The Board of Trustees of the University of IllinoisDownload PDFPatent Trials and Appeals BoardJan 4, 20212020001292 (P.T.A.B. Jan. 4, 2021) Copy Citation UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 14/923,101 10/26/2015 Amelia Bartholomew 1310-54 8869 26259 7590 01/04/2021 LICATA & TYRRELL P.C. 66 E. MAIN STREET MARLTON, NJ 08053 EXAMINER KUO, JONATHAN T ART UNIT PAPER NUMBER 3792 NOTIFICATION DATE DELIVERY MODE 01/04/2021 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): PTOactions@licataandtyrrell.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte AMELIA BARTHOLOMEW, MEGAN O’CONNOR, and RACHANA PATIL ____________ Appeal 2020-001292 Application 14/923,101 Technology Center 3700 ____________ Before: PHILLIP J. KAUFFMAN, ANNETTE R. REIMERS, and TARA L. HUTCHINGS, Administrative Patent Judges. HUTCHINGS, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Appellant1 appeals under 35 U.S.C. § 134(a) from the Examiner’s final rejection of claims 1–3, 5–9, 11, 13–15, 18–20, 23, 25–28, and 30. We have jurisdiction under 35 U.S.C. § 6(b). 1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Our decision references the Specification (“Spec.,” filed Jan. 6, 2016), Final Office Action (“Final Act.,” mailed Feb. 20, 2019), Appeal Brief (“Appeal Br.,” filed Sept. 9, 2019), Answer (“Ans.,” mailed Nov. 1, 2019), and Reply Brief (“Reply Br.,” filed Dec. 3, 2019). Appellant identifies the real party in interest as “The Board of Trustees of the University of Illinois.” Appeal Br. 1. Appeal 2020-001292 Application 14/923,101 2 We REVERSE. CLAIMED INVENTON The present invention “relates generally to methods of treating fibrosis” and, more particularly, to “methods of using laser light of various wavelengths alone or in combination with mesenchymal stem cell [(“MSC”)] therapy for treating and reversing conditions related to diseased or atrophic states of fibrotic tissue and promoting tissue regeneration.” Spec. 1:8–12. Claims 1, 8, and 20 are independent. All three independent claims are reproduced below: 1. A method of treating conditions related to diseased or atrophic states of fibrotic tissue, and promoting endothelial preservation and proliferation for muscle or internal organ tissue regeneration and repair in a subject comprising exposing the fibrotic tissue of the muscle or internal organ of the subject to laser light having a wavelength of 405 nm or 532 nm. 8. A method of treating kidney disease in a subject comprising exposing a kidney and associated nerves to a combination of laser light consisting of wavelengths of 405 nm, 532 nm, and 635 nm. 20. A method of promoting tissue regeneration in a subject comprising exposing the tissue of a muscle or internal organ to a combination of laser light consisting of wavelengths of 405 nm, 532 nm, and 635 nm. REJECTIONS Claims 1–3, 5, 7–9, 11, 14, 15, 18, 20, 23, 25–28, and 30 are rejected under 35 U.S.C. § 103 as unpatentable over Streeter (US 2011/0060266 A1, Appeal 2020-001292 Application 14/923,101 3 pub. Mar. 10, 2011), McDaniel (US 2005/0261750 A1, pub. Nov. 24, 2005), and Altshuler (US 2004/0010298 A1, pub. Jan. 15, 2004). Claims 6, 13, and 19 are rejected under 35 U.S.C. § 103 as unpatentable over Streeter, McDaniel, Altshuler, and Bartholomewq (US 2011/0044958 A1, pub. Feb. 24, 2011). ANALYSIS Independent Claim 1 and Dependent Claims 2, 3, 5, 7, 27, 28, and 30 We are persuaded by Appellant’s argument that the Examiner erred in determining that it would have been obvious to modify and optimize the wavelengths of Streeter to the claimed wavelengths of 405 nm or 532 nm to achieve treatment of fibrotic tissue of the muscle or internal organ, as set forth in claim 1. See Appeal Br. 14–26; Reply Br. 2–8. In rejecting claim 1 under 35 U.S.C. § 103, the Examiner primarily relies on Streeter as disclosing the claimed subject matter. See Final Act. 5– 6 (citing Streeter ¶¶ 19, 96, 103, 104, 219, 221, 224–229, 303, 304, 319, 364, 365, 368, 370). Streeter relates to enhancing the efficacy of various aspects of stem cell therapy. Streeter ¶ 3. Methods for enhancing the suitability of stem cells for use in cell therapy use low level light therapy. Id. ¶ 16. The light energy has a wavelength between about 350 and 1200 nanometers (“nm”), depending on the application. Id. ¶ 19. Streeter teaches measuring the absorption and transmittance of various tissues to determine the utility of various wavelengths. Id. ¶ 227. For example, blood absorbs less in the region above 700 and is particularly transparent above 780 nm. Id. ¶¶ 227, 379. As a result, wavelengths below 700 nm are heavily Appeal 2020-001292 Application 14/923,101 4 absorbed and not likely to be used therapeutically, except for topical indications. Id. The Examiner finds that Streeter does not teach exposing the fibrotic tissue of the muscle or internal organ of the subject to laser light having a wavelength of 405 nm or 532 nm, as required by claim 1. Final Act. 5. However, the Examiner determines that the use of the claimed wavelengths would be the obvious result of routine optimization within Streeter’s range of 350 to 1200 nm. Id. at 5–6 (citing Streeter ¶ 19). The difficulty with the Examiner’s analysis is that Streeter does not disclose that light within the range of 350 to 1200 nm is used for any particular application, such as “treating conditions related to diseased or atrophic states of fibrotic tissue, and promoting endothelial preservation and proliferation for muscle or internal organ tissue regeneration,” as recited in claim 1. Instead, Streeter teaches that particular bands of light are suitable (or unsuitable) depending upon the application. Streeter ¶ 19. For example, wavelengths below 700 nm typically are not used therapeutically (except topically) (id. ¶¶ 227, 379); whereas, wavelengths between 780 and 880 nm are preferable for targeting the brain (id. ¶ 381). Accordingly, the Examiner’s finding that Streeter teaches or suggests using laser light having wavelengths between 350 to below 700 nm for the claimed application of exposing the fibrotic tissue of the muscle or internal organ of the subject, and determination that selection of wavelengths within this range would be a matter of routine optimization for the claimed application is not adequately supported. The Examiner further cites McDaniel and Streeter as disclosing the claimed wavelengths, and determines that it would have been obvious to modify Streeter’s laser light to have a wavelength of 405 nm or 532 nm, as Appeal 2020-001292 Application 14/923,101 5 required by claim 1, because “the prior art of record teaches the general conditions of obtaining wavelengths to maximize therapeutic results.” Final Act. 6 (citing MPEP §2144.05), 7. McDaniel discloses a system and method for the treatment of acne. McDaniel ¶ 2. The method involves applying chlorophyll to the sebaceous oil gland and surrounding tissue and exposing it to a laser having a dominate wavelength around 400 nm. Id. ¶ 51. Light at this wavelength has a limited depth penetration of radiation, which may not treat all acne cysts effectively. Id. ¶ 82. Light having a wavelength of 600 to 660 nm can penetrate to a greater depth if treatment of lower dermal layers is desirable. Id. Therefore, selection of the wavelength of light used depends on the depth of treatment. Id. McDaniel’s disclosure of treating acne with wavelengths below 700 nm is consistent with Streeter’s teaching that wavelengths below 700 nm are not likely to be used therapeutically, except for topical indications. Here, the Examiner has not adequately established why one of ordinary skill in the art would have been motivated to modify Streeter’s laser light having a wavelength over 700 nm to treat tissue of an internal organ to laser light having the claimed wavelength of 405 nm, as recited in claim 1, based on McDaniel’s disclosure of using light having a wavelength of 400 nm to treat topical indications. Altshuler teaches selectively heating blood vessels in a patient’s skin to effect a desired dermatological treatment. Altshuler Abstract. For shallow vessels, radiation is applied in a blue band (380–450 nm). Id. Abstract, ¶12. Depending on the blood vessel treated and the patient’s skin type, other wavelength bands, such as green-yellow (500–610 nm) and near infrared (800–1120), may be used. Id. Abstract, ¶¶ 45–47. For example, the Appeal 2020-001292 Application 14/923,101 6 blue band is used to treat superficial veins, the green yellow band is used to treat intermediate veins, and the near infrared band is used to treat deep veins. See id. ¶ 50. Like Streeter, Altshuler acknowledges that the blue light does not penetrate deep. Altshuler ¶ 52 (“because blue light does not penetrate much below the skin surface, it is best for plexus vessels and superficial veins and is of little value for intermediate veins”). Here, the Examiner has not adequately established why one of ordinary skill in the art would have been motivated to modify the wavelength of the laser light used on tissue of an internal organ from over 700 nm, as disclosed by Streeter, to 405 nm or 532 nm, as recited in claim 1, based on Altshuler’s disclosure of using light in a blue band and/or green yellow band to treat blood vessels in a patient’s skin. See Final Act. 6–7. For example, the Examiner provides no technical reasoning as to why or how a wavelength appropriate for treating blood vessels in skin, as taught be Altshuler, would be understood by one of ordinary skill in the art as an appropriate wavelength for use in Streeter’s treatment of an internal organ of the subject, particularly in view of Streeter’s teaching that wavelengths below 700 are unlikely to be used therapeutically due to the blood’s absorption of these wavelengths. Accordingly, we do not sustain the rejection of independent claim 1 and dependent claims 2, 3, 5, 7, 27, 28, and 30 under 35 U.S.C. § 103 as unpatentable. Appeal 2020-001292 Application 14/923,101 7 Independent Claims 8 and 20, and Dependent Claims 9, 11, 14, 15, 18, 23, 25, and 26 Claim 8 recites “exposing a kidney and associated nerves to a combination of laser light consisting of wavelengths of 405 nm, 532 nm, and 635 nm.” Claim 20 recites “exposing the tissue of a muscle or internal organ to a combination of laser light consisting of wavelengths of 405 nm, 532 nm, and 635 nm.” In rejecting claims 8 and 20, the Examiner determines that the use of the claimed wavelengths are the obvious result of routine optimization within Streeter’s range of 350 to 1200 nm. Final Act. 8–9, 12. As with claim 1, the Examiner cites McDaniel and Altschuler for the recited wavelengths in topical applications. Final Act. 9–10, 12–13. For similar reasons described above with reference to claim 1, we do not sustain the rejection of independent claims 8 and 20 and dependent claims 9, 11, 14, 15, 18, 23, 25, and 26 under 35 U.S.C. § 103. Dependent Claims 6, 13, and 19 The Examiner’s rejection under 35 U.S.C. § 103 of claims 6, 13, and 19 does not cure the deficiencies in the Examiner’s rejection of the independent claims. Therefore, we do not sustain the rejection of claims 6, 13, and 19 under 35 U.S.C. § 103 for the same reasons set forth above with respect to the independent claims. Appeal 2020-001292 Application 14/923,101 8 CONCLUSION In summary: Claims Rejected 35 U.S.C. § References/Basis Affirmed Reversed 1–3, 5, 7–9, 11, 14, 15, 18, 20, 23, 25–28, 30 103 Streeter, McDaniel, Altshuler 1–3, 5, 7–9, 11, 14, 15, 18, 20, 23, 25–28, 30 6, 13, 19 103 Streeter, McDaniel, Altshuler, Bartholomewq 6, 13, 19 Overall Outcome 1–3, 5–9, 11, 13–15, 18– 20, 23, 25– 28, 30 REVERSED Copy with citationCopy as parenthetical citation