Wael Yared et al.Download PDFPatent Trials and Appeals BoardMar 31, 202014054651 - (D) (P.T.A.B. Mar. 31, 2020) 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. 14/054,651 10/15/2013 Wael Yared 008916.00005 9097 155218 7590 03/31/2020 BANNER & WITCOFF, LTD. Client 008916 1100 13th STREET, N.W. SUITE 1200 WASHINGTON, DC 20005-4051 EXAMINER LAMBERSKI, JENNIFER A ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 03/31/2020 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): PTO-155218@bannerwitcoff.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte WAEL YARED, JOSHUA KEMPNER, JORGE RIPOLL LORENZO, and ALICIA ARRANZ1 Appeal 2019-001341 Application 14/054,651 Technology Center 1600 Before ERIC B. GRIMES, RYAN H. FLAX, and CYNTHIA M. HARDMAN, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to an imaging method, which have been rejected as anticipated, obvious, and ineligible for patenting. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 Appellant identifies the real party in interest as VisEn Medical, Inc. Appeal Br. 2. We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appeal 2019-001341 Application 14/054,651 2 STATEMENT OF THE CASE “[T]he invention relates to systems and methods for in vivo tomographic imaging of fluorescent probes and/or bioluminescent reporters, wherein a fluorescent probe and a bioluminescent reporter are spatially co- localized . . . in a diffusive medium (e.g., biological tissue).” Spec. ¶ 8. The Specification states that “[b]y combining detection of both bioluminescence and fluorescence, it is possible to retrieve 3D information of fluorescent probes with the superior signal-to-noise ratio of bioluminescence due to the lack of background signal.” Id. ¶ 49. Claims 1–4, 8, 9, 12, 13, 40, 42, 44, and 48–52 are on appeal. Claim 1, reproduced below, is illustrative: 1. A method for imaging a target region of a diffuse object, the method comprising: (a) administering a probe comprising a fluorescent species to the object, wherein following administration of the probe the fluorescent species is co-located with a bioluminescent reporter in the object; (b) detecting bioluminescent light emitted from the object by the bioluminescent reporter in the target region of the object; (c) directing excitation light into the object at multiple locations and/or at multiple angles, thereby exciting the fluorescent species; (d) detecting fluorescent light, the detected fluorescent light having been emitted by the fluorescent species in the target region of the object as a result of excitation by the excitation light; and (e) processing data corresponding to the detected bioluminescent light and the detected fluorescent light via tomographic reconstruction to provide a tomographic image of the target region of the object. Appeal 2019-001341 Application 14/054,651 3 The claims stand rejected as follows: Claims 1–4, 8, 9, 12, 13, 40, 42, 44, and 48–52 under 35 U.S.C. § 101 as being ineligible for patenting (Ans. 3); Claims 1–3, 9, 12, 13, 40, 42, 44, and 52 under 35 U.S.C. § 102(b) as anticipated by Inoue2 (Ans. 4); Claims 48–51 under 35 U.S.C. § 103(a) as obvious based on Inoue and Ntziachristos3 (Ans. 5); and Claims 4 and 8 under 35 U.S.C. § 103(a) as obvious based on Inoue and Bryan4 (Ans. 6). OPINION Eligibility Claims 1–4, 8, 9, 12, 13, 40, 42, 44, and 48–52 stand rejected under 35 U.S.C. § 101. The Examiner finds that “[c]laims 1 and 48–51 are directed to an abstract idea, specifically, to a method that includes the steps of processing data (claim 1), e.g., by weighting different combinations of data collected (claim 48–51).” Ans. 3. The Examiner finds that “[t]hese steps encompass mental steps and abstract ideas similar to the concepts that have been identified as abstract by the courts . . . e.g., collecting information, analyzing it, and displaying certain results of the collection and analysis; obtaining and comparing intangible data; or storing, gathering, and analyzing data.” Id. 2 Yusuke Inoue et al., In vivo fluorescence imaging of the reticuloendothelial system using quantum dots in combination with bioluminescent tumour monitoring, Eur. J. Nucl. Med. Mol. Imaging 34:2048–2056 (2007). 3 Ntziachristos et al., US 7,383,076 B2; June 3, 2008. 4 Bryan, US 2002/0090659 A1; July 11, 2002. Appeal 2019-001341 Application 14/054,651 4 The Examiner concludes that the claims do not amount to significantly more than the judicial exception because the active steps of the method (i.e., administering a fluorescent species and a bioluminescent species; directing excitation light thereby exciting the fluorescent species; and detecting fluorescence emission . . . and bioluminescent light . . . ) represent conventional steps already engaged by those skilled in the art for imaging a target region of a diffuse object. Id., citing Inoue. The Examiner concludes that the claims are ineligible for patenting. Id. Appellant argues that the Office Action has failed to properly identify what the claims are directed to. Instead, the Office asserts that the claims are directed to “a method that includes the steps of processing data . . . e.g., by weighting different combinations of data collected.” The mere fact that a claim may include step of processing data, even taking this assertion to be true, does not render the entire claim patent ineligible. Appeal Br. 8. Appellant argues that “[c]laim 1 is not directed to the alleged abstract idea or any other abstract idea. Rather, claim 1 is directed to a unique imaging approach including processing a particular type of data in a particular manner to obtain a particular result.” Id. Principles of Law A. Section 101 An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: “[l]aws of nature, natural phenomena, and Appeal 2019-001341 Application 14/054,651 5 abstract ideas” are not patentable. See, e.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014). In determining whether a claim falls within an excluded category, we are guided by the Court’s two-part framework, described in Mayo and Alice. Id. at 217–18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75–77 (2012)). In accordance with that framework, we first determine what concept the claim is “directed to.” See Alice, 573 U.S. at 219 (“On their face, the claims before us are drawn to the concept of intermediated settlement, i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept of hedging, or protecting against risk.”). Concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices (Alice, 573 U.S. at 219–20; Bilski, 561 U.S. at 611); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts determined to be patent eligible include physical and chemical processes, such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191 (1981)); “tanning, dyeing, making water-proof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267–68 (1853))); and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))). In Diehr, the claim at issue recited a mathematical formula, but the Court held that “a claim drawn to subject matter otherwise statutory does not become nonstatutory simply because it uses a mathematical formula.” Diehr, Appeal 2019-001341 Application 14/054,651 6 450 U.S. at 187; see also id. at 191 (“We view respondents’ claims as nothing more than a process for molding rubber products and not as an attempt to patent a mathematical formula.”). Having said that, the Court also indicated that a claim “seeking patent protection for that formula in the abstract . . . is not accorded the protection of our patent laws, and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.” Id. (citations omitted) (citing Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”). If the claim is “directed to” an abstract idea, we turn to the second step of the Alice and Mayo framework, where “we must examine the elements of the claim to determine whether it contains an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract idea into a patent- eligible application.” Alice, 573 U.S. at 221 (quotation marks omitted). “A claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].’” Id. (alterations in original) (quoting Mayo, 566 U.S. at 77). “[M]erely requir[ing] generic computer implementation[] fail[s] to transform that abstract idea into a patent-eligible invention.” Id. B. USPTO Section 101 Guidance In January 2019, the U.S. Patent and Trademark Office (USPTO) published revised guidance on the application of § 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“2019 Appeal 2019-001341 Application 14/054,651 7 Revised Guidance”).5 “All USPTO personnel are, as a matter of internal agency management, expected to follow the guidance.” Id. at 51; see also October 2019 Update at 1. Under the 2019 Revised Guidance and the October 2019 Update, we first look to whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (“Step 2A, Prong One”); and (2) additional elements that integrate the judicial exception into a practical application (see Manual of Patent Examining Procedure “MPEP” § 2106.05(a)–(c), (e)–(h) (9th ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).6 2019 Revised Guidance, 84 Fed. Reg. at 52–55. Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look, under Step 2B, to whether the claim: 5 In response to received public comments, the USPTO issued further guidance on October 17, 2019, clarifying the 2019 Revised Guidance. USPTO, October 2019 Update: Subject Matter Eligibility (the “October 2019 Update”) (available at https://www.uspto.gov/sites/default/files/ documents/peg_oct_2019_update.pdf). 6 This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See 2019 Revised Guidance - Section III(A)(2), 84 Fed. Reg. 54–55. Appeal 2019-001341 Application 14/054,651 8 (3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. 2019 Revised Guidance, 84 Fed. Reg. at 52–56. Step 2(A), Prong 1 Following the 2019 Revised Guidance, we first consider whether the claims recite a judicial exception. The Examiner identifies step (e) of claim 1 as reciting “mental steps and abstract ideas similar to . . . collecting information, analyzing it, and displaying certain results of the collection and analysis; obtaining and comparing intangible data; or storing, gathering, and analyzing data.” Ans. 3. The 2019 Revised Guidance lists “[m]ental processes—concepts performed in the human mind (including an observation, evaluation, judgment, opinion)” as one category of abstract ideas. 84 Fed. Reg. at 52. However, “[c]laims do not recite a mental process when they do not contain limitations that can practically be performed in the human mind, for instance when the human mind is not equipped to perform the claim limitations.” October 2019 Update at 7. Here, the Examiner has not persuasively shown that “processing data corresponding to the detected bioluminescent light and the detected fluorescent light via tomographic reconstruction to provide a tomographic image of the target region of the object” is a process that can practically be performed in the human mind. Claim 1. Thus, the Examiner Appeal 2019-001341 Application 14/054,651 9 has not shown that claim 1 recites an abstract idea in the “mental processes” category. The 2019 Revised Guidance also lists “[m]athematical concepts— mathematical relationships, mathematical formulas or equations, mathematical calculations” as a category of abstract ideas. 84 Fed. Reg. at 52. However, we conclude that claim 1 does not recite an abstract idea in the mathematical concepts category. “A claim does not recite a mathematical concept (i.e., the claim limitations do not fall within the mathematical concept grouping), if it is only based on or involves a mathematical concept.” October 2019 Update at 3. Here, “processing data . . . via tomographic reconstruction to provide a tomographic image,” as stated in claim 1, does not expressly recite any mathematical concept. The Specification provides “[t]hree examples of the approaches that can be used to combine the bioluminescence and fluorescence measurements.” Spec. ¶ 53; see also ¶¶ 54–57. The Specification also states, however, that suitable methods are “not limit[ed] . . . to these approaches.” Id. ¶ 53. And, although the exemplary methods and dependent claims 48–51 involve weighting data corresponding to either the detected fluorescent light or the detected bioluminescent light, no specific mathematical weighting is recited in the claims. Thus, even claims 48–51 fail to recite “mathematical relationships, mathematical formulas or equations, [or] mathematical calculations” that would fall within the “[m]athematical concepts” category of abstract ideas. 84 Fed. Reg. at 52. The final category of abstract ideas listed in the 2019 Revised Guidance is “[c]ertain methods of organizing human activity,” such as “commercial or legal interactions.” 84 Fed. Reg. at 52. The Examiner has Appeal 2019-001341 Application 14/054,651 10 not asserted that an abstract idea of this type is recited in the claims, and we perceive none. In summary, we conclude that the claims on appeal do not recite an abstract idea. “If the claim does not recite a judicial exception, it is not directed to a judicial exception . . . and is eligible. This concludes the eligibility analysis.” 84 Fed. Reg. at 54. The rejection of claims 1–4, 8, 9, 12, 13, 40, 42, 44, and 48–52 under 35 U.S.C. § 101 is reversed. Anticipation Claims 1–3, 9, 12, 13, 40, 42, 44, and 52 stand rejected as anticipated by Inoue. The Examiner finds that Inoue teaches a method meeting all of the limitations of claim 1, including administering bioluminescent cells and fluorescent quantum dots to a mouse, “detecting bioluminescent light . . . by tomographic bioluminescence imaging (BLI),” directing excitation light and “detecting fluorescent light . . . by tomographic fluorescence imaging (FLI),” and “analyzing the detected light signals and signal intensity to provide merged tomographic BLI/FLI images of the mouse.” Ans. 4. Appellant argues that, “in contrast to Appellant’s approach, Inoue obtains separate bioluminescence and fluorescence images and simply overlays the two images.” Appeal Br. 16. Appellant argues that “[o]verlaying a bioluminescence image with a fluorescence image is distinct from performing tomographic reconstruction using data corresponding to detected bioluminescence light and data corresponding to detected fluorescence light to provide a tomographic image.” Id. We agree with Appellant that the Examiner has not persuasively shown that the broadest reasonable interpretation of the claim language encompasses Inoue’s disclosed method. Claim 1 requires detecting Appeal 2019-001341 Application 14/054,651 11 bioluminescent light and fluorescent light, then “processing data corresponding to the detected bioluminescent light and the detected fluorescent light via tomographic reconstruction to provide a tomographic image of the target region of the object.” Claim 1 (emphasis added). “Tomographic” is an adjective referring to tomography, which is defined by Merriam-Webster7 as follows: “a method of producing a three- dimensional image of the internal structures of a solid object (such as the human body . . . ) by the observation and recording of the differences in the effects on the passage of waves of energy impinging on those structures.” The Specification’s description of the claimed method is consistent with the ordinary meaning of “tomographic,” in focusing on three- dimensional imaging. The Specification states, for example, that the disclosed methods increase the accuracy of tomographic reconstructions in diffuse media and enhance the quantitative, three- dimensional structural, functional and molecular information obtained. . . . This increase in accuracy is obtained by reducing the ill-posedness of bioluminescent imaging in order to obtain three-dimensional (3D) reconstructions from measurements of bioluminescence signals with the aid of fluorescence. Spec. ¶ 48.8 “It is the intensity of the fluorescence emission that provides the 3D information needed for the reconstruction, while the bioluminescence emission provides the background-free spatial signal distribution.” Id. ¶ 49. 7 www.merriam-webster.com/dictionary/tomographic, last visited March 9, 2020. 8 The Specification states that “an ill-posed problem” is one for which “there is an infinite combination of concentration, position, and size that will yield exactly the same measurement.” Spec. ¶ 50. Appeal 2019-001341 Application 14/054,651 12 We therefore conclude that the broadest reasonable interpretation of “tomographic reconstruction to provide a tomographic image,” as recited in claim 1, requires reconstructing a three-dimensional (3D) image by processing data corresponding to the detected bioluminescent light and fluorescent light. Inoue describes “in vivo fluorescence imaging (FLI) of the reticulo- endothelial system using quantum dots (QD) and . . . its use in combination with in vivo bioluminescence imaging (BLI).” Inoue 2048, abstract. Inoue “attempted to use fluorescent reticuloendothelial imaging for the localisation of bioluminescent signals.” Id. at 2055, left col. Inoue reports that “[i]n vivo BLI/FLI, accompanied by fusion of both images, improved the accuracy and confidence level of the localisation of the bioluminescent foci compared to BLI alone.” Id. “Fusion of the fluorescent and bioluminescent images was achieved without special data processing.” Id. More specifically, “[f]or detailed comparison between BLI and FLI, fusion images were produced using general-purpose software (Adobe Photoshop . . .) by overlaying the transparent, pseudo-colour bioluminescent image onto the grey-scale fluorescent image.” Id. at 2051, left col. In view of these disclosures, we conclude that the Examiner’s findings that Inoue discloses “tomographic bioluminescence imaging (BLI),” “tomographic fluorescence imaging (FLI),” and “merged tomographic BLI/FLI images,” Ans. 4, are not supported by a preponderance of the evidence. The Examiner has not shown that overlaying two images using Adobe Photoshop, as described by Inoue, would be understood by those skilled in the art to be “processing data . . . via tomographic reconstruction to Appeal 2019-001341 Application 14/054,651 13 provide a tomographic image,” as required by claim 1. In fact, Inoue distinguishes the “projectional images” produced by FLI with the images produced by computed tomography (CT): “Disadvantages of FLI include difficulty in discriminating between overlapping organs because most in vivo FLI studies provide projectional images unlike CT or MRI.” Inoue 2055, right col. Because the Examiner has not established that Inoue discloses a method meeting all of the claim limitations, we reverse the rejection of claim 1, and dependent claims 2, 3, 9, 12, 13, 40, 42, 44, and 52, under 35 U.S.C. § 102(b) based on Inoue. Obviousness Claim 4, 8, and 48–51 stand rejected as obvious based on Inoue and either Ntziachristos or Bryan. Both of these rejections rely on Inoue as disclosing all of the limitations of claim 1, and cite Ntziachristos or Bryan for the additional limitations of the dependent claims. Ans. 5–7. As discussed above, however, we conclude that the Examiner has not shown that Inoue discloses all of the limitations of claim 1. The Examiner has not pointed to any teachings in Ntziachristos or Bryan that would suggest “processing data corresponding to the detected bioluminescent light and the detected fluorescent light via tomographic reconstruction to provide a tomographic image,” as required by claim 1 but missing from Inoue. Therefore, the Examiner has not shown that the claimed method would have been obvious based on the cited references, and we reverse both of the rejections under 35 U.S.C. § 103(a). Appeal 2019-001341 Application 14/054,651 14 DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1–4, 8, 9, 12, 13, 40, 42, 44, 48– 52 101 Eligibility 1–4, 8, 9, 12, 13, 40, 42, 44, 48– 52 1–3, 9, 12, 13, 40, 42, 44, 52 102(b) Inoue 1–3, 9, 12, 13, 40, 42, 44, 52 48–51 103(a) Inoue, Ntziachristos 48–51 4, 8 103(a) Inoue, Bryan 4, 8 Overall Outcome 1–4, 8, 9, 12, 13, 40, 42, 44, 48– 52 REVERSED Copy with citationCopy as parenthetical citation