Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/30/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed on 12/30/2025. Currently, claims 1-8, 10-11, 13-19, 21-22, 27 and 29-32 with claims 29-32 newly added.
Response to Arguments
Applicant’s arguments, see pg. 5, filed 12/30/2025, with respect to the previous rejection of claims 10-11 under 35 USC 112(b) have been fully considered and are persuasive. The previous rejection of claims 10-11 under 35 USC 112(b) has been withdrawn.
Applicant’s arguments, see pgs. 5-8, filed 12/30/2025, with respect to the rejection(s) of:
claim(s) 1-8, 10-11, 13-17 and 23-24 rejected under 35 USC 103 as being unpatentable over Arpino
claim(s) 18-19 rejected under 35 USC 103 as being unpatentable over Arpino in view of Ball
claim(s) 21-23, 25 and 27-28 rejected under 35 USC 103 as being unpatentable over Arpino in view of Hicks
have been fully considered and are persuasive based on applicant’s amendments to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the additional reference of Wagennar Cacciola et al (US 20100010593) as outlined below.
While a new grounds of rejection has been made this is specifically because of the new claim amendments, since much of the same prior art (including the same primary reference) is being used in the new grounds of rejections, the crux of the applicant’s arguments should be addressed to help provide clarity on the record.
The crux of applicant’s arguments appears to be that applying the claimed technical parameters of irradiation duration, emission wavelength, effective fluence, irradiation timing and regimen of light to endothelial cells will lead to increased sprout formation which leads to promotion of angiogenesis and that this result is unexpected. Also, applicant points out examples 1-6 in applicant’s specification as showing specifically the parameters of a fluence of 17 J/cm2 or less and an irradiation time of 15 minutes or less as exhibiting this unexpected result. Therefore, the arguments allege the claims are neither anticipated nor obviated by Arpino as modified by the relevant secondary references (see pgs. 5-8 of applicant’s arguments).
In response this argument is not persuasive because it is not commensurate with the scope of the claims. First the claim never specifically requires applying the parameters specifically to endothelial cells. Instead, the claim recites that the overall result of the method is a promotion of endothelial cell viability, proliferation, migration and/or tubulogenesis, but never actively claims applying the light parameters to specifically endothelial cells, only the wound. Also, this overall result as written is not active step applied to the body, but rather a biological response to the light parameters. Therefore, if one applies the claimed parameters of light to the wound, this result would be understood to occur as this is a biological response. Second the claims are broader that applicant appears to argue. None of the claims require all the technical parameters together. Instead, some combination of light parameters are listed in one claim and other combinations are listed in another. For example, claim 5 (either through dependency or directly) recites effective fluence, power density, time, wavelength, but is notably absent about other parameters. While, claim 27 (either through dependency or directly) fluence, power density, time, wavelength, treatment regimen, but is notably absent about other parameters. For applicant to rely on the rational of the combination of all these different light parameters to result in the unexpected results, the entire combination of the alleged parameters together that result in the unexpected results would need to be claimed. Additionally, with respect to the specific combination of just fluency range and time outlined in examples 1-6 that applicant mentions, Arpino’s effective fluence is entirely below 17 J/cm2 (see para 74 of Arpino which discloses .01 J/cm2 to 10 J/cm2 ) and any time range between 1 second to an hour (see para 74 of Arpino) so Arpino completely encompasses the time range and entirely recites the alleged effective fluence. Thus, it appears like applicant’s arguments are not commensurate with the scope of the claims and the scope of Arpino. Therefore, while the grounds of rejection have changed, Arpino is still applied in the new grounds of rejection.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-8, 10-11, 13-17, 29-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arpino et al (EP 3275506) hereafter known as Arpino in view of Wagennar Cacciola et al (US 20100010593) hereafter known as Wagennar Cacciola.
Independent claim:
Regarding claim 1:
Arpino discloses
A method for inducing angiogenesis in a wound [see para 72… “A method for inducing or promoting growth and proliferation of cells is also proposed.” And para 5… “One observes initially a colonization of the wound by migration and proliferation of the fibroblasts. Then, the migration of endothelial cells starting from the healthy vessels will allow the neovascularization, or angiogenesis, of the injured tissue. In the granulation tissue, the fibroblasts are activated and will be differentiate into myofibroblasts that present important contractile properties.” And abstract… “The invention is also directed to a light source assembly comprising a product adapted to be in contact with the skin or a wound and a light source device (10) connected to the product for providing blue light to at least one skin cell (C), preferably of the wound.” The method is to cell growth and proliferation which results in angiogenesis (i.e. inducing angiogenesis).], comprising:
irradiating a target cell or tissue with visible light for an irradiation time period, wherein the visible light has a dominant emission wavelength ranging from 435 nm to 520 nm [see para 73… “Cells or tissue are irradiated with a light at wavelengths between 435 to 500 nm, and preferably having a dominant emission wavelength comprised between 450 and 460 nm. More particularly, the chosen dominant emission wavelength may be of 453 nm” And para 76… “More generally, the irradiation of blue light performed in this method may be set using all the different values of fluence, power intensity and time described above for the light source device 10 and the light source assembly”],
Also, Arpino discloses:
effective fluence of the visible light ranges from about 0.01 J/cm2 to about 10 J/cm2 [see para 74… “cells or tissue may be irradiated to receive an effective fluence comprised between 0.01 and 10 J/cm2”] and an irradiation time period from 1 to 20 minutes [see para 52… “the exposure ranges from at least 1 second, at least few seconds, or at least 1 minute, or at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20 minutes; or up to about 1 hour or, for any amount of time in a range bounded by, or between, any of these values.”]
However, as outlined directly above, Arpino discloses a broader range of effective fluence of the visible light and a larger time range than what is claimed; thus, Arpino fails to anticipate the limitations: “effective fluence of the visible light ranges from about 0.15 J/cm2 to about 17 J/cm2” and “irradiating a target cell or tissue with visible light for an irradiation time period ranging from about 5 minutes to about 15 minutes”. Arpino also therefore fails to disclose “to thereby promote endothelial cell viability, proliferation, migration, and/or tubulogenesis, and wherein the irradiation is applied during the granulation phase and/or the remodeling phase.”
Wagennar Cacciola discloses in the analogous art of wound healing using phototherapy that the application of light in each of the three phases (i.e. granulation phase, remodeling phase and inflammatory phase) provides a specific set of benefits to the wound healing [see para 3… “It is known from literature that, in either one of the three phases, radiation therapy, for example light therapy, can be beneficial, i.e. in that it can accelerate and enhance the wound healing process in the first two phases and that it can keep the process under control in the last phase of tissue remodeling, counteracting overproduction of scar tissue thus leading to a nice scar.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Arpino by using an effective fluence of 7.2 J/cm2 (i.e. since “about” is defined to be +/- 10% the value as discussed in para 67 of applicant’s specification received on 12/14/2022 this is understood to recite “effective fluence of the visible light ranges from about 0.15 J/cm2 to about 17 J/cm2”) and an irradiation time period of 12 minutes (i.e. reciting irradiating a target cell or tissue with visible light for an irradiation time period ranging from about 5 minutes to about 15 minutes and since all the claimed light parameters are recited, reciting the resulting “to thereby promote endothelial cell viability, proliferation, migration, and/or tubulogenesis”) because these are a subset of disclosed fluence values and irradiation time periods, respectively taught by Arpino.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Arpino by applying the light during the granulation phase, remodeling phase and inflammatory phases similarly to that described by Wagennar Cacciola (i.e. thereby reciting wherein the irradiation is applied during
the granulation phase and/or the remodeling phase) because applying light during each of these phases will provide benefits to wound healing.
Regarding claims 2-4 see rejection to claim 1 above which recites 7.2 J/cm2 which recites value(s) within the claimed ranges in these claims.
Regarding claims 5-6:
Para 49 of Arpino [see ….“To obtain the unexpected proliferation effect with skin cells, preferably with keratinocytes, the irradiance or power density may be in the range of about 0.05 mW/cm2 to about 30 mW/cm2, more particularly 0.1 mW/cm2 to 1 mW/cm2, 1 mW/cm2 to about 2 mW/cm2, 2 mW/cm2 to 5 mW/cm2, 5 mW/cm2 to 10 mW/cm2, 15 mW/cm2 to 25 mW/cm2 or any irradiance in a range bounded by, or between, any of these values.”] discloses using a power density of 5-10 mW/cm2 which recites the power densities of claims 5-6.
Regarding claims 7-8
Arpino in view of Wagennar Cacciola discloses the invention substantially as claimed including all the limitations of claims 1 and 6. Also, Arpino in view of Wagennar Cacciola discloses a power density that includes a range of 5 mW/cm2 to 10 mW/cm2 [see Para 49 of Arpino….“To obtain the unexpected proliferation effect with skin cells, preferably with keratinocytes, the irradiance or power density may be in the range of about 0.05 mW/cm2 to about 30 mW/cm2, more particularly 0.1 mW/cm2 to 1 mW/cm2, 1 mW/cm2 to about 2 mW/cm2, 2 mW/cm2 to 5 mW/cm2, 5 mW/cm2 to 10 mW/cm2, 15 mW/cm2 to 25 mW/cm2 or any irradiance in a range bounded by, or between, any of these values.”]
However, Arpino in view of Wagennar Cacciola fails fully disclose “wherein the incident power density ranges from about 8 mW/cm2 to about 12 mW/cm2” as recited by claim 7 or “wherein the incident power density is about 10 mW/cm2”.
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to further modify Arpino in view of Wagennar Cacciola to use an incident power density of 10 mW/cm2 (i.e. thereby reciting the limitations “wherein the incident power density ranges from about 8 mW/cm2 to about 12 mW/cm2” as recited by claim 7 and “wherein the incident power density is about 10 mW/cm2” as recited by claim 8) because this power density is subset of power density values disclosed by Arpino.
Regarding claims 10-11 and 29:
See rejection to claim 1 above which cites para 73 of Arpino [see… “More particularly, the chosen dominant emission wavelength may be of 453 nm And para 76… “More generally, the irradiation of blue light performed in this method may be set using all the different values of fluence, power intensity and time described above for the light source device 10 and the light source assembly”] which discloses a dominant emission wavelength between 453 which recites these claims.
Regarding claims 13-15, see rejection to claim 1 above which recites a time period of 12 minutes which recites these claimed time periods.
Regarding claims 16-17 see para 54 of Arpino [see…“For thermal issues, light source device may be configured to irradiate cells either continuously or in pulses.”] Which discloses continuous or pulsed (i.e. discontinuous) application of light as recited in these claims.
Regarding claims 30-32:
See rejection to claim 1 above which recites applying light (i.e. irradiation is applied) during all the phases including the granulation phase and remodeling phase thereby reciting these claims.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arpino in view of Wagennar Cacciola as applied to claims 1 and 17 above, and further in view of Ball et al (US 20180093107) hereafter known as Ball.
Arpino in view of Wagennar Cacciola discloses all the limitations of claims 1 and 17 as outlined above.
However, while Arpino in view of Wagennar Cacciola does disclose pulsing the light, Arpino in view of Wagennar Cacciola is silent as to the exposure ratio and frequency. Thus, Arpino fails to disclose “wherein a light exposure ratio is from about 5% to about 80%” as recited by claim 18 and “wherein a frequency of the light is from about 0.001 Hz to about 100 Hz” as recited by claim 19.
Ball discloses in the analogous art of phototherapy for wound healing [see abstract… “A system for healing and/or disinfecting wounds and burns includes an emitter including one or more blue light sources configured to emit blue light at a therapeutic energy level at a wound or burn area of a human or animal subject and one or more ultraviolet-A (UVA) light sources configured to emit UVA light at a therapeutic energy level at the wound or burn area.”] that a known pulse frequency for blue light is .5 Hz-1000 Hz and a known duty cycle (i.e. exposure ratio) is one of 25%, 50% or 75% [see para 10… “The frequency of the blue light may be in the range of about 0.5 Hz to about 1,000 Hz.” And “The one or more duty cycles of the blue light may include one or more of: a 25% duty cycle, a 50% duty cycle, or a 75% duty cycle.“]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Arpino in view of Wagennar Cacciola by pulsing the blue light have a duty cycle of one of 25%, 50% or 75% and a frequency of .5-1000 Hz similarly to that of Ball because these are known parameters for pulsing blue light to treat wounds in the analogous art of phototherapy.
It would have been obvious to having ordinary skill in the art at the time the invention was filed to further modify Arpino in view of Wagennar Cacciola in view of Ball to use a frequency within the range of .001-100 Hz because the disclosed range of .5-1000 Hz discloses sharing an overlap in range including the endpoint; therefore there is a prima facie case of obviousness for one ordinary skill in the art to the claimed range [see MPEP 2144.05 and In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) ].
Claim(s) 21-22 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arpino in view of Wagennar Cacciola as applied to claim 1 above, and further in view of Hicks et al (US 20180304094) hereafter known as Hicks.
Arpino in view of Wagennar Cacciola as modified in the rejection claim 1 above discloses the invention substantially as claimed including all the limitations of claim 1.
However, Arpino in view of Wagennar Cacciola as modified is silent as to wound type and the regimen. Thus, Arpino fails to disclose “wherein the target tissue is a chronic wound” as recited by claim 21, “wherein the wound is venous or arterial ulcer, a diabetic ulcer, a pressure ulcer or sore, a second or third degree burn, a skin graft or donor site, or an amputation wound” as recited by claim 22, “wherein the irradiation is provided in a regimen comprising irradiation from about 1 to 5 times per day, to about 1 to about 7 times per week” as recited by claim 27.
Hicks discloses in the analogous art of wound healing using phototherapy [see abstract… “Described herein are systems, devices, and methods for administering low-level light therapy (LLLT). The systems, devices, and methods aim to accelerate wound healing and reduce the incidence of infection.”] a known light treatment regimen for treating wounds including diabetic foot ulcers (i.e. a chronic wound) with blue light includes application of light every day until the wound heals [see para 3… “Described herein are systems, devices, and methods for administering low-level light therapy (LLLT). The systems, devices, and methods aim to accelerate wound healing, reduce the bioburden on the wound site, and reduce the incidence of infection. For example, the systems, devices, and methods can have an anti-microbial effect in addition to promoting wound healing. As one example, a device can be used in the treatment of diabetic foot ulcers (DFUs). There is no current treatment option using LLLT that actively encourages diabetic foot ulcer healing, complements current procedures, and maintains patient compliance.” And para 41… “In other words, the module box 112 can be programmed with an LLLT treatment regimen.” And “Daily treatment can be provided until the patient's wound heals. In some implementations, treatment is provided for a total of about 2-4 weeks.” And para 46… “In some implementations, the one or more light sources 110 comprise a monochromatic light source. For example, the light sources 110 can be a source of blue light such as blue light having a wavelength of from about 450 nm to about 495 nm.”]
Since Arpino in view of Wagennar Cacciola is silent as to the exact treatment regimen and wound type and Hicks discloses that a known treatment regimen for blue light to treat known wound type of a diabetic ulcer is once a day until the wound heals, it would have been obvious to one having ordinary skill to apply Arpino in view of Wagennar Cacciola’s method to diabetic ulcers once a day until healing similar to that disclosed by Hicks (thereby reciting claims 21-22 and 27) because this a known wound healing treatment for blue light phototherapy.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792