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 November 18, 2025. As directed by the amendment, claims 1, 4-9, 11 and 12 have been amended, and claims 2-3 have been cancelled. Thus, claims 1 and 4-12 as filed are presently pending.
Claim Interpretation
In claims 1, 4, 11 and 12, the phrase, “narrow band light” will be interpreted consistent with the disclosure as filed, (see e.g., claims 5-10) narrow band is considered to have a maximum range of 160 nm (see claim 9 that defines a range of 620 nm to 780 nm). For examination purposes, a prior art that discloses a sensor that obtains tissue image using a band of light of equal to or less that 160nm will be taken to read on this limitation in claims 1-4, 11 and 12. As to claims 5-10, the narrow band will be considered to be the specific range specified in each corresponding claim.
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 (i.e., sensor) 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 (see claim 1):
a first sensor configured to obtain a tissue structure image … (for corresponding structure, see [0019] first imaging element 224a is a CCD image sensor or a CMOS image sensor and [0023] first imaging element 224a represents a first imager);
a second sensor configured to obtain a fluorescence image … (for corresponding structure, see [0019] second imaging element 224b is a CCD image sensor or a CMOS image sensor and [0023] second imaging element 224 represents a second imager);
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.
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 1 and 4-12 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.
Regarding claims 1 and 4-12, claim 1 recite in part, “refer to the tissue structure image to determine a boundary region between a portion in which a tissue structure image is greater than the preset threshold value and a portion in which the tissue structure;”, the phrase is incomplete as the phrase “in which the tissue structure” does not further describe the said tissue structure, thus rendering the scope of the claim unclear. For examination purpose, consistent with the disclosure, it will be presumed that Applicant’s intent is to recite “in which the tissue structure has not changed or is less than the preset threshold to determine the boundary”.
Claims 4-10 are likewise rejected because they include all limitations, and therefore deficiencies of claim 1, while claims 11-12 recite a similar limitation which is rejected under this Statute, for substantially similar rationale as claim 1.
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 and 5-12 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited Ishikawa WO 2021038913 A1 (see English version in US 20220287549 A1 for citations) in view Hiereth et al., US 20190099612 A1 hereinafter “Hiereth” and in view of Laima et al., LT 5823 B hereinafter “Laima” (see attached English machine translation for citations).
Regarding claims 1, 11 and 12, Ishikawa discloses a phototherapy device/method/computer readable medium comprising: a light source configured to emit treatment light for causing a reaction of a drug ([0038, [0065] “e.g., non-thermal red light having a wavelength of about 690 nm is radiated during the treatment of photoimmunotherapy” [0070-0071] “therapeutic light … for treatment”); a first sensor configured to obtain a tissue structure image which is formed using white light applied onto an application position of the treatment light ([0037] and [0044] visible light detector 27 is an imaging device, [0048] in combination with image generator 26 and [0069] to generates a visible light image 42 see Fig. 4, hence an equivalent thereof first sensor); a second sensor configured to obtain a fluorescence image which is formed using excitation light applied onto the application position of the treatment light [0037] and [0042-0043] fluorescence detector 26 is an imaging device, [0048] in combination with image generator 26 and [0069] to generate a fluorescence distribution image 41, see Fig. 3, hence an equivalent thereof second sensor) and; a processor comprising hardware configured to refer to the tissue structure image to determine a boundary region ([0049] image synthesizer 17 generates a composite image 43, see Fig. 5, that depicts a boundary region in which tissue structure has changed); calculate magnitude of variation in fluorescence intensity of the boundary region ([0057] information output 55 outputs information about distribution of fluorescence, see Fig. 9, graph depicts calculated fluorescence intensity variation with integrated amount of energy for the tissue area being monitored that includes the boundary region and will be depicted in Fig. 5); and generate a display image to be used for displaying the magnitude of variation of the fluorescence intensity ([0060] “the information about the distribution state of the fluorescence output from the information output 55 may be displayed on the display 13 under the control of the apparatus controller 14”).
Ishikawa does not explicit disclose that the first sensor is configured to obtain the tissue structure image using narrow band light. However, Hiereth teaches in [0048] that white light and narrow band imaging are art recognized alternative means of imaging a tissue structure. Moreover, Hiereth teaches in [0090] and [0092] that narrow band imaging increase contrast between tumor and non-tumor tissue. In view of these teachings, inasmuch as Hiereth teaches while light and narrow band light as art recognized alternative, at the time of filing the claimed invention, it would have been obvious 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 white light with narrow band light as taught by Hiereth, to perform the same function and for the added advantage of increased contrast to distinguish tumor and non-tumor tissue.
Ishikawa in view of Hiereth does not explicit disclose that the processor comprising hardware is configured to detect a time variation in the tissue structure image; determine a value of the tissue structure image representing a change in the tissue structure based on at least the detected time variation; compare a value of the tissue structure image based on at least the time variation with a preset threshold value; and refer to the tissue structure image to determine a boundary region between a portion in which a tissue structure image is greater than the preset threshold value and a portion in which the tissue structure image value is less than the preset threshold.
However, Laima in the same field of endeavor of diagnosis and/or treatment of tumor and/or cancerous lesions ([0007]) discloses a sensor configured to obtain the tissue structure image using narrow band light ([0025], [0047-0048] regarding activating light from 380 nm to 410 nm with glow of tumor tissue with intensity that coincides with confirmed boundaries of tumor and persists for up to 30 days, [0049-0054] regarding illumination of tumor at different times, morphological studies from fluorescent areas and adjacent non-luminescent areas before and after (i.e., time variation) introduction of photosensitizer/drug, evaluating correlation between histological structure and/or cellular structure of tissue under study and luminescence with tumor boundaries,[0055] regarding slight fluorescence in surrounding health tissue and very intensely fluorescence on tumor tissue [0093-0094] observing glow during illumination, evaluating the intensity of the glow and depicting the glow in filming and photography.
A person of ordinary skill in the art at the time of filing the claimed invention would recognize from the teachings of Laima that healthy tissue adjacent suspected tumor tissue when illuminated with narrow band light would have distinct fluorescence and that tumor tissue is expected to have fluorescence that is greater than a fluorescence threshold of normal tissue within the same narrow band light, e.g. as depicted in Fig. g of Laima, therefore, a threshold value that coincides with tumor tissue can be used to evaluate changes of tissue portion taken before and after an administration of a drug/photosensitizer, to show and verify tumor or cancerous tissue boundaries with health or non-tumor or non-cancerous tissue, and that this distinction can be used with reasonable expectation of success in determining and/or verifying a boundary between a tumor/cancerous tissue and normal tissue using a processor.
In view of this, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art at the time of the invention, to modify the processor comprising hardware of Ishikawa in view of Hiereth, to detect a time variation in the tissue structure image; determine a value of the tissue structure image representing a change in the tissue structure based on at least the detected time variation; compare a value of the tissue structure image based on at least the time variation with a preset threshold value; and refer to the tissue structure image to determine a boundary region between a portion in which a tissue structure image is greater than the preset threshold value that coincided with tumor or cancerous tissue and a portion in which the tissue structure image value is less than the preset threshold , so as to diagnose and depict tumors or cancerous tissue during treatment, as it would further enhance operator to grasp in regards to distribution of the drug and/or therapeutic effect from accumulation in the diseased or tumor tissue as required by Ishikawa in [0070].
Regarding claims 5-9, as modified by Hiereth [0098-0100] RGB light system can be used by completely switching off one or two of laser modules (i.e., red, green and blue) or by mixing the radiation from the corresponding laser modules accordingly. The blue laser module (450-485nm) reads on claim 6, , the green laser module (500-565nm) reads on claim 7, the red laser module (625-700nm) reads on claim 9, combining red and blue laser modules would generate violet light (380-450nm) that reads on claim 5, alternatively, Laima teaches wavelength of 380-410 nm that also reads on this range, and combining red and green laser modules would generate orange light (590-625nm), which reads on claim 8.
Regarding claim 10, see [0040] light source controller 23 and [0074], apparatus controller 14 are configured to control treatment light using cumulative value of light application intensity and light application period as a setting amount of applied light in view of computed integrated light intensity in Fig. 9
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa in view of Hiereth as applied to claim above, and further in view of Hendricks et al., US 20200134820 A1 hereinafter "Hendricks".
Regarding claim 4, Ishikawa in view of Hiereth does not explicitly disclose using a feature that has been calculated by machine learning to determine boundary region. However, Hendricks teaches that it was known in the prior art to determine a boundary region using a feature calculated by machine learning that further provides an indication of reliability ([abstract], [0016]). In view of these teachings, it would have been obvious to one having ordinary skill in the art at the time of filing the claimed invention, to have implemented a feature calculated by machine learning to determine a boundary region, with the added benefit of an indication of reliability, for more accurate boundary detection.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 4-12 have been considered but are moot in light of a new ground of rejection as set forth supra.
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