
collecting at least two datasets from the target arterial segment selected from the group consisting of pressure magnitude as a function of time dataset obtained with a pressure sensor, sound field intensity as a function of time dataset obtained with a sound sensor, and sound amplitude as a function of sound frequency dataset;
generation of the sound spectrogram image in real time as a constantly updating and elongating with the passage of time two-dimensional graphical image combining the sound amplitude as a function of time dataset with the sound amplitude as a function of frequency dataset and overlayed with a curve representing pressure magnitude as a function of time dataset;
identifying the passage of each pulse wave through the arterial segment by monitoring the elevation of the pressure magnitude within the arterial segment;
identifying 1st and 4th Korotkoff events in real time;
estimating of the systolic blood pressure as corresponding to 1st Korotkoff events, and the diastolic blood pressure as corresponding to 4th Korotkoff events;
adjusting user instructions to reflect the estimated systolic and diastolic blood pressure in regard to magnitude of the applanation pressure, duration of its application, timing of its application, and the direction of the vector of the applied pressure;
obtaining the more precise values of systolic and diastolic blood pressure by comparing systolic and diastolic blood pressure values obtained utilizing two distinct and complementary modalities:
the first modality being machine learning-based recognition of 1st, 2nd, 3rd, and 4th Korotkoff events in a two-dimensional graphical image comprised of the sound spectrogram with a pressure data overlay, and
the second modality being machine learning-based recognition of all Korotkoff events, including 0th and 5th in the combined datasets based on establishment of correspondence between first derivatives of pressure magnitude as a function of time and sound amplitude as a function of time as values of said derivatives change with passage of pulse waves;
performing self-validation of the more precise measurement by establishing correspondence between values obtained by the two distinct machine learning-based modalities with said correspondence being no less than a predetermined value of 85 percent or more;
determining the presence or absence of the clinical phenomenon known as the auscultatory gap utilizing two distinct modalities:
the first modality being machine learning-based recognition of a drop of sound intensity during 2nd or 3rd Korotkoff events in a two-dimensional graphical image comprised of the sound spectrogram with pressure data overlay, and
the second modality being machine learning-based recognition of the pattern in the values of first derivatives of pressure magnitude as a function of time and sound amplitude obtained during 2nd and 3rd Korotkoff events;
determining the need for repeated and adjusted measurement based on a predetermined degree but no less than 85% correspondence between the value of systolic and diastolic blood pressure obtained by the two distinct methods and the presence or absence of the auscultatory gap as established by the two distinct methods;
provisioning of a natural language easy-to-understand report to the user with blood pressure values and indication of the presence of the clinical phenomenon known as the auscultatory gap.
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for measuring blood pressure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791