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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (Claims 1-10) and species A (endoscope system 1; Fig. 2) in the reply filed on 9/8/25 is acknowledged. Claims 7 and 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Claims 1-6 and 8-10 are pending examination.
Claim Objections
Claims 1, 7, 9-11 and 12 are objected to because of the following informalities:
[Claim 1] The limitation “the calculated variation” should be “the calculated time variation” to keep the claim terms consistent
[Claims 7, 11 and 12] The status identifier for these claims should be “withdrawn”
[Claims 9 and 10] The limitation “the variation calculated” should be “the time variation calculated” to keep the claim terms consistent
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 8-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
[Claim 1] The limitation “a narrow-band-light image variation calculator configured to calculate a time variation between the narrow band light image obtained before an application of the treatment light and the narrow band light image obtained after the application of the treatment light” fails the written description requirement, as the specification does not provide sufficient details as to 1. What a time variation specifically encompasses and 2. How it is calculated.
MPEP 2163.03 states “an original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated”. The examiner contends that both issues exist with the current claim language. Regarding the broad genus of a “time variation”, this seemingly encompasses any variation that occurs over time that can be interpreted/determined via an image, i.e. detection of light. While applicant has disclosed three examples, e.g. “degree of contrast”, “intelligibility of the extracted structure” and “homogeneity” of a mucous membrane, the examiner takes the position that these 3 examples are not a representative species of the entire genus, which again encompasses any/all changes that can be determined/calculated from any image (of any target/area related to photodynamic therapy), which is seemingly infinite in scope. Regarding the functionality, the specification fails to provide any details as to HOW this calculation is accomplished. For example, what specific characteristics, properties, features and/or details of the images, taken before and after phototherapy, are being compared/looked at and how is their similarity or difference being specifically determined in order to accomplish the claimed calculation?
MPEP 2161.01 states “original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed”. The current specification provides no steps, flowchart, algorithm, etc. as to how this calculations is performed. Other than merely reciting the result/effect, in the same manner its recited in the current claims, there are no details or explanation as to how to achieve this calculation. Therefore, claim 1 fails the written description based both on the breadth and functionality.
[Claims 2-4] While these claims address/solve the breadth issue, as detailed above in relation to claim 1, the functionality remains an issue. Specifically, these claims limit the claimed time variation to a specific parameter (“degree of contrast”, “intelligibility of the extracted structure” and “homogeneity”) but the details related to HOW these parameters/values are calculated remains insufficient. It is reiterated that other than restating the function/effect/result, as it is currently recited in the claims, the specification provides no additional details as to how a POSITA would accomplish such a calculation. For example, how is a degree of contrast, intelligibility of the extracted structure and/or homogeneity calculated when comparing the two images (before and after therapy)? It is noted that a calculation implies that some sort of value/result is output after the calculation is complete. When reading applicant’s specification, it’s unclear what this output is, let alone how it’s calculated. For example, the specification states “the narrow-band-light image variation calculator 413 compares the images and calculates, as the image variation, values indicating the intelligibility and the homogeneity of the superficial tissue pattern, and values indicating the homogeneity and visibility of the thickness of the blood vessels.” While it is understood that the two images are compared to determine some sort of change or variation in the images, it’s unclear what these “values indicating the intelligibility and the homogeneity” are or how they are specifically calculated. For example, what features in the images are being compared and how is their homogeneity, contrast or intelligibility being ultimately determined? Seemingly there can be lots of differences between these two images, e.g. color, size/dimensions, orientation, etc. Which (if any) of these features is being specifically looked at/compared and how does each difference contribute to the overall calculation of homogeneity, contrast or intelligibility? Therefore, these claims fail the written description requirement.
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 1-6 and 8-10 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 1] The limitation “calculate a time variation” when considered in light of the specification and the claims, is indefinite, as there appears to inconsistency with what is claimed versus what is disclosed. MPEP 2173.03 states “A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty”. Specifically, the claim language implies that the variation being calculated is time, i.e. an amount of time from one image to the next. However, when reading/considering the specification, it becomes apparent that this time variation is not a variation with time itself, but a variation (of anything shown in the image) over time, i.e. from before to after therapy. For example, the specification provides examples of property changes of specific tissue, e.g. blood vessels in the superficial portion of the mucous membrane, that occurs over time, i.e. from before to after light therapy, but these changes in tissue property are not a time variation, but a variation in tissue properties/characteristics that take place over time. There is seemingly an important distinction between a variation in time verses a variation in properties/characteristics of tissue that occurs over time. Therefore, this conflict/inconsistency between the specification and the claims makes the limitation “calculate a time variation” indefinite, as it’s unclear what the metes and bounds are. For examination purposes, the examiner is interpreting this limitation consistent with the specification, specifically a time variation is any variation in images that occurs over time.
Additionally, the limitations “the narrow band light image obtained before an application of the treatment light” and “the narrow band light image obtained after an application of the treatment light” lack antecedent basis. For examination purposes the word “the” in the above limitations will be interpreted as “a”.
[Claims 2-4, 6 and 7] The limitation “the narrow band light image” lacks antecedent basis as there are two images recited in the independent claim, i.e. one obtained before treatment and one after. It’s unclear which image this is referring to. For examination purposes, this image could refer to either or both of the previously claimed images.
[Claim 8] This claim recites “the display image generator generates a display image in which a narrow band light image obtained before application of the treatment light and a narrow band light image obtained after application of the treatment light are superimposed” which is indefinite. Specifically, the independent claim already recites “the narrow band light image obtained before an application of the treatment light and the narrow band light image obtained after the application of the treatment light”. So it’s unclear if the images recited in claim 8 are the same images as in claim 1 or if these are somehow different. For examination purposes, these images in claim 8 are interpreted to be the same images as claim 1.
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.
Claims 1, 5, 6 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6,128,525 to Zeng.
[Claim 1] A phototherapy device (Figs. 1 and 4) comprising:
a treatment light emitter (PDT laser 2) configured to emit treatment light for causing a reaction of a drug (Col 2, line 63 to Col 3, line 8);
a narrow band light emitter (fluorescence excitation laser 8) configured to emit narrow band light (a laser, by definition, is inherently configured to emit a narrow band light) having part of wavelength band of a visible light range (442 nm He-Cd laser; Col 4, lines 18-42);
an imager (spectrometer 12; Fig. 1 or CCD camera 30; Fig. 4) configured to obtain a narrow band light image which is formed using the narrow band light applied onto an application position of the treatment light (See Col 2, line 63 to Col 3, line 39 for discussion related to spectroscopy and Col 4, line 57 to Col 5, line 19 for discussion related to the camera);
a narrow-band-light image variation calculator (computer 14) configured to calculate a time variation between the narrow band light image obtained before an application of the treatment light and the narrow band light image obtained after the application of the treatment light (Col 3, lines 34 to Col 4, line 52 detail the operation of the spectrometer/computer to analyze the image, i.e. detected light signal, at various times before and during the application of treatment light and compares the resulting fluorescent signal to determine the level of photosensitizer. Col 5, lines 20-40 detail a similar process related to the camera); and
a display image generator (15) configured to generate a display image including information based on the calculated variation (“Spectrometer 12 communicates with computer 14 and includes a display monitor 15 to view spectral graphs generated in real time.” Col 3, lines 33-38).
[Claim 5] Fig. 2 shows the mutually different timings and mutually nonoverlapping timings of the treatment light and narrow band light (Col 3, lines 39-53)
[Claim 6] Col 5, lines 1-40 detail how the image is divided into a plurality of regions, i.e. pixels, to calculate the variation occurring in each pixel.
[Claim 8] The examiner considers the ratio image (Col 5, lines 1-40) as a superimposed image. If applicant disagrees, see alternative 103 rejection below.
[Claims 9 and 10] Zeng discloses that the amount of treatment light and the duration of the treatment is calculated/estimated by the variation in the images. Specifically, Zeng teaches that the variation in the images, i.e. light detection, is monitored to track the level of photoproducts and when a preset level/threshold is reached the computer will cause the shutter to close which terminates the therapy (at least Col 4, lines 44-52); this is interpreted as both the output of the treatment light and the application period of treatment light.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2008/0221647 to Chamberland et al.
[Claim 1] A phototherapy device (10, Fig. 1) comprising:
a treatment light emitter (PDT light source 12) configured to emit treatment light for causing a reaction of a drug (Pars 0013-15);
a narrow band light emitter (PAT laser source 16) configured to emit narrow band light having part of wavelength band of a visible light range (“narrow linewidth” Par 0016);
an imager (optical transducer 22) configured to obtain a narrow band light image which is formed using the narrow band light applied onto an application position of the treatment light (Pars 0010, 0018 and 0022 make it clear that an optical transducer is used to generate optical images);
a narrow-band-light image variation calculator (control unit 25; Par 0021) configured to calculate a time variation between the narrow band light image obtained before an application of the treatment light and the narrow band light image obtained after the application of the treatment light (“tissue changes during treatment” Par 0012; “Imaging at two or more wavelengths enables an absolute estimation of blood oxygenation and a relative estimation of blood volume in the tissue under the PDT treatment at any time (e.g., before, during, or after treatment), which may permit interactive adjustment of treatment intensity” Par 0017; “SPAT may also help evaluate treatment efficacy by quantifying tissue hemodynamic changes during and after the PDT procedure” Par 0036. See also Pars 0022 and 0028); and
a display image generator (32) configured to generate a display image including information based on the calculated variation (“images may be displayed on computer 32 or another display”; Par 0022).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zeng as applied to claim 1 above, and further in view of WO 2019/215905 to Tsumatori et al.
Zeng is discussed above, but fails to explicitly teach a display image generator configure to superimpose an image before treatment with an image after treatment. However, in the same field of endeavor, Tsumatori discloses such a display image generator; Figs. “9 and 10 show an example in which a pre-treatment composite image 841 and a post-treatment composite image 842 are displayed superimposed on the display device 900”. Therefore, it would have been obvious to modify the display image generator of Zeng to be configured to generate an image where the pre-treatment image is superimposed with a post-treatment image as a use of known technique (superimposition) to improve similar devices in the same way, specifically as a known way for a doctor to visualize the progress of treatment.
Lack of Prior Art Rejections
Claims 2-4 are not rejected over prior art, as the prior art fails to teach or suggest the narrow band light emitter emitting light at the two specific wavelength ranges AND a narrow band light image variation calculator configured to calculate the claimed properties of a mucous surface, in combination with all the limitations recited in claim 1. However, the 112 rejections prevent these claims from being indicated as allowable. It is emphasized that any amendments to resolve the 112 issues would cause the lack of prior art rejection to be reevaluated, i.e. any amendments would require further search and consideration in relation to the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2023/0302291 to Ishikawa (Fig. 1 and Abstract) discloses a similar light therapy device that uses imagers (33 and 34) to determine treatment progress by comparing images taken before and during treatment (Pars 0070-76).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796