Adam Steel et al.Download PDFPatent Trials and Appeals BoardMar 26, 202013757392 - (D) (P.T.A.B. Mar. 26, 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. 13/757,392 02/01/2013 Adam Steel HANLB.087A / P-09896 7150 95896 7590 03/26/2020 Knobbe, Martens, Olson & Bear, LLP 2040 Main Street 14th Floor Irvine, CA 92614 EXAMINER DEJONG, ERIC S ART UNIT PAPER NUMBER 1631 NOTIFICATION DATE DELIVERY MODE 03/26/2020 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): efiling@knobbe.com ip.docket@bd.com jayna.cartee@knobbe.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte ADAM STEEL, THOMAS WOJECK, MICHAEL YOUNG, and MARK LARSEN __________ Appeal 2019-002656 Application 13/757,392 Technology Center 1600 __________ Before DONALD E. ADAMS, FRANCISCO C. PRATS, and RACHEL H. TOWNSEND, Administrative Patent Judges. PRATS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 4, 5, 7, 10, 14–16, 19, 29–31, and 34–36. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant states that “the real party in interest is the current assignee, BECTON, DICKINSON AND COMPANY of Franklin Lakes, NJ.” Appeal Br. 4. Appeal 2019-002656 Application 13/757,392 2 STATEMENT OF THE CASE The Specification explains that automated diagnostic instruments can process and test multiple biological samples in parallel “to facilitate the sample preparation and testing. By way of example, automated diagnostic instruments can prepare samples for nucleic acid amplification assays, and perform the amplification and detection.” Id. ¶ 34. Despite the advantages of automated high throughput testing, “many times, assay protocols are not compatible with each other on the same instrument, either because of physical constraints on the instrument, or for business reasons.” Id. The Specification explains that, when attempting to use a single diagnostic instrument to perform automated high throughput testing on multiple samples, users previously “had to manually compare assay protocols on a chart or table to determine whether they can be performed concurrently on the same rack, or even on different racks of the same instrument. Such manual approaches can be error prone, as well as inefficient and labor intensive.” Id. The Specification discloses that Appellant’s invention addresses the difficulties in configuring a single automated diagnostic instrument to perform multiple distinct assays in high throughput testing procedures. See id. ¶ 35. In particular, Appellant’s invention allows “concurrent performance of discrete assay workflows on an instrument when the assay workflows are compatible, and can prevent the concurrent performance of incompatible assay protocols within the same instrument. The methods provided herein allow for improved reliability and ease of use when performing an assay on an automated instrument.” Id. Appeal 2019-002656 Application 13/757,392 3 Appellant’s claim 1 is illustrative and reads as follows: 1. A method of performing an automated assay on a plurality of samples, said method comprising: providing an automated instrument comprising: a housing, a first area for performing automated assays, the first area located within the housing, a second area for performing automated assays, the second area located within the housing, and a space separating the first area from the second area, wherein each of said first and second areas have a rack configured to hold a plurality of samples to be processed concurrently by the automated instrument according to a plurality of different automated assay workflows using at least one resource of the automated instrument that is shared among the plurality of different automated assay workflows, wherein each different automated assay workflow has an associated unique assay definition file or user-defined protocol file, wherein said assay definition file or user-defined protocol file comprises a first-level compatibility index value and provides one or more parameters for a resource of the automated instrument used to perform the associated automated assay workflow; determining that the first assay workflow for a first sample using a set of resources of the automated instrument is compatible with the second assay workflow for a second sample using the set of resources of the automated instrument based at least in part on a first first-level compatibility index value included in a first assay definition file or user-defined protocol file for the first assay workflow being equal to a second first-level compatibility index value included in a second assay definition file or user-defined protocol file for the second assay workflow, wherein said first-level compatibility index value indicates that first values for parameters associated with respective resources in the set of resources included in the first assay definition file or user-defined protocol file and Appeal 2019-002656 Application 13/757,392 4 second values for the parameters associated with corresponding resources in the set of resources included in the second assay definition file or user-defined protocol file are each within a resource compatibility range for the respective resource; initiating the first assay workflow and the second assay workflow, each according to its own one or more parameters, concurrently at one of: (i) the first area, or (ii) the second area. Appeal Br. 36–37. The following rejections are before us for review: (1) Claims 1, 4, 5, 7, 10, 14–16, 19, 29–31, and 34–36, under 35 U.S.C. § 101, as being directed to a judicial exception without including additional elements that are sufficient to amount to significantly more than the judicial exception itself (Ans. 3–4); (2) Claims 1, 4, 5, 7, 10, 14–16, 19, 29–31, and 34–36, 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 (Ans. 5–6); and (3) Claims 1, 4, 5, 7, 10, 14–16, 19, 29–31, and 34–36, under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA) second paragraph, as being indefinite (Ans. 6–7). DISCUSSION The Examiner’s Position The Examiner finds that Appellant’s claims are “are directed to a method and a computer system for performing an automated assay using configured workstations comprising separated areas. The instant claims only recite a function[] of . . . these configured workstations.” Ans. 3. Moreover, the Examiner finds, Appellant’s claims “only provide for the use of generic computer systems that are configured by a program to perform functionally defined tasks” and are “open to using a generic Appeal 2019-002656 Application 13/757,392 5 computer merely to automate conventional and routine assay procedures.” Id. at 3–4. Based on those findings, the Examiner reasons that Appellant’s claims only delineate an abstract idea in the functional tasks that a[re] applied merely using a generic computer. The instant claims are not limited to any specific programming or configurations. Therefore, the claimed invention merely sets using a generic computer to automate what amounts to nothing more [than] conventional and routine assay activities. Id. at 4. In addition, the Examiner reasons: The claims have further been amended to recite additional functions and features to be performed automatically by an “automated” system. This fails to delineate [anything] new to the claims apart from additional abstract functions and features to be realized using [the] “automated” system. The claims have further been amended to add user-defined protocols files as a source for definitions. This doesn’t alter the scope of content of the claims because all programming and protocols involved in the claims already is provided by a user. Further the recitation of art recognized (as argued by applicant) automated computers to perform automated functions still fails to present anything significantly more to the instant claims than a reliance of routine and conventional technology on which to apply an abstract idea. Therefore, for the reasons set forth above, the instant claims are directed to nonstatutory subject matter. Id. Principles of Law An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. The Appeal 2019-002656 Application 13/757,392 6 Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions, however: “[l]aws of nature, natural phenomena, and abstract ideas” are not patentable. 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 Supreme Court’s two-step framework, described in Mayo Collaborative Services v. Prometheus Laboratories., Inc., 566 U.S. 66 (2012) and Alice, 573 U.S. at 217–18 (citing Mayo, 566 U.S. at 75–77). 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.”). 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 v. Kappos, 561 U.S. 593, 611 (2010)); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594–95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63, 69 (1972)). 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). Early in 2019, the PTO published revised guidance on the application of § 101. USPTO, 2019 Revised Patent Subject Matter Eligibility Guidance, Appeal 2019-002656 Application 13/757,392 7 84 Fed. Reg. 50 (January 7, 2019) (“Memorandum” or “Office Guidance”).2 In light of comments received in response to the Office Guidance, the PTO subsequently issued the October 2019 Update: Subject Matter Eligibility (“October 2019 Update”).3 Following the Office Guidance and the October 2019 Update, under Revised Step 2A, we first look to whether the claim recites the following: (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); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)–(c), (e)–(h)). 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 of the Office Guidance, to whether the claim: (3) adds specific limitations beyond the judicial exception that are 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. See Memorandum. 2 Available at https://www.govinfo.gov/content/pkg/FR-2019-01- 07/pdf/2018-28282.pdf. 3 https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_ update.pdf. Appeal 2019-002656 Application 13/757,392 8 Analysis Office Guidance—Revised Step 2A, Prong 1 As noted above, the Examiner finds that the judicial exception to patent-eligible subject matter recited in Appellant’s claims is an abstract idea. See Ans. 4 (“[T]he instant claims only delineate an abstract idea in the functional tasks that a[re] applied merely using a generic computer.”). Although it appears that the Examiner considers the computer-related functions recited in the claims to be abstract ideas, the Examiner does not clearly identify which specific elements in Appellant’s claims are considered to be abstract ideas. See id. at 3–4. We note, nonetheless, that independent claim 1 recites a step of “determining” whether a first assay is compatible with a second assay, “based at least in part on a first first-level compatibility index value included in a first assay definition file or user-defined protocol file.” Appeal Br. 36. We note also that independent claim 16 recites receiving a “selection of a first assay workflow” from a list of available assays, and further specifies displaying a second list that excludes assays that are incompatible with the assays in the first list, which, in excluding certain assays, also necessarily involves performing a selection. Id. at 39. Because they can be performed in the human mind, the claimed steps of determining and selecting are mental steps that constitute abstract ideas. See Office Guidance (84 Fed. Reg. at 52 (abstract ideas include “(c) Mental processes—concepts performed in the human mind (including an observation, evaluation, judgment, opinion”) (citations omitted); see also id. n.14 (“If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer Appeal 2019-002656 Application 13/757,392 9 components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind.”) (Citing Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016)). Accordingly, applying Revised Step 2A, Prong 1, of the Office Guidance (see 84 Fed. Reg. at 54), we determine that Appellant’s independent claims 1 and 16 recite judicial exceptions. Office Guidance—Revised Step 2A, Prong 2 Having determined that Appellant’s independent claims 1 and 16 recite judicial exceptions under Revised Step 2A, Prong 1, of the 2019 Office Guidance, we turn to Revised Step 2A, Prong 2, of the Office Guidance to determine whether claims 1 and 16 recite additional elements that integrate the judicial exceptions into a practical application. See Office Guidance (84 Fed. Reg. at 54–55). In the present case, we find that Appellant’s claims 1 and 16 recite additional elements that integrate the judicial exceptions into practical applications. In addition to the determining and selecting steps, each of claims 1 and 16 recites an automated instrument capable of performing a plurality of different assays, the instrument including a housing, separated first and second areas for performing the automated assays, and with each of the areas having a rack configured to hold a plurality of samples to be processed concurrently by the automated instrument. See Appeal Br. 36, 39. Because claims 1 and 16 both recite a specific type of device that has tangible elements arranged in a specific way, which device is an integral part of the claim in that the first and second assay workflows that are determined to be compatible to be carried out concurrently in the device are then effected in the device, and therefore these claims implement the judicial Appeal 2019-002656 Application 13/757,392 10 exception in conjunction with “a particular machine or manufacture that is integral to the claim,” see Office Guidance, 84 Fed. Reg. at 55. Thus, we are persuaded that claims 1 and 16 integrate the judicial exception into a practical application. Indeed, because Appellant’s claims 1 and 16 are limited to using a specific type of device that requires a particularized combination of features, we agree with Appellant that, in addition to the abstract ideas, claims 1 and 16 recite elements sufficient to apply the judicial exceptions in a meaningful way beyond a mere drafting effort designed to monopolize the exceptions (mental steps) recited in the claim. See Office Guidance, 84 Fed. Reg. at 55. The fact that automated assay instruments of the type claimed were known in the art (see Spec. ¶ 65) does not persuade us that the claims are ineligible for patenting. See Office Guidance, 84 Fed. Reg. at 54 (“[A] claim that includes conventional elements may still integrate an exception into a practical application, thereby satisfying the subject matter eligibility requirement of Section 101.”). In addition, as Appellant contends (see Appeal Br. 24), the Specification discloses that implementing the compatibility determinations in the manner recited in the claims provides a number of improvements in the specific context of performing automated assays of biological samples in the types of devices claimed. See Spec. ¶¶ 36, 78–80; see also MPEP § 2106.05(a) (“In determining patent eligibility, examiners should consider whether the claim ‘purport(s) to improve the functioning of the computer itself’ or ‘any other technology or technical field.’”) (Citing Alice, 134 S. Ct. at 2359) (emphasis added). We note in particular that the Examiner has not acknowledged, specifically addressed, or specifically disputed Appeal 2019-002656 Application 13/757,392 11 Appellant’s arguments as to the improvements provided by the inventions recited in claims 1 and 16. See Ans. 9. In sum, for the reasons discussed, we conclude that although Appellant’s independent claims 1 and 16 recite mental processes, claims 1 and 16 recite additional elements sufficient to integrate the mental processes into practical applications. Because we conclude, therefore, that claims 1 and 16 are not directed to subject matter that is ineligible for patenting, we reverse the Examiner’s rejection of claims 1 and 16, and their dependent claims, on that ground. WRITTEN DESCRIPTION AND INDEFINITENESS The Examiner’s Rejections The Examiner bases the rejection for lack of written description, as well as the rejection for indefiniteness, on the determination that Appellant’s claims invoke means plus function elements which lack sufficient descriptive support in the Specification, and therefore lack any definite structure. See Ans. 5–8. In particular, the Examiner determines that “[i]Independent claim 1 recites a series of means plus function language in the limitations of . . . a first workstation area and a second workstation area.” Ans. 5, 7. In addition, the Examiner determines, “[i]ndependent claim 16 also recite[s] a series of means plus function language in the recite[d] limitations of a first workstation area, a second workstation area, a program for performing an automated assay with regard to the enunciated separated workstation areas.” Id. The Examiner reasons that “[t]hese terms are considered nonce terms in that they do not provide any specific structure sufficient to perform the Appeal 2019-002656 Application 13/757,392 12 recited functions accompanying them in the instant claims.” Id. (citing Williamson v. Citrix Online, LLC, 792 F.3d 1339 (Fed. Cir. 2015) and EON Corp. IP Holdings LLC v. AT & T Mobility LLC, 785 F.3d 616 (Fed. Cir. 2015)) The Examiner finds that Appellant’s Specification “only reiterates the functional language that is correlated to a generic means as is recited in the instant claims. However, the instant disclosure is inadequate as it fails specify any structure corresponding to the means as instantly claimed.” Ans. 6, 8 (citing Biomedino, LLC v. Waters Technologies Corp., 490 F.3d 946 (Fed. Cir. 2007). Analysis Under 35 U.S.C. § 112(f) and pre-AIA 35 U.S.C. § 112, sixth paragraph, one may use means-plus-function language in a claim, rather than reciting a specific structure for performing a claimed function, and such language “restrict[s] the scope of coverage to only the structure, materials, or acts described in the specification as corresponding to the claimed function and equivalents thereof.” Williamson v. Citrix, 792 F.3d at 1347. However, a claim limitation that does not use the term “means” triggers the rebuttable presumption that 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112, sixth paragraph, do not apply. See id. at 1349. That presumption can be overcome “if the challenger demonstrates that the claim term fails to recite sufficiently definite structure or else recites function without reciting sufficient structure for performing that function.” Id. Ultimately, when a claim does not use the term “means” in relation to a limitation at issue, “[t]he standard is whether the words of the claim are understood by persons of ordinary skill in the art to have a sufficiently Appeal 2019-002656 Application 13/757,392 13 definite meaning as the name for structure.” Id. In the present case, we acknowledge that claim 1 recites an automated instrument that has “a first area for performing automated assays” and “a second area for performing automated assays.” Appeal Br. 36; see also Appeal Br. 39 (claim 16 reciting automated instrument with first and second “areas for performing automated assays”). We are not persuaded, however, that the Examiner has explained why a skilled artisan would fail to understand the scope of the structure of the areas recited in claims 1 and 16. As noted above, and as Appellant contends, the Specification discloses that “[a]utomated instruments which can perform multiple assay protocols concurrently are known to those of skill in the art.” Spec. ¶ 65. The Examiner does not acknowledge or address this disclosure in Appellant’s Specification, nor does the Examiner explain specifically why this, or any of the other disclosures in the Specification identified by Appellant (see Appeal Br. 13–16), fail to demonstrate that a skilled artisan would understand the structure of the areas recited in Appellant’s claims 1 and 16. See Ans. 9. Accordingly, given that automated instruments capable of performing multiple concurrent assay protocols were undisputedly known to skilled artisans, we are not persuaded that the Examiner has explained sufficiently why a skilled artisan would fail to understand the scope of the first and second areas recited in Appellant’s claims 1 and 16. We are also not persuaded, therefore, that the Examiner has sufficiently rebutted the presumption that 35 U.S.C. § 112(f) and/or pre-AIA 35 U.S.C. § 112, sixth paragraph, do not apply in this instance. Appeal 2019-002656 Application 13/757,392 14 Lastly, as noted above, the Examiner finds that Appellant’s claim 16 recites “a program for performing an automated assay with regard to the enunciated separated workstation areas” which triggers the application of 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112, sixth paragraph. Ans. 5, 7. We are not persuaded. We first note, as Appellant contends, that claim 16 does not recite a “program.” See Appeal Br. 39–40. We note, nonetheless, that claim 16 recites a file that “provides one or more parameters for performing the automated assay workflow.” Id. at 39. Given the Specification’s disclosure that the parameters for performing multiple concurrent assay protocols were undisputedly known to skilled artisans (see, e.g., Spec. ¶ 65), we are not persuaded that the Examiner has explained sufficiently why a skilled artisan would fail to understand the scope of the parameters recited in Appellant’s claim 16. In sum, for the reasons discussed, we are not persuaded that the Examiner has shown sufficiently that Appellant’s claims 1 and 16 include means plus function elements that trigger the application of 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112, sixth paragraph. Because the Examiner’s written description and indefiniteness rejections were premised on the application of 35 U.S.C. § 112(f) or pre-AIA 35 U.S.C. § 112 to Appellant’s claims 1 and 16, we reverse both of those rejections as to claims 1 and 16, and their dependent claims. Appeal 2019-002656 Application 13/757,392 15 CONCLUSION In summary: Claims Rejected 35 U.S.C. § Reference(s) /Basis Affirmed Reversed 1, 4, 5, 7, 10, 14–16, 19, 29–31, 34–36 101 Eligibility 1, 4, 5, 7, 10, 14–16, 19, 29–31, 34–36 1, 4, 5, 7, 10, 14–16, 19, 29–31, 34–36 112(a) or pre-AIA 112, first paragraph Lack of Written Description 1, 4, 5, 7, 10, 14–16, 19, 29–31, 34–36 1, 4, 5, 7, 10, 14–16, 19, 29–31, 34–36 112(b) or pre-AIA 112, second paragraph Indefinitenes s 1, 4, 5, 7, 10, 14–16, 19, 29–31, 34–36 Overall Outcome 1, 4, 5, 7, 10, 14–16, 19, 29–31, 34–36 REVERSED Copy with citationCopy as parenthetical citation