Ex Parte Classen

Board of Patent Appeals and Interferences

Aug 23, 2010

10081705 (B.P.A.I. Aug. 23, 2010)

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.
10/081,705 02/21/2002 John Barthelow Classen 22499-68466 1273
67283 7590 08/23/2010
MONTGOMERY, MCCRACKEN, WALKER & RHOADS, LLP
123 SOUTH BROAD STREET
AVENUE OF THE ARTS
PHILADELPHIA, PA 19109
EXAMINER
LEROUX, ETIENNE PIERRE
ART UNIT PAPER NUMBER
2161
MAIL DATE DELIVERY MODE
08/23/2010 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte JOHN BARTHELOW CLASSEN
__________

Appeal 2009-004501
Application 10/081,705
Technology Center 2100
__________

Before JAMES D. THOMAS, CAROLYN D. THOMAS, and
STEPHEN C. SIU, Administrative Patent Judges.

SIU, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
This is a decision on appeal under 35 U.S.C. § 134(a) from the
Examiner’s rejection of claims 250-300. Claims 1-249 are canceled. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Invention
The invention relates to methods of screening for previously
unrecognized adverse events associated with the use of a product or device
(Spec. 3, ll. 8-9).
Independent claim 250 is illustrative:
250. A proprietary method of use for a product of
manufacture or device, wherein the use was established
according to the steps comprising:
accessing one or more data sources, wherein at least one
data source comprises adverse event data;
analyzing and comparing adverse event data associated
with a product of manufacture or device, with at least one
previously-known adverse event associated with the
product or device;
identifying at least one previously unreported essential
adverse event associated with the product or device from
the adverse event data, and then responsive to identifying
of the essential adverse event, identifying the at least one
previously unreported method of use for the product or
device;
documenting inventorship of the at least one method of
use for the product or device; and
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creating a database of proprietary essential adverse event
information, the database storing data regarding the at
least one essential adverse event,
wherein the database comprises at least one of: a patent,
patent application, patent publication, or data contained
in at least one patent, patent application or patent
publication, and
wherein the proprietary method consists of a use selected
from the group consisting of a restricted use, providing
warning(s) about the essential adverse event, providing
instruction(s) for avoiding an essential adverse event, and
any combination thereof.
References
The Examiner relies upon the following references as evidence in
support of the rejection:
Jacob US 3,885,566 May 27, 1975
Colombo US 5,678,234 Oct. 14, 1997
Rivette US 5,991,751 Nov. 23, 1999
Risen US 6,018,714 Jan. 25, 2000
Stanton US 2002/0039990 A1 Apr. 4, 2002
(filed Dec. 7, 2000)
D’Ambra US 6,458,958 B1 Oct. 1, 2002
(filed Aug. 9, 2000)
Appellant’s disclosed prior art, Spec. 7, ll. 15-26 (“ADPA”).
Rejection
Claims 250, 256, 257, 270, 272, 274-276, 281, 285, 287, and 292-298
are rejected under 35 U.S.C. § 103(a) as being unpatentable over ADPA,
Stanton, Rivette, and D’Ambra.
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Claims 251, 252, 254, 258, 2822, 286, 288, and 289 are rejected under
35 U.S.C. § 103(a) as being unpatentable over ADPA, Stanton, Rivette,
D’Ambra, and Colombo.
Claims 253, 255, 2593, 262, 263, 265, 267, 269, 271, 273, 279, and
290 are rejected under 35 U.S.C. § 103(a) as being unpatentable over
ADPA, Stanton, Rivette, D’Ambra, Colombo, and Risen.
Claims 260, 261, 264, 266, 268, 277, 278, 280, 283, 284, and 291 are
rejected under 35 U.S.C. § 103(a) as being unpatentable over ADPA,
Stanton, Rivette, D’Ambra, and Risen.
Claims 299 and 300 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over ADPA, Stanton, Rivette, D’Ambra, and Jacob.
ISSUES
Issue 1
Appellant argues that the Stanton reference “offers neither a written
description, nor a printed publication BEFORE the earliest effective filing
date of Applicant’s invention” (App. Br. 13).

2 In rejecting parent claim 252, the Examiner uses Colombo (Ans. 8); but,
Colombo is not listed as part of the claim 282 rejection (Ans. 3-4). We
discovered similar oversights in the Examiner’s rejections of claims 259,
260-269, 271, 273, 277-280, 283, 284, 286, 288-291, 299, and 300.
Appellant does not make any arguments based on these oversights. We
therefore hold these oversights harmless.
3 The Examiner further relies on the taking of official notice of facts in
rejecting claims 259-269, 277, 283, 284, and 291, as well as claims 271,
278-280, and 290 which depend therefrom.
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Issue: Did the Examiner err in using the Stanton reference in rejecting
Appellant’s claims?
Issue 2
Appellant argues that the “invention expressly excludes pharmo-
genetics/pharmacogenomics” (App. Br. 14).
The Examiner finds that “the features upon which application relies
. . . are not recited” (Ans. 13).
Issue: Did the Examiner err in finding that the claimed invention does
not recite limitations argued by Appellant?
Issue 3
Appellant argues that “Stanton makes no requirement that the
‘adverse event’ MUST be ‘new’ or ‘novel’ or ‘previously unreported’ or
unknown” (App. Br. 15).
Issue: Did the Examiner err in finding that ADPA, Stanton, Rivette,
and D’Ambra would have taught or suggested identifying at least one
previously unreported essential adverse event?
Issue 4
Appellant argues that “Rivette fails to teach or even mention creating
a ‘database of proprietary essential adverse event data’” (App. Br. 16).
Issue: Did the Examiner err in finding that ADPA, Stanton, Rivette,
and D’Ambra would have taught or suggested creating a database of
proprietary essential adverse event information, wherein the database
comprises at least one of: a patent, a patent application, or patent
publication?
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Issue 5
Appellant argues that “the combination of Stanton, Rivette, and
D’Ambra does not allow a ‘predictable use of the prior art elements
according to their established function’” (App. Br. 17).
Issue: Did the Examiner err in finding that it would have been
obvious to an artisan to combine the teachings and suggestions of ADPA,
Stanton, Rivette, and D’Ambra?
Issue 6
Appellant argues that claims 251, 252, and 254 “relate to determining
the ‘value of commercialization’” (App. Br. 18).
Issue: Did the Examiner err in finding that ADPA, Stanton, Rivette,
D’Ambra, and Colombo would have taught or suggested determining the
value of commercializing at least one use for a product of manufacture or
device?
Issue 7
Appellant argues that “the rejection of Applicant’s claims . . .
supplemented with Official Notice taken of facts unsupported by
documentary evidence[] is improper and should be reversed” (App. Br. 21).
Issue: Did the Examiner improperly take official notice of the state
of the art?
Issue 8
Appellant argues that “Jacob fails to teach printed product warning
information in conjunction with a ‘proprietary method of use” (App. Br. 22).
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Issue: Did the Examiner err in finding that ADPA, Stanton, Rivette,
D’Ambra, and Jacob would have taught or suggested a proprietary method
of use comprising providing printed product safety information in
connection with product packaging?
Issue 9
Appellant argues that “evidence in the attached sworn Declaration of
Dr. John B. Classen . . . demonstrates the ultimate evidence of
nonobvious[ness] by offering real world evidence of copying and
infringement of Applicant’s claimed invention by another, and evidence of
that third party’s commercial success using Applicant’s invention despite
expressed skepticism by experts” (App. Br. 23).
Issue: Do secondary considerations of nonobviousness demonstrate
that the Examiner erred in finding that the prior art would have taught or
suggested the claimed invention?
FINDINGS OF FACT
The following Findings of Fact (FF) are shown by a preponderance of
the evidence.
1. The Specification, under “BACKGROUND OF THE
INVENTION,” references U.S. Patent Application No.
09/804,289 (now U.S. Patent No. 6,584,472) (p. 1, ll. 14-20).
2. The Specification discloses that
a new essential adverse event can mean a newly
discovered adverse reaction such as the discovery of an
increased rate of seizures associated with a drug,
improved information such as [a] more accurate
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calculation of the rates of seizures in a group or
subgroup, or the discovery of an increased rate of
seizures in patients taking the drug along with one or
more additional drugs.
(p. 12, l. 30 – p. 13, l. 3).
3. The Specification discloses that “[t]he final determination of what
is ‘essential’ information is determined by a regulatory agency
such as the FDA [Food and Drug Administration]” (p. 23, ll. 2-3).
4. The Specification discloses under the heading “Methods of
Screening Adverse Events For Commercial Value” that “[a]ll
essential adverse event information is not of equal value. Value
depends on the potential value of making a generic product or
device into a proprietary product or device” (p. 28, ll. 3-5).
5. ADPA discloses that “[b]ecause of the large volume of data that
they contain, preferred adverse event database may include those
of insurance companies, managed care organizations,
pharmaceutical and medical device manufacturers and/or
distributors, public health departments, hospitals and the like”
(Spec. 7, ll. 15-18).
6. Stanton discloses
correlating one or more variances in one or more genes in
a plurality of patients with response [sic] to a treatment
or a method of administration of a treatment. . . . The
variances may be previously known to exist or may
also be determined in the present method or
combinations of prior information and newly
determined information may be used. . . . Such
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information is useful, for example, for . . .
demonstrating that a group of patients exists for
which the treatment or method of treatment would be
particularly beneficial or contra-indicated. Such
demonstration can be beneficial, for example, for
obtaining government regulatory approval for a new
drug or a new use of a drug.
(¶ [0053]).
7. Stanton discloses that “[a]ll relevant demographic and historical
data regarding patient drug response will be recorded in an
anonymized database” (¶ [0831]).
8. Rivette discloses “databases of patents” (abstract).
9. Colombo discloses that “[m]odified sulfur cement was developed
employing readily available and relatively inexpensive chemical
modifiers which significantly improved product durability”
(col. 3, ll. 62-65).
10. Jacob discloses that “[a] warning will soon be mandatory on the
label of such disposable diapers stating that ‘the backing
(meaning the release paper strip in the context of this
Specification) on the pull tabs should be disposed of properly to
protect against infants ingesting or choking on them’” (col. 1,
ll. 47-52).
11. The John Barthelow Classen declaration discloses that “I believe
that my interaction with Elan Pharmaceuticals, is evidence of
non-obviousness of my invention, demonstrating unexpectedness
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and superiority of outcome over the prior art, evidence of
commercial success, and evidence of copying” (p. 2).
12. The John Barthelow Classen declaration discloses that “[t]he ’102
[6,683,102] patent is, in fact, the subject of my patent
infringement suit with Elan. The Elan patents cover an adverse
event . . . that is specifically covered by my ’674 [6,219,674]
patent” (p. 3).
13. The John Barthelow Classen declaration discloses that
generic drug competitors have begun copying my
technique in the hope of forcing Elan and King to cross-
license the patents based on claims relating to the
discovered drug/food interaction. Mutual
Pharmaceutical Company, a generic manufacturer, has
received its own patent . . . resulting from an identified
drug/food interaction.
(p. 4).
14. The John Barthelow Classen declaration discloses that “[i]t was
believed at the filing date of my ’674 patent [Nov. 24, 1999] that
it was not possible to completely prevent generic drug
competition for the original formulation and original indication of
a compound after the original patents had expired” (p. 6).
PRINCIPLES OF LAW
Claim interpretation
“In the patentability context, claims are to be given their broadest
reasonable interpretations. . . . [L]imitations are not to be read into the
claims from the specification.” In re Van Geuns, 988 F.2d 1181, 1184 (Fed.
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Cir. 1993) (citations omitted). A claim meaning is reasonable if one of
ordinary skill in the art would understand the claim, read in light of the
specification, to encompass the meaning. See In re American Academy of
Science Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004). Any special
meaning assigned to a term “must be sufficiently clear in the specification
that any departure from common usage would be so understood by a person
of experience in the field of the invention.” Multiform Desiccants Inc. v.
Medzam Ltd., 133 F.3d 1473, 1477 (Fed. Cir. 1998).
Obviousness
The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, and
(3) the level of skill in the art. Graham v. John Deere Co., 383 U.S. 1, 17-18
(1966).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results,”
KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007), especially if the
combination would not be “uniquely challenging or difficult for one of
ordinary skill in the art,” Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485
F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR, 550 U.S. at 418).
Secondary considerations, in the form of objective evidence such as
commercial success, long felt but unresolved need, failure of others, and
copying must be considered when present. Custom Accessories, Inc. v.
Jeffrey-Allan Indus., Inc., 807 F.2d 955, 960 (Fed. Cir. 1986). “It can be the
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most probative evidence of nonobviousness in the record, and enables the
[one] to avert the trap of hindsight.” Id. Secondary considerations, such as
unexpected results, must be established by factual evidence; mere argument
or conclusory statements are insufficient. Cf. In re De Blauwe, 736 F.2d
699, 705 (Fed. Cir. 1984).
One cannot show nonobviousness by attacking references individually
where the rejections are based on combinations of references. In re Merck &
Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). “A reference may be said to
teach away when a person of ordinary skill, upon reading the reference,
would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the
applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994). References
may include published patent applications that were filed by another before
invention by the applicant for patent. See 35 U.S.C. §§ 102(e)(1), 103(a); cf.
In re Giacomini, 2010 WL 2674461, *1 (Fed. Cir. 2010) (a “patent has a
patent-defeating effect as of the filing date of the provisional application to
which it claims priority”).
ANALYSIS
Issue 1
Appellant challenges the Examiner’s use of the Stanton reference
based on the publication date of Stanton and filing date of Appellant’s
application. Appellant claims the benefit of U.S. Provisional Application
No. 60/270,697, filed February 22, 2001 (Spec. 1, ll. 12-13). Stanton was
filed December 7, 2000. It is irrelevant that Stanton was published after
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Appellant filed the present application. The patent-defeating effect of a
published patent application is based on the published patent application’s
filing date, not its publication date. See 35 U.S.C. §§ 102(e)(1), 103(a); cf.
Giacomini, 2010 WL 2674461 at *1.
For at least these reasons, we find no evidence persuasive of error in
the Examiner’s 35 U.S.C. § 103(a) rejection of claim 250-300 with respect
to this issue.
Issue 2
Appellant argues that the references relate to technologies that fall
outside the scope of the claimed invention. The Examiner finds that
Appellant relies on features that are not found in the claim limitations.
Based on Appellant’s arguments in the Appeal Brief, we will decide the
appeal of claims 250-300 with respect to issue 2 on the basis of claims 250
and 253. See 37 C.F.R. § 41.37(c)(1)(vii).
Appellant submits that the Examiner errs in relying on Stanton
because the Specification discloses that “the present invention is not
intended to encompass pharmacogenomic techniques for screening” (App.
Br. 13-14). However, Appellant fails to identify any claim recitation that
limits the scope of the claimed invention to non-pharmacogenomic screening
techniques. Appellant argues that “according to Applicant’s invention there
is no clinical trial required, nor does such a trial provide the necessary
warning(s)” (App. Br. 15). Similarly, Appellant submits that “Stanton
requires a gene database as a critical element of the invention, which
element [sic] is expressly excluded from Applicant’s invention” (App.
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Br. 16) (citation omitted). But Appellant fails to identify any claim
recitations that preclude a clinical trial or a gene database. Furthermore, the
claim uses the open-ended “comprising” transitional phrase. Therefore, we
find no error in the Examiner’s reliance on Stanton.
Appellant argues that “D’Ambra never teaches to discover new
adverse events [sic] how these old ‘side effects’ can be turned into
‘proprietary new uses’” (App. Br. 16). Appellant does not identify the claim
recitations that D’Ambra purportedly fails to teach. The Examiner relies on
D’Ambra as teaching “wherein the proprietary method consists of a use
selected from the group consisting of a restricted use, providing warnings
about the essential adverse event, providing instructions for avoiding an
essential adverse event and any combination thereof” (Ans. 7). These
limitations do not discuss turning new adverse events into proprietary new
uses. Appellant further argues that “D’Ambra never teaches how to patent
‘side effects’ nor that one should patent ‘side effects’” (App. Br. 16).
However, Appellant does not identify any claim recitations that require
patenting. Therefore, we find no error in the Examiner’s reliance on
D’Ambra.
Regarding the Examiner’s use of Risen to show the obviousness of
claim 253, Appellant argues that “[c]ommercialization of an adverse event
has to do more than simply placing a warning on a label [sic]. One has to
obtain specific profit for having it on the label and that value must be
generated through a sale, as opposed to use of a product” (App. Br. 19).
However, claim 253 merely recites that “the commercializing step further
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comprises generating information for incorporation into documents for
selling, leasing or licensing the identified product information.” Appellant
does not show what parts of this recitation require a specific profit or a
particular source of value. Therefore, we find no error in the Examiner’s
reliance on Risen.
Because Appellant relies on limitations that are not supported by
claim recitations, we find no evidence persuasive of error in the Examiner’s
35 U.S.C. § 103(a) rejection of claims 250 and 253, and claims 251-252 and
254-300 which fall therewith with respect to this issue.
Issue 3
Appellant argues that Stanton does not require identifying a
previously unreported adverse event. Based on Appellant’s arguments in the
Appeal Brief, we will decide the appeal of claims 250-300 with respect to
issue 3 on the basis of claim 250. See 37 C.F.R. § 41.37(c)(1)(vii).
We are unpersuaded by Appellant’s argument that “Stanton fails to
make any reference of any kind to an adverse event as being either ‘new’ or
‘essential’” (App. Br. 14). The Specification discloses that “a new essential
adverse event can mean a newly discovered adverse reaction such as the
discovery of an increased rate of seizures associated with a drug, improved
information such as [a] more accurate calculation of the rates of seizures in a
group or subgroup” (FF 2). We therefore find that a reasonably broad
interpretation, in light of the Specification, of the limitation of a previously
unreported (i.e., new) essential adverse event encompass an improved
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understanding of whether a group or subgroup faces an increased risk of an
adverse event associated with a product or device.
Stanton discloses correlating variances in patient genes with treatment
responses (FF 6). In disclosing that “[t]he variances may be previously
known to exist” (id.) (emphasis added), Stanton also discloses or suggests
that the variances may be previously unknown. Stanton teaches that this is
useful in “demonstrating that a group of patients exists for which the
treatment . . . would be . . . contra-indicated” (id.). That is, Stanton teaches
developing an improved understanding that a group exists which faces an
increased risk associated with treatment. Moreover, ADPA discloses
adverse event databases (FF 5). Therefore, ADPA and Stanton would have
taught or suggested identifying (correlating patient genes) at least one
previously unreported (having previously unknown variances) essential
adverse event (with adverse event data to demonstrate that a group exists for
which treatment would be contra-indicated).
We are also unpersuaded by Appellant’s argument that “[w]hat is
patentable in Stanton’s publication, if anything is patentable, is only the
information about the gene variance and the ‘old’ or ‘known’ or ‘previously
reported’ adverse event” (App. Br. 15). We look to the what the prior art
would have taught or suggested, not what would have been patentable in the
prior art.
For at least these reasons, we find no evidence persuasive of error in
the Examiner’s 35 U.S.C. § 103(a) rejection of claims 250, and claims 251-
300 which fall therewith with respect to this issue.
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Issue 4
Appellant argues that Rivette does not disclose the claimed database
of proprietary essential adverse event data. Based on Appellant’s arguments
in the Appeal Brief, we will decide the appeal of claims 250-300 with
respect to issue 4 on the basis of claim 250. See 37 C.F.R.
§ 41.37(c)(1)(vii).
Appellant argues that “[w]hile Rivette does mention a patent database,
the claim limitation mentions a specific type of patent database” (App.
Br. 16). This argument unpersuasively attacks Rivette individually even
though the Examiner relies on the combination of ADPA, Stanton, and
Rivette as having taught or suggested the claimed database limitation
(Ans. 6-7).
Furthermore, ADPA discloses an adverse event database (FF 5),
Stanton discloses creating a patient drug response database (FF 7), and
Rivette discloses databases of patents (FF 8). Therefore, ADPA, Stanton,
Rivette, and D’Ambra would have taught or suggested creating a database
(patient drug response database) of proprietary essential adverse event
information (used as an adverse event database), wherein the database
comprises at least one of: a patent, a patent application, or patent publication
(and also including a database of patents).
For at least these reasons, we find no evidence persuasive of error in
the Examiner’s 35 U.S.C. § 103(a) rejection of claims 250, and claims 251-
300 which fall therewith with respect to this issue.
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Issue 5
Appellant argues that the Examiner erred in finding that Stanton,
Rivette, and D’Ambra would have been combinable. Based on Appellant’s
arguments in the Appeal Brief, we will decide the appeal of claims 250-300
with respect to issue 5 on the basis of claim 250. See 37 C.F.R.
§ 41.37(c)(1)(vii).
Appellant submits that “Stanton actually teaches away from
Applicant’s required ‘essential’ adverse event, since the term ‘essential’ as
defined by Applicant, implies a manufacture must disclose the adverse event
information – as opposed to getting government approval . . . before
disclosing the information – as taught by Stanton” (App. Br. 16) (emphasis
added). This is unpersuasive because a meaning that is merely implied is
not sufficiently clear so that an artisan would understand its specialized
meaning. Furthermore, the Specification discloses that “a new essential
adverse event can mean a newly discovered adverse reaction” (FF 2)
(emphasis added) and that “[t]he final determination of what is ‘essential’ is
determined by a regulatory agency such as the FDA” (FF 3) (emphasis
added). The Specification’s disclosure of what “essential adverse event”
means is therefore very broad, encompassing any adverse reaction that any
regulatory agency could define as essential.
Even if we were to read the scope of an essential adverse event
narrowly, we would not be persuaded by Appellant’s arguments. Stanton
merely describes obtaining government regulatory approval as a potential
benefit of “demonstrating that a group of patients exists for which [a]
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treatment or method of treatment would be particularly beneficial or contra-
indicated” (FF 6). Appellant does not show that this disclosure of an
example of a potential benefit would have discouraged an artisan from using
Stanton’s teachings and suggestions for other benefits.
Appellant further argues that “D’Ambrosa actually teaches away from
Classen [U.S. Patent Application No. 09/804,289] by teaching to develop
new proprietary derivatives of Terfadine rather develop [sic] new proprietary
uses for Terfadine responsive to identifying new adverse events” (App.
Br. 16-17). Appellant submits that Classen “is included by reference and
cited in the present application” (App. Br. 14).
We are unpersuaded that differences between Classen and D’Ambra
are appurtenant. Classen is merely referenced as part of the invention’s
background (FF 1). Thus, an artisan would reasonably believe that Classen
does not describe the present invention itself. Therefore, the inclusion by
reference of Classen does not make any special claim term meaning
sufficiently clear.
Even if Classen could impact the scope of the claimed invention,
Appellant fails to identify claim language that Classen defines. Therefore,
we are not persuaded that D’Ambra teaches away from the claimed
invention.
For at least these reasons, we find no evidence persuasive of error in
the Examiner’s 35 U.S.C. § 103(a) rejection of claims 250, and claims 251-
300 which fall therewith with respect to this issue.
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Issue 6
Appellant argues that Colombo would not have taught or suggested
determining the value of commercializing. Based on Appellant’s arguments
in the Appeal Brief, we will decide the appeal of claims 251-255, 258, 259,
262, 263, 265, 267, 269, 271, 273, 282, 286, 288-290, and 300 with respect
to issue 6 on the basis of claim 251. See 37 C.F.R. § 41.37(c)(1)(vii).
Appellant submits that “the Colombo passage has nothing to do with
. . . . determining the ‘value of commercialization’” (App. Br. 18).
Appellant submits that determining the value of commercialization “is
defined in the specification paragraphs 123-127, under the Heading
‘Methods of Screening Adverse Events for Commercial Value’” (id.).
However, Appellant’s argument is based on a non-existent disclosure. For
example, Appellant submits that the second sentence of paragraph [0124]
reads “‘Commercial value’ depends on the potential value of making a
generic product or device into a proprietary product or device” (id.)
(emphasis added). In the Specification, the second sentence of this
paragraph actually reads “Value depends on the potential value of making a
generic product or device into a proprietary product or device” (FF 4)
(emphasis added). Because Appellant’s argument relies on a faulty
presentation of the Specification’s disclosure, we are not convinced that the
Specification defines “determining the value of commercialization” such
that ADPA, Stanton, Rivette, D’Ambra, and Colombo would not have taught
or suggested determining the value of commercializing at least one use for a
product of manufacture or device.
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Even if Appellant has accurately quoted the Specification in its
current state, we would not be persuaded of error. The passage Appellant
provides discusses “commercial value” and “potential commercial value”
(App. Br. 18). However, neither of these terms clearly limits the meaning of
“determining the value of commercialization.” Colombo teaches using
readily available and relatively inexpensive chemical modifiers to develop
modified sulfur cement with improved product durability (FF 9). Therefore,
ADPA, Stanton, Rivette, D’Ambra, and Colombo would have taught or
suggested determining the value (i.e., improved product durability by) of
commercializing at least one use (modifying sulfur cement) for a product of
manufacture or device (using readily available and relatively inexpensive
chemical modifiers).
For at least these reasons, we find no evidence persuasive of error in
the Examiner’s 35 U.S.C. § 103(a) rejection of claims 251, and claims 252-
255, 258, 259, 262, 263, 265, 267, 269, 271, 273, 282, 286, 288-290, and
300 which fall therewith with respect to this issue.
Issue 7
Appellant argues that the Examiner erred by taking official notice of
facts. Based on Appellant’s arguments in the Appeal Brief, we will decide
the appeal of claims 259-269, 271, 277-280, 283, 284, 290, and 291 with
respect to issue 7 on the basis of claim 259. See 37 C.F.R.
§ 41.37(c)(1)(vii).
Appellant submits that “the gaps between the cited art and Applicant’s
invention are great . . . relying on facts such as: raw commercial or sales
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data, proprietary information, medical products, non-medical products,
product exposure time, and date of inventorship” (App. Br. 20-21).
However, Appellant does not state why Examiner’s taking of official notice
of the state of the art includes noticed facts not considered to be common
knowledge or well-known in the art. Furthermore, Appellant does not
demonstrate adequate traversal of the Examiner’s taking of official notice
during prosecution. Therefore, Appellant does not offer any arguments or
evidence to show a basis for appealing the Examiner’s taking of official
notice.
Appellant further argues that “the facts of which the Examiner has
taken Official Notice do not provide one skilled in the art to arrive at
Applicant’s invention because one would not arrive at a database of
‘proprietary essential adverse events’ given the additional facts” (App.
Br. 21). We find this argument unpersuasive because the Examiner does not
rely on the taking of official notice in finding that the prior art would have
taught or suggested this limitation. As discussed above, ADPA, Stanton,
Rivette, and D’Ambra would have taught or suggested creating a database of
proprietary essential adverse event information.
For at least these reasons, we find no evidence persuasive of error in
the Examiner’s 35 U.S.C. § 103(a) rejection of claim 259, and claims 258-
269, 271, 277-280, 283, 284, 290, and 291 which fall therewith with respect
to this issue.
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Issue 8
Appellant challenges the Examiner’s use of Jacob’s printed product
warning information teachings. Based on Appellant’s arguments in the
Appeal Brief, we will decide the appeal of claims 299 and 300 with respect
to issue 8 on the basis of claim 299. See 37 C.F.R. § 41.37(c)(1)(vii).
Appellant argues that “[s]imply placing a warning as does Jacob does
not teach creating ‘proprietary methods of use wherein the use comprises
providing printed product warning information . . .’” (App. Br. 22). This
argument unpersuasively attacks Jacob individually, even though the
rejection is based on the combined teachings and suggestions of ADPA,
Stanton, Rivette, D’Ambra, and Jacob. The Examiner relies on ADPA,
Stanton, Rivette, and D’Ambra to show that the claimed proprietary methods
of use would have been obvious to an artisan (Ans. 3-7). Jacob teaches a
warning on disposable diapers labels regarding the risks associated with
release paper strips (FF 10). Appellant has not shown that it would be
uniquely challenging or difficult for an artisan to combine the teachings and
suggestions of these references. Therefore, we find that ADPA, Stanton,
Rivette, D’Ambra, and Jacob would have taught or suggested a proprietary
method of use (as taught or suggested by ADPA, Stanton, Rivette, and
D’Ambra) comprising providing printed product safety information (a
warning) in connection with product packaging (regarding release paper
strips).
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For at least these reasons, we find no evidence persuasive of error in
the Examiner’s 35 U.S.C. § 103(a) rejection of claim 299, and claim 300
which falls therewith with respect to this issue.
Issue 9
Appellant submits the sworn declaration of Dr. John B. Classen, the
inventor of the present application, as evidence of the invention’s
patentability. We have reviewed this declaration, along with the attached
evidence, but are not persuaded.
As the inventor, Dr. Classen is not a disinterested party. Thus, his
opinions are presumed to be mere arguments or conclusory statements, not
factual evidence of non-obviousness. Cf. In re De Blauwe, 736 F2d at 705.
Even if Dr. Classen’s opinions are accepted as factual evidence, the
declaration is not persuasive. The declaration purports to show non-
obviousness based on interactions between Dr. Classen and Elan
Pharmaceuticals (FF 11). Yet, these interactions include a patent
infringement suit based on two other patents (FF 12). Dr. Classen also
declares that “generic drug competitors have begun copying [his] technique”
(FF 13) and that others were skeptical at the time the previously issued
patent was filed (FF 14).
Dr. Classen’s submissions are not persuasive because the issued
patents, and the currently claimed invention, are referenced without
distinction. Even if Dr. Classen’s existing patents are valid and are being
infringed, other applications, even if related, are not automatically
patentable. Each patent application must be reviewed on a case-by-case
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basis. For example, Dr. Classen’s declaration regarding skepticism about
whether it is “possible to completely prevent generic drug competition for
[an] original formulation . . . after the original patents had expired” in 1999
(FF 14) does not provide convincing evidence that skepticism existed
regarding the currently claimed invention in 2001, the priority date for the
current application. Because the declaration fails to show how evidence of
nonobviousness pertains to the claimed invention, we are not persuaded that
secondary considerations demonstrate error in the Examiner’s rejection.
For at least these reasons, we find no evidence persuasive of error in
the Examiner’s 35 U.S.C. § 103(a) rejection of claims 250-300 with respect
to this issue.
CONCLUSIONS OF LAW
Based on the findings of facts and analysis above, we find no
evidence persuasive:
1. that the Examiner erred in using the Stanton reference in rejecting
Appellant’s claims (issue 1);
2. that the Examiner erred in finding that the claimed invention does
not recite limitations argued by Appellant (issue 2);
3. that the Examiner erred in finding that ADPA, Stanton, Rivette, and
D’Ambra would have taught or suggested identifying at least one previously
unreported essential adverse event (issue 3);
4. that the Examiner erred in finding that ADPA, Stanton, Rivette, and
D’Ambra would have taught or suggested creating a database of proprietary
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essential adverse event information, wherein the database comprises at least
one of: a patent, a patent application, or patent publication (issue 4);
5. that the Examiner erred in finding that it would have been obvious
to an artisan to combine the teachings and suggestions of ADPA, Stanton,
Rivette, and D’Ambra (issue 5);
6. that the Examiner erred in finding that ADPA, Stanton, Rivette,
D’Ambra, and Colombo would have taught or suggested determining the
value of commercializing at least one use for a product of manufacture or
device (issue 6);
7. that the Examiner improperly took official notice of the state of the
art (issue 7);
8. that the Examiner erred in finding that ADPA, Stanton, Rivette,
D’Ambra, and Jacob would have taught or suggested a proprietary method
of use comprising providing printed product safety information in
connection with product packaging (issue 8); and
9. that secondary considerations of nonobviousness demonstrate that
the Examiner erred in finding that the prior art would have taught or
suggested the claimed invention (issue 9).
DECISION
We affirm the Examiner’s decisions rejecting claims 250-300 under
35 U.S.C. § 103(a).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

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AFFIRMED

msc

MONTGOMERY, MCCRACKEN, WALKER & RHOADS, LLP
123 SOUTH BROAD STREET
AVENUE OF THE ARTS
PHILADELPHIA, PA 19109