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 Interpretation
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 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:
“a light detection portion that detects a first fluorescence intensity” as recited in claim 10
“a computation portion that calculates, by employing the first fluorescence intensity and reference data, progress information representing the progress of the phototherapy of the affected portion” as recited in claim 10
“an intensity-data generation portion that stores the first fluorescence intensity in a time sequence and generates intensity data representing a temporal change of the first fluorescence intensity” as recited in claim 12
“a storage portion that stores a plurality of the preset data” as recited in claim 12
“a therapeutic-light adjustment portion that adjusts an intensity of the therapeutic light beam radiated onto the affected portion” as recited by claim 14.
“a determination portion that determines, on the basis of the progress information, whether the phototherapy of the affected portion has been completed” as recited in claim 16
All these limitations raise 112 issues, please see 112 rejection section below for how these limitations were interpreted.
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 10-20 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 10’s limitation “a light detection portion that detects a first fluorescence intensity” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support for this limitation can be found in para 17 of applicant’s specification received on 10/11/2023 (hereafter referred to as applicant specification) which states:
“The light detection portion 11 detects the intensity F of the fluorescence Lf transmitted through the barrier filter 7d and transmits the fluorescence intensity F to the intensity-data generation portion 12. For example, the light detection portion 11 has an imaging element provided in the endoscope processor 101 or in the scope 7 and acquires fluorescence images containing information about the fluorescence intensity F. The fluorescence images may be transmitted to the display portion 6 via the image processing portion 5 and displayed on the display portion 6. The light detection portion 11 may have an arbitrary type of photodetector other than the imaging element.”
This section describes light detection portion as including structural examples of photodetectors. However, this is only an example of a light detection portion and therefore the exact scope of the limitation is not exactly clear. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For this examination any type of structure that can perform the function detecting fluorescence intensity as claimed is interpreted as reciting this limitation.
Claim 10’s limitation “a computation portion that calculates, by employing the first fluorescence intensity and reference data, progress information representing the progress of the phototherapy of the affected portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support can be found in para 16 of applicant’s specification which states the following:
“The phototherapy progress measuring device 10 has at least one processor, such as a central processing unit, and a storage device, such as a RAM (random access memory) or a ROM (read-only memory). Processing by the intensity-data generation portion 12, the computation portion 14, the determination portion 15, and the therapeutic-light adjustment portion 16, described later, is realized as a result of the processor executing the processing in accordance with programs stored in the storage device. The storage portion 13 consists of a storage device.”
The section describes the computation portion as being part of a processor and therefore the structure appears to be a processor. However, while it is clear from the disclosure that the computation portion is a processor, since it is described as being one among many parts of a processor it is not exactly clear what the metes and boundaries are for the element. For example, is it an entire processor among multiple processors, part of a processor or something else? For this examination, any processor or its structural equivalents capable of performing the function of calculating, by employing the first fluorescence intensity and reference data, progress information representing the progress of the phototherapy of the affected portion is interpreted as reciting the claimed limitation.
Claim 12’s limitation “an intensity-data generation portion that stores the first fluorescence intensity in a time sequence and generates intensity data representing a temporal change of the first fluorescence intensity” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support can be found in para 16 of applicant’s specification which states the following:
“The phototherapy progress measuring device 10 has at least one processor, such as a central processing unit, and a storage device, such as a RAM (random access memory) or a ROM (read-only memory). Processing by the intensity-data generation portion 12, the computation portion 14, the determination portion 15, and the therapeutic-light adjustment portion 16, described later, is realized as a result of the processor executing the processing in accordance with programs stored in the storage device. The storage portion 13 consists of a storage device.”
The section describes the generation portion as being part of a processor and therefore the structure appears to be a processor. However, while it is clear from the disclosure that the generation portion is part of a processor, since it is described as being one among many parts of a processor it is not exactly clear what the metes and boundaries are for the element. For example, is it an entire processor among multiple processors, part of a processor or something else? For this examination, any processor or its structural equivalents capable of performing the function of storing fluorescence intensity in a time sequence and generating intensity data representing a temporal change of the first fluorescence intensity is interpreted as reciting the claimed limitation.
Claim 12’s limitation “a storage portion that stores a plurality of the preset data” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support can be found in para 16 of applicant’s specification which states the following:
“The phototherapy progress measuring device 10 has at least one processor, such as a central processing unit, and a storage device, such as a RAM (random access memory) or a ROM (read-only memory). Processing by the intensity-data generation portion 12, the computation portion 14, the determination portion 15, and the therapeutic-light adjustment portion 16, described later, is realized as a result of the processor executing the processing in accordance with programs stored in the storage device. The storage portion 13 consists of a storage device.”
The section describes the storage portion as including that of memory. However, while it is clear from the disclosure storage includes memory, this is only example what the storage portion making the metes and bounds of this limitation unclear? For this examination, any non-transitory storage (including memory) capable of storing a plurality of the preset data is interpreted as reciting the limitation.
Claim 14’s limitation “a therapeutic-light adjustment portion that adjusts an intensity of the therapeutic light beam radiated onto the affected portion” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support can be found in para 16 of applicant’s specification which states the following:
“The phototherapy progress measuring device 10 has at least one processor, such as a central processing unit, and a storage device, such as a RAM (random access memory) or a ROM (read-only memory). Processing by the intensity-data generation portion 12, the computation portion 14, the determination portion 15, and the therapeutic-light adjustment portion 16, described later, is realized as a result of the processor executing the processing in accordance with programs stored in the storage device. The storage portion 13 consists of a storage device.”
The section describes the therapeutic-light adjustment portion as being part of a processor and therefore the structure appears to be a processor. However, while it is clear from the disclosure that the therapeutic-light adjustment portion is part of a processor, since it is described as being one among many parts of a processor it is not exactly clear what the metes and boundaries are for the element. For example, is it an entire processor among multiple processors, part of a processor or something else? For this examination, any processor or its structural equivalents capable of performing the function of adjusting an intensity of the therapeutic light beam radiated onto the affected portion is interpreted as reciting the limitation.
Claim 16’s limitation “a determination portion that determines, on the basis of the progress information, whether the phototherapy of the affected portion has been completed” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The closest support can be found in para 16 of applicant’s specification which states the following:
“The phototherapy progress measuring device 10 has at least one processor, such as a central processing unit, and a storage device, such as a RAM (random access memory) or a ROM (read-only memory). Processing by the intensity-data generation portion 12, the computation portion 14, the determination portion 15, and the therapeutic-light adjustment portion 16, described later, is realized as a result of the processor executing the processing in accordance with programs stored in the storage device. The storage portion 13 consists of a storage device.”
The section describes the determination portion as being part of a processor and therefore the structure appears to be a processor. However, while it is clear from the disclosure that determination portion is part of a processor, since it is described as being one among many parts of a processor it is not exactly clear what the metes and boundaries are for the element. For example, is it an entire processor among multiple processors, part of a processor or something else? For this examination, any processor or its structural equivalents capable of performing the function of determining, on the basis of the progress information, whether the phototherapy of the affected portion has been completed is interpreted as reciting the limitation.
Additionally, claims 11-20 are additionally rejected under 35 USC 112(b) based on dependency to one or more of the above cited claims with 112(b) issues.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea (specifically a mental process) without significantly more.
The claim(s) 1 recite(s):
“detecting a first fluorescence intensity, which is an intensity of fluorescence generated in the affected portion as a result of radiating therapeutic light beam onto the affected
portion”
“calculating, by employing the first fluorescence intensity and reference data, progress information representing the progress of the phototherapy of the affected portion”
This is a mental process because the human mind is fully capable of observing (i.e. detecting) and comparing the broadly claimed differences in intensity. This judicial exception is not integrated into a practical application because the only additional feature is that the reference data are determined on the basis of a fluorescence intensity associated with the fluorescent agent that is in the affected portion and that is not involved in the phototherapy. This additional feature is essentially a form of relative data normalization (i.e. specifically it is merely scaling the value which is a feature of statistical analysis which is insignificant post-solution activity). And, as ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) such insignificant extra-solution activity does not integrate the judicial exception into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim never positive recites any additional structures. The claim does recite the use of fluorescent agent and a light beam, but even these are not positively recited. However, both fluorescent agent and a light beam are well-known and conventional in the field of phototherapy. This can be seen in the references of: Ishikawa et al (US 20210378494) hereafter known as Ishikawa [see Fig. 2 and abstract], Loupis et al (US 20160016001) hereafter known as Loupis [see Fig. 1, abstract and para 27] and Nilsen et al (WO 2012076631 cited in applicant’s IDS received on 10/11/2023 [see reference 10 under foreign documents cited as Spectracure with copy provided by applicant]) hereafter known as Nilsen [see Figs. 1 and 5, abstract, and pg. 11 lines 1-40]. Thus, because these additional elements are well known and conventional these structures don’t amount to significantly more than the judicial exception Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 1 is rejected under 101.
Regarding dependent claims 2-9, these claims only further describe the mental process and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception with the exception of claim 4 which recites an additional light beam. However, as discussed above in rejection to claim 1, light beams are well-known and conventional. Thus, claims 2-9 are rejected under 35 USC 101 for similar reasons as claim 1.
The claim(s) 10 recite(s):
“a computation portion that calculates, by employing the first fluorescence intensity and reference data, progress information representing the progress of the phototherapy of the affected portion”. This is a mental process because the human mind is fully capable of observing and comparing the broadly claimed differences in intensity. This judicial exception is not integrated into a practical application because the only additional feature is that the reference data are determined on the basis of a fluorescence intensity associated with the fluorescent agent that is in the affected portion and that is not involved in the phototherapy. This is essentially a form of relative data normalization (i.e. specifically it is merely scaling the value which is a feature of statistical analysis which is insignificant post-solution activity). And, as ruled by Parker v. Flook, 437 U.S. 584, 588-89, 198 USPQ 193, 196 (1978) in MPEP 2106.05(g) such insignificant extra-solution activity does not integrate the judicial exception into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only additional elements are a light detection portion (e.g. a photodetector) and a computation portion (e.g. a generic processor). These elements are well known as evidenced by disclosure in Ishikawa et al (US 20210378494) hereafter known as Ishikawa [see Figs. 1-2 and abstract, paras 43-44 and 55-56 ], Loupis [see Figs. 1 and 6, abstract, para 169 and 174] and Nilsen [see Figs. 1 and 5, abstract, pg. 14 lines 10-32 and pg. 44 lines 30-32 and pg. 45 lines 1-5]. Thus, because these additional structures are well known and conventional these structures don’t amount to significantly more than the judicial exception. Therefore, as the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 10 is rejected under 101.
Regarding claims 11-16, these claims only further describe the mental process and the previously discussed processor and not further integrate the judicial exception into a practical application or amount to significantly more than the judicial with exception of claim 12 which recites a storage portion (e.g. non-transitory medium), but non-transitory medium is well known and convention as can be seen the cited sections of Ishikawa, Loupis and Nilsen in the explanation to claim 10 directly above. Thus, for similar reasons as claim 10, these claims are rejected under 35 USC 101 as well.
Regarding claims 17-20, these claims further disclose a probe, an image element and a display. However, these features are well known and conventional. This is evidence by disclosure in Ishikawa [see Fig. 1-2 elements 51, 13 and 52, para 30, para 41 and para 33], Loupis [see Fig. 1 element 106 and 112 and para 46, para 144, para 69]. Thus, for similar reasons as claim 10 these claims are rejected under 35 USC 101 as well.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 9-10, 16-17 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ishikawa et al (US 20210378494) hereafter known as Ishikawa.
Independent claim:
Regarding claim 1
A phototherapy progress measuring method for measuring a progress of a phototherapy of an affected portion by employing a fluorescent agent [see para 2… “The present invention relates to a treatment support device and a method of setting a region of interest.” and Fig. 10 and claims 11-12], the method comprising:
detecting a first fluorescence intensity, which is an intensity of fluorescence generated in the affected portion as a result of radiating therapeutic light beam onto the affected portion [see claim 11… “acquiring fluorescence intensity of fluorescence emitted by the fluorescent material of the medical agent excited by the treatment light”]; and
calculating, by employing the first fluorescence intensity and reference data, progress information representing the progress of the phototherapy of the affected portion [see Fig. 9 and claim 11… “the first region of interest being a region for selectively acquiring a temporal change in the fluorescence intensity acquired” and para 13… “As a result, by associating the treatment light image with the position of the acquired fluorescence intensity, it is possible to provide a method of setting a region of interest capable of accurately setting the first region of interest, which is a region for selectively acquiring the temporal change in the acquired fluorescence intensity, in a region in which the progress of the treatment at the treatment site is desired to be grasped.”],
wherein the reference data are determined on the basis of a fluorescence intensity associated with the fluorescent agent that is in the affected portion and that is not involved in the phototherapy [see Fig. 9 and para 81… “That is, the second region of interest 42d is a region in which the treatment light is not emitted by the irradiation unit 50 and is a region in which no treatment is performed. Therefore, the fluorescence intensity in the second region of interest 42d is the fluorescence intensity of a region in which the fluorescent material of the medical agent 300 does not emit fluorescence and is fluorescence intensity serving as a reference index for completion of the treatment.”]
Independent claim:
Regarding claim 10:
A processor that measures a progress of a phototherapy of an affected portion by employing a fluorescent agent [see Fig. 2 and para 93… “the treatment support device 100”], the processor comprising:
a light detection portion that detects a first fluorescence intensity, which is an intensity of fluorescence generated in the affected portion as a result of radiating therapeutic light beam onto the affected portion [Fig. 2 element 13 and para 41… “a fluorescence imaging unit 13” and para 44… “the fluorescence imaging unit 13 is configured to acquire (capture) the fluorescent image 41 (see FIG. 3) based on the fluorescence emitted by the fluorescent material of the medical agent 300 excited by the treatment light.”]; and
a computation portion that calculates, by employing the first fluorescence intensity and reference data, progress information representing the progress of the phototherapy of the affected portion [see Fig. 2 elements 21 and 22 and Fig. 9 and para 52… “The image collection unit 21 is configured so that the image data of the fluorescent image 41 captured by the fluorescence imaging unit 13 and the image data of the treatment light image 42 captured by the treatment light imaging unit 14 are input as electric signals. The image collection unit 21 is configured to collect the data of the fluorescent image 41 and the data of the treatment light image 42 based on the time series.” And para 54-55… “the image data of the treatment light image 42 collected by the image collection unit 21 are superimposed. That is, the image synthesis unit 22 is configured to generate the synthetic image 43 in which a plurality of image data collected by the image collection unit 21 is superimposed. The image collection unit 21 and the image synthesis unit 22 include a processor, such as, e.g., a GPU (Graphics Processing Unit)” And para 93… “As a result, by associating the treatment light image 42 with the position of the fluorescence intensity acquired by the fluorescence imaging unit 13, it is possible to accurately set the first region of interest 42c, which is a region for selectively acquiring the temporal change in the fluorescence intensity acquired by the fluorescence imaging unit 13, in the region in which the progress of the treatment in the treatment site is desired to be grasped.”],
wherein the reference data are determined on the basis of a fluorescence intensity associated with the fluorescent agent that is in the affected portion and that is not involved in the phototherapy [see Fig. 9 and para 81… “That is, the second region of interest 42d is a region in which the treatment light is not emitted by the irradiation unit 50 and is a region in which no treatment is performed. Therefore, the fluorescence intensity in the second region of interest 42d is the fluorescence intensity of a region in which the fluorescent material of the medical agent 300 does not emit fluorescence and is fluorescence intensity serving as a reference index for completion of the treatment.”].
Dependent claims:
Regarding claim 9: see Fig. 9 which discloses end of treatment occurring when the first and second regions have the same fluorescence intensity.
Regarding claim 16, see Fig. 9 (see “end of treatment” treatment occurring based on when the first and second regions have the same fluorescence intensity) and Fig. 2 element 23 and para 56 [see “The control unit 23 includes a CPU (Central Processing Unit), a ROM (Read Only Memory), a RAM (Random Access Memory), and the like. The control unit 23 is configured to control the entire treatment support device 100.”] which discloses a determination portion as claimed.
Regarding claim 17:
A phototherapy system that performs a phototherapy of an affected portion by means of a fluorescent agent by radiating therapeutic light beam onto the affected portion [see Fig. 2 and para 61… “as shown in FIG. 2, the treatment support device 100 is provided with an operation unit 60. The operation unit 60 is a user interface for operating the treatment support device 100.”], the system comprising:
a therapeutic light source that outputs the therapeutic light beam [see Fig. 2 element 51 and para 62… “treatment light source 51”];
a probe that radiates the therapeutic light beam onto the affected portion [see Fig. 2 element 52 and para 64… “the treatment probe 52 is inserted and the treatment light transmitted through the body of the cancer patient 200.”]; and
the processor according to Claim 16 [see rejection to claim 16 above], wherein the processor outputs determination results [see rejection to claim 16 above].
Regarding claim 19:
an image acquisition portion that comprises an imaging element and that acquires an image of the affected portion [see Fig. 2 element 13 and para 87… “the fluorescence imaging unit 13 initiates the image capturing of the fluorescent image 41 based on the fluorescence emitted by the fluorescent material of the medical agent 300 excited by the treatment light under the control of the control unit 23.”]; and
a display [see Fig. 1 element 40 and para 30… “The display unit 40 is configured by, for example, a liquid crystal display or an organic EL display.”] that displays the image acquired by the image acquisition portion, wherein the display displays the progress information [see Figs. 8-9 element 40 and para 80-82… “Further, the display unit 40 is configured to display the fluorescence intensity acquired in the first region of interest 42c and the fluorescence intensity acquired in the second region of interest 42d as shown in FIG. 9.”]
Regarding claim 20, see Fig. 7 and para 79 [see “in the display unit 40, as shown in FIG. 7, a synthetic image 43 in which the fluorescent image 41 collected by the image collection unit 21 and the treatment light image 42 are superimposed may be displayed together with the first region of interest 42c.”] which shows displaying as claimed.
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.
Claim(s) 8, 15, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa.
Regarding claims 8 and 15:
Ishikawa discloses the invention substantially as claimed including all the limitations of claims 1 and 10. Also, Ishikawa discloses calculating / the computation portion calculating the change in fluorescence intensity as the treatment progresses which is understood to include (determining / determines whether a change amount of the first fluorescence intensity per unit time is negative as) [see Fig. 9 and paras 81-83… “The fluorescence intensity displayed in the display unit 40 may not be a graph showing the change in the relative value of the fluorescence intensity during the treatment (see FIG. 9), and only the numerical value thereof may be displayed. Alternatively, the graph and the numerical value may be displayed simultaneously.”
However, as Ishikawa merely discloses the treatment ending when first fluorescence intensity is equal to the reference [see Fig. 9 point on graph labelled “end of treatment”], Ishikawa fails to explicitly disclose “wherein the progress information is calculated after it is determined that the change amount is not negative” as recited by claim 8 or the computation portion “calculates the progress information after it is determined that the change amount is not negative” as recited by claim 15.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Ishikawa to calculate the progress information after it is determined that the change amount is not negative similarity to that recited by claims 8 and 15 because the treatment progress is determined through comparison of fluorescence intensity per unit time between the first fluorescence and the second fluorescence (i.e. reference fluorescence); therefore, absent unpredictable results one of ordinary skill would expect to achieve the result through routine experimentation through the application of known factors (i.e. comparison of fluorescence intensity per unit time) to achieve a known result (i.e. progress in process) when optimizing phototherapy.
Regarding claim 18:
Ishikawa discloses the invention substantially as claimed including all the limitations of claims 10 and 16-17 as outlined above. Also, Ishikawa discloses the processor determines that the phototherapy of the affected portion has been completed [see Fig. 9 see “end of treatment”] and the processor is configured to turn on/turn off the therapeutic light beam [see para 57… “The control unit 23 is configured to control turning on and off the irradiation unit 50 (treatment light source 51). That is, the control unit 23 is configured to control the irradiation and the irradiation stop of the treatment light.”]
However, Ishikawa is silent as to what happens to the therapeutic light beam after it has been determined the phototherapy has been completed. Thus, Ishikawa fails to fully disclose “wherein in a case in which the processor determines that the phototherapy of the affected portion has been completed, the processor decreases the intensity of the therapeutic light beam”.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Ishikawa to configure the processor to turn off the therapeutic light beam (i.e. the processor decreases the intensity of the therapeutic light beam) because there are a limited number of ways the processor can control the light beam after completion (i.e. keep the light on or turn the light off) and turn the light off is one of those limited possible ways.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792