Robyn Haines et al.Download PDFPatent Trials and Appeals BoardMar 31, 20212020006456 (P.T.A.B. Mar. 31, 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. 12/925,221 10/13/2010 Robyn Aylor Haines AYLOR-US4 8371 7590 03/31/2021 Robert B. Aylor 9502 Bluewing Terrace Cincinnati, OH 45241 EXAMINER WEARE, MEREDITH H ART UNIT PAPER NUMBER 3791 MAIL DATE DELIVERY MODE 03/31/2021 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 ROBYN AYLOR HAINES and ROBERT BENSON AYLOR Appeal 2020-006456 Application 12/925,221 Technology Center 3700 Before MICHAEL L. HOELTER, BRETT C. MARTIN, and CARL M. DEFRANCO, Administrative Patent Judges. MARTIN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 96–111. See Final Act. 1. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Robyn A. Haines and Robert B. Aylor. Appeal Br. 1. Appeal 2020-006456 Application 12/925,221 2 CLAIMED SUBJECT MATTER The claims are directed to a diagnostic testing. Claims 96 and 106, reproduced below, are illustrative of the claimed subject matter: 96. A digital health record for a living entity comprising the results obtained by collecting at least one sample of volatile headspace material given off from said living entity at a specific time; electron-ionization of said volatile headspace material using a head space-mass spectrometer to obtain mass spectral channel signals (m/z); and storing said mass spectral channel signals to create said digital health record. 106. A method of determining whether the health of an individual living entity has changed wherein the digital health record of said individual entity at a time in the past as in Claim 96 is compared with the digital health record of the same individual entity as in Claim 96 at the present time using pattern recognition software to determine if there has been a change. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Fletcher US 4,003,257 Jan. 18, 1977 Braun US 7,101,340 B1 Sep. 5, 2006 Agus US 2004/0096896 A1 May 20, 2004 Cotter US 2008/0258054 A1 Oct. 23, 2008 Al US 2011/0105339 A1 May 5, 2011 REJECTIONS Claims 106–111 are rejected under 35 U.S.C. § 112(b) or pre-AIA 35 U.S.C. § 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Final Act. 2. Appeal 2020-006456 Application 12/925,221 3 Claims 96–111 stand rejected under 35 U.S.C. § 101 as directed to non-statutory subject matter. Final Act. 3. Claims 96–105 and 108–111 stand rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Agus and Fletcher. Final Act. 9. Claims 96–98, 100, and 106–108 stand rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Braun, Fletcher, and Cotter. Final Act. 14. Claims 96–105 and 108–111 stand rejected under pre-AIA 35 U.S.C. § 103(a) as unpatentable over Braun, Fletcher, and Agus. Final Act. 16. OPINION Patent Eligibility In issues involving subject matter eligibility, our inquiry focuses on whether the claims satisfy the two-step test set forth by the Supreme Court in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). The Supreme Court instructs us to “first determine whether the claims at issue are directed to a patent-ineligible concept,” id. at 216–18, and, in this case, the inquiry centers on whether the claims are directed to an abstract idea. If this initial condition is met, we then move to the second step, in which 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.” Id. at 217 (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79, 78 (2012)). The Supreme Court describes the second step as a search for “an ‘inventive concept’—i.e., an element or combination of elements that is ‘sufficient to ensure that the patent in practice amounts to significantly more Appeal 2020-006456 Application 12/925,221 4 than a patent upon the [ineligible concept] itself.’” Id. (quoting Mayo, 566 U.S. at 72–73). The USPTO published revised guidance on the application of § 101. 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”), 84 Fed. Reg. 50 (Jan. 7, 2019).2 Under that guidance, 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, and mental processes) (“Step 2A, Prong One”); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)–(c), (e)–(h) (9th ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”). 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: (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. 2 In response to received public comments, the Office issued further guidance on October 17, 2019, clarifying the 2019 Revised Guidance. USPTO, October 2019 Update: Subject Matter Eligibility, https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_ update.pdf. Appeal 2020-006456 Application 12/925,221 5 See generally Guidance. Our reviewing court has warned that “the Office Guidance is not, itself, the law of patent eligibility” and “does not carry the force of law.” In re Rudy, 956 F.3d 1379, 1382 (Fed. Cir. 2020); see also cxLoyalty, Inc. v. Maritz Holdings Inc., No. 2021-1307, 2021 WL 416719, *6 n.1 (Fed. Cir. Feb. 8, 2021); Cleveland Clinic Found. v. True Health Diagnostics LLC, 760 F. App’x 1013, 1020 (Fed. Cir. 2019). Rather, “it is our [reviewing court’s] caselaw, and the Supreme Court precedent it is based upon, that must control.” Rudy, 956 F.3d at 1383 (citation omitted). Thus, although our analysis may be framed in terms of the 2019 Revised Guidance, our decision is based upon governing precedent of the United States Supreme Court and our reviewing court’s interpretation and application thereof. ANALYSIS Claim Grouping Appellant argues the claims as a group for the purpose of the rejection under a judicial exception to § 101. Appeal Br. 6–15. As to this rejection, we select claims 96 and 106 as representative of the group, and the remaining claims stand or fall with these claims. See 37 C.F.R. § 41.37(c)(1)(iv). Examiner’s Findings and Conclusion In the first step of the Alice inquiry, the Examiner first rejects claims 96 as not directed to statutory subject matter. Final Act. 3. Regarding claims 106, the Examiner finds that these claims are directed to a judicial exception without significantly more, namely mental processes. Final Act. 4. At Alice step 2, the Examiner additionally finds that the claims do not add Appeal 2020-006456 Application 12/925,221 6 a meaningful limitation to the abstract idea so as to amount to significantly more than the judicial exception. Id. Analysis According to the Guidance Step One: Do Claims 96 and 106 Fall within a Statutory Category of § 101? We first examine whether the claim recites one of the enumerated statutory classes of subject matter, i.e., process, machine, manufacture, or composition of matter, eligible for patenting under 35 U.S.C. § 101. Claim 96 is directed to nothing more than a record, which as the Examiner notes is nothing more than data. Data is not one of the statutory classes and as such, the claims are not patent eligible. Claim 106 is directed to a method, which is one of the statutory classes (i.e., a process) under 35 U.S.C. § 101. Step 2A, Prong One: Does Claim 106 Recite a Judicial Exception? We next look to whether the claim recites 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, and mental processes. In this instance, claim 106 recites steps that amount to mental processes. Specifically, the claim recites: “determining whether the health of an individual living entity has changed,” comparing a past digital health record to a present health record, “using pattern recognition software to determine if there has been a change.” Although these steps are claimed as being done by a computer, the activities themselves are all capable of being performed by a human without a computer, and fall into the abstract idea of mental processes. See, e.g., CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1375 (Fed. Cir. Appeal 2020-006456 Application 12/925,221 7 2011) (“That purely mental processes can be unpatentable, even when performed by a computer, was precisely the holding of the Supreme Court in Gottschalk v. Benson.”). We therefore determine that claim 106 recites the abstract idea of mental processes, which is a judicial exception to patent- eligible subject matter. Step 2A, Prong Two: Does Claim 106 Recite Additional Elements that Integrate the Judicial Exception into a Practical Application? Following our Office guidance, having found that claim 106 recites a judicial exception, we next determine whether the claim recites “additional elements that integrate the exception into a practical application” (see MPEP §§ 2106.05(a)–(c), (e)–(h)). See Guidance, 84 Fed. Reg. at 54. As noted above, each of the claimed steps is recited as being performed by a computer or storage device specified at a high level of generality and, does not result in an improvement in the functioning of a computer or other technology or technological field. The recitations of the generic structures with which the recited steps are performed are merely instructions to use a generic computer system as a tool to perform the abstract idea. Thus, claim 106 does not apply, rely on, or use the mental process steps in a manner that imposes a meaningful limit on those steps. Rather, the claim is simply a drafting effort designed to monopolize the mental process steps of claim 106. See MPEP § 2106.05(f) (“Use of a computer or other machinery in its ordinary capacity for . . . tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea . . . does not . . . provide significantly more.”). In short, the additional elements discussed above: (1) do not result in an improvement to the functioning of a computer or other technology; (2) are not any particular machine; (3) do not effect a transformation of a Appeal 2020-006456 Application 12/925,221 8 particular article to a different state; and (4) are not applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment. See MPEP §§ 2106.05(a)–(c), (e)–(h). Consequently, the claimed invention does not integrate the abstract idea into a “practical application.” For these reasons, the additional elements of claim 106 do not integrate the judicial exception into a practical application. Thus, claim 106 is directed to an abstract idea, which is a judicial exception to patent-eligible subject matter under 35 U.S.C. § 101. Step 2B: Does Claim 106 Recite an Inventive Concept? We next consider whether claim 106 recites any additional elements, individually or as an ordered combination, that transform the abstract idea into a patent-eligible application, e.g., provide an inventive concept. Alice, 573 U.S. at 217–18. The only additional elements are a computer, a database, and pattern recognition software. Ans. 3. These additional elements do not provide, either individually or as a combination, improvements to another technology or technical field or the functioning of the computer itself, but merely are conventional computing components included to perform the method. According to Office guidance, under Step 2B, “examiners should . . . evaluate the additional elements individually and in combination . . . to determine whether they provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself).” See Guidance, 84 Fed. Reg. at 56 (emphasis added). Thus, the second step of the inquiry (Step 2B) looks at the additional elements in combination. See BSG Tech LLC v. BuySeasons, Inc., 899 F.3d 1281, 1290 (Fed. Cir. Appeal 2020-006456 Application 12/925,221 9 2018) (“It has been clear since Alice that a claimed invention’s use of the ineligible concept to which it is directed cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept.”). As noted above, the storage device, computer, database, and software are invoked as conventional tools. Apart from being used to perform the abstract idea itself, the generic computer system components only serve to perform well-understood functions (e.g., retrieving, determining, presenting, providing, etc.). See FairWarning IP, LLC v. Iatric Sys., Inc., 839 F.3d 1089, 1096 (Fed. Cir. 2016) (“[T]he use of generic computer elements like a microprocessor or user interface do not alone transform an otherwise abstract idea into patent-eligible subject matter.”). In our view, claim 106 fails to add a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field, but instead “simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.” See Guidance, 84 Fed. Reg. at 56. That is, claim 106 is not directed to a specific application designed to achieve an improved technological result, as opposed to being directed to merely ordinary functionality of the above-recited additional elements to apply an abstract idea. For the reasons discussed above, we find no additional element, alone or in combination, recited in claim 106 that contains any “inventive concept” or adds anything “significantly more” to transform the abstract concept into a patent-eligible application. See Alice, 573 U.S. at 221. Appellant’s Contentions Regarding claim 96, Appellant asserts that “[t]he claims cannot be read as covering data per se” because “[t]he data is tied to a patient or it is not a health record.” Reply Br. 7. This argument does not rebut the Appeal 2020-006456 Application 12/925,221 10 Examiner’s findings, and, in fact, confirms that claim 96 is directed to a health record, which is nothing more than a specific type of data. It does not matter that the data at issue “have to be in a form that can be used for computer comparisons” because all that means is that the data is in a computer readable form. Id. The records are still nothing more than data, which is not a statutory category of eligible subject matter. As to claim 106, Appellant asserts that “no one could seriously believe that any human mind is equipped to practically perform a comparison of health records using pattern recognition software.” Reply Br. 10. This argument misunderstands the eligibility analysis. It does not matter if the claim utilizes computers, programming, software, etc. to perform what is otherwise a mental process. In this case, as identified by the Examiner, the abstract idea in claim 106 is the comparing of records to determine a difference between a past and a present record. A computer may be used to speed up the process, but a comparison of two medical records is something that may be done by the human mind. Again, it does not matter that the health record is claimed as being digital because, first, a digital record in and of itself is not patent eligible, and second a digital record is just a digital representation of something that could also be printed out onto paper as was done before computers. Similarly, a doctor having a past record and a present record could review the paper records and do a comparison to determine if any change had occurred. As such, the claims do nothing more than perform on a computer what may otherwise be performed in the human mind. Obviousness Regarding the § 1.131 declaration, the Examiner is correct that such a declaration “is not appropriate for the Cotter reference,” because “Cotter was Appeal 2020-006456 Application 12/925,221 11 published more than a year before the effective filing date of the present application.” Ans. 13. Appellant appears to misunderstand the availability of a declaration to rebut obviousness. A § 1.131 declaration may only be used to remove a reference from consideration if that reference is within a year of the filing of the application. Because Cotter is more than a year prior to Appellant’s filing date, it is ineffective as a tool to overcome Cotter. As to Fletcher, the Examiner is correct that “[t]he output of a mass spectrometer, by definition, is the mass-to-charge ratio (m/z) of ions following [the] ionization of a sample.” Ans. 13. Accordingly, Appellant’s argument that “[i]t is clear that Fletcher does not teach appellants’ mass spectral channel signals (m/z)” is not persuasive. Regarding the combination of Braun and Fletcher, Appellant argues that the motivation to combine the references “ignores the simple fact that Fletcher does not disclose any use of the mass spectral signals per se and discloses only patterns based upon compounds that have no extraneous data present.” Appeal Br. 16. This argument misunderstands the Examiner’s rejection. According to the Examiner, Braun teaches the use of the medical record that comprises saving a profile of compounds produced by a spectrometer. Ans. 14. The Examiner admits that Braun does not explicitly disclose the use of a mass spectrometer as the source of the record and points to Fletcher as specifically disclosing that “a mass spectrometer is a sensitive analyzer that can be used to produce a profile of a headspace volatile material.” Id. Accordingly, the Examiner uses the teaching of the use of the medical record in Braun with the specific disclosure of a record containing data obtained from a mass spectrometer, which falls within the general class of spectrometers described in Braun. Appeal 2020-006456 Application 12/925,221 12 As to Cotter, Appellant asserts that “[t]he Cotter samples are derived from blood or plasma which are not volatile materials.” Appeal Br. 16–17. The Examiner, however, states that Cotter is not used for the specific “disclosure of using a volatile material or its sample preparation,” rather Cotter is merely used for disclosing “the use of pattern recognition software to perform a comparison(s) of a patient profile/mass spectrum to a reference profile/mass spectrum.” Ans. 15. The Examiner is correct that Appellant attacks Cotter as lacking something for which it was not used to teach. The Examiner is also correct that “Appellant’s assertion that ‘there is no need for using pattern recognition software [in Cotter],’ appears in direct opposition to the disclosure of Cotter” in that Cotter teaches the use of a pattern recognition system throughout its disclosure. Ans. 15. We also agree with the Examiner that Cotter discloses a comparison to a known antigen merely as an optional step. Ans. 16. As the Examiner states, Cotter “further discloses the pattern recognition is performed directly on the mass spectrum (i.e., signals from the mass spectrometer) to identify patterns therein.” Id. (citing Cotter ¶ 30). Accordingly, Cotter adequately teaches the use of pattern recognition software for the comparison as claimed. As such, we are not persuaded of error in the Examiner’s rejection of claims 96–98, 100, and 106–108 as unpatentable over Braun, Fletcher, and Cotter. Regarding Agus, as with Cotter above, a § 1.131 declaration is not effective against a reference that is more than one year prior to Appellant’s filing date. Additionally, as with the previous rejection, Appellant attacks the Examiner’s use of Agus for aspects not alleged to be taught by Agus. The Examiner is correct that “Agus expressly discloses saving mass spectral signals (i.e., mass spectrum) as a health record along with other patient data for subsequent pattern recognition and comparison to reference profiles.” Appeal 2020-006456 Application 12/925,221 13 Ans. 17 (citation omitted). As the Examiner states, “[t]he examiner does not contend that Agus alone teaches/suggests collecting the headspace from said materials, only that one of ordinary skill in the art would recognize at least some of the body fluids disclosed by Agus are materials that emit VOCs.” Id. It is Fletcher that is used to disclose “producing a record/profile for a volatile headspace material using a mass spectrometer.” Id. Appellant’s arguments attack the references for aspects they were not alleged to have taught for the purpose of the rejection. Accordingly, we are not persuaded of error in the Examiner’s rejection of claims 96–105 and 108–111 as being obvious over Braun, Fletcher, and Agus. Indefiniteness The Examiner rejects claim 106 for failing to claim a positively recited method step. Ans. 5. The Examiner is correct that claim 106 uses passive voice, which is not a preferred manner of claiming a method step. Although we urge Appellant to address this issue in any further prosecution, we conclude that one of ordinary skill in the art would understand what is meant and therefore do not sustain the rejection on this basis. The Examiner is also correct that claim 106 lacks a clear transitional phrase. We agree with the Examiner that “because of the numerous ‘wherein’ clauses and use of passive voice and/or past participles, the metes and bounds of the claimed invention were unable to be determined.” Ans. 6. Appellant states that there is no requirement of a transitional phrase, but we note that the claims should include a preamble ending in “comprising,” “consisting of,” or “consisting essentially of.” Such phrases signal to the public whether the claim is open-ended (i.e., may contain more than the claim), closed-ended (i.e., may contain only what is claimed), or closed- ended but allowing for insignificant additional elements. Appellant appears Appeal 2020-006456 Application 12/925,221 14 to concede the indefiniteness by stating that he would be amenable to changing the claims as recommended. See, e.g., Appeal Br. 8. Appellant will be able to correct these drafting errors in any further prosecution. Accordingly, we sustain the Examiner’s rejection regarding the lack of a clear transitional phrase. CONCLUSION The Examiner’s rejections are AFFIRMED. More specifically, DECISION SUMMARY Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 96–111 101 Eligibility 96–111 96–105, 108–111 103(a) Agus, Fletcher 96–105, 108–111 96–98, 100, 106–108 103(a) Braun, Fletcher, Cotter 96–98, 100, 106–108 96–105, 108–111 103(a) Braun, Fletcher, Agus 96–105, 108–111 106–111 112 Indefiniteness 106–111 Overall Outcome 96–111 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED Copy with citationCopy as parenthetical citation