Ex Parte Simard

Patent Trial and Appeal Board

Aug 31, 2017

14044418 (P.T.A.B. Aug. 31, 2017)

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.
14/044,418 10/02/2013 John Simard 5407-0175 1000
88684 7590
XBiotech, Inc.
5425 Park Central Court
Suite 111
Naples, EL 34109
09/05/2017 EXAMINER
SEHARASEYON, JEGATHEESAN
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
09/05/2017 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
sakptomail@iplawpro.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN SIMARD1
Appeal 2017-002064
Application 14/044,418
Technology Center 1600
Before ULRIKE W. JENKS, TAWEN CHANG,
and JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for reducing the occurrence of a major adverse clinical event
(“MACE”) which have been rejected as obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
“Restenosis of coronary arteries following balloon angioplasty and
stent placement is one of the major sources of morbidity in interventional
1 Appellant identifies the Real Party in Interest as XBiotech, Inc. Appeal Br.
3.
Appeal 2017-002064
Application 14/044,418
cardiology.” Spec. 13. It is thought that restenosis is caused by an
inflammatory response to injury caused by procedures such as balloon
angioplasty or a reaction to a stent. Id. The Specification describes a
method for “reducing the chance or severity of a major adverse clinical
event occurring in a mammalian subject having received or expected to
receive surgical treatment for a stenosed blood vessel.” Spec. 17.
Claims 1—3 and 6—8 are on appeal. Claims 1 and 6 are the sole
independent claims and read as follow:
1. A method of reducing the chance of a major
adverse clinical event occurring in a human subject having
received or expected to receive surgical treatment for a stenosed
blood vessel, the method comprising the step of administering
to the subject a pharmaceutical composition comprising a
pharmaceutically acceptable carrier and an amount of an anti-
IL-la antibody effective to reduce the chance of a major
adverse clinical event occurring in the subject, wherein the
chance of a major adverse clinical event occurring in the subject
is reduced.
6. A method of reducing the chance of restenosis
occurring in a human subject having received or expected to
receive surgical treatment for a stenosed blood vessel, the
method comprising the step of administering to the subject a
pharmaceutical composition comprising a pharmaceutically
acceptable carrier and an amount of an anti-IL-la antibody
effective to reduce the chance that the vessel will become
restenosed, wherein the chance that the vessel will become
restenosed is reduced.
The claims stand rejected as follows:
2
Appeal 2017-002064
Application 14/044,418
Claims 1—3 and 6—8 have been rejected under 35 U.S.C. § 102(b) as
anticipated by XBiotech.2
Claims 1—3 and 6—8 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Morton3 in view of Simard.4
ANTICIPATION
Issue
The issue with respect to this rejection is whether a preponderance of
evidence supports the Examiner’s conclusion that claims 1—3 and 6—8 are
anticipated by XBiotech.
The Examiner finds that XBiotech teaches the administration of an IL-
la antagonist, CV-18C3, to prevent “early IL-la mediated inflammation that
leads to vascular smooth muscle hypertrophy and restenosis as well as late
IL-la mediated atherosclerotic plaque formation.” Final Act. 5. The
Examiner finds that XBiotech teaches
the method of reducing the chance of a major adverse clinical
event occurring in a human subject having received or expected
to receive surgical treatment for a stenosed blood vessel, and a
method of reducing the chance of restenosis occurring in a
human subject having received or expected to receive surgical
treatment for a stenosed blood vessel, by administering the
2 XBiotech, Safety and Preliminary Efficacy of Anti-inflammatory
Therapeutic Antibody in Reducing Restenosis, Clinical Trial No.
NCT1270945, filed Jan. 4, 2011,
httpd://clinicaltrials.gov/ct2/show/NCT01270945 (“XBiotech”).
3 Morton et al., Interleukin-1 receptor antagonist alter the response to vessel
wall injury in a porcine coronary artery model, 68 Cardiovascular Res. 492
(2005).
4 Simard, US 2009/0298096 Al, published Dec. 3, 2009 (“Simard”).
3
Appeal 2017-002064
Application 14/044,418
pharmaceutical composition of the CV-18C3 (MABpl)
antibody of the NCT01270945 study.
Id. at 6. The Examiner concludes that the claims are anticipated by
XBiotech.
Appellant contends that XBiotech does not anticipate the claims, as
the claims call for the reducing the chance for a major adverse clinical event
or reducing the chance for restenosis. Appeal Br. 7. Appellant contends that
the Examiner has not established that such a limitation would be inherent
from the disclosure in XBiotech. Appeal Br. 8—10. Appellant argues that
XBiotech does not mention a major adverse clinical event. Appeal Br. 10.
Appellant argues that the facts in the instant case distinguish the present case
from In re Montgomery, 677 F.3d 175 (Fed. Cir. 2012).
Principles of Law
“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
“[Ajnticipation does not require actual performance of suggestions in
a disclosure. Rather, anticipation only requires that those suggestions be
enabling to one of skill in the art.” Bristol-Myers Squibb Co. v. Ben Venue
Labs., Inc., 246 F.3d 1368, 1379 (Fed. Cir. 2001) (citing In re Donohue, 766
F.2d 531, 533 (Fed. Cir. 1985) (“It is not, however, necessary that an
invention disclosed in a publication shall have actually been made in order
to satisfy the enablement requirement.”).).
“[Pjroof of efficacy is not required for a prior art reference to be
enabling for purposes of anticipation. . . . [T]he proper issue is whether the
4
Appeal 2017-002064
Application 14/044,418
[prior art] is enabling in the sense that it describes the claimed invention
sufficiently to enable a person of ordinary skill in the art to carry out the
invention.” Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1383
(Fed. Cir. 2006).
“[W]hile it is true that claims are to be interpreted in light of the
specification . . . , it does not follow that limitations from the specification
may be read into the claims. . . . [T]he claims define the invention.” Sjolund
v. Musland, 847 F.2d 1573, 1581-82 (Fed. Cir. 1988).
Analysis
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. We find the Examiner has established that
the claims are anticipated by XBiotech. Appellant has not produced
evidence showing, or persuasively argued, that the Examiner’s
determinations on anticipation are incorrect. Only those arguments made by
Appellant in the Briefs have been considered in this Decision. Arguments
not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv)
(2015). Appellant does not separately argue the claims. We have identified
claim 1 as representative; therefore, all claims fall with claim 1. We address
Appellant’s arguments below.
Appellant contends that claim 1 is not anticipated, as the claim
requires that “the chance of a major adverse clinical event [be] reduced” and
XBiotech does not teach this limitation. Appeal Br. 7. We are unpersuaded.
As the Examiner points out, administering and anti-IL-1 a antibody would
5
Appeal 2017-002064
Application 14/044,418
inevitably lead to a reduction in the chance of a MACE or the development
of restenosis. Ans. 7. We agree with The Examiner that this case is similar
to that in In re Montgomery where our reviewing court held that if an
applicant has initiated human clinical trials for a therapeutic product or
process, Office personnel should presume that the applicant has established
that the subject matter of the trial is reasonably predictive of having the
asserted therapeutic utility. Id.
Appellant argues that XBiotech does not make it clear that the
described method of treatment would inevitably lead to a reduction of
MACE or restenosis. Appeal Br. 8. This argument is unpersuasive in that
XBiotech clearly teaches the method of the claims, namely administering an
IL-la antibody to reduce inflammation, i.e., the condition that leads to
vascular smooth muscle hypertrophy and restenosis as well as
atherosclerotic plaque formation. Ans. 8—9. These, in turn, are conditions
that can lead to a major averse clinical event. See, XBiotech 1—2.
Appellant next contends that the Examiner’s reliance on Montgomery
is misplaced in that the cited portion of Montgomery related to the utility
requirement of section 101, not novelty. Appeal Br. 8—10. Again we are
unpersuaded. Our reviewing court in Montgomery specifically found that a
preclinical trial disclosure that described the procedure to be used to
administer a rennin-angiostensin inhibitor to prevent stroke anticipated
claims directed to that method. Montgomery, 677 F.3d at 1381. Moreover,
as the Examiner has noted, Montgomery does not stand for the proposition
that anticipation requires the method to be actually performed. Ans. 10.
Indeed, our reviewing court has long held that actual practice of the
6
Appeal 2017-002064
Application 14/044,418
invention is not required for a reference to anticipate. Bristol-Myers, 246
F.3d at 1379. All that is required is that the disclosure be enabling. Id.
Appellants go on to argue that the XBiotech reference is nothing more
than an invitation to investigate and does not rise to the level of an
anticipating inherent disclosure. Appeal Br. 10. Again we are unpersuaded.
As the Examiner points out, the XBiotech clinical trial reference presents
more that an abstract theory. Ans. 11. Instead, it indicated that the method
is in an advanced stage of testing designed to secure regulatory approval. Id.
This demonstrates that the clinical trial applicant has established that the
subject matter of the trial is reasonably predictive of having the asserted
therapeutic value. Ans. 11.
Appellant attempts to distinguish the present application from that in
Montgomery by arguing that there are significant factual difference between
the two applications. Appeal Br. 10. Appellant points out that the treatment
method disclosed in the clinical trial document of Montgomery was identical
to that recited in the patent. Id. Appellant argues that XBiotech only gives
vague instructions as to the dosage and duration of the treatment method
whereas the present Specification is based on the actual results achieved in
the trial. We are unpersuaded. The dosage amounts and duration limitations
argued by Appellant are not recited in claim 1 or any of the claims on
appeal.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 is anticipated by XBiotech.
7
Appeal 2017-002064
Application 14/044,418
Claims 2, 3, and 6—8 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
OBVIOUSNESS
Issue
The issue with respect to this rejection is whether a preponderance of
evidence supports the Examiner’s conclusion that claims 1—3 and 6—8 would
have been obvious over Morton combined with Simard.
The Examiner finds that Morton discloses the administration of an
interleukin-1 receptor antagonist modulates the inflammatory response of
the coronary artery to injury. Final Act. 9. The Examiner also finds that
Morton teaches that inflammatory response is associated with restenosis. Id.
The Examiner finds that Simard teaches treating pathologies associated with
aberrant IL-la expression by administering monoclonal antibodies to IL-la.
Id. The Examiner concludes that
it would have been obvious to administer an anti-IL-la
antibody such as MABpl to reduce the chance of a major
adverse clinical event occurring in a human subject having
received or expected to receive surgical treatment for a stenosed
blood vessel, and reducing the chance of restenosis occurring in
a human subject having received or expected to receive surgical
treatment for a stenosed blood vessel, by administering an
amount of an anti-IL-a antibody effective to reduce the chance
that the vessel will become restenosed. The involvement of IL-
1 in the restenosis is taught by Morton et al. The use of
antibodies to inhibit IL-la in human therapy is taught by
Simard et al. In addition, Simard discloses a particular antibody
that would have been known to be effective in inhibiting IL-la.
Therefore, one of skilled in the art would be motivated to
combine the teachings to reduce major adverse clinical
event/restenosis in a human patient.
8
Appeal 2017-002064
Application 14/044,418
Final Act. 9—10
Appellant contends that the Examiner has failed to establish a prima
facie case of obviousness in that the Examiner has not connected the
inhibition of IL-la with reduction in MACE or restenosis in human subjects
following surgical treatment of a stenosed vessel. Appeal Br. 15. Appellant
contends that Morton does not specifically describe experiments which
inhibit IL-la and Simard does not refer to the reduction of MACE or
restenosis. Id. at 15—16.
Appellant argues that Morton discloses experiments that “are highly
experimental and do not replicate normal disease process.” Appeal Br. 16.
Appellant argues that Morton dopes not teach the blocking of IL-la alone.
Id. Appellant also argues that Morton uses a pig model which does not
mimic the situation in humans. Id.
Principles of Law
[T]he examiner bears the initial burden, on review of the
prior art or on any other ground, of presenting a prima facie
case of unpatentability. If that burden is met, the burden of
coming forward with evidence or argument shifts to the
applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Analysis
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
9
Appeal 2017-002064
Application 14/044,418
Answer regarding this rejection. We find the Examiner has established that
the claims would have been obvious over Morton combined with Simard.
Appellant has not produced evidence showing, or persuasively argued, that
the Examiner’s determinations on obviousness are incorrect. Only those
arguments made by Appellant in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
§ 41.37(c)(l)(iv) (2015). Appellant does not separately argue the claims.
We have identified claim 1 as representative; therefore, all claims fall with
claim 1. We address Appellant’s arguments below.
Appellant contends that the Examiner has failed to connect the
inhibition of IL-la with reduction of MAC or restenosis. Appeal Br. 15.
We are unpersuaded. Morton teaches that restenosis arises from stereotypic
response to injury to the arterial wall and that inflammation is associate with
restenosis. Morton 494, col 1. Morton also teaches that the inflammation is
initiated by action of IL-1 and that the use of an IL-1 antagonist inhibits
damage to the vessel wall and reduces inflammation. Morton 499. In
addition, Simard teaches the use of an IL-1 a antibody to treat pathologies
caused by aberrant IL-1 a expression including vascular disorders. Simard 1
3.
Appellant next argues that the work disclosed in Morton is highly
experimental and does not replicate normal disease processes. Appeal Br.
16. Again, we are unpersuaded. As the Examiner points out and discussed
further below, the art recognizes that the porcine model is applicable to
human restenosis. Ans. 16.
10
Appeal 2017-002064
Application 14/044,418
Appellant argues that Morton does not differentiate between the
different IL-1 receptor ligands and that this would not lead one to use an IL-
1 a antagonist. Appeal Br. 16. Appellant’s argument is not persuasive. As
the Examiner correctly finds that Morton does provide data which
differentiates the effect of different IL-1 ligands. Ans. 17.
Finally, Appellant argues that Morton teaches that the porcine model
used in Morton does not mimic human disease. Appeal Br. 16—17. We
remain unpersuaded. While Morton does point out some of the limitations
of using a porcine model, Morton goes on to note that, notwithstanding the
limitations of the porcine model, “the model has correctly predicted clinical
response, both the beneficial effects of sirolimus and paclitaxel and
deleterious effect of gold stent coatings.” Morton 500, col. 2. Morton
concludes that based on the porcine model, IL-1 antagonist therapy has
beneficial effects on coronary artery response to injury. Id.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 would have been obvious over Morton
combined with Simard.
Claims 2, 3, and 6—8 have not been argued separately and therefore
fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection under 35 U.S.C. § 102(b).
We affirm the rejection under 35 U.S.C. § 103(a).
11
Appeal 2017-002064
Application 14/044,418
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
12