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 Arguments
Regarding the 112f claim interpretation, while applicant has amended some of the limitations so that they no longer recite a nonce term and therefore do not meet the requirements of 112f, it is emphasized that not all of the 112f limitations have been amended. Therefore, some of the claim limitations continue to be interpreted under 112f; see below.
Regarding the claim objections, applicant’s amendments to change “necroses” to “necrosis” has overcome these objections and they are hereby withdrawn.
Regarding the 112b rejections, applicant’s amendments have overcome some, but not all of the previous rejections. Regarding claim 8, the examiner disagrees that the claim language serves to further limit the first integrated energy amount, as it actually defines it as something different than how it was defined in claim 5. Additionally, applicant’s amendments have created new 112b rejections; see below.
Regarding the 102 rejection to Zeng, applicant’s amendments and related arguments have been fully considered but are not persuasive. While the examiner understands applicant’s position, it is emphasized that the effect the light has on an unclaimed/hypothetical/imaginary photosensitive substance is a functional limitation, i.e. intended use; See MPEP 2112, 2114 and 2115. Applicant themselves admit that “these recitations reflect utilization of a shared specific wavelength bandwidth for two distinct purposes: (1) therapeutic treatment and (2) distribution monitoring” and “the present disclosure configures the light source to use the same specific wavelength bandwidth for both functions. For example, when using talaporfin sodium, both the therapeutic and the excitation light can reside in a bandwidth including 664 nm.”. Therefore, it’s abundantly clear that this is an intended effect based on a hypothetical and unclaimed photosensitive substance. There is nothing in applicant’s remarks to indicate or show that Zeng is incapable of such an intended effect, e.g. depending on the chosen photosensitive substance. MPEP 2114 states… "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. The examiner maintains that Zeng’s light source is capable of such an intended effect depending on the chosen/desired photosensitive substance, which is currently not required by applicant’s claims.
Additionally or alternatively, in an attempt to provide compact prosecution, the examiner has found new prior art references that teach the claimed concept of using a single light source for both therapy, i.e. killing cells, and excitation, i.e. generating fluorescence for monitoring purposes. See alternative 103 rejections below, as well as references cited in the conclusion section as pertinent prior art.
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:
Distribution information output unit in claims 1, 5-12. From Par 0032 of the specification… the image collection unit 4 is one example of the "distribution information output unit" as recited in claims. From Par 0043-45, it’s clear that the image collection unit is a processor configured for image processing.
Image composition unit in claim 12. From Par 0032 of the specification… The PC 5 is one example of the "image composition unit" as recited in claims.
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 1-12 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.
[Claim 1] The preamble of a “photodynamic therapy treatment support device” is indefinite, based on the amendments. Previously, the claimed light source provided monitoring for PDT, but didn’t require therapy/treatment, and therefore could be considered a support device for therapy. However, applicant has amended the claims to make it clear that the light source also provides therapy/treatment, i.e. causing necrosis of the tumor cells. It’s unclear how such a light source, specifically one that provides treatment/therapy, can be considered a therapy treatment support device, as it’s actually a photodynamic therapy treatment device. For examination purposes, the preamble will be interpreted as a photodynamic therapy treatment device.
Additionally, the preamble recites “causing necrosis of tumor cells by active oxygen generated based on a photochemical reaction caused by irradiating a photosensitive substance with an excitation light of a specific wavelength bandwidth” while the body of the claim recites “the excitation light having energy capable of generating fluorescence from the photosensitive substance without causing necrosis of the tumor cells”. These are seemingly contradictory statements. In the preamble, the excitation light causes necrosis, but in the body of the claims the excitation light does not cause necrosis. This creates confusion and is therefore indefinite.
[Claim 8] The limitations defining the first integrated energy amount and the second energy amount are indefinite, as it seemingly tries to redefine these amounts which have already been defined in claim 5. These limitations do not serve to further limit the previous definition of claim 5, but instead completely redefine what these terms mean, which is improper, in terms of a dependent claim. For example, claim 5 defines the first integrated amount as “an integrated amount of energy given by the excitation light”, while claim 8 defines the first integrated amount as “an integrated value of irradiation intensity of the excitation light of the specific wavelength bandwidth and an irradiation time of the excitation light of the specific wavelength bandwidth”. These are very different definitions of what the first integrated amount is. Nothing in the claim language serves to further limit this limitation, but instead serves to redefine it as something else.
Claim Rejections - 35 USC § 102 and/or 35 USC § 103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6,128,525 to Zeng et al. or, in the alternative, under 35 U.S.C. 103 as obvious over Zeng in view of US 2014/0378831 to Park or US 2023/0041277 to Uusimaa et al.
[Claim 1] Zeng discloses a photodynamic therapy treatment support device (Figs. 1 and 4) for use in photodynamic therapy (PDT) for causing necroses of tumor cells by active oxygen generated based on a photochemical reaction caused by irradiating a photosensitive substance with an excitation light of a specific wavelength bandwidth (Abstract/Background sections detail the inherent properties/characteristics/processes of PDT), the photodynamic therapy treatment support device comprising:
a light source (fluorescence excitation laser 8; “Means for monitoring the spectrum peak are provided comprising a light source 8 for generating excitation light”; Col 3, lines 9-16) configured to irradiate the photosensitive substance administered to a body of a subject with a therapeutic light of the specific wavelength bandwidth causing necrosis of the tumor cells and the excitation light of the specific wavelength bandwidth, the excitation light having energy capable of generating fluorescence from the photosensitive substance without causing necroses of the tumor cells (Abstract; “the method of the present invention uses fluorescence imaging to monitor treatment by taking into account the distribution of the photoproducts over the treatment site” Col 2, lines 12-18. The reference, as a whole, makes it clear the excitation/monitoring light does not provide necrosis. Therefore, excitation laser 8 explicitly teaches the claimed excitation light that does not cause necrosis, but fails to explicitly teach the claimed therapeutic light. See below for detailed discussion of the examiner’s interpretation regarding the therapeutic light.); and
a distribution information output unit (computer 14) configured to output information on a distribution state of the fluorescence generated from the photosensitive substance, based on the fluorescence generated from the photosensitive substance (“Computer 14 runs a computer program that analyses the fluorescence spectrum in real time in order to isolate the spectral peak of the photoproducts and determine the level of the photoproduct”. See also Col 3, line 64 to Col 5, line 65 which details the process of how the fluorescence image is processed to determine a “spatial distribution of the photoproducts over the lesion being treated”. It is noted that the reference also refers to the claimed “distribution state” as “the level of photoproduct”).
Regarding a light source that emits both therapeutic light (that causes necrosis) and excitation light (that is for monitoring purposes and does not cause necrosis), it’s clear that Zeng discloses two separate lasers for each of these purposes, however that does not mean that either light source is not capable of such an intended effect/function. The effect that the light has on the tissue, i.e. necrosis or fluorescence without necrosis, is a result of the chosen/desired photosensitive substance and the energy/fluence applied to this photosensitive substance. MPEP 2114 states… "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Additionally, MPEP 2115 states… A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935). Therefore, since no photosensitive substance, let alone a specific photosensitive substance, is required/positively recited, the examiner takes the position that the either laser/light source of Zeng is structurally capable of providing either/both of the claimed effects. If applicant disagrees, see alternative 103 below.
As discussed above, Zeng discloses two different lasers, one for therapy/killing cells and one for fluorescence monitoring. While seemingly either light source is structurally capable of either/both functions/effects, i.e. depending on the chosen photosensitive substance, the reference is technically silent to a single light source that provides both functions. However, this concept of a single laser that provides both therapeutic light and excitation light, specifically by adjusting the energy level of the laser, is well-known in the art. Specifically, in the same field of endeavor, Park discloses that the same light source can be used for excitation light and therapeutic light by adjusting the intensity of the light (Par 0095). Similarly, in the same field of endeavor, Uusimaa discloses “a single laser source can also be used both as a treatment beam and for monitoring, for example for detection and/or activation monitoring excitation light such as fluorescence light” (Par 0031). In particular, Uusimaa discloses that the same wavelength can be used to provide excitation light for fluorescence monitoring, i.e. “using low-energy excitation wavelength(s)”, and therapy/treatment for killing of cells, i.e. using a “high-power laser” (Par 0068). Therefore, it would have been obvious to one of ordinary skill in the art to substitute the two separate light sources taught by Zeng for a single light source, as taught by Park or Uusimaa, as this is a simple substitution of one known element (two separate light sources that separately provide excitation and therapeutic light) for another (a single light source that provides both excitation and therapeutic light) to provide predictable results. It’s clear that the same result is achieved by either two separate light sources or a single light source, and it would be obvious to choose/try either option.
[Claims 2-3] Zeng discloses a fluorescence detection unit (spectrometer 12, Fig. 1 or CCD camera 30, Fig. 4). These are imaging sensors, which are the same fluorescence detection units disclosed by applicant, and are therefore at least capable of providing the claimed function; see MPEP 2114. Furthermore, Zeng explicitly discloses a filter (13) so that only the desired fluorescent wavelength is detected (Col 3, lines 17-26). Additionally, the examiner takes the position that fluorescence, by definition/inherently, results in a longer wavelength being emitted, as compared to the excitation wavelength. This is supported by Zeng in Col 4, lines 18-42, which discloses excitation at 442 nm and a resulting peak fluorescence peak at 650 nm, which is detected by the fluorescence detection unit.
[Claims 5-6] Zeng discloses that the distribution information output unit (computer 14) is configured to output a fluorescence distribution image (see image shown on display 15 in Figs. 1 and 4; Col 3, lines 34-39. The “spectral graphs” are interpreted as a fluorescence distribution image, as they “represent” the distribution.)
As discussed above, both Park and Uusimaa make it clear that the energy level or intensity of the single laser is adjusted/controlled based on the desired effect on the photosensitive substance. Specifically, both references disclose that a lower energy/intensity is used for excitation (that does not cause necrosis) while a higher, i.e. more powerful, energy/intensity is used for therapy/treatment (that causes necrosis). While neither reference explicitly ties this particular adjustment in energy/intensity to a controller, the examiner takes the position that such a controller is inherent/implicit, as seemingly some sort of controller must be involved to make the disclosed adjustment. See Par 0051 of Park. Furthermore, if applicant disagrees that such a controller configured in the claimed manner is inherent/implicit to the disclosure of either Park or Uusimaa, then the examiner takes official notice that a controller configured to adjust the energy level/intensity of a light source within the field of laser medical treatments is common, well-known and conventional, and including such a controller in either/both Park or Uusimaa would have been obvious to a POSITA.
[Claim 7] Zeng discloses that fluorescence emissions from the photosensitizer drug decrease as treatment progresses (Col 4, 8-17), which appears to be what is being claimed; This is a natural/inherent response of the photosensitizer to the treatment light, as the treatment progresses. Specifically, as the energy level/intensity/amount of therapeutic light increases, the intensity of the monitored fluorescence emissions decreases because the photosensitive substance is being depleted. Therefore, this is inherently/implicitly taught by Zeng or the combination of Zeng and Park/Uusimaa. Alternatively, at the very least this concept is obvious in order to provide an effective and efficient treatment.
[Claim 8] See explanation of claims 5-7, above. The examiner takes the position that combination of Zeng and Park/Uusimaa inherently/implicitly operate in the claimed manner. If applicant disagrees, the examiner contends that this is merely routine optimization of a result effective variable, and based on the explicit teachings of Park and Uusimaa that a lower energy/intensity is used for excitation as compared to a higher energy/intensity for therapy, it would be obvious to try/choose different parameters to achieve the desired effect and provide effective/efficient treatment.
[Claims 9-10] As seen in Fig. 2, the control unit controls the irradiation intensity (on/off), the irradiation time (duration of each pulse) and the number of irradiations (number of pulses) based on the “integrated spectral intensity” of the fluorescence from the photosensitizer; see Col 3, line 40 to Col 4, line 56.
[Claim 11] As discussed above, either/both Park or Uusimaa explicitly disclose adjusting the intensity of the light depending on the desired purposes, specifically when the light is used for excitation the intensity is lower than when the light is used for treatment. It is noted that excitation light becomes the treatment light when the intensity of this light is increased, as the light is the exact same the only difference is its intensity and the desired result/effect the light has on the tissue. Therefore, it stands to reason that implicitly/inherently there exists a controller that adjusts the intensity in the claimed manner, i.e. when treatment is occurring the intensity is higher than when fluorescence/monitoring is occurring. See also Par 0051 of Park which discloses a controller that controls the light parameters.
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Zeng or Park/Uusimaa as applied to claim 3 above, and further in view of US 2018/0093104 to Ikeshita et al.
[Claim 4] Zeng and Park/Uusimaa are discussed above including explicitly teaching “selecting a photoproduct having an identifying characteristic, which can be a fluorescence peak, and monitoring the photoproduct using the identifying characteristic (e.g. fluorescence) to determine the level of the photoproduct being generated”, but is silent regarding the specific photosensitizer of talaporfin sodium and therefore fails to necessarily teach a light source that is configured to generate fluorescence from such a photosensitizer. However, in the same field of endeavor, Ikeshita discloses that a known/common type of photosensitizer/photoproduct used for similar PDT treatments of cancer is talaporfin sodium (Pars 0074-76 and 0098). Therefore, it would have been obvious to substitute the photosensitizer taught by Zeng, or the combination of Zeng and Park/Uusimaa, for talaporfin sodium, as taught by Ikeshita, as a simple substitution of one known photosensitizer for another to effectively provide PDT treatment of cancer. It is noted that when using a different photosensitizer, it’s clear from both Zeng and Ikeshita, that the necessary wavelength emitted from the light source to excite fluorescence from the photosensitizer would also be modified; see e.g. Par 0076 of Ikeshita
[Claim 12] Zeng and Park/Uusimaa are discussed above, but fails to teach the features of claim 12. However, in the same field of endeavor, Ikeshita discloses a similar photodynamic therapy treatment support device (Figs. 2-4) including a visible light detection unit (second imaging unit 31, specifically a “natural light observation camera”; Pars 0106 and 0112-115); an image composition unit (camera controller/image processing device; Fig. 4) configured to generate a composite image in which a plurality of images generated by the distribution information output unit is superimposed (Pars 0117-123 and 0127); and a display unit (monitor 1 and/or monitor 2) configured to display the composite image (Pars 0122-123 and 0127; Fig. 6), wherein the distribution information output unit is configured to generate a visible image based on the visible light detected by the visible image detection unit (Pars 0116-119), wherein the image composite unit is configured to generate the composite image in which the fluorescence distribution image and the visible light image are superimposed (“fusion image”; Fig. 6; Pars 0122-123), and wherein the control unit is configured to perform control to display at least the composite image on the display unit (Pars 0116-130, particularly Par 0127). Therefore, it would have been obvious to one of ordinary skill in the art to modify the device of Zeng, or the combination of Zeng and Park/Uusimaa, to include these features (discussed above) of Ikeshita, as this is combining prior art elements according to known methods to yield predictable results. Specifically, Ikeshita discloses that these structural elements/arrangement allows the surgeon to compare the diagnostic images with the observation image at the surgery with high accuracy (Par 0127 of Ikeshita), and such a modification would be obvious in Zeng or the combination of Zeng and Park/Uusimaa for the same reasons/motivation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The concept of using a single light source for both photodynamic therapy and diagnostic/monitoring/fluorescence is well known in the art:
US 4,336,809 to Clark
US 5,111,821 to Potter
US 2010/0145416 to Kang et al.
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 Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
Prosecution Insights