Ex Parte Jung et al

Patent Trial and Appeal Board

Jul 31, 2014

11222031 (P.T.A.B. Jul. 31, 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.
11/222,031 09/08/2005 Edward K.Y. Jung SE1-0968-US 4332
80118 7590 08/01/2014
Constellation Law Group, PLLC
P.O. Box 580
Tracyton, WA 98393
EXAMINER
CLOW, LORI A
ART UNIT PAPER NUMBER
1631
MAIL DATE DELIVERY MODE
08/01/2014 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 2012-004226
Application 11/222,031
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 for anticipation, obviousness, and obviousness-
type double patenting. 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 endothelium
layer . . . may enable the targeted delivery of one or more treatment agents to
a vicinity of the diseased tissue” (Spec. 8, ¶ 40). In tissue that includes a
tumor that has grown over time, for example,
a corresponding growth or development of a site on the
endothelium 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 endothelium 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 8, ¶ 41.) “[S]uch tissue ancestry-correlated sites may be used to direct
treatment agents” (id. at 8, ¶ 42).
The Specification’s Figure 5 shows an example of treatment data
(Spec. 21, ¶ 85), including “Treatment Parameter Direct End Target” and
“Target-Related Tissue Ancestry-Correlated Binding Site” (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 21–22, ¶ 86).
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Claims 1–4, 6–10, 12, 13, 15–17, 20, 21, 24–27, 29, 30, 32, 35–39,
43, 46, 49–52, 54, and 57–61 are on appeal. Claim 1 is illustrative and reads
as follows:
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 site, and
the at least one treatment characteristic 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
assigning the association to at least one memory including a relational
database,
wherein each step is performed on a suitable microprocessor.

The claims stand rejected as follows:
Claims 1–4, 7–10, 12, 13, 15–17, 20, 21, 24–27, 29, 32, 35–37, 49–
52, 54, 57, 58, 60, and 61 under 35 U.S.C. § 102(b) as anticipated by Oh2
(Ans. 5);
Claims 6, 30, and 59 under 35 U.S.C. § 103(a) as obvious based on
Oh and Hood3 (Ans. 21);

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 Hood et al., Tumor Regression by Targeted Gene Delivery to the
Neovasculature, 296 SCIENCE 2404–2407 (2002).
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Claims 1, 38, 39, 43, and 46 under 35 U.S.C. § 103(a) as obvious
based on Oh and Arnaud4 (Ans. 23, 25);
Claims 1, 39, 43, 46, 49, and 50 (provisionally) for obviousness-type
double patenting based on the claims of each of the following applications:
11/586,349; 11/586,439; 11/585,784; 11/503,501; 11/516,689; 11/478,295;
11/362,545; and 11/311,906 (Ans. 29–32); and
Claims 1, 50, and 63 (provisionally) for obviousness-type double
patenting based on the claims of application 11/262,499 (Ans. 32).
I.
Issue
The Examiner has rejected claims 1–4, 7–10, 12, 13, 15–17, 20, 21,
24–27, 29, 32, 35–37, 49–52, 54, 57, 58, 60, and 61 as anticipated by Oh.
The Examiner finds that Oh anticipates claim 1 because it teaches defining
an association between a treatment parameter, including “target related
tissue ancestry binding sites which are aminopeptidase P (APP) and OX-45”
and treatment characteristics such as “target related binding agents, such as
APP and OX-45 monoclonal antibodies” (Ans. 6), as well as “the use of
relational database management systems for data organization, comparison
and information retrieval, thus teaching assigning the associations to
memory (page 634, column 2, ‘database search’ section)” (id.).
Appellants argue that “the PTO-identified portions of Oh do not recite
the text of . . . Claim 1” (App. Br. 55) and “insofar as Oh does not recite the
text of at least [the ‘defining’ step] of Appellant’s Independent Claim 1, . . .

4 Arnaud et al., US 2002/0186818 A1, published Dec. 12, 2002.
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the PTO-cited technical material does not establish a prima facie case of the
unpatentability of Independent Claim 1” (id.).
The issue presented is whether the Examiner has established prima
facie that Oh discloses all of the limitations of claim 1.
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. 21–22, ¶ 86, 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
the 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 22, ¶ 87.)
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
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identified. Then, these uniquely-occurring proteins were used as targets for
generated antibodies.” (Id. at 22, ¶ 88.)
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 22, ¶ 88).
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 22, ¶ 89.)
7. The Specification states that
the 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 23, ¶ 90.)
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 23, ¶ 92.)
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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 24, ¶ 93).
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.)
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.)
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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.).
18. Oh states: “We used relational models for database design based
on entity relationship and implemented the database in the MySQL
relational database management system (MySQL) to support database query
and management” (id. at 634, right 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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“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631
(Fed. Cir. 1987).
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 (d) 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).
Oh also discloses “a database of vascular endothelial cell surface
proteins containing accessible proteins apparently modulated by the tissue”
(FF 17), which is reasonably understood to include assigning the above
associations to memory using a microprocessor. Finally, Oh discloses
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“us[ing] relational models for database design based on entity relationship
and implement[ing] the database in the MySQL relational database
management system (MySQL) to support database query and management”
(FF 18). We agree with the Examiner’s finding that Oh discloses all of the
limitations of claim 1.
Appellants argue that Oh “fails to recite several express recitations of
Claim 1” and the Examiner has not provided evidence to show that it teaches
what is recited in the text of claim 1 (App. Br. 48).5 Appellants proceed to
reproduce a statement of rejection (id. at 49–50),6 claim 1 (id. at 50), and
several passages of Oh (id. at 54). Appellants conclude that “the PTO-
identified portions of Oh do not recite the text of . . . Independent Claim 1”
(id. at 55). According to Appellants, insofar as that “Oh does not recite the
text of . . . Independent Claim 1, . . . the PTO-cited technical material does
not establish a prima facie case of the unpatentability of Independent Claim
1” (id.).

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 anticipation. 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.”).
6 The rejection reproduced is for obviousness and allegedly derived from an
Office Action mailed Nov. 15, 2010. The rejection being disputed, however,
is for anticipation and was last set out in an Office Action mailed May 26,
2011.
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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 anticipated under 35 U.S.C. § 102(b) (Ans. 5) and cited specific
passages in Oh, by page and column, that were the basis for the rejection (id.
at 6). The Examiner’s rejection satisfies the notice requirement of § 132,
and therefore meets the burden of establishing a prima facie case of
anticipation. 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.”).
In addition, and as the Examiner has pointed out (Ans. 34),
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
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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 compare to the elements described by Oh.
Appellants also argue that the rejection is based on hindsight (App.
Br. 56, 62–63); that Arnaud also fails to recite the text of claim 1 (id. at 57–
62); that “the Examiner has attempted to support the present rejection based
on a ‘mere conclusory statement[ ]’” (id. at 65, quoting KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398 (2007)); that combining Oh and Arnaud would
change Oh’s principle of operation (App. Br. 65–69); and that combining Oh
and Arnaud “would render the technologies of Oh and/or Arnaud
unsatisfactory for their intended purposes” (id. at 69–71).
These arguments are all unpersuasive because the Examiner rejected
claim 1 as anticipated, not obvious, and the arguments summarized in the
preceding paragraph do not apply to the issue of anticipation.
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
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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.
In summary, the Examiner has made a prima facie case that claim 1 is
anticipated by Oh, and Appellants have not provided persuasive evidence or
reasoning to support a finding to the contrary. We therefore affirm the
rejection of claim 1 as anticipated by Oh.
Conclusion of Law
The Examiner has established that Oh discloses all of the limitations
of claim 1.
Claims 2–4, 7–10, 12, 13, 15–17, 20, 21, 24–27, 29, 32, 35–37, 49–
52, 54, 57, 58, 60, and 61 have not been argued separately and therefore fall
with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
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II.
The Examiner has rejected claims 6, 30, and 59 under 35 U.S.C.
§ 103(a) as obvious based on Oh and Hood (Ans. 21–23). Appellants have
waived any arguments based on Hood (App. Br. 72–73). We therefore
affirm the rejection of claims 6, 30, and 59 under 35 U.S.C. § 103(a) for the
reasons set out in the Answer.
The Examiner has rejected claims 1, 38, 39, 43, and 46 under
35 U.S.C. § 103(a) as obvious based on Oh and Arnaud (Ans. 23-28).
Appellants argue that claims 38, 39, 43, and 46 are patentable for the same
reasons that claim 1 is patentable (App. Br. 72). As discussed above,
however, we find that Oh anticipates claim 1. Because anticipation is the
epitome of obviousness, In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir.
2002), we affirm the rejection of claim 1 as obvious based on Oh and
Arnaud. Claims 38, 39, 43, and 46 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
III.
The Examiner has provisionally rejected claims 1, 39, 43, 46, 49, 50,
and 63 for obviousness-type double patenting based on several copending
applications (Ans. 29–33). The Examiner finds that the instant claims and
the claims in the other cited applications are all directed to systems or
methods for accepting a treatment parameter where the parameter includes a
tissue ancestry-correlated binding agent, and that additional limitations
specified in one or the other set of claims would have been obvious
variations to a person of ordinary skill in the art (id.).

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Appellants argue that
Each of these obviousness-type double-patenting
rejections is based on improper conclusory statements that are
not apparently grounded in objective evidence of obviousness.
The PTO has provided no objectively verifiable evidence, nor
argument based on objectively verifiable evidence, in support
of PTO assertions regarding what the copending applications
“teach.”
(App. Br. 74–75.)
This argument is not persuasive. The Examiner provided a reasoned
basis for each of the obviousness-type double patenting rejections, which are
based on a lack of patentable distinction between the inventions defined in
the claims of present application when compared to the inventions defined in
the claims of each of the cited, copending applications. Rejections for
obviousness-type double patenting are not based on what is taught in
different patents or applications, but on whether the claims in the separate
applications are merely obvious variants of each other. We affirm the
provisional rejections for obviousness-type double patenting.
SUMMARY
We affirm all of the rejections on appeal.
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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