DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The preliminary amendment to the claims filed 07 March 2024 has been entered. Claim(s) 7-12 is/are currently amended. New claim(s) 13-17 has/have been added. Claim(s) 1-17 is/are pending.
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 ("BRI") 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 BRI 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(I), claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) 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), 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), except as otherwise indicated in an Office action.
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 7 and claims dependent thereon is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 7 and claims dependent thereon, the preamble "A computer-readable medium in which a biological information recording program is recorded, the biological information recording program causing a computer to execute" is indefinite. The claim/preamble lacks any of the common/typical transitional phrases (see MPEP 2111.03), such that it is unclear what is or is not excluded from the claim. For example, it is unclear if the claim is intended to be open ended (i.e., not excluding additional, unrecited steps executed by the computer), limited to only the recited steps, etc. For the purpose of this Office action, claim 7 (and claims dependent thereon) will be further discussed with the understanding that the claim does not exclude unrecited steps from being performed by the computer, consistent with the term "comprising," e.g., within the scope of: "A computer-readable medium in which a biological information recording program is recorded, the biological information recording program causing a computer to execute a method, the method comprising: […]."
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 6-7 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2017060571 A ("Sutoko," cited by Applicant).
Regarding claims 1 and 6, Sutoko discloses a biological information recording device, comprising:
an acquisition processor configured to acquire biological information on a subject (input unit 101), which is detected by a biological information sensor (measuring unit 107) (¶ [0019]), wherein the biological information includes an electroencephalogram detected by an electro-encephalograph as the biological information sensor (¶ [0012]); and
a recording processor configured to record the biological information acquired by the acquisition processor (¶ [0019] memory 102 for storing information and data acquired by the input unit 101, which includes the acquired biological information, as discussed above, and/or means controlling storage of said information and data in said memory), and to further record, when a designation operation that designates a task to be carried out by the subject is performed by an observer who observes the subject during recording of the biological information (¶ [0022] task selected by a doctor or operator), the task in association with the biological information (¶ [0023] task type is stored in storage unit 102).
Regarding claims 7 and 12, Sutoko discloses a computer-readable medium in which a biological information recording program is recorded, the biological information recording program causing a computer to execute a method comprising:
acquiring biological information on a subject, which is detected by a biological information sensor (measuring unit 107) (¶ [0019]), wherein the biological information includes an electro-encephalogram detected by an electroencephalograph as the biological information sensor (¶ [0012]); and
recording the acquired biological information (¶ [0019] memory 102 stores information and data acquired by the input unit 101, which includes the acquired biological information, as discussed above), and further recording, when a designation operation that designates a task to be carried out by the subject is performed by an observer who observes the subject during recording of the biological information (¶ [0022] task selected by a doctor or an operator), the task in association with the biological information (¶ [0023] task type is stored in storage unit 102).
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim(s) 2-4, 8-10 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutoko in view of US 2019/0059770 A1 ("Gunasekar") and "Acquiring an EEG Examination Quick Reference Guide" ("Nihon Kohden").
Regarding claims 2, 8 and 14, Sutoko as modified discloses the limitations of claims 1 and 7, and discloses the biological information includes an ECG detected by an ECG sensor, as discussed above, but does not disclose wherein when a determination operation that determines an event that occurs in the subject is performed by the observer during recording of the biological information and the task, the recording processor/computer further records the event in association with the biological information and the task.
Gunasekar discloses a method comprising, when a determination operation that determines an event that occurs in the subject is performed by the observer during recording of biological information during a test, recording the event in association with the biological information (e.g., ¶¶ [0068]-[0069] throughout the EEG test, a technician viewing the patient being tested may manually enter annotations related to the EEG test and/or to the subject, and these annotations can be timestamped and stored with EEG test data). Nihon Kohden comparably discloses manual annotation/notation of events by an operator (e.g., pg. 6, select a preset annotation located on the bottom event bar); including events Gunasekar discloses may be associated with signal artifacts (e.g., ¶¶ [0061]-[0065] blinking, yawning, movement, etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device/medium of Sutoko with, when a determination operation that determines an event that occurs in the subject is performed by the observer during recording of the biological information and the task, the recording processor/computer further records the event in association with the biological information and the task as taught/suggested by Gunasekar and Nihon Kohden in order to facilitate generating biological information annotated with event information for later viewing/review (Gunasekar, ¶¶ [0068]-[0069]); enable confirming any automatically detected artifacts associated with events (Gunasekar, ¶¶ [0063]-[0064]); etc.
Regarding claims 3, 9 and 15, Sutoko as modified discloses the limitations of claims 2 and 8, and discloses the biological information includes an ECG detected by an ECG sensor, as discussed above. Sutoko as modified further discloses/suggests a display processor/the computer is configured to display a recording image on a display screen (e.g., Fig. 13), the recording image including a second region where a name of the task is displayed (subject information display area 601; ¶ [0065]), but does not disclose the recording image further includes a first region where a change over time of the biological information is displayed, and a third region where a first user interface that receives an input of the determination operation is displayed, during recording of the biological information and the task. However, Sutoko does disclose the display layout and contents can be customized as desired by a doctor or operator (e.g., ¶ [0119]).
Nihon Kohden discloses a display processor configured to display a recording image on a display screen (computer executing NeuroWorkbench software), the recording image including a first region where a change over time of the biological information is displayed (e.g., pg. 11, examination launches with EEG waveforms on the right) and a third region where a first user interface that receives an input of the determination operation is displayed, during recording of the biological information and the task (pg. 27, bottom event bar having preset annotation(s)). Gunasekar similarly discloses a recording image including a first region where a change over time of the biological information is displayed and a third region where a first user interface that receives an input of the determination operation is displayed, during recording of the biological information and the task (e.g., ¶ [0068] rendering EEG data collected during the EEG test within a viewport and presenting icons for recording annotations).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device/medium of Sutoko with the recording image further includes a first region where a change over time of the biological information is displayed, and a third region where a first user interface that receives an input of the determination operation is displayed, during recording of the biological information and the task as taught/suggested by Nihon Kohden and Gunasekar in order to facilitate (e.g., provide an input interface for) entering annotations by the observer (Nihon Kohden, pg. 27; Gunasekar, ¶ [0068]).
Regarding claims 4, 10 and 16, Sutoko as modified discloses the limitations of claims 3 and 9, and discloses the biological information includes an ECG detected by an ECG sensor, as discussed above, but does not disclose the recording image further includes a fourth region where a second user interface that receives an input of a change operation that changes the task to re-perform the designation operation is displayed. However, as noted above, Sutoko discloses a task to be performed by the patient is selected by the operator (e.g., ¶ [0022]). Sutoko further discloses the selected/displayed task information can be modified, e.g., by pressing/interacting with an "edit" button (e.g., ¶ [0064]) to select information such as the examination task (e.g., ¶ [0065]). Each of Nihon Kohden (e.g., pg. 12) and Gunasekar (e.g., ¶ [0068]) disclose comparable selections may be made by a user selecting from, e.g., a displayed drop-down list. Since Sutoko discloses/suggests a test may include multiple tasks (e.g., ¶ [0103] ADHD test including go/no-go and oddball tasks), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device/medium of Sutoko with the recording image further includes a fourth region where a second user interface that receives an input of a change operation that changes the task to re-perform the designation operation is displayed (e.g., pressable "edit" button with associated dropdown for selecting a task) as taught/suggested by the cited prior art in order to enable the operator to readily switch between multiple tasks of a particular test.
Claim(s) 5, 11, 13 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sutoko in view of Gunasekar and Nihon Kohden as applied to claim(s) 3-4 and 9, and further in view of US 2016/0041674 A1 ("Xia")
Regarding claims 5, 11, 13 and 17, Sutoko as modified discloses the limitations of claims 3-4 and 9, and discloses the biological information includes an ECG detected by an ECG sensor, as discussed above. Sutoko further discloses wherein the display processor displays a preparation image (e.g., layout setting screen 800) on the display screen before displaying the recording image on the display screen for receiving input indicative of user display layout preferences (e.g., ¶ [0067] layout setting screen 800 is accessible from initial setting screen of Fig. 6). Sutoko does not disclose the preparation image including a fifth region where a third user interface, which receives an input of a switching operation that switches whether the third region is disposed on a left side or a right side of the first region in the recording image, is displayed.
Xia discloses/suggests a method comprising displaying a preparation image (e.g., settings menu), which receives an input of a switching operation that switches a user interface (e.g., icon) is disposed on a left side or a right side of the first region in the recording image, is displayed (e.g., ¶ [0006] existing technologies relating to Human-Computer Interaction may provide a settings menu, by which a user sets his/her hand use preference, wherein for example, if a user prefers to use the left hand while operating a portable electronic device, the user can set a corresponding user preference on the settings menu such that icons on the user's portable electronic device touchscreen are displayed on the left hand side).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device/medium of Sutoko with the preparation image including a fifth region where a third user interface, which receives an input of a switching operation that switches whether the third region is disposed on a left side or a right side of the first region in the recording image, is displayed, as taught/suggested by Xia in order to ensure the third region is easily accessible by the observer's preferred hand (Xia, ¶ [0006]), particularly when the display screen is an input interface (e.g., a touchscreen), such as those commonly included in portable electronic devices, such as tablets, smartphones, etc. (Gunasekar, ¶ [0068]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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