Ex Parte Jung et al

Patent Trial and Appeal Board

Jul 29, 2014

11241868 (P.T.A.B. Jul. 29, 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.
11/241,868 09/30/2005 Edward K.Y. Jung SE1-0970-US 2412
80118 7590 07/30/2014
Constellation Law Group, PLLC
P.O. Box 580
Tracyton, WA 98393
EXAMINER
CLOW, LORI A
ART UNIT PAPER NUMBER
1631
MAIL DATE DELIVERY MODE
07/30/2014 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, ROBERT W. LORD, and
LOWELL L. WOOD, JR. 1
__________

Appeal 2012-003664
Application 11/241,868
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 relating to
methods for associating treatment parameters with treatment characteristics,
which have been rejected as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.

1 According to Appellants, the real party in interest is Searete LLC, which is
wholly owned by Intellectual Ventures Management, LLC (App. Br. 5).
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STATEMENT OF THE CASE
The Specification states that “[c]ertain properties of the endothelial
layer . . . may enable the targeted delivery of one or more treatment agents to
a vicinity of the diseased tissue” (Spec. 9, ¶ 40).
For example, the diseased tissue 114 may include a
tumor that has grown over a period of time. During that period
of time, a corresponding growth or development of a site on the
endothelial layer 118 may reflect, or otherwise be correlated
with and/or affected by, the growth of the diseased tissue
(tumor) 114. This correlation between the history or ancestry
of the site on the endothelial layer 118 in the vicinity of the
diseased tissue 114 may result in unique, or almost unique,
properties of the tissue ancestry-correlated site, such as, for
example, a display of specific and identifiable proteins.
(Id. at 9, ¶ 41.) “[S]uch tissue ancestry-correlated sites may be used to direct
treatment agents” (id. at 9, ¶ 42).
The Specification’s Figure 5 shows an example of treatment data,
including “Treatment Parameter Direct End Target” and “Target-Related
Tissue Ancestry-Correlated Binding Site” (Spec. 23, ¶ 86, Fig. 5). The
Figure shows, for example, that the direct end target “Diseased Lung Tissue”
is associated with the target-related tissue ancestry-correlated binding site of
“15 differentially expressed proteins associated with Endothelial Tissue” (id.
at Fig. 5, row 506). The Specification states that this row in Figure 5
“refer[s] to examples that may be found in Oh, P. et al., ‘Subtractive
Proteomic Mapping of the Endothelial Surface in Lung and Solid Tumours
for Tissue-Specific Therapy,’ Nature, vol. 429, pp. 629-635 (June 10, 2004)”
(id. at 23, ¶ 87).
Claims 1-39, 43, 46, 49, 50, and 62 are on appeal. Claim 1 is
illustrative and reads as follows:
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1. A method comprising:
defining an association between at least two instances of at least one
treatment parameter and at least one instance of at least one treatment
characteristic,
the at least one treatment parameter including at least one target-
related tissue ancestry-correlated binding agent, at least one
direct end target, at least one discriminated end target, at least
one direct intermediate target, at least one discriminated
intermediate target, at least one treatment agent delivery
mechanism relative to the at least one target-related tissue
ancestry-correlated binding agent, at least one treatment agent,
or at least one treatment agent precursor, and
the at least one treatment characteristic including at least one target-
related tissue ancestry-correlated binding site; and
assigning the association to at least one memory for providing a clinician
with treatment information and allowing the update of existing
treatment data, wherein each step is performed using a suitable
microprocessor.

DISCUSSION
Issue
The Examiner has rejected claims 1-5, 7-29, 31-39, 43, 46, 49, 50, and
62 under 35 U.S.C. § 103(a) as obvious based on Oh2 and Arnaud3 (Ans. 5).
The Examiner has rejected claims 1, 6, and 30 under 35 U.S.C. § 103(a) as
obvious based on Oh, Arnaud, and Hood4 (Ans. 20-21). Because Appellants
rely on the same arguments with respect to both rejections (App. Br. 25), we
will consider them together.

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.
4 Hood et al., Tumor Regression by Targeted Gene Delivery to the
Neovasculature, 296 SCIENCE 2404-2407 (2002).
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The Examiner finds that Oh teaches “defining an association between
at least two instances of a treatment parameter and at least one instance of a
treatment characteristic and assigning the association to a memory” (Ans. 6).
More specifically, the Examiner finds that Oh teaches “target related tissue
ancestry binding sites which are aminopeptidase P (APP) and OX-45
associated binding sites for endothelial tissue (Figure 2, page 630; page 631,
column 1)” (id.), as well as “target related binding agents, such as APP and
OX-45 monoclonal antibodies (page 631, column 2)” (id.) and “the use of
relational database management systems . . . thus teaching assigning the
associations to memory” (id.).
Regarding independent claims other than claim 1, the Examiner finds
that Oh does not teach a computer program product or a system to
implement the steps recited in claim 1 but Arnaud teaches “a program and
system for building a medical database which uses data tags (also known as
attributes) and metadata which are various characteristics of the particular
datapoints” (id. at 20). The Examiner concludes that it would have been
obvious “to have completely automated the methods of Oh et al. by using
the formats as taught by Arnaud et al. to further optimize defining
associations amongst tissue-ancestry correlated binding sites and agents for
the purpose of targeted cancer therapies” (id.).
Appellants’ main contention is that the Examiner has not made out a
prima facie case of obviousness with respect to claim 1 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. 61, 68-69).
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Appellants also contend that combining the references as proposed by the
Examiner would change Oh’s principle of operation (id. at 74-75) and would
render the technologies of Oh and/or Arnaud unsatisfactory for their
intended purposes (id. at 79-80).
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 first and second [sic] rows of the
table of FIG. 5 (i.e., rows 502, 504, and 506, respectively) refer to examples
that may be found in Oh” (Spec. 23, ¶ 87, 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, discriminated end targets, direct
intermediate targets, discriminated intermediate 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, ¶ 88.)
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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 23, ¶ 89.)
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 (i.e., treatment agents 320)
that were attached to appropriate antibodies (target-related tissue ancestry-
correlated binding agents 316)” (id. at 23-24, ¶ 89).
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.’ In this example, the discriminated end target 308 includes
‘non-lung tissue.’” (Id. at 24, ¶ 90.)
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). . . . I-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 (i.e., the discriminated end target 308).
(Id. at 24, ¶ 91.)
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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,’ while the discriminated end target
308 is illustrated as ‘non-diseased lung tissue.’” (Id. at 25, ¶ 93.)
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, i.e.,
the endothelial tissue proximate to the diseased lung tissue” (id. at 25, ¶ 94).
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.).
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.)
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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.).
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.).
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
or references relied upon in a sufficiently articulate and informative manner
as to meet the notice requirement of § 132.” Id. at 1363.
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“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
Oh discloses target-related tissue ancestry-correlated binding sites
(FFs 1, 2, 14). The disclosed binding sites include aminopeptidase P (APP)
in lung endothelial plasma membranes (FF 14). Oh also discloses each of
the “treatment parameters” recited in claim 1 except for a treatment agent
precursor (FFs 1, 2, 14, 15). The disclosed treatment parameters include
target-related tissue ancestry-correlated binding agents such as monoclonal
anti-APP antibodies (FF 15) and the treatment agent 125I (FF 15).
Oh discloses associations between, at least, a target-related tissue
ancestry-correlated binding site (APP) and (a) a direct end target (lung
tissues; FFs 7, 14), (b) a target-related tissue ancestry-correlated binding
agent (monoclonal antibodies; FFs 7, 15), (c) a treatment agent (125I; FFs 7,
15), and a discriminated end target (non-lung tissue; FFs 7, 15). For
example, Oh discloses that 125I-labeled monoclonal anti-APP antibodies
specifically targeted lung tissue (FF 15), indicating an association between
the binding site (APP) and (a) a binding agent (anti-APP antibodies), (b) a
direct end target (lung tissue), and (c) a treatment agent (125I).
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Oh also discloses “a database of vascular endothelial cell surface
proteins containing accessible proteins apparently modulated by the tissue”
(FF 27), and therefore at a minimum suggests assigning the above
associations to memory using a microprocessor, in order to generate a list of
agents and their specific targets for use in drug and gene delivery in the
treatment of disease (see FF 16). We conclude that Arnaud is not necessary
to support a prima facie case of obviousness with respect to claim 1 and,
indeed, the Examiner cited it only in connection with claims directed to a
computer program product or a system (see Ans. 20).
Appellants argue that the Examiner has provided “neither claim
interpretation nor a reasoned application of the cited material to the claims”
(App. Br. 49).5 Appellants argue that
[p]arenthetical indications of art placed in proximity to claim
language do not constitute a proper claim rejection since it is
impossible to know whether the examiner is alleging an
interpretation of the claim that reaches the cited art, or is
alleging some “teaching” of the cited art that reaches the claim
language, or is alleging some combination of the foregoing.
(Id. at 50.)
Appellants proceed to reproduce claim 1 (id.), the Examiner’s
rejection (id. at 51-52, 55-56), and the cited passages of Oh (id. at 57-59).

5 Appellants address all of their arguments toward showing that the
Examiner has not met the initial burden of setting out a prima facie case.
Appellants have not provided evidence or argument to rebut the prima facie
case of obviousness. Arguments that Appellants could have made but chose
not to make have been waived. See 37 C.F.R. § 41.37(c)(1)(vii) (“Any
arguments or authorities not included in the brief or a reply brief filed
pursuant to § 41.41 will be refused consideration by the Board, unless good
cause is shown.”).
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Appellants conclude that “the USPTO-identified portions of Oh do not recite
the text of . . . Independent Claim 1” (id. at 60). According to Appellants,
insofar as that Oh does not recite the text of . . . Independent
Claim 1, and insofar as that the USPTO has provided no
objectively verifiable evidence, or argument based on
objectively verifiable evidence, as to how Oh could be
modified/combined to teach . . . Independent Claim 1, . . . the
USPTO-cited technical material does not a establish a prima
facie case of the unpatentability of Independent Claim 1.
(Id. at 61.)
This argument is 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 at 1363. 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. 5) 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 6, 20). The 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
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specific column and line number was more than sufficient to meet this
burden.”).
In addition, and as the Examiner has pointed out (Ans. 23-24),
Appellants’ own Specification admits that Oh discloses many of the
limitations of claim 1 (see FFs 1-10). Thus, to the extent that evidence is
needed to show that the terms of claim 1 read on Oh’s disclosure, that
evidence is provided by Appellants’ own description of what Oh discloses.
Appellants’ current position—that they cannot determine whether Oh
discloses the limitations of claim 1 because it does not recite the same words
as claim 1—is belied by their own Specification, which shows that
Appellants fully understood, at the time this application was filed, how the
limitations of claim 1 compared to the elements described by Oh.
Appellants also argue that “the USPTO has attempted to support the
present rejection based on a ‘mere conclusory statement[ ]’” (App. Br. 72,
citing 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. 20: “[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 (cf. FFs 13, 16).
Appellants also argue that combining Oh and Arnaud as proposed by
the Examiner would change Oh’s principle of operation (App. Br. 73-76)
and “would render the technologies of Oh and/or Arnaud unsatisfactory for
their intended purposes” (id. at 77-80).
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These arguments are also unpersuasive. First, as discussed above, we
conclude that Oh’s disclosure by itself is enough to support a prima facie
case of obviousness with respect to claim 1. Second, even if Arnaud were
required to support a prima facie case, Appellants have not persuasively
shown that combining Oh’s database (FF 17) with Arnaud’s program and
system for building a database (Ans. 20) would change Oh’s principle of
operation or render it 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.
Finally, with respect to claim 1, 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
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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.
In summary, the Examiner has made a prima facie case that claim 1
would have been obvious to a person of ordinary skill in the art, and
Appellants have not provided persuasive evidence or reasoning to support a
contrary conclusion. We therefore affirm the rejection of claim 1 as obvious
based on Oh and Arnaud. See In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992):
[T]he examiner bears the initial burden, on review of the prior
art or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
With respect to claim 9,6 Appellants argue that the cited portions of
Oh do not recite the text of either claim 1 or claim 9 and therefore the
Examiner has not made out a prima facie case of obviousness (App. Br. 80-

6 Claim 9 depends from claim 1 and adds the limitation that the target-
related tissue ancestry-correlated binding agent is an antibody that is
associated with the target-related tissue ancestry-correlated binding site.
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83). With respect to claim 10,7 Appellants argue that the cited portions of
Oh do not recite the text of either claim 1 or claim 10 and therefore the
Examiner has not made out a prima facie case of obviousness (App. Br. 83-
85).
These arguments are not persuasive. The Examiner specifically
addressed the additional limitations of dependent claims 9 and 10 (Ans. 9)
and pointed to passages in Oh that describe those limitations (id., citing the
disclosure of “125I-labelled monoclonal antibodies to (APP) and OX-45 at
page 631, column 2”). As discussed above, a prima facie showing of
obviousness requires only notice sufficient to satisfy the requirements of
35 U.S.C. § 132. The Examiner made that showing and therefore made out
a prima facie case of obviousness with respect to claims 9 and 10.
Conclusion of Law
The Examiner has provided evidence and reasoning sufficient to show
prima facie obviousness.
SUMMARY
We affirm the rejection of claims 1, 9, and 10 under 35 U.S.C.
§ 103(a) based on Oh and Arnaud. We affirm the rejection of claims 1, 6,
and 30 under 35 U.S.C. § 103(a) based on Oh, Arnaud, and Hood. Claims
2-5, 7, 8, 11-29, 31-39, 43, 46, 49, 50, and 62 were not argued separately
and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).

7 Claim 10 depends from claim 1 and adds the limitation that the target-
related tissue ancestry-correlated binding agent is a monoclonal antibody
that is associated with the target-related tissue ancestry-correlated binding
site.
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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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