Michael A. ReesDownload PDFPatent Trials and Appeals BoardMay 29, 202014215807 - (D) (P.T.A.B. May. 29, 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. 14/215,807 03/17/2014 Michael A. Rees 55064-1/207514 8251 43935 7590 05/29/2020 Shumaker, Loop & Kendrick, LLP 1000 Jackson Street Toledo, OH 43604-5573 EXAMINER DIOP, ROKHAYA ART UNIT PAPER NUMBER 3774 NOTIFICATION DATE DELIVERY MODE 05/29/2020 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): cgolupski@shumaker.com dmiller@shumaker.com tlopez@shumaker.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte MICHAEL A. REES ____________________ Appeal 2018-009226 Application 14/215,807 Technology Center 3700 ____________________ Before ANTON W. FETTING, PHILIP J. HOFFMANN, and BRADLEY B. BAYAT, Administrative Patent Judges. HOFFMANN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s rejection of claims 1, 2, 4–8, 11–19, and 22–49. We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE. According to Appellant, the invention “relates to methods and systems for transplantation of biological material from a donor to a recipient, donor- recipient matching, and transplantation networks.” Spec. ¶ 2. Claims 1, 19, 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 “[t]he inventor[,] Michael A. Rees.” Appeal Br. 1. Appeal 2018-009226 Application 14/215,807 2 22, 31, 33, 37, and 42 are the independent claims under appeal. Below, we reproduce independent claim 1 as representative of the appealed claims. 1. A method for providing a transplantable biological material and transplantation of the biological material, the method including a pool of a plurality of donor-recipient pairs, each donor-recipient pair including a recipient in need of the biological material and a donor willing to provide the biological material to the recipient, the method comprising: providing and transplanting a first biological material from a first donor to a first recipient, the first donor and the first recipient not from the same donor-recipient pair, the first recipient overcoming a first barrier including an immunological barrier, the first barrier preventing transplantation between the donor-recipient pair of the first recipient; and providing and transplanting a second biological material from a second donor to a second recipient, the second donor and the second recipient not from the same donor-recipient pair, the second recipient overcoming a second barrier including a financial barrier, the financial barrier preventing transplantation between the donor-recipient pair of the second recipient; wherein a projected cost of care over a period of time for the first recipient is reduced due to the providing and transplanting of the first biological material from the first donor to the first recipient and a saving in the projected cost of care is used to offset a transplant cost for the second recipient, the transplant cost for the second recipient including a cost of transplanting the second biological material from the second donor to the second recipient, thereby providing the first biological material to the first recipient to allow the first recipient to overcome the first barrier including the immunological barrier, and providing the second biological material to the second recipient to allow the second recipient to overcome the second barrier including the financial barrier. Appeal 2018-009226 Application 14/215,807 3 REJECTIONS AND PRIOR ART The Examiner rejects the claims as follows: I. Claims 1, 2, 4–8, 11–19, and 22–49 under 35 U.S.C. § 101 as reciting only patent-ineligible subject matter; II. Claims 1, 2, 4–8, 11–19, and 38–49 under Pre-AIA 35 U.S.C. § 112, second paragraph, as indefinite for failing to particularly point out and distinctly claim the subject matter that Appellant regards as the invention; III. Claims 1, 2, 4–6, 11, 12, 39–42, 45, 48, and 49 under Pre-AIA 35 U.S.C. § 103(a) as unpatentable over Bradley C. Wallis et al., Kidney paired donation, 26(7) Nephrology Dialysis Transplantation 2091–2099 (2011) (“Wallis”), and Kevin Sack, 60 Lives, 30 Kidneys, All Linked, N.Y. Times, February 18, 2012, at A1, https://www.nytimes.com/2012/02/19/health/lives- forever-linked-through-kidney-transplant-chain-124.html (“Sack”); IV. Claims 7 and 8 under 35 U.S.C. § 103(a) as unpatentable over Wallis, Sack, and Abukwedar (US 2005/0010449 A1, pub. Jan. 13, 2005); V. Claims 13–18 under 35 U.S.C. § 103(a) as unpatentable over Wallis, Sack, and KentuckyOne Health, Jewish Hospital Transplant Center Participates in First International Paired Kidney Exchange In America, Louisville- Area Facilities, (6/1/2012) (“KentuckyOne Health”); VI. Claim 38 under 35 U.S.C. § 103(a) as unpatentable over Wallis, Sack, and Dorry L. Segev et al., Kidney Paired Donation and Appeal 2018-009226 Application 14/215,807 4 Optimizing the Use of Live Donor Organs, 293(15) JAMA 1883–1890 (2005) (“Segev”); VII. Claim 43 under 35 U.S.C. § 103(a) as unpatentable over Wallis, Sack, and Willis, Human Capital Practice Alert: Health Care Reform Bill, HHS Issues Additional Guidance on Transitional Reinsurance Program (January 2013), www.willis.com (“Willis”); VIII. Claim 44 under 35 U.S.C. § 103(a) as unpatentable over Wallis, Sack, and JustSaveLives https://webarchive.org/web/20l306065938/http://justsavelives. com/ (“JustSaveLives”); and IX. Claims 46 and 47 under 35 U.S.C. § 103(a) as unpatentable over Wallis, Sack, and American Kidney Fund, Paying for Kidney Disease and Dialysis Treatment (2/19/2016 1:22:26 PM), http://www.kidneyfund.org/kidney-disease/esrd- treatment/paying-for-treatment/. PRINCIPLES OF LAW CONCERNING 35 U.S.C. § 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. The 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. E.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014) (citation omitted). In determining whether a claim falls within an excluded category, the Supreme Court’s two-step framework, described in Mayo and Alice, guides Appeal 2018-009226 Application 14/215,807 5 us. See 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.” Id. 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 that the courts 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 that the courts 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, although the claim at issue recited a mathematical formula, the Supreme Court held that “a claim drawn to subject matter otherwise statutory does not become nonstatutory simply because it uses a mathematical formula.” Diehr, 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.”). Appeal 2018-009226 Application 14/215,807 6 Nonetheless, the Supreme 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. (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 (citation 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. (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. 2019 Revised Patent Subject Matter Eligibility Guidance In early 2019, the U.S. Patent and Trademark Office published revised guidance on the application of § 101. See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”). 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 i) a fundamental economic practice, or ii) managing personal behavior or relationships or interactions between people, or mental processes); and Appeal 2018-009226 Application 14/215,807 7 (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)). A practical application “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” Guidance, 84 Fed. Reg. at 54. Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim either: (3) adds a specific limitation beyond the judicial exception which is not “well-understood, routine, [or] conventional” in the field (see MPEP § 2106.05(d)); or (4) simply appends well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See generally Guidance. ANALYSIS Rejection I—§ 101 rejection of claims 1, 2, 4–8, 11–19, and 22–49 The Examiner determines that the claims recite the judicial exception of mental processes. Answer 3. We assume arguendo that, in accordance with point (1) of the Guidance referenced above, claim 1 recites a judicial exception. Nonetheless, in accordance with point (2) of the Guidance, claim 1 recites additional element that integrates the judicial exception into a practical application—i.e., something that “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner that imposes a meaningful limit on the Appeal 2018-009226 Application 14/215,807 8 judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” Guidance, 84 Fed. Reg. at 54. As set forth above, independent claim 1’s preamble recites that it is “[A] method for providing a transplantable biological material and transplantation of the biological material.” Appeal Br., Claims App. Thus, to the extent that the claim otherwise recites an abstract idea, in accordance with the claim’s preamble, the abstract idea is used in a surgical method of transplanting biological materials removed from one or more donors to one or more recipients. See, e.g., Spec. ¶¶ 4, 81. Further, the body of claim 1 does, in fact, recite steps taken to transplant biological materials from multiple donors to multiple recipients—i.e., “providing and transplanting a first biological material from a first donor to a first recipient, the first donor and the first recipient not from the same donor-recipient pair,” and “providing and transplanting a second biological material from a second donor to a second recipient.” Therefore, in view of the fact that claim 1 recites transplanting biological materials from multiple donors to multiple recipients, we determine that the claim “appl[ies], rel[ies] on, or use[s] the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” Guidance, 84 Fed. Reg. at 54. Because of this, claim 1 is directed to eligible subject matter. Rejection II—§ 112, second paragraph, rejection of claims 1, 2, 4–8, 11–19, and 38–49 As set forth above, the Examiner rejects claims 1, 2, 4–8, 11–19, and 38–49 as indefinite for failing to particularly point out and distinctly claim the subject matter that Appellant regards as the invention. Based on our review of the record, the Examiner does not support adequately that any Appeal 2018-009226 Application 14/215,807 9 of the claim recitations the Examiner identifies are indefinite. See Answer 6–9. Thus, we do not sustain the rejection. Below we discuss specific, exemplary statements made by the Examiner, and our reasons for determining that the Examiner errs. According to the Examiner, “it is unclear what the scope of the [claims’] ‘financial barrier’ is[,] since it corresponds to any sum of money that prevents the indigent recipient from receiving a transplant.” Answer 7; see also id. 7–8. We agree with Appellant, however, that “the term ‘financial barrier,’ as used in the context of the entire [S]pecification, including the claims, is understood . . . as a financial or monetary factor that prevents a transplantation from taking place between a particular donor- recipient pair.” Appeal Br. 12; see also id. 9–13; see also, e.g., id. at Claims Appendix (Claim 1) (“the second recipient overcoming a second barrier including a financial barrier, the financial barrier preventing transplantation between the donor-recipient pair of the second recipient.”). According to the Examiner, “[independent] [c]laims 1, 19, and 42 are indefinite because the [S]pecification does not support the infinite controlling variants that are responsible for cost reduction.” Answer 8. We do not sustain the Examiner’s rejection on this basis, as the Examiner does not explain adequately why an alleged deficiency in Appellant’s Specification results in the claims being indefinite. Also according to the Examiner, [t]he recitation of “overcoming a first barrier including an immunological barrier” remains indefinite because the claim fails to positively define the metes and bounds of this step. All transplanted tissues (non-autologous) are subjected to immunological rejection. It remains unclear how the step for overcoming the barriers is tied to the step of transplanting. Appeal 2018-009226 Application 14/215,807 10 Answer 8. We determine that the claims are not indefinite based on the “immunological barrier” recitation, as it is clear from claim 1, for example, that the claimed immunological barrier includes an immunological incompatibility, which cannot be overcome such as by using an immunosuppressant, and accordingly which prevents transplantation from a potential donor to a specific recipient. See Appeal Br. 9–13, 15–16 (citations omitted); see Spec. ¶¶ 4, 16, 29, 44; see Declaration of Dr. Michael A. Rees, October 29, 2015, ¶¶ 7–11; see also Appeal Br., Claims App. (Claim 1) (“the first recipient overcoming a first barrier including an immunological barrier, the first barrier preventing transplantation between the donor-recipient pair of the first recipient.”). Still further, according to the Examiner, [t]he claims are indefinite because one having ordinary skill in the art would not be able to ascertain the metes and bounds of the [claims’ recitations of “a projected cost of care over a period of time for the first recipient is reduced due to the providing and transplanting of the first biological material.”] Additionally, the claimed “period of time” can conceivably refer to any amount of time (from zero to infinity), and therefore the projections in the cost reduction span an undetermined range even if one was able to calculate the reduction in cost. Answer 8–9. We agree with Appellant that the claim recitation is not indefinite, as “[t]he plain language [of independent claim 1 itself, for example,] indicates that the ‘projected cost of care’ . . . is reduced as a result of the providing and transplanting step[s].” Appeal Br. 17. Further, the Examiner does not support adequately that the Examiner’s determinations with respect to the claimed “period of time” provide a basis for an Appeal 2018-009226 Application 14/215,807 11 indefiniteness rejection—instead, it appears that the claims, due to their breadth, may cover time periods of different lengths. Rejection III—§ 103 rejection of claims 1, 2, 4–6, 11, 12, 39–42, 45, 48, and 49 As set forth above, independent claim 1 recites the following: 1. A method for providing a transplantable biological material and transplantation of the biological material, the method including a pool of a plurality of donor-recipient pairs, each donor-recipient pair including a recipient in need of the biological material and a donor willing to provide the biological material to the recipient, the method comprising: providing and transplanting a first biological material from a first donor to a first recipient, the first donor and the first recipient not from the same donor-recipient pair, the first recipient overcoming a first barrier including an immunological barrier, the first barrier preventing transplantation between the donor-recipient pair of the first recipient; and providing and transplanting a second biological material from a second donor to a second recipient, the second donor and the second recipient not from the same donor-recipient pair, the second recipient overcoming a second barrier including a financial barrier, the financial barrier preventing transplantation between the donor-recipient pair of the second recipient; wherein a projected cost of care over a period of time for the first recipient is reduced due to the providing and transplanting of the first biological material from the first donor to the first recipient and a saving in the projected cost of care is used to offset a transplant cost for the second recipient, the transplant cost for the second recipient including a cost of transplanting the second biological material from the second donor to the second recipient, thereby providing the first biological material to the first recipient to allow the first recipient to overcome the first barrier including the immunological barrier, and providing the second biological material to the second recipient to allow the second recipient to overcome the second barrier including the financial barrier. Appeal 2018-009226 Application 14/215,807 12 Appeal Br., Claims App. (emphases added). For the reasons discussed below, the Examiner does not support adequately that combinations of Wallis and Sack disclose a projected cost of care over a period of time for a first biological-material recipient is reduced due to providing and transplanting the first biological material to the first recipient, and a saving in the first recipient’s the projected cost of care is used to offset a transplant cost for a second biological-material recipient. The Examiner does not rely on Wallis to disclose offsetting a transplant cost for a second biological-material recipient based on savings resulting from transplanting biological material to a first recipient. Answer 10–11. Instead, the Examiner relies on Sack. Id. at 11. Specifically, according to the Examiner, [Sack] teaches (page 5, paragraph 4 ): “[T]he federal Medicare program, which pays most treatment costs for chronic kidney disease, saves an estimated $500,000 to $1 million each time a patient is removed from dialysis through a live donor transplant (the operations typically cost $100,000 to $200,000) . . . .” In cases where the Federal Medicare program covers the transplantation costs for both the first and second recipients, the estimated $500,000 to $1 million saved each time the first recipient is removed from dialysis may be used to fund several others kidney transplant operations, including the transplant cost for the second recipient. Answer 11–12. Even assuming we agree with the Examiner’s characterization of Sack, and that Sack discloses using (or that it would have been obvious to modify the combination of Wallis and Sack to use) the money saved by performing a kidney transplant instead of performing dialysis on a first kidney recipient, to offset the cost of performing a kidney transplant on a second kidney recipient, the Examiner does not support adequately that Sack is concerned with anything other than money that is Appeal 2018-009226 Application 14/215,807 13 actually saved and available for use. Conversely, claim 1 recites that a saving in the projected cost of care—i.e., an expected sum of money—is used to offset the transplant cost. Appeal Br., Claims App. “Based on the projected cost of care over a period of time, a saving in the projected cost of care is used to offset a transplant cost for the second recipient. In other words, the expectation of future savings are used to overcome the financial barrier and allow transplanting to the second recipient.” Id. at 23. As set forth above, the Examiner does not support adequately that the prior art discloses anything about using savings from a projected cost of care. Accordingly, we do not sustain the Examiner’s rejection of independent claim 1. Independent claim 42 includes a similar recitation. Therefore, we do not sustain the Examiner’s obviousness rejection of claim 42 for the same reasons we do not sustain claim 1’s rejection. We also do not sustain the Examiner’s obviousness rejection of claims 2, 4–6, 11, 12, 39–41, 45, 48, and 49 that depend from independent claims 1 and 42. Rejections IV–IX—§ 103 rejections of claims 7, 8, 13–19, 38, 43, 44, 46, and 47 Dependent claims 7, 8, 13–18, 38, 43, 44, 46, and 47 The Examiner does not rely on any reference to remedy the above deficiency in the obviousness rejection of independent claims 1 and 42. Therefore, we do not sustain the obviousness rejections of dependent claims 7, 8, 13–18, 38, 43, 44, 46, and 47. Independent claim 19 Independent claim 19 includes a similar recitation to that discussed above for claim 1. See Appeal Br., Claims App. (Claim 19) (“wherein . . . a projected cost of care over a period of time for the first recipient is reduced due to the providing and transplanting of the first biological material from Appeal 2018-009226 Application 14/215,807 14 the first donor to the first recipient, [and] a reduction in the projected cost of care is used to offset a transplant cost for the second recipient.”). Therefore, we do not sustain the Examiner’s obviousness rejection of claim 19 for the same reasons we do not sustain claim 1’s rejection. Appeal 2018-009226 Application 14/215,807 15 CONCLUSION We REVERSE the Examiner’s §§ 101, 112, and 103 rejections of claims 1, 2, 4–8, 11–19, and 22–49. In summary: Claims Rejected 35 U.S.C. § Basis/Reference(s) Affirmed Reversed 1, 2, 4–8, 11–19, 22–49 101 Eligibility 1, 2, 4–8, 11– 19, 22–49 1, 2, 4–8, 11–19, 38–49 112 ¶ 2 Indefiniteness 1, 2, 4–8, 11– 19, 38–49 1, 2, 4–6, 11, 12, 39–42, 45, 48, 49 103(a) Wallis, Sack 1, 2, 4–6, 11, 12, 39–42, 45, 48, 49 7, 8 103(a) Wallis, Sack, Abukwedar 7, 8 13–18 103(a) Wallis, Sack, KentuckyOne Health 13–18 38 103(a) Wallis, Sack, Segev 38 43 103(a) Wallis, Sack, Willis 43 44 103(a) Wallis, Sack, JustSaveLives 44 46, 47 103(a) Wallis, Sack, American Kidney Fund 46, 47 Overall Outcome 1, 2, 4–8, 11– 19, 22–49 REVERSED Copy with citationCopy as parenthetical citation