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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/18/2025 and 11/21/2025 are being considered by the examiner.
Status of Claims
Claims 16-33 are currently pending. As per the amendments filed on 12/19/2025, claim 16 is amended and claim 33 is newly added. Claims 22-29 and 31-32 are withdrawn. Claims 16-21, 30, and 33 are under examination.
Response to Arguments
Applicant’s arguments, see Remarks pages 6-8 (Claim Interpretation, Objection, and Rejection under 35 USC § 112), filed 12/19/2025, with respect to the 35 U.S.C. § 112(b) rejection of claim 16 (and dependent claims) have been fully considered and are persuasive. The fluorescent reagent is definitively identified as being IR700. See below for Examiner’s response to remarks regarding prior art rejections.
Applicant’s arguments, see Remarks pages 8-10 (Rejection under 35 USC § 102), filed 12/19/2025, with respect to the 35 U.S.C. § 102 rejections of claims 16-21 and 30 over Fengler have been fully considered. Applicant argues:
Applicant has carefully considered the Examiner's remarks and has further specified the structural limitations required in Claim 16 (and also in claim 33), which include at least the following:
(1) a treatment device that is used to carry out imagery of a subject and also a photoimmunotherapy for a subject;
(2) that is equipped with a treatment drug being a combination of a IR.700 fluorescent reagent and an epidermal growth factor receptor (EGFR) antigen; which
(3) contains a controller having a stored exposure time data and instructions that do not let a treatment progress by the treatment drug; and
(4) contains a controller having a stored predetermined pulse width.
As a result, in addition to the above, Applicant previously established that the rejection for Fengler et al. (PG Pub. No. US 2017/0209050) discloses only a fluorescence imaging system which includes a light source assembly including a white light provider that emits white light, and an excitation light provider that emits excitation light in a plurality of nonoverlapping excitation wavebands for causing the object to emit fluorescent light (paragraphs 0016, 0137 etc.). However, Fengler provides no teaching, suggestion, or arrangement, on the relationship between the stored timing of the exposure to the light, the stored pulse width, or the physical properties of emitted lights and reaction of a treatment drug bonded to fluorescent reagent. This is because the Fengler system aims to acquire medical images for visualizing tissue of a subject by collecting reflected white light and emitted fluorescent light as noted above. Variations of Fengler system simply include real-time blood flow imaging, tissue perfusion imaging, lymphatic imaging, or a combination thereof (e.g., paragraphs 0069, 0073 etc.). (12/19/2025 Remarks, page 9)
This argument is not persuasive. Claim 1 states the device is “an imaging apparatus for acquiring images which are used when carrying out photoimmunotherapy for a subject.” This is interpreted as different than the “treatment device” in Applicant’s remarks because the instant device is used to acquire images during an existing treatment/procedure. Based on the language of the apparatus preamble in claim 1, the “imaging apparatus” is the structure and the “for acquiring images which are used when carrying out photoimmunotherapy for a subject” is the intended use of the “imaging apparatus.” MPEP 2111.02 states:
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
Reviewing the limitations of claim 1 with respect to the fluorescent reagent, the first limitation states: an excitation light source that irradiates a predetermined area of the subject, to which a treatment drug, including a combination of IR700 which is a fluorescent reagent and an epidermal growth factor receptor (EGFR) antibody, has been administered, with an excitation light that excites the IR700. In this case, the structural element being claimed is “an excitation light source that irradiates a predetermined area of the subject,” where the subject area is characterized as having had a treatment drug administered. The second limitation states: an imaging unit that acquires a fluorescent image by imaging fluorescent light generated from the IR700 in the predetermined area when irradiating with the excitation light. Similarly, the structural element being claimed is “an imaging unit that acquires a fluorescent image,” where the predetermined area is characterized as having had a treatment drug administered. The fluorescent reagent and antibodies are not interpreted as being claimed as part of structural element (such as claimed in Applicant’s remarks where the treatment device is “equipped with a treatment drug”). The drug applied to the predetermined area is therefore interpreted as a characteristic of the area upon which the claimed imaging device works (see MPEP 2115 (II) - “Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, ‘[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims.’ In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935)).
Applicant also argues:
In spite of the fact that a wavelenth of the excitation light emitted in an imaging system of Fengler relates to such treatment, Fengler completely fails to provide a structure in which reaction of the treatment drug at the irradiated position of the subject does not progress unintentionally due to the stored time limitation so that irradiation may be carried out within a range that does not let treatment progress. Accordingly, the systems of Fengler and the present invention are structured in entirely different ways for entirely different purposes. The features of the present invention as recited in independent claim and in the remaining claims which depend from the independent claim patentably distinguish the present invention over Fengler. Therefore, due to fundamental differences between Fengler and the presently claimed invention, the Applicant respectfully proposes that the claims are in condition for allowability. (12/19/2025 Remarks, pages 9-10)
While the treatment drug or unclaimed treatment drug application component are not interpreted as being claimed as part of the imaging apparatus, the claims do require the imaging apparatus in Fengler to be able to activate the treatment drug for the intended use. IR 700 is activated by near-infrared light, which appears to be further defined in claim 21 as being activated by 600-700 nm light. Fengler describes a first light source as a white light and a second light source as an excitation light ([0016] – “Generally, one variation of a fluorescence imaging system may include a light source assembly including a white light provider that emits white light; an excitation light provider that emits excitation light in a plurality of nonoverlapping excitation wavebands for causing the object to emit fluorescent light”) with an image sensor which receives reflected light from both sources ([0016] – “at least one image sensor that receives reflected white light and emitted fluorescent light from the object”). Fengler describes wavelengths of the excitation light centered on 450-650 nm, 670 nm, 770 nm, or 805 nm ([0017]), thereby being able to produce excitation light centered on 670 nm (which is within the 600-700 nm range provided in the instant application in Specification [0021]). Fengler describes a pulsing scheme for both light sources matching the field timing capabilities ([0129-0130]) as required in claims 17-20 (Specification [0036], [0045]). Therefore, the apparatus in Fengler is interpreted as able to activate IR 700 with a specified pulsing pattern. Therefore, the 35 U.S.C. § 102 rejections of claims 16-21 and 30 over Fengler are maintained.
Newly added claim 33 is evaluated in light of the above arguments and rejected under 35 U.S.C. § 102 over Fengler (see “Claim Rejections - 35 USC § 102” section for a discussion of the “stored time” limitation).
Summary: The 35 U.S.C. § 102 rejections of claims 16-21 and 30 over Fengler are maintained. A 35 U.S.C. § 102 rejection for newly added claim 33 over Fengler is added.
Claim Objections
The following claims are objected to because of the following informalities:
• Claim 1: The statement “IR700 which is a fluorescent reagent and” appears to be a parenthetical statement which would be more understandably represented as “IR700, which is a fluorescent reagent, and”
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 16-21, 30, and 33 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 16, 30, and 33 contain limitations which claim the “predetermined area of the subject.” In order to provide a distinction between the device and the human organism (“predetermined area of the subject”), the claim could incorporate language equivalent to “configured to” with respect to the device.
Claim 19 recites “an excitation light source that irradiates a predetermined area of the subject” and “an imaging unit that acquires a fluorescent image by imaging fluorescent light generated […] in the predetermined area.” The rejection may be overcome by amending the claim so that “the excitation light source” and “imaging unit” use “configured to” language.
Claim 30 recites “another imaging unit that images the predetermined area and acquires a white-light image visualization of the predetermined area as a visible moving image.” The rejection may be overcome by amending the claim so that “another imaging unit” uses “configured to” language.
Claim 33 recites “an excitation light source that irradiates a predetermined area of the subject” and “an imaging unit that acquires a fluorescent image by imaging fluorescent light generated from the IR700 fluorescent reagent in the predetermined area.” The rejection may be overcome by amending the claim so that “the excitation light source” and “imaging unit” use “configured to” language.
Claims 17-21 are rejected for being dependent on rejected claims.
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 35 U.S.C. 112 (pre-AIA ), 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.
Claims 16-21, 30, and 33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16: is directed to both a product and a process, which renders the claim indefinite. MPEP 2173.05(p).II states:
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011)
The limitation “wherein the excitation light source irradiates the excitation light having a predetermined pulse width for a predetermined period of time that does not let treatment progress by the treatment drug” is a method step.
In this context, the limitations “an excitation light source that irradiates a predetermined area of the subject, to which a treatment drug, including a combination of IR700 which is a fluorescent reagent and an epidermal growth factor receptor (EGFR) antibody, has been administered, with an excitation light that excites the IR700,” “an imaging unit that acquires a fluorescent image by imaging fluorescent light generated from the IR700 in the predetermined area when irradiating with the excitation light” and “an image display unit that displays the fluorescent image” could be understood as either explaining the configuration of a structural element or a method step. This rejection may be overcome by amending the claim to recite the apparatus configuration for the above limitations, rather than actual method steps.
Claim 30: is directed to both a product and a process, which renders the claim indefinite (see MPEP 2173.05(p).II). The limitation “wherein the image display unit displays the composite image” is a method step.
In this context, the limitations “another imaging unit that images the predetermined area and acquires a white-light image visualization of the predetermined area as a visible moving image” and “a composite image generating unit that generates a composite image by superimposing the fluorescent image on the visible moving image” could be understood as either explaining the configuration of a structural element or a method step. This rejection may be overcome by amending the claim to recite the apparatus configuration for the above limitations, rather than actual method steps.
Claim 33: is directed to both a product and a process, which renders the claim indefinite (see MPEP 2173.05(p).II). The limitation “wherein the excitation light source irradiates the excitation light having said stored predetermined pulse width for said stored predetermined period of time that does not let treatment progress by the treatment drug” is a method step.
In this context, the limitations “an excitation light source that irradiates a predetermined area of the subject, to which a treatment drug, including a combination of an IR700 fluorescent reagent and an epidermal growth factor receptor (EGFR) antibody, has been administered, with an excitation light that excites the IR700 fluorescent reagent,” “a light source controller for said excitation light source, said light source controller having stored a predetermined period of treatment time, said predetermined period of time being a period of time for irradiation of said predetermined area does not progress treatment by said treatment drug,” “an imaging unit that acquires a fluorescent image by imaging fluorescent light generated from the IR700 fluorescent reagent in the predetermined area when irradiating with the excitation light,” “said light source controller for said excitation light source having stored a predetermined pulse width,” and “an image display unit that displays the fluorescent image” could be understood as either explaining the configuration of a structural element or a method step. This rejection may be overcome by amending the claim to recite the apparatus configuration, rather than actual method steps. This rejection may be overcome by amending the claim to recite the apparatus configuration for the above limitations, rather than actual method steps.
Claims 17-21 are rejected for being dependent on rejected claims.
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.
Claims 16-21, 30, and 33 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Fengler (US PG Pub. 2017/0209050 A1, cited in 02/22/2022 IDS), which incorporates US 9,173,554 B2 (to be referred to as ‘554) in its entirety by reference.
Regarding Claim 16, Fengler discloses an imaging apparatus for acquiring images (Fig 5; Abstract – “A fluorescence imaging system for imaging an object, the system includes a white light provider that emits white light, an excitation light provider that emits excitation light in a plurality of excitation wavebands for causing the object to emit fluorescent light”) comprising:
• an excitation light source that irradiates a predetermined area of a subject (514, [0137] - “excitation light provider 514 that emits excitation light in a plurality of excitation wavebands for causing the object 502 to emit fluorescent light”) to which a fluorophore has been administered, with excitation light that excites the fluorescent reagent;
• an imaging unit that acquires a fluorescent image by imaging fluorescent light generated (520, [0137] – “a camera 520 with at least one image sensor 540 that receives reflected white light and emitted fluorescent light from the object”) from the fluorescent reagent in the predetermined area when irradiating with the excitation light;
• an image display unit that displays the fluorescent image ([0014] – “In some variations, the system may include at least one image processor that receives image signals from the image sensor assembly and processes the received image signals to generate images from the received image signals … the system may include a display that displays at least one image generated from image signals from the image sensor assembly”).
-and wherein the excitation light source irradiates the excitation light having a predetermined pulse width for a predetermined period of time ([0129-0130] – pulsing schemes are disclosed: “The visible light output and the fluorescence light output are pulsed so that different wavebands are illuminating the area to be imaged at different times”).
Fengler fails to disclose (A) which are used when carrying out photoimmunotherapy for a subject, (B) to which a treatment drug, including a combination of IR 700 which is a fluorescent reagent and an epidermal growth factor receptor (EGFR) antibody has been administered, with excitation light that excites the IR 700, and (C) that does not let treatment progress by the treatment drug.
Based on the structure of the apparatus preamble, the “imaging apparatus” is the structure and the “for acquiring images which are used when carrying out photoimmunotherapy for a subject” is the intended use of the “imaging apparatus.” MPEP 2111.02 states:
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
The imaging apparatus in Claim 16 is comprised of: (1) an excitation light source (“an excitation light source which irradiates a predetermined area of the subject … with excitation light that excites the fluorescent reagent … wherein the excitation light source irradiates the excitation light having a predetermined pulse width for a predetermined period of time”), (2) an imaging unit (“an imaging unit that acquires a fluorescent image by imaging fluorescent light generated … in the predetermined area when irradiating with the excitation light”) and (3) an image display (“an image display unit that displays the fluorescent image”). The treatment drug is not part of the imaging apparatus as the imaging apparatus structural components presented above would function (emitting light, detecting any fluorescence, and displaying the detected image) in the same manner with or without the presence of the treatment drug ( “to which a treatment drug, including a combination of a fluorescent reagent (IR 700) and an epidermal growth factor receptor (EGFR) antibody has been administered”).
MPEP 2114 (II) states:
[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.
MPEP 2115 (II) states:
Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
The treatment drug is not part of the claimed imaging apparatus and only defines an application where the imaging apparatus could be used. No structural element is claimed for administering the treatment drug as part of the apparatus. The instant specification states:
The light source 24 includes a first light source 241 which is a white light source, and a second light source 242 which is an excitation light source. When the first light source 241 is turned on, the subject ST is irradiated with white light, and the white light sensor 28 detects reflected white light reflected from the subject ST. The second light source 242 irradiates with excitation light for exciting the fluorescent reagent (IR700). When the second light source 242 is turned on, the subject ST is irradiated with near infrared light (excitation light) of a wavelength 600 to 700 nm, exciting the fluorescent reagent (IR700) of the treatment drug (RM-1929) administered to the subject ST. When the fluorescent reagent (IR700) is excited, near infrared light having a peak of approximately 700 or 770 nm emits as fluorescent light and is detected by the excitation light sensor 29 Note that if an excitation light is being irradiated over a long period of time, reaction of the treatment drug (Rlvf-1929) progresses and treatment progresses unintentionally, so that pulse-lighting occurs for only a duration corresponding to the imaging time of one field ( e.g., 16 msec) of the excitation light sensor 29 ( details will be described later) according to this embodiment. [0020-0021]
Fengler describes a first light source as a white light and a second light source as an excitation light ([0016] – “Generally, one variation of a fluorescence imaging system may include a light source assembly including a white light provider that emits white light; an excitation light provider that emits excitation light in a plurality of nonoverlapping excitation wavebands for causing the object to emit fluorescent light”) with an image sensor which receives reflected light from both sources ([0016] – “at least one image sensor that receives reflected white light and emitted fluorescent light from the object”). Fengler describes wavelengths of the excitation light centered on 450-650 nm, 670 nm, 770 nm, or 805 nm ([0017]), thereby being able to produce excitation light centered on 670 nm (which is within the 600-700 nm range provided in the instant application). Fengler describes a pulsing scheme for both light sources which can either be synchronized or unsynchronized ([0129-0130]).
The instant specification associates the ability of the light not being capable of progressing treatment with the emission light pulsing ([0021]), although this appears to be related to a decrease in overall energy applied and could be limited by other waveform modifications. Fengler’s disclosure of the pulsing scheme in [0129-0130] with matching field timing capabilities would inherently create the ability in the apparatus to provide an emission pulse profile which allows for imaging but avoids activating immunotherapy. Therefore, the imaging apparatus in Fengler is structurally the same (light sources, sensor, wavelength, pulsing scheme) as the imaging apparatus in the instant application and is capable of providing the same light sources and sensors as described in instant Claim 16.
Therefore, Claim 16 is anticipated by Fengler.
Regarding Claim 17, Fengler anticipates the imaging apparatus according to Claim 16, as indicated hereinabove. Fengler discloses the fluorescence excitation light is strobed in synchronous operation with image acquisition at a rate such as 60 Hz ([0167]). However, Fengler does not explicitly disclose the strobing pulse width in the predetermined pulse width is a duration of one field synchronized with the imaging timing of the imaging unit.
Fengler incorporates US 9,173,554 B2 (to be referred to as ‘554) in its entirety by reference ([0131]). Patent ‘554 teaches a full image frame rate of 30 fps where the emitter is active for one field period of 16.7 ms (Fig. 4, col 6, lines 52-66 – note a field is presented as half a frame) in a synchronized fashion (col 3, lines 2-7).
Therefore, Claim 17 is anticipated by Fengler.
Regarding Claim 18, Fengler anticipates the imaging apparatus according to Claim 17, as indicated hereinabove. Fengler discloses the fluorescence excitation light is strobed in synchronous operation with image acquisition at a rate such as 60 Hz ([0167]). However, Fengler does not explicitly disclose the predetermined pulse width is approximately 16 ms.
Fengler incorporates US 9,173,554 B2 (to be referred to as ‘554) in its entirety by reference ([0131]). Patent ‘554 teaches a full image frame rate of 30 fps where the emitter is active for one field period of 16.7 ms (Fig. 4, col 6, lines 52-66 – note a field is presented as half a frame) in a synchronized fashion (col 3, lines 2-7). Note 16.7 ms, being tied to a 30 Hz frame rate, is interpreted as approximately 16 ms.
Therefore, Claim 18 is anticipated by Fengler.
Regarding Claim 19, Fengler anticipates the imaging apparatus according to Claim 16, as indicated hereinabove. Fengler discloses the fluorescence excitation light is strobed in synchronous operation with image acquisition at a rate such as 60 Hz, although synchronicity is not required and frequencies can be mismatched between emitters and sensors ([0167]). However, Fengler does not explicitly disclose the strobing pulse width in the predetermined pulse width is a duration of two fields unsynchronized with the imaging timing of the imaging unit.
Fengler incorporates US 9,173,554 B2 (to be referred to as ‘554) in its entirety by reference ([0131]). Patent ‘554 teaches a full image frame rate of 30 fps where the emitter is active for one field period of 16.7 ms with the white light component emitted over two field periods of 33.3 ms (Fig. 4, col 6, lines 52-66 – note a field is presented as half a frame). Claim 5 suggests the time durations of the fluorescence emission and white light can be identical (where two fields is established as a duration). Additionally, patent ‘554 teaches the fluorescence emission is capable of maintaining emissions in a continuous fashion (Fig. 6, col 7, lines 42-64). Therefore, patent ‘554 teaches the fluorescence emission can have a duration of two field periods.
Therefore, Claim 19 is anticipated by Fengler.
Regarding Claim 20, Fengler anticipates the imaging apparatus according to Claim 19, as indicated hereinabove. Fengler discloses the fluorescence excitation light is strobed in synchronous operation with image acquisition at a rate such as 60 Hz, although synchronicity is not required and frequencies can be mismatched between emitters and sensors ([0167]). However, Fengler does not explicitly disclose the strobing pulse width in the predetermined pulse width is approximately 33 ms.
Fengler incorporates US 9,173,554 B2 (to be referred to as ‘554) in its entirety by reference ([0131]). Patent ‘554 teaches a full image frame rate of 30 fps where the emitter is active for one field period of 16.7 ms with the white light component emitted over two field periods of 33.3 ms (Fig. 4, col 6, lines 52-66 – note a field is presented as half a frame). Claim 5 suggests the time durations of the fluorescence emission and white light can be identical (where two fields is established as a duration). Additionally, patent ‘554 teaches the fluorescence emission is capable of maintaining emissions in a continuous fashion (Fig. 6, col 7, lines 42-64). Therefore, patent ‘554 teaches the fluorescence emission can have a duration of two fields, which at 30 fps gives a pulse width of 33.3 ms. Note 33.3 ms, being tied to a 30 Hz frame rate, is interpreted as approximately 33 ms.
Therefore, Claim 20 is anticipated by Fengler.
Regarding Claim 21, Fengler anticipates the imaging apparatus according to Claim 16, as indicated hereinabove. Fengler further discloses the excitation light is a light of a wavelength 600 to 700 nm ([0017]). Fengler teaches “in some of these variations, at least one of the plurality of wavebands may be centered at about 670 nm, about 770 nm, or about 805 nm” ([0017] – see centered at 670 nm as placing emission wavelengths within the 600 to 700 nm range according to MPEP 2144.05: “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations).
Therefore, Claim 21 is anticipated by Fengler.
Regarding Claim 30, Fengler anticipates the imaging apparatus according to Claim 16, as indicated hereinabove. Fengler further discloses another imaging unit that images the predetermined area (Abstract) and acquires a white-light image visualization of the predetermined area as a visible moving image ([0127] – “In a non-fluorescence mode of operation, the fluorescence imaging system may provide real time full color visible (white) light image data for display on a video monitor and/or for recording”); a composite image generating unit that generates a composite image by superimposing the fluorescent image on the visible moving image ([0074] – “The NIR fluorescent positive LNs (e.g., using ICG) may be represented as a black and white NIR fluorescence image(s) for example and/or as a full or partial color (white light) image, full or partial desaturated white light image, an enhanced colored image, an overlay (e.g., fluorescence with any other image), a composite image ( e.g., fluorescence incorporated into another image) which may have various colors, various levels of desaturation or various ranges of a color to highlight/visualize certain features of interest”); and wherein the image display unit displays the composite image ([0125] – “As shown in FIG. 1, one variation of a data module includes a video display 140a or other monitor (e.g., computer monitor, touch screen, etc.) that enables display of substantially real-time and/or recorded image and data to a clinician, patient, or other user”).
Therefore, Claim 30 is anticipated by Fengler.
Regarding Claim 33, Fengler discloses an imaging apparatus for acquiring images (Fig 5; Abstract – “A fluorescence imaging system for imaging an object, the system includes a white light provider that emits white light, an excitation light provider that emits excitation light in a plurality of excitation wavebands for causing the object to emit fluorescent light”), comprising:
• an excitation light source that irradiates a predetermined area of the subject (514, [0137] - “excitation light provider 514 that emits excitation light in a plurality of excitation wavebands for causing the object 502 to emit fluorescent light”), to which a fluorophore has been administered, with an excitation light that excites the fluorescent reagent;
• a light source controller for said excitation light source ([0113-0114] – controller module), said light source controller having stored a predetermined period of time ([0113] – “the controller module may include an internal clock to enable control of the various elements and help establish correct timing of illumination and sensor shutters”);
• an imaging unit that acquires a fluorescent image by imaging fluorescent light generated (520, [0137] – “a camera 520 with at least one image sensor 540 that receives reflected white light and emitted fluorescent light from the object”) from the fluorescent reagent in the predetermined area when irradiating with the excitation light;
-said light source controller for said excitation light source having stored a predetermined pulse width ([0129-0130] – pulsing schemes are disclosed: “The visible light output and the fluorescence light output are pulsed so that different wavebands are illuminating the area to be imaged at different times”);
- an image display unit that displays the fluorescent image ([0014] – “In some variations, the system may include at least one image processor that receives image signals from the image sensor assembly and processes the received image signals to generate images from the received image signals … the system may include a display that displays at least one image generated from image signals from the image sensor assembly).
Fengler fails to disclose (A) which are used when carrying out photoimmunotherapy for a subject, (B) to which a treatment drug, including a combination of IR 700 which is a fluorescent reagent and an epidermal growth factor receptor (EGFR) antibody has been administered, with excitation light that excites the IR 700, (C) wherein the excitation light source irradiates the excitation light having said stored predetermined pulse width for said stored predetermined period of time that does not let treatment progress by the treatment drug, and (D) said predetermined period of time being a period of time for irradiation of said predetermined area does not progress treatment by said treatment drug.
Based on the structure of the apparatus preamble, the “imaging apparatus” is the structure and the “for acquiring images which are used when carrying out photoimmunotherapy for a subject” is the intended use of the “imaging apparatus.” MPEP 2111.02 states:
The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.
The imaging apparatus in Claim 33 is comprised of: (1) an excitation light source (“an excitation light source which irradiates a predetermined area of the subject … with excitation light that excites the fluorescent reagent … wherein the excitation light source irradiates the excitation light having a predetermined pulse width for a predetermined period of time”), (2) a light source controller (“a light source controller for said excitation light source, said light source controller having stored a predetermined period of treatment time”), (3) an imaging unit (“an imaging unit that acquires a fluorescent image by imaging fluorescent light generated … in the predetermined area when irradiating with the excitation light”) and (4) an image display (“an image display unit that displays the fluorescent image”). The treatment drug is not as part of the imaging apparatus as the imaging apparatus structural components presented above would function (emitting light, controlling light emission, detecting any fluorescence, and displaying the detected image) in the same manner with or without the presence of the treatment drug ( “to which a treatment drug, including a combination of a fluorescent reagent (IR 700) and an epidermal growth factor receptor (EGFR) antibody has been administered”).
MPEP 2114 (II) states:
[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.
MPEP 2115 (II) states:
Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
The treatment drug is not a part of the claimed imaging apparatus and only defines an application where the imaging apparatus could be used. No structural element is claimed for administering the treatment drug as part of the apparatus. The instant specification states:
The light source 24 includes a first light source 241 which is a white light source, and a second light source 242 which is an excitation light source. When the first light source 241 is turned on, the subject ST is irradiated with white light, and the white light sensor 28 detects reflected white light reflected from the subject ST. The second light source 242 irradiates with excitation light for exciting the fluorescent reagent (IR700). When the second light source 242 is turned on, the subject ST is irradiated with near infrared light (excitation light) of a wavelength 600 to 700 nm, exciting the fluorescent reagent (IR700) of the treatment drug (RM-1929) administered to the subject ST. When the fluorescent reagent (IR700) is excited, near infrared light having a peak of approximately 700 or 770 nm emits as fluorescent light and is detected by the excitation light sensor 29 Note that if an excitation light is being irradiated over a long period of time, reaction of the treatment drug (Rlvf-1929) progresses and treatment progresses unintentionally, so that pulse-lighting occurs for only a duration corresponding to the imaging time of one field ( e.g., 16 msec) of the excitation light sensor 29 ( details will be described later) according to this embodiment. [0020-0021]
Fengler describes a first light source as a white light and a second light source as an excitation light ([0016] – “Generally, one variation of a fluorescence imaging system may include a light source assembly including a white light provider that emits white light; an excitation light provider that emits excitation light in a plurality of nonoverlapping excitation wavebands for causing the object to emit fluorescent light”) with an image sensor which receives reflected light from both sources ([0016] – “at least one image sensor that receives reflected white light and emitted fluorescent light from the object”). Fengler describes wavelengths of the excitation light centered on 450-650 nm, 670 nm, 770 nm, or 805 nm ([0017]), thereby being able to produce excitation light centered on 670 nm (which is within the 600-700 nm range provided in the instant application). Fengler describes a pulsing scheme for both light sources which can either be synchronized or unsynchronized ([0129-0130]).
The instant specification associates the ability of the light not being capable of progressing treatment with the emission light pulsing ([0021]), although this appears to be related to a decrease in overall energy applied and could be limited by other waveform modifications. Fengler’s disclosure of the pulsing scheme in [0129-0130] with matching field timing capabilities would inherently create the ability in the apparatus to provide an emission pulse profile which allows for imaging but avoids activating immunotherapy. Additionally, Fengler also discloses a timing mechanism using an internal clock to properly order irradiation from the light source and image capture from the camera. Therefore, the imaging apparatus in Fengler is structurally the same (light sources, sensor, wavelength, pulsing scheme, timing) as the imaging apparatus in the instant application and is capable of providing the same light sources and sensors as described in instant Claim 33.
Therefore, Claim 33 is anticipated by Fengler.
Discussion of Prior Art Cited but Not Applied
The treatment drug regimen including a combination of a fluorescent reagent (specifically IR 700) and an epidermal growth factor receptor (EGFR) antibody was known by the effective filing date of the instant application. For example, Kobayashi (US 2012/0010558 A1, see previously cited) teaches an antibody-IR 700 conjugate which kills bound cells after irradiation with infrared light ([0002], [0092]). Specifically, Kobayashi teaches: “The fluorophore IR700 (Licor Co. Lincoln, Nebr.) can become a photosensitizer when conjugated to an antibody specific for a cell surface receptor and can thus be used for target specific photodynamic therapy of undesired cells, such as tumor or cancer cells. Further, because these agents also emit a diagnostic fluorescence, they can be used to direct the application of light to minimize light exposure to non-relevant tissues and non-invasively monitor therapeutic effects” ([0091]). Therefore, the intended use of the apparatus would be known in the art based on the language of instant claims 16 and 33.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796