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 .
Status of Claims
Claims 1-20 are currently pending and under examination. As per the amendments filed on 03/11/2026, claims 1 and 18 are amended.
Priority
The instant application (filed on 08/10/2023) is a non-provisional application filed under 35 USC 111(a). Acknowledgment is made of Applicant's claim for domestic priority based on provisional application 63/399,982 (filed on 08/22/2022). Amended claims 1 and 18 are sufficiently described in the provisional application to receive an effective filing date of 08/22/2022 for the instant application. Therefore, all prior art will be evaluated with respect to this date.
Response to Arguments
Applicant's arguments, see Remarks pages 7-11 (§102 and §103 Rejections), filed
03/11/2026, with respect to the rejections of claims 1-20 under either USC § 102 or 35 USC § 103 have been fully considered. Regarding claim 1, Applicant argues:
Claim 1 recites emitting light from a lead implanted in the tissue using an implanted light source according to a first delivery program; repeatedly estimating an amount, speed, or time of any one, or any combination of, a temperature or a temperature change of, or amount of heat generated by, the implanted light source or repeatedly estimating an amount, speed, or time of any one, or any combination of, a temperature or a temperature change of tissue receiving the emitted light; and when the estimate exceeds a first threshold value and the light is emitted according to the first delivery program, emitting light from the implanted lead using the implanted light source according to a second delivery program, wherein the second delivery program results in lower heat generation by the implanted light source over a period of time than the first delivery program, wherein light is emitted during both the first delivery program and the second delivery program.
Claim 1 recites two delivery programs for delivery of light from an implanted lead. In addition, claim 1 recites estimating at least one value selected from a specific set of values and further recites that when that estimated value exceeds a first threshold value then the light, which was emitted according to the first delivery program, will now be emitted according to the second delivery program.
The Office Action asserts that Luu discloses all of the elements of claim 1. Office Action, pp. 7-9. However, the Office Action acknowledges that the second delivery program corresponds "to turn[ing] the light off in Luu." Office Action, p. 8. The Applicant respectfully submits that one of skill in the art would not consider "turning the light off' to be a "delivery program". When the lights are off, there is no delivery and there is no program. Accordingly, "turning the light off' is not a "delivery program" according to the plain meaning of the term "delivery program", as well as the meaning of the term as used in the present specification.
For clarity, however, the Applicant has amended claim 1 to recite that "light is emitted during both the first delivery program and the second delivery program." This is clearly implied in the term "delivery program" and, therefore, the Applicant believes that this amendment does not narrow claim 1.
Luu fails to teach or suggest the two different delivery programs (i.e., the first delivery program and the second delivery program), as recited in claim 1, and fails to teach changing from the first delivery program to the second delivery program when an estimated value exceeds a first threshold value. Accordingly, Luu fails to teach or suggest all of the elements of claim 1. None of the other references address these deficiencies of Luu. For at least these reasons, claim 1, as well claims 2-17 which depend therefrom, is patentable over the cited references. The Applicant respectfully requests withdrawal of the rejections of these claims. (03/11/2026 Remarks, pages 7-8)
This argument is persuasive. While the Examiner still interprets shutting off a light source due to overheating (as discussed in Luu [0041]) as transitioning from a first light delivery program to a second light delivery program in terms of programmed settings for the light source, the amendment now explicitly requires the second delivery program to emit light (albeit at a less intense setting to reduce heating). Luu does not explicitly disclose the light source as still emitting light when the light source delivery program is adjusted during overheating. Therefore, the anticipation rejection of claim 1 is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tranberg (US PG Pub 2016/0067519 A1), see “Claim Rejections - 35 USC § 103” section.”
Regarding claim 18, Applicant argues:
Claim 18 recites receiving a selection of a value for each of a plurality of delivery parameters, wherein the selection of the value for each of the delivery parameters is limited by expected heat generation or temperature change arising from the selection of the value and any previously selected values; and after the selection of all of the values, estimating, using a model, a look-up table, or curve or template matching, expected heat generation and, when the expected heat generation or temperature change exceeds a threshold either i) providing a warning or recommendation to a programmer or ii) requiring the programmer to alter at least one of the selected values.
Neither Luu nor De Taboada teach or suggest making such estimates using a model, a lookup table, or curve or template matching. In particular, although De Taboada does mention a temporal profile in [0154], De Taboada does not teach any specifics regarding how this temporal profile is used. Any assertion that De Taboada uses "a model, a look-up table, or curve or template matching" is speculative and lacks support in the reference. Accordingly, Luu and De Taboada fail to teach or suggest all of the elements of claim 18. None of the other references address these deficiencies of Luu and De Taboada. For at least these reasons, claim 18 is patentable over the cited references. The Applicant respectfully requests withdrawal of the rejections of this claim. (03/11/2026 Remarks, pages 8-9)
This argument is not persuasive. The amended limitation “estimating, using a model, a look-up table, or curve or template matching, expected heat generation” is taught by De Taboada using the plain meaning of the term “model.” De Taboada teaches a feature of estimating temperature increases in tissue based on the calculated power output of a light irradiation waveform (determined by amplitude, pulse width, and duty cycle) vs. the estimated heat dissipation of the tissue ([0154]). This is interpreted as constituting a model (used to determine appropriate power settings) of expected heat generation in the tissue based on the calculated power irradiated from the light source and thermal relaxation calculations. Therefore, the obviousness rejection of claim 18 is maintained.
Regarding claim 19, Applicant argues:
Claim 19 recites an implantable light source; and a thermoelectric cooling device coupled to the implantable light source and configured for removing heat generated by the implantable light source. The Office Action acknowledges that Luu does not teach or suggest these elements of claim 18. Office action, p. 21. The Office Action turns to Bornstein. Office Action, pp. 21-22. However, Bornstein is not directed to an implantable light source. The optical fiber and cooling device described at [0507] of Borstein (as cited in the Office Action) is clearly not implanted into the patient. There is no indication in Bornstein or Luu that the optical fiber with a cooling device described in Bornstein would be suitable for implantation. In particular, Bornstein provides no information about the thermoelectric cooler and so there is no indication that the thermoelectric cooler is made of implantable materials, that it has a form factor suitable for implantation, that any supporting hardware for operation of the thermoelectric cooler is implantable, and so on. The assertion that the implantable lead of Luu could be modified to include the optical fiber and cooling device of Bornstein is speculative for these reasons and such a modification lacks support in either Luu or Bornstein.
The Office Action asserts that the cooling device of Bornstein would be suitable for implantation with the lead of Luu but there is simply no information that supports this and suggests that the cooling device of Bornstein is implantable. Contrary to the assertion in the Office Action, the cooling device (or associated hardware) of Bornstein may be too large to be implanted or may be made of materials that are not suitable for implantation. There is not sufficient information in Bornstein to know the suitability of the cooling device of Bornstein for implantation and, therefore, the Office Action lacks sufficient information to support its proposed modification of Luu in view of Bornstein.
Accordingly, Luu and Bornstein fail to teach or suggest all of the elements of claim 19. None of the other references address these deficiencies of Luu and Bornstein. For at least these reasons, claim 19, as well as claim 20 which depends therefrom, is patentable over the cited references. The Applicant respectfully requests withdrawal of the rejection of these claims. (03/11/2026 Remarks, pages 9-10)
This argument is not persuasive. Bornstein establishes the use of a cooling device attached to diffusion tip 10:
In various embodiments, diffusion tip 10 may include any number of sensors, e.g., temperature sensors which may communicate (by wire or wirelessly) with therapeutic system 110. Information provided by these sensors may be used to control applied dosages of therapeutic light, e.g. for safety purposes. Tip 10 may also include one or more cooling devices (e.g. a thermoelectric cooler), or attachments suitable for engagement with external cooling devices (e.g. tubular plumbing for circulation of cooling fluids). [0507]
Bornstein further teaches the tip can be applied to treat internal tissue as part of an implantable device:
Other embodiments of tip 10 may be used to direct treatment light to other areas such as tissue spaces ( e.g. the periodontal pocket or within a joint e.g. in an orthopedic surgical procedure), interfaces between body tissue and other surfaces (e.g. the surface of an implantable medical device), over a wide area such as a dermal surface, etc. [0483]
Therefore, sufficient evidence exists to suggest Bornstein’s device can be applied to an implantable system, such as the implantable device in Luu. This would establish sufficient motivation to use a tip containing a thermoelectric cooler as part of an implantable device. Therefore, the obviousness rejection of claim 19 is maintained.
Regarding dependent claims 2-3, Applicant argues:
The dependent claims include additional patentable features. For example, claim 2 recites that, when the estimate falls below a second threshold value and the light is emitted according to the second delivery program, emitting light from the implanted lead using the implanted light source according to the first delivery program. The Office Action asserts that "[0041] - reverse of the situation in claim 1 where the original irradiation is provided again once temperatures fall below the threshold; in Luu the light is only turned off when the temperature is above a particular threshold: "temperature sensor 251 such as a thermistor may also be coupled to the flexible substrate in order to allow temperature monitoring at the target treatment area since light may generate heat and overheating is undesirable and may damage tissue. If excessive heat is generated the lights may be turned off'; the claim merely states the light is emitted according to the second delivery program (which is to tum the light off in Luu)." Office Action, p. 8.
Luu does not teach process for returning back to the first delivery program when a second threshold is reached. Luu only discloses turning off the light, not turning it back on based on measurements from the light monitor. The Office Action is assuming operations in Luu that are not explicitly or inherently taught. Accordingly, Luu fails to teach or suggest all of the elements of claim 2. None of the other references address these deficiencies of Luu. For at least these reasons, claim 2, as well as claim 3 which depends therefrom, is patentable over the cited references. The Applicant respectfully requests withdrawal of the rejection of these claims. In view of the above, each of the presently pending claims in this application is believed to be in immediate condition for allowance. (03/11/2026 Remarks, pages 10-11)
This argument is not persuasive. Luu discloses the temperature as being monitored to prevent overheating in [0039-0041]. The method of Luu ([0028] - method of use) involves monitoring during therapy and may be turned off if excessive heat is generated ([0041]). Luu [0039-0041] is interpreted as reducing power output of the light source to allow temperatures to cool to a point where therapy can be safely reestablished once the tissue is no longer overheated. Due to the dependence of claims 2-3 on claim 1, a new grounds of rejection is made in view of Tranberg.
Summary: The prior art rejections for claims 1-17 are withdrawn. New 35 U.S.C. § 103 for claims 1-17 are added in view of Tranberg (US PG Pub 2016/0067519 A1). Prior art rejections for claims 18-20 are maintained.
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.
Claims 1-9 and 16-17 are rejected under U.S.C 103 as being unpatentable over Luu (US PG Pub 2021/0113852 A1, see previously cited) in view of Tranberg (US PG Pub 2016/0067519 A1, see previously cited).
Regarding Claim 1, Luu discloses a method for photobiomodulation of tissue ([0029]), the method comprising:
• emitting light from a lead implanted in the tissue using an implanted light source (Fig. 1, [0029-0030] – a light source 400 attached to housing 200 via tether wire 300 is implanted into tissue to irradiate a target tissue);
• repeatedly estimating an amount, speed, or time of any one, or any combination of, a temperature or a temperature change of, or amount of heat generated by, the implanted light source ([0039] – the light source power transmission is monitored for excessive temperature)
or repeatedly estimating an amount, speed, or time of any one, or any combination of, a temperature or a temperature change of tissue receiving the emitted light ([0039] – temperature estimated by a sensor at the target treatment site); and
• when the estimate exceeds a first threshold value and the light is emitted according to the first delivery program, emitting light from the implanted lead using the implanted light source according to a second delivery program, wherein the second delivery program results in lower heat generation by the implanted light source over a period of time than the first delivery program ([0041] – “temperature sensor 251 such as a thermistor may also be coupled to the flexible substrate in order to allow temperature monitoring at the target treatment area since light may generate heat and overheating is undesirable and may damage tissue. If excessive heat is generated the lights may be turned off”; the claim merely states the light is emitted according to the second delivery program (which is to turn the light off in Luu)).
Note the term “estimating” is being interpreted as obtaining a temperature measurement from a sensor as an approximation of the actual temperature (such as the use of “estimate” in the Specification on Page 10, Lines 13-22). Luu discloses the ability to adjust the irradiation intensity of the light source ([0040]). However, Luu does not disclose wherein light is emitted during both the first delivery program and the second delivery program.
Tranberg, in the same field of endeavor of an implantable unit with light irradiation and a temperature regulation feature ([0009]), teaches the use of an optical fiber emitting light to heat target tissue to a particular tissue temperature as part of a treatment ([0009]). If a tissue temperature is exceeded, the light source can either be adjusted to attenuate power output or be fully deactivated ([0095]).
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 Luu’s implantable phototherapy method by incorporating the ability to reduce light power settings in Tranberg. This would have been obvious because both Luu and Tranberg discuss implantable light therapy leads with thermal monitoring and Tranberg provides a solution/improvement by allowing greater control of the light source by either have its output reduced or turned off depending on the desired rate of cooling needed during overheating. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Luu by incorporating the ability to reduce light power settings in Tranberg.
Therefore, Claim 1 is obvious over Luu in view of Tranberg.
Regarding Claim 2, the method according to Claim 1 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu further discloses when the estimate falls below a second threshold value and the light is emitted according to the second delivery program ([0041] – reverse of the situation in claim 1 where the original irradiation is provided again once temperatures fall below the threshold; in Luu the light is only turned off when the temperature is above a particular threshold) emitting light from the implanted lead (Fig. 1, [0029-0030] – a light source 400 attached to housing 200 via tether wire 300 is implanted into tissue to irradiate a target tissue) using the implanted light source according to the first delivery program ([0034] – electronics in housing control the light source). Luu [0039-0041] is interpreted as reducing power output of the light source to allow temperatures to cool to a point where therapy can be safely reestablished once the tissue is no longer overheated.
Therefore, Claim 2 is obvious over Luu in view of Tranberg.
Regarding Claim 3, the method according to Claim 2 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu discloses monitoring temperature and modifying the light irradiation program (stopping irradiation) once a maximum threshold has been reached ([0041]). However, Luu does not disclose wherein the first threshold value and the second threshold value are different.
Tranberg, in the same field of endeavor of an implantable unit with light irradiation and a temperature regulation feature ([0009]), teaches the use of an optical fiber emitting light to heat target tissue to a particular tissue temperature as part of a treatment ([0009]). If a tissue temperature is exceeded, the light source can either be adjusted to reduce power output reduced or fully deactivated ([0095]). Multiple thresholds can be considered where a high threshold exists where irradiation is downregulated ([0095],[0097]) and a low threshold exists where irradiation is upregulated ([0096-0097]).
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 Luu’s implantable phototherapy method by incorporating multiple temperature thresholds to control a light therapy device in Tranberg. This would have been obvious because both Luu and Tranberg discuss implantable light therapy leads with thermal monitoring and Tranberg provides a solution/improvement by allowing more exact control by establishing different gradations of temperature with different corresponding irradiation settings. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Luu by incorporating multiple temperature thresholds to control a light therapy device in Tranberg.
Therefore, Claim 3 is obvious over Luu in view of Tranberg.
Regarding Claim 4, the method according to Claim 1 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu further discloses wherein the estimating comprises making a measurement to estimate the amount, speed, or time of any one, or any combination, of the temperature, temperature change, or amount of heat generated ([0039] – temperature estimated by a sensor at the target treatment site). Note the term “estimating” is being interpreted as obtaining a temperature measurement from a sensor as an approximation of the actual temperature (such as the use of “estimate” in the Specification on Page 10, Lines 13-22).
Therefore, Claim 4 is obvious over Luu in view of Tranberg.
Regarding Claim 5, the method according to Claim 4 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu further discloses wherein making the measurement comprises making the measurement regularly with a specified periodicity ([0039] – temperature is monitored by the sensor (having its own sampling rate), which would suggest a certain periodicity to make sure temperatures remain below a specified threshold in [0041] to prevent tissue damage).
Therefore, Claim 5 is obvious over Luu in view of Tranberg.
Regarding Claim 6, the method according to Claim 4 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu further discloses making the measurement comprises making a temperature measurement using a thermistor ([0041] - thermistor). Luu does not explicitly disclose a thermocouple, a resistance thermal detector (RTD), infrared sensor, or an integrated circuit thermal sensor, but only one of the temperature sensors on the claim’s list is interpreted as being necessary for representation in the prior art.
Therefore, Claim 6 is obvious over Luu in view of Tranberg.
Regarding Claim 7, the method according to Claim 4 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu further discloses wherein making the measurement comprises making an electrical measurement of the light source ([0032] – electrical power can be assessed and controlled: “energy captured by the coil 101 is delivered to the housing 200 which contains various electronic components for managing the power and controlling the duty cycle of the light source 400”).
Therefore, Claim 7 is obvious over Luu in view of Tranberg.
Regarding Claim 8, the method according to Claim 7 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu further discloses wherein making the electrical measurement comprises making a measurement of current, voltage, or impedance, or of a change in current, voltage, or impedance, of the light source ([0032] – power to the light source is controlled, [0039] – more specifically the voltage, current, and impedance are assessed and adjusted to control the irradiation provided by the light source).
Therefore, Claim 8 is obvious over Luu in view of Tranberg.
Regarding Claim 9, the method according to Claim 4 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu further discloses wherein making the measurement comprises making a measurement of the light emitted by the light source ([0100] – fluence and radiant power of the light source measured).
Therefore, Claim 9 is obvious over Luu in view of Tranberg.
Regarding Claim 16, a system for photobiomodulation of tissue ([0029]), the system comprising:
• a light source (400, Fig. 1);
• an implantable lead (tether 300) comprising a distal region and a light emitter disposed along the distal region (Fig. 1, [0033] – the light source is disposed on the distal end of the tether), wherein the light emitter is either the light source or coupled to the light source by at least one optical waveguide so that light from the light source is emitted from the light emitter ([0035] – the light source 400 is the emitter); and
• an implantable control module coupled to the light source for directing the light source to generated light ([0034] – a tether wire electrically connected the electronics in the housing with the light source), the implantable control module comprises a memory storing instructions ([0039] – microcontroller, which controls the operation of the light source, would have memory to store instructions) and a processor configured to execute the instructions ([0039] – “A microcontroller 230 may also be included in the housing to control the system”, meaning it contains a microprocessor), the instructions comprising the method of claim 1 (see claim 1 rejection, the method in claim 1 is obvious over Luu in view Tranberg).
Therefore, Claim 16 is obvious over Luu in view of Tranberg.
Regarding Claim 17, the system according to Claim 16 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu further discloses wherein the instructions further comprise when the estimate falls below a second threshold value and the light is emitted according to the second delivery program ([0041] – reverse of the situation in claim 16 where the original irradiation is provided again once temperatures fall below the threshold; in Luu the light is only turned off when the temperature is above a particular threshold), emitting light from the implanted lead (Fig. 1, [0029-0030] – a light source 400 attached to housing 200 via tether wire 300 is implanted into tissue to irradiate a target tissue) according to the first delivery program ([0032] – system control circuit used to control the light source).
Therefore, Claim 17 is obvious over Luu in view of Tranberg.
Claims 10-15 are rejected under U.S.C 103 as being unpatentable over Luu (US PG Pub 2021/0113852 A1, see previously cited) in view of Tranberg (US PG Pub 2016/0067519 A1, see previously cited) and Vansickle (US PG Pub 2021/0008388 A1, see previously cited).
Regarding Claim 10, the method according to Claim 1 is obvious over Luu in view of Tranberg, as indicated hereinabove. Luu discloses wherein emitting light from the implanted lead using the implanted light source according to the second delivery program (Fig. 1, [0029-0030] – a light source 400 attached to housing 200 via tether wire 300 is implanted into tissue to irradiate a target tissue) comprises:
• when the estimate exceeds a first threshold value and the light is emitted according to the first delivery program, switching to the second delivery program ([0041], the claim merely states the light is emitted according to the second delivery program (which is to turn the light off in Luu)); and
• emitting light from the implanted lead using the implanted light source according to the second delivery program (Fig. 1, [0029-0030] – a light source 400 attached to housing 200 via tether wire 300 is implanted into tissue to irradiate a target tissue);
Luu does not disclose requesting user confirmation to switch to the second delivery program, and after receiving the user confirmation, emitting light from the implanted lead using the implanted light source according to the second delivery program.
Vansickle, in the same field of endeavor of implantable optical lead stimulation ([0002]), teaches a prompting message for a user to decide whether to make a change based on recommended settings ([0087]). If the user does not receive a response within a specified time period, the system will implement the recommended changes ([0090] – “The device may direct or prompt the user to make the adjustment (or select the predefined stimulation program). If the user does not respond, the device optionally may send a warning to the patient, a clinician, a care giver, or any other suitable individual or device. In some embodiments, the system may automatically make the adjustment (or select the predefined stimulation program) if the user does not respond in a specified time period”).
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 Luu’s implantable phototherapy method by incorporating the prompting of the user with a recommendation to change settings via the user interface in Vansickle. This would have been obvious because both Luu and Vansickle discuss implantable light therapy leads with monitoring and Vansickle provides a solution/improvement by adding a step to consult the user before alterations are made to prevent unilateral changes by the system. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Luu by incorporating the prompting of the user with a recommendation to change settings via the user interface in Vansickle.
Therefore, Claim 10 is obvious over Luu in view of Tranberg and Vansickle.
Regarding Claim 11, the photobiomodulation method in Claim 10 is obvious over Luu in view of Tranberg and Vansickle, as indicated hereinabove. Luu discloses further comprising:
• when the estimate falls below a second threshold value and the light is emitted according to the second delivery program, switching to the first delivery program ([0041] – reverse of the situation in claim 10 where the original irradiation is provided again once temperatures fall below the threshold), and
• emitting light from the implanted lead using the implanted light source according to the first delivery program ([0034] – electronics in housing control the light source).
Luu does not disclose requesting user confirmation to switch to the first delivery program, and after receiving the user confirmation, emitting light from the implanted lead using the implanted light source according to the first delivery program.
Vansickle, in the same field of endeavor of implantable optical lead stimulation ([0002]), teaches a prompting message for a user to decide whether to make a change based on recommended settings ([0087]). If the user does not receive a response within a specified time period, the system will implement the recommended changes ([0090]).
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 Luu’s implantable phototherapy method by incorporating the prompting of the user with a recommendation to change settings via the user interface in Vansickle. This would have been obvious because both Luu and Vansickle discuss implantable light therapy leads with monitoring and Vansickle provides a solution/improvement by adding a step to consult the user before alterations are made to prevent unilateral changes by the system. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Luu by incorporating the prompting of the user with a recommendation to change settings via the user interface in Vansickle.
Therefore, Claim 11 is obvious over Luu in view of Tranberg and Vansickle.
Regarding Claim 12, the photobiomodulation method in Claim 10 is obvious over Luu in view of Tranberg and Vansickle, as indicated hereinabove. Luu further discloses wherein the estimating comprises making a measurement to estimate the amount, speed, or time of any one, or any combination, of the temperature, temperature change, or amount of heat generated ([0039] – temperature estimated by a sensor at the target treatment site). Note the term “estimating” is being interpreted as obtaining a temperature measurement from a sensor as an approximation of the actual temperature (such as the use of “estimate” in the Specification on Page 10, Lines 13-22).
Therefore, Claim 12 is obvious over Luu in view of Tranberg and Vansickle.
Regarding Claim 13, the photobiomodulation method in Claim 12 is obvious over Luu in view of Tranberg and Vansickle, as indicated hereinabove. Luu further discloses wherein making the measurement comprises making the measurement regularly with a specified periodicity ([0039] – temperature is monitored by the sensor (having its own sampling rate), which would suggest a certain periodicity to make sure temperatures remain below a specified threshold in [0041] to prevent tissue damage).
Therefore, Claim 13 is obvious over Luu in view of Tranberg and Vansickle.
Regarding Claim 14, the photobiomodulation method in Claim 12 is obvious over Luu in view of Tranberg and Vansickle, as indicated hereinabove. Luu further discloses making the measurement comprises making a temperature measurement using a thermistor ([0041] - thermistor). Luu does not explicitly disclose a thermocouple, a resistance thermal detector (RTD), infrared sensor, or an integrated circuit thermal sensor, but only one of the temperature sensors on the claim’s list is interpreted as being necessary for representation in the prior art.
Therefore, Claim 14 is obvious over Luu in view of Tranberg and Vansickle.
Regarding Claim 15, the photobiomodulation method in Claim 12 is obvious over Luu in view of Tranberg and Vansickle, as indicated hereinabove. Luu further discloses wherein making the measurement comprises making an electrical measurement of the light source ([0032] – electrical power can be assessed and controlled: “energy captured by the coil 101 is delivered to the housing 200 which contains various electronic components for managing the power and controlling the duty cycle of the light source 400”).
Therefore, Claim 15 is obvious over Luu in view of Tranberg and Vansickle.
Claim 18 is rejected under U.S.C 103 as being unpatentable over Luu (US PG Pub 2021/0113852 A1, see previously cited) in view of De Taboada (WO 2012/024243 A1, see previously cited).
Regarding Claim 18, Luu discloses a photobiomodulation system ([0029]), comprising:
• a programmer comprising a processor ([0039] – “A microcontroller 230 may also be included in the housing to control the system”, meaning it contains a microprocessor), configured for programming of an implantable control unit for generating a delivery program for an implanted light source (Fig. 2, [0036] – electronics used to control light source stored within implantable housing 200) the processor configured to perform actions comprising:
receiving a selection of a value for each of a plurality of delivery parameters ([0076] – user interface can be used to control settings; [0089] – fluence rate, light cycling, and total treatment time are given as examples of parameters which can be controlled).
Luu does not disclose the processor configured to perform actions comprising: wherein the selection of the value for each of the delivery parameters is limited by expected heat generation or temperature change arising from the selection of the value and any previously selected values; and after the selection of all of the values, estimating, using a model, a look-up table, or curve or template matching, expected heat generation and, when the expected heat generation or temperature change exceeds a threshold either i) providing a warning or recommendation to a programmer or ii) requiring the programmer to alter at least one of the selected values.
De Taboada, in the same field of endeavor of implantable light therapy ([0002]), teaches the use of temperature thresholds for safety where light therapy parameters are selected based on keeping temperature below these thresholds ([0150]). Changes in tissue temperature can be predicted in response to parameters based on assumptions about tissue heat transfer relationships ([0152, 0154] - only settings which are predicted to result in an effective treatment while remaining below a threshold are considered for the programming element). Using the plain meaning of the term “model,” De Taboada teaches a feature of estimating temperature increases in tissue based on the calculated power output of a light irradiation waveform (determined by amplitude, pulse width, and duty cycle) vs. the estimated heat dissipation of the tissue ([0154]). This would be interpreted as constituting a model of expected heat generation in the tissue based on the calculated power irradiated from the light source and thermal relaxation calculations.
De Taboada also teaches an alarm or warning mechanism prompting the user to change settings in response to problems identified by the light therapy system ([0105]). This alarm or warning system is interpreted as being applicable to any identified change recommended by the light therapy system, including changes in settings due to predictions of temperature changes due to selected parameters.
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 Luu’s implantable phototherapy system by incorporating the thermal prediction feature and warning to the user about changing parameters in De Taboada. This would have been obvious because both Luu and De Taboada discuss implantable light therapy with adjustable settings and temperature sensors and De Taboada provides a solution/improvement by predicting the thermal results of settings changes in order to facilitate the adjustment of settings before encountering excessive tissue temperatures. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Luu by incorporating the thermal prediction feature and warning to the user about changing parameters in De Taboada.
Therefore, Claim 18 is obvious over Luu in view of De Taboada.
Claims 19-20 are rejected under U.S.C 103 as being unpatentable over Luu (US PG Pub 2021/0113852 A1, see previously cited) in view of Bornstein (US PG Pub 2012/0319010 A1, see previously cited).
Regarding Claim 19, Luu discloses a photobiomodulation system ([0029]), comprising:
• an implantable light source (400, Fig. 1; the light source at the distal end of tether 300 in Figs. 2 and 3, [0028] – device is implanted);
• an implantable lead (tether 300) comprising a distal region and a light emitter disposed along the distal region (Fig. 1, [0033] – the light source is disposed on the distal end of the tether), wherein the light emitter is either the implantable light source or coupled to the implantable light source by at least one optical waveguide so that light from the implantable light source is emitted from the light emitter into tissue ([0035] – the light source 400 is the emitter);
• an implantable control module coupled to the implantable light source for directing the implantable light source to generate light ([0034] – a tether wire electrically connected the electronics in the housing with the light source).
Luu does not disclose a thermoelectric cooling device coupled to the implantable light source and configured for removing heat generated by the implantable light source; and an implantable control module coupled to the thermoelectric cooling device for directing the thermoelectric cooling device to remove heat generated by the implantable light source.
Bornstein, in the same field of endeavor of an implantable optical delivery apparatus ([0483]), teaches a thermoelectric cooling device attached near the diffusion tip ([0507]). Bornstein describes the diffusion tip as “treatment system 110 employs a diffusion tip 10 to diffuse therapeutic treatment light delivered from a therapeutic light source by optical fiber 118. The tip operates to provide a desired illumination profile (i.e. emitted intensity profile) at the application region 116” ([0483]). The thermoelectric cooling device is interpreted as being controlled by device controller 118 ([0465-0466]) in order to cool in response to temperature readings.
Bornstein teaches the diffusion tip can be placed to apply phototherapy to internal targets ([0483] – “For example, as described above, in embodiments where treatment light is applied to the nares, a substantially uniform cylindrical illumination profile is desirable. Other embodiments of tip 10 may be used to direct treatment light to other areas such as tissue spaces (e.g. the periodontal pocket or within a joint e.g. in an orthopedic surgical procedure), interfaces between body tissue and other surfaces (e.g. the surface of an implantable medical device), over a wide area such as a dermal surface, etc.”). Therefore, sufficient evidence exists to suggest Bornstein’s device can be applied to an implantable system, such as the implantable system in Luu. This would establish sufficient motivation to use a tip containing a thermoelectric cooler as part of an implantable device.
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 Luu’s implantable phototherapy system by incorporating the thermoelectric cooling feature in the lead tip in Bornstein. This would have been obvious because both Luu and Bornstein discuss implantable light therapy leads with thermal monitoring and Bornstein provides a solution/improvement by adding a cooling device to the lead for more direct temperature regulation. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Luu by incorporating the thermoelectric cooling feature in the lead tip in Bornstein.
Therefore, Claim 19 is obvious over Luu in view of Bornstein.
Regarding Claim 20, the photobiomodulation system in Claim 19 is obvious over Luu in view of Bornstein, as indicated hereinabove. Luu discloses wherein the implantable light source is disposed in the implantable lead (Fig. 1, [0033] – the light source is disposed on the distal end of the tether). Luu does not disclose a thermoelectric cooling device disposed in the implantable lead.
Bornstein, in the same field of endeavor of an implantable optical delivery apparatus ([0483]), teaches a thermoelectric cooling device attached near the diffusion tip ([0507]). Bornstein describes the diffusion tip as “treatment system 110 employs a diffusion tip 10 to diffuse therapeutic treatment light delivered from a therapeutic light source by optical fiber 118. The tip operates to provide a desired illumination profile (i.e. emitted intensity profile) at the application region 116” ([0483]). The thermoelectric cooling device is interpreted as being controlled by device controller 118 ([0465-0466]) in order to cool in response to temperature readings.
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 Luu’s implantable phototherapy system by incorporating the thermoelectric cooling feature in the lead tip in Bornstein. This would have been obvious because both Luu and Bornstein discuss implantable light therapy leads with thermal monitoring and Bornstein provides a solution/improvement by adding a cooling device to the lead for more direct temperature regulation. Therefore, a person of ordinary skill in the art would be motivated to improve the system of Luu by incorporating the thermoelectric cooling feature in the lead tip in Bornstein.
Therefore, Claim 20 is obvious over Luu in view of Bornstein.
Conclusions
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
Prosecution Insights