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 § 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, 4-6, and 9-11 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 recites the limitation "a rate of decrease of the intensity of the fluorescence" in lines 13-14. Applicant then defines it as “calculate a rate of decrease of the intensity of the fluorescence as a difference between a first stored intensity of the fluorescence and a second stored intensity of the fluorescence” which is not the known definition of “a rate of decrease”. A rate of decrease is the amount of change of a value over time, in this case it would be the change in intensity divided by the change in time. Instead, applicant is claiming that the “rate of decrease” is simply the change in intensity over two time periods using a formula P2-P1. For the purposes of examination, examiner will interpret the limitation “a rate of decrease” to mean what the applicant set forth in the claim, being the difference between intensities at two different time periods. Examiner suggests amending or clarifying the definition.
Claims 4, 5, and 11 are rejected based on their dependency on claim 1.
Claim 6 recites the limitation "a rate of decrease of the intensity of the fluorescence" in lines 13-14. Applicant then defines it as “calculate a rate of decrease of the intensity of the fluorescence as a difference between a first stored intensity of the fluorescence and a second stored intensity of the fluorescence” which is not the known definition of “a rate of decrease”. A rate of decrease is the amount of change of a value over time, in this case it would be the change in intensity divided by the change in time. Instead, applicant is claiming that the “rate of decrease” is simply the change in intensity over two time periods using a formula P2-P1. For the purposes of examination, examiner will interpret the limitation “a rate of decrease” to mean what the applicant set forth in the claim, being the difference between intensities at two different time periods. Examiner suggests amending or clarifying the definition.
Claims 9 and 10 are rejected based on their dependency on claim 6.
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, 4-6, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0123642 Yamaguchi et al., hereinafter “Yamaguchi”, in view of US 2017/0032521 Kubo et al., hereinafter “Kubo” (both cited previously).
Regarding claim 1, Yamaguchi discloses a treatment support device (Abstract and Figure 1, element 1) configured to control therapeutic light emitted toward a treatment site of a subject (Para 9-14 and Figure 3, element 110 and 300) to whom a therapeutic agent containing a fluorescent dye used in photoimmunotherapy has been administered (Abstract and Para 9-14) and excite the fluorescent dye by means of the therapeutic light to perform treatment (Para 9-14), the treatment support device comprising:
a light source configured to emit the therapeutic light (Figure 3, elements 110 and 300);
a control unit configured to control an irradiation of the therapeutic light (Figure 3, element 150, Para 27, 120, 157, 198, and 232);
a detection unit configured to detect intensity of fluorescence generated from the fluorescent dye (Figure 3, element 130 and Para 142), when the therapeutic light is being emitted (Para 142); and
a storage unit (Figure 3, element 160) configured to sequentially store the intensity of the fluorescence (Para 123 and 158) detected by the detection unit at successive detection times separated by a predetermined time interval (Para 123 discloses that the storage unit records “information on fluorescence intensity obtained from the detection unit 130 is in relation with time information obtained from a timing measurement unit” these measurements are occurring over time and the change of fluorescence is determined over separate time periods, separated by a time interval; this is also shown in Figure 7 that shows different intensities at different time periods),
wherein the control unit is configured to
calculate a rate of decrease of the intensity of the fluorescence as a difference between a first stored intensity of the fluorescence and a second stored intensity of the fluorescence (Para 213; “the controller 150 calculates fluorescence intensity. The controller 150 creates display information of the temporal change of the fluorescence intensity based on the calculated fluorescence intensity”; a change in fluorescence intensity is known in the art to be a difference between the calculated intensity and a previous intensity, this is also shown in Figure 12), the second stored intensity of the fluorescence being stored prior to the first stored intensity of the fluorescence by the predetermined time interval (Para 213; this limitation is subject to interpretation, the second intensity can be the intensity determined in the storage unit, before the first calculated intensity that is shown in Para 213, examiner suggests defining the timings), the rate of decrease being calculated repeatedly during emission of the therapeutic light (This is shown in Figure 12, this shows the change in florescence over time, thereby showing repeated measurements, see also Para 230),
compare the calculated rate of decrease to a predetermined threshold (Para 120 discloses that the change of fluorescence intensity determined the cytocidal effect, now consider Para 231 that discloses considering if the intensity is below a threshold, therefore decreased below a threshold, decreased beyond a rate of change that is set, if Yes then a cytocidal effect has occurred and irradiation comes to a stop; this can also be seen in Figure 20, elements S113 and S114), and
stop irradiation of the therapeutic light in response to the calculated rate of decrease becoming equal to or less than the predetermined threshold while the intensity of the fluorescence is decreasing (Again refer to Para 231 and Figure 20, element S113 and S114; Given that the calculated fluorescence intensity is below a threshold, means that the change in intensity from compared to the threshold is met, thereby prompting the stopping of irradiation in steps S115 or S116, also refer to Para 120 that discloses that the change of fluorescence intensity determined the cytocidal effect).
Yamaguchi does not explicitly disclose wherein the control unit is configured to stop irradiation of the therapeutic light.
However, Kubo discloses a treatment device/method that emits light towards a tissue of a subject that was administered with fluorescent dye (Abstract) and teaches the control unit is configured to stop irradiation of the therapeutic light (Para 138; This is only relied upon to disclose automatic stopping of light).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed automatic stopping of the light as taught by Kubo, in the invention of Yamaguchi, in order to shut off the application of light in response to preset variables (Kubo; Para 138).
Regarding claim 4, Yamaguchi discloses an imaging unit (Para 115).
Yamaguchi does not disclose acquire a fluorescence image by imaging the fluorescence generated from the fluorescent dye, when the therapeutic light is being emitted, wherein the detection unit detects the intensity of the fluorescence based on a luminance value of the fluorescence image.
However, Kubo discloses a treatment device/method that emits light towards a tissue of a subject that was administered with fluorescent dye (Abstract) and teaches acquire a fluorescence image by imaging the fluorescence generated from the fluorescent dye (Abstract), when the therapeutic light is being emitted (Abstract),
wherein the detection unit detects the intensity of the fluorescence based on a luminance value of the fluorescence image (Abstract and Para 152).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a luminance value as taught by Kubo, in the invention of Yamaguchi, in order to determine the fluorescence intensity (Kubo; Para 152).
Regarding claim 5, Yamaguchi discloses the therapeutic light is light having a wavelength of 600 nm to 750 nm (Para 108).
Regarding claim 6, Yamaguchi discloses a therapeutic light control method (Abstract, Para 1, and Figure 1, element 1) configured to control therapeutic light emitted toward a treatment site of a subject (Para 9-14 and Figure 3, element 110 and 300) to whom a therapeutic agent containing a fluorescent dye used in photoimmunotherapy has been administered (Abstract and Para 9-14) and excite the fluorescent dye the therapeutic light to perform treatment (Para 9-14), the therapeutic light control method comprising the steps of:
emitting the therapeutic light by a light source (Para 33 and Figure 3, elements 110 and 300);
controlling an irradiation of the therapeutic light by a control unit (Figure 3, element 150, Para 27, 120, 157, 198, and 232);
detecting intensity of fluorescence generated from the fluorescent dye by a detection unit (Figure 3, element 130 and Para 142); and
sequentially storing the intensity of the fluorescence in a storage unit (Figure 3, element 160 and Para 123 and 158) at successive detection times separated by a predetermined time interval (Para 123 discloses that the storage unit records “information on fluorescence intensity obtained from the detection unit 130 is in relation with time information obtained from a timing measurement unit” these measurements are occurring over time and the change of fluorescence is determined over separate time periods, separated by a time interval; this is also shown in Figure 7 that shows different intensities at different time periods),
wherein the step of controlling the irradiation of the therapeutic light includes
calculating, by the control unit, a rate of decrease of the intensity of the fluorescence as a difference between a first stored intensity of the fluorescence and a second stored intensity of the fluorescence (Para 213; “the controller 150 calculates fluorescence intensity. The controller 150 creates display information of the temporal change of the fluorescence intensity based on the calculated fluorescence intensity”; a change in fluorescence intensity is known in the art to be a difference between the calculated intensity and a previous intensity, this is also shown in Figure 12), the second stored intensity of the fluorescence being stored prior to the first stored intensity of the fluorescence by the predetermined time interval (Para 213; this limitation is subject to interpretation, the second intensity can be the intensity determined in the storage unit, before the first calculated intensity that is shown in Para 213, examiner suggests defining the timings), the rate of decrease being calculated repeatedly during emission of the therapeutic light (This is shown in Figure 12, this shows the change in florescence over time, thereby showing repeated measurements, see also Para 230),
comparing, by the control unit, the calculated rate of decrease to a predetermined threshold (Para 120 discloses that the change of fluorescence intensity determined the cytocidal effect, now consider Para 231 that discloses considering if the intensity is below a threshold, therefore decreased below a threshold, decreased beyond a rate of change that is set, if Yes then a cytocidal effect has occurred and irradiation comes to a stop; this can also be seen in Figure 20, elements S113 and S114), and
stopping, by the control unit, irradiation of the therapeutic light in response to the calculated rate of decrease becoming equal to or less than the predetermined threshold while the intensity of the fluorescence is decreasing (Again refer to Para 231 and Figure 20, element S113 and S114; Given that the calculated fluorescence intensity is below a threshold, means that the change in intensity from compared to the threshold is met, thereby prompting the stopping of irradiation in steps S115 or S116, also refer to Para 120 that discloses that the change of fluorescence intensity determined the cytocidal effect).
Yamaguchi does not explicitly disclose stopping irradiation of the therapeutic light by the control unit.
However, Kubo discloses a treatment device/method that emits light towards a tissue of a subject that was administered with fluorescent dye (Abstract) and teaches stopping irradiation of the therapeutic light by the control unit (Para 138; This is only relied upon to disclose automatic stopping of light)
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed automatic stopping of the light as taught by Kubo, in the invention of Yamaguchi, in order to shut off the application of light in response to preset variables (Kubo; Para 138).
Regarding claim 9, Yamaguchi discloses all the limitations of claim 6.
Yamaguchi does not disclose the step of acquiring a fluorescence image by imaging the fluorescence generated from the fluorescent dye by an imaging unit, when the therapeutic light is being emitted, wherein the step of detecting the intensity of the fluorescence, the intensity of the fluorescence is detected based on a luminance value of the fluorescence image by the imaging unit.
However, Kubo discloses a treatment device/method that emits light towards a tissue of a subject that was administered with fluorescent dye (Abstract) and teaches the step of
acquiring a fluorescence image by imaging the fluorescence generated from the fluorescent dye by an imaging unit (Abstract and Para 37), when the therapeutic light is being emitted (Abstract),
wherein the step of detecting the intensity of the fluorescence, the intensity of the fluorescence is detected based on a luminance value of the fluorescence image by the imaging unit (Abstract and Para 152).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a luminance value as taught by Kubo, in the invention of Yamaguchi, in order to determine the fluorescence intensity (Kubo; Para 152).
Regarding claim 10, Yamaguchi discloses the therapeutic light is light having a wavelength of 600 nm to 750 nm (Para 108).
Regarding claim 11, Yamaguchi discloses all the limitations of claim 4.
Yamaguchi does not disclose the luminance value is one of a mean luminance value of the fluorescence image and a maximum luminance value of the fluorescence image.
However, Kubo teaches the luminance value is one of a mean luminance value of the fluorescence image and a maximum luminance value of the fluorescence image (Para 90, 113, and 155; mean luminance value is disclosed; see also Abstract and Para 152).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a luminance value as taught by Kubo, in the invention of Yamaguchi, in order to determine the fluorescence intensity (Kubo; Para 152).
Response to Arguments
Applicant’s arguments have been fully considered but are moot because of the new ground of rejection.
Refer to the U.S.C. 112(b) rejection above.
Regarding applicants’ arguments examiner respectfully disagrees.
First regarding argument A., applicant argues that “A rate of decrease” is not calculated in Yamaguchi. Examiner respectfully disagrees. Para 213 specifically states “the controller 150 calculates fluorescence intensity. The controller 150 creates display information of the temporal change of the fluorescence intensity based on the calculated fluorescence intensity”; a change in fluorescence intensity is known in the art to be a difference between the calculated intensity and a previous intensity, this is also shown in Figure 12. This disclosure discusses calculating intensity and based on that calculated intensity is determining a change in intensity. Thereby a change is calculated. Yamaguchi also states in Para 120 “The controller 150 determines, based on change of the fluorescence intensity during excitation light irradiation, whether an abnormal situation such as a foreign substance or a breakage occurs or not, and determines the cytocidal effect (foreign-substance/breakage-monitoring operation, and cytocidal-effect-determining operation). The controller 150 controls the light source 110 to stop irradiating the excitation light based on determination results.” Now consider Figure 20 that shows these steps and Para 231 that discusses the threshold. Based on the change of fluorescence intensity (change being known in the art to be between two values) being lower than a threshold, the system determines a cytocidal effect S113, thereby stops irradiation S115 and S116. Even if one were to interpret Para 231 alone, a threshold is a value of intensity, thereby by comparing an intensity value to a threshold intensity value, one is looking at the rate of change between the two of them to determine whether a threshold is met or not. Examiner still believes the reference reads on the limitations as currently written.
Regarding argument B., applicant states that Yamaguchi does not disclose “rate of decrease”. Applicant argues against Para 217, examiner does not rely on Para 217 in the rejection above, kindly refer to the U.S.C. 103 rejection above for the rejection of that limitation. However, regarding the argument “the purpose and the consequence of the determination in paragraph 0217 are entirely different from those of amended claim 1. The determination of paragraph 0217 is part of Yamaguchi's foreign-substance/breakage-monitoring operation […] Paragraph 0217 therefore describes a fault interlock that detects apparatus malfunction. It does not describe, and provides no reason to arrive at, a criterion for determining that treatment has been completed and automatically terminating irradiation on that basis” examiner states that this argument does not support the limitations in the claims. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “a criterion for determining that treatment has been completed and automatically terminating irradiation on that basis”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The claims do not recite anything about determining that treatment has been completed and terminating radiation based on completion.
Examiner suggests amending the claim to recite that the decrease in intensity represents an end of treatment, thereby terminating radiation, however, keep in mind that an end of treatment is whenever radiation stops, so whether it stops because treatment naturally came to an end or because a foreign-substance/breakage stops the operation, both can be interpreted to mean an end of treatment (for differing reasons). Therefore, examiner suggests amending a reason for the end of treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796
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