Ex Parte Hossainy et al

Patent Trial and Appeal Board

Apr 13, 2017

13953656 (P.T.A.B. Apr. 13, 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.
13/953,656 07/29/2013 Syed F.A. Hossainy 050623.01644 2924
45159 7590
SQUIRE PB (Abbott)
275 BATTERY STREET, SUITE 2600
SAN FRANCISCO, CA 94111-3356
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
04/17/2017 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):
sfripdocket @ squirepb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SYED F.A. HOSSAINY,
FUH-WEI TANG, LOTHAR W. KLEINER, THIERRY GLAUSER,
YIWEN TANG, WOUTER E. ROORDA, STEPHEN D. PACETTI,
GINA ZHANG, YUNG-MING CHEN, ANDREW F. MCNIVEN,
SEAN A. MCNIVEN, and BRANDON J. YOE
Appeal 2016-002125
Application 13/953,65 61
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN G. NEW, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a process in
which pressure greater than ambient pressure is applied to a medical device
with a polymer coating. The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We reverse.
1 Appellants identify Abbott Cardiovascular Systems Inc., as the real party in
interest. App. Br. 3.
Appeal 2016-002125
Application 13/953,656
STATEMENT OF THE CASE
The following rejections have been entered and maintained by the
Examiner:
(1) Claims 1—3, 5, 12, 16, 17, 21, and 22, rejected under
35 U.S.C. § 103(a) as unpatentable over Pacetti ’4622 and DesNoyer3
(Final Act. 5—9; Ans. 3);
(2) Claims 1—3, 5, 12, 16, 17, 21, and 22, rejected for
obviousness-type double patenting over claims 1—3, 8, and 10 of
Pacetti ’462 (Final Act. 2—\\ Ans. 3); and
(3) Claims 1—3, 5, 12, 16, 17, 21, and 22, rejected for
obviousness-type double patenting over claims 1—3, 8, and 10 of
Pacetti ’3914 (Final Act. 4; Ans. 3)
Claims 1 and 21, the sole independent claims on appeal, are
representative and read as follows (App. Br. 15, 18 (emphasis
added)):
1. A method comprising:
obtaining a medical device with a polymeric coating
layer, the polymeric coating layer having been dried;
applying a pressure greater than ambient to the dried
polymeric layer of the medical device using a pressure vessel;
and
optionally applying heat to the dried polymeric layer of
the medical device in combination with the application of the
pressure.
2 US 6,743,462 B1 (issued June 1, 2004).
3 US 2005/0288481 A1 (published Dec. 29, 2005).
4 US 7,335,391 B1 (issued Feb. 26, 2008).
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Application 13/953,656
21. A method comprising:
obtaining a medical device with a polymeric coating
layer, the polymeric coating layer having been dried;
applying a pressure greater than ambient to the dried
polymeric layer of the medical device using a pressure vessel,
the pressure sufficient to create a mechanical deformation of the
polymeric layer of the medical device; and
optionally applying heat to the dried polymeric layer of
the medical device in combination with the application of the
pressure.
OBVIOUSNESS
The Examiner’s Prima Facie Case
The Examiner found that Pacetti ’462 discloses a process that differs
from the rejected claims in that Pacetti ’462 dries and pressurizes the
polymer coating on its device simultaneously, whereas Appellants’
independent claims 1 and 21 require the polymer coating on the medical
device to first be dried, after which pressure is applied to the coating. Final
Act. 6—7. The Examiner contends, however, that
absent evidence of criticality, it would have been obvious to dry
the polymeric coating layer before application of pressure in
view of MPEP 2144.04 which discloses[] “Ax parte Rubin, 128
USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a
process of making a laminated sheet wherein a base sheet is
first coated with a metallic film and thereafter impregnated with
a thermosetting material was held to render prima facie obvious
claims directed to a process of making a laminated sheet by
reversing the order of the prior an process steps.). See also In
re[\Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946)
(selection of any order of performing process steps is prima
facie obvious in the absence of new or unexpected results);
In re[\Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).”
Final Act. 7 (underlining emphasis by Examiner).
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Application 13/953,656
The Examiner cited DesNoyer to show the obviousness of pulsed
pressure application, recited in certain dependent claims. Final Act. 7—8.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability. . . .
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.
Appellants persuade us that the Examiner’s conclusion of obviousness
is not supported by a preponderance of the evidence.
Although the Supreme Court has emphasized “an expansive and
flexible approach” to the obviousness question, KSR Int 7 Co. v. Teleflex
Inc., 550 U.S. 398, 415 (2007), the Court also has reaffirmed the importance
of determining “whether there was an apparent reason to combine the known
elements in the fashion claimed by the patent at issue.” Id. at 418 (emphasis
added).
Thus, as our reviewing court has explained, “section 103 requires a
fact-intensive comparison of the claimed process with the prior art rather
than the mechanical application of one or another per se rule.” In re Ochiai,
71 F.3d 1565, 1571 (Fed. Cir. 1995); see also id. at 1572 (“[RJeliance on per
se rules of obviousness is legally incorrect and must cease.”).
Ultimately, therefore, “[i]n determining whether obviousness is
established by combining the teachings of the prior art, the test is what the
combined teachings of the references would have suggested to those of
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Application 13/953,656
ordinary skill in the art.” In re GPACInc., 57 F.3d 1573, 1581 (Fed. Cir.
1995) (internal quotations omitted).
In the present case, as seen above, independent claims 1 and 21 both
require obtaining a medical device with a dried polymeric coating, and then
applying a pressure greater than ambient to the dried polymeric coating.
App. Br. 15, 18.
In contrast, Pacetti ’462 discloses that pressure greater than ambient
should be applied while the coating is drying, that is, before the polymeric
coating has dried:
For a solvent having a high vapor pressure (e.g., above
30 torr at the temperature of application), or in other words
volatile solvents, the solvent evaporates extremely rapidly from
the composition, leading to difficulties in the application of the
composition to the stent. Application of such compositions
often lead to coatings having powdered consistency and poor
adhesion of the coating to the surface of the stent. Increasing
the pressure in pressure chamber 10 above ambient pressure
causes the solvent to evaporate more slowly leading to a
coating with a smoother surface, more uniform composition,
and better adhesion.
Pacetti ’462, 4:20-30 (emphasis).
Thus, as is evident, Pacetti ’462’s reason for increasing the pressure
while the polymer coating is drying is to slow solvent evaporation, thereby
improving the properties of the resulting dried coating. As is also evident,
applying pressure after the polymer has dried as recited in claims 1 and 21,
that is, after the solvent has already evaporated, would not slow solvent
evaporation and, therefore, would not yield the improvement in the coating
process taught in Pacetti ’462. Accordingly, because applying pressure to
the coating after the coating has dried would negate Pacetti ’462’s entire
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Application 13/953,656
reason for applying pressure, the Examiner does not persuade us that
Pacetti ’462, even when viewed in light of DesNoyer, would have suggested
the process recited in Appellants’ claims 1 and 21. We, therefore, reverse
the Examiner’s rejection of those claims, and their dependents, over
Pacetti ’462 and DesNoyer.
We acknowledge the Examiner’s reliance on MPEP § 2144.04. See
Ans. 4. Nevertheless, we see nothing in that section or the cases cited
therein requiring us, based solely on an alleged per se rule, to hold obvious a
process claim when the Examiner has advanced no specific evidence, based
either on the prior art or an ordinary artisan’s general knowledge, suggesting
the particular order of steps required by the claim.
To the contrary, as noted above, our reviewing court has expressly
explained to the PTO that “reliance on per se rules of obviousness is legally
incorrect and must cease.” In re Ochiai, 71 F.3d at 1572; see also id. at
1571 (“[Sjection 103 requires a fact-intensive comparison of the claimed
process with the prior art rather than the mechanical application of one or
another per se rule.”).
In sum, for the reasons discussed, we reverse the Examiner’s rejection
of claims 1 and 21, and their dependents, over Pacetti ’462 and DesNoyer.
DOUBLE PATENTING
In rejecting Appellants’ claims 1—3, 5, 12, 16, 17, 21, and 22 for
obviousness-type double patenting over claims 1—3, 8, and 10 of
Pacetti ’462, the Examiner contends that the rejected claims and allegedly
conflicting claims of Pacetti ’462 recite “common subject matter as follows:
applying greater than ambient pressure to a polymer coating layer on the
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surface of a medical device, wherein the polymer can comprise poly D,L
lactide and wherein the active ingredients include anti-proliferative agents.”
Final Act. 4.
In rejecting Appellants’ claims 1—3, 5, 12, 16, 17, 21, and 22 for
obviousness-type double patenting over claims 1—3, 8, and 10 of
Pacetti ’391, the Examiner similarly finds that the allegedly conflicting
claims of Pacetti ’391 recite “common subject matter” with the rejected
claims. Final Act. 4.
We reverse these rejections as well. As the Examiner concedes
(Ans. 9), claim 1 of Pacetti ’462 recites a process in which greater than
ambient pressure is applied while the polymer coating is being placed on the
medical device, rather than after the coating is dried, as required by
Appellants’ claims 1 and 21. See Pacetti ’462, 7:14—28 (solvent-containing
composition applied to medical device while device is disposed in
pressurized environment (step (c)).
Claim 1 of Pacetti ’391 similarly recites pressurizing before and
during coating, rather than after the coating is dried. See Pacetti ’391, 7:21—
31 (adjusting pressure is “followed by” applying coating to medical device).
Thus, contrary to the Examiner’s assertion, because the rejected
claims recite a different order of steps than the order recited in the allegedly
conflicting claims of Pacetti ’462 and ’391, the rejected claims do not recite
“common subject matter” with the claims of Pacetti ’462 and ’391.
In addition, the Examiner does not advance evidence explaining why
an ordinary artisan would have considered it obvious to modify the
processes recited in the claims of Pacetti ’462 and ’391 to arrive at a process
having the order of steps required by the rejected claims. Rather, the
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Examiner again bases the conclusion of obviousness on MPEP § 2144.04.
Ans. 9.
Essentially for the reasons discussed above as to the Examiner’s
obviousness rejection, we are not persuaded that the Examiner has explained
adequately why the process recited in the rejected claims would have been
obvious over the claims of Pacetti ’462 and ’391. We, therefore, reverse
both of the Examiner’s rejections for obviousness-type double patenting.
SUMMARY
We reverse each of the Examiner’s rejections.
REVERSED
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