Michael A. Rees

Patent Trials and Appeals Board

May 29, 2020

2018009226 (P.T.A.B. May. 29, 2020)

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.
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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.

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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
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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
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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.”).
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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
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(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
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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
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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.
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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
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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.
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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
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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
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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.

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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