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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/29/2025 has been entered.
Status of Claims
Claims 1-2, 4-6, 8-12, 14-16, and 18-24 are currently pending. Claims 3, 7, 13, and 17 are canceled. Claims 23-24 are newly added. As per the amendments filed on 10/29/2025, claims 1-2, 4, 6, 8, 10-12, 14, 16, 18, 20, and 22 are amended. Note amended claims 11 and 18 are labeled previously presented in the 10/29/2025 claims.
Priority
The following is the Examiner’s current view on priority:
Acknowledgment is made of applicant's claim for domestic priority based on provisional application 63/275,304 filed on 11/03/2021. The 63/275,304 disclosure is a nine-page document which includes images. The specification describes an embedded controller (Pages 1-3), an ultraviolet photobiomodulation system (Pages 4-5), a “VESA standard mounting interface to photobiomodulation devices,” and “Human-Machine Integration software framework.” Note: It is difficult to discern details in the figures provided in the provisional application due to image quality.
Claims 1 and 11: 63/275,304 does disclose a controller which controls a plurality of light sources (Page 1 – “It can control a light-source of any wavelength. It can control simply powered sources that turn On & Off. It can also control power sources that allow variable intensity of the applied light. The remote controlling software can switch and vary the intensity of any connected light sources. The PBM Controller can also accept a series of commands to vary the intensity and wavelength of the applied light. This is deemed a "Recipe" to the user. These programmed recipes can be prescribed to specific user needs according to the constraints of the attached light-source). While 63/275304 does not use the terms “memory” and “light-emitting array,” the recipes are accessible or stored within the system for use (akin to the use of memory) and the multiple light sources could be considered an array of lights. While the controller is configured to accept operating instructions from a user (page 8 - “the Recipe system allows owners to create and prescribe particular programs of operations "recipes" for particular devices), the data is not specified as a user assessment of effectiveness in 63/275,304.
Claims 2 and 12: 63/275,304 does disclose the use of the programed instructions for a therapeutic use (Page 2 – “The PBM Controller of the present disclosure can interface using standard protocols. It also allows for remote control of these PBM light-sources. Via the "recipe" system it also allows for prescription of a light program for personal, commercial, and therapeutic use”).
Claims 4 and 14: 63/275,304 fails to disclose a plurality of driving circuits distinct from the general controller or organization of the light sources into sub-groups.
Claims 5 and 15: 63/275,304 fails to disclose either light emitting diodes or low-level laser emitters when describing the light sources.
Claims 6 and 16: 63/275,304 discloses the control of wavelength and intensity (Page 1 – “The PBM Embedded Controller allows a remote, or connected, computing device to control one or more light-source's wavelength and intensity”) and duration, pattern, and pattern cycles (Page 4 – “In conjunction with a controlling device this can automatically disseminate a "dosage" of UV in accordance with a prescribed protocol designed to generate a specific health outcome. This dosage is, essentially, the exposure time, exposure intensity, and any pattern or cycle of application”), which form the parameters in instant Claims 6 and 16.
Claims 8-10 and 18-20: 63/275,304 fails to disclose an assessment of effectiveness as a feedback mechanism for altering devices settings. The only mention of feedback explicitly is “the PBM Controller can also feedback applicable signals from the light-sources, if they are available, such as temperature and battery strength” (Page 1), which does not specify that this is based on light treatment effectiveness or that settings are altered based on this metric. There is no mention of changing parameters based on effectiveness in the rest of the disclosure.
Claim 21: 63/275,304 fails to disclose distance sensors or adjustments based on distance sensor readings.
Claim 22: 63/275,304 discloses the VESA mounting feature but fails to disclose the specific features of the wireless interface or that the light emitting elements are placed on the front surface.
Claims 23-24: 63/275,304 does not disclose other user data included in the aggregate.
Claims 1-2, 4-6, 8-12, 14-16, and 18-24 are not sufficiently described in the provisional application and will receive an effective filing date matching the filing date of the instant application (11/03/2022) and all prior art will be evaluated with respect to this date.
Response to Arguments
Applicant’s arguments, see Remarks pages 9-10 (Independent Claims 1 and 11 are Patentable Under 35 USC 102(a)(l) and 102(a)(2)), filed 10/29/2025, with respect to the 35 U.S.C. § 102 rejections of independent claims 1 and 11 over Cooper (US PG Pub 2013/0304019 A1) have been fully considered but they are not persuasive. Specifically, Applicant argues:
Applicant respectfully submits that Cooper's feedback relates to sensations perceived during Cooper's treatment (see, e.g., Cooper at [0049] ("in the event in response to experiencing a tingling sensation or discomfort or the absence of any physical sensation") without regard to when Cooper's user enters the data (i.e., Cooper's feedback could be entered during or after treatment). Cooper therefore fails to describe, either expressly or inherently, "data input by a user that is representative of the user's assessment of an effectiveness of the first changing spectrum of light as a photobiomodulation therapy designed for the user to obtain a specific medical health outcome as a result of the photobiomodulation therapy," where "the data representative of the user's assessment of the effectiveness of the photobiomodulation therapy to obtain the specific medical health outcome as a result of the photobiomodulation therapy is different from data representative of sensations perceived during the photobiomodulation therapy, as recited in independent claims 1 and 11. For at least these reasons, Cooper fails to anticipate independent claims 1 and 11. Accordingly, Applicant respectfully requests withdrawal of the 35 USC 102(a)(l) and (a)(2) rejections of independent claims 1 and 11. (pages 9-10, 10/29/2025 Remarks)
The Examiner does not find this argument persuasive in light of the disclosure in Cooper. Applicant’s argument regarding claim language “data input by a user that is representative of the user's assessment of an effectiveness of the first changing spectrum of light as a photobiomodulation therapy designed for the user to obtain a specific medical health outcome as a result of the photobiomodulation therapy” is interpreted as data not being collected during the photobiomodulation therapy (i.e. input from a user entered after discontinuation of the light therapy). Cooper defines the feedback as: “additionally or alternatively, the feedback can correspond to a user input that is received via the user interface 34. For example, the patient or other user (e.g., a physician or technician) can employ an input device to provide feedback associated with the treatment, demonstrated an input/output (I/O) device 40” ([0048]). With respect to when the feedback is collected, Cooper discloses feedback can be obtained before, during, or after the treatment and stored in memory ([0050] – “the controls 38 can vary the power delivery during operation […] in response to feedback by a user (e.g., the patient or other user) […] feedback such as power levels and other information (e.g., feedback) obtained before, during and after treatment can be stored in the memory 30, such as part of treatment data 54 for the respective patient”) and used to determine settings in subsequent treatment processes ([0061]). Given that Cooper has the capability to use feedback collected during non-treatment time periods to assess control settings, the rejections of claims 1 and 11 over Cooper are maintained.
Applicant’s arguments, see Remarks page 10 (All Dependent Claims Are Patentable Under 35 USC 102(a)(l), 102(a)(2), and 103) filed 10/29/2025, with respect to the 35 U.S.C. § 102 rejections of dependent claims 2-6, 8-10, 12-16, and 18-20 over Cooper, dependent claim 21 under 35 U.S.C. 103 over Cooper in view of Chakravarthy (US PG Pub 2016/0263396 A1), and dependent claim 22 under 35 U.S.C. 103 over Cooper in view of Chakravarthy and VESA 2006 (NPL, “VESA Flat Display Mounting Interface Standard (for Flat Panel Monitors/Displays/Flat TV's). Version 1, Rev. 1. January 16, 2006”) have been fully considered but they are not persuasive. Claims 3 and 13 are newly canceled. Specifically, Applicant argues:
Applicant respectfully submits that dependent claims 2, 4-6, 8-10, 12, 14-16, 18-20, 21, and 22 are patentably distinguishable over Cooper, Chakravarthy, and/or VESA 2006, either individually or in any combination, at least because they each depend directly or indirectly from an allowable independent claim or for reasons related to their own subject matter. (page 10, 10/29/2025 Remarks)
The rejections for claims 1 and 11 are maintained based on the previous analysis. Therefore, the rejections for claims 2, 4-6, 8-10, 12, 14-16, and 18-22 are maintained as well.
Newly added claims 23-24 are evaluated in light of the above arguments and rejected under 35 U.S.C. § 103 over Cooper in view of Knight (US PG Pub 2017/0080246 A1), see “Claim Rejections - 35 USC § 103” section.
Summary: The prior art rejections of claims 1-2, 4-6, 8-12, 14-16, and 18-22 are maintained. New 35 U.S.C. § 103 rejections for newly added claims 23-24 are added (see “Claim Rejections - 35 USC § 103”). New 35 U.S.C. § 112(b) rejections for independent claims 1 and 11 (and corresponding dependent claims) are added. See “Priority” and “Claim Rejections - 35 USC § 101” for updated analyses.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 8, 18, 23, and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (a mental process) without significantly more.
Step 1
The invention in Claims 8, 18, 23, and 24 is to a statutory subject matter as the claims recite a photobiomodulation device or method of using a photobiomodulation device.
Step 2A, Prong One
Claims 8, 18, 23, and 24 recite abstract ideas in the form of mental processes that "can be performed in the human mind, or by a human using a pen and paper" (see MPEP 2106.04(a)(2) subsection (III)).
Regarding Claim 8, the limitation “determine, based on the data input by the user that is representative of the user's assessment of the effectiveness of the first changing spectrum of light, a modification to the first set of instructions to increase the effectiveness of the first changing spectrum of light emitted” could be performed by the human mind.
Regarding Claim 18, the limitation “determining, based on the data representative of the user's assessment of the effectiveness of the first changing spectrum of light, a modification to the first set of instructions to increase the effectiveness of the first changing spectrum of light emitted” could be performed by the human mind.
Regarding Claim 23, the limitations “aggregate the data input by the user and additional data from at least some other users from the plurality of users according to the demographic,” and “generate a second set of instructions using the aggregated data to refine, for the demographic, the first set of instructions” could be performed by the human mind.
Regarding Claim 24, the limitations “aggregating the data input by the user and additional data from at least some other users from the plurality of users according to the demographic” and “generating a second set of instructions using the aggregated data to refine, for the demographic, the first set of instructions” could be performed by the human mind.
Step 2A, Prong Two
For the Claims 8 and 23 limitations from Step 2A Prong One, the claims do not recite additional elements that integrate the judicial exceptions into a practical application. Additional elements from claim 1 include: “a memory,” “a light emitting array,” “at least one sensor,” and “a controller coupled to the memory and the light emitting array” where the controller is “configured to: cause a plurality of light sources of the light emitting array to respectively emit a first changing spectrum of light according to a first set of instructions stored in the memory; and receive data input by a user that is representative of the user's assessment of an effectiveness of the first changing spectrum of light as a photobiomodulation therapy designed for the user to obtain a specific medical health outcome.” The sensor is part of the insignificant extra-solution activity of data gathering. The memory and controller describe a generic computer structure for performing generic computer functions such as controlling the storing of instructions and receiving data entered by the user. The light emitting array generally links the exception to a particular technological environment or field of use.
Additional elements from Claim 8 are: “a controller configured to output a message offering an opportunity to accept the modification to the first set of instructions” and “store in the memory a modified set of instructions in place of the first set of instructions.” The memory and controller describe generic computer structures for performing generic computer functions such as prompting a user and receiving data to be stored in memory. There are no additional elements to consider from claim 23.
Dependent claim 9 recites a practical application of the judicial exception in claim 8 in that the instructions are used to produce a specific light irradiation.
For the Claims 18 and 24 limitation from Step 2A Prong One, the claims do not recite additional elements that integrate the judicial exceptions into a practical application. Additional elements from Claim 11 include: “causing a plurality of light sources of a light emitting array of the photobiomodulation device to respectively emit a first changing spectrum of light according to a first set of instructions” and “receive data input by a user, the data representative of the user's assessment of an effectiveness of the first changing spectrum of light as a photobiomodulation therapy designed for the user to obtain a specific medical health outcome as a result of the photobiomodulation therapy.” Receiving data input by the user is part of the insignificant extra-solution activity of data gathering. The light emitting array generally links the exception to a particular technological environment or field of use.
Additional elements from Claim 18 include: “outputting a message offering an opportunity to accept the modification to the first set of instructions” and “storing, in response to receiving an input indicative of an acceptance of the modification to the first set of instructions, a modified set of instructions in place of the first set of instructions.” These would involve generic computer structure for performing generic computer functions such as prompting a user and receiving data to be stored in memory. There are no additional elements to consider from claim 24.
Dependent claim 19 recites a practical application of the judicial exception in claim 18 in that the instructions are used to produce a specific light irradiation.
Step 2B
For the Claims 8 and 23 limitations from Step 2A Prong One, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. Additional elements from claim 1 include: “a memory,” “a light emitting array,” “at least one sensor,” and “a controller coupled to the memory and the light emitting array” where the controller is “configured to: cause a plurality of light sources of the light emitting array to respectively emit a first changing spectrum of light according to a first set of instructions stored in the memory; and receive data input by a user that is representative of the user's assessment of an effectiveness of the first changing spectrum of light as a photobiomodulation therapy designed for the user to obtain a specific medical health outcome.” The sensor is part of the insignificant extra-solution activity of data gathering. The memory and controller describe a generic computer structure for performing generic computer functions such as controlling the storing of instructions and receiving data entered by the user. The light emitting array generally links the exception to a particular technological environment or field of use.
Additional elements from Claim 8 are: “a controller configured to output a message offering an opportunity to accept the modification to the first set of instructions” and “store in the memory a modified set of instructions in place of the first set of instructions.” The memory and controller describe generic computer structures for performing generic computer functions such as prompting a user and receiving data to be stored in memory. There are no additional elements to consider from claim 23.
Dependent claim 9 recites a practical application of the judicial exception in claim 8 in that the instructions are used to produce a specific light irradiation.
For the Claims 18 and 24 limitations from Step 2A Prong One, the claims do not recite additional elements that are sufficient to amount to significantly more than the judicial exception. Additional elements from Claim 11 include: “causing a plurality of light sources of a light emitting array of the photobiomodulation device to respectively emit a first changing spectrum of light according to a first set of instructions” and “receive data input by a user, the data representative of the user's assessment of an effectiveness of the first changing spectrum of light as a photobiomodulation therapy designed for the user to obtain a specific medical health outcome as a result of the photobiomodulation therapy.” Receiving data input by the user is part of the insignificant extra-solution activity of data gathering. The light emitting array generally links the exception to a particular technological environment or field of use.
Additional elements from Claim 18 include: “outputting a message offering an opportunity to accept the modification to the first set of instructions” and “storing, in response to receiving an input indicative of an acceptance of the modification to the first set of instructions, a modified set of instructions in place of the first set of instructions.” These would involve generic computer structures for performing generic computer functions such as prompting a user and receiving data to be stored in memory. There are no additional elements to consider from claim 24.
Dependent claim 19 recites a practical application of the judicial exception in claim 18 in that the instructions are used to produce a specific light irradiation.
Therefore, Claims 8, 18, 23, and 24 are directed to a judicial exception, as abstract ideas (mental processes), without significantly more.
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 1-2, 4-6, 8-12, 14-16, and 18-24 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.
Claims 1 and 11: The limitation “wherein the data representative of the user's assessment of the effectiveness of the photobiomodulation therapy to obtain the specific medical health outcome as the result of the photobiomodulation therapy is different from data representative of sensations perceived during the photobiomodulation therapy” renders the claim indefinite because it is unclear from the claim language how the user’s assessment data is different from “data representative of sensations perceived during the photobiomodulation therapy.” From the arguments presented in the 10/29/2025 remarks, the limitation is currently interpreted as the user’s assessment data not being entered during the treatment period while the light therapy is active (i.e. the assessment is provided after the treatment period). Alternative interpretations are possible such as (1) a distinction between the user’s perception of an overall change post-treatment vs. the user’s recollection of perceptions as the procedure is carried out or (2) a distinction between assessment of effectiveness vs. sensation (where a positive or negative sensation could be a factor in whether a treatment is considered effective). Additionally, a situation is possible where a user could recall a sensation related to effectiveness that occurred during the therapy but wait until the end of the treatment to provide post-treatment feedback. If the Examiner’s interpretation of the timing in which the feedback is entered is correct, it would be beneficial to clarify claim language to clearly state user effectiveness data is created after the light therapy treatment ends.
Dependent claims 2, 4-6, 8-10, 12, 14-16, and 18-24 are rejected for being dependent on rejected claims 1 and 11.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-6, 8-12, 14-16, and 18-20 are rejected under U.S.C 102(a)(1) and U.S.C 102(a)(2) as being anticipated by Cooper (US PG Pub 2013/0304019 A1, see previously cited).
Regarding Claim 1, Cooper discloses a photobiomodulation device (Abstract), comprising:
• a memory ([0043]; Figure 1 - Memory 30);
• a light emitting array ([0004] – “a photodynamic therapy system can include a flexible panel comprising a plurality of light sources distributed across a conformable light delivery surface
thereof”; Figure 1 – Photodynamic Therapy Devices 12); and
• at least one sensor ([0034] – temperature sensor); and
• a controller coupled to the memory and the light emitting array ([0042] – description of control system, Figure 1 – Control System 24 with Processor 32), wherein the controller is configured to:
-cause a plurality of light sources of the light emitting array ([0042] – “The control system 24 can be configured to control the light sources 14 in each of the PDT devices 12, such as by providing power and/or control information to the PDT devices 12 via respective power and control buses”) to respectively emit a first changing spectrum of light ([0026] – “A control system can also control parameters (e.g., wavelength, fluence, duration and/or fluence rate) associated with the delivery of the treatment light”) according to a set of first instructions stored in the memory ([0043] – “the control system 24 can include memory 30 that can store computer readable instructions and data associated with the operation of the PDT system 10. The processor 32 can access the memory and execute instructions therein for implementing the control functions for the system”); and
- receive data input by a user ([0048] – user feedback input via device), that is representative of a user's assessment of an effectiveness of the first changing spectrum of light as a photobiomodulation therapy designed for the user to obtain a specific medical health outcome as a result of the photobiomodulation therapy ([0048] - a clinician or patient-supplied feedback mechanism related to the user perception of photobiomodulation treatment), wherein the data representative of the user's assessment of the effectiveness of the photobiomodulation therapy to obtain the specific medical health outcome as the result of the photobiomodulation therapy is different from data representative of sensations perceived during the photobiomodulation therapy (This limitation is interpreted as a user assessment not being collected during the photobiomodulation therapy (i.e. input from a user state after discontinuation of the light therapy); [0050] - feedback can be obtained before, during, or after the treatment and be stored in memory: “the controls 38 can vary the power delivery during operation […] in response to feedback by a user (e.g., the patient or other user) […] feedback such as power levels and other information (e.g., feedback) obtained before, during and after treatment can be stored in the memory 30, such as part of treatment data 54 for the respective patient”; [0061] – feedback used in determine settings in subsequent treatment processes).
Note: The term “changing spectrum of light” is being interpreted as a spectrum of light emitted by the light sources which can be changed based on settings.
Therefore, Claim 1 is anticipated by Cooper.
Regarding Claim 2, Cooper anticipates the photobiomodulation device according to Claim 1, as indicated hereinabove. Cooper further discloses the first set of instructions is generated to provide the photobiomodulation therapy designed to obtain the specific medical health outcome ([0005] – “The plurality of light sources can be configured to provide a treatment light to achieve a desired therapeutic effect at a predetermined distance from the light delivery surface”). The “set of instructions is generated to provide a photobiomodulation therapy designed to obtain the specific health outcome” is being interpreted as a set of instructions to the device which are meant to provide light therapy associated with a particular therapeutic effect.
Therefore, Claim 2 is anticipated by Cooper.
Regarding Claim 4, Cooper anticipates the photobiomodulation device according to Claim 1, as indicated hereinabove. Cooper further discloses a plurality of light source driving circuits ([0033] – “Each PDT device 12 can also include corresponding circuitry 16 to operate the light sources 14 for delivering the treatment light”; Figure 1 – Circuitry 16 for each phototherapy device), wherein the plurality of light sources is divided into a plurality of subgroups and each of the plurality of subgroups is driven by one of the plurality of light source driving circuits according to the first set of instructions ([0051] – Each phototherapy device, where light sources are operated by driving circuits, can be broken into subgroups: “As disclosed herein, the light sources may be arranged in individually controllable groups, such as implemented at one or more PDT device panels. The controls 38 can be programmed to selectively activate or deactivate each of such groups independently of each other. For example, the light groups can be arranged in individual tiles that are connected together to provide the light delivery surface of each PDT device 12”). Note this claim only requires that any grouping of light sources is driven by a driving circuit (while having multiple driving circuits).
Therefore, Claim 4 is anticipated by Cooper.
Regarding Claim 5, Cooper anticipates the photobiomodulation device according to Claim 1, as indicated hereinabove. Cooper further discloses each of the plurality of light sources is at least one of a light emitting diode or a low level laser emitter ([0026] – “In one example, a PDT panel can include a plurality of tiles that each includes a plurality of light sources (e.g., light emitting diodes (LEDs)) distributed across the surface thereof. Each of the tiles can be flexibly connected as to provide the conformable light delivery surface of the PDT panel”). The options for light sources are further described: “For example, the light sources 14 can be implemented as semiconductor light sources, such as light emitting diodes (LEDs), including organic LEDs, quantum dot LEDs or other types of light sources that may provide treatment light with a fluence and wavelength sufficient to achieve the desired therapeutic effect” ([0031]). Note that a low-level laser emitter is not explicitly disclosed in Cooper.
Therefore, Claim 5 is anticipated by Cooper.
Regarding Claim 6, Cooper anticipates the photobiomodulation device according to Claim 1, as indicated hereinabove. Cooper further discloses the first set of instructions define at least two of:
• a wavelength of illumination ([0026] – “A control system can also control parameters (e.g., wavelength, fluence, duration and/or fluence rate) associated with the delivery of the treatment light),
• a duration of illumination ([0045] – “The treatment duration can also be programmable via the user interface 34, such as may be less than one hour (e.g., ranging from about 15 minutes to about 30 minutes), which further can vary depending on the fluence rate”),
• an intensity of illumination ([0045] - “As another example, for certain applications, the controls 38 can be implemented to control the PDT device to supply the treatment light at the treatment area with a power ranging from about 80 J/cm2 to about 120 J/cm2 for a predetermined treatment duration”), and
• a pattern of illumination ([0045] – “The controls 38 can be implemented to control the PDT devices 12 independently of one another, which can include concurrent operation or individual operation at separate times (e.g., sequentially in a rotating pattern)”).
While the number of repetitions of the pattern of illumination associated with one or more light sources of the plurality of light sources is not explicitly disclosed as a control value, the rotating pattern in [0045] could be programmed to repeat any number of times.
Therefore, Claim 6 is anticipated by Cooper.
Regarding Claim 8, Cooper anticipates the photobiomodulation device according to Claim 1, as indicated hereinabove. Cooper further discloses the controller is further configured to:
• determine, based on the data input by the user that is representative of the user's assessment of the effectiveness of the first changing spectrum of light ([0048] - a clinician or patient-supplied feedback mechanism related to the user perception of treatment), a modification to the first set of instructions to increase the effectiveness of the first changing spectrum of light emitted ([0115] – “At 560, instructions or feedback can be received by the control system. A determination can be made at 562 to ascertain whether adjustment of the control process is required. If adjustment is required (YES), the method can proceed to 564 in which parameters can be adjusted accordingly. The instructions or feedback received at 560 can correspond to a user input such as can be provided by a patient, or a treating physician or technician. Feedback can also be provided automatically based on one or more sensed conditions such as can be implemented by circuitry at the PDT device”). Figure 17 displays the feedback mechanism process.
• output a message offering an opportunity to accept the modification to the first set of instructions ([0063] – “the remote device can be employed to adjust or authorize adjustments to one or more treatment parameters 36, such as those disclosed herein (e.g., selecting a protocol and related treatment parameters). For example, the remote device 52 can employ a user interface (not shown) to view and/or control the functions and methods implemented by the control system 24”). This is interpreted in this instance as an automated feedback suggestion of parameter adjustment which needs permission from an authorized user before adjustments are implemented in the control system; and
• store in the memory, in response to receiving an input indicative of an acceptance of the modification to the first set of instructions, a modified set of instructions in place of the first set of instructions ([0063] – the idea of getting authorization for a settings change is to implement the setting change if authorization is given. The confirmed adjusted settings would be stored in the memory according to [0043]).
Therefore, Claim 8 is anticipated by Cooper.
Regarding Claim 9, Cooper anticipates the photobiomodulation device according to Claim 8, as indicated hereinabove. Cooper further discloses the controller is further configured to cause the plurality of light sources of the light emitting array to emit a second changing spectrum of light according to the modified set of instructions ([0114] – describes initial settings: “At 558, the method can operate to activate the light sources based upon the parameters at 554. The light sources can in turn supply a treatment light to the patient area at the patient's skin. As disclosed herein, the light sources can be operative to provide the treatment light with a selected fluence and fluence rate onto the treatment area”; [0115] – describes how initial settings are modified based on feedback: “At 560, instructions or feedback can be received by the control system. A determination can be made at 562 to ascertain whether adjustment of the control process is required. If adjustment is required (YES), the method can proceed to 564 in which parameters can be adjusted accordingly”).
Therefore, Claim 9 is anticipated by Cooper.
Regarding Claim 10, Cooper anticipates the photobiomodulation device according to Claim 1, as indicated hereinabove. Cooper further discloses an application associated with the photobiomodulation device ([0063]) is configured to:
• receive the data input by the user ([0048], [0050] – user feedback input via device),
• transmit the data input by the user to a server associated with the photobiomodulation device ([0061] – “As a further example, the control system 24 can include a network interface 48 that enables communication of data and instructions via a network 50”)
Therefore, Claim 10 is anticipated by Cooper.
Regarding Claim 11, Cooper discloses a method operational at a photobiomodulation device (Abstract – how the photodynamic therapy device is being used), comprising:
• causing a plurality of light sources of a light emitting array ([0004] – “a photodynamic therapy system can include a flexible panel comprising a plurality of light sources distributed across a conformable light delivery surface thereof”; Figure 1 – Photodynamic Therapy Devices 12) of the photobiomodulation device to respectively emit a first changing spectrum of light according to a first set of instructions ([0042] – “The control system 24 can be configured to control the light sources 14 in each of the PDT devices 12, such as by providing power and/or control information to the PDT devices 12 via respective power and control buses”; [0043] – “the control system 24 can include memory 30 that can store computer readable instructions and data associated with the operation of the PDT system 10. The processor 32 can access the memory and execute instructions therein for implementing the control functions for the system”). Note: The term “changing spectrum of light” is being interpreted as a spectrum of light emitted by the light sources which can be changed based on settings.
• receive data input by a user ([0048] – user feedback input via device), the data representative of the user's assessment of an effectiveness of the first changing spectrum of light as a photobiomodulation therapy designed for the user to obtain a specific medical health outcome ([0048] - a clinician or patient-supplied feedback mechanism related to the user perception of photobiomodulation treatment) as a result of the photobiomodulation therapy, wherein the data representative of the user's assessment of the effectiveness of the photobiomodulation therapy to obtain the specific medical health outcome as the result of the photobiomodulation therapy is different from data representative of sensations perceived during the photobiomodulation therapy (This limitation is interpreted as a user assessment not being collected during the photobiomodulation therapy (i.e. input from a user state after discontinuation of the light therapy); [0050] - feedback can be obtained before, during, or after the treatment and be stored in memory: “the controls 38 can vary the power delivery during operation […] in response to feedback by a user (e.g., the patient or other user) […] feedback such as power levels and other information (e.g., feedback) obtained before, during and after treatment can be stored in the memory 30, such as part of treatment data 54 for the respective patient”; [0061] – feedback used in determine settings in subsequent treatment processes).
Therefore, Claim 11 is anticipated by Cooper.
Regarding Claim 12, Cooper anticipates the method operational at a photobiomodulation device according to Claim 11, as indicated hereinabove. Cooper further discloses the first set of instructions is generated to provide the photobiomodulation therapy designed to obtain the specific medical health outcome ([0005] – “The plurality of light sources can be configured to provide a treatment light to achieve a desired therapeutic effect at a predetermined distance from the light delivery surface”). The “set of instructions is generated to provide the photobiomodulation therapy designed to obtain the specific health outcome” is being interpreted as a set of instructions to the device which are meant to provide light therapy associated with a particular therapeutic effect.
Therefore, Claim 12 is anticipated by Cooper.
Regarding Claim 14, Cooper anticipates the method operational at a photobiomodulation device according to Claim 11, as indicated hereinabove. Cooper further discloses the plurality of light sources is divided into a plurality of subgroups, the method further comprising: driving each of the plurality of subgroups by a respective one of a plurality of light source driving circuits ([0033] – “Each PDT device 12 can also include corresponding circuitry 16 to operate the light sources 14 for delivering the treatment light”; Figure 1 – Circuitry 16 for each phototherapy device) according to the first set of instructions ([0051] – Each phototherapy device, where light sources are operated by driving circuits, can be broken into subgroups: “As disclosed herein, the light sources may be arranged in individually controllable groups, such as implemented at one or more PDT device panels. The controls 38 can be programmed to selectively activate or deactivate each of such groups independently of each other. For example, the light groups can be arranged in individual tiles that are connected together to provide the light delivery surface of each PDT device 12”). Note that this claim only requires that any grouping of light sources is driven by a driving circuit (while having multiple driving circuits).
Therefore, Claim 14 is anticipated by Cooper.
Regarding Claim 15, Cooper anticipates the method operational at a photobiomodulation device according to Claim 11, as indicated hereinabove. Cooper further discloses each of the plurality of light sources is at least one of a light emitting diode or a low level laser emitter ([0026] – “In one example, a PDT panel can include a plurality of tiles that each includes a plurality of light sources (e.g., light emitting diodes (LEDs)) distributed across the surface thereof. Each of the tiles can be flexibly connected as to provide the conformable light delivery surface of the PDT panel”). The options for light sources are further described: “For example, the light sources 14 can be implemented as semiconductor light sources, such as light emitting diodes (LEDs), including organic LEDs, quantum dot LEDs or other types of light sources that may provide treatment light with a fluence and wavelength sufficient to achieve the desired therapeutic effect” ([0031]). Note that a low-level laser emitter is not explicitly disclosed in Cooper.
Therefore, Claim 15 is anticipated by Cooper.
Regarding Claim 16, Cooper anticipates the method operational at a photobiomodulation device according to Claim 11, as indicated hereinabove. Cooper further discloses the first set of instructions define at least two of:
• a wavelength of illumination ([0026] – “A control system can also control parameters (e.g., wavelength, fluence, duration and/or fluence rate) associated with the delivery of the treatment light”),
• a duration of illumination ([0045] – “The treatment duration can also be programmable via the user interface 34, such as may be less than one hour (e.g., ranging from about 15 minutes to about 30 minutes), which further can vary depending on the fluence rate”),
• an intensity of illumination ([0045] - “As another example, for certain applications, the controls 38 can be implemented to control the PDT device to supply the treatment light at the treatment area with a power ranging from about 80 J/cm2 to about 120 J/cm2 for a predetermined treatment duration”), and
• a pattern of illumination ([0045] – “The controls 38 can be implemented to control the PDT devices 12 independently of one another, which can include concurrent operation or individual operation at separate times (e.g., sequentially in a rotating pattern)”).
While the number of repetitions of the pattern of illumination associated with one or more light sources of the plurality of light sources is not explicitly disclosed as a control value, the rotating pattern in [0045] could be programmed to repeat any number of times.
Therefore, Claim 16 is anticipated by Cooper.
Regarding Claim 18, Cooper anticipates the method operational at a photobiomodulation device according to Claim 11, as indicated hereinabove. Cooper further discloses:
• determining, based on the data representative of the user's assessment of the effectiveness of the first changing spectrum of light ([0048] - a clinician or patient-supplied feedback mechanism related to the user perception of treatment), a modification to the first set of instructions to increase the effectiveness of the first changing spectrum of light emitted ([0115] – “At 560, instructions or feedback can be received by the control system. A determination can be made at 562 to ascertain whether adjustment of the control process is required. If adjustment is required (YES), the method can proceed to 564 in which parameters can be adjusted accordingly. The instructions or feedback received at 560 can correspond to a user input such as can be provided by a patient, or a treating physician or technician. Feedback can also be provided automatically based on one or more sensed conditions such as can be implemented by circuitry at the PDT device”). Figure 17 displays the feedback mechanism process.
• outputting a message offering an opportunity to accept the modification to the first set of instructions ([0063] – “the remote device can be employed to adjust or authorize adjustments to one or more treatment parameters 36, such as those disclosed herein (e.g., selecting a protocol and related treatment parameters). For example, the remote device 52 can employ a user interface (not shown) to view and/or control the functions and methods implemented by the control system 24”). This is interpreted in this instance as an automated feedback suggestion of parameter adjustment which needs permission from an authorized user before adjustments are implemented in the control system; and
• storing, in response to receiving an input indicative of an acceptance of the modification to the first set of instructions, a modified set of instructions in place of the first set of instructions ([0063] – the idea of getting authorization for a settings change is to implement the setting change if authorization is given. The confirmed adjusted settings would be stored in the memory according to [0043]).
Therefore, Claim 18 is anticipated by Cooper.
Regarding Claim 19, Cooper anticipates the method operational at a photobiomodulation device according to Claim 18, as indicated hereinabove. Cooper further discloses causing the plurality of light sources of the light emitting array of the photobiomodulation device to emit a second changing spectrum of light according to the modified set of instructions ([0114] – describes initial settings: “At 558, the method can operate to activate the light sources based upon the parameters at 554. The light sources can in turn supply a treatment light to the patient area at the patient's skin. As disclosed herein, the light sources can be operative to provide the treatment light with a selected fluence and fluence rate onto the treatment area”; [0115] – describes how initial settings are modified based on feedback: “At 560, instructions or feedback can be received by the control system. A determination can be made at 562 to ascertain whether adjustment of the control process is required. If adjustment is required (YES), the method can proceed to 564 in which parameters can be adjusted accordingly”).
Therefore, Claim 19 is anticipated by Cooper.
Regarding Claim 20, Cooper anticipates the method operational at a photobiomodulation device according to Claim 11, as indicated hereinabove. Cooper further discloses:
• receiving, by an application associated with the photobiomodulation device ([0063]), the data input by the user ([0048] - a clinician or patient-supplied feedback mechanism related to the user perception of treatment), and
• transmitting, by the application, the data input by the user to a server associated with the photobiomodulation device ([0061] – “As a further example, the control system 24 can include a network interface 48 that enables communication of data and instructions via a network 50”).
Therefore, Claim 20 is anticipated by Cooper.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claim 21 is rejected under U.S.C 103 as being unpatentable over Cooper (US PG Pub 2013/0304019 A1, see previously cited) in view of Chakravarthy (US PG Pub 2016/0263396 A1, see previously cited).
Regarding Claim 21, Cooper anticipates the photobiomodulation device according to Claim 1, as indicated hereinabove. Cooper discloses light sources are configured to provide a therapeutic light at a particular distance from the target surface ([0005] – “The plurality of light sources can be configured to provide a treatment light to achieve a desired therapeutic effect at a predetermined distance from the light delivery surface. The system can also include a spacer configured at the light delivery surface to position the light delivery surface at the predetermined distance from a treatment area of a patient”) by adapting a variety of irradiation settings ([0026] – “A control system can also control parameters (e.g., wavelength, fluence, duration and/or fluence rate) associated with the delivery of the treatment light. The control system can also selectively control parameters for operating one or more groups of the light sources independently, as disclosed herein”). However, Cooper does not disclose one or more distance sensors configured to determine a distance between the light emitting array and a target body part, wherein the controller is further configured to: automatically adjust at least one of: a frequency or an intensity of the light emitting array in response to the distance measured by the one or more distance sensors.
Chakravarthy, in the same field of endeavor of providing phototherapy with an LED array ([0009]), teaches inputs to the LED array can be automatically adjusted based on a distance sensor measuring the distance between the LED array and target surface ([0058] – “The power or current input
to the LED strings can also be automatically adjusted based on the measured distance between the light source and the treatment surface. The distance between the light source and the treatment surface may be measured by a distance meter integrated with or coupled to the phototherapy device or to a mounting structure attached to the phototherapy device. The distance meter may comprise a sensor, such as art optical range finder, to detect the distance between the phototherapy device and the treatment surface of the patient”). The LED’s can be adjusted in general based on frequency or intensity in order to provide a specified therapeutic light to the target surface ([0047] - “The LED arrangement 130 can provide a uniform and precise phototherapeutic light exposure on a subject. The on/off switch 115 of the phototherapy device 110 may be used to turn one or more of the device 110 and the LED arrangement on or off, e.g., turn the power supplied to the device 110 on or off, and in some embodiments to adjust the intensity and/or emission wavelengths of the LEDs. The on/off switch 115 of the phototherapy device 110 may be used to turn one or more of the device 110 and the LED arrangement on or off, e.g., turn the power supplied to the device 110 on or off, and in some embodiments to adjust the intensity and/or emission wavelengths of the LEDs”).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Cooper’s LED array apparatus for phototherapy by incorporating the distance sensor and automatic adjustment of LED settings based on changes in distance between the array and target surface in Chakravarthy. This would have been obvious because both Cooper and Chakravarthy discuss matching LED array settings to a particular distance between the LED array and target surface and Chakravarthy provides a solution/improvement to automatically adjust settings based on measured distance to provide a more precise setting than an assumed distance. Therefore, a person of ordinary skill in the art would be motivated to improve the apparatus of Cooper by incorporating the distance sensor and automatic adjustment of LED settings based on changes in distance between the array and target surface in Chakravarthy.
Therefore, Claim 21 is obvious over Cooper in view of Chakravarthy.
Claim 22 is rejected under U.S.C 103 as being unpatentable over Cooper (US PG Pub 2013/0304019 A1, see previously cited) in view of Chakravarthy (US PG Pub 2016/0263396 A1, see previously cited) and VESA 2006 (NPL, “VESA Flat Display Mounting Interface Standard (for Flat Panel Monitors/Displays/Flat TV's). Version 1, Rev. 1. January 16, 2006”, see previously cited).
Regarding Claim 22, Cooper anticipates the photobiomodulation device according to Claim 1, as indicated hereinabove. Cooper discloses a light panel containing the LED light sources ([0095] – “the example of FIG. 11, the PDT device 400 provides a light panel that includes a plurality of light sources 404 to define a corresponding light delivery surface of the device 400. The light sources 404 are distributed across an arrangement of tiles that are attached to a flexible substrate 408”). Cooper discloses the control system interface can use other wireless input devices ([0103] - Bluetooth® and WiFi® explicitly disclosed). However, Cooper does not disclose an enclosure, wherein: a plurality of light emitting elements is associated with a front surface of the enclosure, and a plurality of mounting features compliant with a Video Electronics Standards Association (VESA) Interface Standard are associated with a rear surface of the enclosure.
Chakravarthy, in the same field of endeavor of providing phototherapy with an LED array ([0009]), teaches a half shell housing where the LED’s shine through the front of the device ([0059] –
“As illustrated in FIGS. 6-9, the array of LEDs 225 can be covered by a half-shell housing 222 that can be mechanically fastened to the metal plate such as with supports or engagement elements 232 as shown in FIG. 10. The half-shell 222 can be made of a variety of polymers and has circular cutouts over each LED lens to allow the light source to shine through”). The housing is mounted for static or adjustable placement in a variety of locations ([0040]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Cooper’s LED array apparatus for phototherapy by incorporating the LED array housing and mounting capabilities in Chakravarthy. This would have been obvious because both Cooper and Chakravarthy discuss positioning LED arrays to shine in a particular adaptable position and Chakravarthy provides a solution/improvement to mount the array in protective housing to irradiate the subject from a variety of adjustable distances after mounting. Therefore, a person of ordinary skill in the art would be motivated to improve the apparatus of Cooper by incorporating the LED array housing and mounting capabilities in Chakravarthy.
The VESA 2006 document, in the same field of light emitting devices, teaches the use of standardized mounting conventions so that any display could be readily mounted for any application with standardized parts (Page 1, 1.2 Objectives). The conventions of how to place mounting features on the back of the display (see Figures on Pages 5-6) are broken down by type in sections 1.3.1 – 1.3.8 (Pages 1-3). The VESA 2006 document describes the rationale of adopting a standard mounting configuration as: “Low cost, standardized mounting interfaces for a broad range of FD sizes and applications. Low cost, standardized mounting interfaces to meet specialized needs and applications. Full mounting and/or positioning flexibility of FDs to provide ergonomic benefits, space savings and broad industry utilization of FDs. Standardized mounting apparatus for low cost installation in a broad range of applications” (Page 4, 1.8 Features and Benefits).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Cooper’s LED array apparatus for phototherapy by incorporating the mounting types stipulated in VESA 2006. At the time, there would have been a recognized need to implement a specific type of mounting to position the LED array to face the patient. Given the limited options for mounting due to the standardization of mounts, the mounting fixtures in VESA 2006 would have been a known option for mounting a light-emitting device and obvious to try. A person of ordinary skill in the art would have a reasonable expectation of successfully using the mounting fixtures recommended in the VESA 2006 guidelines.
Therefore, Claim 22 is obvious over Cooper in view of Chakravarthy and VESA 2006.
Claims 23-24 are rejected under U.S.C 103 as being unpatentable over Cooper (US PG Pub 2013/0304019 A1, see previously cited) in view of Knight (US PG Pub 2017/0080246 A1, see “Notice of References Cited”).
Regarding Claim 23, Cooper anticipates the photobiomodulation device according to Claim 1, as indicated hereinabove. Cooper discloses data for multiple users can be stored in memory on a device and data for a particular patient’s stored settings can be selected for subsequent treatments ([0061], [0109]). Cooper also discloses “multiple protocols can be established depending upon various patient characteristics” ([0113]). However, Cooper does not disclose the data input by the user is linked to a demographic associated with the plurality of users, and the controller is further configured to:
• aggregate the data input by the user and additional data from at least some other users from the plurality of users according to the demographic; and
• generate a second set of instructions using the aggregated data to refine, for the demographic, the first set of instructions.
Knight, in the same field of endeavor of providing phototherapy ([0054]) with an LED array ([0100]), teaches the collection of post therapy information regarding the user after a light therapy session ([0054]) where this information can be feedback from the user ([0081] – “A light setting may
be configurable by the operator during the course of a therapy session based on, for example, feedback from the user”). A variety of physical attributes are collected from users ([0112]). Therapy settings can be adjusted by comparing the user data to the data of other users ([0054]) based on a similarity shared between the user and other users ([0115]). The data from other users can be aggregated for comparison when determining light therapy recommendations ([0130]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Cooper’s LED array apparatus for phototherapy by incorporating the comparison of average data from other users to inform light therapy settings in Knight. This would have been obvious because both Cooper and Knight discuss storage of user settings and changing current light therapy settings based on stored patient characteristic data and Knight provides a solution/improvement to allow comparisons between current user data and users with similar attributes to produce a more informed light therapy setting recommendation. Therefore, a person of ordinary skill in the art would be motivated to improve the apparatus of Cooper by incorporating the comparison of average data from other users to inform light therapy settings in Knight.
Therefore, Claim 23 is obvious over Cooper in view of Knight.
Regarding Claim 24, Cooper anticipates the method operational at a photobiomodulation device according to Claim 11, as indicated hereinabove. Cooper discloses data for multiple users can be stored in memory on a device and data for a particular patient’s stored settings can be selected for subsequent treatments ([0061], [0109]). Cooper also discloses “multiple protocols can be established depending upon various patient characteristics” ([0113]). However, Cooper does not disclose wherein the data input by the user is linked to a demographic associated with the plurality of users, and the method further comprises:
• aggregating the data input by the user and additional data from at least some other users from the plurality of users according to the demographic; and
• generating a second set of instructions using the aggregated data to refine, for the demographic, the first set of instructions.
Knight, in the same field of endeavor of providing phototherapy ([0054]) with an LED array ([0100]), teaches the collection of post therapy information regarding the user after a light therapy session ([0054]) where this information can be feedback from the user ([0081] – “A light setting may
be configurable by the operator during the course of a therapy session based on, for example, feedback from the user”). A variety of physical attributes are collected from users ([0112]). Therapy settings can be adjusted by comparing the user data to the data of other users ([0054]) based on a similarity shared between the user and other users ([0115]). The data from other users can be aggregated for comparison when determining light therapy recommendations ([0130]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Cooper’s method for phototherapy by incorporating the comparison of average data from other users to inform light therapy settings in Knight. This would have been obvious because both Cooper and Knight discuss storage of user settings and changing current light therapy settings based on stored patient characteristic data and Knight provides a solution/improvement to allow comparisons between current user data and users with similar attributes to produce a more informed light therapy setting recommendation. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Cooper by incorporating the comparison of average data from other users to inform light therapy settings in Knight.
Therefore, Claim 24 is obvious over Cooper in view of Knight.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 8:30 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796