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 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.
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 measurement unit”, “a detection unit”, “a biological information measurement unit” (all claim 1), and “an electrocardiogram measurement unit” (claim 4).
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 1 – 13 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. With regard to claim 1, the relationship between the “detection unit” which is “configured to measure the biological information” and the “biological measurement unit” that is indicated as “which measures the biological information using the detection unit” is either unclear or redundant, in that both units appear to be measuring the same parameter (“biological information”) with the same component (“detection unit”).
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 – 13 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). At least claims 1, 4, 5, 6, 7, and 10 set forth structural elements in positive relation to the living being through use of phrasing of: “which is wound around”; “fixes”; and “which comes into contact with” which improperly encompasses the living being in the scope of the claimed subject matter. Applicant should consider amending the phrases to indicate the elements are “configured to” or “adapted to” be brought into relation to the portion of the living being to avoid capturing the portion of the living being within the claimed scope.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant cites references related to measurement of blood pressure in a subject. Of particular relevance, Chang (JP2014-036843) teaches a device for collecting blood pressure and additional biological information (Summary of the Invention; Figures 1, 4A, 4B, etc). Additionally, Mori et al. (USPGPub 2020/0297224) teaches a blood pressure estimation apparatus (Figures 1, 4, 5) in which a first and second fluid bag are provided on the inner circumference of a wearable belt (paragraph [0033]), wherein each bag may be supplied fluid from a pump and is in communication with an associated valve. The apparatus further includes pulse wave sensor electrode elements for sensing a biological parameter. However, as shown and discussed in Mori et al., the electrode elements are provided on the first bag, not a detection unit support portion of the support member. Ozawa et al. (USPGPub 2020/0390338) teaches a biological information measuring device (Figures 1 and 7 – 9 and the descriptions thereof) in which pressure cuff and additional sensing elements are positioned on a common band to permit blood pressure to be measured via both PTT and oscillometric techniques. Ozawa et al. do not suggest that the sensing elements on the band could be configured for measuring a parameter other than blood pressure. Nishida et al. (USPGPub 2021/0290090) teaches a wearable blood pressure measurement device (Figures 1, 5), comprising belt, curler, plural fluid bags, pump, and valve components. However, while the general arrangement of these elements is known, as disclosed in the references, there is no teaching or suggestion to arrange the detection unit in a manner where it is supported by a detection unit support portion which is the support member exposed to an inner circumferential side between a first bag portion and a second bag portion, and is arranged at a position which allows a change in a contact state between a detection unit and a measurement target site due to movement of the detection unit support portion accompanying a volume change of the first bag portion and the second bag portion to be limited to a predetermined range, the position being a position separated by a first predetermined distance from a first end portion of the first bag portion on the detection unit side and separated by a second predetermined distance from a first end portion of the second bag portion on the detection unit side, in combination with the other claimed elements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC FRANK WINAKUR whose telephone number is (571)272-4736. The examiner can normally be reached Mon-Fri 9 am - 6 pm.
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791