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 of Species A drawn to Figure 2 in the reply filed on 6/15/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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).
Claims 4-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/15/2026.
Claims 1-3 and 6-7 remain pending and under prosecution.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
a blood pressure estimation unit of Claim 1 drawn to the entire device
a reference blood pressure measurement unit including a sound wave detection unit of Claim 1
a feature amount acquisition unit of Claim 1 including a first pulse wave detection unit
and a second pulse wave detection unit of Claims 2-3
a correspondence relationship determination unit of Claim 1
an estimated blood pressure acquisition unit of Claim 1
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-3 and 6-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 1 recites:
“detect Korotkoff sound generated in accordance with the pulsation,”
“acquire the circulatory organ-related feature amount”
“determine a correspondence relationship between the reference blood pressure value and an acquired value of the circulatory organ-related feature amount corresponding to a specific pulsation corresponding to the Korotkoff sound with which the reference blood pressure value in the pulsation is measured” and
“calculate the blood pressure value from the circulatory organ-related feature amount based on the correspondence relationship.”
Claim 7 recites:
“detecting Korotkoff sound generated in accordance with the pulsation;”
“acquiring the circulatory organ-related feature amount corresponding to a specific pulsation corresponding to the Korotkoff sound with which the reference blood pressure value in the pulsation is measured”; and
“determining the correspondence relationship between the reference blood pressure value and the obtained circulatory organ-related feature amount.”
Under the first of the two-prong inquiry of step 2A for evaluating 101, these limitations are considered a mental process because the steps as claimed may be easily performed in the user’s mind. The detecting Korotkoff sounds can be listened to by the user, and the feature amount, the correspondence relationship, and blood pressure value can be mentally calculated or observed and thus acquired, determined, and calculated, respectively, or by using pen and paper.
Under the second of the two-prong inquiry of step 2A, this judicial exception is not integrated into a practical application because there are no limitations that indicate improvements to the functioning of a computer or to the technology/technical field; effecting a particular treatment or prophylaxis for a disease/condition; applying the judicial exception with a particular machine (the control unit and sensor are recited with such generality that they are not considered a particular machine); effecting a transformation or reduction of a particular article to a different state/thing; applying the judicial exception in a meaningful way beyond generally linking to a particular technological environment.
Since the second of the two-prong inquiry of step 2A is not satisfied, the claims are then evaluated under step 2B.
Under step 2B for evaluating 101, the claim(s) does not include additional elements that are sufficient to amount to significantly more than the judicial exception because even though Claim 1 recites a sound wave detection unit configured to detect Korotkoff sound generated in accordance with the pulsation and the reference blood pressure measurement unit being configured to measure a reference blood pressure value by using the Korotkoff sound, said sound wave detection unit and reference blood measurement unit are recited with a high level of generality and thus merely constitute well-known, routine, and conventional data gathering structures in the Korotkoff blood pressure measurement art.
Similarly, the generic recitation of the other components to perform said steps including a blood pressure estimation unit, a feature amount acquisition unit, a correspondence relationship determination unit, and an estimated blood pressure acquisition unit are recited with such a high level of generality that they do not constitute special machines to perform the steps and thus, do not add significantly more to the abstract idea.
Claim 7 does not provide any structural limitations nor any additional steps that add significantly more to the abstract idea. While Claim 7 does recite measuring a reference blood pressure value by using the Korotkoff sound, said step constitutes common data gathering in the blood pressure measurement art and thus does not add meaningfully more to the abstract idea because it is well-understood, routine, and common.
Claims 2-3 and 6 also do not provide a practical application of the above abstract idea and do not further add significantly more because a first pulse wave detection unit and a second pulse wave detection unit are additional common data gathering structures in the pulse wave and blood pressure measurement art and thus, do not meaningfully add to the abstract idea.
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 1-3 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Fuji et al (WO 2019193974, with citations from US Pub No. 20210000353) in view of Higuchi et al (US Pat No. 5000187).
In regard to Claim 1, Fuji et al disclose a blood pressure estimation device comprising:
a blood pressure estimation unit 30 configured to acquire a circulatory organ-related feature amount that is a feature amount related to a state of a circulatory organ and changes in accordance with pulsation of a heart – pulse transit time –
and to calculate a blood pressure value from the circulatory organ-related feature amount, best seen in Figure 1 – “the first blood pressure measurement unit 30 performs blood pressure measurement based on a pulse transit time. Specifically, the first blood pressure measurement unit 30 measures the pulse transit time at the user's wrist and calculates a blood pressure value on the basis of measurement results of the pulse transit time. The first blood pressure measurement unit 30 can perform continuous blood pressure measurement for obtaining the blood pressure value for each beat” (0034); and
a reference blood pressure measurement unit 40 configured to detect Korotkoff sound generated in accordance with the pulsation, the reference blood pressure measurement unit being configured to measure a reference blood pressure value by using the Korotkoff sound, best seen in Figure 1 –
“the second blood pressure measurement unit 40 performs blood pressure measurement using a method different from that of the first blood pressure measurement unit 30. The second blood pressure measurement unit 40 is based on, for example… a Korotkoff method and performs the blood pressure measurement at a specific timing” (0034),
wherein the blood pressure estimation unit includes
a feature amount acquisition unit 31 configured to acquire the circulatory organ-related feature amount, i.e. pulse transit time, best seen in Figure 1 – “The pulse transit time measurement unit 31 can obtain the pulse transit time for each beat” (0035, 0037),
a correspondence relationship determination unit 60 configured to determine a correspondence relationship – equation 1 for example -- between the reference blood pressure value and an acquired value of the circulatory organ-related feature amount corresponding to a specific pulsation corresponding to the Korotkoff sound with which the reference blood pressure value in the pulsation is measured, best seen in Figure 1 – “The parameters A.sub.1 and A.sub.2 are determined by the calibration unit 60” (0036, 0041) , and
an estimated blood pressure acquisition unit 32 configured to calculate the blood pressure value from the circulatory organ-related feature amount based on the correspondence relationship, best seen in Figure 1 – “blood pressure value calculation unit 32 calculates the blood pressure value on the basis of the pulse transit time measured by the pulse transit time measurement unit 31 and a relational expression representing a correlation between the pulse transit time and the blood pressure” (0036).
However, Fuji et al do not expressly disclose the reference blood pressure measurement unit to detect Korotkoff sounds includes a sound wave generation unit.
Higuchi et al teach that it is well-known in the art to have a sound wave generation unit to effectively detect Korotkoff sounds when measuring blood pressure – “apparatus include means for continuously detecting (a) Korotkoff sounds produced as pressure in an inflatable cuff set around a body portion of a subject is varied” (Col.1: 12-21).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Fuki et al such that the reference blood pressure measurement unit to detect Korotkoff sounds includes a sound wave generation unit as taught by Higuchi et al to provide an effective means to detect the Korotkoff sounds as well-known in the art.
2. The blood pressure estimation device according to claim 1, wherein the feature amount acquisition unit 31 includes a pulse wave detection unit configured to detect a pulse wave – “the pulse transit time measurement unit 31 includes two pulse wave sensors provided on the belt unit 20 and non-invasively measures the pulse transit time using these pulse wave sensors” (0035).
3. The blood pressure estimation device according to claim 2, wherein the feature amount acquisition unit includes a first pulse wave detection unit and a second pulse wave detection unit – “the pulse transit time measurement unit 31 includes two pulse wave sensors provided on the belt unit 20 and non-invasively measures the pulse transit time using these pulse wave sensors” (0035)
configured to detect the pulse wave at two points having different pulse wave arrival times, the feature amount acquisition unit being configured to acquire, as the circulatory organ-related feature amount, a pulse transit time between the two points, best seen in Figure 4 – “the pair of first detection electrodes 312 and 313 form a first pulse wave sensor 310-1. The pair of second detection electrodes 314 and 315 form a second pulse wave sensor 310-2. The pair of second detection electrodes 314 and 315 are disposed on a downstream side of a blood flow in the radial artery 91 from the pair of first detection electrodes 312 and 313… This distance D corresponds to a substantial interval between the first pulse wave sensor 310-1 and the second pulse wave sensor 310-2” (0056).
6. The blood pressure estimation device according to claim 1, wherein the blood pressure estimation unit 30 and the reference blood pressure measurement unit 40 are integrally configured – “ the blood pressure measurement (estimation) based on the pulse transit time and the blood pressure measurement… can be performed by an integrated device” (0092), wherein it is also well-understood in the art that both can be implemented on the same computing or analysis device.
In regard to Claim 7, Fuji et al disclose a method for calibrating a blood pressure estimation device that is configured to calculate, based on a correspondence relationship between a circulatory organ-related feature amount that is related to a state of a circulatory organ and changes in accordance with pulsation of a heart and a blood pressure value – pulse transmit time, the blood pressure value from the circulatory organ-related feature amount – “blood pressure value calculation unit 32 calculates the blood pressure value on the basis of the pulse transit time measured by the pulse transit time measurement unit 31 and a relational expression representing a correlation between the pulse transit time and the blood pressure” (0036),”
the method comprising:
measuring a reference blood pressure value by using the Korotkoff sound – “the second blood pressure measurement unit 40 performs blood pressure measurement using a method different from that of the first blood pressure measurement unit 30. The second blood pressure measurement unit 40 is based on, for example… a Korotkoff method and performs the blood pressure measurement at a specific timing” (0034);”
acquiring the circulatory organ-related feature amount corresponding to a specific pulsation corresponding to the Korotkoff sound with which the reference blood pressure value in the pulsation is measured – “The pulse transit time measurement unit 31 can obtain the pulse transit time for each beat” (0035, 0037); and
determining the correspondence relationship – equation 1 for example – between the reference blood pressure value and the obtained circulatory organ-related feature amount – “the parameters A.sub.1 and A.sub.2 are determined by the calibration unit 60” (0036), “the calibration unit 60 performs calibration of the above relational expression (1) on the basis of a plurality of measurement result sets acquired from each of the plurality of postures. For example, the calibration unit 60 determines the parameters A.sub.1 and A.sub.2 on the basis of the plurality of measurement result sets by applying a fitting method such as a least squares method” (0041).
However, Fuji et al do not expressly disclose detecting Korotkoff sound generated in accordance with the pulsation but do disclose using the Korotkoff method (0034).
Higuchi et al teach that it is well-known in the art to detect Korotkoff sounds when measuring blood pressure using said Korotkoff method – “apparatus include means for continuously detecting (a) Korotkoff sounds produced as pressure in an inflatable cuff set around a body portion of a subject is varied” (Col.1: 12-21).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Fuki et al such that the method includes detecting Korotkoff sounds as taught by Higuchi et al to effectively perform the Korotkoff method as is as well-known in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Huong Q NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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