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 .
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4-10, and 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melone (US Publication no. 2018/0360665).
In regard to claims 1 and 17, Melone describes a photobiomodulation (i.e., light) therapy device 103 (figure 2-4), comprising:
a receiving pad 203 that is constructed to receive a portion of a user's body (e.g., see figure 5 wrapping around or receiving a user’s forearm);
a first plurality of blue light emitting diodes (LEDs), wherein at least a first portion of the first plurality of blue LEDs is attached to the receiving pad (para 35, pad 203 comprises LEDs 209; para 40, wherein LEDs may contain Blue);
a second plurality of red LEDs, wherein at least a first portion of the second plurality of red LEDs is attached to the receiving pad (para 35, pad 203 comprises LEDs 209; para 40, wherein LEDs may contain Red); and
a third plurality of infrared LEDs, wherein at least a first portion of the third plurality of infrared LEDs is attached to the receiving pad (para 35, pad 203 comprises LEDs 209; para 40, wherein LEDs may contain infrared);
control circuitry 112 (i.e., control unit 112) operably coupled to the first plurality of blue LEDs, the second plurality of red LEDs, and the third plurality of infrared LEDs (para 27, control unit 112 is coupled to pad 103; para 31, control unit uses a control signal to control operation of the LEDs 209 of pad 103), wherein the control circuitry is configured at least to:
activate the first plurality of blue LEDs so that the first plurality of blue LEDs each have a pulse rate of 146 Hz (para 40, one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz);
stepwise increase the pulse rate of the first plurality of blue LEDs from 146 Hz to 946 Hz (para 40, one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz, additionally, the pulsing frequency may be considered to be varied from about 292 Hz to about 4,672 Hz during the treatment program; as the lights can be varied in this range, it is considered that the structure of Melone is capable of providing stepwise increases or decreases);
deactivate the first plurality of blue LEDs (para 40, LEDs of red, blue and infrared are pulse sequentially, which is considered to comprise activating and deactivating the specific color the LEDs in a sequence. Moreover, the device of Melone include structure capable of performing this function);
activate the second plurality of red LEDs and the third plurality of infrared LEDs so that the second plurality of red LEDs and the third plurality of infrared LEDs each have a pulse rate of 146 Hz (para 40, LEDs of red, blue and infrared are pulse sequentially, which is considered to comprise activating and deactivating the specific color the LEDs in a sequence; one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz Moreover, the device of Melone include structure capable of performing this function);
stepwise increase the pulse rate of the second plurality of red LEDs and the third plurality of infrared LEDs from 146 Hz to 2487 Hz (para 40, one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz, additionally, the pulsing frequency may be considered to be varied from about 292 Hz to about 4,672 Hz during the treatment program; as the lights can be varied in this range, it is considered that the structure of Melone is capable of providing stepwise increases or decreases;
decrease the pulse rate of the second plurality of red LEDs and the third plurality of infrared LEDs from 2487 Hz to 292 Hz (para 40, one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz, additionally, the pulsing frequency may be considered to be varied from about 292 Hz to about 4,672 Hz during the treatment program; as the lights can be varied in this range, it is considered that the structure of Melone is capable of providing stepwise increases or decreases;
stepwise increase the pulse rate of the second plurality of red LEDs and the third plurality of infrared LEDs from 292 Hz to 4950 Hz (para 40, one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz, additionally, the pulsing frequency may be considered to be varied from about 292 Hz to about 4,672 Hz during the treatment program; as the lights can be varied in this range, it is considered that the structure of Melone is capable of providing stepwise increases or decreases);
decrease the pulse rate of the second plurality of red LEDs and the third plurality of infrared LEDs from 4950 Hz to 586 Hz (para 40, one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz, additionally, the pulsing frequency may be considered to be varied from about 292 Hz to about 4,672 Hz during the treatment program; as the lights can be varied in this range, it is considered that the structure of Melone is capable of providing stepwise increases or decreases);
stepwise increase the pulse rate of the second plurality of red LEDs and the third plurality of infrared LEDs from 586 Hz to 9950 Hz (para 40, one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz, additionally, the pulsing frequency may be considered to be varied from about 292 Hz to about 4,672 Hz during the treatment program; as the lights can be varied in this range, it is considered that the structure of Melone is capable of providing stepwise increases or decreases; additionally Melone teaches that the range of frequencies may be varied between 1 Hz to 10,000 Hz);
decrease the pulse rate of the second plurality of red LEDs and the third plurality of infrared LEDs from 9950 Hz to 1146 Hz (para 40, one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz, additionally, the pulsing frequency may be considered to be varied from about 292 Hz to about 4,672 Hz during the treatment program; as the lights can be varied in this range, it is considered that the structure of Melone is capable of providing stepwise increases or decreases; additionally Melone teaches that the range of frequencies may be varied between 1 Hz to 10,000 Hz);
stepwise increase the pulse rate of the second plurality of red LEDs and the third plurality of infrared LEDs from 1146 Hz to 12345 Hz (para 40, one or more LEDs may be pulsed at a frequency of about 292 Hz, about 584 Hz, about 1,168 Hz, about 2,336 Hz, about 4,672 Hz, about 73 Hz, and/or about 146 Hz, additionally, the pulsing frequency may be considered to be varied from about 292 Hz to about 4,672 Hz during the treatment program; as the lights can be varied in this range, it is considered that the structure of Melone is capable of providing stepwise increases or decreases; additionally Melone teaches that the range of frequencies may be varied between 1 Hz to 10,000 Hz).
Melone teaches that the LED frequencies may be varied within a range of 1 Hz t0 10,000 Hz and provides specific frequencies for pulse rages includes 146 Hz, 292 Hz, 2,336 Hz and 4,672 Hz. These frequencies not only anticipate several of the recited frequencies, but also substantially overlap with certain specificity the ranges as claimed, that only routine skill in the art would be required to use the ranges of Melone as a starting point to optimize the therapeutic effect. This overlap is also considered similarly close to the recited value of 12345 Hz (which is not disclosed with any criticality in the specification and is considered to be an arbitrary end point) and is rendered obvious since Melone provides similar properties that are effected by the range. Therefore, the claimed ranges are considered obvious to one of ordinary skill in the art since they were substantially suggested by Melone and discovery of the optimal value or range within that suggested range would not require undue experimentation.
Additionally, the present invention is directed to a device, wherein the limitations of the control circuitry are functional recitations. While functional recitations are proper, there must be a structural difference. MPEP 2114 states "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The device of Melone includes all structural limitations recited by the present invention. Moreover, the structure of Melone is capable of generating light therapy in the manner claimed of selectively activating and deactivating light sources, pulsing the light at specific frequencies, and varying the pulsed output within a range of frequencies. As the present invention fails to disclose any criticality to the sequence of activating and deactivating light sources, pulsing the light at specific frequencies, and varying the pulsed output within a range of frequencies, the present invention is deemed an obvious optimization of the prior art.
In regard to claims 4 and 13, Melone includes a portable battery constructed and arranged to provide power to the first plurality of blue LEDs, the second plurality of red LEDs, and the third plurality of infrared LEDs (para 52, control unit 112 serves as the power source and is considered portable). The power source of Melone is considered a suitable alternative equivalent to a battery to provide power to the LEDs 209.
In regard to claims 5, 14, and 18, Melone includes a first plurality of blue LEDs emits light having wavelengths, however not in the range from 461 nm to 477 nm. Melone emits blue light at 485 nm (para 40). However, this value is considered substantially similar to the range claimed since the value of Melone is still recognized as blue light and would provide similar effect. Additionally, the value of Melone provides a starting point for further discovery. The claimed range is deemed obvious as optimization of the result effective variable.
In regard to claims 6, 15, and 19, Melone includes a second plurality of red LEDs emits light having wavelengths primarily in the range from 627 nm to 645 nm (para 40, red light is 640 nm). The value of Melone anticipates the red range presently recited.
In regard to claims 7, 16, and 20, Melone includes third plurality of infrared LEDs emits light having wavelengths, however not in the range from 842 nm to 860 nm. Melone emits infrared light at 880 nm (para 40). However, this value is considered substantially similar to the range claimed since the value of Melone is still recognized as infrared light and would provide similar effect. Additionally, the value of Melone provides a starting point for further discovery. The claimed range is deemed obvious as optimization of the result effective variable.
In regard to claim 8, Melone teaches that the first plurality of blue LEDs, the second plurality of red LEDs, and the third plurality of infrared LEDs have a duty cycle of approximately 40% (para 40, the duty cycle is in the range of 25%-75%). The range of Melone anticipates the present duty cycle value. Additionally, the range of Melone provides a starting point for further discovery. The claimed range is deemed obvious as optimization of the result effective variable.
In regard to claim 10, Melone substantially suggests the invention as claimed, however does not teach the second receiving pad that is constructed to receive a second portion of the user’s body. In view that this claimed second pad is structurally identical to the first receiving pad (i.e., pad 103 recited in present claim 1), the second receiving pad is considered to have been obvious to one of ordinary skill in the art as the duplication of another working part. This has been held by the reviewing courts as only requiring routine skill.
Claim(s) 2, 3, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melone (US Publication no. 2018/0360665) in view of Coggins (US Publication no. 2022/0133518).
In regard to claims 2 and 11, Melone substantially suggests the invention as claimed however does not teach a base plate; a first arm pivotally connected to the base plate; a second arm pivotally connected to the base plate; wherein the receiving pad is disposed on the base plate and positioned between the first arm and second arm. Coggins in figures 1-4 describe an apparatus constructed in a manner with comprising a base plate 22, a first arm 16 pivotally connected to base plate 22 via pinion 18, a second arm 16 (there are 2 arms 16 connected to plate 22) pivotally connected to base plate 22 via pinion 18. Plate 22 serves as a location on which pad 103 of Melone may be placed and situated between arms 16. Pad 103 of Melone may be placed on plate 22 to hold pad 103 in place while treating a wound that may be located on the bottom of a user’s foot. Modification of Melone to place pad 103 on base plate 22 of Coggins is considered to have been obvious to one of ordinary skill in the art as the combination of known prior art elements such that base 22 serves as a plane support of treatment pad 103 when used to treat a wound on the bottom of a user’s foot, which would be advantageous for patient’s with diabetic neuropathy. It is further noted that the present specification fails to provide written criticality for this location, and may be construed as design choice.
In regard to claims 3 and 12, Melone substantially suggests the invention as claimed however does not teach a second portion of the second plurality of red LEDs is attached to the first arm; a third portion of the second plurality of red LEDs is attached to the second arm; a second portion of the third plurality of infrared LEDs is attached to the first arm; a third portion of the third plurality of infrared LEDs is attached to the second arm. Coggins describes the apparatus comprising the arms and base plate. Placing the pad 103 of Melone on plate 22 is considered to secure pad under the foot for treatment. Placing additional pad structures on legs 16 is considered to have been obvious to one of ordinary skill in the art since it would involve the duplication of the pad element and choice of location of in manner that would effect function or performance of the pad. Duplication and rearrangement of parts in a manner that does not impact the structure or function of the duplicated or relocated element has been held be reviewing courts as obvious routine activity. Moreover, the present specification fails to provide written criticality for these locations, and is therefore construed as design choice. One of ordinary skill in the art would be motivated to place the wound treatment pad on the arms of Coggins in order to provide support to pad 103 when treating wounds that may be the result of surgery located in or around the ankle or knee.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Melone (US Publication no. 2018/0360665) in view of Cabana et al. (US Publication no. 2024/0091551).
In regard to claim 9, Melone describes the invention as claimed, however does not teach that the receiving pad includes an attached proximity sensor. Cabana et al. discloses a device for providing light therapy to a part of a user’s body from light emitted by a plurality of LEDs (para 55). The device of Cabana et al. includes a photodiode proximity sensor as part of the device in order to detect a distance to an object by measuring the intensity of the light reflected back onto the photodiode by the object. The one or more photodiode proximity sensors may be configured such that the plurality of light sources will only light if they are within a predetermined distance from a body area to be treated, and such that the plurality of light sources will turn off if they are moved more than the predetermined distance away from the body area to be treated (para 61). It is considered obvious to one of ordinary skill in the art to modify Melone with a proximity sensor since it is explicitly taught by Cabana et al. that the sensor serves to control illumination of the light sources. Such control would reduce drain on the power source when the pad 103 is not being used as intended (i.e., when a body part is received by the pad).
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 27 February 2026