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 .
Specification
The amendment filed 10/15/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Paragraph [0041] has been amended to state “the plurality of light sources are pulsed on and off 130 to avoid the burning the user’s skin”. This appears to be broadening the disclosure and is not directed to correction of a minor informality. Applicant is required to cancel the new matter in the reply to this Office Action.
Response to Arguments
The previous 112(a) rejection has been overcome. It is noted that the amendments have introduced a new 112(a) rejection as identified below.
Applicant's arguments filed 10/25/2025 have been fully considered but they are not persuasive. Regarding the 112(b) rejection the applicant argues methylene blue is administered as a preparatory step performed before the wearable device is operational, and not a function performed by the claimed system itself. The examiner notes MPEP 2114(II) discloses "[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. The examiner notes that the claim appears to be a recitations with respect to the manner in which a claimed apparatus is intended to be employed and does not differentiate the claimed apparatus from a prior art apparatus. The previous 112(b) and 112(d) rejections have been withdrawn. Regarding the 101 rejection, the applicant argues claim 4 recites the wearable device is adapted to be strapped to a user’s appendage in lines 4-5 and therefore does not positively claim a human organism. The examiner acknowledges in these instance it is clear that the claim does not positively recite a human organism; however in lines 6-7 states “the LED light therapy further comprising: exposing the user’s appendage to the plurality of light sources having a wavelength”. The examiner notes this requires a user’s appendage. The examiner suggests amending the claim to indicate the LED light therapy further comprises a plurality of light sources having a wavelength which are configured to expose to the user’s appendage.
Applicant argues Salinas and Luttrull disclose different mechanisms of action and thus cannot be properly combined. The examiner notes the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Salinas similar to the instant disclosure teaches disaggregation of red blood cells (e.g. Paragraph [0008]-[0009] using low level light). Salinas in Paragraph [0007] discloses the importance of non-aggregated red blood cells for purposes such as supplying oxygen to the living tissues (e.g. Paragraph [0007]). While Salinas does not explicitly disclose treating respiratory illness, Luttrull teaches that it is known to treat various respiratory illnesses. Therefore, the modification with Salinas would be to use the disaggregation of red blood cells to treat respiratory illness which provides a supply of oxygen to living tissues via the hemoglobin internally carried by RBCs.
Regarding Lewis the Applicant argues there is no disclosure in Lewis of altering the light wavelength at a frequency period of 432 milliseconds and the range provided by Lewis encompasses thousands of possible values and provides no guidance toward the specific frequency period of 432 milliseconds. The examiner respectfully disagrees as discuses rapid cycling and delivering many pulse sets per second. A frequency period of 432 milliseconds is about 2.31 Hz and having many cycles would encompass 2 or 3 cycles per second. Therefore, the rejection regarding routine optimization and deign choice are maintained.
In addition, Applicant argues that 432 milliseconds is a specific number and that reading the disclosure as a whole (e.g. Paragraph [0020]) provides the advantage. Then the Applicant argues Canitano that the specific nanosecond time range has been deleted in favor of a recitation that the pulsed LED light sources is for predetermined on and off time periods (and amends the disclosure to remove the values). The examiner notes that in the previous rejection the examiner noted that the disclosure did not provide a specific advantage, or solves a stated problem for the 432 milliseconds recitation. This interpretation is maintained as the disclosure does not state 432 milliseconds is critical and Paragraph [00041] of the instant disclosure originally stated approximately 432 milliseconds. The disclosure indicates the wavelengths for the period of time allows for deep penetration of the arteries of the body in order to induce energy into the blood and to photoactivate photosensitive molecules such as a red blood cells. The examiner notes the wavelength provides a specific advantage and solves a stated problem. The examiner notes that in the same original paragraph the light source is pulsed approximately 60 nanoseconds on and approximately 40 nanoseconds off to avoid burning the user’s skin. This is a specific advantage and solves a problem. However, the pulsed parameters are now deleted and would now encompass 1 minute on 1 nanosecond off, which would likely raise the risk of burning the user’s skin. While the frequency period is not disclosed in the specification to have any particular purpose, it is argued that it is integral to treatment for respiratory illnesses using light therapy. While parameters being recited for a specific purpose are deleted. Therefore, the examiner maintains that the frequency period of 432 milliseconds is not disclosed to provide a specific advantage, or solves a stated problem. Since the wavelength is disclosed as infusing energy into the blood and to photoactivate photosensitive molecules, but the frequency period appears to be arbitrary and does not solve a specific problem.
Applicant argues that Canitano discloses laser light and not LED light therapy. The examiner notes the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Salinas discloses the use of LED light source (e.g. Paragraphs [0023] and [0031]).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, and 4-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 4 require alternating the emission of light from the at least one first and the at least one second LED light source for predetermined on and off time periods. The claims have been amended to recite a broader range of values than those in the originally filed disclosure; therefore introducing new matter. Dependent claims inherit the same deficiencies.
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 4-5 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claims requires “the light therapy further comprising exposing the user’s appendage to the plurality of light sources having a wavelength”.
Applicant recites part of a human, i.e. "…a user’s appendage”(Claim 4, lines 6-7). Thus, these claims include a human within the scope and are non-statutory.
The examiner suggest the light therapy configured to expose the user’s appendage to the plurality of light sources, the light therapy further comprising the plurality of light sources a wavelength.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Salinas et al. (US 2016/0367833 A1) in view of Luttrull et al. (US 2018/0339167 A1), Lewis (US 2008/0269849 A1) and Canitano et al. (US 2006/0129211 A1).
Regarding claim 1, Salinas et al. discloses a method by applying light therapy in a process of disaggregating red blood cells (pars. [0008]-[0009]) comprising: exposing a user to a plurality of LED light sources, the LED light sources having a wavelength (Fig 8A; Par. [0023] and par. [0140]); the plurality of LED light sources comprising at least one first LED light source and at least one second LED light source, the at least one first LED light source emitting a light at a first wavelength of 625 nanometers and the at least one second LED light source emitting light at a second wavelength of 670 nanometers (par. [0140] discloses more than one light sources selected from: 630 nm±20 nm and 660 nm±20 nm); pulsing the plurality of light sources on and off (par. [0009] - "configured to provide … biostimulation using low level light therapy (LLLT), … at particularly beneficial wavelengths, … pulsing at a duty cycle", par. [0015] - "50 microsecond on and 250 microsecond off"), par. [0143]); and powering down the plurality of LED light sources after an active therapy session of no more than 30 minutes (par. [0031]- "where the customized treatment may permit selection of a treatment time", par. [0110]).
Salinas et al. does not disclose that the method is of treating respiratory illnesses; the LED light source wavelength emissions are alternated at a frequency period of approximately 432 milliseconds; that the light sources are pulsed for approximately 60 nanoseconds on and approximately 40 nanoseconds off.
However, Luttrull et al. discloses that the method is of treating respiratory illnesses (par. [0160]). It would have been obvious to a person skilled in the art to modify the method of Salinas et al. in accordance with the teachings of Luttrull et al. such that the method is of treating respiratory illnesses, since it would enable treating a wide array of illnesses (see Luttrull et al. par. [0160]). Lewis teaches that it is known to use the wavelength is alternated at a frequency (Abstract; Fig. 2 (showing the sources 205a and 210a being alternated); par. [0095]; par. [0105] - "delivering at least a second pulse 210 of light to the target tissue of the subject from the one or more emitter wherein the one or more emitters provides at least one peak wavelength of light 210 that is different from the peak wavelength 205 of the first pulse of light 205"), where the frequency period is in the range of hundreds of milliseconds (par. [0102] - "In another embodiment very rapid cycling well under a second is utilized, and many cycles of the pulse sets may be delivered per second"). to provide since it would reduce the chance of injury (see Lewis par. [0118]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Salinas et al, with the wavelength is alternated at a frequency period where the frequency period is in the range of hundreds of millisecond as taught by Lewis, since such a modification would provide the predictable results of reduce the chance of injury.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Salinas et al in view of Lewis with at a frequency period of 432 milliseconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Additionally, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method as taught by Salinas et al in view of Lewis with a frequency period of 432 milliseconds, because Applicant has not disclosed that a frequency period of 432 milliseconds provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wavelength is alternated at a frequency period where the frequency period is in the range of hundreds of millisecond as taught by Salinas et al in view of Lewis, because it reduce the chance of injury and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Salinas et al in view of Lewis.
Therefore, it would have been an obvious matter of design choice to modify Salinas et al in view of Lewis to obtain the invention as specified in the claim(s).
Canitano et al teaches that it is known to use pulsing a light source in the nanosecond range (par. [0041] - "When the duty cycle selection is set at 50%, the pulse train operates in equal proportions, being on and off during one complete cycle of a specific pulse width, preferably 375 ns. The duty cycle is utilized in 10% incremental steps between 10 percent to 90 percent") to provide optimum biostimulation of tissue to promote efficient treatment as disclosed in Canitano et al. (see Canitano et al. par. [0010]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Salinas et al, with pulsing a light source in the nanosecond range as taught by Canitano et al, since such a modification would provide the predictable results of optimum biostimulation of tissue to promote efficient treatment.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Salinas et al in view of Canitano et al with pulsing the light at 60 nanoseconds on and 40 nanoseconds off, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Salinas et al. (US20160367833A1) in view of Luttrull et al. (US20180339167A1), Lewis (US20080269849A1), Canitano et al. (US20060129211A1), and in further view of Khan et al. (US20130103123A1).
Regarding claim 2, Salinas et al. in view of Luttrull et al., Lewis, and Canitano et al. discloses the method of Claim 1, but does not disclose that the user intakes a medically effective amount of methylene blue prior to being exposed to the plurality of LED light sources. Khan et al. discloses that the user intakes a medically effective amount of methylene blue prior to being exposed to the plurality of light sources (pars. [0074]-[0075], [0079]). It would have been obvious to a person skilled in the art to further modify the method of Salinas et al. in accordance with the teachings of Khan et al. such that the user intakes a medically effective amount of methylene blue prior to being exposed to the plurality of light sources, since it would provide a therapeutic effect (see Khan et al. par. [0075]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Salinas et al. (US20160367833A1) in view of Luttrull et al. (US20180339167A1), Min (US Publication 2016/0271415), Lewis (US20080269849A1), and Canitano et al. (US20060129211A1).
Regarding claim 4, Salinas et al. discloses a system comprising: a user's appendage (Fig 8A); a wearable device comprising a top face (see annotated figure below), a bottom face (see annotated figure below and 101), and side walls (see annotated figure below), wherein the bottom face is embedded with a plurality of light sources (par. [0140]) and strapped to the user's appendage such that the bottom face is in contact with the user's appendage (Figure 8A and par. [0140]) and wherein the wearable device applies a LED light therapy (Figs 8A, par. [0023] and par. [0140]), the light therapy further comprising: exposing the user's appendage to the plurality of light sources wherein each light source has a wavelength (Figs 8A par. [0140]); the plurality of LED light sources comprising at least one first LED light source and at least one second LED light source, the at least one first LED light source emitting a light at a first wavelength of 625 nanometers and the at least one second LED light source emitting light at a second wavelength of 670 nanometers (par. [0140] discloses more than one light sources selected from: 630 nm±20 nm and 660 nm±20 nm); pulsing the plurality of light sources (pars. [0009]; [0015] - "50 microsecond on and 250 microsecond off"); and powering down the plurality of LED light sources after an active therapy session of no more than 30 minutes (pars. [0031]; [0110]).
Annotated Figure 1:
PNG
media_image1.png
334
700
media_image1.png
Greyscale
Salinas et al. does not disclose that the system is for the treatment of respiratory illnesses; wherein the side walls includes at least one battery indicator; the LED light source wavelength emissions are alternated at a frequency period of approximately 432 milliseconds; that the light sources are pulsed for approximately 60 nanoseconds on and approximately 40 nanoseconds off.
However, Luttrull et al. discloses that the system is for the treatment of respiratory illnesses (par. [0160]). It would have been obvious to a person skilled in the art to modify the system of Salinas et al. in accordance with the teachings of Luttrull et al. such that the system is for the treatment of respiratory illnesses, since it would enable treating a wide array of illnesses (see Luttrull et al. par. [0160]).
Min teaches that it is known to use the side walls including at least one battery indicator as set forth in Figure 6, Element 520 to provide an easy to view indicator of the battery status so the user can determine when to recharge or replace the batteries. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Salinas et al, with side walls including at least one battery indicator as taught by Min, since such a modification would provide the predictable results of an easy to view indicator of the battery status so the user can determine when to recharge or replace the batteries.
Lewis teaches that it is known to use the wavelength is alternated at a frequency (Abstract; Fig. 2 (showing the sources 205a and 210a being alternated); par. [0095]; par. [0105] - "delivering at least a second pulse 210 of light to the target tissue of the subject from the one or more emitter wherein the one or more emitters provides at least one peak wavelength of light 210 that is different from the peak wavelength 205 of the first pulse of light 205"), where the frequency period is in the range of hundreds of milliseconds (par. [0102] - "In another embodiment very rapid cycling well under a second is utilized, and many cycles of the pulse sets may be delivered per second"). to provide since it would reduce the chance of injury (see Lewis par. [0118]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Salinas et al, with the wavelength is alternated at a frequency period where the frequency period is in the range of hundreds of millisecond as taught by Lewis, since such a modification would provide the predictable results of reduce the chance of injury.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Salinas et al in view of Lewis with at a frequency period of 432 milliseconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Additionally, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Salinas et al in view of Lewis with a frequency period of 432 milliseconds, because Applicant has not disclosed that a frequency period of 432 milliseconds provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wavelength is alternated at a frequency period where the frequency period is in the range of hundreds of millisecond as taught by Salinas et al in view of Lewis, because it reduce the chance of injury and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Salinas et al in view of Lewis.
Therefore, it would have been an obvious matter of design choice to modify Salinas et al in view of Lewis to obtain the invention as specified in the claim(s).
Canitano et al teaches that it is known to use pulsing a light source in the nanosecond range (par. [0041] - "When the duty cycle selection is set at 50%, the pulse train operates in equal proportions, being on and off during one complete cycle of a specific pulse width, preferably 375 ns. The duty cycle is utilized in 10% incremental steps between 10 percent to 90 percent") to provide optimum biostimulation of tissue to promote efficient treatment as disclosed in Canitano et al. (see Canitano et al. par. [0010]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Salinas et al, with pulsing a light source in the nanosecond range as taught by Canitano et al, since such a modification would provide the predictable results of optimum biostimulation of tissue to promote efficient treatment.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Salinas et al in view of Canitano et al with pulsing the light at 60 nanoseconds on and 40 nanoseconds off, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Salinas et al. (US20160367833A1) in view of Luttrull et al. (US20180339167A1), Min (US Publication 2016/0271415), Lewis (US20080269849A1), Canitano et al. (US20060129211A1), and further in view of Khan et al (US20130103123A1).
Regarding claim 5, Salinas et al. in view of Luttrull et al., Min, Lewis, and Canitano et al. discloses the system of Claim 4, but does not disclose that a medically effective amount of methylene blue is administered to the user prior to the user being exposed to the plurality of LED light sources. Khan et al. discloses that the user intakes a medically effective amount of methylene blue prior to being exposed to the plurality of light sources (pars. [0074]-[0075]; [0079]). It would have been obvious to a person skilled in the art to further modify the system of Salinas et al. in accordance with the teachings of Khan et al. such that the user intakes a medically effective amount of methylene blue prior to being exposed to the plurality of light sources, since it would provide a therapeutic effect (see Khan et al. par. [0075]). The examiner also notes this is a recitation of intended use on how the system is to be used and does not recite any further structure or limitations of the device (see MPEP 2114(II)).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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, David Hamaoui can be reached at (571)270-5625. 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.
/William J Levicky/Primary Examiner, Art Unit 3796