DETAILED ACTION
This action is pursuant to the claims filed on 01/15/2026. Claims 1-3 and 5-20 are pending. A first action on the merits of claims 1-3 and 5-20 is as follows.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/15/2026 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-3, 5-14, 16, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toselli (U.S. PGPub No. 2010/0198316) in view of Mayer (U.S. PGPub No. 2009/0319008) in view of Kerns (U.S. PGPub No. 2022/0193444), and in view of Hirschberg (U.S. PGPub No. 2002/0087206).
Regarding claim 1, Toselli teaches A system for percutaneous delivery of photobiomodulation comprising: a light source (Fig 7A, light source 101); a controller ([0103] light source 101 disclosed as externally based-control device (i.e., a controller)) comprising: a memory storing a predefined dosing requirement; a processor configured to access the memory and signal the light source to generate a light signal for photobiomodulation of a target area within a patient's body based on the predefined dosing requirement ([0065-0067] disclosing dosing requirements of light source; light source being capable of repeatedly applying said light dose defines a memory and processor of the device); a port configured to span a portion of a skin of a patient (Fig 7A, light port 109 is capable of spanning a portion of skin given it is implanted within a patient (i.e., must necessarily span a portion of a skin to be implanted)); and an attachment device to deliver the light through a port (Fig 7A, optical wave guide 103), wherein the attachment device is configured to transmit the light signal from the light source through the port for transmission to the target area (Fig 7A [0103]); wherein the processor is further configured to signal the light source to generate the light signal when the attachment device is properly connected to the port (Light source 101 generates light when the wave guide 103 is attached properly to the light port 109).
Toselli fails to explicitly teach a controller comprising a memory.
In related prior art, Mayer teaches a similar photobiomodulation system comprising a controller and memory for storing and applying predefined dosing requirements (Fig 1, [0091]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Toselli in view of Mayer to incorporate the controller with a memory for applying predefined dosing requirements as claimed. Doing so would be obvious to one of ordinary skill in the art as the use of controllers and memory to store and apply treatment parameters is well-known in the art to yield predictable results therein.
Toselli fails to teach wherein the processor is further configured to determine whether the attachment device is properly connected to the port.
In related prior art, Kerns teaches a similar device wherein the processor is further configured to determine whether the attachment device is properly connected to the port ([0012] [0066] [0093] “circuitry determines whether light guide is correctly connected to the light source”). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Toselli in view of Kerns to incorporate the light sensors that enable the processor to determine whether the attachment device is properly connected to the port and generate light when the attachment device is properly connected. Doing so would advantageously provide the device with a safety mechanism to alert a user when the device is not properly connected to prevent ineffective treatment ([0093]).
Toselli fails to teach the port configured to span a portion of skin of a patient from an extracorporeal region to an intracorporeal region.
In related prior art, Hirschberg teaches a similar system wherein a similar port is configured to span a portion of skin of a patient from an extracorporeal region to an intracorporeal region (Fig 6 [0062], transdermal optical connector 68 with optical coupler 66 creates an extracorporeal to intracorporeal port for photobiomodulation). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the port of Toselli in view of Hirschberg to incorporate the port configured to span from the extracorporeal to intracorporeal region to arrive at claim 1. Doing so would be a simple substitution of one well-known port configuration (Toselli, Fig 7A intracorporeal port 109 with implanted optical wave guide 103) for another well-known port configuration (Hirschberg Fig 6 transdermal optical connector 68 to connect fiber 34 outside the skin to optical coupler 66 inside the skin) to yield the predictable result of providing photobiomodulation directly to a target region from an extracorporeal region to an intracorporeal region of the patient.
Regarding claim 2, Toselli teaches wherein the light source, the controller and the attachment device are each external to the patient's body (Fig 7A, light source 110, controller within light source, and wave guide 103 are external to body).
Regarding claim 3, Toselli teaches wherein the light source is within the controller, the attachment device, or a portion of the port (Fig 7A, light source and controller are within same device 110).
Regarding claim 5, Toselli teaches wherein the predefined dosing requirement comprises an optical power ([0065]) and at least one of a pulse width, a frequency, an intensity, and a cycling parameter comprising a period of on time or off time ([0065] on time of 1-3 minutes).
Regarding claim 6, Toselli teaches wherein the predefined dosing requirement comprises an amount of light delivered per unit time ([0065] 25-50 mW/cm^2 for 1-3 minutes defines a light delivered per unit time) and/or a total amount of light to be delivered.
Regarding claim 7, Toselli teaches wherein the attachment device comprises an external light pipe extending from the light source to the port (Fig 7A, optical wave guide 103).
Regarding claim 8, Toselli teaches wherein the attachment device comprises a light- conveying needle instrument (Fig 7A, optical wave guide 103 [0104]).
Regarding claim 9, Toselli teaches wherein the port is configured to be implantable as a subdermal receptacle (Fig 7A, port 109).
Regarding claim 10, Toselli teaches wherein the port is connectable to an implantable light pipe that extends from the port to the target tissue (Fig 7A, optical wave guide 221).
Regarding claim 11, Toselli teaches wherein the implantable light pipe is configured to deliver the predefined dosing requirement of the light signal from the port to the target area (Fig 7A [0103], wave guide 221 delivers predefined dosing of light from port to target area).
Regarding claim 12, in view of claim 10 above,
Toselli fails to explicitly teach wherein the port is configured to be external to the patient's body and the implantable light pipe is configured to span through the patient's skin.
In related prior art, Hirschberg teaches a similar system wherein the port is configured to be external to the patient's body (Fig 6, optical connector 68 is external to skin and physically connected to optical coupler 66 [0062]) and the implantable light pipe is configured to span through the patient's skin (optical fiber 34 is spanned through skin via port of optical coupler 68). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Toselli in view of Hirschberg to incorporate the port external to the patient’s body to arrive at the device of claim 12. Doing so would be a simple substitution of one well-known photobiomodulation port (Toselli, internal port 109 with needle like optical fiber waveguide 103) for another well-known photobiomodulatoin port (Hirschberg, Fig 6 optical coupler 66 with external port 68 for feeding optical fiber 34 therein) to yield the predictable result of transmitting said light source through the skin to the target tissue.
Regarding claim 13, in view of the combination of claim 12 above, Hirschberg further teaches wherein the port comprises a fixation device configured to connect to the patient and a connector configured to connect to an external portion of the implantable light pipe (Fig 6 optical connector 68 defines a fixation device connected to the patient and an upper opening that connects to optical fiber 34). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Toselli in view of Hirschberg to incorporate the port external to the patient’s body to arrive at the device of claim 13. Doing so would be a simple substitution of one well-known photobiomodulation port (Toselli, internal port 109 with needle like optical fiber waveguide 103) for another well-known photobiomodulatoin port (Hirschberg, Fig 6 optical coupler 66 with external port 68 for feeding optical fiber 34 therein) to yield the predictable result of transmitting said light source through the skin to the target tissue.
Regarding claim 14, Toselli teaches wherein the light source comprises at least one of a laser diode or a light emitting diode ([0071] disclosing LED and laser; [0062-0063] disclosing laser).
Regarding claim 16, Toselli teaches A method comprising: accessing, by a controller comprising a processor, a predefined dosing requirement ([0103] light source 101 disclosed as externally based-control device (i.e., a controller); [0065-0067] disclosing dosing requirements of light source; light source being capable of repeatedly applying said light dose defines a memory and processor of the device); wherein the port is configured to span skin of the patient (Fig 7A, light port 109 is capable of spanning a portion of skin given it is implanted within a patient (i.e., must necessarily span a portion of a skin to be implanted)); signaling, by the controller, a light source to generate a light signal for photobiomodulation of a target area within a patient's body based on the predefined dosing requirement when the attachment device is properly connected to the port; ([0065-0067] disclosing dosing requirements of light source; light source being capable of repeatedly applying said light dose defines a memory and processor of the device; the light signal is generated when the attachment device is properly connected to the port); delivering the light signal received from the light source to the target area through a port (Fig 7A, optical wave guide 103 delivers through port 109 to target tissue).
Toselli fails to explicitly teach a controller comprising a memory.
In related prior art, Mayer teaches a similar photobiomodulation system comprising a controller and memory for storing and applying predefined dosing requirements (Fig 1, [0091]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Toselli in view of Mayer to incorporate the controller with a memory for applying predefined dosing requirements as claimed. Doing so would be obvious to one of ordinary skill in the art as the use of controllers and memory to store and apply treatment parameters is well-known in the art to yield predictable results therein.
Toselli fails to teach determining, by the controller, whether an attachment device connecting a light source and a port is properly connected to the port.
In related prior art, Kerns teaches determining, by the controller, whether an attachment device connecting a light source and a port is properly connected to the port ([0012] [0066] [0093] “circuitry determines whether light guide is correctly connected to the light source”). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Toselli in view of Kerns to incorporate the light sensors that enable the processor step of determining whether an attachment device connecting a light source and a port is properly connected to the port and generating light when the attachment device is properly connected. Doing so would advantageously provide the device with a safety mechanism to alert a user when the device is not properly connected to prevent ineffective treatment ([0093]).
Toselli fails to teach the port configured to span a portion of skin of a patient from an extracorporeal region to an intracorporeal region.
In related prior art, Hirschberg teaches a similar method wherein a similar port is configured to span a portion of skin of a patient from an extracorporeal region to an intracorporeal region (Fig 6 [0062], transdermal optical connector 68 with optical coupler 66 creates an extracorporeal to intracorporeal port for photobiomodulation). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the port of Toselli in view of Hirschberg to incorporate the port configured to span from the extracorporeal to intracorporeal region to arrive at claim 16. Doing so would be a simple substitution of one well-known port configuration (Toselli, Fig 7A intracorporeal port 109 with implanted optical wave guide 103) for another well-known port configuration (Hirschberg Fig 6 transdermal optical connector 68 to connect fiber 34 outside the skin to optical coupler 66 inside the skin) to yield the predictable result of providing photobiomodulation directly to a target region from an extracorporeal region to an intracorporeal region of the patient.
Regarding claim 18, Toselli teaches wherein the predefined dosing requirement comprises an optical power ([0065]) and at least one of a pulse width, a frequency, an intensity, and a cycling parameter comprising a period of on time or off time ([0065] on time of 1-3 minutes).
Regarding claim 19, Toselli teaches wherein the predefined dosing requirement comprises an amount of light delivered per unit time ([0065] 25-50 mW/cm^2 for 1-3 minutes defines a light delivered per unit time) and/or a total amount of light to be delivered.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toselli in view of Mayer, Kerns, Hirschberg and Williams (U.S. PGPub No. 2019/0246463).
Regarding claim 15, Toselli/Mayer/Kerns/Hirschberg teaches the device of claim 1 as stated above and further contemplates the use of wireless technology ([0109]).
Toselli fails to explicitly teach wherein the controller further comprises a wireless transmitter to communicate with the cloud, a device associated with a clinician, or a device associated with the patient.
In related prior art, Williams teaches a similar device wherein the controller further comprises a wireless transmitter to communicate with the cloud, a device associated with a clinician, or a device associated with the patient ([0521], Fig 73 disclosing wireless transmitter to communicate with external devices associated with patient, clinician, and/or cloud). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller of Toselli in view of Mayer, Kerns, Hirschberg and Williams to incorporate the wireless transmitter to communicate with the cloud, a device associated with a clinician, or a device associated with the patient to arrive at claim 15. Doing so would be obvious to one of ordinary skill in the art as the use of wireless transmitters to communicate with external devices is well-known in the art to yield predictable results therein.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toselli in view of Mayer, Kerns, Hirschberg, and Gregg (U.S. PGPub No. 2017/0215989).
Regarding claim 17, Toselli/Mayer/Kerns/Hirschberg teaches the method of claim 16 as stated above.
Toselli fails to teach receiving, by the controller, the predefined dosing requirement from a clinician.
In related prior art, Gregg teaches receiving, by the controller, the predefined dosing requirement from a clinician ([0318] “use of individually selectable Pulse Duration, Energy, Repetition Rate, and intuitive Average Power groupings within a safe therapeutic treatment window”). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Toselli in view of Mayer, Kerns, Hirschberg and Gregg to incorporate the step of receiving by the controller dosing requirements form a clinician to arrive at claim 17. Doing so would be obvious to one of ordinary skill in the art as a clinician making procedural decisions as it relates to a treatment plan of dosing requirements is well-known in the art to yield the predictable results of safe and effective treatments for patients.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toselli in view of Mayer, Kerns, Hirschberg and Streeter (U.S. PGPub No. 2003/0125782).
Regarding claim 20, Toselli/Mayer/Kerns/Hirschberg teaches the method of claim 16 as stated above.
Toselli fails to teach logging, by the controller, a number of doses given to the patient.
In related prior art, Streeter teaches logging, by the controller, a number of doses given to the patient ([0014] total number of treatments over time is a controllable parameter (i.e., the number of treatments is necessarily tracked). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Toselli in view of Mayer, Kerns, Hirschberg and Streeter to incorporate the step of logging, by the controller, a number of doses given to the patient to arrive at claim 20. Doing so would be obvious to one of ordinary skill in the art as logging a number of treatment doses is well-known in the art to yield the predictable results of providing a safe and effective treatments for patients.
Response to Arguments
Applicant's arguments filed 01/15/2026 have been fully considered but they are not persuasive. Applicant’s arguments, on pages 10-11 of the remarks, against the Hirschberg reference are directed to the embodiment of Figure 1, and does not address the teachings of at least Figure 6 and para. [0062] which was relied upon in the prior and instant rejections of record. As such, these arguments are unpersuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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