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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-17 in the reply filed on 06/16/2025 is acknowledged. Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/16/2025.
Specification
The abstract of the disclosure is objected to because it includes a second paragraph with “(FIG. 2)” listed as the only text. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 8 is objected to because of the following informalities: the current claim reads “The apparatus of claim 1, wherein the target comprises an in-vitro or an in-vivo sample”. However, Applicant elected an “in-vivo sample” in the Response to Election/ Restriction filed on 06/16/2025. The claim should be amended to remove the “in-vitro” portion of the claim, and Examiner has interpreted the claim to solely refer to an in-vivo use. Appropriate correction is required.
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.
Claims 1-6, 8, 11-12, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nilsen et al. (hereinafter “Nilsen”) (WO 2012/076631 A1).
Regarding claim 1, Nilsen teaches an apparatus for adaptive light fractionation in phototherapy (Page 15, lines 1-2 and 4-6, where “apparatus 100 allows for therapeutic light delivery and treatment monitoring via optical fibers 105 ... While in treatment mode, light from the therapeutic light unit 102 is guided into the distribution module 104 and directed into the patient fibers. Intermittently, the therapeutic irradiation is interrupted.” Examiner takes the position that since the light is interrupted, this is equivalent to light fractionation which involves delivering the light in pulses or fractions with dark intervals in between.), the apparatus comprising: at least one processor (Page 44, lines 25-27, where “the present invention may take the form of a computer program product on a computer-usable storage medium having computer-usable program code embodied in the medium,” Page 44, line 32 – Page 45, lines 1-5, where “computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.”); and at least one memory; the at least one memory comprising instructions (Page 45, lines 6-8, where “These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner”) which, when executed by the at least one processor, cause the apparatus at least to: obtain measurements of one or more physical parameters associated with a target while an illumination program is performed on the target (Page 12, lines 2-4, where “Some examples are given below, describing measurement methods which may be used for direct or indirect measurement of PDT parameters. The measured parameters provide for determination of a target tissue status during PDT treatment.” Examiner takes the position that the PDT treatment is equivalent to an illumination program.); determine, based on the measurements, that a predefined limit for at least one of the physical parameters is met (Page 15, lines 26-31, where “A PDT session may be interrupted and resumed, restricted, or aborted in dependence of certain attributes such as thresholds of photodynamic treatment parameters. For instance, when tissue oxygenation falls below a level where activation of a photosensitizing agent is ineffective, PDT treatment is interrupted and resumed when a sufficient level of oxygen is again present in the tissue to be treated.” Examiner takes the position that the treatment parameters are inherently measured in order to determine a threshold and that a threshold is equivalent to a predefined limit.); determine a change in at least one light fractionation setting of the illumination program based on the at least one predefined limit that was met (Page 15, lines 26-31, where “A PDT session may be interrupted and resumed, restricted, or aborted in dependence of certain attributes such as thresholds of photodynamic treatment parameters. For instance, when tissue oxygenation falls below a level where activation of a photosensitizing agent is ineffective, PDT treatment is interrupted and resumed when a sufficient level of oxygen is again present in the tissue to be treated.” Examiner takes the position that by adjusting the treatment based on a treatment parameter such as an oxygen level that a change to the settings is inherently determined.); and initiate at least one action to change the at least one light fractionation setting (Page 16, lines 9-12, where “A control device may be arranged as a regulator or a thresholding device in the PDT system to stop, or reduce or otherwise restrict the delivery of therapeutic light treatment at least temporary upon passing of at least one threshold value of the photodynamic treatment parameter.”).
Regarding claim 2, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the illumination program is performed on the target during photodynamic therapy (Page 12, lines 3-5, where “measured parameters provide for determination of a target tissue status during PDT treatment, and may be useful as input data in a calculation method for monitoring and adjusting treatment parameters during PDT”), direct laser therapy or laser thermotherapy.
Regarding claim 3, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the at least one change comprises initiation of a dark interval (Page 15, lines 26-28, where “A PDT session may be interrupted and resumed, restricted, or aborted in dependence of certain attributes such as thresholds of photodynamic treatment parameters.” Examiner takes the position that an interruption in the application of light during a PDT session is equivalent to a dark interval since a dark interval is when the illumination is turned off.).
Regarding claim 4, Nilsen teaches all limitations of claim 3 as described in the rejection above.
Furthermore, Nilsen teaches that the at least one change further comprises a duration for the dark interval (Page 15, lines 4-6, 11-12, 28-31, where “While in treatment mode, light from the therapeutic light unit 102 is guided into the distribution module 104 and directed into the patient fibers. Intermittently, the therapeutic irradiation is interrupted in order to perform measurement sequences … measurements related to PDT parameters, such as fluence rate distribution, photosensitizer concentration and distribution, and tissue blood content and oxygenation are monitored ... when tissue oxygenation falls below a level where activation of a photosensitizing agent is ineffective, PDT treatment is interrupted and resumed when a sufficient level of oxygen is again present in the tissue to be treated.” Examiner takes the position that a duration of the interval is inherent during interruption for a measurement sequence as a specific amount of time will need to be utilized to take measurements and that the duration of the interval adjusts since it is dependent on measured parameters.).
Regarding claim 5, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the at least one change comprises an adjustment of an irradiation level of the illumination (Page 26, line 29, where “P” is the current value of the photodynamic treatment parameter, Page 17, lines 28-32, where “in addition to the thresholding device, a derivative determining device may be provided, taking into consideration the gradient and direction of a curve of P. for instance, when in range A and the curve has a negative gradient, i.e. declines towards range B, this might be an indication to maintain illumination at a high level or even increase light intensity to compensate for this effect.” Examiner takes the position that light intensity is equivalent to irradiation level.).
Regarding claim 6, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the at least one action comprises sending a command to a medical device performing the illumination to change the at least one light fractionation setting (Page 16, lines 9-12, where “A control device may be arranged as a regulator or a thresholding device in the PDT system to stop, or reduce or otherwise restrict the delivery of therapeutic light treatment at least temporary upon passing of at least one threshold value of the photodynamic treatment parameter.”).
Regarding claim 8, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the target comprises an in-vivo sample (Page 1, lines 14-15, where “the invention refers to a system and method for controlling light in an interstitial tumor PDT system in combination with photosensitizers”).
Regarding claim 9, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the target comprises a tumor cell or tumor tissue with or without healthy cells or healthy tissue (Page 1, lines 14-15, where “the invention refers to a system and method for controlling light in an interstitial tumor PDT system in combination with photosensitizers”).
Regarding claim 10, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the measurements are obtained from measurement equipment (Page 15, lines 3-4, where “The apparatus 100 additionally comprises … diagnostic light source 103”) configured to measure at least one of temperature, oxygen level (Page 15, lines 10-12, where “Utilizing the diagnostic light source, measurements related to PDT parameters, such as … tissue blood content and oxygenation are monitored.”), target fluorescence, drug or photosensitizer fluorescence, drug absorption, target transparency, or blood flow.
Regarding claim 11, Nilsen teaches all limitations of claim 10 as described in the rejection above.
Furthermore, Nilsen teaches that the apparatus further comprises the measurement equipment (Page 15, lines 3-4, where “The apparatus 100 additionally comprises … diagnostic light source 103”).
Regarding claim 15, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the measurements are repeated sequentially (“While in treatment mode, light from the therapeutic light unit 102 is guided into the distribution module 104 and directed into the patient fibers. Intermittently, the therapeutic irradiation is interrupted in order to perform measurement sequences, during which light from each of the diagnostic light sources is successively coupled into each of the optical fibers”).
Regarding claim 16, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the apparatus comprises a biomedical illumination device (Page 15, lines 1-2, where “apparatus 100 allows for therapeutic light delivery and treatment monitoring via optical fibers 105.”).
Regarding claim 17, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the apparatus comprises a phototherapeutic laser device (Page 15, lines 2-3 and 5-7, where “apparatus 100 additionally comprises a … diagnostic light source 103 … the therapeutic irradiation is interrupted in order to perform measurement sequences, during which light from each of the diagnostic light sources is successively coupled into each of the optical fibers,” Page 18, lines 28-29, where “An example of a typical spectrum recorded when a diode laser emitting at 635 nm was used as the diagnostic light source”).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsen as applied to the rejection of claim 1 above, and further in view of Morita et al. (hereinafter “Morita”) (U.S. Pub. No. 2019/0321654 A1).
Regarding claim 7, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Although Nilsen teaches instructions that are implemented by a computer, Nilsen does not teach providing instructions to a user to change the setting.
Morita teaches a phototherapeutic apparatus (Abstract) where the at least one action comprises providing instructions to a user to change the setting (¶[0010], where “a protocol setting method for a phototherapeutic apparatus according to claim 6 of the invention is a protocol setting method for a phototherapeutic apparatus that reads a treatment protocol, in which a set value of light is set, and performs irradiation with the light in accordance with the treatment protocol, the method including: … transmitting protocol change information from the medical institution to the user; receiving the protocol change information by the user; and changing the set value of the read treatment protocol based on the protocol change information,” Claim 8, where “the user changes the set value of the read treatment protocol based on the protocol change information”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Morita, which teaches that the at least one action comprises providing instructions to a user to change the setting, with the invention of Nilsen in order to ensure the affected part is appropriately irradiated with the light, to perform the accurate treatment, and to enable irradiation with light beams at an appropriate set value (Morita ¶[0012] and ¶[0014]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Nilsen as applied to the rejection of claim 1 above, and further in view of Fournier et al. (hereinafter “Fournier”) (U.S. Pat. No. 6,011,563 A).
Regarding claim 12, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the at least one memory comprises instructions (Page 45, lines 6-8, where “These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner”), executed by the at least one processor (Page 44, line 32 – Page 45, lines 1-5, where “computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks”).
Although Nilsen teaches a photodynamic light therapy device that provides real-time delivery of a therapeutic light treatment depending on at least one attribute of a photodynamic treatment parameter, Nilsen does not teach that the apparatus stores data comprising the determined changes of the light fractionation settings and corresponding measurements to the memory with information about the target; determines, based on the data, light fractionation settings for an illumination program to be performed on a similar target, the settings comprising a sequence and durations for illumination and dark intervals; and provides the light fractionation settings to at least one of a medical device or a user.
Fournier teaches a system and method for optimizing a laser light fractionation during photodynamic therapy of a tumor (Abstract) where the apparatus stores data (Col. 4, lines 6-8, where “simulation data and results are stored in the control system for controlling the actual PDT treatment cycle”) comprising the determined changes of the light fractionation settings and corresponding measurements to the memory with information about the target (Col. 5, lines 50-55, where “computer 30 is used to conduct one or more simulations of a PDT treatment process based on the data inputted into the computer 30. The optimum fractionation cycle is determined as part of the simulation process. The data and results of the simulations are stored in the computer 30 for use during the actual PDT treatment process,” Col. 10, lines 33-35, where “parameters can be varied to test a number of different options for treatment of a tumor.” Examiner takes the position that changes of the light fractionation settings are determined through the fractionation cycle, with corresponding measurements and information about the target being inherently found since the results are stored based on inputted parameters about the target tumor.); determines, based on the data, light fractionation settings for an illumination program to be performed on a similar target (Col. 10, lines 32-43, where “The results of the simulation may be stored in the computer 30 or a disc for future use and reference. The parameters can be varied to test a number of different options for treatment of a tumor. Different sensitizers can be tested without having to perform actual treatments. Different laser settings may be considered to determine the necessary treatment time and on-off cycles for fractionating the laser output. Once an appropriate treatment for the photodynamic therapy is selected, the medical staff selects the data which has been stored during the simulation for actual operation of the PDT treatment”), the settings comprising a sequence and durations for illumination and dark intervals (Col. 14, lines 44-49, where “The starting oxygen profile 54 and select output data 56 are used in the system 10 to optimize the fractionation cycle. The output data specifies oxygen as the control variable and allows for data input of the triplet oxygen lower limit and the triplet oxygen upper limit. The computer 30 is programmed to calculate the optimum light and dark intervals,” Col. 15, liens 39-41, where “The computer 30 stores in memory the light and dark cycles for the desired time of the fractionation cycle.” Examiner takes the position that by finding the optimal light and dark intervals for treatment with desired cycle times, that the sequences and durations of the illumination and dark intervals are inherently found.); and provides the light fractionation settings to at least one of a medical device (Col. 4, lines 6-11, where “simulation data and results are stored in the control system for controlling the actual PDT treatment cycle. A computer is linked to the laser and a beam splitter or other cycling device to control the fractionated photodynamic therapy irradiation process for optimal treatment of a specific tumor”) or a user.
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Fournier, which teaches instructions executed by the at least one processor to cause the apparatus to: store data comprising the determined changes of the light fractionation settings and corresponding measurements to the memory with information about the target; determine, based on the data, light fractionation settings for an illumination program to be performed on a similar target, the settings comprising a sequence and durations for illumination and dark intervals; and provide the light fractionation settings to at least one of a medical device or a user, with the invention of Nilsen since a number of options can be tested for a tumor and since the photodynamic therapy process can be administered with a high degree of accuracy (Fournier Col. 10, lines 52-53 and 55-56).
Regarding claim 13, Nilsen in combination with Fournier teaches all limitations of claim 12 as described in the rejection above.
Furthermore, Nilsen teaches that the measurements are obtained from a plurality of medical devices (Page 15, lines 5-7, where “the therapeutic irradiation is interrupted in order to perform measurement sequences, during which light from each of the diagnostic light sources is successively coupled into each of the optical fibers”).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsen as applied to the rejection of claim 1 above.
Regarding claim 14, Nilsen teaches all limitations of claim 1 as described in the rejection above.
Furthermore, Nilsen teaches that the measurements are repeated continuously (Page 15, lines 17-21, where “In some embodiments of the apparatus these measurements of PDT parameters may be performed in real time, simultaneously with the therapeutic light delivery to the extent that such PDT parameter measurements are feasible without the therapeutic light interfering with the diagnostic measurements of the PDT parameters”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of an embodiment of Nilsen, which teaches that the measurements are repeated continuously, with the invention of Nilsen so that PDT parameter measurements are feasible without the therapeutic light interfering with the diagnostic measurements of the PDT parameters (Nilsen Page 15, lines 19-21).
Conclusion
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/SEFRA D. MANOS/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792