DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Notice to Applicant
2. This communication is in response to the communication filed 3/2/2026. Claim 10 is cancelled. Claims 1-2, 7-8, 11, 13-14, 17 and 19-21 are currently amended. Claims 1-9 and 11-21 are currently pending.
Claim Rejections - 35 USC § 101
3. 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.
3.1. Claims 1-9 and 11-21 are rejected under 35 U.S.C. § 101 because while the claims (1) are to a statutory category (i.e., process, machine, manufacture or composition of matter, the claims (2A1) recite an abstract idea (i.e., a law of nature, a natural phenomenon); (2A2) do not recite additional elements that integrate the abstract idea into a practical application; and (2B) are not directed to significantly more than the abstract idea itself.
In regards to (1), the claims are to a statutory category (i.e., statutory categories including a process, machine, manufacture or composition of matter). In particular, independent claims 1, 8 and 9, and their respective dependent claims are directed, in part, to an apparatus, a method and program for interpreting biological information.
In regards to (2A1), the claims, as a whole, recite and are directed to an abstract idea because the claims include one or more limitations that correspond to an abstract idea including mental processes and/or certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. For example, independent claims 1, 8 and 9, as a whole, are directed to interpreting biological information by, in part, displaying biological information, displaying an interpretation request, receiving designation of a feedback item as an interpretation result, and transmitting the feedback item with an analysis result which are human activities and/or interactions and therefore, certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. The dependent claims include all of the limitations of their respective independent claims and thus are directed to the same abstract idea identified for the independent claims but further describe the elements and/or recite field of use limitations.
Furthermore, assuming arguendo, the claims are not directed to certain methods of organizing human activities, the claims, nevertheless, are directed to an abstract idea because the claims, except for certain limitations (* identified below in bold), under the broadest reasonable interpretation, can be reasonably and practically performed in the human mind and/or with pen and paper using observation, evaluation, judgment and/or opinion. That is, other than reciting the certain additional elements, nothing in the claims precludes the limitations from being practically performed in the mind and/or with pen and paper.
CLAIM 1:
A biological information interpretation support apparatus, comprising:
an operation display that includes a display screen and receives an input operation by an operator;
a communication device that communicates with an external terminal via a network;
a controller that controls the operation display and the communication device, wherein the controller is configured to
cause the operation display to display and of: biological information, information on an analysis result of the biological information, or a combination thereof on the display screen;
cause the operation display to display an interpretation request reception section on the display screen displaying the biological information and/or the information on the analysis result, or a combination thereof, wherein the interpretation request reception section is configured to receive an interpretation request operation for the biological information by the operator;
cause the operation display to receive an operation for a designation of a feedback item by the operator during the interpretation request operation, the feedback item being an item that the operator requests required as an interpretation result of the biological information,
generate additional information for supporting an interpretation request by the operator when the interpretation request is made, wherein the additional information is generated based on predetermined information stored in an internal or external storage,
cause the communication device to transmit the interpretation request to the external terminal via the network,
wherein the interpretation request includes any of: the biological information with the designation of the feedback item added thereto, the information on the analysis result with the designation of the feedback item added thereto, or a combination thereof, and
wherein one or both of the biological information and the information on the analysis result includes the generated additional information,
cause the operation display to display a request destination reception section, wherein the request destination reception section is configured to indicate whether a request destination is in a state capable of receiving the interpretation request and to receive an operation for designation of the request destination of the interpretation request, and
cause the communication device to transmit the interpretation request including the generated additional information to the request destination that is capable of receiving the interpretation request,
thereby enabling the interpretation result to be returned faster.
CLAIM 2:
The biological information interpretation support apparatus according to claim 1, wherein the controller is further configured to cause the operation display to display a feedback item designation section on the display screen displaying any of: the biological information, the information on the analysis result, or a combination thereof, the feedback item designation section being for receiving the operation of the designation of the feedback item by the operator.
CLAIM 3:
The biological information interpretation support apparatus according to claim 2, wherein the feedback item is selectable.
CLAIM 4:
The biological information interpretation support apparatus according to claim 2, wherein the feedback item designation section is displayed after reception of the interpretation request operation.
CLAIM 5:
The biological information interpretation support apparatus according to claim 4, wherein the controller is further configured to cause the operation display to display the feedback item designation section and the request destination reception section sequentially in response to the reception of the interpretation request operation.
CLAIM 6:
The biological information interpretation support apparatus according to claim 5, wherein the controller is further configured to cause the operation display to display one or more request destinations on the request destination reception section and to receive the operation for the designation of the request destination from among the displayed one or more request destinations, the one or more request destinations being capable of receiving the interpretation request.
CLAIM 7:
The biological information interpretation support apparatus according to claim 2, wherein the controller is further configured to cause the operation display to display an operation for input column that receives an operation for input of any of: first additional information including at least one of a history, a symptom, a prescription, and/or a chief complaint that is related to a living body for which the biological information is acquired and/or second additional information of one or more living bodies in a group to which the living body belongs, or a combination thereof, and wherein the additional information is generated based on the input of the first additional information, the second additional information, or a combination thereof.
CLAIM 8:
A biological information interpretation support method for supporting biological information interpretation using a biological information interpretation support apparatus, the method comprising:
causing, by a controller, an operation display to display any of: biological information, information on an analysis result of the biological information, or a combination thereof, on a display screen,
wherein the biological information interpretation support apparatus comprises the operation display that includes the display screen and receives an input operation by an operator, a communication device that communicates with an external terminal via a network, and the controller that controls the operation display and the communication device;
causing, by the controller, the operation display to display an interpretation request reception section on the display screen displaying any of: the biological information, the information on the analysis result, or a combination thereof,
wherein the interpretation request reception section is configured to receive an interpretation request operation for the biological information by the operator;
causing, by the controller, the operation display to receive an operation for designation of a feedback item by the operator during the interpretation request operation, the feedback item being an item that the operator requests as an interpretation result of the biological information;
generating, by the controller, additional information for supporting an interpretation request by the operator when the interpretation request is made, wherein the additional information is generated based on predetermined information stored in an internal or external storage,
causing, by the controller, the communication device to transmit the interpretation request to the external terminal via the network,
wherein the interpretation request includes any of: the biological information with the designation of the feedback item added thereto,, the information on the analysis result with the designation of the feedback item added thereto, or a combination thereof, and
wherein any one or both of the biological information and the information on the analysis result includes the generated additional information;
causing, by the controller, the operation display lo display a request destination reception section, wherein the request destination reception section Is configured to indicate whether a request destination is in a state capable of receiving the interpretation request and io receive an operation for designation of the request destination of the interpretation request and
causing, by the controller, the communication device to transmit the interpretation request including the generated additional information io the request destination that is capable of receiving the interpretation request,
thereby enabling the interpretation result io be improved in quality and to be returned faster.
CLAIM 9:
A biological information interpretation support program, which causes a computer to execute the biological information interpretation support method according to claim 8.
CLAIM 11:
The biological information interpretation support apparatus according to claim 1, wherein
the controller is further configured to cause the communication device to receive from the external terminal via the network the interpretation result of any of: the biological information, the information on the analysis result, or a combination thereof, and
the controller is further configured to cause the operation display to display the received interpretation result on the display screen, the received interpretation result being displayed so as to be tied to any of: the biological information corresponding to the received interpretation result, the information on the analysis result corresponding to the received interpretation result, or a combination thereof.
CLAIM 12:
The biological information interpretation support apparatus according to claim 1, wherein the controller is further configured to cause the operation display to display a list of one or more selectable request destinations on the request destination reception section, the one or more selectable request destinations being in the state capable of receiving the interpretation request.
CLAIM 13:
The biological information interpretation support apparatus according to claim 7, wherein the second additional information includes at least one or both biological waveform data of a family member or biological waveform data of a relative of a patient, wherein the first additional information, the second additional information, or a combination thereof is stored in the internal storage of the biological information interpretation support apparatus.
CLAIM 14:
The biological information interpretation support apparatus according to claim 1, wherein
the controller is further configured to cause the operation display to display a feedback item designation section on the display screen displaying any of the biological information, the information on the analysis result, or a combination thereof, wherein the feedback item designation section is configured for receiving the operation of the designation of the feedback item by the operator, and
the feedback item designation section is displayed after reception of the interpretation request operation.
CLAIM 15:
The biological information interpretation support apparatus according to claim 1, wherein the information on an analysis result of the biological information is an automatic analysis result of the biological information measured and automatically analyzed by a separate device.
CLAIM 16:
The biological information interpretation support apparatus according to claim 1, wherein the displayed one or more request destinations include a facility at which a patient has seen a doctor.
CLAIM 17:
The biological information interpretation support apparatus according to claim 1, wherein
the controller is further configured to cause the communication device to receive from the external terminal via the network the interpretation result of any of: the biological information, the information on the analysis result, or a combination thereof, and
the controller is further configured to: cause the operation display to display the received interpretation result on the display screen, wherein
the received interpretation result is displayed to be tied to any of: the biological information corresponding to the received interpretation result, the information on the analysis result corresponding to the received interpretation result, or a combination thereof, by any of: displaying an induced biological waveform underlying the interpretation result, marking a part of a biological waveform, or a combination thereof, and/or
the second interpretation result is stored in a storage of the biological information interpretation support apparatus, to be tied to any of: the biological information corresponding to the received interpretation result, the information on the analysis result corresponding to the received interpretation result, or a combination thereof.
CLAIM 18:
The biological information interpretation support apparatus according to claim 1, wherein the feedback item is displayed on the operation display by tiers.
CLAIM 19:
The biological information interpretation support apparatus according to claim 1, wherein the controller is further configured to cause the operation display to display the generated additional information requested by a request destination selected from among the displayed one or more request destinations.
CLAIM 20:
The biological information interpretation support apparatus according to claim 7, wherein any of the first additional information, the second additional information, or a combination thereof, is automatically input from the internal storage of the biological information interpretation support apparatus.
CLAIM 21:
The biological information interpretation support apparatus according to claim 2, wherein the feedback item is displayed on the feedback item designation section superimposed on any of: the displayed biological information, and/or information on the analysis result, or a combination thereof.
* The limitations that are in bold are considered “additional elements” that are further analyzed below in subsequent steps of the 101 analysis. The limitations that are not in bold are abstract and/or can be reasonably and practically performed in the human mind and/or with pen paper.
In regards to (2A2), the claims do not recite additional elements that integrate the abstract idea into a practical application. The additional elements in the claims (i.e., * identified above in bold) do not integrate the abstract idea into a practical application because the additional elements merely add insignificant extra-solution activity to the abstract idea; merely link the use of the judicial exception to a particular technological environment or field of use; and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements (e.g., biological information interpretation support apparatus, display screen, program, computer, etc.) are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies. Moreover, the claims recite “causing a display screen to”, “causes a computer to”, etc. devoid of any meaningful technological improvement details and thus, further evidence the additional elements are merely being used to leverage generic technologies to automate what otherwise could be done manually. Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Furthermore, the additional elements do not recite improvements to the functioning of a computer, or to any other technology or technical field—the additional elements merely recite general purpose computer technology; the additional elements do not recite applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition—there is no actual administration of a particular treatment; the additional elements do not recite applying the judicial exception with, or by use of, a particular machine—the additional elements merely recite general purpose computer technology; the additional elements do not recite limitations effecting a transformation or reduction of a particular article to a different state or thing—the additional elements do not recite transformation such as a rubber mold process; the additional elements do not recite applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment—the additional elements merely leverage general purpose computer technology to link the abstract idea to a technological environment.
In regards to (2B), the claims, individually, as a whole and in combination with one another, do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of (A) a generic computer structure(s) that serves to perform computer functions that serve to merely link the abstract idea to a particular technological environment (i.e., computers); and/or (B) functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Here, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer technologies. Mere instructions to apply an exception using generic computer technologies cannot provide an inventive concept.
Moreover, paragraphs [0041]-[0044] of applicant's specification (US 2023/0420087) recites that the system/method may be implemented using a computer, portable terminal, a smartphone, tablet computer and the like which are well-known general purpose or generic-type computers and/or technologies. The use of generic computer components recited at a high level of generality to process information through an unspecified processor/computer does not impose any meaningful limit on the computer implementation of the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Furthermore, the additional elements are merely well-known general purpose computers, components and/or technologies that receive, transmit, store, display, generate and otherwise process information which are akin to functions that courts consider well-understood, routine, and conventional activities previously known to the pertinent industry, such as, performing repetitive calculations; receiving or transmitting data over a network; electronic recordkeeping; retrieving and storing information in memory; and sorting information (See, for example, MPEP § 2106).
Therefore, the claims are not patent-eligible under 35 U.S.C. § 101.
Response to Arguments
4. Applicant's arguments filed 3/2/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 3/2/2026.
4.1. Applicant argues, on pages 11-16 of the response, that (1) the amended claims cannot be reasonably and practically performed in the human mind and hence are not directed to an abstract idea; and (2) even if it is assumed for the sake of arguments that the claims are directed to the abstract idea, the claims as a whole integrates the alleged judicial exception into a practical application because the additional elements provide a technological improvement in the field of biological information, interpretation support and makes the technology better, faster and more efficient using the invention as claimed.
In regard to (1), it is noted that the pending claims are directed to a system for a biological information interpretation support whereby an operator uses the system to request interpretation support from others. The system and method obtain interpretation support by, in part, by displaying biological information, displaying an interpretation request, receiving designation of a feedback item as an interpretation result, and transmitting the feedback item with an analysis result. These are human activities and/or interactions and therefore, an abstract idea under the grouping of certain methods of organizing human activity which encompasses both certain activity of a single person, certain activity that involves multiple people, and certain activity between a person and a computer. As such, it is moot whether or not the claims are directed to a mental concept.
Nevertheless, it is submitted that the claims also fall under the abstract grouping of mental concepts because the claims can be reasonably and practically performed in the human mind and/or with pen and paper. For example, aside from additional elements recited at a high-level of generality, nothing in the claims precludes a person from performing the steps of the claims in their mind and/or with pen and paper, such as, sending and/or receiving a biological information interpretation request to another person, adding additional information to for supporting an interpretation request, determining if the interpretation request destination is capable of providing the support, etc. Including additional elements, such as an interface, computer, processor, etc. to facilitate the abstract idea does not ipso facto render the claims non-abstract.
In regard to (2), it is respectfully reiterated that the additional elements are recited at a high-level of generality such that it amounts to no more than mere instructions to apply the abstract idea using generic computer technologies whereby the additional elements merely add insignificant extra-solution activity to the abstract idea (e.g., receive, transmit, display, etc. information); merely link the use of the judicial exception to a particular technological environment or field of use (e.g., computer automation); and/or simply append technologies and functions, specified at a high level of generality, to the abstract idea (i.e., the additional elements do not amount to more than a recitation of the words “apply it” (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer).
Here, the additional elements merely facilitate the performance of the abstract idea by linking the abstract idea to a computer environment and implementing the abstract idea on a computer thereby amounting to mere instructions. While the use of computer technologies may facilitate interpretation, improve interpretation speed, improve interpretation efficiencies, and the like, these are not technological improvements. Rather, these are improvements to the abstract idea and a business practice, namely, biological information interpretation support management by performing the abstract idea better, faster, and more efficient. In other words, the focus of the pending claims is not on an improvement in computers as tools, but on certain abstract ideas that use computers as tools. Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea or evidence a technological improvement that is sufficient to integrate the abstract idea into a practical application.
As such, it is respectfully submitted that the claims recite and are directed to an abstract idea, the additional elements do not integrate the abstract idea into a practical application, the additional elements do not amount to significantly more than the abstract idea itself, and thus, are not patent-eligible subject matter under 35 U.S.C. § 101.
Conclusion
5. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Tomaszewski whose telephone number is (313)446-4863. The examiner can normally be reached M-F 5:30 am - 2:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469) 295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL TOMASZEWSKI/Primary Examiner, Art Unit 3681
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