Biaoyang Lin

Patent Trials and Appeals Board

Jan 27, 2020

12949420 - (D) (P.T.A.B. Jan. 27, 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.
12/949,420 11/18/2010 Biaoyang Lin 146655.010104 5769
160605 7590 01/27/2020
Venture Partner, LLC
Weisun Rao
401 N. Michigan Ave.
Suite 1200
Chicago, IL 60611
EXAMINER
VANNI, GEORGE STEVEN
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
01/27/2020 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):
chen@venturepartnerllc.com
ipmail@venturepartnerllc.com
rao@venturepartnerllc.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BIAOYANG LIN
Appeal 2018-007658
Application 12/949,420
Technology Center 1600
Before JEFFREY N. FREDMAN, DEBORAH KATZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, 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 10 and 11. 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(a). Appellant identifies the real party in interest as the inventor,
Biaoyang Lin. Appeal Br. 2.
Appeal 2018-007658
Application 12/949,420
2
CLAIMED SUBJECT MATTER
The claims are directed to a reagent kit useful for diagnosing liver
cancer. Claim 10, reproduced below, is illustrative of the claimed subject
matter:
10. A reagent kit for the in vitro measurement of YKL-40 and
MASP2 and diagnosis of cancer of a test individual, comprising:
(1) capturing antibodies for capturing YKL-40;
(2) capturing antibodies for capturing MASP2; and
(3) detecting antibodies for detecting YKL-40 or MASP2
when YKL-40 or MASP2 is bound by the antibodies stated
in (1) or (2),
wherein the detected amounts of YKL-40 and MASP2, as
compared to the amounts in a non-cancerous individual, are
indicative of the occurrence of cancer in the test individual.
The Examiner has rejected claims 10 and 11 under 35 U.S.C. § 101 as
directed to non-statutory subject matter.2
OPINION
Issue
The issue we are presented with is whether the Examiner has properly
determined that the claims are directed to non-statutory subject matter.
The Examiner finds that claims 10 and 11 are directed to a natural
phenomenon and a law of nature without significantly more. Final Act. 6.
The Examiner applied the two step analysis outlined in the 214 Interim
eligibility Guidance. Id. With respect to step 1, the Examiner found that the
claims are directed to a product. Id. Turning to step 2A, the Examiner
found that the claims are directed to a natural phenomenon as they claim

2 Claims 10 and 11 were also rejected under 35 U.S.C. § 112, first and
second paragraphs. Final Act. 2–6. Those rejections were withdrawn by the
Examiner. Ans. 2.
Appeal 2018-007658
Application 12/949,420
3
antibodies which capture YKL-40 and MASP2, as well as antibodies that
detect the proteins when they are capture. Id. at 6–7. The Examiner found
that such antibodies occur naturally. The Examiner also found that the
claims embrace a law of nature as the association of YKL-40 and MAPS2
naturally correlates to the presence of cancer. Id. The Examiner found that
When the instant claims are viewed as a whole there are
no markedly different characteristics to the nature-based
products of antibodies that bind naturally occurring YKL-40
and MASP2. The enzymes and substrates for detection recited
in claim 11, are also considered naturally occurring. Therefore
the result of Step 2A analysis is that the claims are directed
towards a judicial exception, i.e. natural phenomena of nature-
based products.

Id. at 8.
Turning to step 2B, the Examiner found that the claims do not recite
any additional steps or elements which amount to something significantly
more than the judicial exception. Id.
Appellant contends that the claims are directed to antibodies which
are made in vitro using modern biotechnology and are not naturally
occurring. Appeal Br. 5. Appellant also contends that claims 10 and 11
recite something significantly more in that they produce the unexpected
result of quickly and accurately diagnosing cancer. Id. at 5–6.
Analysis
An invention is patent-eligible if it claims a “new and useful process,
machine, manufacture, or composition of matter.” 35 U.S.C. § 101.
However, the Supreme Court has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: “[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).
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Application 12/949,420
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To determine if a claim falls within an excluded category, we are
guided by the Supreme Court’s two-step framework, described in Mayo and
Alice. 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.” 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.”); 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 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
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 187 n.7 (quoting Corning v. Burden, 56 U.S.
252, 267–68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69
(citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))).
In Diehr, the claim at issue recited a mathematical formula, but 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 176; 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.”). Having
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Application 12/949,420
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said that, 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 (quotation marks 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. (alterations in original) (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.
The PTO recently published revised guidance on the application of
§ 101. USPTO’s January 7, 2019 Memorandum, 2019 Revised Patent
Subject Matter Eligibility Guidance (“2019 Revised 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 interactions such as a fundamental economic practice, or
mental processes); and
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Application 12/949,420
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(2) additional elements that integrate the judicial exception into a
practical application (see MPEP § 2106.05(a)–(c), (e)–(h)).
See 84 Fed. Reg. at 54–55. 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:
(3) adds a specific limitation 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 2019 Revised guidance.
As discussed more fully below, we have considered the positions of
the Examiner and Appellant and conclude that the claims, as drafted are
directed to a natural phenomenon without anything significantly more. We,
therefore, agree with the Examiner that the claims are not patent eligible.
Step 1
As the Examiner correctly found, the claims are directed to a kit
which is an article of manufacture. Thus, the claims are directed to patent
eligible subject matter unless one of the exceptions applies.
Step 2A
Having found that the claims are directed to an article of manufacture,
we must then determine if one of the exceptions applies. Here the kit
comprises at least three sets of antibodies – capturing antibodies for YLK-
40, capturing antibodies for MASP2 and detecting antibodies. Resp. to Non-
Compliant Br. 2. As the Examiner points out, the claims as drafted embrace
naturally occurring antibodies. Final Act. 7; Ans. 6. While Appellant
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Application 12/949,420
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contends that the claims are directed to antibodies produced in vitro, there is
nothing in the present claims which limits the antibodies to those produced
in vitro. See Resp. to Non-Complaint Br. 2. As claimed, the antibodies in
the kit possess the same characteristics as naturally occurring antibodies.
Final Act. 7. Thus, the claims are directed to a natural phenomenon.
We also find that the three sets of antibodies is similar to the
combination of known rhizobium bacterial inoculant components found
ineligible in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127
(1948). Funk Brothers explained that the “combination of species produces
no new bacteria, no change in the six species of bacteria, and no enlargement
of the range of their utility.” Id. at 131. Appellant presents no evidence that
the combination of the antibodies, which may be naturally occurring
polyclonal antibodies (see Spec. ¶ 39), result in any change in the antibodies
themselves or enlargement in the range of their utility as protein binding
components.
We next ask if the claims comprise additional elements which
integrate the exception into a practical application. Here the antibodies are
incorporated into a diagnostic kit, however the claims do not include any
other meaningful limitation other than the presence of the antibodies. The
section of the claim discussing the levels of antibodies being indicative of
cancer do not render the claims patentable as the section merely recites a
natural phenomenon – that high antigen levels are indicative of cancer.
Step 2B
We now look to see if the claims recited a limitation that not well-
know, routine or conventional. Appellant contends that the fact that the use
of the three sets of antibodies together results in faster and more accurate
Appeal 2018-007658
Application 12/949,420
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diagnosis rendering the claims patent eligible. Appeal Br. 6. We are not
persuade by this argument.
As shown in the Specification, the capturing and detecting antibodies
were known, were commercially available, were purchased, and were used
to diagnose cancer. See Spec. ¶¶ 54 and 58 (“A YKL-40 kit produced by
Quidel Company” and “a MASP2 kit produced by Dutch Hycult
Biotechnology Company” were used for the examples) Moreover, as the
Examiner points out, Clark also teaches the use of YKL-40 or MASP2
antibodies to detect cancer. Ans. 6–7. Appellant’s invention is to use the
two kits together to diagnose cancer. See Spec. ¶¶ 62–65. The combination
of two commercially available or well known antibodies into a single kit
diagnostic kits is conventional and well know. Thus, the claim does not
recite an element which renders the invention as claimed patent eligible.
CONCLUSION
For the reasons stated above, the Examiner’s rejection is affirmed
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
10 and 11 101 Patent eligibility 10 and 11

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