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 .
The amendment filed on July 8, 2026 has been received and considered. By this amendment, claims 1, 3, and 8-10 are amended, claim 3 is cancelled, claims 21-22 are added, and claims 1, 2, 4-17, and 19-22 are now pending in the application.
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 16, 17, 19, 20, and 22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim(s) recite(s) a method (process) and apparatus for processing physiological information.
Step 2A, Prong One
Regarding claims 16 and 19, the limitations of “acquire/acquiring physiological information data indicating physiological information of a subject”, “acquire/acquiring a value of a parameter relevant to an autonomic nerve function of the subject in each of first time intervals based on the physiological information data”, “acquire/acquiring a plurality of abnormality index values indicating an extent of abnormality in the autonomic nerve function of the subject based on the values of the parameter acquired in the first time intervals”, “display/displaying a radar graph indicating the plurality of abnormality index values”, and “acquire an abnormality index value indicating an extent of abnormality in the autonomic nerve function of the subject based on the values of the parameter acquired in the first time intervals” are processes that, as drafted, cover performance of the limitations that can be performed by a human in their mind or using pen and paper under broadest reasonable interpretation standard. For example, acquiring data encompasses nothing more than a user obtaining a written record of the data. Similarly, displaying information requires nothing more than a user writing down information indicating the abnormality index value. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in human mind or by a human using a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See MPEP 2106.04(a)(2)(III).
Step 2A, Prong Two
This judicial exception is not integrated into a practical application. In particular, the claim recites additional elements of “a processor”, “a memory that stores a computer-readable command”, and “a central monitor”. The processor, memory, and central monitor are recited at a high-level of generality (i.e., any processor) and they amount to no more than mere pre-solution activity information processing. This additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a processor, memory, and central monitor amounts to no more than mere pre-solution activity of information processing, which does not amount to an inventive concept. Therefore, the claim is not patent eligible.
Claim Rejections - 35 USC § 102
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 19 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tadokoro (U.S. 2005/0209522, previously cited). Tadokoro discloses a system comprising: a central monitor 500; and a physiological information processing apparatus 100 connected to the central monitor through a network interface, the physiological information processing apparatus comprising: a processor 202, and a memory 600 that stores a computer-readable command, wherein when the computer-readable command is executed by the processor, the physiological information processing apparatus is configured to: acquire physiological information data indicating physiological information of a subject; acquire a value of a parameter relevant to an autonomic nerve function of the subject in each of first time intervals based on the physiological information data; acquire an abnormality index value indicating an extent of abnormality in the autonomic nerve function of the subject based on the values of the parameter acquired in the first time intervals, and cause the central monitor to display information indicating the abnormality index value (see paragraph [0008]).
Regarding claim 21, Tadokoro discloses that the physiological information includes RR interval information (“frequency analysis to the acquired pattern of the heartbeat (fluctuation of R-R interval detected from electrocardiogram by pattern recognition or the like)”, paragraph [0039]), and the physiological information processing apparatus is configured to acquire the value of the parameter relevant to an autonomic nerve function by: performing a frequency analysis of the RR interval information (“frequency analysis to the acquired pattern of the heartbeat (fluctuation of R-R interval detected from electrocardiogram by pattern recognition or the like)”, paragraph [0039]); identifying a low frequency component of the acquired physiological information and a high frequency component of the physiological information based on the frequency analysis (“Concretely, the information processing circuit 202 carries out frequency analysis to R-R interval of electrocardiogram (pattern of heartbeat) at a predetermined processing interval (ex. about 60 sec) to calculate the HF value and the LF/HF ratio value.”, paragraph [0040]); and acquiring a first parameter relevant to a sympathetic nerve function of the subject based on the low frequency component, and a second parameter relevant to a parasympathetic nerve function of the subject and based on the high frequency component (“an information processing circuit 202 which has a function of calculating a value [msec.sup.2] of a high frequency component (a HF value) defined as an indicator for parasympathetic activity and a value of a ratio of a low frequency component (LF) to the high frequency component (a LF/HF ratio value) defined as an indicator for sympathetic activity “, paragraph [0039]).
Claim Rejections - 35 USC § 103
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 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 16, 17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Tadokoro (U.S. 2005/0209522, previously cited) in view of Hasegawa et al. (U.S. 2015/0212506). Regarding claim 16, Tadokoro discloses a physiological information processing method comprising: a step of acquiring physiological information data indicating physiological information of a subject; a step of acquiring a value of a parameter relevant to an autonomic nerve function of the subject in each of first time intervals based on the physiological information data; a step of acquiring a plurality of abnormality index values indicating abnormality in the autonomic nerve function of the subject based on the values of the parameter acquired in the first time intervals, and a step of displaying information indicating the plurality of abnormality index values (see paragraph [0008]). However, Tadokoro fails to disclose that the displayed information indicating the plurality of abnormality index values is a radar graph. Hasegawa teaches an apparatus 20 that acquires physiological information data (vital data VD) and processes the data to acquire a plurality of index values (at index data calculator 25a, see paragraph [0044]) and display a radar graph indicating the plurality of index values (Figures 8A and 8B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tadokoro to include displaying the information indicating the plurality of abnormality index value on a radar graph, as taught by Hasegawa, in order to provide a visual indicator as to the normal versus abnormal state of such values, and as it has been held the combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Regarding claim 17, Tadokoro discloses a computer-readable storage medium in which a physiological information processing program for making a computer execute a physiological information processing method according to Claim 16 is stored (see paragraph [0008]).
Regarding claim 20, Tadokoro discloses the invention substantially as claimed, but fails to disclose that the displayed information indicating the plurality of abnormality index values is a radar graph. Hasegawa teaches an apparatus 20 that acquires physiological information data (vital data VD) and processes the data to acquire a plurality of index values (at index data calculator 25a, see paragraph [0044]) and display a radar graph indicating the plurality of index values (Figures 8A and 8B). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Tadokoro to include displaying the information indicating the plurality of abnormality index value on a radar graph, as taught by Hasegawa, in order to provide a visual indicator as to the normal versus abnormal state of such values, and as it has been held the combining prior art elements according to known methods to yield predictable results requires only routine skill in the art.
Allowable Subject Matter
Claims 1, 2, and 4-15 are allowed.
Response to Arguments
Applicant's arguments filed July 8, 2026 have been fully considered but they are not persuasive. Regarding the rejection of the claims under 35 USC 101, the Applicant argues that the claims are amended as discussed during the interview, however it is noted that independent claim 1 is the only independent claim amended, which has overcome the rejection under 35 USC 101. Applicant’s further arguments are based on the subject matter that was added only to independent claim 1 and, thus, not material to the rejections that are submitted above. It is respectfully submitted that if the other independent claims are amended in a similar fashion as claim 1 was amended, such amendments would likely overcome the rejections under 35 USC 101.
Regarding the rejection of claims 19 and 20 as being anticipated by Tadokoro, Applicant argues that the display of Tadokoro is an element of the blood component collecting apparatus 100 and is thus, not connected over a network interface. Applicant points to paragraph [0036] of the specification for description of the claimed network interface and indicates that “one of ordinary skill would at least appreciate the interface as one that connects the central monitor and physiological information processing apparatus over a communication of like network”. It is respectfully submitted that the broadest reasonable interpretation for “network interface” would encompass a hard wired connection, such as one wherein a display is hard wired to the other components. If Applicant intends for the interface to be a wireless interface, it is suggested that the claims be amended in such a fashion to recite a wireless interface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached on Monday through Friday from 8 am until 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached on 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
