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
The amendment filed 07/01/2026 has been entered. Claim 2 has been amended. Claims 1-6 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed 04/07/2026.
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/01/2026, with respect to Whitehurst failing to teach “an imager configured to detect fluorescence emitted from the lower body in response to irradiation of the excitation light” has been considered and is persuasive. Therefore, the rejection using Whitehurst to teach such has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Shinaoka (US20190201555) who cures the deficiency of Whitehurst.
Applicant further argues there is no motivation to add an imager to Whitehurst as Whitehurst is directed to a light irradiation device for therapy. Applicant argues a person of ordinary skill in the art would have no reason or motivation to incorporate a fluorescence-detecting imager into the therapeutic light source of Whitehurst and further combine it with positioning marks of an MRI apparatus. Applicant argues the Office Action’s combination is based on impermissible hindsight.
Examiner respectfully disagrees. Whitehurst teaches wherein the lamp of its invention may be used for photodiagnosis (¶ [0046]) and wherein the light source, i.e. tubes 2, may be broadly for diagnosis (Claim 1). Therefore, Whitehurst’s invention is not only directed to a light irradiation device for therapy as Whitehurst expressly discloses wherein the device may be used for diagnosis. Moreover, because Whitehurst discloses wherein their device may be used for fluorescence detection via photodiagnosis (¶ [0046]), it would be obvious to incorporate a fluorescence-detecting imager for said photodiagnosis, like the imager (3) taught by Shinaoka (US20190201555) (Fig. 3, [0110]). In addition, the purpose of the feet marks disclosed by Biglieri is so that personnel may position a patient or subject reproducibly in a receiving space to be imaged ([0098-0102]). This problem is not limited to MRI; both Whitehurst and Biglieri disclose devices in which a patient stands inside for imaging with a fixed imaging source and both need the patient to stand in a known location. Combining Whitehurst with the feet marks of Biglieri amounts to applying a known technique to a known device ready for improvement to yield predictably results, see MPEP § 2143(I)(C). Accordingly, the combination of Whitehurst with Biglieri and/or Shinaoka is not based on impermissible hindsight.
Applicant’s arguments with respect to claim 2 has been considered but is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument; the rejection is now based on a combination of Biglieri and newly cited Shinaoka (US20190201555).
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 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst (US20020035386) in view of Shinaoka (US20190201555) and Biglieri (US20080081988). Whitehurst is cited in the IDS filed 03/06/2026.
Regarding claim 1, Whitehurst teaches a lymphatic system examination device (Figs. 9a-9b, Claim 1, [0043], [0046], [0062], wherein the lamp shown in figures 9a-9b being configured for fluorescence detection is suitable for lymphatic examination) comprising:
a main body portion (4) including a placement portion (floor) on which a subject (P) in which a fluorescent dye is injected into a lymphatic system stands, and configured to position a lower body of the subject in an imaging region on the placement portion (Figs. 9a-9b, [0062], wherein the subject having fluorescent dye injected does not limit the structure of the main body portion or housing 4);
an illuminator (2) configured to irradiate the lower body with excitation light (Figs. 9a-9b, [0043], wherein about 500 nm is an excitation light wavelength for at least the fluorophore/fluorescent dye fluorescein, [0062]).
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However, Whitehurst fails to teach an imager configured to detect fluorescence emitted from the lower body in response to irradiation of the excitation light.
In an analogous apparatus for evaluating the lymphatic system field of endeavor, Shinaoka teaches such a feature. Shinaoka teaches a system (1) for evaluating a lymphatic system, the system including a camera unit (7) comprising a fluorescence detector having an imaging device (3) and a light irradiation device (5) built therein (Fig. 3, [0110]). Shinaoka teaches exciting a fluorescent dye for fluorescence observation of an observation object (P) ([0112]). Shinaoka teaches the imaging device (3) captures an image of observation light including fluorescence from the observation object (Fig. 3, [0114]). Moreover, Shinaoka teaches wherein the imaging device (3) includes an optical filter (3a) that transmits light including the wavelength of fluorescence emitted from the fluorescent dye ([0114]). Shinaoka further teaches wherein the lymphography examination is of the lower limbs, wherein the injection sites are of the lower limbs, and wherein the lower limbs are imaged to detect fluorescence (Figs. 1 & 6A-9A, [0008], [0013-0032], [0154]). Shinaoka therefore teaches an imager configured to detect fluorescence emitted from the lower body in response to irradiation of an excitation light.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Whitehurst to include an imager configured to detect fluorescence emitted from the lower body as taught by Shinaoka (Figs. 1, 3, & 6A-9A, [0008], [0110], [0112], [0114], [0154]). Whitehurst discloses wherein their lamp may be used for fluorescence detection ([0046]). Shinaoka supplies Whitehurst the imager for fluorescence detection. By including an imager configured to detect fluorescence, the apparatus may include the additional function of being able to examine the lymphatic system of the lower body including the four lymphatic routes in the legs, like taught by Shinaoka.
However, the modified combination noted above fails to teach wherein the placement portion is provided with a positioning portion that indicates a standing position of the subject.
In an analogous diagnosis field of endeavor, Biglieri teaches such a feature. Biglieri teaches an MRI apparatus including a base (201) configured for a patient (P) to stand on (Figs. 1-2, Abstract, [0057-0058], [0098-0101]). Biglieri teaches wherein the base (201) may include positioning marks or feet position shapes for placement of the patient’s feet while standing (Fig. 2, [0102]). Biglieri therefore teaches wherein a placement portion (base 201) is provided a positioning portion that indicates a standing position of a subject.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Whitehurst to include feet positioning markers on a base or floor of the device for the patient to stand on as taught by Biglieri (Figs. 1-2, [0102]). The feet positioning markers may facilitate better and more effective patient placement for imaging as recognized by Biglieri ([0102]).
Regarding claim 2, Whitehurst in view of Shinaoka and Biglieri teaches the invention as claimed above in claim 1.
However, Whitehurst fails to teach wherein the positioning portion includes: a foot rest indicating a placement of feet for the subject.
In an analogous diagnosis field of endeavor, Biglieri teaches such a feature. Biglieri teaches an MRI apparatus including a base (201) configured for a patient (P) to stand on (Figs. 1-2, Abstract, [0057-0058], [0098-0101]). Biglieri teaches wherein the base (201) may include positioning marks or feet position shapes for placement of the patient’s feet while standing (Fig. 2, [0098-0102]). Biglieri therefore teaches wherein a placement portion (base 201) is provided a positioning portion that indicates a standing position of a subject and includes a foot rest (the feet positioning marks themselves comprise a foot rest as the subject rests their feet on them).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Whitehurst to include feet positioning markers on the base or floor of the device for the patient to stand on as taught by Biglieri (Figs. 1-2, [0098-0102]). The feet positioning markers may facilitate better and more effective patient placement for imaging as recognized by Biglieri ([0098-0102]). The modification of Whitehurst with the teachings of Biglieri would result in the addition of feet positioning markers on the base of the housing (4) of Whitehurst (Figs. 9a-9b).
However, the modified combination noted above fails to teach to multiple foot rests, with a foot rest indicating a placement of feet for the subject to face the imager side; and a foot rest indicating a placement of feet for the subject to face a side opposite the imager.
In an analogous apparatus for evaluating the lymphatic system field of endeavor, Shinaoka teaches such a feature. Shinaoka teaches a system (1) for evaluating a lymphatic system, the system including a camera unit (7) comprising a fluorescence detector having an imaging device (3) and a light irradiation device (5) built therein (Fig. 3, [0110]). Shinaoka teaches exciting a fluorescent dye for fluorescence observation of an observation object (P) ([0112]). Shinaoka teaches the imaging device (3) captures an image of observation light including fluorescence from the observation object (Fig. 3, [0114]). Shinaoka teaches wherein the lymphatic system in the lower limbs includes a plurality of lymphatic routes comprising an anteromedial route, an anterolateral route, posteromedial route, and posterolateral route ([0123]). Shinaoka further teaches selecting a route for examination, i.e. imaging ([0088-0089]). Shinaoka therefore teaches imaging of different lymphatic routes which are positioned in different locations of a subject’s legs, such as at the front or back of the legs.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Whitehurst in view of Biglieri to include foot rests for facing the imager and facing a side opposite the imaging as taught by Shinaoka ([0088-0089], [0123]). Whitehurst modified by Biglieri ([0098-0102]) results in the addition of foot rests for indicating to a subject how to position their feet for imaging. Shinaoka discloses wherein the lower limbs include four differently positioned lymphatic routes. In order to image both anterior and posterior routes, a subject’s feet must be positioned toward the imager and away from the imager. Therefore, Whitehurst in view of Biglieri further modified by Shinaoka would predictably result in foot rests indicating to a subject to face towards and to face opposite the imager. By including these foot rests, anterior and posterior lymphatic routes may be imaged at a better perspective which better shows or visualizes the routes.
Regarding claim 3, Whitehurst in view of Shinaoka and Biglieri teaches the invention as claimed above in claim 1.
Whitehurst further teaches wherein the main body portion (4) further includes:
a support portion (4) supporting the illuminator (2) (Figs. 9a-9b, [0046], [0062], “FIGS. 9a and 9b show a lamp using fluorescent tubes 2, for treatment of the lower half of a patient's body. The tubes are arranged on the inner reflective surface of a housing 4 within which the patient P stands”); and
a wall portion (4) composing a housing (4) that defines the imaging region and accommodates the illuminator (2) (Figs. 9a-9b, [0046], [0062]), and
an opening through which the subject is disposed is formed in the wall portion (4) (Figs. 9a-9b, [0062], “The housing 4 is a slightly tapered cylinder with a diameter which increases with height so as to keep the distance between the patient's skin and the tubes 2' approximately constant”).
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However, Whitehurst fails to teach wherein the support portion also supports the imager; and wherein the housing also accommodates the imager.
In an analogous apparatus for evaluating the lymphatic system field of endeavor, Shinaoka teaches such a feature. Shinaoka teaches a system (1) for evaluating a lymphatic system, the system including a camera unit (7) comprising a fluorescence detector having an imaging device (3) and a light irradiation device (5) built therein (Fig. 3, [0110]). Shinaoka teaches exciting a fluorescent dye for fluorescence observation of an observation object (P) ([0112]). Shinaoka teaches the imaging device (3) captures an image of observation light including fluorescence from the observation object (Fig. 3, [0114]). Moreover, Shinaoka teaches wherein the imaging device (3) includes an optical filter (3a) that transmits light including the wavelength of fluorescence emitted from the fluorescent dye ([0114]). Shinaoka therefore teaches wherein the imaging device (3) comprises an imager and the light irradiation device (5) comprises an illuminator. Shinaoka teaches wherein both of these devices are housed within the camera unit (7) (Fig. 3, [0110]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Whitehurst to have the illuminator and imager housed in the same object as taught by Shinaoka (Fig. 3, [0110]). Whitehurst teaches wherein a housing (4) both supports and accommodates tubes (2) which comprise an illuminator. Therefore, Whitehurst modified by the teachings of Shinaoka to have the same object also accommodate the imager would predictably result in the housing (4) of Whitehurst to also support and accommodate the imager. By having the housing additionally support and accommodate the imager, the examination device may predictably be made more compact.
Regarding claim 5, Whitehurst in view of Shinaoka and Biglieri teaches the invention as claimed above in claim 3.
Whitehurst further teaches wherein the wall portion (4) (Fig. 9b, [0062]) includes:
a first wall portion (4) (Fig. 9b, [0062], see annotated figure 9b below); and
a second wall portion (4) attached to the support portion (4) (Fig. 9b, [0062], wherein second wall portion and support portion may be portions of the door as shown in the annotated figure 9b below, or alternatively the first wall portion may be the door and the second wall portion and support portion may be the other side, i.e. where the door closes), and
the support portion (4) and the second wall portion (4) are detachable from the placement portion (floor/base) and the first wall portion (4) (Fig. 9b, see annotated figure 9b below; wherein the door is detachable from the base/floor and the first wall portion).
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However, Whitehurst fails to explicitly teach wherein the first wall portion is attached to the placement portion (i.e. the floor/base).
In an analogous diagnosis field of endeavor, Biglieri teaches such a feature. Biglieri teaches an MRI apparatus including a base (201) configured for a patient (P) to stand on (Figs. 1-2, Abstract, [0057-0058], [0098-0101]). Biglieri teaches wherein the base (201) may include positioning marks or feet position shapes for placement of the patient’s feet while standing (Fig. 2, [0102]). In addition, Biglieri teaches wherein the base (201) is attached to the walls (101) of the MRI apparatus (Figs. 1-2, [0056], [0058]). Biglieri therefore teaches wherein a first wall portion (101) is attached to a placement portion (201).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Whitehurst to have the wall portions be attached or connected to a base of the apparatus as taught by Biglieri (Figs. 1-2, [0056], [0058]). The base may include the feet positioning markers as recognized by Biglieri ([0102]), and the base being physically attached to the walls of the apparatus or lamp of Whitehurst may further add mechanical stability to the apparatus/lamp.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst (US20020035386) in view of Shinaoka (US20190201555) and Biglieri (US20080081988) as applied to claim 3 above, and further in view of Johns Hopkins University (hereinafter “JHU”) (“A stand-up CT machine”).
Regarding claim 4, Whitehurst in view of Shinaoka and Biglieri teaches the invention as claimed above in claim 3.
However, Whitehurst fails to teach the invention further comprising a cover configured to cover the opening in a state of being attached to the subject.
In an analogous imaging of the lower body field of endeavor, JHU teaches such a feature. JHU teaches a stand-up CT scanner configured to image a patient’s leg (Title, Pages 1-2). JHU teaches wherein the CT scanner includes a bore or opening for placing the patient’s leg in and teaches an orange cover configured to be attached to the patient and to cover the opening/bore (Figure on page 2, reproduced below).
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It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Whitehurst to include a covering attached to the patient to cover the top of the opening as taught by JHU (Figure on page 2). In the context of fluorescence imaging as taught by Whitehurst, a cover may predictably help contain excitation and emission light, in addition to blocking ambient room light, thereby improving accuracy and signal-to-noise ratio.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Whitehurst (US20020035386) in view of Shinaoka (US20190201555) and Biglieri (US20080081988) as applied to claim 3 above, and further in view of Kim (US20230329654).
Regarding claim 6, Whitehurst in view of Shinaoka and Biglieri teaches the invention as claimed above in claim 3.
However, Whitehurst fails to teach the invention further comprising a camera configured to capture an image of the positioning portion.
In an analogous examination field of endeavor, Kim teaches such a feature. Kim teaches a radiography apparatus (1) including an X-ray irradiating portion (2) and an X-ray detecting portion (3) (Fig. 1, [0039]). Kim further teaches a positioning portion (7) which is where a patient should stand on a base (6), i.e. placement portion, of the apparatus (1) for image taking (Fig. 1, [0060]). Kim teaches taking an image of the patient’s feet as they stand on the positioning portion (7) and using the image as a reference to make the patient stand in the same position as a first time an image was taken ([0083]). Kim further teaches wherein the patient’s feet position may be monitored via images acquired by a camera (23) and displayed on a monitor (29) (Figs. 8 & 11, [0105], [0108], [0120-0121]). Kim teaches this is to instruct the patient in proper feet positioning ([0111], [0120]). Kim teaches after the feet and other portions of the patient’s body are aligned, X-ray images may then be acquired ([0138]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Whitehurst to include a camera configured to capture an image of a feet positioning portion as taught by Kim (Figs. 8 & 11, [0060], [0105], [0108], [0120]). The camera may predictably help instruct a patient in aligning their feet correctly for subsequent patient imaging as recognized by Kim ([0060], [0083], [0120]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
