Ex Parte Hofmann et al

Patent Trial and Appeal Board

Jun 24, 2016

12376124 (P.T.A.B. Jun. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/376, 124 0410612009
23117 7590 06/28/2016
NIXON & V ANDERHYE, PC
901 NORTH GLEBE ROAD, 11 TH FLOOR
ARLINGTON, VA 22203
FIRST NAMED INVENTOR
Heinrich Hofmann
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
DMB-2590-276 4213
EXAMINER
BECKHARDT, LYNDSEY MARIE
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
06/28/2016 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):
PTOMAIL@nixonvan.com
pair_nixon@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HEINRICH HOFMANN,
LAURENT-DOMINIQUE PIVETEAU,
and FREDERIC NEFTEL
Appeal2013-004376 1
Application 12/376, 124
Technology Center 1600
Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
MELANIE L. McCOLLUM, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to porous
coatings that allow controlled release of fluids, including drugs. The
Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b ). We reverse.
1 DEBIOTECH S.A. is the real party in interest. App. Br. 3.
Appeal2013-004376
Application 12/376, 124
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner's rejection of
claims 1-5 and 8-15 under 35 U.S.C. § 103(a), for obviousness over
Brandau, 2 Yan, 3 Kelemen, 4 and Zaffaroni5 (Final Action 3-7).
Claim 1, the sole independent claim under rejection, illustrates the
appealed subject matter and reads as follows (App. Br. 13):
1. Porous coating for the controlled release of a fluid
such as a drug comprising:
a porous structure with internal reservoirs and with
passages made of walls,
said reservoirs communicating with an external
environment through said passages in such a way that the fluid
can move between the reservoirs and the external environment,
wherein for at least a group of said passages, each
passage contains a restricting element that is distinct from the
passage walls, and the restricting element partially reduces a
cross section of the passage and thereby induces a flow
restriction for the fluid circulating through said passage.
The Specification explains that coatings with the claimed features are
useful for delivering drugs in a controlled fashion from implanted devices
such as stents or dental implants. Spec. 7.
2 US Patent No. 6,709,379 Bl (issued Mar. 23, 2004). We note that the
Examiner entered an incorrect patent number for Brandau on page 3 of the
Final Action. See Final Action 3.
3 US Patent No. 5,843,172 (issued Dec. 1, 1998).
4 US Patent No. 5,716,526 (issued Feb. 10, 1998).
5 US Patent No. 3,948,254 (issued Apr. 6, 1976).
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Application 12/376, 124
OBVIOUSNESS
The Examiner's Position
The Examiner cited Brandau as disclosing a coating having a majority
of the features of the claimed coating, and cited Yan, Kelemen, and
Zaffaroni as evidence that the claimed features not present in Brandau' s
coating would have been considered obvious elements of Brandau's coating.
Final Action 3-7. In particular, the Examiner found that Brandau did not
"ipsis verbis teach wherein the restricting element is distinct from the
passage walls (claim 1)." Id. at 4. The Examiner found also that Brandau
did not "ipsis verbis teach wherein the restricting element partially reduces a
cross section of the passage (claim 1)." Id. at 5.
To address those deficiencies, the Examiner cited Kelemen as
teaching a ceramic filter "wherein the pores comprise an additional coating
layer (figure IA) and the filter is taught to be used bioactive agents (column
3, lines 60-65). [Kelemen] teaches the use of partial plugs in the pores
(Figures 3B and 3C, column 3, lines 15-25)." Id. at 6.
Based on these teachings, the Examiner reasoned that an ordinary
artisan would have considered it obvious to use Kelemen's partial plug in
the pores of Brandau's coating "because [Kelemen] teaches a partial plug as
a modification of the pores within a membrane (column 6, lines 30-40) and
[Brandau] teaches additional coating layer as a cover protective layer
(column 5, lines 5-18)." Id.
The Examiner reasoned that an ordinary artisan would have had a
reasonable expectation of success in making this modification "because
[Zaffaroni] teaches the use of a porous membrane covering a drug
containing reservoir is known in the art and is used to control the rate for
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Application 12/376, 124
prolonged release (abstract, figures 1-2)." Id. The Examiner further
reasoned that an ordinary artisan would have had "a reasonable expectation
of success as [Zaffaroni] exemplifies the use of a microporous membrane
covering a drug reservoir (column 21, lines 5-20) and [Kelemen] specifically
teaches the use of partial plugs inside a pore (Figures 3B and 3C, column 3,
lines 15-25)." Id. at 6-7.
Analysis
As stated inin 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.
In KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), although
the Supreme Court emphasized "an expansive and flexible approach" to the
obviousness question, the Court also 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.
Thus, even post-KSR, "[ o ]bviousness requires more than a mere
showing that the prior art includes separate references covering each
separate limitation in a claim under examination." Unigene Laboratories,
Inc. v. Apotex, Inc., 655 F.3d 1352, 1360 (Fed. Cir. 2011).
Instead, "[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 ordinary skill
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Application 12/376, 124
in the art." In re GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal
quotations omitted).
We are not persuaded that a preponderance of the evidence supports
the Examiner's prima facie case of obviousness. In particular, we are not
persuaded that the cited references would have suggested modifying the
cavities or passages in Brandau's coating to include the partial plugs
described in Kelemen, as the Examiner posits.
We acknowledge Brandau's disclosure, identified by the Examiner, of
an implant coating with cavities that include a drug-containing reservoir and
passage allowing movement of the drug from the reservoir to the outer
environment. Brandau, Fig. 5b; see also id. at col. 9, 11. 3-17. We
acknowledge also Brandau's teaching that its coating can include a
dissolving or removable covering layer separating the reservoir/passage
from the outer environment. Id. at col. 5, 11. 6-18. We acknowledge further
Brandau's teaching that the anodization process used to produce the cavities
in the coating can be varied to optimize shape and drug release properties of
the cavities. Id. at col. 3, 11. 55----67. We acknowledge further that the
surfaces of the cavities can be modified to include substances allowing
binding of the drug to the cavity surfaces. Id. at col. 4, 11. 61----65.
As Appellants argue, however (App. Br. 9-10; Reply Br. 5----6), rather
than being directed to a drug-releasing coating, Kelemen is directed to a
filter that is used to separate liposomes from a fluid medium. See, e.g.,
Kelemen, abstract. We acknowledge specifically Kelemen's disclosure,
identified by the Examiner, of including partial plugs in the pores of the
membrane portion of a two-layer filter used for separating liposomes from a
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Application 12/376, 124
liquid. Id. at Fig. 3B; see also id. at col. 6, 11. 31--42 (describing
modification of pores with partial plugs).
We are not persuaded, however, that the Examiner has explained
adequately why Kelemen's disclosure, of an element used to optimize the
filtration of liposomes from a liquid medium, would have prompted an
ordinary artisan to use that element in an entirely different application
(Brandau's drug-releasing coating). In particular, we agree with Appellants
that the Examiner has not explained adequately why Kelemen's teaching of
the usefulness partial plugs in a filter for purifying liposomes would have
prompted an ordinary artisan to include those plugs in Brandau's drug-
releasing coating.
The Examiner's arguments do not persuade us to the contrary. As the
Examiner argues (Ans. 10-11), and as noted above, Brandau teaches
methods by which the size, shape, and drug-binding properties of the
cavities in its coatings can be optimized to affect the coating's drug release
properties. As the Examiner contends (Final Action 6-7; Ans. 12-13)
Zaffaroni discloses and exemplifies a drug-releasing device that includes a
microporous membrane that covers a drug-containing reservoir or core. See
Zaffaroni, col. 3, 11. 42--63; col. 21, 11. 5-22. As the Examiner contends also
(Final Action 7), Yan teaches that the pores of a drug-containing stent may
range in size from 0.01to20 microns. Yan, col. 3, 11. 55--67. Those facts do
not persuade us, however, that, rather than using methods expressly taught in
Brandau, an ordinary artisan instead would have looked to teachings in a
reference (Kelemen), directed to a substantially different pursuit, for
techniques that might be useful in modifying Brandau's coatings.
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Application 12/376, 124
In sum, for the reasons discussed, we are not persuaded that the cited
references would have suggested modifying the cavities or passages in
Brandau's coating to include the partial plugs described in Kelemen, as the
Examiner posits. Accordingly, we are not persuaded that the Examiner has
shown that a coating having all of the features required by claim 1 would
have been obvious to an ordinary artisan. We, therefore, reverse the
Examiner's obviousness rejection of claim 1, and its dependent claims 2-5
and 8-15 over Brandau, Yan, Kelemen, and Zaffaroni.
SUMMARY
For the reasons discussed, we reverse the Examiner's rejection of
claims 1-5 and 8-15 for obviousness over Brandau, Yan, Kelemen, and
Zaffaroni.
REVERSED
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