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 .
DETAILED ACTION
Claims status
Claims 1-12, 16-17 and 19-25 are pending and examined on the merits.
Specification
The disclosure is objected to because of the following informalities: p30 [0149] incorrectly refers to Figure 1b in relation to “To avoid UVA leakage to other parts of the plate during therapy, areas 2, 3 and 4 were covered with a sterile device which blocked the passage of light through the top and sides of the plate”.
Figure 1b is a figure which does not address blocked UVA light. Figure 1A presents a diagram of a tissue culture plate with sections that are not exposed to UV light. Thus Figure 1A is presumed to relate to the statement “areas 2, 3 and 4 were covered”.
The figure reference in paragraph [0149] of the instant specification should be changed from Fig. 1B to Fig. 1A.
Appropriate correction is required.
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 8 – 9 and 11 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 claims contain 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.
Regarding claims 8 and 9: Claim 8 recites exposing nasal or oral olfactory epithelial cells to UVA increases MAVS protein expression in epithelial cells in the subject’s trachea or bronchi.
Claim 9 recites exposing nasal, olfactory or oral epithelial cells increases MAVS protein expression in epithelial cells in the subject’s lung.
Regarding claim 11: Claim 11 recites multiple primary UVA exposure sites (urethral, vaginal, urogenital etc.) and multiple distant secondary sites where protein expression is presumably elevated (e.g. bladder, uterine).
The claims rely on exposure of epithelial sites in the upper respiratory tract (nasal, oral or olfactory) to increase expression of MAVS protein at a site in the lower epithelial tract (trachea, bronchi or lung) or a site in another primary location that causes effects at a distant location in the subject (e.g. urethral epithelial cells and bladder epithelial cells).
The upper and lower respiratory tracts are separated by the larynx and the sites of exposure are not physically adjacent to the sites of presumed protein expression changes. Urethral epithelial cells are distant from bladder epithelial cells and the sites of exposure are not physically adjacent to the sites of presumed protein expression changes.
The instant specification
The instant specification teaches in vitro and in vivo embodiments of the claimed invention.
The in vitro embodiments comprise exposure human tracheal cells to UVA, which is shown to increase the expression of MAVS protein (Figure 1b and c, p4 [0020-21). The instant specification also teach that cells in close proximity to UVA exposed cells have increased MAVS expression and levels of expression decrease with increased distance from the site of UVA exposure (Figure H, p5 [0026]). The instant specification further teach the adjacent areas from the plate were blocked from UVA light (p27 [0140].
Figures 1A and H of the instant specification shows that as distance from the UVA light source increases, UVA protein expression decreases. The instant specification states “the induction of MAVS protein is transmitted to
cells not directly exposed to NB-UV A light… likely results from direct cell-to-cell signaling, and possibly a cytosolic mediator”.
The instant specification teaches an in vivo embodiment in which ventilated COVID-19 subjects were treated with endotracheally-delivered UVA light exhibited a decrease in SARS-CoV-2 viral load by day 6 of therapy (p33 [0161]). The in vivo embodiment does not address expression of MAVS in the SARS-CoV-2 subjects.
The state of the art
Rezaie et al (US 2019/0175938 A1, as cited in the IDS filed 10/24/2023, hereafter referred to as Rezaie‘938) teach UV-A and UV-B light have anti-inflammatory and antibiotic effects which are induced via damage to haploid DNA/RNA of microorganisms such as bacteria, archaea, fungi, yeast and viruses within minutes (p1 [0005]).
Rezaie’938 further teach devices than can deliver therapeutic doses of UVA light to treat infections and inflammatory conditions inside a patient (p1 [0008]).
Rezaie et al (WO 2021/189020 A1, as cited in the IDS filed 10/24/2023, hereafter referred to as Rezaie‘020) teach a UV light delivery device configured to be utilized in conjunction with an endotracheal tube or a nasopharyngeal airway. Rezaie‘020 teach endotracheal administration of UVA light therapy on patients with SARS-CoV-2 (p66). Rezaie ‘020 teach administration of UVA light for 20 min daily for 5 days (p66 [00346]) and that UVA was delivered at a maximum of 2mW/cm2 (p66 [00355]).
Anderson et al (US 2020/0121943 A1) teach methods for treatment with the use of UV light (abstract). Anderson teach an apparatus for applying ultraviolet (e.g., UVA, UVB) illumination in a contained manner within a patient’s body (p2 [0020]). Anderson also teach methods of applying ultraviolet within a patient’s body comprising turning on a UV emitter that is positioned withing a lumen to irradiate biological material (p2 [0021]). Anderson further teach the methods may be used in any tissue in the body including regions having a natural body lumen, such as blood vessels, lymph vessels, lung cavities, and any other vessel, tube, tract, canals, etc. within the body (p2 [0023]).
Conclusion
The instant specification teaches in vivo embodiments the invention- UVA exposure of human tracheal epithelial cells and an embodiment of in vivo exposure of endotracheally-delivered UVA light.
There are multiple examples in the art of treatment with UVA at specific locations.
However, neither the art nor the instant specification provide support or enablement for exposing an in vivo site to UVA and observing a change in epithelial cells at a distant site, as described in claims 8-9 and 11. While the instant specification envisions the application of UVA at a primary site effecting protein expression at a distant secondary site (p4 [0016]) there is no support that such a result would occur in vivo.
The closest support the instant specification provides is that with localized UVA exposure to confluent cells in a 60mm tissue culture plate, cells distant from the treated cells exhibit an effect, which diminishes with distance from the directly exposed cells. In a 60mm tissue culture plate, the cells farthest from the UV source can be no more than 6 cm, while the distances envisaged by in in vivo experiments range and would generally require signaling over a much longer distance than 6 cm (e.g. nasal to bronchi).
While it is common practice to use in vitro cell culture experiments to test and an inform in vivo studies, the difference between treating a section of a confluent plate of homogenous cells and inducing changes in cells in vivo at various anatomical sites is large. Cells in organisms exist in a vastly more complex system than those in a simplified cell culture model, and one of ordinary skill in the art would not have a reasonable expectation of success that the results of in vitro experiments from a simplified cell culture system would translate to the claimed in vitro results.
Per the discussion supra, Applicant is considered to have possession to an increase of MAVS protein in the epithelial cells that are directly exposed to UV light. Applicant is not considered to have possession of an increased expression of MAVS in distant epithelial cells unexposed to the effective amount of UVA as this encompasses an in vivo system and support is not found for this in either the instant disclosure or the art.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2-5, 12, 17, 19-20 and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rezaie et al (WO 2021/189020 A1, as cited in the IDS filed 10/24/2023, hereafter referred to as Rezaie ‘020).
The applied reference has a common Inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1: The claim recites “an effective amount of ultraviolet A (UVA). The instant specification is silent on an explicit definition for “an effective amount”. Claim 19 of the instant disclosure establishes an effective amount as “5 milliWatt/cm2 (mW/cm2) or more for a duration of 1 minute” or “a UVA intensity of 5 mW/cm2 or more”. Claim 20 of the instant disclosure establishes an effective amount as “2-5 mW/cm2 for a duration of at least 20 minute” or “a UVA intensity of 2-5 mW/cm2”.
Therefore an “effective amount” as recited in claim 1 is interpreted as the UVA exposure conditions recited in claims 19 and 20, or any amount of UVA that has a measurable effect.
Turning to the art, Rezaie‘020 teach a UV light delivery device configured to be utilized in conjunction with an endotracheal tube or a nasopharyngeal airway. Rezaie‘020 teach endotracheal administration of UVA light therapy on patients with SARS-CoV-2 (p66). This reads on epithelial cells in a subject in need thereof. Rezaie‘020 teach administration of UVA light for 20 min daily for 5 days (p66 [00346]) and that UVA was delivered at a maximum of 2mW/cm2 (p66 [00355]). This reads on an effective amount of UVA as interpreted supra (a UVA intensity of 2-5 mW/cm2).
Regarding the expression of MAVS protein; the claim recites “so as to increase expression of MA VS protein in the epithelial cells or”. The phrase “so as” is considered equivalent to a “wherein” clause.
MPEP states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”.
The language following the “so as” clause does not confer a structural requirement or a manipulative step beyond exposing, so it is not considered limiting to the disclosure.
Furthermore, if the expression of MAVS protein were limiting, it is considered inherent to the exposed cells per the following discussion:
Rezaie ‘020 do not explicitly address the expression of mitochondrial antiviral signaling protein in the epithelial cells, however Rezaie teach the required method steps. The cells of Rezaie ‘020 are exposed to “an effective amount” of UVA as defined by the instant disclosure. Therefore, because the UVA amount is effective, the cells of Rezaie would have increased expression of MAVS protein compared to cells not having been exposed to an effective amount of UVA if the expression of MAVS protein was compared to cells not having been exposed to the effective amount of UVA. Thus the increased expression of MAVS is considered to be inherent, if it were limiting.
Regarding claims 2-5: The teaching of Rezaie‘020 are discussed supra. Rezaie’020 teach exposure of tracheal epithelial cells (tracheal mucosa) in humans (p67 [00355]). As evidenced by Hou et al (Stem Cells Technology mini review (2015) 1-4) large airway epithelium include ciliated cells (p1 col1 ¶2). Thus the human tracheal epithelial cells of Rezaie‘202 read on ciliated epithelial cells as required by the instant claims.
Regarding claim 12: The teachings of Rezaie’020 are discussed supra. Rezaie’020 also teach subjects (subject 1 and 5) exhibit viral load (a symptom of microbial infection) at day 5 and that viral load (symptom) is not detected at day 6 (Fig 75). This reads on a symptom for no more than 10 days as required by the instant claim.
Regarding claim 16: Rezaie’020 teach administration of UVA light via catheter introduced into an endotracheal tube of intubated mechanically ventilated adults with SARS-CoV-2 infection (p65 [00346]). While Rezaie’020 teach anesthesia is used on mouse subjects (p55 ¶[00294]), Rezaie’020 do not teach anesthesia is administered to the human subjects. Thus the procedure reads on the instant claim limitations.
Regarding claim 17: The teachings of Rezaie‘020 are discussed supra. Rezaie‘020 also teach endotracheal administration of UVA light therapy on patients with SARS-CoV-2, a viral infection (p66). This reads on selecting a subject who exhibits one or more symptoms of a microbial infection because a subject would not be patient unless they exhibited symptoms.
Regarding claims 19-20: The teaching of Rezaie‘020 are discussed supra. Rezaie‘020 also teach that UVA was delivered at a maximum of 2mW/cm2 (p66 [00355]). Claim 22 of Rezaie‘020 recites the radiating is performed between 1-5 mW/cm2. This reads on the intensities as required by the instant claims.
MPEP 2131.03 reads “"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated' if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”.
Thus the disclosure of Rezaie‘020 reads on the limitations as claimed.
Regarding claim 21: The teaching of Rezaie‘020 are discussed supra. Rezaie‘020 teach administration of UVA light for 20 min daily for 5 days (p66 [00346]) which reads on the limitation of the instant claim.
Thus the teachings of Rezaie’020 anticipate the invention as claimed.
Claim 1 is are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rezaie et al (US 2019/0175938, as cited in the IDS filed 10/24/2023, hereafter referred to as Rezaie’938).
Regarding claim 1: As discussed supra, an “effective amount” as recited in claim 1 is interpreted as the UVA exposure conditions recited in claims 19 and 20, or any amount of UVA that has a measurable effect.
Rezaie’938 teach a method of delivering UVA light to treat infections in a patient cavity (abstract, claim 23). This reads on exposing cells a subject in need thereof as required by the instant claim.
Claim 23 of Rezaie’939 further teaches an amount of UVA radiation effective for treatment of the condition. This reads on “an effective amount of UVA” as required by the instant claim.
Figure 5 of Rezaie’938 teach delivery of the light source to the colon (p6 [0110]). The colon is lined with epithelial cells and thus the disclosure reads on exposing epithelial cells to an effective amount of UVA in a subject in need thereof, as required by the instant claim 1.
Regarding the expression of MAVS protein; the claim recites “so as to increase expression of MA VS protein in the epithelial cells or”. The phrase “so as” is considered equivalent to a “wherein” clause.
MPEP states “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure”.
The language following the “so as” clause does not confer a structural requirement or a manipulative step beyond exposing, so it is not considered limiting to the disclosure.
Furthermore, if the expression of MAVS protein were limiting, it is considered inherent to the exposed cells per the following discussion:
Rezaie’938 do not explicitly address the expression of mitochondrial antiviral signaling protein in the epithelial cells, however Rezaie’938 teach the required method steps. The cells of Rezaie’938 are exposed to “an effective amount” of UVA as defined by the instant disclosure. Therefore, because the UVA amount is effective, the cells of Rezaie’938 would have increased expression of MAVS protein compared to cells not having been exposed to an effective amount of UVA, if the expression of MAVS protein was compared to cells not having been exposed to the effective amount of UVA. Thus the increased expression of MAVS is considered to be inherent, if it were limiting.
Claims 1-5 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AP press Release (Aytu BioScience Signs Exclusive Global License [retrieved 03/04/2026] Retrieved from the Internet: Aytu BioScience Signs Exclusive Global License with Cedars-Sinai for Potential Coronavirus Treatment | AP News).
Regarding claim 1-5 and 17: The AP Press Release teaches administering UVA light via an endotracheal medical device for use in treatment of coronavirus in intubated patients (p2 ¶1). As discussed supra, exposing via an endotracheal medical device would expose cells of the human trachea, which comprises ciliated tracheal epithelial cells. Thus this reads on exposing epithelial cells to UVA.
The AP Press release further teaches the technology eradicates a wide range of viruses and bacteria, inclusive of coronavirus. The UVA treatment disclosed by the press release is considered “an effective amount” because it has an impact on eradicating a wide range of viruses and bacteria (p2 ¶1). This reads on “an effective amount of UVA” per the claim interpretation discussed supra.
While the press release does not explicitly address the expression of mitochondrial antiviral signaling protein in the epithelial cells, the press release teaches the required method steps of the claimed invention.
Because the UVA exposure taught by the press release is “an effective amount”, the tracheal endothelial cells would have increased expression of MAVS protein compared to cells not having been exposed to an effective amount of UVA if the expression of MAVS was measured.
Thus the AP press release anticipates the invention as claimed.
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) 6-11 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Rezaie et al (WO 2021/189020 A1, hereafter referred to as Rezaie ‘020) as applied to claims 1, 2-5, 17, 19-20 and 21 above, and further in view of Rezaie et al (WO 2021/189020 A1, hereafter referred to as Rezaie ‘020).
Rezaie ‘020 anticipate the invention of claims 1, 2-5, 17, 19-20 and 21 and thus render them obvious (see above).
Regarding claims 6-9 and 10-11: The teachings of Rezaie‘020 are discussed supra. Rezaie‘020 teaches exposing human tracheal epithelial cells in a subject, but does not teach exposing human lung epithelial cells in a subject, nasal epithelial cells or rectal epithelial cells in a single embodiment.
Rezaie‘020 also teach that experimental data validates the application for irradiating lung tissues and that UVA light will kill coronavirus after infecting epithelial lung tissue (lung epithelial cells) (p64 [00341]). Rezaie’020 also teach delivering UVA through a nasal canal, which reads on nasal epithelial cells (p76 embodiment 37).
It would have been obvious to one of ordinary skill in the art to adapt the methods of Rezaie‘020 drawn to treating human tracheal epithelial cells by treating additional types of epithelial cells (lung, nasal) as also taught by Rezaie’020.
One of ordinary skill in the art would have been motivated to modify the method as taught by Rezaie‘020 to for the purposes of treating additional type of epithelial cells (such as nasal and lung) because Rezaie’020 teach inserting the UV light through a nasal canal to treat an infection and that UVA light will kill coronavirus after infecting the epithelial lung tissue.
One would have had a reasonable expectation of success because Rezaie’020 teach UVA light is effective in killing coronavirus in epithelial lung tissue and one of ordinary skill in the art would therefore have a reasonable expectation of success of killing viral infections in other infected epithelial tissues.
While Rezaie’020 do not address the expression of MAVS, Rezaie’020 does teach the required active steps of the claims and thus the disclosure of Rezaie’020 reads on the invention as stated.
Thus the teachings of Rezaie’020 render obvious the invention as claimed.
Claim(s) 1-6 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 2020/0121943 A1) as evidenced by NIH definition of a Lumen (Definition of lumen - NCI Dictionary of Cancer Terms - NCI) and Leeds Histology (The Histology Guide Respiratory Trachea, bronchioles and bronchi [online]. Leeds University [retrieved 03/02/2026] Retrieved from the Internet: https://www.histology.leeds.ac.uk/respiratory/conducting.php).
Regarding claims 1-2 and 19-20: As discussed supra, the claim recites “an effective amount of ultraviolet A (UVA). The instant specification is silent on an explicit definition for “an effective amount”.
Claim 19 of the instant disclosure establishes an effective amount as “5 milliWatt/cm2 (mW/cm2) or more for a duration of 1 minute” or “a UVA intensity of 5 mW/cm2 or more”. Claim 20 of the instant disclosure establishes an effective amount as “2-5 mW/cm2 for a duration of at least 20 minute” or “a UVA intensity of 2-5 mW/cm2”. Therefore an “effective amount” as recited in claim 1 is interpreted as the UVA exposure conditions recited in claims 19 or 20, or an amount of UVA that has a measurable effect.
Turning to the art, Anderson teach methods for treatment with the use of UV light (abstract). Anderson teach an apparatus for applying ultraviolet (e.g., UVA, UVB) illumination in a contained manner within a patient’s body (p2 [0020]). A patient’s body reads on a subject in need, as required by the instant claim.
Anderson further teach methods of applying ultraviolet within a patient’s body comprising turning on a UV emitter that is positioned withing a lumen to irradiate biological material (p2 [0021]). Anderson teach the methods may be used in any tissue in the body including regions having a natural body lumen, such as blood vessels, lymph vessels, lung cavities, and any other vessel, tube, tract, canals, etc. within the body (p2 [0023]).
Anderson do not explicitly teach epithelial cells in a subject, however the disclosure of Anderson is interpreted to read on epithelial cells, as discussed below.
Anderson disclose methods used in any tissue in the body including regions having a natural body lumen. As evidenced by the NIH NCI dictionary of terms, a lumen is “[t]he cavity or channel within a tube or tubular organ such as a blood vessel or the intestine” (Definition of lumen - NCI Dictionary of Cancer Terms - NCI). As evidenced by Leeds University Leeds histology guide (Respiratory: The Histology Guide) the trachea is an organ which comprises a lumen (p1 “Trachea” ¶1) and epithelium (p2 ¶1) and thus the disclosure of Anderson reads on human trachea epithelial cells.
Anderson further teach the intensity of the light sources (as discussed supra the light source includes UVA) may be between 0.001 mW/cm2 and 10 mW/cm2). This reads on an effective amount of UVA as discussed supra.
MPEP 2131.03 reads “"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated' if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985)”. Thus the UV intensity disclosed by Anderson reads on that of the instant claim.
While Anderson do not explicitly address the expression of mitochondrial antiviral signaling protein in the epithelial cells, Anderson teach the required method steps of the claimed invention. The cells of Anderson are exposed to “an effective amount” of UVA as recited by the instant disclosure and discussed supra. Therefore, because the UVA amount is effective, the cells of Anderson would have increased expression of MAVS protein compared to cells not having been exposed to an effective amount of UVA if the expression of MAVS was measured.
Regarding claims 3-5: The teachings of Anderson are discussed supra.
As discussed supra, Anderson teach UVA exposure to a natural body lumen. Also discussed supra, the trachea reads on a natural body lumen.
As further evidenced by Leeds University Leeds histology guide, the epithelium of the trachea comprises cells with cilia (p1 “Trachea ¶3).
Thus the disclosure of Anderson reads on ciliated tracheal epithelial cells.
Regarding claim 6: The teachings of Anderson are addressed supra. As discussed supra Anderson teach UVA exposure to a natural body lumen.
A human lung reads on a natural body lumen, and human lungs comprise human lung epithelial cells.
Thus the disclosure of Anderson reads on human lung epithelial cells.
Regarding claims 7-9: The teachings of Anderson are addressed supra. Anderson also teach additional probes to light the nose and mouth (p10 [0097]). This reads on exposing nasal epithelial cells and oral epithelial cells of the instant claims.
While Anderson do not address the expression of MAVS, Anderson does teach the required active steps of the claims and thus the disclosure of Anderson reads on the invention as stated.
Regarding claims 10 and 11: The teachings of Anderson are addressed supra. Anderson also teach the intestinal wall is exposed (Fig 15). This reads on gastrointestinal epithelial cells other than rectal epithelial cells of claims 10 and 11.
While Anderson does not address the expression of MAVS, Anderson does teach the required active steps of the claims and thus the disclosure of Anderson reads on the invention as stated.
Regarding claim 21: The teachings of Anderson are addressed supra. Anderson also teach a dose frequency of between 1 and 200 doses/day (claim 104). Multiple doses read on exposing for a first period of time followed by exposing for a subsequent period of time.
Claims 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 2020/0121943 A1) as applied to claims 1-6 19-21 above, and further in view of Rezaie et al (US 2019/0175938 A1, as cited in the IDS filed 10/24/2023, hereafter referred to as Rezaie‘938).
Regarding claim 12: The teachings of Anderson are discussed supra. Anderson do not teach the subject exhibits symptoms of a microbial infection for no more than 10 days.
Rezaie‘938 teach UV-A and UV-B light have anti-inflammatory and antibiotic effects which are induced via damage to haploid DNA/RNA of microorganisms such as bacteria, archaea, fungi, yeast and viruses within minutes (p1 [0005]).
Rezaie’938 further teach devices than can deliver therapeutic doses of UVA light to treat infections and inflammatory conditions inside a patient (p1 [0008]). Rezaie’938 also teach different amounts or time period dosages of UV radiation may be administered depending on the type of disease and severity of the infection.
It would have been obvious to one of ordinary skill in the art to adapt the methods of Anderson drawn to exposing epithelial cells in a subject to an effective amount of UVA by using a subject that has symptoms of a microbial infection for no more than 10 days because Rezai’938 teach the UVA light to treat infection and an infection is diagnosed based on symptoms. Thus a subject with an infection would exhibit symptoms.
One of ordinary skill in the art would have been motivated to modify method as taught by Anderson to for the purposes of using a subject that has symptoms of a microbial infection for no more than 10 days because Rezaie’938 teach that UVA can be used to treat infection.
One would have had a reasonable expectation of success because Anderson discloses a device that can administer UVA and Rezaie’938 teach that UVA exposure decreases bacterial growth (Figure 16a).
It would be obvious to use a subject that has symptoms of a microbial infection for the claimed time period because the claimed time periods of exhibiting symptoms before treatment is a matter of routine optimization of a treatment protocol which would depend on known methods in the art for treating a particular infection.
Regarding claim 17: The teachings of Anderson are discussed supra. Anderson do not teach selecting a subject who exhibits one or more symptoms of a microbial infection wherein the microbial infection is a viral infection, bacterial infection or fungal infection.
Rezaie’938 teach UV-A and UV-B light have anti-inflammatory and antibiotic effects which are induced via damage to haploid DNA/RNA of microorganisms such as bacteria, archaea, fungi, yeast and viruses within minutes (p1 [0005]).
It would have been obvious to one of ordinary skill in the art to adapt the methods of Anderson drawn to exposing epithelial cells in a subject to an effective amount of UVA by selecting a subject who exhibits one or more symptom of a microbial infection because Rezaie’938 teaches UVA light has antibiotic effects and induces damage to haploid DNA/RNA of microorganisms such as bacteria.
One of ordinary skill in the art would have been motivated to modify method as taught by Anderson by selecting a subject who exhibits one or more symptom of a microbial infection because Rezai’938 teach UVA both prevents bacteria (E. coli) from proliferating and also kills the bacteria (Fig. 11-12; p8 [0135]).
One would have had a reasonable expectation of success because both disclosures are drawn to exposing epithelial cells with UV Rezaie’938 teach UVA can kill microbes. One of ordinary skill in the art would understand that a subject with an infection is identified by exhibiting symptoms.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 2020/0121943 A1) as applied to claims 1-6 19-21 above, and further in view of Sapadin (Phototherapy Specialist [online]. Dermatologist [retrieved on 03/02/2026]. Retrieved from the Internet: <https://web.archive.org/web/20190719103822/https://www.doctorsapadin.com/services/phototherapy).
Regarding claim 16: The teachings of Anderson are discussed supra. Anderson do not teach the subject is not administered anesthesia.
Sapadin teach phototherapy using an excimer laser (which comprises UV) is an excellent solution for chronic skin conditions (p1 ¶1). Skin reads on epithelial cells. Sapadin further teach phototherapy is well-tolerated by most people and anesthesia is not needed for treatment (p1 ¶4).
It would have been obvious to one of ordinary skill in the art to adapt the methods of Anderson drawn to exposing epithelial cells in a subject to an effective amount of UVA by not administering anesthesia to the subject as taught by Sapadin because Sapadin teaches administration of UV to skin epithelial cells does not require anesthesia.
One of ordinary skill in the art would have been motivated to modify method as taught by Anderson by not administering anesthesia to a subject because Sapadin teaches phototherapy is well-tolerated and does not require anesthesia. One of ordinary skill in the art would understand that a procedure that does not require anesthesia would result in a procedure that is simpler and would have fewer potential complications that a procedure which did use anesthesia.
One would have had a reasonable expectation of success because both disclosures are drawn to exposing epithelial cells with UV and one of ordinary skill in the would understand that use of anesthesia would be determined by the site of UV exposure and, as taught by Sapadin, exposure of skin epithelial cells to UV would not require anesthesia.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 2020/0121943 A1) as applied to claims 1-6 19-21 above, and further in view of Liu et al (US 2021/0054462 A1).
Regarding claim 22: The teachings of Anderson are discussed supra. Anderson do not teach a control reference of epithelial cells before exposure to UVA.
Liu teach differential gene expression in skin samples (epithelial cells) that have been exposed to solar ultraviolet radiation (p1 [0009]). Solar ultraviolet radiation comprises ultraviolet A (UVA) and thus reads on exposing epithelial cells to ultraviolet A. The amount of UVA exposure is considered to be effective because Liu teach it induces differential gene expression. Table 2 of Liu teach gene expression for some genes is upregulated with exposure to UVA (p8). Liu also teach differential expression means that expression levels of certain genes are different between biological samples in different states, tissues, or types of cells (p21 [0036]).
It would have been obvious to one of ordinary skill in the art to adapt the methods of Anderson drawn to exposing epithelial cells in a subject to an effective amount of UVA by using a control reference value of epithelial cells before exposure to UVA, as taught by Liu. Table 8 of Liu lists the expression profile of UV-induced differentially expressed genes
One of ordinary skill in the art would have been motivated to modify the method as taught by Anderson by using a control reference value of epithelial cells before exposure to UVA, as taught by Liu because Liu teach differential gene expression of cells before and after exposure to UVA.
One would have had a reasonable expectation of success because the references teach the active steps of the method and thus if MAVS were interrogated in the gene set of Liu one would have a reasonable expectation of success.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Brusie et al (nurse news [online]. UV Light Therapy as Covid-19 Treatment [retrieved on 03/02/2026]. Retrieved from the Internet: https://nurse.org/articles/uv-light-therapy-coronavirus-covid19/), Liu et al (US 2021/0054462 A1) and Ren et al (Frontiers in Immunology (2020) 11;1-12, as cited in the IDS filed 10/24/2023).
Regarding claims 23-24: Brusie teach a technology to deliver intermittent UVA light through an endotracheal catheter as a potential treatment for coronavirus and other respiratory infections (p2 ¶2). Brusie further teach that administering UVA light can eradicate viruses (including coronaviruses) while preserving healthy cells (p2 ¶5).
Liu et al (US 2021/0054462 A1, as cited in the IDS teach differential gene expression in skin samples (epithelial cells) that have been exposed to solar ultraviolet radiation (p1 [0009]). Solar ultraviolet radiation comprises ultraviolet A (UVA) and thus reads on exposing epithelial cells to ultraviolet A. The amount of UVA exposure is considered to be effective because Liu teach it induces differential gene expression. Table 2 of Liu teach gene expression for some genes is upregulated with exposure to UVA (p8). Liu also teach differential expression means that expression levels of certain genes are different between biological samples in different states, tissues, or types of cells (p21 [0036]).
Ren teach Mitochondrial antiviral-signaling protein (MAVS) is a key adapter protein required for defense against RNA viruses (p2 col1 ¶1). Ren further teach some viruses escape the host antiviral immune response by promoting the cleavage or degradation of MAVS (p7 col2 ¶3). Ren further teach a protein encoded by coronavirus SARS catalyzes the degradation of the MAVS signaling complex and may contribute to viral escape (p8 col1 ¶2).
It would have been obvious to one of ordinary skill in the art to adapt the methods of Brusie drawn UVA treatment in a subject in need thereof (Sars-CoV2 patient) to include assaying a biological sample for MAVS expression level as taught by Liu and Ren.
One of ordinary skill in the art would have been motivated to modify the method as taught by Brusie by assaying a biological sample obtained from a subject having been exposed to UVA treatment, as taught by Liu, to assay form MAVS protein expression level because Ren teach SARS CoV-2 reduces MAVS protein expression.
One would have had a reasonable expectation of success because REN teach downregulation of MAVS represents a mechanism through which Sars-CoV-2 escapes immunity and Brusie teach UVA treatment is a potential therapy for Sars-CoV-2.
Furthermore, it would be obvious to continue to administer any treatment once treatment has begun.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 2020/0121943 A1) as applied to claims 1-6 19-21 above, and further in view Brusie et al (nurse news [online]. UV Light Therapy as Covid-19 Treatment [retrieved on 03/02/2026]. Retrieved from the Internet: https://nurse.org/articles/uv-light-therapy-coronavirus-covid19/), Liu et al (US 2021/0054462 A1, as cited in the IDS and Ren et al (Frontiers in Immunology (2020) 11;1-12)..
Regarding claim 25: The teachings of Anderson are discussed supra. Anderson do not teach a subject with low MAVS expression compared to a control.
Brusie teach a technology to deliver intermittent UVA light through an endotracheal catheter as a potential treatment for coronavirus and other respiratory infections (p2 ¶2). Brusie further teach that administering UVA light can eradicate viruses (including coronaviruses) while preserving healthy cells (p2 ¶5).
Ren teach Mitochondrial antiviral-signaling protein (MAVS) is a key adapter protein required for defense against RNA viruses (p2 col1 ¶1). Ren further teach some viruses escape the host antiviral immune response by promoting the cleavage or degradation of MAVS (p7 col2 ¶3). Ren teach a protein encoded by coronavirus SARS catalyzes the degradation of the MAVS signaling complex and may contribute to viral escape (p8 col1 ¶2).
Liu teach differential gene expression in skin samples (epithelial cells) that have been exposed to solar ultraviolet radiation (p1 [0009]). Solar ultraviolet radiation comprises ultraviolet A (UVA) and thus reads on exposing epithelial cells to ultraviolet A. The amount of UVA exposure is considered to be effective because Liu teach it induces differential gene expression. Table 2 of Liu teach gene expression for some genes is upregulated with exposure to UVA (p8). Liu also teach differential expression means that expression levels of certain genes are different between biological samples in different states, tissues, or types of cells (p21 [0036]).
It would have been obvious to one of ordinary skill in the art to adapt the methods of Anderson drawn to exposing epithelial cells in a subject to an effective amount of UVA by administering the UVA to a subject in need (e.g. Sars-Cov-2 patient) as taught by Brusie.
One of ordinary skill in the art would have been motivated to modify the method as taught by administering the UVA to a subject in need (e.g. Sars-Cov-2 patient) as taught by Brusie because Brusie teach UVA is being studied as a potential treatment for coronavirus.
One would have had a reasonable expectation of success because Ren teach MAVS expression is reduced Sars infection, and thus cells that were successfully treated for Sars would exhibit an increase in MAVS protein expression.
Conclusion
No claims are allowed.
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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631