Ex Parte Jung et al

Patent Trial and Appeal Board

Oct 15, 2014

11362545 (P.T.A.B. Oct. 15, 2014)

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.
11/362,545 02/24/2006 Edward K.Y. Jung SE1-1037-US 4274
80118 7590 10/15/2014
Constellation Law Group, PLLC
P.O. Box 580
Tracyton, WA 98393
EXAMINER
CLOW, LORI A
ART UNIT PAPER NUMBER
1631
MAIL DATE DELIVERY MODE
10/15/2014 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte EDWARD K. Y. JUNG, ROYCE A. LEVIEN,
ROBERT W. LORD, MARK A. MALMUD,
JOHN D. RINALDO, JR. and LOWELL L. WOOD, JR.1
__________

Appeal 2012-004532
Application 11/362,545
Technology Center 1600
__________

Before DONALD E. ADAMS, ERIC B. GRIMES, and LORA M. GREEN,
Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a system
and method for providing a treatment option based on a treatment parameter.
The claims have been rejected for obviousness and obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm the rejection for obviousness and reverse the rejection for
obviousness-type double patenting.

1 According to Appellants, the Real Party in Interest is Searete LLC, which
is wholly owned by Intellectual Ventures Management, LLC (App. Br. 4).
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STATEMENT OF THE CASE
The Specification describes a “treatment system 102 [that] may be
used to diagnose or treat patients by storing and/or providing information as
to whether or how treatment agent(s) may be applied to a specific region(s)
of interest of the human body” (Spec. 7, ¶ 29). The Specification states that
“the user interface 132 may be used to receive a request for a treatment
option. . . . A query parameter, such as a Boolean operator and/or an
operand, may be associated with the request.” (Id. at 38, ¶ 123.)
“[T]he query parameter may specify a desired efficacy of the
treatment agent on a direct end target (e.g., on ‘cancer cells in lung,’ . . .),
and/or a risk, side effect, or consequence of the treatment agent on the at
least one direct end target” (id. at 38, ¶ 124). The Specification states that
“it should be generally understood that such query parameter(s) may include
virtually any diagnostic, symptomatic, screening, preventative, and/or
research parameter(s) that may be correlated . . . with the treatment
parameter(s)” (id. at 38, ¶ 125).
The Specification discloses that a “target-related tissue ancestry
correlated binding site” can be, for example, a protein that is differentially
expressed on diseased cells but not on non-diseased cells, and a “target-
related tissue ancestry correlated binding agent” can be, for example, a
monoclonal antibody that binds such a protein (id. at 25, ¶¶ 89, 90).
Claims 41 and 44 are on appeal. Claim 41 reads as follows:
41. A system comprising:
a computing device; and
instructions that when executed on the computing device cause the
computing device to
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(a) receive a request for a treatment option, the request associated with
at least one symptomatic query parameter, the symptomatic query parameter
including at least one consequence of treatment on an end target,
(b) determine at least one treatment parameter, based on the request,
the at least one treatment parameter including at least one target-related
tissue ancestry-correlated binding site and/or at least one target-related tissue
ancestry-correlated binding agent, and
(c) provide the treatment option, based on the at least one treatment
parameter and the at least one symptomatic query parameter.

Claim 44 is also independent and is directed to a method comprising
carrying out the same steps as recited in parts (a), (b), and (c) of claim 41
using a microprocessor.
Claims 41 and 44 stand rejected under 35 U.S.C. § 103(a) for
obviousness based on Oh2 and Arnaud3 (Ans. 8) and, provisionally, for
obviousness-type double patenting based on claim 1 of application
11/586,349 (id. at 6).
I.
Issue
The Examiner has rejected claims 41 and 44 as obvious based on Oh
and Arnaud. The Examiner finds that Oh teaches treatment parameters
including target-related tissue ancestry-correlated binding sites and agents
(Ans. 9). The Examiner also finds that Oh teaches targeting tissue-specific
proteins that can act as end targets for targeting a specific organ or tumor,

2 Oh et al., Subtractive proteomic mapping of the endothelial surface in lung
and solid tumours for tissue-specific therapy, 429 NATURE 629-635 (2004).
3 Arnaud et al., US 2002/0186818 A1, patented Dec. 12, 2002.
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“thus teaching a consequence of a treatment parameter (treatment of the
target)” (id.), as well as using databases and therefore microprocessing (id.).
The Examiner finds that Oh does not teach a computer system for
receiving request information but Arnaud teaches a system for building a
medical database that can be used for treatment information (id.). The
Examiner concludes that it would have been obvious to automate the
methods of Oh “to further optimize defining associations amongst tissue-
ancestry correlated binding sites and agents for the purpose of targeted
cancer therapies . . . because the systems of Arnaud et al. are specifically for
medical diagnostics and treatment” (id. at 10).
Appellants’ main contention is that the Examiner has not made out a
prima facie case of obviousness with respect to claim 41 because the cited
references do not recite the text of the claim and the Examiner has not
provided objectively verifiable evidence to show that the references teach or
suggest the limitations of the claim (see, e.g., App. Br. 13–27). Appellants
also contend that combining the references as proposed by the Examiner
would change Oh’s principle of operation (id. at 31–32) and would render
the technologies of Oh and/or Arnaud unsatisfactory for their intended
purposes (id. at 34-36).
The issue presented is whether the Examiner has provided evidence
and reasoning sufficient to show prima facie obviousness.
Findings of Fact
1. The Specification states that the “rows of the table of FIG. 5 (e.g.,
rows 502, 504, and 506, respectively) refer to examples that may be found in
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Oh” (Spec. 23, ¶ 83, citing the same Oh reference relied on by the
Examiner).
2. The Specification’s Figure 5 shows that Oh’s examples include
descriptions of direct end targets, target-related tissue ancestry-correlated
binding sites, target-related tissue ancestry-correlated binding agents, a
treatment agent delivery mechanism relative to a target-related tissue
ancestry-correlated binding agent, and a treatment agent. (Spec. Fig. 5,
Rows 502 and 506.)
3. The Specification states that “[t]he Oh reference identified specific
proteins that were found to be expressed at an endothelial surface by
specifying two regions of interest (e.g., a ‘lung region’ and a ‘non-lung
region’), and then determining proteins within the two regions. Then, by
subtracting the two sets of proteins from one another, non-common proteins
were identified.” (Id. at 23–24, ¶ 84.)
4. The Specification states that “[i]n this way, uniquely occurring
proteins at a specific endothelial site (e.g., the target-related tissue ancestry-
correlated binding site 314 at a specific direct intermediate target 310) were
identified. Then, these uniquely-occurring proteins were used as targets for
generated antibodies.” (Id. at 24, ¶ 85.)
5. The Specification states that, “[a]s a result, . . . it was determined
to be possible to target tumor-induced endothelial cell proteins (i.e., target-
related tissue ancestry-correlated binding sites 314) for delivery thereto of
drugs, imaging agents, and/or radiation agents (e.g., treatment agents 320)
that were attached to appropriate antibodies (target-related tissue ancestry-
correlated binding agents 316)” (id.).
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6. The Specification states that “row 502 [in Figure 5] illustrates an
example in which the direct end target 306 includes a treatment parameter of
‘lung tissue’” (id. at 24, ¶ 86).
7. The Specification states that
[t]he target-related tissue ancestry-correlated binding site 314 in
this example includes aminopeptidase-P (APP), which is a
protein that was detected substantially only in endothelial
plasma membranes from the lung tissue (e.g., direct end target
306). . . . I125-labeled monoclonal antibodies were used as the
target-related tissue ancestry-correlated binding agent 316, and
were intravenously injected into test rats. Subsequent imaging
of the lungs illustrated rapid and specific targeting of APP
antibody to the lung (i.e., direct end target 306), with
significantly reduced accumulation of the injected dose at non-
lung tissue.
(Id. at 24, ¶ 87.)
8. The Specification states that “row 506 [of Figure 5] illustrates
another example from the Oh reference. In the row 506, the direct end target
306 is illustrated as ‘diseased lung tissue’” (id. at 25, ¶ 89).
9. The Specification states that, in row 506, “the target-related tissue
ancestry-correlated binding site 314 is illustrated as fifteen differentially-
expressed proteins . . . associated with the direct intermediate target 310,
e.g., the endothelial tissue proximate to the diseased lung tissue” (id. at 25,
¶ 90).
10. The Specification states that, in row 506, “the target-related tissue
ancestry-correlated binding agent 316 is selected and illustrated as I-labeled
monoclonal APP [sic] antibodies that may be generated for one or more of
the fifteen differentially-expressed proteins” (id.).
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11. Oh discloses that “[t]he tissue microenvironment surrounding
blood vessels seems to control the endothelial cell phenotype in vivo. . . .
Indirect evidence of endothelial cell molecular heterogeneity comes from the
reported ability of certain cells and peptide sequences to home to specific
tissues after intravenous injection.” (Oh 629, bridging paragraph.)
12. Oh discloses an “approach to identifying a small subset of
proteins induced at the tissue–blood interface that are inherently accessible
to antibodies injected intravenously” (id. at 629, abstract).
13. Oh discloses that “two of these proteins, aminopeptidase-P and
annexin A1, [are] selective in vivo targets for antibodies in lungs and solid
tumours, respectively. Radio-immunotherapy to annexin A1 destroys
tumours and increases animal survival.” (Id.)
14. Oh discloses that “[t]wo proteins, aminopeptidase P (APP) and
OX-45, were detected only in endothelial plasma membranes from lung. . . .
Thus subtractive proteomic analysis provided a subset of endothelial cell
proteins not expressed in vitro and differentially expressed in vivo.” (Id. at
631, bridging paragraph.)
15. Oh discloses that intravenous injection of 125I-labelled monoclonal
anti-APP antibodies rapidly and specifically targeted lung tissue (id. at 631,
right col.).
16. Oh states that “[w]e expect that site-directed vascular and
caveolar targeting will benefit both drug and gene delivery in the treatment
of many diseases” (id. at 634, right col.).
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17. Oh discloses “the creation of a database of vascular endothelial
cell surface proteins containing accessible proteins apparently modulated by
the tissue” (id. at 634, left col.).
18. Arnaud discloses a “system for collecting, processing, and storing
medical data derived from medical images, or other diagnostic information”
(Arnaud 1, ¶ 3).
19. Arnaud discloses that “[t]he practice of [its] invention employs,
unless otherwise indicated, conventional methods of database storage and
manipulation, within the skill of the art. Such techniques are explained fully
in the literature.” (Id. at 2, ¶ 23.)
20. Arnaud’s system includes a computing device (id. at 11, ¶¶ 178-
183) and instructions that allow the database to receive queries and extract
the relevant information (id. at 12, ¶ 187; 15, ¶ 220).
21. Arnaud discloses formulating a database by collecting data points
and associating them with data point attributes (id. at 12-13, ¶ 192).
Principles of Law
[T]he PTO carries its procedural burden of establishing a prima
facie case when its rejection satisfies 35 U.S.C. § 132, in
“notify[ing] the applicant ... [by] stating the reasons for [its]
rejection, or objection or requirement, together with such
information and references as may be useful in judging of the
propriety of continuing the prosecution of [the] application.”
In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (quoting 35 U.S.C. § 132,
alterations by the Jung court).
“[A]ll that is required of the office to meet its prima facie burden of
production is to set forth the statutory basis of the rejection and the reference
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or references relied upon in a sufficiently articulate and informative manner
as to meet the notice requirement of § 132.” Id. at 1363.
“If a person of ordinary skill can implement a predictable variation [of
a known work], § 103 likely bars its patentability.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 417 (2007).
“[T]he analysis need not seek out precise teachings directed to the
specific subject matter of the challenged claim, for a court can take account
of the inferences and creative steps that a person of ordinary skill in the art
would employ.” Id. at 418.
Analysis
Claim 41 is directed to a system comprising a computing device and
instructions that cause it to receive a request for a treatment option, where
the request is associated with a consequence of treatment on an end target;
e.g., causing tumor cells to die. Claim 41 also requires instructions that
cause the device to determine either a target-related tissue ancestry-
correlated binding site (e.g., a tumor antigen) or a target-related tissue
ancestry-correlated binding agent (e.g., a monoclonal antibody that binds to
a tumor antigen) based on the request, and to provide a treatment option
based on the initial query and the determined parameter.
The Examiner found that Oh discloses databases that include target-
related tissue ancestry-correlated binding sites and agents (i.e., tissue-
specific proteins such as APP and OX-45 and monoclonal antibodies that
bind to them), as well as using them “for targeting single organs or solid
tumors, thus teaching a consequence of a treatment parameter (treatment of
the target)” (Ans. 9). The Examiner found that Arnaud discloses a system
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for building a medical database that can be used for treatment information
(id.), and concludes that it would have been obvious to automate the
methods of Oh using the system taught by Arnaud for the purpose of
targeted cancer therapies because Arnaud’s systems are for medical
diagnosis and treatment (id. at 10).
We agree with the Examiner’s fact-finding and conclusion. Oh
discloses tissue-specific proteins (e.g., APP; FF 14) and tumor-specific
proteins (e.g., annexin-A1; FF 13), and a database containing such proteins
(FF 17). Oh also discloses radiolabeled antibodies that specifically target
these proteins (FFs 13, 15) and states that it expects that such targeting “will
benefit both drug and gene delivery in the treatment of many diseases”
(FF 16). Arnaud discloses a system for building a medical database by
collecting data points and associating them with data point attributes (FF
21). Arnaud discloses that its system includes instructions that allow the
database to receive queries and extract information relevant to the queries
(FF 20).
We agree with the Examiner that, based on these teachings, it would
have been obvious to modify Oh’s system to include instructions that direct
a computing device to receive a request for a treatment option, the request
including a consequence of treatment on an end target (e.g., causing the
death of lung tumor cells); to determine based on the request a target-related
tissue ancestry-correlated binding site or a target-related tissue ancestry-
correlated binding agent (e.g., a tumor antigen expressed by the specified
tumor, or a monoclonal antibody that binds to it); and to provide the
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determined treatment option (e.g., treatment with a radiolabeled antibody
that binds to a relevant tumor antigen).
Appellants argue that “the PTO has overlooked several express
recitations of Independent Claim 41” and the Examiner “has not provided
any objectively verifiable evidence” to show that the references teach what
is recited in claim 41 (App. Br. 12). Appellants conclude that “the PTO-
identified portions of Oh do not recite the text of . . . Independent Claim 41”
(id. at 17). According to Appellants, “insofar as that Oh does not recite the
text of . . . Independent Claim 41, . . . the PTO-cited technical material does
not a establish a prima facie case of the unpatentability of Independent
Claim 41” (id. at 18). Appellants make a similar argument with respect to
Arnaud (id. at 20-26).
These arguments are unpersuasive. “[A]ll that is required of the office
to meet its prima facie burden of production is to set forth the statutory basis
of the rejection and the reference or references relied upon in a sufficiently
articulate and informative manner as to meet the notice requirement of
§ 132.” In re Jung, 637 F.3d 1356, 1363 (Fed. Cir. 2011). Section 132, in
turn, requires notice to the applicant sufficient to inform him of the reasons
for rejection, “together with such information and references as may be
useful in judging of the propriety of continuing the prosecution of his
application.” 35 U.S.C. § 132.
Here, the Examiner notified Appellants that the claims were being
rejected as unpatentable under 35 U.S.C. § 103(a) (Ans. 8-10) and cited
specific passages in Oh and Arnaud, by page and column or paragraph, that
were the basis for the conclusion of obviousness (id. at 8-9, 12, 14). The
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Examiner’s rejection satisfies the notice requirement of § 132, and therefore
meets the burden of establishing a prima facie case of unpatentability. Cf.
Jung, 637 F.3d at 1363 (“[T]he examiner’s discussion of the theory of
invalidity . . . , the prior art basis for the rejection . . . , and the identification
of where each limitation of the rejected claims is shown in the prior art
reference by specific column and line number was more than sufficient to
meet this burden.”).
Appellants also argue that “the USPTO has attempted to support the
present rejection based on a ‘mere conclusory statement[ ]’” (App. Br. 29,
quoting KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)).
This argument is unpersuasive because the Examiner provided a
reasoned basis for the conclusion of obviousness (Ans. 10: “[T]o further
optimize defining associations amongst tissue-ancestry correlated binding
sites and agents for the purpose of targeted cancer therapies.”). The
Examiner’s conclusion is supported by the evidence (see FF 16).
Appellants also argue that combining Oh and Arnaud as proposed by
the Examiner would change Oh’s principle of operation (App. Br. 29-32)
and would render the technologies of Arnaud unsatisfactory for their
intended purposes (id. at 33-36).
These arguments are also unpersuasive. Appellants have not
persuasively shown that combining Oh’s database with Arnaud’s program
for building a database would change Oh’s principle of operation or render
Arnaud’s medical database unsatisfactory for its intended purpose. The fact
that the database would not contain medical images, as intended by Arnaud,
is immaterial to the basis of the rejection.
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Finally, Appellants argue that “[w]hether or not the Patent Office has
carried its burden in establishing a prima facie case of unpatentability is a
question of law, not fact” (Reply Br. 7). Appellants argue that “[s]ince the
resolution of this question controls whether or not Appellant must produce
evidence in rebuttal of the prima facie case, Appellant asserts that it would
be premature/improper for the Board to decide this appeal on the issue of the
Patent Office fact finding” (id. at 7–8). Appellants request that, for those
claims where we conclude that the Examiner has made out a prima facie
case, “the Board should remand with instructions to the Patent Office to
reopen prosecution for the purpose of receiving evidence/argument in
rebuttal of the prima facie case” (id. at 8).
The Court of Appeals for the Federal Circuit has specifically rejected
this argument. See In re Jung, 637 F.3d at 1363:
Jung, without any basis, would have this court impose
additional prima facie procedural requirements and give
applicants the right first to procedurally challenge and appeal
the prima facie procedural showing before having to
substantively respond to the merits of the rejection. Such a
process is both manifestly inefficient and entirely unnecessary.
Appellants have had the opportunity to provide “evidence/argument in
rebuttal of the prima facie case” (Reply Br. 8) throughout the prosecution of
this application. That they have chosen not to do so reflects their choice of
prosecution strategy and does not merit a remand of this application to the
Examiner.
Conclusion of Law
The Examiner has provided evidence and reasoning sufficient to show
that claim 41 would have been prima facie obvious based on Oh and
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Arnaud. Appellants have not provided persuasive evidence or reasoning to
support a contrary conclusion. We therefore affirm the rejection of claim
41. Claim 44 has not been argued separately and therefore falls with claim
41. 37 C.F.R. § 41.37(c)(1)(vii).
II.
The Examiner has rejected claims 41 and 44 for obviousness-type
double patenting based on claim 1 of application 11/586,349 (Ans. 6). The
Examiner concludes that the claims on appeal are not patentably distinct
because claim 1 of the ’349 application is “drawn to a system with a ‘means
for’ receiving a request for a treatment option associated with at least one
query parameter. The ‘means for’ performing the method and the device
with instructions for performing the method of said claims are obvious over
one another, as the ‘means for’ could be the device, as claimed” in instant
claim 41 (id.).
Appellants contend that that the double patenting rejection is “based
on improper conclusory statements that are not apparently grounded in
objective evidence of obviousness” (Appeal Br. 10).
We agree with Appellants that the Examiner has not shown that the
claims 41 and 44 on appeal are obvious variants of the invention defined by
claim 1 of the ’349 application, which reads as follows:
1. A system comprising:
means for receiving a request for a treatment option, the request
associated with at least one symptomatic query
parameter, the symptomatic query parameter including at
least one consequence of treatment on an end target;
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means for determining at least one treatment parameter, based
on the request,
the at least one treatment parameter including at least one
target-related tissue ancestry-correlated binding site
and/or at least one target-related tissue ancestry-
correlated binding agent; and
means for providing the treatment option, based on the at least
one treatment parameter and the at least one symptomatic
query parameter.
(’349 application, Amdt. filed March 22, 2011, page 2.)
Claim 1 of the ’349 application is in means-plus-function format.
“Use of the term ‘means’ in a claim limitation creates a presumption that
section 112, paragraph 6 has been invoked, but that presumption may be
rebutted if the properly construed claim limitation itself recites sufficiently
definite structure to perform the claimed function.” Kemco Sales, Inc. v.
Control Papers Co. Inc., 208 F.3d 1352, 1361 (Fed. Cir. 2000). Here, claim
1 of the ’349 application uses the term “means” and recites no structures to
perform the claimed functions. We therefore conclude that the claim
invokes 35 U.S.C. § 112, sixth paragraph.
“Section 112, paragraph 6 provides that a patentee [or applicant] may
define the structure for performing a particular function generically through
the use of a means expression, provided that it discloses specific structure(s)
corresponding to that means in the patent specification.” Kemco Sales, 208
F.3d at 1360. “[S]tructure disclosed in the specification is ‘corresponding’
structure only if the specification or prosecution history clearly links or
associates that structure to the function recited in the claim. This duty to
link or associate structure to function is the quid pro quo for the convenience
of employing § 112, ¶ 6.” B. Braun Medical, Inc. v. Abbott Labs., 124 F.3d
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1419, 1424 (Fed. Cir. 1997). “A computer-implemented means-plus-
function term is limited to the corresponding structure disclosed in the
specification and equivalents thereof, and the corresponding structure is the
algorithm.” Harris Corp. v. Ericsson Inc., 417 F.3d 1241, 1253 (Fed. Cir.
2005).
Here, the Examiner has not identified what structure is disclosed in
the written description of the ’349 application as corresponding to each of
the means that are recited in claim 1 of that application. The Examiner
reasons instead that instant claim 41 is “drawn to a system with a computing
device and instructions. . . . The ‘means for’ performing the method and the
device with instructions for performing the method of said claims are
obvious over one another, as the ‘means for’ could be the device, as
claimed.” (Ans. 6.)
The Examiner, however, has not pointed to any disclosure in the
written description of the ’349 application that would support interpreting
the means-plus-function limitations of its claim 1 as having the structure of
the system defined by claim 41 on appeal. Because the Examiner’s rejection
does not address the scope of claim 1 of the ’349 application when its
means-plus-function language is considered in light of that application’s
written description, the Examiner has not persuasively shown that the claims
on appeal are obvious variants of claim 1 of the ’349 application.
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SUMMARY
We affirm the rejection of claims 41 and 44 under 35 U.S.C. § 103(a)
based on Oh and Arnaud.
We reverse the provisional rejection of claims 41 and 44 for
obviousness-type double patenting based on claim 1 of application
11/586,349.
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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