Ex Parte MOVALIA et al

Patent Trial and Appeal Board

Feb 14, 2019

14219218 (P.T.A.B. Feb. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/219,218 03/19/2014
133485 7590 02/19/2019
Nelson Mullins Riley & Scarborough LLP/Alexion
One Post Office Square
30th Floor
Boston, MA 02109-2127
Mayur MOV ALIA
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
AXJ-150USDV 9859
EXAMINER
FAN,LYNNY
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
02/19/2019 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):
ipbos ton.docketing@nelsonmullins.com
chris.schlauch@nelsonmullins.com
ipqualityassuranceboston@nelsonmullins.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MA YUR MOVALIA, ANDREA ILLINGWORTH,
SUSAN FAAS MCKNIGHT, and RUSSELL P. ROTHER
(APPLICANT: ALEXION PHARMACEUTICALS, INC.)
Appeal 2018-003948
Application 14/219 ,218 1
Technology Center 1600
Before DONALD E. ADAMS, JOHN E. SCHNEIDER, and
RYAN H. FLAX, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1, 3-11, and
20-23 (Br. 2). Examiner entered a rejection under 35 U.S.C. § 101. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
STATEMENT OF THE CASE
Appellants' "disclosure provides methods for determining whether a
patient is at an increased risk for thrombocytopenia and/or thrombosis based
1 Appellants identify "Alexion Pharmaceuticals, Inc." as the real party in
interest (Appellants' September 8, 2017 Replacement Appeal Brief (Br.) 2).
Appeal 2018-003948
Application 14/219 ,218
on the relative population of PNH Type II cells in the patient" (Spec. 2:32-
3: 1 ). Appellants' claim 1 is representative and reproduced below:
1. A method for predicting whether a paroxysmal nocturnal
hemoglobinuria (PNH) patient is at an increased risk for
developing thrombosis, the method comprising:
contacting a blood sample from the patient with a
detectably-labeled first reagent that binds to a GPI moiety and a
detectably-labeled second reagent that binds to a
glycosylphosphatidylinositol ( GPI)-anchored protein;
subjecting the blood sample to flow cytometry analysis
and separating PNH Type II granulocytes from PNH Type I and
PNH Type III granulocytes based on intermediate signals
detected from the first and second reagents;
determining the percentage of PNH Type II granulocytes
of the total granulocytes of the same histological type; and
predicting whether the patient is at an increased risk for
developing thrombosis, wherein the patient is at an increased
risk for developing thrombosis if the percentage of PNH Type
II granulocytes is greater than or equal to 1.2%.
(Br. 13.)
Grounds of rejection before this Panel for review:
Claims 1, 3-11, and 20-23 stand rejected under 35 U.S.C. § 101.
ISSUE
Does the preponderance of evidence of record support Examiner's
finding that Appellants' claimed invention is directed to patent ineligible
subject matter?
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Appeal 2018-003948
Application 14/219 ,218
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. The
Supreme Court, however, has long interpreted 35 U.S.C. § 101 to include
implicit exceptions: "Laws of nature, natural phenomena, and abstract ideas
are not patentable." Alice Corp. v. CLS Bank Int 'l, 134 S.Ct. 2347, 2354
(2014).
In determining whether a claim falls within an excluded category, we
are guided by the Supreme Court's two-step framework, described in Alice.
Id. at 2355 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 312
S.Ct. 1289, 1295-97 (2012)). In accordance with Alice's framework, we
first determine what concept the claim is "directed to." See Alice, 134 S.Ct.
at 2356 ("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.").
If the claim is "directed to" a patent-ineligible concept, e.g., a law of
nature, natural phenomenon, or abstract idea, we tum 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
ensure that the patent in practice amounts to significantly more than a patent
upon the ineligible concept itself. See Alice, 134 S.Ct. at 2354--55.
On January 7, 2019, the United States Patent and Trademark Office
published the 2019 Revised Patent Subject Matter Eligibility Guidance in
the Federal Register in which the Office revised its examination procedure.
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Appeal 2018-003948
Application 14/219 ,218
84 Fed. Reg. 50 ("Revised Guidance"). Under the Revised Guidance, we
first determine 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
(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 determine whether the
claim:
(3) adds a specific limitation beyond the judicial exception that
is not a "well-understood, routine, conventional activity" 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.
(Revised Guidance.)
On this record, Appellants' claim 1 is directed to a method for
predicting whether a paroxysmal nocturnal hemoglobinuria (PNH) patient is
at an increased risk for developing thrombosis by determining whether the
percentage of PNH Type II granulocytes of the total granulocytes of the
same histological type is over a particular threshold (see Final Act. 3--4;
Ans. 3--4; cf Br. 13). Stated differently, Appellants' claimed method is
directed to the naturally existing correlation between the percentage of PNH
Type II granulocytes of the total granulocytes of the same histological type
and an increased risk for developing thrombosis (see Final Act. 3 and 9;
Ans. 3 and 5; see also Spec. 2:24--29 (identifying inventors' discovery of
this natural correlation between PHH Type II cells and thrombocytopenia).
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Appeal 2018-003948
Application 14/219 ,218
See Mayo, 132 S.Ct. at 1290 ("The patent claims here set forth processes
embodying researchers' findings that identify correlations between
metabolite levels and likely harm or ineffectiveness with precision").
For the foregoing reasons, we find that Appellants' claims recite a
judicial exception and do not integrate that exception into a practical
application. To the contrary, the correlation recited in Appellants' claim 1
exists in nature apart from any human action. See Athena Diagnostics v.
Mayo Collaborative Servs., No. 2017-2508, 2019 WL 453489, at *4 (Fed.
Cir. Feb. 6, 2019) ("the correlation between the presence ofnaturally-
occurring MuSK autoantibodies in bodily fluid and MuSK related
neurological diseases" that "exists in nature apart from any human action.");
see also Mayo, 132 S.Ct. at 1296-97 ("the patents effectively claim natural
laws or natural phenomena-namely the correlations between thiopurine
metabolite levels and the toxicity and efficacy of thiopurine drug dosages-
and so are not patentable," because "[t]he relation is a consequence of the
ways in which thiopurine compounds are metabolized by the body----entirely
natural processes. And so a patent that simply describes that relation sets
forth a natural law").
Therefore, having concluded the claims to be directed to a natural
process or phenomenon, we determine whether Appellants' claims add a
specific limitation beyond the judicial exception that is not a "well-
understood, routine, conventional activity" or simply appends well-
understood, routine, conventional activities previously known to the
industry, specified at a high level of generality, to the judicial exception (see
Revised Guidance). In this regard, we note Appellants' contention that their
claim 1 "require[ s] a combination of specific procedures and steps that are
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Appeal 2018-003948
Application 14/219 ,218
unconventional and improved over prior techniques" (Br. 6). According to
Appellants these "particular techniques and steps amount[ing] to
significantly more than [merely] applying natural principles"
include contacting a blood sample from the patient with a
detectably-labeled first reagent that binds to a GPI moiety and a
detectably-labeled second reagent that binds to a GPI-anchored
protein; subjecting the blood sample to flow cytometry analysis
and separating paroxysmal nocturnal hemoglobinuria (PNH)
Type II granulocytes from PNH Type I and PNH Type III
granulocytes based on intermediate signals detected from the
reagents; determining the percentage of PNH Type II
granulocytes of the total granulocytes of the same histological
type; and predicting whether the patient is at an increased risk
for developing thrombosis, wherein the patient is at an
increased risk for developing thrombosis if the percentage of
PNH Type II granulocytes is greater than or equal to 1.2%.
(id.; see also id. at 7-8.) Examiner, however, finds that the additional steps
of "contacting a blood sample from a patient with detectably-labeled
reagents that bind to a GPI moiety and a GPI-anchored protein, and
subjecting the blood sample to flow cytometry analysis are steps routinely
practiced in the field of PNH diagnosis" (Ans. 6 ( citing Hall2 and
Brodsky3)). 4
Examiner further finds that the determining step of Appellants' claim
1 is simply a mental step (Ans. 5). See Mayo, 132 S.Ct. at 1291 ("The
'determining' step tells a doctor to measure patients' metabolite levels,
2 Sharon E. Hall and Wendell F. Rosse, The Use of Monoclonal Antibodies
and Flow Cytometry in the Diagnosis of Paroxysmal Nocturnal
Hemoglobinuria, 87 BLOOD 5332-5340 (2015).
3 Robert A. Brodsky, New Insights into Paroxysmal Nocturnal
Hemoglobinuria, HEMATOLOGY 24--28 (2006).
4 Appellants did not contest Examiner's findings with regard to Hall or
Brodsky.
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Appeal 2018-003948
Application 14/219 ,218
through whatever process the doctor wishes to use."). In addition, here, as in
Mayo, "[b ]ecause methods for making such determinations were well known
in the art, this step simply tells doctors to engage in well-understood,
routine, conventional activity previously engaged in by scientists in the
field" (id.; see also Brodsky 5333: col. 2, 11. 4--22; Brodsky 5335: Table 2
(Brodsky discloses the step of determining the percentage of PNH Type II
granulocytes of the total granulocytes of the same histological type). Lastly,
here, as in Mayo, "[t]he 'wherein' clause[] simply tell[s] a doctor about the
relevant natural law[], adding, at most, a suggestion that they should
consider the test results when making their treatment decisions." Mayo, 132
S.Ct. at 1291; see generally Ans. 6.
CONCLUSION
The preponderance of evidence of record supports Examiner's finding
that Appellants' claimed invention is directed to patent ineligible subject
matter. The rejection of claim 1 under 35 U.S.C. § 101 is affirmed. Claims
3-11 and 20-23 are not separately argued and all with claim 1.
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).
AFFIRMED
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