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 .
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1, 12, 15-17, 27, 30-32, 24-36, 39-44, 75 in the reply filed on 03 August 2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 41 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 41, Applicant recites “a pump for recirculating the coolant fluid”. However, Claim 41 purports to be dependent on Claim 1 which fails to previously introduce “a coolant fluid”. It is unclear if Claim 41 was intended to be dependent on Claim 1 and further introduce “a coolant fluid” and “a cavity” or if Claim 41 was intended to be dependent on Claim 40 which does provide antecedent basis for the coolant (see Clm. 39) and cavity (Clm. 40).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 75 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2018/0015298 (“Iguchi”).
Regarding Claims 1 and 75, Iguchi discloses a kit (Fig. 1) for improving infection healing behavior of a biological wound (see e.g. Par. 42 – re: treatment of a MSRA infected skin ulcer, a specific species of biological wound OR Par. 2 – re: treatment of “acne”, another specific species of biological wound), the kit comprising:
A matrix (3) dimensioned to cover a wound (see generally Fig. 8 – see the “treatment area” over which the matrix is superimposed);
A light-emitting layer (see 4-6) comprising a plurality of light sources (4), the light emitting layer being configured to irradiate the wound or a region adjacent to the mount with light at a range of wavelengths (Abstract; Par. 42, 49);
A controller (8) configured to be placed in electrical communication with the light sources of the light-emitting layer (see Fig. 1), the controller being configured to execute a program stored in the controller to activate the light sources of each light-emitting layer to irradiate the wound or the region adjacent the wound when the matrix is placed over the wound (Par. 103); and
A drug (21), wherein in exemplary configurations (re: the treatment of acne) the drug may comprise, for example, methyl aminolevulinate (MAL) or aminolevulinic acid (ALA), species which Examiner submits constitutes examples of “antimicrobial adjuvants” which will synergistically potentiate an antimicrobial activity of the light, i.e. exposure of MAL and ALA to light creates reactive oxygen species which are bactericidal.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0015298 (“Iguchi”) as applied above, and further in view of U.S. Publication No. 2006/0217787 (“Olson”)
Regarding Claim 12, Iguchi discloses the plurality of light sources comprise an array of light emitting diodes (see Fig. 8). Iguchi discloses the invention substantially as claimed except that that the layer further includes at least one lens for focusing or dispersing light from at least a portion of the LEDs. However, Olson discloses a similar wound treatment light therapy array which provides a light extraction layer (75) which can include a plurality of micro-prisms or micro-lenses (or the like) disperse light from the array (Par. 46, 54, 57). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the invention of Iguchi with lens(es), as disclosed by Olson, in order to help diffuse and scatter the generated light to ensure a more even distribution of light about the entire treatment area.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0015298 (“Iguchi”) as applied above, and further in view of “Inactivation of Bacteria via Photosensitization of Vitamin K3 by UV-A Light” (“Xu”).
Regarding Claim 15-17, Iguchi discloses the invention substantially as claimed except that that the antimicrobial adjuvant comprises a substituted naphthalene, specifically, an oxygen substituted naphthalene, particularly 2-methyl-1,4-naphthoquinone. However, Xu discloses that it is known that vitamin K3 (aka “menadione”, aka 2-methyl 1,4-napthoquinone) can be useful when paired with light therapy where it exhibits antimicrobial properties (Abstract). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide 2-methyl-1,4-naphthoquinone as a drug within the invention of Iguchi based on its ability to combine with light therapy to have an antimicrobial/bactericidal property, as disclosed by Xu, thereby enhancing wound healing.
Claim(s) 30-32 and 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0015298 (“Iguchi”) as applied above, and further in view of U.S. Publication No. 2016/0000611 (“Niederauer”) and CN 207768916 (“Wang”).
Regarding Claim 30-32, 34-36, Iguchi discloses the invention substantially as claimed except that the device further comprises oxygen delivery. However, Niederauer discloses a related wound treatment patch device which is further provided with matrix (120) having a surface (see Fig. 4) having a plurality of channels (150, 152-159), the surface facing the wound when the patch is placed over the wound, a source of irrigation fluid in fluid communication with an inlet (140) of the channel, wherein the irrigation fluid may comprise oxygen, a therapeutic, (Par. 50), whereby the addition of oxygen to the wound is found to improve healing (Abstract). Wang discloses that oxygen therapy and light therapy can be beneficially combined for promoting wound healing (Abstract).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide the patch device of Iguchi with oxygen delivery through the matrix via a plurality of channels disposed therein, as disclosed by Niederauer, in order to increase oxygen saturation at the tissue to help promote wound healing in aid to the effect of the light and drug system of Iguchi.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0015298 (“Iguchi”), U.S. Publication No. 2016/0000611 (“Niederauer”), and CN 207768916 (“Wang”) as applied above, and further in view of
U.S. Patent No. 5,788,682 (“Maget”).
Regarding Claim 27, Iguchi, as modified, discloses the invention substantially as claimed except that the system further comprises an oxygen sensor in communication with the controller. However, Niederauer does discuss oxygen sensors, but appears to only consider them in association with testing of the system and not using the sensor output to provide control over the system. Maget discloses a related wound treatment patch which includes a controller (44) having an oxygen sensor for measuring the concentration/partial pressure of oxygen delivered to the patch in order to alter the delivery of oxygen based upon measured need (Col. 9). It would have been obvious for one having ordinary skill in the art at the time the invention was made to provide an oxygen sensor to the modified invention of Iguchi, as disclosed by Maget, in order to measure the amount of oxygen delivered to the wound via the matrix and adjust the amount of oxygen as needed in order to improve healing by allowing optimized dosing.
Claim(s) 39-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0015298 (“Iguchi”) as applied above, and further in view of
U.S. Patent No. 6,290,713 (“Russell”).
Regarding Claim 39-42, Iguchi, as modified, discloses the invention substantially as claimed except that the device further comprises a coolant fluid to be received within a cavity of the matrix. However, Russell discloses that one known problem with such light generating devices (120) is heat management (Abstract) where in order to maintain proper functioning of the device and protect a patient’s skin it is useful to transfer heat away from the skin/patch through the use of a fluid coolant system which provides a coolant fluid pathway/cavity (140, 142) through the matrix of the patch in order to circulate a cooling fluid to (144) and away (148) from the patch. The system using the controller (49) to operate a pump (54) in order to pump the coolant from a source (52) to the cavity and adjust the rate of recirculation. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the device of Iguchi to incorporate a cooling cavity through the matrix through which a coolant fluid can be actively pumped via the controller, as disclosed by Russell, in order to help mitigate the heat generated by the LED array to ensure proper continued function of the array and to avoid transferring excess heat to the patient’s skin.
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0015298 (“Iguchi”) and U.S. Patent No. 6,290,713 (“Russell”) as applied above, and further in view of U.S. Publication No. 2010/0160904 (“McMillan”).
Regarding Claim 43, Iguchi, as modified, discloses the invention substantially as claimed except that that the coolant is “biocompatible”. However, McMillan discloses a photothermal treatment device which is actively cooled by a fluid coolant, wherein the coolant is biocompatible and non-toxic (Par. 174). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize a biocompatible coolant in association with the modified device of Iguchi, as disclosed by McMillan, such that the coolant should not harm the patient should they be exposed directly to it.
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0015298 (“Iguchi”), U.S. Patent No. 6,290,713 (“Russell”), and U.S. Publication No. 2010/0160904 (“McMillan”) as applied above, and further in view of CN 114727841 (“Bhawalkar”).
Regarding Claim 44, Iguichi, as modified, discloses the invention substantially as claimed except that that the coolant is a “dielectric” fluid. However, Bhawalkar discloses that coolant fluids may be dielectric fluids (Pg. 2). It would have been obvious for one having ordinary skill in the art at the time the invention was made to use a dielectric fluid for the coolant of modified Iguchi, as disclosed by Bhawalkar, in order to be non-conductive and not damage the circuitry in the event that the circuits are exposed to the coolant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 09/30/2026
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