RICE UNIVERSITY (PATENT OWNER) et al.

Patent Trials and Appeals BoardAug 3, 2020

90013883 - (D) (P.T.A.B. Aug. 3, 2020)

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. 90/013,883 12/21/2016 6685730 16-21025-US-RX 3156 98820 7590 08/03/2020 Reed Smith LLP P.O. Box 488 Pittsburgh, PA 15230 EXAMINER DAWSON, GLENN K ART UNIT PAPER NUMBER 3993 MAIL DATE DELIVERY MODE 08/03/2020 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte WILLIAM MARSH RICE UNIVERSITY Patent Owner and Appellant ____________ Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 Technology Center 3900 ____________ Before RICHARD M. LEBOVITZ, GEORGIANNA W. BRADEN, and JANE E. INGLESE, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. §§ 134(b) and 306, Patent Owner1 appeals from the final rejection of claims 75–80 under 35 U.S.C. § 112 as lacking a written description. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Patent Owner identifies the real party in interest as William Marsh Rice University. Appeal Br. 1. Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 2 STATEMENT OF THE CASE This appeal involves U.S. Patent No. 6,685,730 B2 (“the ’730 patent), which issued Feb. 3, 2004. A Request for Ex Parte Reexamination under 35 U.S.C. §§ 301–307 and 37 C.F.R. § 1.501 et seq. was filed December 21, 2016 by Patent Owner, William Marsh Rice University. Reexamination was ordered (Order Granting Request for Reexamination mailed Jan. 26, 2017). Patent Owner appeals from the Examiner’s final rejection of claims 75–80 under 35 U.S.C. § 112(a) or pre-AIA 35 U.S.C. § 112, first paragraph, as lacking a written description. Claims 75, 77, and 79 are representative and reproduced below: 75. A method for reducing wrinkles in tissue comprising the steps of: delivering plasmonic nanoparticles to the tissue, said plasmonic nanoparticles comprising silver or gold, and exposing said delivered plasmonic nanoparticles to light at one or more wavelengths between approximately 750 to 1300 nm wherein said plasmonic nanoparticles absorb said light and emit heat at a surface of said plasmonic nanoparticle. 77. A method for resurfacing tissue comprising the steps of: delivering plasmonic nanoparticles to the tissue, said plasmonic nanoparticles comprising silver or gold, and exposing said delivered plasmonic nanoparticles to light at one or more wavelengths between approximately 750 to 1300 nm wherein said plasmonic nanoparticles absorb said light and emit heat at a surface of said plasmonic nanoparticle. 79. A method for ablating tissue comprising the steps of: delivering plasmonic nanoparticles to the tissue, said plasmonic nanoparticles comprising silver or gold, and exposing said delivered nanoparticles to light at one or more wavelengths between approximately 750 to 1300 nm wherein said plasmonic nanoparticles absorb said light and emit heat at a surface of said plasmonic nanoparticle. Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 3 Claims 75–80 were added by amendment on July 6, 2018. The Examiner responded to the amendment in a Final Office Action on September 11, 2018 by rejecting the claims as obvious over prior art. However, after a phone interview with the attorney for the Patent Owner (summarized by Patent Owner in paper entered Nov. 9, 2018), and after one intervening Office Action, the Examiner rejected claims 75–80 under 35 U.S.C. § 112(a) or pre-AIA 35 U.S.C. § 112, first paragraph, as lacking a written description in the Specification. Non-Final Act. 4 (mailed Feb. 15, 2019). After considering a response by Patent Owner (entered Apr. 12, 2019), the Examiner maintained the written description rejection in a Final Action (entered May 15, 2019). All of the amended claims require “exposing said delivered plasmonic nanoparticles to light at one or more wavelengths between approximately 750 to 1300 nm.” The basis of the written description rejection by the Examiner is that while the Specification discloses “conductive metallic, as well as gold and silver nanoparticles, and it discloses that conductive metal nanoparticles can absorb light in the NIR [near infrared] of between approximately 750–1300nm, and . . . that nanoparticles can be used to reduce wrinkles, resurface tissue and ablate tissue,” the Specification does not disclose that “conductive metal, silver or gold nanoparticles are used to reduce wrinkles, resurface tissue and ablate tissue by absorbing light at wavelengths between approximately 750–1300 nm.” Non-Final Act. 4–5 (mailed Feb. 15, 2019). The Examiner explained that the Specification “goes to no effort to distinguish between the different requirements of the nanoparticles and the Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 4 light matched in such a way that they would be useful in performing the claimed methods of reducing wrinkles, resurfacing tissue or ablating tissue.” Final Act. 6. The Examiner states “there is no reason to conclude that the full claimed range of light wavelengths would be useable to perform the methods of reducing wrinkles, resurfacing tissue and ablating tissue” because “the disclosure of methods of reducing wrinkles, resurfacing tissue or ablating tissue contains no parameters for the light wavelength.” Id. The Examiner’s main complaint with the written description in the ’730 patent is that where wrinkle reduction and resurfacing treatment is described, there is no disclosure of the specific wavelengths used to accomplish these treatments. The pertinent disclosures from the Specification of the ’730 patent are reproduced below: In a specific embodiment of the present invention, a method for reducing wrinkles or other cosmetic defects such as stretch marks in tissue comprises delivering nanoparticles that absorb light at one or more wavelengths to the tissue and exposing said nanoparticles to light at one or more wavelengths that are absorbed by the nanoparticles. In other specific embodiments, methods for cosmetic or therapeutic laser resurfacing of tissue are used. ’730 patent, col. 4, ll. 34–41. EXAMPLE 6 Heat-induced Modification of Tissues This invention is also useful for heal-induced modification of tissues or proteins. Conventional laser resurfacing is a technique used for removal and/or minimization of wrinkles and involves the direct application of laser light to the tissue to be treated. Laser light is applied to the skin and as a result of heating, collagen and elastin fibers in the dermis are reorganized. Such laser treatments, often referred to as laser resurfacing, have been Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 5 found to be effective for the reduction of wrinkles in the skin, presumably through the generation of heat within the tissue. Reduction in wrinkles has been attributed to the remodeling of matrix proteins, including the stimulation of collagen and elastin synthesis and the contracture of collagen fibrils (Fitzpatrick, et al., 2000; Goldberg, et al., 2000; Bjerring, et al., 2000). . . . Nanoparticles can be targeted, either mechanically or chemically to a specific region of the tissue in order to localize light absorption, and thus heating, to the desired area. In wrinkle reduction, nanoparticles are targeted to the dermis to initiate matrix remodeling while minimizing damage to the epidermis. The highly controlled heating of tissue of is accomplished by targeting nanoparticles to a specific depth or region of tissue to more strictly localize heating and more effectively avoid damage to “non-targeted” tissue. In the case of skin and wrinkle reduction, it is possible to target nanoparticles to “sub- epidermis” tissue using ballistic devices similar to the so-called “Gene Gun” or using tattoo needles. ’730 patent, col. 12, l. 59–col. 13, l. 29. The Examiner is correct that the pertinent disclosures reproduced above do not identify a specific wavelength of the light that the nanoparticles are exposed to for the purpose of reducing wrinkles and resurfacing tissue. For this reason, the Examiner found the written description of the claim recitation of “exposing said delivered plasmonic nanoparticles to light at one or more wavelengths between approximately 750 to 1300 nm” to be defective. We first address the legal standard under which compliance with the written description requirement is determined. To satisfy the written description requirement of 35 U.S.C. § 112, the inventor must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.” Vas-Cath Inc. v. Mahurkar, Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 6 935 F.2d 1555, 1563–64 (Fed. Cir. 1991) (emphasis omitted). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations . . . .” Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (emphasis omitted). In describing the claimed invention, there is no requirement that the wording be identical to that used in the specification as long as there is sufficient disclosure to show one of skill in the art that the inventor “invented what is claimed.” Union Oil Co. v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000). The written description “need not recite the claimed invention in haec verba but [it] must do more than merely disclose that which would render the claimed invention obvious.” ICU Med., Inc. v. Alaris Med. Sys., Inc., 558 F.3d 1368, 1377 (Fed. Cir. 2009). Thus, as long as a person “of ordinary skill in the art would have understood the inventor to have been in possession of the claimed invention at the time of filing, even if every nuance of the claims is not explicitly described in the specification, then the adequate written description requirement is met.” In re Alton, 76 F.3d 1168, 1175 (Fed. Cir. 1996). The issue in this appeal is whether Patent Owner identifies reversible error in the Examiner’s determination that one of ordinary skill in the art, upon reading the ’730 patent, would not have recognized that the inventors “invented” methods of reducing wrinkles in tissue and resurfacing tissue using by exposing nanoparticles “to light at one or more wavelengths between approximately 750 to 1300 nm wherein said plasmonic nanoparticles absorb said light and emit heat at a surface of said plasmonic nanoparticle.” Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 7 While it is correct that the Specification of the ’730 patent does not disclose at column 4, lines 34–41 and column 12, line 59–column 13, line 29 (reproduced above) the wavelengths of light used to accomplish the claimed tissue treatment, we do not agree with the Examiner that the inventor did not invent, or have possession of, the specifically claimed wavelengths to achieve wrinkle reduction and tissue resurfacing. We explain this is more detail below. The Specification discloses that the subject invention is a “method of joining tissue [that] comprises delivering nanoparticles that absorb light at one or more wavelengths to the tissue and, exposing the nanoparticles to light at one or more wavelengths that are absorbed by the nanoparticles.” ’730 patent, col. 3, ll. 32–36. The Specification discloses that near-infrared (“NIR”) light can be used for this purpose “in the wavelength range of 600– 2000 nm” and in “a preferred . . . wavelength range of 700–1200 nm.” Id. at col. 3, ll. 50–53. The Specification also discloses using NIR light at wavelengths of 750 to 1300 in the described method, the same range which is claimed. Id. at col. 8, ll. 21–22. Because the disclosure of wrinkle reduction and tissue resurfacing in the Specification does not specifically identify what wavelength to use to treat the tissue, one of ordinary skill in the art would have looked for guidance in the Specification and found it in the aforementioned disclosure of what wavelengths of light the same nanoparticles are exposed to in order to be effective in treating tissue. The Examiner did not provide evidence that the nanoparticles operate any differently in wrinkle reduction and tissue resurfacing than in the other tissue treatment methods described in the ’730 Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 8 patent. Therefore, based on the disclosure throughout the ’730 patent of effective wavelengths of light for treating tissue, the skilled worker would have recognized that the inventors invented the treatment methods of claims 75 and 77 comprising “exposing said delivered plasmonic nanoparticles to light at one or more wavelengths between approximately 750 to 1300 nm.” The Examiner stated that “there is no reason to conclude that the full claimed range of light wavelengths would be useable to perform the methods of reducing wrinkles, resurfacing tissue and ablating tissue” (Final Act. 6), but provides no reasoning as to why one of ordinary skill in the art would have doubted that these wavelengths would work in the claimed methods.2 See In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971) (“[A] specification disclosure which contains a teaching of the manner and process of making and using an invention in terms which correspond in scope to those used in describing and defining the subject matter sought to be patented must be taken as being in compliance with the enablement requirement” of 35 U.S.C. § 112(a) “unless there is a reason to doubt the objective truth of the statements contained therein which must be relied on for enabling support.”). The Examiner did not provide sufficient evidence to doubt that the light wavelengths described in the Specification would not be “useable” to reduce wrinkles and resurface tissue. 2 The Examiner framed the rejection as failing to comply with the written description requirement of § 112, but the Examiner also raised this enablement issue in framing the basis of the § 112 rejection. Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 9 The description in the Specification of the mechanism of how the nanoparticles work when applied to tissue provides further evidence that the inventors invented and possessed the claimed methods of “exposing said delivered plasmonic nanoparticles to light at one or more wavelengths between approximately 750 to 1300 nm wherein said plasmonic nanoparticles absorb said light and emit heat at a surface of said plasmonic nanoparticle.” The Specification discloses that “[i]n many applications, it is desirable to target cells and tissue for localized heating. The therapeutic effects range from the destruction of cancerous cells and tumors, to the therapeutic or cosmetic removal of benign tumors and other tissue.” ’730 patent, col. 2, ll. 16–20. Example 6, which describes a method of wrinkle reduction and tissue resurfacing, characterized the method as “Heat-Induced Modification of Tissues” and describes targeting the nanoparticles to the specific region of tissue “to localize light absorption, and thus heating, to the desired area.” Id. at col. 12, l. 60; col. 13, ll. 16–18. This example also discloses that the “highly controlled heating of tissue . . . is accomplished by targeting nanoparticles to a specific depth or region of tissue to more strictly localize heating and more effectively avoid damage to ‘non-targeted’ tissue.” Id. at col. 12, ll. 21–25. Thus, “localized heating” of the tissue is enabled by exposing the nanoparticles to the disclosed wavelengths of light and serves as a common mechanism in both the therapeutic and cosmetic applications (wrinkle reduction and resurfacing) described in the ’730 patent. The Specification explains that when NIR light at a wavelength of 600–2000 nm is used, it “interacts with nanoparticles designed to strongly Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 10 absorb NIR light” such that “heat will be generated rapidly and sufficiently to induce tissue welding.” ’730 patent, col. 7, l. 65–col. 8, l. 6. In other words, NIR light at a wavelength of 600–2000 nm accomplishes the “localized heating” which is useful for cosmetic treatments, including wrinkle reduction and tissue resurfacing (Example 6 at cols. 12–13). The subsequent disclosure at column 8, lines 21–22, of exposing tissue to NIR light of 750–1300 nm, the same range which is claimed, would have been recognized by one of ordinary skill in the art as useful to achieve the benefits of localized heating for the claimed cosmetic applications because the light absorption and heating mechanism is the same for all the methods described in the ’730 patent. In sum, we find that the ’730 patent provides a written description of methods of reducing wrinkles and resurfacing tissue by “exposing said delivered plasmonic nanoparticles to light at one or more wavelengths between approximately 750 to 1300 nm” as recited in independent claims 75 and 77. The written description rejection of these claims, and dependent claims 76 and 78, is reversed. Claim 79 is directed to a “method for ablating tissue” employing the same nanoparticles and wavelengths recited in independent claims 75 and 77. With respect to this method, the Specification describes that “[i]n a specific embodiment of the invention, tissue is ablated by the method.” ’730 patent, col. 4, ll. 48–50. The “method” is described in the preceding sentence as “a method of heating tissue comprises delivering nanoparticles that absorb light at one or more wavelengths to the tissue and exposing the nanoparticles to light at one or more wavelengths that are absorbed by the nanoparticles.” Appeal 2020-004461 Reexamination Control 90/013,883 Patent 6,685,730 B2 11 Id. at col. 4, ll. 42–46 (emphasis added). The mechanism of “ablating tissues” is described as “heating tissue,” and therefore is the same mechanism described for reducing wrinkles, resurfacing skin, and the other tissue treatments described in the ’730 patent. Accordingly, for the same reasons as for claims 75 and 77, we conclude that claim 79, and dependent claim 80, are described in the Specification of the ’730 patent. The written description rejection of these claims is reversed. CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 75–80 112 Written Description 75–80 REVERSED For Patent Owner: Reed Smith LLP P.O. Box 488 Pittsburgh PA 15230