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 .
Response to Amendment
This Office action is responsive to the amendment filed February 25, 2026. As directed by the amendment, the specification and claims have been amended. Claims 1, 3-6, 7-13 and 15-16 have been amended and claims 2 and 14 have been cancelled. Thus, claims 1, 3-13 and 15-16 are presently pending.
The amendment to the specification and claims noted above are sufficient to overcome the objection to the specification and claims and the 35 U.S.C 112(b) rejections of claims 3, 4, 6, 8 and 15 from the previous Office action. Those objections and rejections are hereby withdrawn.
Response to Arguments
Applicant’s arguments in page 11 of the response regarding claim interpretation under 35 U.S.C 112(f) have been considered in light of the amendments to the claims, the term “imaging apparatus” in claims 1, 13 and 16 is a generic placeholder, as such, is interpreted to invoke claim interpretation under this statute. Moreover, claim 5 still recites an intention detection device and an intention confirmation device that both invoke claim interpretation under this statue. The limitations noted above meet prongs A, B and C required to invoke claim interpretation under this statue as detailed in the claim interpretation section to follow.
Applicant’s argument directed to the prior art rejections have been fully considered and are not persuasive. In page 13 of the remarks, it has been argued that “Unlike Lee, the displayed video in the claimed invention is not provided for reducing stress, stabilizing a physiological parameter, or including a particular biological response, but rather is displayed to confirm the subject's intention regarding continuation or termination of the examination when an abnormal vital condition or change is detected”, here, Applicant attempts to distinguish from the prior art in terms of functional language. Note to Applicant regarding claim interpretation: the word "for" in the claim(s) may be interpreted as intended use and functional language. Intended use/functional language does not require that the reference specifically teach the intended use of the element. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use or function, then it meets the claim. In the instant case, the displayed video in Lee is capable of confirming to the operator whether subject intends to continue or stop examination, i.e. in the event that the video reduces stress and/or stabilizes physiological parameter, it is an indication to at least the operator to continue with the examination while the opposite, i.e. worsening stress or further destabilization of physiological parameter would indicate to the operator to stop the examination as the patient/subject condition is worsening and would negatively affect the medical examination. As such, the video of Lee is capable of performing the claimed function, Applicant does not address this rationale (i.e., the video of Lee is capable of confirming whether the subject intends to continue or stop with examination) that was presented in the previous Office action and remains applicable as discussed above.
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:
“examination of the subject using an imaging apparatus …” claims 1, 13 and 16;
“biological sensor that detects vital information …” claims 1, 13 and 16;
“an intention detection device that detects an intention …” claim 5;
“an intention confirmation device that transmits a detection result …” claim 5.
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.
Examiner note: each limitation listed above meets the three prongs, i.e., the bolded claim terminology meets prong A, the italic claim terminology meets both prongs B and C and therefore invoke claim interpretation under 35 U.S.C 112(f).
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:
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.
Claims 1, 4-7, 9, 11-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited Lee et al. US 20150045654 A1 ("Lee") in view of Kim et al. US 20160058397 A1 (“Kim 2016”).
Regarding claims 1, 11-13 and 16, Lee discloses a medical image diagnostic and display system thereof, as well as an operation method of said medical image diagnostic system, comprising: a display device that displays a video in an aspect visible to a subject during an examination of the subject using an imaging apparatus ([0094] regarding video content, [0168-0174] regarding output unit 130, for outputting a video signal and may include an liquid crystal display (LCD), thin film transistor-liquid display, an OLED, flexible display, 3D display an electrophoretic display or transparent display - MRI, CT or X-ray apparatus are an equivalent thereof imaging apparatus as specified in claim 12); a biological sensor that detects vital information of the subject during the examination ([0092-0093] and [0161-0163] regarding state information acquirer 112 and examples of sensors and measurers that are an equivalent thereof biological sensor disclosed in [0044] of specification as filed); and a processor, wherein the processor acquires the vital information from the biological sensor ([0177] regarding a control unit 140 and claim 20 regarding processor of a computer that performs method of claim 1) and causes the display device to display a predetermined video based on the acquired vital information (see e.g. [0093-0094] in response to a determination that stress increases or heart rate is equal to or higher than a predetermined reference value, content, such as a video, is provided to decrease the stress or stabilize heartbeat, the video can be described as or alternatively is capable for confirming an intention of the subject of whether or not to be able to continue the examination, because reduced stress or stabilize heartbeat after watching the video would confirm that the subject is able to continue with examination, while the opposite would confirm that the subject cannot continue with the examination as increased stress and destabilized heartbeat reflect condition or situation that would negatively affect the medical examination.
Lee that differs with the claimed invention, in regards to the display device being a projector. However, Kim 2016 discloses in [0091] “The MRI apparatus 100a includes a display 120 for displaying a 3D image on an inner wall 112 of the bore. For example, the display 120 may be implemented as a projection type display. As another example, the display 120 may be implemented as any of a liquid crystal display (LCD) panel, an organic light-emitting display panel, etc. formed of a non metallic material”. Inasmuch as Kim 2016disclose a projector and LCD panel, organic LED panel etc. as art recognized alternatives, at the time of filing the claimed invention it would have been obvious to one of ordinary skill in the exercise art to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), in the instant case, substitute the LCD or organic LED of Lee with a projector of Kim 2016 to perform the same function and arrive at the claimed invention.
Regarding claim 4-6, Lee in view of Kim 2016 discloses the claimed invention as discussed above, Lee further discloses wherein the processor determines whether the vital information or amount of change of vital information exceeds a threshold value ([0093-0094] as discussed in claim 1 above, Lee also disclose in [0005-0006] that a user of a medical apparatus communicates with an object by using a microphone and a speaker, such a system would necessarily require a first speaker and first microphone that are used by the subject/object undergoing examination and a second microphone and second speaker of a user to communicate. In view of these teaching, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have applied the teachings of [0005-0006] of Lee include a first and second microphone and speaker for the object/subject undergoing examination and the user respectively, to enable communication between the user and the object/subject undergoing examination. As modified, the first and/or second microphone and/or speaker reads on and are equivalent thereof the intention detection device and intention confirmation devices as specified in claim 6.
Regarding claims 7 and 9, see discussion in claim 1 above, Lee [0092-0093] and [0161-0163] the sensors and/or measurers disclosed and associated vital information.
Claims 3 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Kim 2016 as applied to claim 1 or 13 above, and further in view of previously cited Simon et al., US 20180353145 A1 (“Simon”).
Regarding claim 3 and 15, Lee in view of Kim 2016 discloses the claimed invention as discussed above, Lee further discloses s wherein the processor determines whether the vital information or amount of change of vital information exceeds a threshold value ([0093-0094] as discussed in claim 1 above, and that a user of a medical apparatus communicates with an object by using a microphone and a speaker [0005-0006]. Lee does not disclose a first camera that image an operator, and a projector.
Attention is directed to Simon, Fig. 8 and discussion in [0059] “… microphone 66, video camera 56, and speaker 50 may be provided to allow patient 14 to communicate with remote personnel in the event that live audio and/or video network streaming instruction and response is desired” and [0063] “… the patient 14 may be provided with instructions for proper positioning to allow the image acquisition procedure. This may include prerecorded audio played back over the speaker 50, text messages displayed on a monitor 52, or recorded video instructions played back using both the speaker 50 and monitor 52, or even live streamed video via the connected WAN 22 from a technician or practitioner who may communicate with and view the patient 14 over the same two-way video stream using the camera 56 within imaging apparatus 40. Audio and/or visual feedback may be provided to the patient 14 to indicate successful positioning and equipment setup.”
Inasmuch as Simon discloses live audio and/or video network streaming as art recognized means of communication between a user/operator of a medical imaging device an object/subject undergoing medical examination, it would have been obvious to one of ordinary skill in the exercise art to substitute one for the other, In re Fout, 675 F.2d 297, 301, 213 USPQ 532, 536 (CCPA 1982), in the instant case, substitute audio communication with audio and video streaming as taught by Simon, to perform the same function of communication between an operator/user and an object/subject undergoing examination and for the added advantage of video communication. In modified Lee, video streaming would include providing a first and second camera and cause the projector to display video of operator to provide further instructions in the event that the vital information exceeds the threshold.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Kim 2016 as applied to claim 1 above, and further in view of previously cited Weiss et al. EP 4124875 A1 (“Weiss”).
Regarding claim 8, Lee in view of Kim 2016 discloses the claimed invention as discussed in claim 1 above but does not explicitly disclose a camera that images the subject during examination, and analyzes an image captured by the camera to detect one of heart rate or respiratory rate of the subject. However, Weiss discloses that it was known in the prior art to analyze images captured by a camera, to detect one of heart rate or respiratory rate of a subject undergoing examination ([0004], [0016]).
In view of these teaching, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the medical imaging system of Lee with a camera to capture images and to analyze the images to detect one of heart rate or respiratory rate of a subject undergoing examination, as an art recognized way of technique of collecting vital information to further process concomitantly obtained MRI images.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Kim 2016 as applied to claim 1 above, and further in view of previously cited Kim, US 20140350381 A1 (“Kim 2014”).
Regarding claim 10, Lee in view of Kim 2016 discloses the claimed invention as discussed in claim 1 above , Lee further discloses that one of the vital information is a temperature [0162], does not disclose the limitation of claim 10. However, Kim 2014 teaches that it was known in the prior art to obtain temperature of a subject by a obtaining a temperature distribution image from a camera.
In view of these teaching, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have modified the medical imaging system of Lee n view of Kim 2016 with a camera as an imaging apparatus that obtains temperature distribution of the object/subject undergoing examination, as an art recognized way of temperature measurement, and for the added advantage of a remote or non-contact means of temperature detection. In modified Lee, the camera would transmit temperature distribution data to a signal processor that would generate temperature distribution based on the image captured.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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//BONIFACE N NGANGA/ Primary Examiner, Art Unit 3797
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