CARDIONOVUM GMBH

Patent Trials and Appeals Board

Aug 11, 2021

2021002014 (P.T.A.B. Aug. 11, 2021)

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.
14/888,380 10/30/2015 Michael Orlowski ABK004.002APC 4641
20995 7590 08/11/2021
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE, CA 92614
EXAMINER
WESTERBERG, NISSA M
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
08/11/2021 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):
efiling@knobbe.com
jayna.cartee@knobbe.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MICHAEL ORLOWSKI
__________

Appeal 2021-002014
Application 14/888,380
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, TAWEN CHANG, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to an
angioplasty balloon catheter coated with paclitaxel and a water soluble
shellac salt. The Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as
Cardionovum GmbH (see Appeal Br. 6). We have considered the
Specification of Oct. 30, 2015 (“Spec.”); Non-Final Office Action of May
13, 2020 (“Non-Final Act.”); Appeal Brief of Oct. 10, 2020 (“Appeal Br.”);
Examiner’s Answer of Nov. 27, 2020 (“Ans.”); and Reply Brief of Jan. 27,
2021 (“Reply Br.”). An oral hearing was held on Aug. 2, 2021.
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Statement of the Case
Background
“Implantation of vessel grafts such as stents has become a well-
established surgical intervention for the treatment of stenosis. In this
context, so-called restenosis (recurrent stenosis), i.e. the reocclusion of the
vessel is a frequently occurring complication” (Spec. 1:10–14). “To avoid
such problems . . . while the catheter balloon is dilated . . . a sufficient
amount of pharmacological agent is transferred to the vessel wall to avoid
re-constriction or reocclusion of the vessel due to the dilatation of the vessel
and the delivery of active agents” (id. at 1:22–28).
The Specification teaches an objective of the present invention is that
“a coating is created which is homogenously detached from the balloon and
can be effectively transferred to the vessel wall so that an optimal
bioavailability of the active agent and a therapeutic effect concerning
reduction of restenosis can be achieved” (Spec. 2:32–35).
The Claims
Claims 1–4, 11, 12, 14, 15, 21, 22, and 24–27 are on appeal.
Independent claim 1 is representative and reads as follows:
1. An angioplasty balloon catheter comprising a balloon
which has a coating, wherein the coating consists of paclitaxel
and a water soluble shellac salt as a matrix, wherein the coating
transfers a therapeutically effective amount of the paclitaxel
directly to a vessel wall during a balloon angioplasty procedure.

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The Issues
A. The Examiner rejected claims 1, 2, 11, 12, 14, 15, 21, 22, and 24–27
under 35 U.S.C. § 103(a) as obvious over Orlowski ’5012 and Durig3 (Ans.
3–5).
B. The Examiner rejected claims 3 and 4 under 35 U.S.C. § 103(a) as
obvious over Orlowski ’501, Durig, and Shanley4 (Ans. 6–7).
C. The Examiner rejected claim 26 under 35 U.S.C. § 103(a) as obvious
over Orlowski ’501, Durig, and Shobu5 (Ans. 7–8).
D. The Examiner rejected claims 1, 2, 11, 12, 14, 15, 21, 22, and 24–27
under 35 U.S.C. § 103(a) as obvious over Orlowski ’501 and Reduick6 (Ans.
8–9).
E. The Examiner rejected claim 26 under 35 U.S.C. § 103(a) as obvious
over Orlowski ’501, Reduick, and Shobu (Ans. 10–11).
F. The Examiner rejected claims 3 and 4 under 35 U.S.C. § 103(a) as
obvious over Orlowski ’501, Reduick, Shobu, and Shanley (Ans. 11).
G. The Examiner rejected claims 1, 2, 11, 12, 14, 15, 21, 22, and 24–27
on the grounds of non-statutory obviousness-type double patenting over
claims 1–5 of US 10,293,085 and Orlowski ’501, Durig, and Reduick (Ans.
11–12).

2 Orlowski, EP 2,243,501 A1, published Oct. 27, 2010.
3 Durig et al., WO 2009/064429 A1, published May 22, 2009.
4 Shanley, US 2008/0097581 A1, published Apr. 24, 2008.
5 Shobu et al., US 2004/0103821 A1, published June 3, 2004.
6 Reduick et al., US 3,390,049, issued June 25, 1968. This somewhat
illegible reference has been identified as Rednick (see Non-Final Act. 18;
Appeal Br. 25) or Reduick (see Ans. 8; Reply Br. 1). We will use “Reduick”
consistent with the more recent papers.
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H. The Examiner rejected claims 1–4, 11, 12, 14, 15, 21, 22, and 24–27
on the grounds of non-statutory obviousness-type double patenting over
claims 1–5 of US 10,293,085 and Orlowski ’501, Durig, Reduick, and
Shanley (Ans. 12–13).
I. The Examiner rejected claims 1, 2, 11, 12, 14, 15, 21, 22, and 24–27
on the grounds of non-statutory obviousness-type double patenting over
claims 1–5 of US 10,293,085 and Orlowski ’501, Durig, Reduick, and
Shobu (Ans. 13–14).
J. The Examiner rejected claims 1, 2, 11, 12, 14, 15, 21, 22, and 24–27
on the grounds of non-statutory obviousness-type double patenting over
claims 1–6, 9–12, 14, and 15 of US Application 16/411,801 and Orlowski
’501, Durig, Reduick (Ans. 14–15).
K. The Examiner rejected claims 1–4, 11, 12, 14, 15, 21, 22, and 24–27
on the grounds of non-statutory obviousness-type double patenting over
claims 1–6, 9–12, 14, and 15 of US Application 16/411,801 and Orlowski
’501, Durig, Reduick, and Shanley (Ans. 15–16).
L. The Examiner rejected claims 1, 2, 11, 12, 14, 15, 21, 22, and 24–27
on the grounds of non-statutory obviousness-type double patenting over
claims 1–6, 9–12, 14, and 15 of US Application 16/411,801 and Orlowski
’501, Durig, Reduick, and Shobu (Ans. 16–17).

A. 35 U.S.C. § 103(a) over Orlowski ’501 and Durig
The issues with respect to this rejection are:
(i) Does a preponderance of the evidence of record support the
Examiner’s conclusion that the prior art renders the claims obvious?
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(ii) If so, has Appellant provided evidence of unexpected results that,
when balanced with the prima facie case, supports a finding of non-
obviousness?
Findings of Fact
1. Orlowski ’501 teaches “a method for coating catheter balloons
preferably textured catheter balloons with the pharmacological agent
paclitaxel and the biological and biodegradable polymer composition
shellac” (Orlowski ’501 ¶ 1).
2. Orlowski ’501 teaches “[p]roperties of shellac are: . . . Shellac
is water soluble in water-alkaline solutions . . . Examples for industrial uses:
Coating of pills & tablets” (Orlowski ’501 ¶ 20).
3. Orlowski ’501 teaches “it is an objective to apply the active
agent paclitaxel onto a catheter balloon in such manner that a coating is
created which is easily detached from the balloon and can be effectively
transferred to the vessel wall” (Orlowski ’501 ¶ 6).
4. Orlowski ’501 teaches that “[d]ue to the inventive coating
method, the paclitaxel-shellac composite dried at the surface of the catheter
balloon has a special consistence, which is hard to characterize but seems to
be essential for the transfer to the cell wall and the incorporation, especially
into the smooth muscle cells” (Orlowski ’501 ¶ 70).
5. The Examiner finds Orlowski ’501 does not exemplify the use
of a water soluble shellac salt (Ans. 4).
6. Durig teaches: “Traditionally these water soluble coatings have
been applied from organic solvent based coating solutions. However due to
environmental and safety concerns and the costs associated with organic
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solvent coating, aqueous based dispersions and pseudo-latex systems of
some of the above polymers are increasingly preferred” (Durig ¶ 5).
7. During teaches
Shellac is a natural, food approved, resinous material
obtained from the exudate of the insect Karria lacca. It is a
complex mixture of materials. The two main components with
enteric properties being shelloic and aleuritic acid. While
shellac is well known as a material with enteric-like properties,
it has a number of drawbacks. Due to insolubility in water,
shellac has traditionally been used in the form of organic
solvent based solutions. Additionally in its natural state, shellac
is generally not soluble below a pH of 7.5 to 8.0. Rather shellac
films simply soften and disintegrate after immersion in water
for a number of hours. This is problematic as enteric coatings
should generally be soluble or rupturable at approximately pH
6.8. Lastly shellac coatings have been reported to undergo
esterification during aging, rendering the film completely water
insoluble even in alkaline pH.
(Durig ¶ 9).
8. Durig teaches “[s]everal forms of aqueous ammoniated shellac
dispersions are also commercially available, for example Certiseal® FC
300A film coat product, manufactured by Mantrose Haeuser, a subsidiary of
RPM Corporation. Esterification of the shellac is also limited in these
systems as shellac forms a salt with the ammonia or protonated amino acid”
(Durig ¶ 11).
9. Durig teaches the “present invention also relates to a dry form
of shellac, anionic polymer and ammonium carbonate which can be readily
dispersed in water to produce shellac coatings on various substrates” (Durig
¶ 19).
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10. Durig teaches
the advantage of the dry powder formulation as an enteric
coating delivery system which can be prepared in advance and
stored for an extended period of time and transported without
concern for stability and without the added cost and bulk of
shipping water, but can be prepared in a single step for coating
in as little as minutes, with good results.
(Durig ¶ 45).
11. The Examiner finds that both Orlowski ’501 and Durig
“disclose the application of a shellac coating to a pharmaceutical substrate
and thus it would be obvious to replace the non-water soluble shellac of
Orlowski with the water-soluble shellac of” Durig (Non-Final Act. 13)
because, “[d]ue to environmental, safety and cost considerations, aqueous
based coatings are increasingly preferred” (id. at 11).
Principles of Law
“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). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id at 417.
Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Ans. 3–5, FF 1–11) and agree that the combination of Orlowski ’501 and
Durig renders the claims obvious. We address Appellant’s arguments
below.
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Prima facie obviousness
Appellant contends “Durig teaches the use of a dry powder
formulation as an outer, enteric coating for an oral tablet. . . .Thus, Durig is
not in the same field of endeavor as Claim 1 of the present application,
which is directed to an angioplasty catheter balloon” (Appeal Br. 12).
Appellant further asserts
the pertinent problem faced by the inventor in the present
application is to apply an active agent, especially preferring the
active agent to be paclitaxel or sirolimus, onto a catheter
balloon in such a manner that a coating is created which is
homogenously detached from the balloon and can be effectively
transferred to the vessel wall so that an optimal bioavailability
of the active agent and a therapeutic effect concerning reduction
of restenosis can be achieved. . . . Durig, which teaches the use
of a dry powder formulation as an outer, enteric coating for an
oral tablet, is not reasonably pertinent to the aforementioned
problem.
(id.).
We are not persuaded based on the analogous arts test. “Prior art is
analogous if it is from the same field of endeavor or if it is reasonably
pertinent to the particular problem the inventor is trying to solve.” Circuit
Check Inc. v. QXQ Inc., 795 F.3d 1331, 1335 (Fed. Cir. 2015). As to the
field of endeavor, Bigio requires us “to determine the appropriate field of
endeavor by reference to explanations of the invention’s subject matter in
the patent application, including the embodiments, function, and structure of
the claimed invention.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004).
While the field of endeavor might be viewed as coatings on medical
materials used in the human body, a framing that would encompass
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Orlowoski ’501, Durig and the claimed invention, we think the court would
likely find this overbroad.
As to whether the prior art is pertinent to the inventor’s problem,
however, the Specification teaches the “application of aqueous shellac
solutions of water soluble shellac salts, such as Aqualacca® or Aquagold®
does not only avoid the problems with organic solvent systems but also
reproves the performance of the obtained coating by stable dissolution or
respectively release characteristics, especially after extended storage time”
(Spec. 8:7–11). In these passages, the Specification identifies two problems
with the prior art shellac coatings, the use of organic solvent systems and
concerns with regard to stability and storage time.
Durig teaches, relative to coatings, that “due to environmental and
safety concerns and the costs associated with organic solvent coating,
aqueous based dispersions and pseudo-latex systems of some of the above
polymers are increasingly preferred” (FF 6). Durig further teaches a dry
form of shellac that “can be prepared in advance and stored for an extended
period of time and transported without concern for stability” (FF 9).
Thus, Durig is pertinent to both problems identified by the
Specification. Durig teaches that aqueous systems such as the disclosed
forms of shellac are preferred to compositions with organic solvents, a
concern shared with the Specification, and Durg teaches a stable form of
shellac that addressed the extended storage time concern of the
Specification. We, therefore, agree with the Examiner that Durig is
analogous art because Durig is reasonably pertinent to the particular problem
the inventor is trying to solve.
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Appellant contends
In view of Orlowski’s teachings about paclitaxel (poor
solubility in water and instability at alkaline pH) and the need
for an organic solvent, Appellant respectfully submits that a
person of skill in the art would not be motivated to select a
water soluble shellac salt to “obviate the need for organic
solvents” because such a combination would not be expected to
work in the absence of an organic solvent.
(Appeal Br. 14). Appellant further contends a “person of ordinary skill in
the art would not expect sequential coating to result in the coating recited in
Claim 1 in which paclitaxel and water soluble shellac salt are in a matrix
arrangement” (id.).
We find these arguments unpersuasive because, as the Examiner
points out, “sequentially applied coating solutions would be free to mix,
forming a coating paclitaxel and shellac as the matrix on the outside of the
balloon” (Ans. 20). We do not find any definition of the term “matrix”
within the Specification, or any specific limitation rquiring that the “matrix”
cannot be composed of two separate, adjacent layers. Thus, two layers, one
of paclitaxel and a protecting layer of shellac fall within the broadest
reasonable scope of the claim. “[D]uring patent prosecution when claims
can be amended, ambiguities should be recognized, scope and breadth of
language explored, and clarification imposed.” In re Zletz, 893 F.2d 319,
321 (Fed. Cir. 1989).
Moreover, Appellant does not provide any persuasive evidence that
paclitaxel would have been insufficiently water soluble to form a mixture
with the water soluble shellacs to result in a matrix form of intermixed
components with an therapeutically effective amount of paclitaxel.
Orlowski ’501 teaches that shellac may be water soluble (FF 2). Orlowski
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’501 does state paclitaxel is “comparatively poorly soluble in water”
(Orlowski ’501 ¶ 30), but Orlowski ’501 does not state that paclitaxel is
insoluble in water. Thus, the ordinary artisan would recognize paclitaxel has
some aqueous solubility based on this teaching in Orlowski ’501. Appellant
provides no persuasive evidence that the combination would not be expected
to function in aqueous solution.
Also, Durig teaches “aqueous ammoniated shellac dispersions are also
commercially available” (FF 8) and that polymer and shellac “can be readily
dispersed in water to produce shellac coatings on various substrates” (FF 9).
We appreciate that the claims exclude polymer due to the “consisting of”
language, but Durig teaches that shellac dispersions were known, and
disclosed examples and preferred embodiments do not constitute a teaching
away from a broader disclosure or non-preferred embodiments. In re Susi,
440 F.2d 442, 446 n.3 (CCPA 1971).
Thus, we agree with the Examiner that Durig’s aqeous, commercially
available shellac would have advantages of stability and be preferred “due to
environmental and safety concerns” (FF 6) and therefore provide a reason
and motivation for the use of Durig’s shellac salt in the place of the shellac
of Orlowski ’501.
Appellant contends:
The evidence of record establishes that water soluble shellac
salt, as recited in Claim 1, is a different material having
different properties from the non-salt form of shellac disclosed
in Orlowski. The Examiner has not cited to any disclosure in
Durig establishing that water soluble shellac is suitable for the
same uses as a shellac that is only soluble in organic solvents.
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(Appeal Br. 15).7
We are not persuaded because Durig teaches both organic soluble
shellacs and commercially available aqueous ammoniated shellac
dispersions (FF 7–8) and expressly recognizes that both water soluble and
organic soluble coatings may be applied to medical components being
placed for dissolution into the human body (FF 6) including as enteric
coatings on medicaments (FF 10). This similarity of use in body lumens
with the functional shellac of Orlowski ’501 (FF 2, 4) provide evidence for a
reasonable expectation of success in replacing the shellac of Orlowski ’501
with the water-soluble shellac disclosed by Durig. “Obviousness does not
require absolute predictability of success . . . all that is required is a
reasonable expectation of success.” In re Kubin, 561 F.3d 1351, 1360 (Fed.
Cir. 2009).
Appellant cites Farag8 for rates of dissolution of shellacs (see Appeal
Br. 17) and contends
based on the disclosures of Durig and Farag, one of skill in the
art would have no reasonable expectation of success in using a
water-soluble shellac salt in an angioplasty balloon catheter
coating to transfer a therapeutically effective amount of the
paclitaxel to a vessel wall during a balloon angioplasty
procedure, as recited in Claim 1, because such a water-soluble

7 We also are unpersuaded by Appellant’s argument analogizing the shellac
differences to iron where “though both are largely composed of iron, steel
and rust are completely different” (Reply Br. 6). Unlike rust and steel, the
prior art evidences that both types of shellac may be used as coatings for
biological materials in human body lumens, a very different situation.
8 Y. Farag et al., Physicochemical Properties of Various Shellac Types,
http://dissolutiontech.com/DTresour/200905Articles/DT200905_A04.pdf
(2009).
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shellac salt would be expected to dissolve too slowly at the pH
in the bloodstream (approximately 7.37-7.43).
(id. at 17–18). Appellant further contends “there is no indication in the cited
disclosure that the Durig coating would allow a matrix arrangement of
paclitaxel and water soluble shellac to be transferred from the balloon
catheter to a tissue in a short period of time (around 30 seconds)” (id. at 19).
We find these arguments unpersuasive as a red herring. Neither the
Specification nor Orlowski ’501 deliver the paclitaxel/shellac coating with
an expectation that it will dissolve in the 30 to 60 seconds during which the
angioplasty procedure occurs as Appellant argues here, nor is this a
limitation of claim 1. Indeed, claim 1 recites the “coating transfers a
therapeutically effective amount of the paclitaxel directly to a vessel wall”,
not that paclitaxel is released in 30 to 60 seconds.
Also, Orlowski ’501 expressly states “a coating is created which is
easily detached from the balloon and can be effectively transferred to the
vessel wall” (FF 3). Similarly, the Specification states “a coating is created
which is homogenously detached from the balloon and can be effectively
transferred to the vessel wall so that an optimal bioavailability of the active
agent and a therapeutic effect concerning reduction of restenosis can be
achieved” (Spec. 2:32–35). Thus, both the Specificaton and Orlowski ’501
expect the coating to transfer to the vessel during the angioplasty procedure
and more slowly release the active paclitaxel agent, not dissolve in 30 to 60
seconds as Appellant argues here.
Appellant contends regarding Durig’s coating that “[t]here is no
indication that such a coating would allow for release of an active ingredient
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over a short period of time as is required for an angioplasty catheter balloon”
(Appeal Br. 18). Appellant further contends:
One of skill in the art would have no reasonable expectation of
success in arriving at the claimed balloon catheter based on
Durig because there is no indication in the cited disclosure that
the Durig coating would allow a matrix arrangement of
paclitaxel and water soluble shellac to be transferred from the
balloon catheter to a tissue in a short period of time (around 30
seconds) using a mechanical force based release mechanism
after introduction to a pH between approximately 7.37-7.43 to
deliver a therapeutically effective amount of paclitaxel.
(Appeal Br. 18).
We are not persuaded because Orlowski ’501 teaches that the
paclitaxel/shellac composition results in a coating “which is easily detached
from the balloon and can be effectively transferred to the vessel wall” (FF
3). Thus, the Examiner finds “the person of ordinary skill in the art would
have a reasonable expectation of success that a water-soluble salt form of
shellac could be used to prepare the coatings of Orlowski” (Ans. 24). Here,
the Examiner has established a prima facie case of obviousnss, so “the
burden shifts to the applicant to come forward with rebuttal evidence or
argument.” In re Brandt, 886 F.3d 1171, 1176 (Fed. Cir. 2018). Appellant
identifies no persuasive reason or evidence why substitution of the obvious
water-solbule shellac of Durig for the shellac of Orlowski ’501 would alter
the ability to transfer a coating from the angioplasty balloon to the vessel
wall. In particular, we are not persuaded that the pH would be expected to
alter the ability of a coating to be transferred to the vessel wall because
Appellant provides no evidence that pH plays a role in this transfer.
Appellant contends “a person of ordinary skill in the art, taking note
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of the teachings in Durig, would not arrive at a balloon catheter coating as
presently claimed in which the paclitaxel and water soluble shellac salt are
combined in a matrix arrangement” (Appeal Br. 20).
We find this unpersuasive because, as discussed above, neither claim
1 nor the Specification provide any definition of the term “matrix”,
particularly a definition that would distinguish a coated angioplasty balloon
composed of the coatings of Orlowski ’501 and Durig, whether that coating
is composed of paclitaxel embedded in a water-soluble shellac or
overlapping coats of water-soluble shellac and paclitaxel where a coat of
paclitaxel is enclosed by water-soluble shellac. 9 Under either interpretation
of “matrix”, we agree with the Examiner that all elements of the claim are
disclosed in the prior art (FF 1–4, 6–10), and there are reasons for combining
these components (FF 11) with a reasonable expectation of success.
“Absent an express definition in their specification, the fact that appellants
can point to definitions or usages that conform to their interpretation does
not make the PTO’s definition unreasonable when the PTO can point to
other sources that support its interpretation.” In re Morris, 127 F.3d 1048,
1056 (Fed. Cir. 1997). Here, Appellant does not point to any source for a
definition of “matrix” that excludes the composition rendered obvious by
Orlowski ’501 and Durig.
Appellant contends “[a]s described in the Declaration, a top coat . . .
in the field of angioplasty only allows an indirect transfer of an active agent.
Declaration at para. 3. Thus, Appellant submits that the combination of

9 One definition of matrix is a “material in which something is enclosed or
embedded.” See https://www.merriam-webster.com/dictionary/matrix.
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Orlowski and Durig would not ‘consist[] of paclitaxel and a water soluble
shellac salt’” (Appeal Br. 22).
We find this argument unpersuasive for two reasons. First, “[n]on-
obviousness cannot be established by attacking references individually
where the rejection is based upon the teachings of a combination of
references. . . . [The reference] must be read, not in isolation, but for what it
fairly teaches in combination with the prior art as a whole.” In re Merck &
Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Here, the argument and
Declarant’s position fails to read the references together. As the Examiner
points out, “[u]se of the ammonium shellac salt taught by Durig in place of
the non-water soluble shellac in Orlowski results in a coating consisting of
paclitaxel and a water soluble shellac salt while reducing the need for
organic solvents” (Ans. 27). Thus, the combined teachings would be
expected to result in compositions with paclitaxel intermixed with water-
soluble shellac consistent with the disclosure of Orlowski ’501 (FF 4).
Second, to the extent that the Declarant focuses on simply overlapping
layers of paclitaxel and water-soluble shellac that together form a coating on
a balloon catheter, claim 1 does not exclude such transfer. See In re Self,
671 F.2d 1344, 1348 (CCPA 1982) (“[A]ppellant’s arguments fail from the
outset because . . . they are not based on limitations appearing in the
claims.”)
Unexpected results
Appellant contends
the paclitaxel concentration in tissue after deployment of a
catheter balloon as presently claimed was approximately 10
times higher than the concentration after using a catheter
balloon coated with shellac in its acid form. Specification at p.
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37, 11. 6-12. Such a result could not have been contemplated
based on Orlowski and Durig, either alone or in combination.
The specific features that generate these unexpected results are
recited in Claim 1, i.e., a coating with paclitaxel and a water
soluble shellac salt.
(Appeal Br. 22).
Based on the current record, we agree with the Examiner that the
unexpected results are unpersuasive because both the Specification and
Orlowski Declaration10 do not state that the results were compared to the
closest prior art of Orlowski ’501. See In re Baxter Travenol Labs., 952
F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as
evidence of nonobviousness, the results must be shown to be unexpected
compared with the closest prior art.”).
The Orlowski Declaration addresses the comparison by citing to the
Specification (see Orlowski Decl. ¶ 4), which describes a comparison in
Example 10 where “catheters with the following coatings were evaluated:
. . . 3.0 μg/mm2 Paclitaxel and 3.0 μg/mm2 shellac applied as ethanolic
solution (shellac in its acid form; balloon of the prior art)” (Spec. 33:36 to
34:2). The Specification compares the results of Example 10 as shown in
Table 3 to a statement in Example 9 that “inventive catheter balloons
delivered paclitaxel in a concentration of 454.27 μg/g and 515.9 μg/g,
respectively” (Spec. 32:22–23) to conclude the “paclitaxel concentration in
the tissue after deployment of a catheter balloon according to the invention
was approximately 10 times higher (about 500 μg/g) than using a catheter

10 Declaration of Dr. Michael Orlowski, entered Feb. 25, 2020 (date on
Declaration is not legible).
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balloon coated with shellac in its acid form (prior art balloon; after 1 h about
50 μg/g)” (Spec. 37:6–9).
What is lacking from these examples and from the Orlowski
Declaration is any statement evidencing that the prior art balloon is the
closest prior art balloon of Orlowski ’501 as relied upon by the Examiner.
The cited prior art example showed equal amounts of paclitaxel and shellac,
with 3.0 μg/mm2 of each (see Spec. 34:1). While the units are different, in
each of the Examples of Orlowski ’501, non-equal amounts of paclitaxel and
shellac were used, with Example 1 using “50 μg paclitaxel and 100 μg
shellac”; Example 2 using “80 μg of paclitaxel in 1.0 ml of ethyl acetate and
a solution of 100 μg shellac”; and Example 3 using “70 μg of paclitaxel and
50 μg of shellac” (Orlowski ’501 ¶¶ 80, 85, 91). Thus, a reasonable
evaluation of the evidence appears to show that whatever comparison was
made, it was not made with one of the Examples of Orlowski ’501. “[T]he
PTAB is permitted to weigh expert testimony and other record evidence and,
in so doing, rely on certain portions of an expert’s declaration while
disregarding others.” Icon Health and Fitness, Inc. v. Strava, Inc., 849 F.3d
1034, 1041 (Fed. Cir. 2017). Here, there is no persuasive evidence that the
comparison relied upon for the unexpected results was made to the closest
prior art of Orlowski ’501.

Conclusion of Law
(i) A preponderance of the evidence of record supports the Examiner’s
conclusion that the combination of Orlowski ’501 and Durig renders the
claims obvious.
(ii) Appellant has not provided evidence of unexpected results that,
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when balanced with the prima facie case, supports a finding of non-
obviousness.

B.–C. U.S.C. § 103(a) over Orlowski ’501, Durig, and Shanley or Shobu,
Appellant does not separately argue these obviousness rejections,
instead relying upon their arguments to overcome the combination of
Orlowski ’501 and Durig (see Appeal Br. 23–25). Having affirmed the
obviousness of claim 1 for the reasons given above, we also find that the
further combination renders the rejected claims obvious for the reasons
given by the Examiner.

D.–F. U.S.C. § 103(a) over Orlowski ’501 and Reduick
We find Rejections D.–F. cumulative to Rejections A.–C. Therefore,
we do not reach Rejections D.–F. in favor of cumulative Rejections A.–C.
discussed above. See generally Ex parte Heiman, No. 2009-009257, 2010
WL 1003899 (BPAI 2010) (nonprecedential) (vacating cumulative
rejections); Ex parte Gutsch, No. 2009-000249, 2009 WL 1899607 (BPAI
2009) (non-precedential) (vacating cumulative rejections).

G.–L Obviousness-type double patenting
Appellant does not separately argue these obviousness-type double
patenting rejections and provisional obviousness-type double patenting
rejections, instead relying upon their arguments to overcome the
combination of Orlowski ’501 and Durig with the other cited prior art
discussed above. Having affirmed the obviousness of claim 1 for the
reasons given above, we also find that these obviousness-type double
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patenting rejections and provisional obviousness-type double patenting
rejections would have been obvious over the claims of the patents and
applications along with the prior art for the reasons given by the Examiner
(see Ans. 11–17).

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 2, 11, 12,
14, 15, 21,
22, 24–27
103 Orlowski ’501, Durig 1, 2, 11, 12,
14, 15, 21,
22, 24–27

3, 4 103 Orlowski ’501, Durig,
Shanley
3, 4
26 103 Orlowski ’501, Durig,
Shobu
26
1, 2, 11, 12,
14, 15, 21,
22, 24–27
103 Orlowski ’501,
Reduick11

3, 4 103 Orlowski ’501,
Reduick, Shanley12

26 103 Orlowski ’501,
Reduick, Shobu13

1, 2, 11, 12,
14, 15, 21,
22, 24–27
Nonstatutory OTDP
over claims 1–5 of US
10,293,085, Orlowski
’501, Durig, and
Reduick
1, 2, 11, 12,
14, 15, 21,
22, 24–27

11 As indicated above, we do not reach this rejection.
12 As indicated above, we do not reach this rejection.
13 As indicated above, we do not reach this rejection.
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21
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–4, 11, 12,
14, 15, 21,
22, 24–27
Nonstatutory OTDP
over claims 1–5 of US
10,293,085, Orlowski
’501, Durig, Reduick,
Shanley
1–4, 11, 12,
14, 15, 21,
22, 24–27

1, 2, 11, 12,
14, 15, 21,
22, 24–27
Nonstatutory OTDP
over claims 1–5 of US
10,293,085, Orlowski
’501, Durig, Reduick,
Shobu
1, 2, 11, 12,
14, 15, 21,
22, 24–27

1, 2, 11, 12,
14, 15, 21,
22, 24–27
Nonstatutory OTDP
over claims 1–6, 9–
12, 14, 15 of US
Application
16/411,801, Orlowski
’501, Durig, Reduick
1, 2, 11, 12,
14, 15, 21,
22, 24–27

1–4, 11, 12,
14, 15, 21,
22, 24–27
Nonstatutory OTDP
over claims 1–6, 9–
12, 14, 15 of US
Application,
16/411,801, Orlowski
’501, Durig, Reduick,
Shanley
1–4, 11, 12,
14, 15, 21,
22, 24–27

1, 2, 11, 12,
14, 15, 21,
22, 24–27
Nonstatutory OTDP
over claims 1–6, 9–
12, 14, 15 of US
Application
16/411,801, Orlowski
’501, Durig, Reduick,
Shobu
1, 2, 11, 12,
14, 15, 21,
22, 24–27

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Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
Overall
Outcome
1–4, 11, 12,
14, 15, 21,
22, 24–27

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