Ex Parte McBride et al

Patent Trial and Appeal Board

Sep 29, 2016

12812365 (P.T.A.B. Sep. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/812,365 09/24/2010
52034 7590 10/03/2016
Parker Highlander PLLC
1120 South Capital of Texas Highway
Bldg. 1, Suite 200
AUSTIN, TX 78746
FIRST NAMED INVENTOR
Jere W. McBride
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.
CLFR.P0303US 6549
EXAMINER
DEVI, SARV AMANGALA JN
ART UNIT PAPER NUMBER
1645
NOTIFICATION DATE DELIVERY MODE
10/03/2016 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):
docket@phiplaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JERE W. McBRIDE and TIAN LUO 1
Appeal2015-006216
Application 12/812,365
Technology Center 1600
Before JOHN G. NEW, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is Research Development
Foundation. App. Br. 3.
Appeal2015-006216
Application 12/812,365
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 1-10, 35, 45, 61, and 62 as
unpatentable under 35 U.S.C. § 101 as being directed to unpatentable subject
matter. 2
We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
NATURE OF THE CLAIMED INVENTION
The present invention is directed to VLPT immunoreactive
compositions for E. chaffeensis and compositions related thereto, including
vaccines, antibodies, polypeptides, peptides, and polynucleotides. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
1. A polypeptide composition comprising one or more
of the following:
(a) an isolated polypeptide that is no more than 50 amino
acids in length comprising one or more amino acid
sequences selected from the group consisting of: SEQ ID
N0:3; SEQ ID N0:4; SEQ ID N0:8; SEQ ID N0:9; SEQ
ID NO:lO; and SEQ ID NO:l 1; or
2 Claims 36, 61, and 62 were also rejected by the Examiner as unpatentable
under 35 U.S.C. § 112(b), as being indefinite. Final Act. 4. Appellants have
canceled claim 36, rendering the rejection moot, and the Examiner has
withdrawn the rejections of claims 61 and 62 under 35 U.S.C. § 112(b). See
Advisory Act. 4 (October 27, 2014).
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Application 12/812,365
(b) an isolated polypeptide that is at least 95% identical to
the polypeptide of (a); and
wherein the one or more isolated polypeptide(s) are bound to a
solid support.
App. Br. 9.
ISSUES AND ANALYSES
Issue 1
Appellants argue the Examiner erred in finding the claims are not
directed to patentable subject matter. App. Br. 4--7.
Analysis
Appellants dispute the Examiner's construction of the claim term
"solid support" to include a "naturally occurring stone or rock" which the
Examiner finds constitutes a judicial exception under 35 U.S.C. § 101. App.
Br. 4 (citing Final Act. 3--4 ). According to Appellants, this is an
unreasonable construction of the claim term, even under the "broadest
reasonable interpretation" standard employed by the Examiner. Id.; see In re
ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007) (Claims
under examination before the PTO are given their broadest reasonable
interpretation consistent with the specification). According to Appellants,
construing a "solid support" as including a "naturally occurring rock or
stone," is inconsistent with the "[p ]lain [ m ]eaning" requirement of the
Manual of Patent Examining Procedure § 2111.01. Id. at 5.
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Appellants further argue that the Examiner's construction is
inconsistent with Appellants' Specification, which discloses exemplary
embodiments in which the "solid support" is described as being "a column
matrix and/or well of a microtitre plate." Id. (citing Spec. if 297). Appellants
contend the Examiner fails to explain how a naturally occurring rock or
stone is consistent with a reasonable interpretation of the claim term "solid
support" in the context of Appellants' Specification, and that the Examiner
fails to explain how one of ordinary skill would, upon reading the
Specification and after understanding the claimed subject matter, conclude
that a naturally occurring rock or stone is within the scope of claim term
"solid support." Id.
Appellants also decry the Examiner's finding that: "[t]he binding of a
peptide or a polypeptide to a solid support amounts to said peptide or a
polypeptide being laid on a naturally occurring solid support, which does not
appear to change the structure of the peptide or the polypeptide
significantly." App. Br. 4, 6 (quoting Final Act. 3--4 (emphasis omitted)).
Appellants contend that even if, arguendo, "solid support" can be construed
as meaning a naturally occurring rock or stone, the Examiner is still required
to show that Appellants' claimed polypeptides can be found, in nature,
bound to a naturally occurring rock or stone. Id. at 6. According to
Appellants, it is not enough for the Examiner to merely assert that the
peptides and the rock or stone are naturally occurring, the Examiner must
also provide evidence that (a) such a combination is found in nature, and (b)
that the combination is bound together (and the polypeptide is not merely
"laid on" the naturally occurring rock or stone). Id.
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Application 12/812,365
The Examiner responds that the broadest reasonable interpretation of
the claim term "solid support" is not limited to, nor does it require limiting
to, the examples disclosed in an embodiment of Appellants' Specification.
Ans. 7-8. Rather, the Examiner finds the broadest reasonable interpretation
of the claim term "solid support" includes, in addition to those set forth in
the Final Office Action, any number of unlimited solid support judicial
exceptions, including glass, natural cellulose, magletite, etc., as are well
known to those of skill in the art. Id. at 8. The Examiner points to
O'Connor, Jr. et al. (US 2009/0081708 Al, March 26, 2009) ("O'Connor,
Jr."), an analogous prior art reference, which teaches: "Antibodies of the
invention or antigen-binding fragments thereof can be bound to a support
and used to detect the presence of Ehrlichia chaffeensis antigens. Supports
include, for example, glass, polystyrene, polypropylene, polyethylene,
dextran, nylon, amylases, natural and modified celluloses, polyacrylamides,
agaroses and magletite." Id. (quoting O'Connor, Jr. i-f 54 (emphasis
omitted)).
Similarly, the Examiner finds chromatography solid support
substances that were well known in the art included charcoal and silica
(sand). Ans. 8. As evidence, the Examiner points to Shukla et al. (US
7,427,659 B2, September 23, 2008) ("Shukla"), which teaches: "For
example, commonly used support substances include organic materials such
as cellulose, polystyrene, agarose, sepharose, polyacrylamide
polymethacrylate, dextran and starch, and inorganic materials, such as
charcoal, silica (glass beads or sand) and ceramic materials." Id. (quoting
Shukla, col. 8, 11. 1---6 (emphasis omitted)). Therefore, the Examiner finds,
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both charcoal and sand are art-accepted "solid support" judicial exceptions
to which proteins may be bound or adsorbed. Id.
The Examiner also finds the claimed polypeptide sequences are also
phenomena of nature and therefore a judicial exception to patentable subject
matter under Section 101. Ans. 9. The Examiner finds one of ordinary skill
in the art would readily recognize that Ehrlichia sp., along with its
polypeptide exists in nature, being present in infested ticks, as well as in
animals such as dogs or humans infected with Ehrlichia sp. Id.
The Examiner further finds the limitation of claim 1 reciting
"polypeptide(s) ... bound to a solid support" includes within its scope non-
covalent binding or non-covalent adsorption that does not confer markedly
different characteristic( s) to either of the two elements recited in the claims.
Ans. 9--10. The Examiner construes the claim term "bound" as broadly
including non-specific binding or non-specific association between the
recited two naturally occurring judicial exception elements such as those
occurring due to electrostatic binding, van der Waals bonding, hydrophobic
interactions, ionic interactions, etc. Id. The Examiner therefore concludes
that the two recited elements in the claims are merely two naturally
occurring elements left together in a non-specific way and that the claim
term "bound" recited in the claim(s) does not structurally or functionally
modify one or both of the recited elements and therefore does not render the
two recited elements markedly different. Id.
Appellants have the better position. As an initial matter, we agree
with the Examiner that the claimed polypeptide sequences are phenomena of
nature and are thus subject to the two-step analysis set forth by the Director.
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See 2014 Interim Guidance on Patent Subject Matter Eligibility, December
10, 2014, subsequently updated in 2015 and 2016 (the "Interim Guidance").
O'Connor, Jr. et al. (WO 2006/091421 A2, August 31, 2006) ("O'Connor,
Jr. II") teaches that the sequences in question "correspond[ ] to amino acid
numbers ... of an E. ewingii membrane protein." O'Connor, Jr. II 4. As
such, they are naturally occurring sequences of a transmembrane protein
occurring in a known species of bacterium.
However, we are not persuaded by the Examiner's finding that the
claim term "solid support" can be reasonably construed as including "a
naturally occurring rock or stone." Although the Examiner can interpret
claim terms in the broadest reasonable manner, such an interpretation must
be reasonable in light of Appellants' Specification. See ICON Health &
Fitness, 496 F.3d at 1379. Appellants' Specification twice provides
exemplars of "solid support" as including "a column matrix and/or well of a
microtitre plate." See Spec. i-fi-1270, 297. We agree with the Examiner that
such exemplary embodiments are not limiting upon the Examiner's
interpretation, but the disclosures of Appellants' Specification, in which
solid supports are mentioned, are directed to immunodetection methods and
ELISAs. See Spec. i-fi-1268-91. We do not agree with the Examiner that a
person of ordinary skill in the relevant art would reasonably understand a
naturally occurring rock or stone, picked up, say, from one's back garden, to
be a "solid support" within that context. Furthermore, the list of supports
cited by the Examiner in O'Connor, Jr. and Shukla are largely artificial.
Even the charcoal and sand cited by the Examiner are not in their natural
states when used in immunodetection methods, but are refined, purified, and
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incorporated into a non-naturally occurring device, such as an affinity
column.
However, even if we were to agree with the Examiner's construction
of "solid support," the Examiner provides no evidence that there exists in
nature these particular polypeptide sequences "bound to" a naturally
occurring rock or stone. By "bound to" we mean, similarly to the Examiner,
some sort of physical, electrostatic, or other connection binding the two
elements to each other. The Examiner points to no evidence that this
binding of the elements to each other exists in the natural world.
Consequently, and because we disagree with the Examiner's
interpretation of the claims, we are not persuaded that the Examiner has
performed the proper analysis or established upon the evidence of record a
prima facie case that the claims do not constitute patentable subject matter
Issue 2
Appellants argue dependent claim 62 separately. App. Br. 6. Claim
62 recites: "The polypeptide composition of claim 1, wherein the solid
support is a microtiter well, nitrocellulose sheet, immunoblot membrane or
column matrix." Id. at 10. Appellants argue the Examiner erred in finding
this claim is directed to ineligible subject matter. Id. at 6.
Analysis
Appellants dispute the Examiner's finding that a column matrix could
be naturally occurring charcoal. App. Br. 7. Appellants assert that the
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Examiner provides no evidence that "naturally occurring charcoal" is an
acceptable solid support for antibody-antigen columns. Id. But, Appellants
argue, even if it had been shown that some relevant column matrices include
naturally occurring charcoal, the issue is whether the peptide bound to a
"column matrix" that happens to be made of charcoal occurs in nature. Id.
Appellants contend that the Examiner has adduced no evidence that such
occurs. Id.
The Examiner responds that both charcoal and sand are accepted in
the art as solid support judicial exceptions to which proteins become
naturally adsorbed. Ans. 11. The Examiner finds a microtiter well, as
recited in claim 62, is nothing more than a containment vessel which does
not add significantly more. Id. at 12. The Examiner points out that the
combination of natural products or judicial exceptions does not make the
resulting composition patent eligible. Id. (citing Funk Brothers Seed Co. v.
Katoinoculant Co., 333 U.S. 127, 131 (1948).
We do not agree with the Examiner's findings and reasoning of
record. Claim 62 requires that the solid support is a microtiter well,
nitrocellulose sheet, immunoblot membrane, or column matrix. Even
assuming, arguendo, that these devices contain naturally-occurring sand or
charcoal, that does not make a device such as a well, sheet, or membrane
containing or incorporating them a phenomenon of nature. See, e.g.,
Diamond v. Diehr, 450 U.S. 175, 187-88 (1981) (inclusion ofpatent-
ineligible subject matter in an otherwise patent-eligible invention does not
render the invention patent ineligible). We consequently reverse the
Examiner's rejection of claim 62.
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DECISION
The Examiner's rejection of claims 1-10, 35, 45, 61, and 62 as
unpatentable under 35 U.S.C. § 101 is reversed.
REVERSED
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