Ex Parte Schmitz et al

Patent Trial and Appeal Board

Nov 2, 2018

13454008 (P.T.A.B. Nov. 2, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/454,008 04/23/2012
20350 7590 11/06/2018
KILPATRICK TOWNSEND & STOCKTONLLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
Juergen Schmitz
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.
89346-838080 (000713US) 1006
EXAMINER
EWOLDT, GERALD R
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
11/06/2018 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):
ipefiling@kilpatricktownsend.com
KTSDocketing2@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUERGEN SCHMITZ, ANDRZEJ DZIONEK,
and DAVID WILLIAM BUCK 1
Appeal2017-010045
Application 13/454,008
Technology Center 3700
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims to methods of detecting BDCA-2 protein
in a biological sample and of ligating an antibody or binding fragment to the
BDCA-2 protein. The Examiner rejected the claims under 35 U.S.C. § 112
for lack of enablement and as indefinite, and under 35 U.S.C. § 101 as
directed to patent ineligible subject matter. Appellants appeal the
Examiner's determination that the claims are unpatentable. We have
jurisdiction under 35 U.S.C. § 6(b ). The rejections are reversed.
1 The Appeal Brief ("Appeal Br.") (Jan. 6, 2014), page 2, lists Miltenyi
Biotec as the real-party-in-interest.
Appeal2017-010045
Application 13/454,008
STATEMENT OF THE CASE
Claims 2-7 and 9-20 stand finally rejected by the Examiner as
unpatentable for the following reasons:
Claims 2-7 and 10-20 under 35 U.S.C. § 101 because the claimed
invention is directed to non-statutory subject matter. Ans. 7.
Claims 4, 19 and 20 under 35 U.S.C. § 112, second paragraph, as
indefinite for failing to particularly point out and distinctly claim the subject
matter which applicant regards as the invention. Ans. 2.
Claims 5, 7, and 11-20 are rejected under 35 U.S.C. § 112, first
paragraph, as containing subject matter which was not described in the
specification in such a way as to enable one skilled in the art to which it
pertains, or with which it is most nearly connected, to make and/ or use the
invention. Ans. 3.
Claim 2, which is representative of the rejected claims, is reproduced
below:
2. A method of detecting BDCA-2 protein in a biological
sample, comprising:
a) combining the sample with a monoclonal, synthetic, or
recombinant antibody or antigen binding fragment under
conditions where the antibody or fragment will bind to BDCA-
2 protein in the sample to form a complex, and
b) detecting complex formed in step (a);
wherein said antibody or antigen-binding fragment
comprises a polypeptide domain that specifically binds a
BDCA-2 protein encoded by SEQ ID NO: 1;
wherein the BDCA-2 protein is encoded by exons 1-6;
exons 1 and 3-6; exons 1-2 and 4-6; or exons 1-3 and 5-6 of
SEQIDNO: 1.
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Application 13/454,008
REJECTION UNDER§ 101
The Examiner found that claims 2-7 and 10-20 are unpatentable
under 35 U.S.C. § 101 as ineligible subject matter for a patent because the
claims rely on a law of nature in which an anti-BDCA-2 antibody binds to a
BDCA-2 protein "and cause[s] the 'modulations' of dependent Claims 4, 5,
and 7." Ans. 7. For this reason, the Examiner concluded that the claims
"simply recite the observation of the natural relationship between an
antibody binding to its ligand and the physiological processes therein
induced." Id. The Examiner also found that the method steps of the claims
"i.e., the detecting of antibody binding, add nothing significant beyond the
sum of their parts taken separately." Id.
We do not agree with the Examiner's analysis and reverse the
rejection.
Claim 2 comprises a step (a) of combining antibody or antigen
binding fragment with a sample containing BDCA-2 protein under
conditions where the antibody or fragment binds to the protein. The second
step (b) is detecting the complex formed in step (a). According to the
Specification, the BDCA-2 protein is novel and the antibodies and binding
fragments were newly produced against the BDCA-2 protein. Application
Specification ("Spec.") ,r 88.
While we agree with the Examiner that the claim involves a natural
phenomenon because the binding of an antibody or antigen binding fragment
to a protein is based on natural interactions between both molecules, the
analysis does not end there. As held in in Mayo Collaborative Services v.
Prometheus Laboratories, Inc., 566 U.S. 66 (2012), the fact that a claim
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Application 13/454,008
invokes a natural phenomenon does not necessarily exclude it from being
patentable subject matter. The Mayo Court held:
The Court has recognized, however, that too broad an
interpretation of this exclusionary principle could eviscerate
patent law. For all inventions at some level embody, use,
reflect, rest upon, or apply laws of nature, natural phenomena,
or abstract ideas.
Mayo, 566 U.S. at 78.
To determine whether an unpatentable law of nature has been
transformed "into a patent-eligible application of such law," the Court
further held that the claim as a whole must be examined to determine
whether it "also contain[ s] other elements or a combination of elements,
sometimes referred to as an 'inventive concept,' sufficient to ensure that the
patent in practice amounts to significantly more than a patent upon the
natural law itself." Id. at 72-73. The Court further added that the additional
recitation of "well-understood, routine, conventional activity previously
engaged in by researchers in the field" is not sufficient to transform an
ineligible law of nature into eligible subject matter. Id.
In this case, we are not convinced that the detection of BDCA-2 is a
natural law or a natural phenomenon because it has not been established that
the antibody and antigen binding fragments utilized to detect it are naturally-
occurring. Thus, the binding between BDCA-2 and the antibody or binding
fragment are only a natural phenomenon to the extent that the underlying
molecular interaction reflects a natural process. The process, itself, has not
been demonstrated to be merely a natural law or detection of natural process,
but rather involves the production of, on the record before us, a new
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Application 13/454,008
antibody or binding fragment. Spec. ,r 88. Consistently, the Examiner did
not cite prior art against the claim.
In addition to this, even if the binding step of the claimed process is
itself a natural law and ineligible for a patent, the additional element of the
claim in which an antibody or binding fragment binds to the BRCA-2
protein enabling its detection is an "inventive concept" because the recited
antibody and binding fragment are new and therefore do not constitute
routine and conventional activity engaged in by researchers in the field.
Mayo, 566 U.S. 72-73. Consequently, the claim is eligible for a patent
under the guidance set forth in Mayo.
Our analysis is consistent the "Subject Matter Eligibility Examples:
Life Sciences" issued by the US PTO on May 2016. 2 Example 29 in the
Eligibility Examples is of a method claim of detecting a protein in a sample
comprising a step in which the sample is contacted with an antibody and the
binding between the protein and antibody is detected. Eligibility Examples
10. The eligibility guidance characterized the claim as eligible for a patent
because the process is not directed to a judicial exception. Id. at 11.
With regard to claims 4 and 5, the Examiner stated that the claims are
ineligible for a patent because they "simply recite the observation of the
natural relationship between an antibody binding to its ligand and the
physiological processes therein induced." Ans. 7.
In claims 4 and 5, the step of detecting comprises detecting a response
of a cell to the antibody or fragment binding. While the observed response
is a physiological and natural phenomenon, it is elicited by the new antibody
2 https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf
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and binding fragment and therefore the process as a whole is not routine and
conventional. The claim as a whole must be examined for eligibility, not the
individual steps which comprise it. Mayo, 566 U.S. at 79, 78.
Claim 6, and dependent claim 7, also involve binding of the new
antibody and binding fragment to BDCA-2 and thus the same analysis for
claim 2 applies.
For the foregoing reasons, the rejection of claims 2-7 and 10-20 as
ineligible for a patent under 35 U.S.C. § 101 is reversed.
REJECTION UNDER§ 112, FIRST PARAGRAPH
The Examiner rejected claims 5, 7, and 11-20 for lack of enablement.
The Examiner stated that the claimed method "is clearly nonsensical as the
same binding of an anti-BDCA-2 antibody to BDCA-2 is claimed to have
several opposite effects, e.g., both the induction and down[-]regulation of
both CD4+ and CD8+ responses, polarization towards both a Thl and Th2
response, etc." Ans. 5. We do not agree with the Examiner's reasoning.
Claims 5 and 7 recite the following responses to antibody or fragment
binding to BDCA-2 (numbering added in brackets for reference):
[1] down-regulation of type I interferon production,
[2] down-regulation of Thl immune responses,
[3] induction of intracellular ca++ mobilization, and/or
[ 4] polarization of an immune response to Th2.
The Specification explains that the binding of BDCA-2 with an anti-
BDCA-2 antibody [3] induces intracellular ca++ mobilization. Spec. ,r 245.
The mobilization of intracellular calcium, in tum, leads to physiological
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responses, such as [1] the inhibition of secretion of a type I interferon (id. at
The Specification also discloses:
As type I interferon can induce Th 1 type immune responses in
humans (Parronchi et al. (1996) Eur. J. Immunol. 26:697-703),
triggering of BDCA-2 polarizes CD4+ T cell responses towards
Th2 cell development, whereas inhibition of BDCA-2 signaling
polarizes CD4+ T cell responses towards Thl cell development.
Id. at ,I 246
Thus, triggering BDCA-2 with antibody binding [1] reduces
interferon production ("down-regulation") and [2] down regulates the Thl
response, i.e., since interferon is reduced by the antibody binding, the Thl
response is reduced and down-regulated in comparison with the same
conditions in the absence of the antibody. The immune response is therefore
[ 4] polarized to Th2 (in a negative fashion). Id.
In sum, the functional consequences of antibody binding to BDCA-1
are not opposite or nonsensical, but rather emanate from the ability of the
antibody to regulate the intracellular calcium pools and other responses of
the cell triggered by the antibody or binding fragment's ability to activate
BRCA-2.
To the extent that there are apparently "opposite" effects induced by
bonding to BDCA-2, such effects would depend on whether the antibody or
binding fragment is activating BDCA-2 or inhibiting its normal activation.
Appeal Br. 6-7; Spec. ,r,r 245, 246.
Because the Examiner did not establish that the claims were not
enabled by the Specification, the enablement rejection of claims 5, 7, and
11-20 is reversed.
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REJECTION UNDER§ 112, 2ND PARAGRAPH
The Examiner found that recitation of "modulation of B cell responses
and/or NK responses" in claims 4, 19, and 20 is indefinite because "the word
has no real definition in the context in which it is being used in this line of
the claim." Ans. 3. The Examiner further states that it is "unclear whether
the word encompasses on/off, up/down, slower/faster, and/or
induction/inhibition, etc. of said responses" and that "Clearly the claimed
method could not accomplish all." Id.
The Examiner did not establish that the claim term is indefinite. First,
claim 4 does not refer to modulating B or NK cell responses, but rather
refers to modulating a dendritic cell. Second, it is clear from the
Specification that "functional modulation" of a cell refers to changing,
altering, enhancing, etc., a function of the cell by causing the antibody to
bind to the BDCA-2 protein on the cell on the cell and elicit a response. See
Spec. ,r,r 40, 42, 46, 225. "[B]readth is not to be equated with
indefiniteness." In re Miller, 441 F.2d 689,693 (CCPA 1971). Thus, we do
not agree with the Examiner that "modulation" has "no real definition in the
context" of the claim. In addition to this, as indicated by Appellants, the
term "modulation" is regularly used in the scientific literature. Appeal Br. 9.
With regard to the statement that claimed method could not
accomplish an up and down, on and off, etc., modulation, as discussed in the
rejection under§ 112, first paragraph, the Specification discloses that
antibody and binding fragment can cause different responses depending on
whether BDCA2 signaling is activated (triggered) or inactivated (inhibited).
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Spec. ,r,r 245, 246. Thus, we are not persuaded, that the claims are
indefinite. The rejection of claims 4, 19 and 20 is reversed.
REVERSED
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