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 with traverse of Species A-2 and B-2 in the reply filed on 16 April 2026 is acknowledged. The traversal is on the ground(s) that a search for one species within a group of species would encompass a search for the other species within that group. This is not found persuasive because the physical structures of Species A-1 and A-2, and Species B-1 and B-2, are entirely distinct and involve different components, such that no search for one structure would encompass a search for the alternative structures.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2 and 4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 16 April 2026.
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 Objections
Claim 1 is objected to because of the following informalities:
The final clause of claim 1 is grammatically incorrect in its lack of an article before “contact state stabilizer”.
Appropriate correction is required.
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:
blood pressure measurement unit, first recited in claim 1 - assembly which controls a cuff assembly including a control unit and calculation unit as part of a CPU, a pump, and exhaust valve (paragraph [0038] as filed)
support member, first recited in claim 1 – part of the belt portion (paragraph [0017] as filed) or a curler integrally provided with the belt portion (paragraphs [0023]-[0024] as filed)
electrocardiogram measurement unit, first recited in claim 1 – CPU components including a control unit and calculation unit (paragraph [0040] as filed)
contact resistance measurement unit, first recited in claim 10 – part of the blood pressure measurement unit’s calculation unit measuring conduction between first and second electrodes (paragraphs [0077]-[0079] as filed)
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 § 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 3 and 5 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.
Claim 3 recites that “the contact state stabilizer is the support member”. Claim 1 does not positively recite the support member being a part of the device, but describes it in the context of its relationship to the second electrode and the fluid bag. It is unclear if the support member is actually part of the invention as claimed, and how it relates to the other components, particularly as the contact site stabilizer is defined in claim 1 as an element wholly separate from the second electrode or the fluid bag, but if the stabilizer is the support member, then their relationship should be more clearly defined.
Similarly, claim 5 defines only a feature of “the support member” which is not positively recited as being an element of the device of claim 1. Clarification is required.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1, 3, 5-10 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). As presented, the claimed invention encompasses a human organism in that the invention is defined by its active involvement and interaction with the human organism – see, for example, claim 1’s “fluid bag which is wound around a measurement target site of the subject”, “blood pressure measurement unit which compresses the measurement target site”, “electrode which comes into contact with a first site of the subject”, and so forth. The invention should be presented in terms of what it is configured to do, not what it actively does, particularly when it is actively interacting with the human body. Correction is required.
Conclusion
No art has been applied against the claims at this time; however, as all the claims are rejected under at least 101 they are not presently allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2024/0197248 to Hamaguchi and US 2024/0197194 to Hamaguchi disclose devices having similar structures, including a fluid bag configured to be circumferentially wound around a measurement site, a blood pressure measurement unit configured to measure blood pressure by controlling inflation/deflation of the fluid bag, a first electrode, and a second electrode which is configured to be connected to the fluid bag and supported by a support member which extends from an end portion of the fluid bag, the second electrode being separated from the end portion by a distance, an electrocardiogram unit which measures with the electrodes, and a contact site stabilizer which is configured to suppress a change in the second electrode’s contact state when the fluid bag is inflated or deflated, but do not pre-date the effective filing date of the instant invention.
US 2024/0197189 to Mori, US 2024/0041338 to Kubo, US 2019/0269914 to Moaddeb all disclose similar devices with blood pressure measurement via a fluid bag and electrocardiogram measurement via electrodes, but do not disclose one of the electrodes being separated from an end portion of the fluid bag and supported by a support member with a contact site stabilizer configured to suppress any potential change in the second electrode’s contact site during operation of the fluid bag.
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/KAREN E TOTH/ Examiner, Art Unit 3791
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