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 .
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(s) 1-6 and 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 6,214,033) in view of Kobayashi et al. (US 2012/0010558), Bukesov et al. (US 2021/0044079), and Perelman et al. (US 6,922,583.
Li et al. discloses a treatment support apparatus (Figs. 2 and 4-5) comprising: an excitation light source (21; 31; 51a; 51b) configured to irradiate a fluorescent substance of a drug (6) administered into a body of a subject (5) with excitation light in a specific waveband, which is pulsed radiated with the irradiation time (col. 1, lines 52-62) having energy that excites the fluorescent substance but does not kill a cancer cell before or after treatment to kill the cancer cell based on irradiating the drug containing the fluorescent substance with light in a specific waveband (col. 1, lines 23-40; col. 2, lines 28-39); a storage configured to store an irradiation time and an irradiation intensity of the excitation light corresponding to the drug (55; col. 16, lines 56-63); a controller configured to retrieve the irradiation time and the irradiation intensity stored in the storage (7; col. 6, lines 47-54; col. 10, lines 19-24), and control the excitation light source to irradiate the drug with the excitation light with the irradiation time and the irradiation intensity retrieved from the storage (7; col. 6, lines 47-54; col. 10, lines 19-24); a fluorescent detector (25; 35; 37; 38) configured to detect fluorescence emitted by the fluorescent substance of the drug due to excitation by the excitation light (col. 2, lines 7-27; col. 7, lines 13-15); and an image generator (26; 35; 36) configured to generate a fluorescence distribution image, which is an image showing a distribution state of the fluorescence emitted by the fluorescent substance, based on the fluorescence from the fluorescent substance detected by the fluorescence detector (col. 2, lines 7-27; col. 8, lines 4-19). The Examiner’s position is that the claims recite the apparatus and the limitations of excitation of the particular drug or substance (e.g. IRDye 700DX) is considered intended use. However, Kobayashi et al. teaches in the same field of endeavor using IRDye 700DX ([0069]; [0156]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with IRDye 700DX as taught by Kobayashi et al. as it is a well-known substance for fluorescence imaging of cancer cells. Li et al. discloses the subject matter substantially as claimed except for an operation unit configured to receive an operation of a user. However, Bukosov et al. teaches in the same field of endeavor an operation unit wherein the user may control activation of the pulse via an actuator ([0186]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with user controlled actuator as taught by Bukosov et al. in order for the user to control activation of the pulse. Li et al. discloses “setting of the output intensity of the irradiating light and the setting of the irradiation energy quantity can be performed independently at any time. The setting of these values influences calculation of an irradiation time.” (col. 15, lines 26-30). Therefore, the Examiner’s position is that the reference performs the intended use of a single pulse when the selected output intensity and irradiation quantity calculates the irradiating time for a single pulse. This procedure is repeated in S143 see Fig. 13 until termination, which can be interpreted to be each time the user performs the operation. Li et al. discloses the subject matter substantially as claimed except for a single pulse. However, Perelman et al. teaches in the same field of endeavor single pulse excitation is used in order to avoid motion artifacts (col. 11, lines 2-4). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with single pulse excitation as taught by Perelman et al. in order to reduce motion artifacts.
With respect to claims 2-5, Li et al. discloses controlling the integrated energy (col. 17, line 66 to col. 18, line 32).
With respect to claims 6 and 8-9, Li et al. discloses controlling a limit to an irradiation intensity, an irradiation time, and a number of times of irradiation of the excitation light (col. 18, lines 23-32 and 39-57).
With respect to claim 10, Li et al. discloses a treatment support apparatus (Figs. 2 and 4-5) comprising: an excitation light source (21; 31; 51a; 51b) configured to irradiate a fluorescent substance of a drug (6) administered into a body of a subject (5) with excitation light in a specific waveband having energy that excites the fluorescent substance but does not kill a cancer cell before or after treatment to kill the cancer cell based on irradiating the drug containing the fluorescent substance with light in a specific waveband (col. 1, lines 23-40; col. 2, lines 28-39); a fluorescent detector (25; 35; 37; 38) configured to detect fluorescence emitted by the fluorescent substance of the drug due to excitation by the excitation light (col. 2, lines 7-27; col. 7, lines 13-15); and a distribution information output generator (26; 35; 36) configured to output information about a distribution of the fluorescence distribution emitted by the fluorescent substance, based on the fluorescence from the fluorescent substance detected by the fluorescence detector (col. 2, lines 7-27; col. 8, lines 4-19). The Examiner’s position is that the claims recite the apparatus and the limitations of excitation of the particular drug or substance (e.g. IRDye 700DX) is considered intended use. However, Kobayashi et al. teaches in the same field of endeavor using IRDye 700DX ([0069]; [0156]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with IRDye 700DX as taught by Kobayashi et al. as it is a well-known substance for fluorescence imaging of cancer cells. Li et al. discloses the subject matter substantially as claimed except for an operation unit configured to receive an operation of a user. However, Bukosov et al. teaches in the same field of endeavor an operation unit wherein the user may control activation of the pulse via an actuator ([0186]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with user controlled actuator as taught by Bukosov et al. in order for the user to control activation of the pulse. Li et al. discloses “setting of the output intensity of the irradiating light and the setting of the irradiation energy quantity can be performed independently at any time. The setting of these values influences calculation of an irradiation time.” (col. 15, lines 26-30). Therefore, the Examiner’s position is that the reference performs the intended use of a single pulse when the selected output intensity and irradiation quantity calculates the irradiating time for a single pulse. This procedure is repeated in S143 see Fig. 13 until termination, which can be interpreted to be each time the user performs the operation. Li et al. discloses the subject matter substantially as claimed except for a single pulse. However, Perelman et al. teaches in the same field of endeavor single pulse excitation is used in order to avoid motion artifacts (col. 11, lines 2-4). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with single pulse excitation as taught by Perelman et al. in order to reduce motion artifacts.
With respect to claim 11, Li et al. discloses an image generation method comprising: irradiating a fluorescent substance of a drug (6) administered into a body of a subject (5) with excitation light in a specific waveband having energy that excites the fluorescent substance but does not kill a cancer cell before or after treatment to kill the cancer cell based on irradiating the drug containing the fluorescent substance with light in a specific waveband (col. 1, lines 23-40; col. 2, lines 28-39); storing an irradiation time and an irradiation intensity of the excitation light corresponding to the drug (55; col. 16, lines 56-63); retrieving the irradiation time and the irradiation intensity stored (7; col. 6, lines 47-54; col. 10, lines 19-24); controlling the excitation light source to irradiate the drug with the excitation light with the irradiation time and the irradiation intensity retrieved (7; col. 6, lines 47-54; col. 10, lines 19-24);detecting fluorescence emitted by the fluorescent substance of the drug due to excitation by the excitation light (col. 2, lines 7-27; col. 7, lines 13-15); and generating a fluorescence distribution image, which is an image showing a distribution state of the fluorescence emitted by the fluorescent substance, based on the fluorescence from the fluorescent substance detected by the fluorescence detector (col. 2, lines 7-27; col. 8, lines 4-19). Li et al. does not teach IRDye 700 DX and an antibody. However, Kobayashi et al. teaches in the same field of endeavor using IRDye 700DX and an antibody ([0069]; [0156]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with IRDye 700DX and an antibody as taught by Kobayashi et al. as it is a well-known substance for fluorescence imaging of cancer cells. Li et al. discloses the subject matter substantially as claimed except for an operation unit configured to receive an operation of a user. However, Bukosov et al. teaches in the same field of endeavor an operation unit wherein the user may control activation of the pulse via an actuator ([0186]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with user controlled actuator as taught by Bukosov et al. in order for the user to control activation of the pulse. Li et al. discloses “setting of the output intensity of the irradiating light and the setting of the irradiation energy quantity can be performed independently at any time. The setting of these values influences calculation of an irradiation time.” (col. 15, lines 26-30). Therefore, the Examiner’s position is that the reference performs the intended use of a single pulse when the selected output intensity and irradiation quantity calculates the irradiating time for a single pulse. This procedure is repeated in S143 see Fig. 13 until termination, which can be interpreted to be each time the user performs the operation. Li et al. discloses the subject matter substantially as claimed except for a single pulse. However, Perelman et al. teaches in the same field of endeavor single pulse excitation is used in order to avoid motion artifacts (col. 11, lines 2-4). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with single pulse excitation as taught by Perelman et al. in order to reduce motion artifacts.
With respect to claim 12, Li et al. discloses controlling the integrated energy (col. 17, line 66 to col. 18, line 32).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (US 6,214,033) in view of Kobayashi et al. (US 2012/0010558), Bukesov et al. (US 2021/0044079), and Perelman et al. (US 6,922,583) as applied to claim 1, further in view of Wu et al. (US 2013/0053699).
Li et al. discloses the subject matter substantially as claimed except for further comprising a visible light detector and an image synthesizer configured to generate a composite image. However, Wu et al. teaches in the same field of endeavor comprising detecting white light image and synthesizing a composite image to superimpose the white light image and the fluorescent image ([0017]). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with the composite image as taught by Wu et al. as superimposing white light and fluorescent images are well known in the art.
Response to Arguments
Applicant's arguments filed 7/28/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the excitation light is a single pulse having a duration of the irradiation time each time the user performs the operation, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues the reference does not teach a single pulse having a duration of the irradiation time. However, the Examiner respectfully disagrees with the applicant. Li et al. discloses “setting of the output intensity of the irradiating light and the setting of the irradiation energy quantity can be performed independently at any time. The setting of these values influences calculation of an irradiation time.” (col. 15, lines 26-30). Therefore, the Examiner’s position is that the reference performs the intended use of a single pulse when the selected output intensity and irradiation quantity calculates the irradiating time for a single pulse. This procedure is repeated in S143 see Fig. 13 until termination, which can be interpreted to be each time the user performs the operation.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Li et al. discloses the subject matter substantially as claimed (see above), including “setting of the output intensity of the irradiating light and the setting of the irradiation energy quantity can be performed independently at any time. The setting of these values influences calculation of an irradiation time.” (col. 15, lines 26-30). The Examiner’s position is that the reference performs the intended use of a single pulse when the selected output intensity and irradiation quantity calculates the irradiating time for a single pulse. Although Li et al. does not explicitly recite the intended use of a single pulse. Perelman teaches in the same field of endeavor single pulse excitation is used in order to avoid motion artifacts (col. 11, lines 2-4). Therefore, it would have been obvious to one of ordinary skill in the art to have provided Li et al. with single pulse excitation as taught by Perelman et al. in order to reduce motion artifacts.
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 PETER LUONG whose telephone number is (571)270-1609. The examiner can normally be reached M-F 9-6.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan T Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER LUONG/Primary Examiner, Art Unit 3797
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