Ex Parte Montgomery et al

Board of Patent Appeals and Interferences

Nov 18, 2010

11118824 (B.P.A.I. Nov. 18, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte HUGH EDWARD MONTGOMERY, JOHN FRANCIS MARTIN,
and JORGE DANIEL ERUSALIMSKY
__________

Appeal 2011-000170
Application 11/118,824
Technology Center 1600
__________

Before DEMETRA J. MILLS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for the treatment or prevention of stroke. The Examiner rejected the claims
on appeal as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We
affirm.

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
The Claims
Claims 42-56 are on appeal.2 Claims 42, 43 and 45 stand rejected,
while claims 44 and 46-56 stand withdrawn as directed to non-elected
species (see Ans. 2; App. Br. 4). Appellants petitioned a restriction
requirement and election of species (see Petition, Dec. 23, 2009). The
petition decision withdrew the restriction requirement, but decided that the
“provisional election of species requirement [as] set forth on 21 May 2009
has been maintained, pending allowability of the generic claim” (Petition
Dec. 8, Jan. 25, 2010). We therefore address only the elected claims 42, 43
and 45, consistent with the petition decision (see Petition Dec. 8, Jan. 25,
2010).
Claims 42, 43 and 45 read as follows:
42. A method for the treatment or prevention of
stroke or its recurrence, wherein said method
comprises administering, to a patient diagnosed as
in need of such treatment or prevention, an
inhibitor of the rennin-angiotensin system, said
inhibitor having a ClogP of greater than about 1.

43. The method as claimed in claim 42, wherein
the inhibitor of the rennin--angiotensin system
comprises at least one inhibitor of angiotensin-
converting enzyme.

45. The method as claimed in claim 43, wherein
the inhibitor of angiotensin-converting enzyme
comprises ramipril.

2 Claims 1-41 were cancelled in Appellants’ Amendment filed Jan.
14, 2010.
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The issues
A. The Examiner rejected claims 42, 43 and 45 under 35 U.S.C. § 102(b)
as anticipated by AIRE3 (Ans. 7-8).
B. The Examiner rejected claims 42, 43 and 45 under 35 U.S.C. § 102(b)
as anticipated by HOPE4 (Ans. 8).
C. The Examiner rejected claims 42, 43 and 45 under 35 U.S.C. § 102(b)
as anticipated by Gohlke5 as evidenced by Richer6 (Ans. 8-9).
D. The Examiner rejected claims 42, 43 and 45 under 35 U.S.C. § 102(b)
as anticipated by Frampton7 (Ans. 9).

3 The Acute Infarction Ramipril Efficacy (AIRE) Study
Investigators, Effect of ramipril on mortality and morbidity of
survivors of acute myocardial infarction with clinical evidence of
heart failure, 342 LANCET 821-828 (1993) (Hereinafter referred to
as “AIRE” for consistency with the Appeal Brief).
4 The HOPE Study Investigators, The HOPE (Heart Outcomes
Prevention Evaluation) Study: The design of a large, simple
randomized trial of an angiotensin-converting enzyme inhibitor
(ramipril) and vitamin E in patients at high risk of cardiovascular
events, 12 CANADIAN J. CARDIOLOGY 127-137 (1996) (Hereinafter
“HOPE”).
5 Gohlke et al., Angiotensin-Converting Enzyme Inhibition
Improves Cardiac Function. Role of Bradykinin, 23
HYPERTENSION 411-418 (1994) (Hereinafter “Gohlke”).
6 Richer et al., Antihypertensive drugs in the stroke-prone
spontaneously hypertensive rat, 19 CLIN. EXP. HYPERTENS. 925-36
(1997)(Abstract Only) (Hereinafter “Richer”).
7 Frampton, James E. and Peters, David H., Ramipril: An Updated
Review of its Therapeutic Use in Essential Hypertension and Heart
Failure, 49 DRUGS 440-466 (1995)(Abstract Only) (Hereinafter
“Frampton”). We will only address the abstract which is provided.
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A. 35 U.S.C. § 102(b) over AIRE
The Examiner finds that AIRE “teaches a method of administering
ramipril orally to post myocardial infarction patients (See the abstract for
example). The ClogP properties recited in the claim is inherently present in
ramipril” (Ans. 8). The Examiner “notes that some patients are suffering
from hypertension (See page 822, Table 1). In other words, ramipril was
administered to patients diagnosed with hypertension. Hypertensive patients
are in need of prevention of stroke” (id.).
Appellants contend that “AIRE explicitly teaches away from the
claimed method” (App. Br. 21). Appellants contend that “AIRE teaches that
treatment with a RAS inhibitor (enalapril) is more dangerous than treatment
with placebo” (id.).
Appellants contend that “AIRE found that ramipril has no effect on
stroke prevention: AIRE says that the ramipril-treated group had a rate of
stroke of 2%: no better than placebo” (id. at 22). Appellants contend that
“AIRE thus teaches the claimed invention would not work” (id.).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that AIRE anticipated claims 42, 43 and
45?
Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
1. AIRE teaches patient characteristics in Table 1, reproduced in
pertinent part below:
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“Table 1, Patient characteristics, trial therapy, and concomitant medication
at baseline” (AIRE 822, col. 2).
2. AIRE teaches that in “this selected high-risk subset of patients
we investigated the effect of therapy with the angiotensin converting enzyme
(ACE) inhibitor ramipril, postulating that it would lengthen survival” (AIRE
abstract).
3. AIRE teaches that “[a]nalysis of prespecified secondary
outcomes revealed a risk reduction of 19% for the first validated outcome
(ie, first event in an individual patient)—namely, death, severe/resistant
heart failure, myocardial infarction, or stroke” (AIRE abstract).
4. AIRE teaches that “[t]able 2 shows all-cause mortality (primary
endpoint) and secondary events validated by the outcomes subcommittee.
For the formal analysis we used only the findings for the first validated event
in any individual patient – namely, death, reinfarction, stroke, or
development of severe/resistant heart failure” (AIRE 824, col. 2).
5. AIRE teaches that the “incidence of stroke was higher in the
active drug group but the numbers were small and an adverse effect of the
drug can be neither supported nor refuted” (AIRE 826, col. 1).
Principles of Law
“To anticipate a claim, a prior art reference must disclose every
limitation of the claimed invention, either explicitly or inherently.” In re
Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
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A single prior art reference that discloses, either
expressly or inherently, each limitation of a claim
invalidates that claim by anticipation. Thus, a prior art
reference without express reference to a claim limitation
may nonetheless anticipate by inherency. “Under the
principles of inherency, if the prior art necessarily functions
in accordance with, or includes, the claims limitations, it
anticipates.” Moreover, “[i]nherency is not necessarily
coterminous with knowledge of those ordinary skill in the
art. Artisans of ordinary skill may not recognize the
inherent characteristics or functioning of the prior art.”

Perricone v. Medicis Pharmaceutical Corp., 432 F.3d 1368, 1375-76 (Fed.
Cir. 2005) (citations omitted); see also In re Spada, 911 F.2d 705, 709 (Fed.
Cir. 1990 (“When the claimed compositions are not novel they are not
rendered patentable by recitation of properties, whether or not these
properties are shown or suggested in the prior art.”).
Analysis
The dispute in this case centers around interpreting the phrase a
“patient diagnosed as in need of such treatment or prevention,” where the
disease being treated or prevented is stroke.
The Examiner finds that “ramipril was administered to patients
diagnosed with hypertension. Hypertensive patients are in need of
prevention of stroke” (Ans. 8).
Appellants acknowledge that “[h]ypertension is a ‘risk factor of
stroke’” (Reply Br. 4). Appellants contend that “[e]quating the claim term
‘stroke prevention’ with ‘managing a risk factor of stroke’ means that the
claim term ‘stroke prevention’ would encompass increasing stroke risk by
43%” (id.). Appellants contend that the “Examiner cannot interpret the term
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‘stroke prevention’ so broadly that it encompasses acts which increase
stroke risk” (Reply Br. 4).
We find that the Examiner has the better position here. Claim 42 has
two elements. The first is to administer an inhibitor of the rennin-
angiotensin system, where one specific such inhibitor is ramipril as in claim
45. The second is the patient population receiving the inhibitor, which
encompasses patients diagnosed as requiring stroke treatment or prevention.
There is no dispute that AIRE teaches first element of a method of
administering ramipril to a patient population (FF 2). AIRE also teaches that
one endpoint under study for the patient population was stroke (FF 3-4).
Since Appellants acknowledge that hypertension is a known “risk
factor for stoke” (see Reply Br. 4), and since AIRE teaches that a portion of
the patient population was diagnosed with hypertension (FF 1), the AIRE
study inherently treated patients who had been diagnosed with hypertension
with ramipril, and were therefore inherently in need of treatment or
prevention of stroke.
We are not persuaded by Appellants’ argument that “[e]quating the
claim term ‘stroke prevention’ with ‘managing a risk factor of stroke’ means
that the claim term ‘stroke prevention’ would encompass increasing stroke
risk by 43%” (Reply Br. 4).
Appellants’ argument presents an incorrect syllogism, which says that
treatment of hypertension could lead to treatment with captopril (where
captopril treatment is neither taught nor suggested nor contemplated by
AIRE), which Appellants state increases stroke risk (id.). However, that is
not the anticipation rejection, which is that AIRE expressly teaches
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administration of ramipril to patients with hypertension (FF 1-4), and if
treatment with ramipril functions to prevent stroke or stroke recurrence, then
application of that method to that specific hypertensive patient population
will inherently obtain the result of preventing stroke or stroke recurrence.
Appellants contend that “AIRE found that ramipril has no effect on
stroke prevention: AIRE says that the ramipril-treated group had a rate of
stroke of 2%: no better than placebo” (App. Br. 22).
We are not persuaded because the inherent anticipation issue is not
whether AIRE recognized the invention, but rather whether AIRE
anticipated the steps of the invention. As discussed, AIRE identified
patients with hypertension who are known to be at risk of stroke, and treated
this patient population with ramipril (FF 1-4). It does not matter whether
AIRE appreciated that this treatment, which was actually performed on 289
patients with hypertension (FF 1), would treat or prevent stroke. “It matters
not that those of ordinary skill heretofore may not have recognized these
inherent characteristics.” In re Cruciferous Sprout Litigation, 301 F.3d 1343,
1350 (Fed. Cir. 2002). Also see, e.g., MEHL/Biophile Int’l Corp. v.
Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999) (“Under the principles of
inherency, if the prior art necessarily functions in accordance with, or
includes, the claimed limitations, it anticipates.”)
Appellants contend that “AIRE thus teaches the claimed invention
would not work” (App. Br. 22).
We note that the Court of Appeals for the Federal Circuit has
determined that “[t]eaching away is irrelevant to anticipation.” Seachange
Int’l, Inc., v. C-Cor, Inc., 413 F.3d 1361, 1380 (Fed. Cir. 2005) (citing
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Celeritas Tech., Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed. Cir.
1998). Insofar as Appellants may intend to argue that AIRE is not enabled,
AIRE treated 289 hypertensive patients with ramipril, thereby actually
performing the method steps (FF 1).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that AIRE
anticipated claims 42, 43 and 45.
B. 35 U.S.C. § 102(b) over HOPE
The Examiner finds that “HOPE teaches a method of administering
ramipril in combination of vitamin E in patients whom are at high risk of
cardiovascular event such as myocardial infarction and stroke (See the
abstract for example). Therefore, the patients therein are diagnosed to be in
need of the prevention of stroke” (Ans. 8).
Appellants contend that “HOPE, however, is not a concluded research
project. To the contrary, it is merely a proposal for future research. HOPE
provides no hint of whether the claimed compounds would prevent stroke or
would, like captopril, increase stroke” (App. Br. 23). Appellants contend
that “HOPE provides no hint of whether the claimed compounds would
prevent stroke or would, like captopril, increase stroke” (id.).
Appellants contend that “HOPE fails to anticipate the claimed
invention because the inventors completed their research, made their
discovery and filed their patent years before HOPE had even completed its
‘patient follow up’ phase” (id. at 24).
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that HOPE anticipated claims 42, 43 and
45?
Findings of Fact
6. Figure 1 of Hope is reproduced below:

“The study design is summarized in Figure 1” (HOPE 132, col. 1).
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7. HOPE teaches that the “HOPE Study is a large, randomized
clinical trial of the efficacy of an angiotensin-converting enzyme inhibitor
(ACE-I), ramipril, and of a naturally occurring antioxidant, vitamin E, in
reducing myocardial infarction (MI), stroke, or CVD death in over 9000
men and women at high risk of CVD” (HOPE 128, col. 1; emphasis added).
8. Figure 1 of Hope teaches that eligible patients include those
with previous stroke (see FF 7).
9. Hope teaches that as “of January 1, 1996 the study has
completed randomizing 9541 patients. This includes 2543 women, 7553
patients with previous CVD, 3654 with diabetes and 4406 with
hypertension” (Hope 134, col. 1).
Analysis
Hope teaches testing the ability of “ramipril, and of a naturally
occurring antioxidant, vitamin E, in reducing myocardial infarction (MI),
stroke, or CVD death in over 9000 men and women at high risk of CVD”
(HOPE 128, col. 1; FF 7). Hope specifically identifies patients as including
those with previous stroke (FF 6, 8). Hope teaches treating actual patients
with ramipril (FF 9).
Appellants contend that “HOPE, however, is not a concluded research
project. To the contrary, it is merely a proposal for future research. HOPE
provides no hint of whether the claimed compounds would prevent stroke or
would, like captopril, increase stroke” (App. Br. 23).
Anticipation does not require actual performance of suggestions in a
disclosure, only that those suggestions be enabling to a skilled artisan. See
Novo Nordisk Pharm., Inc. v. BioTechnology Gen. Corp., 424 F.3d 1347,
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1355 (Fed. Cir. 2005) (“Significantly, [this court has] stated that
‘anticipation does not require actual performance of suggestions in a
disclosure. Rather, anticipation only requires that those suggestions be
enabled to one of skill in the art.’”) In the instant case, the HOPE study was
clearly enabled to treat patients, including patients with previous stroke, with
ramipril (FF 6-9).
Appellants contend that “HOPE provides no hint of whether the
claimed compounds would prevent stroke or would, like captopril, increase
stroke” (App. Br. 23). Appellants contend that “HOPE fails to anticipate the
claimed invention because the inventors completed their research, made
their discovery and filed their patent years before HOPE had even completed
its ‘patient follow up’ phase” (id. at 24). Appellants also argue that “HOPE
cannot anticipate the claimed invention as a matter of law because (a) it fails
to enable with a reasonable expectation of success” (Reply Br. 13).
We are not persuaded. In Schering, the Federal Circuit noted that
“this court rejects the contention that inherent anticipation requires
recognition in the prior art.” Schering Corp. v. Geneva Pharm., Inc., 339
F.3d 1373, 1377 (Fed. Cir. 2003). Schering also commented that “[o]ther
precedents of this court have held that inherent anticipation does not require
that a person of ordinary skill in the art at the time would have recognized
the inherent disclosure. E.g., In re Cruciferous Sprout Litig., 301 F.3d 1343,
1351 (Fed.Cir.2002).” Id. Also see MEHL/Biophile Int'l Corp. v. Milgraum,
192 F.3d at 1366 (“Where … the result is a necessary consequence of what
was deliberately intended, it is of no import that the article’s authors did not
appreciate the results.”)
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This logic applies to HOPE, since treatment of patients diagnosed as
in need of prevention of stroke (see FF 6) with ramipril would necessarily
result in the treatment or prevention of stroke, whether the authors of the
HOPE study recognized that fact or not at the time of publication.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
HOPE anticipated claims 42, 43 and 45.
C. 35 U.S.C. § 102(b) over Gohlke and Richer
The Examiner finds that “Gohlke et al. teaches ramipril being
administered to stroke-prone hypertensive rats (SHRSP) (see for example,
page 412, Experiment 1 and 2)” (Ans. 8). The Examiner finds that Richer
teaches that “SHRSP is an experimental model that has been widely used to
investigate the potential preventive effects vs stroke and mortality of
numerous antihypertensive agents (see the abstract). The examiner notes that
SHRSP is a well- known model wherein the animal patient is at risk of
having stroke” (id. at 8-9).
Appellants contend that Gohlke “provides a reasonable explanation
for the AIRE observations: ACE inhibitors reduce heart attack risk because
they increase cardiac blood supply and reduce ‘left ventricular
hypertrophy.’” (App. Br. 24). Appellants contend that “GOHLKE thus
teaches a use which is very valuable. That use, however, is different from the
claimed use” (id.).
Appellants contend that “even assuming that a skilled artisan had
accepted spontaneously hypertensive rats as analogous to humans,
GOHLKE fails to teach - nor even imply - that the claimed compounds
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prevent stroke in humans. To the contrary, GOHLKE fails to even prevent
stroke in rats” (App. Br. 25).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Gohlke as evidenced by Richer
anticipated claims 42, 43 and 45?
Findings of Fact
10. Gohlke teaches that “we investigated the effects of chronic
high- and low-dose treatment with the ACE inhibitor ramipril on functional
and biochemical cardiac parameters in stroke-prone spontaneously
hypertensive rats” (Gohlke 411, col. 2).
11. Gohlke teaches that “early-onset chronic treatment with the
ACE inhibitor ramipril improved cardiac function and metabolism event at a
low dose that did not affect the development of hypertension and left
ventricular hypertrophy” (Gohlke 417, col. 1).
12. Gohlke teaches that the “observed cardiac effects of the ACE
inhibitor were due to bradykinin potentiation because they could be
prevented by the bradykinin receptor antagonist Hoe 140” (Gohlke 417, col.
1).
13. Richer teaches that the “stroke-prone spontaneously
hypertensive rat (SHR-SP) is an experimental model that has been widely
used to investigate the potential preventive effects vs stroke and mortality of
numerous antihypertensive agents. Among the latter, angiotensin I-
converting enzyme inhibitors . . . have proven to be very effective” (Richer
abstract).

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Analysis
Gohlke teaches treatment of a “patient” which is expressly identified
as “stroke-prone” (FF 10). Gohlke teaches that the stroke-prone
hypertensive rats were treated with ramipril (FF 10-12).
Appellants contend that “GOHLKE thus teaches a use which is very
valuable. That use, however, is different from the claimed use” (App. Br.
24). Appellants also contend that “even assuming that a skilled artisan had
accepted spontaneously hypertensive rats as analogous to humans,
GOHLKE fails to teach - nor even imply - that the claimed compounds
prevent stroke in humans. To the contrary, GOHLKE fails to even prevent
stroke in rats” (id. at 25).
We are not persuaded. As an initial matter, we agree with the
Examiner that the term “patient” as used in the claims may be reasonably
interpreted to encompass species other than humans, such as rats. Thus,
performance of the method on rats constitutes performance of the claimed
method. There is no requirement that Gohlke teach prevention of stroke in
humans with the compounds.
Also, there is no requirement that Gohlke recognize that treatment of
the stroke-prone rats with ramipril would inherently treat or prevent stroke.
See MEHL, 192 F.3d at 1366 (“Where … the result is a necessary
consequence of what was deliberately intended, it is of no import that the
article’s authors did not appreciate the results.”) All that is required by
claims 42, 43 and 45 is identifying a patient in need of the treatment, and
administering ramipril to that patient. Gohlke meets that requirement,
identifying the rats, here reasonably interpreted as the patients, as “stroke-
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prone” and then teaches administering ramipril to the rats (FF 10-12). There
is no requirement that Gohlke recognize that the treatment would inherently
prevent stroke.
Appellants contend that the “Examiner fails to provide any evidence
to support his speculation that administering ramipril to spontaneously
hypertensive rats necessarily prevented stroke in those rats. This failure is
not surprising, because the undisputed evidence contradicts it” (Reply Br.
14).
We are not persuaded. Appellants do not identify, and we do not find,
any specific teaching in Gohlke which addresses the rate of stroke
occurrence in rats after treatment with ramipril. Having found that the rats
are “stroke-prone” and are subjected to administration with ramipril, the
burden of proving that the ramipril administration does not inherently satisfy
the preamble requirement of the claim to treat or prevent stroke is properly
placed on Appellants. See In re Best, 562 F.2d 1252, 1255 (CCPA 1977)
(“Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102, on
‘prima facie obviousness' under 35 U.S.C. § 103, jointly or alternatively, the
burden of proof is the same, and its fairness is evidenced by the PTO's
inability to manufacture products or to obtain and compare prior art
products.”) Appellants have provided no evidence to rebut this inherency
argument.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Gohlke as evidenced by Richer anticipated claims 42, 43 and 45.

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D. 35 U.S.C. § 102(b) over Frampton
The Examiner finds that “Frampton et al. teaches ramipril was
administered to diabetic patients with mild to moderate hypertension (See
page 3 of the abstract, second paragraph)” (Ans. 9). The Examiner finds that
“those patients receiving ramipril have been diagnosed with mild to
moderate hypertension (a risk factor of stroke). Therefore, the patients are
diagnosed to be in need of prevention of stroke” (id.).
Appellants contend that “FRAMPTON cannot anticipate because it
fails to teach each and every element of any claim. Pointedly, the Examiner
fails to even allege where FRAMPTON even mentions preventing stroke”
(App. Br. 26). Appellants contend that “FRAMPTON is ineligible as a
reference, for two reasons. First, it was written in 1995, but fails to say
whether it was ever published and if so, where and when” (id.). Appellants
also contend that “FRAMPTON is ineligible because it is only an Abstract.
Controlling legal precedent requires a prior art reference be read ‘as a
whole.’” (Id.).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Frampton anticipated claims 42, 43
and 45?
Findings of Fact
14. Frampton teaches that the “antihypertensive efficacy of ramipril
has been confirmed in large-scale noncomparative studies conducted in
general practice as well as in more rigorously controlled clinical trials”
(Frampton abstract).
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15. Frampton teaches that “clinical data confirm ramipril as a
useful alternative ACE inhibitor for the treatment of patients with mild to
moderate hypertension, and indicate a beneficial effect of the drug in
patients with clinical evidence of heart failure after acute myocardial
infarction” (Frampton abstract).
16. Frampton teaches that an “intention-to-treat analysis revealed
that ramipril significantly decreased the risk of all-cause mortality by 27%
and the combined incidence of prespecified secondary outcomes (i.e. first
validated event in an individual patient, namely death, progression to
severer/resistant heart failure, reinfarction or stroke) by 19% compared with
placebo” (Frampton abstract).
Analysis
Frampton teaches treatment of hypertensive patients with ramipril (FF
14-16).
Appellants contend that “FRAMPTON cannot anticipate because it
fails to teach each and every element of any claim. Pointedly, the Examiner
fails to even allege where FRAMPTON even mentions preventing stroke”
(App. Br. 26).
We are not persuaded. As discussed above, Appellants acknowledge
that “[h]ypertension is a ‘risk factor of stroke’” (Reply Br. 4). Since
Appellants acknowledge that hypertension is a known “risk factor for stoke”
(see Reply Br. 4), and since Frampton teaches that a patient population
which was diagnosed with hypertension (FF 1), Frampton expressly treated
patients who had been diagnosed with hypertension with ramipril, and were
therefore inherently at risk of stroke. See MEHL, 192 F.3d at 1366 (“Where
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… the result is a necessary consequence of what was deliberately intended, it
is of no import that the article’s authors did not appreciate the results.”)
Appellants contend that “FRAMPTON is ineligible as a reference, for
two reasons. First, it was written in 1995, but fails to say whether it was ever
published and if so, where and when” (App. Br. 26).
Whether a document constitutes a printed publication under § 102 is a
question of law based upon the underlying facts of each particular case.
Cordis Corp. v. Boston Scientific Corp., 561 F.3d 1319, 1332-33 (Fed. Cir.
2009). Here, to qualify as a printed publication, the Frampton abstract must
have been disseminated or otherwise made accessible to persons interested
and ordinarily skilled in the subject matter prior to the critical date. See
Kyocera Wireless Corp. v. Int’l Trade Comm’n, 545 F.3d 1340, 1350 (Fed.
Cir. 2008); In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986) (explaining that
public accessibility is the “touchstone in determining whether a reference
constitutes a ‘printed publication’ bar under 35 U.S.C. § 102(b)”).
At the bottom of the page, the Frampton abstract states that it is from
the website http://adisonline.com/drugs/Abstract/1995/49030/Ramipril.
That link directs the browser to the journal titled “Drugs,” volume 49, issue
3, where the Frampton article is listed as pages 440-466. Appellants have
provided no evidence to dispute that the Frampton abstract was not
published in the journal “Drugs” in 1995 as taught by the website.
Appellants also contend that “FRAMPTON is ineligible because it is
only an Abstract. Controlling legal precedent requires a prior art reference
be read ‘as a whole.’” (App. Br. 26).
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Appellants do not identify, and we are not aware, of any legal rule
which renders abstracts ineligible as references simply because they are
abstracts. Appellants refer to MPEP § 706.02(II)(2010), but this section
simply recognizes that the full text document is a superior reference to an
abstract since it may have nuances which will either support or detract from
the rejection. Appellants here do not point to evidence that the full text of
Frampton is inconsistent with the Frampton abstract.
Further, there are a number of Federal Circuit opinions in which
abstract references were relied upon. See, e.g., Nichols Institute
Diagnostics, Inc. v. Scantibodies Clinical Laboratory, Inc., 195 Fed.Appx.
947, 950 (Fed. Cir. 2006) (“[W]e hold that the abstract was sufficiently
publicly accessible to be considered a printed publication under 35 U.S.C. §
102(b). . . . We also hold, for the reasons below, that the abstract anticipates
the asserted claims, because no reasonable juror could have found that the
abstract does not inherently disclose the claimed antibody”). Also see
Monsanto Co. v. Bayer Bioscience N.V., 514 F.3d 1229, 1234 (Fed. Cir.
2008).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Frampton anticipated claims 42, 43 and 45.
SUMMARY
In summary, we affirm the rejection of claims 42, 43 and 45 under 35
U.S.C. § 102(b) as anticipated by AIRE.
We affirm the rejection of claims 42, 43 and 45 under 35 U.S.C. §
102(b) as anticipated by HOPE.
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We affirm the rejection of claims 42, 43 and 45 under 35 U.S.C. §
102(b) as anticipated by Gohlke as evidenced by Richer.
We affirm the rejection of claims 42, 43 and 45 under 35 U.S.C. §
102(b) as anticipated by Frampton.
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)(2006).

AFFIRMED

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