Ex Parte Campbell et alDownload PDFPatent Trial and Appeal BoardMar 15, 201712878266 (P.T.A.B. Mar. 15, 2017) 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. 12/878,266 09/09/2010 JAMES CAMPBELL 033945.00015 4710 38485 7590 ARENT FOX LLP 1675 BROADWAY NEW YORK, NY 10019 EXAMINER MYERS, CARLA J ART UNIT PAPER NUMBER 1634 NOTIFICATION DATE DELIVERY MODE 03/17/2017 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): patentdocket @ arentfox. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAMES CAMPBELL, MADHAV THAMBISETTY, and SIMON LOVESTONE1 Appeal 2016-006303 Application 12/878,266 Technology Center 1600 Before MELANIE L. McCOLLUM, JEFFREY N. FREDMAN, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134 involving claims to a prognostic method for determining whether a human subject has rapidly progressing Alzheimer’s disease. The claims have been rejected as directed to patent-ineligible subject matter. The claims have also been rejected as indefinite, failing the written description requirement, nonenabled, and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the Real Parties in Interest as King’s College London and Electrophoretics Ltd. (Br. 3.) Appeal 2016-006303 Application 12/878,266 STATEMENT OF THE CASE Appellants’ “invention relates to compositions and methods for assessing Alzheimer’s disease [AD] severity, progression and pathology . . . [by measuring] biomarkers having prognostic utility.” (Spec. 1:11—15.) According to the Specification, the present inventors have found that clusterin (also known as Apolipoprotein J or apoJ) is a biologically relevant peripheral biomarker of AD, with higher levels being associated with more aggressive AD. In particular, elevated blood plasma concentration of clusterin is associated with brain atrophy, cognitive impairment and speed of progression of AD. {Id. at 3:7-13.) Claims 28—33 and 35 are on appeal. Claim 28 is illustrative: 28. A prognostic method for determining whether a human subject with Alzheimer’s disease (AD) has rapidly progressing AD or non-rapidly progressing AD, said method comprising: (i) measuring human clusterin protein concentration in a serum or plasma sample obtained from said human subject with AD or isolated from said human subject with AD said measuring comprising: quantifying, in the serum or plasma sample, by two- dimensional gel electrophoresis (“2DGE”) and mass- spectrometry at least one of: the concentration of human clusterin; the concentration of a fragment of human clusterin; the concentration of each of a multiplicity of fragments of human clusterin; and (ii) quantifying a difference between the measured human clusterin protein concentration in (i) and a predetermined reference level provided in an accessible data record of human clusterin protein concentration in serum or plasma samples from human subjects with non-rapidly progressing AD; wherein when the measured human clusterin protein concentration is greater than that of said pre-determined reference level the human subject has rapidly progressing AD, 2 Appeal 2016-006303 Application 12/878,266 and when the measured serum or plasma concentration of human clusterin protein is equal to or lower than said pre-determined reference level, the human subject has non-rapidly progressing AD, wherein said human clusterin protein comprises the full- length human clusterin amino acid sequence set forth in SEQ ID NO: 7, wherein said rapidly progressing AD is characterised by one or both of: a decline in a mini-mental state examination (MMSE) score of said subject at a rate of at least 2 MMSE points per year; and a decline in an AD assessment scale-cognitive (ADAS-Cog) score of said subject at a rate of at least 2 ADAS- Cog points per year. (Br. 15 (Claims App’x).) The claims stand rejected as follows: Claims 28—33 and 35 under 35 U.S.C. § 101 for lack of patentable subject matter. (Final Act. 2.) Claims 28—33, and 35 under 35 U.S.C. § 112, second paragraph, for indefmiteness. {Id. at 12—14.)2 Claim 35 under 35 U.S.C. § 112, first paragraph, for failure to satisfy the written description requirement {id. at 14—18) and for lack of enablement {id. at 18—24). Claims 28—33 and 35 under 35 U.S.C. § 103(a) over Westbrook et al., US 2008/0070995 Al, published Mar. 20, 2008 (“Westbrook”). {Id. at 24- 29.) 2 The Examiner partially withdrew the indefmiteness rejection based on certain grounds that were overcome by an after-final claim amendment. {See Adv. Act. dated Dec. 7, 2015.) 3 Appeal 2016-006303 Application 12/878,266 Except for the rejection under Section 101, Appellants do not contest the rejections of the pending claims. We summarily affirm the rejections under Section 112, first and second paragraphs, and under Section 103. Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to contest a ground of rejection to the Board,... the Board may treat any argument with respect to that ground of rejection as waived. In the event of such a waiver, the PTO may affirm the rejection of the group of claims that the examiner rejected on that ground without considering the merits of those rejections.”) Our discussion below thus focuses on the rejection under Section 101. DISCUSSION In analyzing patent eligibility under 35 U.S.C. § 101, the Supreme Court has set forth a “framework for distinguishing patents that claim [patent-ineligible] laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts.” Alice Corp. Pty. Ltd. v. CLS Bank Inti, 134 S.Ct. 2347, 2355 (2014). According to that framework, first “we determine whether the claims at issue are directed to one of those patent-ineligible concepts.” Id. “If so, we then ask, ‘[w]hat else is there in the claims before us?’” Id. (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1297 (2012).) To answer this second question, we consider the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent-eligible application. [The Supreme Court has] described step two of this analysis as a search for an inventive concept — i.e., an element or combination of elements that is sufficient to ensure that the 4 Appeal 2016-006303 Application 12/878,266 patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself. Id. (internal citations and quotation marks omitted). Appellants argue the patentability of the claims as a group. We select claim 28 as representative. 37 C.F.R. § 41.37(c)(l)(iv). The Examiner rejected claim 28 as directed to a patent-ineligible law of nature. (Final Act. 3.) According to the Examiner, “[t]he correlation between the plasma or serum concentration of clusterin protein and progression of AD is a naturally occurring relationship . . . [and] this relation itself is a natural phenomenon that exists apart from any human action.” (Id. at 4.) Inasmuch as claim 28 includes a step of “quantifying a difference . . .,” the Examiner finds the step is abstract and encompasses mental processes, such as “looking at data in a data base or report and mentally calculating a difference between the clusterin protein concentration of a test subject and the reference level in the database.” (Id.) The Examiner then finds that “the claims as a whole do not recite any additional steps or elements that amount to significantly more than routine and conventional activity.” (Id. at 6.) The Examiner finds, for instance, that Westbrook “teaches methods of determining an amount of human clusterin protein in a biological [plasma] sample from a human subject with AD . . . wherein the concentration of human clusterin protein in the sample is determined by 2DGE and mass spectrometry.” (Id. (citations omitted).) The Examiner reasons “the claims do not recite any elements or steps that do more than describe the judicial exceptions [law of nature/abstract idea] with instructions for applying it.” (Id. at 7.) Thus, the Examiner concludes, “the claims are not considered to recite something significantly more than a 5 Appeal 2016-006303 Application 12/878,266 judicial exception and thereby are not directed to patent eligible subject matter.” (Id. at 8.) We agree with and adopt the Examiner’s findings of fact, reasoning, and conclusion that claim 28 is ineligible for patenting under 35 U.S.C. § 101. (Final Act. 2—8; Ans. 2—7.) Shorn of the elements relating to how the protein is measured and quantified, Claim 28 is directed to a law of nature — the correlation between concentration of clusterin protein in a human sample and the progression of Alzheimer’s disease. As Appellants’ Specification confirms, the inventors’ discovery was this correlation and, more specifically, “higher [clusterin] levels being associated with more aggressive [rapidly progressing] AD.” (Spec. 3:7—13.) Turning to step 2 of the Alice/Mayo framework, the claim as a whole, considering the elements individually and as an ordered combination do not impart a sufficient inventive concept. As noted by the Examiner, the claimed step reciting “quantifying a difference between the measured human clusterin protein concentration [] and a predetermined reference level” is itself abstract and encompasses mere mental processes. It is also not materially different than routine steps employed by those skilled in the art, where a patient sample is compared against a control to test for overexpression or increased concentration of a protein associated with a particular disease. Westbrook, for example, “identifies and describes proteins that are differentially expressed in the Alzheimer’s disease state relative to their expression in the normal state.” (Westbrook |7; see also id. at || 8—15, claim 8.) See Mayo, 132 S.Ct. at 1298 (“well-understood, routine, conventional activity previously engaged in by scientists who work in the field ... is normally not sufficient to transform an unpatentable law of 6 Appeal 2016-006303 Application 12/878,266 nature into a patent-eligible application of such law.”); see also Parker v. Flook, 437 U.S. 584, 590 (1978) (“The notion that post-solution activity, no matter how conventional or obvious in itself, can transform an unpatentable principle into a patentable process exalts form over substance.”) We further agree with the Examiner that the claims as a whole are little more than an instruction to apply the natural law. To exploit the natural correlation between clusterin concentration and the patient’s AD prognosis, one obtains a patient sample and measures/quantifies the level of clusterin in the sample with 2DGE and mass-spectrometry. That is precisely what the steps of the claim instruct the skilled person to do. Yet the steps employed are, here again, well-known and conventional techniques. Indeed, Westbrook (like claim 28) teaches measuring human clusterin in a serum or plasma sample, and determining protein levels with 2D gel electrophoresis and mass spectrometry. (See, e.g., Westbrook || 19, 21, 25, 56—57, and 61.) The claim limitations are thus insufficient to transform the patent-ineligible natural law into patent-eligible subject matter. Mayo, 132 S.Ct. at 1298. Appellants discuss the law under 35 U.S.C. § 101, with an emphasis on so-called preemption. (Br. 5—8.) Appellants contend the “issue of pre emption (i.e., ‘tying up a judicial exception’) is an important consideration in 35 U.S.C. § 101 jurisprudence.” (Id. at 6.) Appellants then contend “if there is no risk of pre-emption, that is, if there is no risk that the claim forecloses all practical applications of a judicial exception, then there is no need to evaluate the claim under the ‘something more’ analysis.” (Id. at 7.) From this, Appellants argue, because “not all practical applications of correlating human clusterin concentration with progression of AD have been foreclosed by the instant claims” the claims are patent eligible and “there is 7 Appeal 2016-006303 Application 12/878,266 no need to consider the ‘something more’ analysis.” (Id. at 9—11.) In support, Appellants contend “that, assuming arguendo, even if the claims could be determined to be directed to a judicial exception,” claim 28 “recites particular method steps for measuring human clusterin protein concentration including quantifying by two-dimensional gel electrophoresis and mass- spectrometry.” (Id. at 9-10.) Appellants cite their Specification as evidence that “there are a number of ways of achieving the ‘measuring step’ including two dimensional gel electrophoresis, various mass spectrometry techniques, liquid chromatography, [and] various assays (e.g., antibody-based assays).” (Id. at 10—11.) So, Appellants contend, claim 28 covers a method using 2DGE and mass-spectrometry “only and not [] any other suitable application.” (Id. at 11.) Appellants’ suggestion that complete preemption of all practical applications of the law of nature (or other judicial exception) is required to sustain a rejection under Section 101 is unpersuasive. For one, it is not the law. As noted by the Examiner, “while preemption is a consideration when performing a § 101 analysis, whether the claims preempt all uses of the judicial exception is not dispositive.” (Ans. 3.) On this point, the Federal Circuit’s analysis in Ariosa is instructive. Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015), cert, denied 136 S.Ct. 2511 (2016). In Ariosa, the patent owner argued “the particular application of the natural phenomena that the [] patent claims embody are narrow and specific” and, thus, did not “preclude alternative methods [of using cffDNA] in the same field.” (Id. at 1378.) The Federal Circuit rejected that argument and held that “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility.” 8 Appeal 2016-006303 Application 12/878,266 {Id. at 1379.)3 And, according to the Federal Circuit, “[wjhere a patent’s claims are deemed only to disclose patent ineligible subject matter under the Mayo framework,. . . preemption concerns are fully addressed and made moot.” {Id.) We are also unpersuaded that the Supreme Court requires that the claims completely preempt a law of nature, abstract idea, etc. as a condition to rejecting claims under Section 101. As the Examiner correctly points out, “in Flook, the Supreme Court held that the claims were drawn to ineligible subject matter even though the Supreme Court acknowledged that the claims did not wholly preempt the mathematical formula at issue.” (Ans. 3; see Flook, 437 U.S. at 586 (explaining that the claims, while broadly applicable in certain fields, “do not, however, cover every conceivable application of the formula”). Indeed, in Flook, the patent applicant argued that “[h]e does not seek to wholly preempt the mathematical formula, since there are uses of his formula outside the petrochemical and oil-refining industries that remain in the public domain.” Flook, 437 U.S. at 589-90 (internal quotation marks omitted). Yet the Court rejected that argument; narrowing the claims by 3 See also Ultramercial Inc. v. Hulu LLC, 722 F.3d 1335, 1346 (Fed. Cir. 2013) (“the Supreme Court has stated that, even if a claim does not wholly pre-empt an abstract idea, it still will not be limited meaningfully if it contains only insignificant or token pre- or post-solution activity—such as identifying a relevant audience, a category of use, field of use, or technological environment.”) (citations omitted), vacated and remanded, Wildtangent, Inv. v. Ultramercial LLC, 134 S.Ct. 2870 (2014) (remanding for consideration in light of Alice Corp. Pty. Ltd. v. CLS Banklnt’l, 134 S.Ct. 2347 (2014)). 9 Appeal 2016-006303 Application 12/878,266 requiring conventional post-solution activity did not make the claims patentable. (Id. at 590.)4 Appellants’ argument about complete preemption fares no better than the similar, but rejected, arguments in Ariosa and Flook. Here, as in Ariosa, Appellants’ “attempt to limit the breadth of the claims by showing alternative uses of [the law of nature] outside the scope of the claims does not change the conclusion that the claims are directed to patent ineligible subject matter.” Ariosa, 788 F.3d at 1379. For claim 28, Appellants picked 2DGE and mass-spectrometry from the list of conventional measuring techniques provided in the Specification. (See, e.g., Spec. 20:12—21:5.) But we are unpersuaded this makes claim 28 patentable under Section 101. Were it otherwise, the clever draftsperson could circumvent Section 101 by appending one or a few routine techniques to a particular claim — appending other routine techniques to claims sought separately or later. Indeed, nothing would prevent Appellants from later crafting claims where the protein concentration is measured with the other routine techniques (e.g., antibody-based assays) described in Appellants’ Specification, which Appellants suggest are techniques that are not foreclosed at present. Cf. In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litig., 11A 4 Appellants also cite the “2014 Interim Guidance on Patent Subject Matter Eligibility (December 2014)” (“December Guidance”), which Appellants contend supports their position. (Br. 5—9, 11.) We are unpersuaded. More recent, updated guidance recognizes that “the courts do not use preemption as a stand-alone test for eligibility” and instructs that “while a preemptive claim may be ineligible, the absence of complete preemption does not guarantee that a claim is eligible.” (See July 2015 Update on Subject Matter Eligibility, 80 Fed. Reg. 45429 at 8 (July 30, 2015) (footnotes and citations omitted)); Ans. 3.) 10 Appeal 2016-006303 Application 12/878,266 F.3d 755, 764 n. 4 (Fed. Cir. 2014) (“The preemptive nature of the claims is not ameliorated even if we accept Myriad’s argument that other methods of comparison exist. If the combination of certain routine steps were patent eligible, so too would different combinations of other routine steps.”) Appellants argue that “claim 28 expressly recites a step of quantifying a concentration by two dimensional gel electrophoresis and mass spectrometry” and thus “clearly demonstrate [s] a practical application of the correlation between clusterin and AD progression, implemented according to a specific, non-preemptive protocol.” (Br. 12.) Appellants’ argument is unpersuasive in overcoming the Examiner’s rejection. As the Examiner again notes, the “methods for measuring proteins, including human clusterin protein, using 2DGE and mass spectrometry were well-known, routine and conventional in the art at the time the invention was made.” (Ans. 4.) Put differently, although the claims are limited to quantifying the protein via 2DGE and mass-spectrometry, such limitations are not enough to supply an inventive concept. See Ariosa, 788 F.3d at 1377 (holding dependent claims invalid despite limitations requiring use of a routine technique (polymerase chain reaction) to amplify a particular type of DNA.) As with the claims in Mayo (involving the level of metabolite in the blood and determining the appropriate dosage of a drug, 6- thioguanine, given to the patient), it is not enough that the claims suggest a practical or even important application of the natural correlation. Mayo, 132 S.Ct. at 1291. Where the practical application is supplied merely through the addition of conventional steps like those here, the claims remain patent ineligible. Ariosa, 788 F.3d at 1377 (“‘simply appending conventional 11 Appeal 2016-006303 Application 12/878,266 steps, specified at a high-level of generality, ’ [is] not enough to supply an inventive concept.”) (quoting Mayo, 132 S.Ct. at 1300). Finally, Appellants argue “the claimed methods, viewed as a whole, comprise more than just routine and conventional steps applied to a natural law.” (Br. 12.) In support, Appellants contend the Examiner “misconstrues the teachings of Westbrook” as “Westbrook [] is not related to determining fast progressing AD.” (Id.) And, Appellants contend, “notwithstanding that it may appear that using 2DGE in conjunction with mass spectrometry is a conventional methodology, it is its application in this particular prognostic method for discriminating between slow and fast progressing AD, together with other the other elements which renders it not routine in the present scenario.” (Id. at 12—13.) We are unpersuaded. Appellants’ argument is, in effect, that the rejection fails because Westbrook does not disclose Appellants’ discovery of the correlation between clusterin concentration and fast-progressing AD, and thus it was not known in the art or routine to exploit the natural correlation exactly in the way that is claimed. The law does not, however, require that the judicial exception itself be well known or otherwise disclosed in the art. To the contrary, as exemplified in Flook, the Supreme Court “assume[d] that respondent’s [mathematical] formula [was] novel and useful and that he discovered it,” but the Court still held the claim was drawn to a patent- ineligible abstract idea. Flook, 437 U.S. at 588—595; see also Mayo, 132 S.Ct. at 1293 (“‘Phenomena of nature, though just discovered, mental 12 Appeal 2016-006303 Application 12/878,266 processes, and abstract intellectual concepts are not patentable.’”) (quoting Gottschalkv. Benson, 409 U.S. 63, 67 (1972)) (emphasis added).5 The Examiner acknowledges that “[t]he [Section 101] rejection does not assert that Westbrook [] teaches a method for determining rapidly- progressing AD.” (Ans. 5.) Rather, as the Examiner explains, “the correlation between human clusterin protein levels in serum and plasma and rapidly progressing AD is the law of nature (judicial exception) itself.” {Id. at 6.) And, as persuasively shown by the Examiner, the additional elements are well-known, conventional, and routine techniques that, as a postscript to the claim, are nothing more than an instruction to the relevant audience to apply the law of nature. (Ans. 6—7.)6 For the reasons above, we conclude the Examiner established by a preponderance of the evidence that claim 28 is unpatentable under 35 U.S.C. § 101. Claims 29-33 and 35 have not been argued separately and therefore fall with claim 28. 37 C.F.R. § 41.37(c)(l)(iv). SUMMARY We affirm the rejection of claims 28—33 and 35 under 35 U.S.C. §101. 5 See also Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S.Ct. 2107, 2117 (2013) (“Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.”); Ariosa, 788 F.3d at 1379 (holding that the claims were unpatentable even though “no one was using the plasma or serum of pregnant mothers to amplify and detect paternally-inherited cffDNA.”). 6 The Examiner finds, for example, that “Westbrook exemplifies methods of measuring clusterin protein using 2DGE and mass spectrometry in serum and plasma samples obtained from human subjects that have been diagnosed with AD (e.g., para [0010-001], [0031], [0046-0048] and [0054]).” (Ans. 6.) 13 Appeal 2016-006303 Application 12/878,266 We affirm the rejection of claims 28—33 and 35 under 35 U.S.C. § 112, second paragraph, for indefiniteness. We affirm the rejection of claim 35 under 35 U.S.C. § 112, first paragraph, for failure to satisfy the written description requirement and for lack of enablement. We affirm the rejection of claims 28—33 and 35 under 35 U.S.C. § 103(a) over Westbrook. TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED 14 Copy with citationCopy as parenthetical citation