Ronald A. Sahatjian et al.

Patent Trials and Appeals Board

Jul 29, 2019

15185851 - (D) (P.T.A.B. Jul. 29, 2019)

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.
15/185,851 06/17/2016 Ronald A. Sahatjian 8150BSC0044D2C1 5002
121974 7590 07/29/2019
KACVINSKY DAISAK BLUNI PLLC
America's Cup Building
50 Doaks Lane
Marblehead, MA 01945
EXAMINER
WEISBERG, AMY REGINA
ART UNIT PAPER NUMBER
3649
NOTIFICATION DATE DELIVERY MODE
07/29/2019 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):
bbonneville@kdbfirm.com
docketing@kdbfirm.com
ehysesani@kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte RONALD A. SAHATJIAN, FRANCISCA TAN,
PATRICK T. MATHER, CHANGDENG LIU, and QING GE
__________

Appeal 2018-007980
Application 15/185,851
Technology Center 3700
__________

Before STEFAN STAICOVICI, MICHAEL J. FITZPATRICK, and
JEREMY M. PLENZLER, Administrative Patent Judges.

FITZPATRICK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant, Boston Scientific Scimed, Inc.,1 appeals under 35 U.S.C.
§ 134(a) from the Examiner’s final decision rejecting claims 38–57. We
have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Boston Scientific Scimed, Inc. is the assignee. See Combined Declaration
and Power of Attorney (filed Dec. 6, 2016). Also, Boston Scientific Scimed,
Inc. is identified as the sole real party in interest. Appeal Br. 2.
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STATEMENT OF THE CASE
The Specification
The Specification states that “the invention relates to a coated
endoprosthesis. The endoprosthesis may be, e.g., a metal or a metal alloy
stent. The coating may include a therapeutic agent, e.g., a restenosis
inhibiting agent, and may degrade in biological systems.” Spec. 2:13–15.
The Rejected Claims
Claims 38–57 are pending and all are rejected. Final Act. 1. Claims
38, 46, and 52 are independent. Appeal Br. 16–18. Claim 38 is
representative and reproduced below.
38. A method of treating a cavity or lumen in a
mammal, the method comprising:
implanting, into the lumen or cavity of the mammal, an
endoprosthesis comprising a tubular member having a coating,
the coating comprising a therapeutic agent and a polymeric
material including a reaction product of a polyol, an isocyanate
and a silsesquioxane having at least two pendant hydroxyl
groups, wherein the coating is configured to release
substantially all of the therapeutic agent in less than about 200
days at body temperature.
Appeal Br. 16.

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The Appealed Rejections
The following rejections, all under 35 U.S.C. § 103(a) (pre-AIA), are
before us for review:
1. claims 38, 40, 42–44, 52, 54, and 56 over Ding,2 Fu,3 and Hubbell4
(Final Act. 25);
2. claims 39 and 53 over Ding, Fu, Hubbell, and Masters6 (id. at 6);
3. claims 41 and 55 over Ding, Fu, Hubbell, and Goldberg7 (id. at 7);
4. claims 45 and 57 over Ding, Fu, Hubbell, and Llanos8 (id. at 8);
5. claims 46 and 48 over Ding and Fu (id. at 9);
6. claim 47 over Ding, Fu, and Masters (id. at 10);
7. claim 49 over Ding, Fu, and Goldberg (id. at 11);
8. claim 50 over Ding, Fu, and Hubbell (id. at 12); and
9. claim 51 over Ding, Fu, and Llanos (id. at 13).
DISCUSSION
Related Appeals
Appellant’s Appeal Brief erroneously represents: “There are no prior
or pending appeals, interferences, or judicial proceedings that are related to,

2 US 6,099,562, issued Aug. 8, 2000 (“Ding”).
3 Bruce X. Fu, et al., “Nanoscale reinforcement of polyhedral oligiomeric
silsesquioxane (POSS) in polyurethane elastomer,” 49 POLYMER INT’L 437–
40 (2000) (“Fu”).
4 US 6,958,212 B1, issued Oct. 25, 2005 (“Hubbell”).
5 The Examiner did not list claim 54 in the first sentence of Rejection 1.
However, claim 54 was included in Rejection 1, as it appears in the body of
Rejection 1. See Final Act. 6; Ans. 2.
6 US 2002/0028243 A1, published Mar. 7, 2002 (“Masters”).
7 US 4,874,360, issued Oct. 17, 1989 (“Goldberg”).
8 US 8,182,527 B2, issued May 22, 2012 (“Llanos”).
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directly affect, are directly affected by, or otherwise bear upon the Board's
decision in this Appeal.” Appeal Br. 3; see also 37 C.F.R. § 41.37(c)(ii)
(requiring the identification of, among other things, prior related appeals).9
This representation is erroneous because Appellant, Boston Scientific
Scimed, Inc., is the assignee of related U.S. application No. 13/053,461 (“the
’461 Application”). See Statement Under 37 C.F.R. § 3.73(c) (filed Feb. 28,
2016, in application No. 13/053,461).
The ’461 Application, like the instant Specification, is titled and
directed to “ENDOPROSTHESES.” Compare ’461 Application 1, with
Spec. 1. The ’461 Application includes a claim of priority identical to that
of the instant Specification. Compare ’461 Application 1:6–14, with Spec.
1:6–14.
In the ’461 Application, Appellant unsuccessfully sought, among
other claims, independent claim 23, which is reproduced below.
23. A method of treating a cavity or lumen in a
mammal, the method comprising:

9 More specifically, the cited Rule requires in appeal briefs the following:
A statement identifying by application, patent, appeal,
interference, or trial number all other prior and pending appeals,
interferences, trials before the Board, or judicial proceedings
(collectively, “related cases”) which satisfy all of the following
conditions: involve an application or patent owned by the
appellant or assignee, are known to appellant, the appellant’s
legal representative, or assignee, and may be related to, directly
affect or be directly affected by or have a bearing on the Board’s
decision in the pending appeal, except that such statement is not
required if there are no such related cases.
37 C.F.R. § 41.37(c)(ii).
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implanting, into the lumen or cavity of the mammal, an
endoprosthesis comprising a tubular member having a coating
comprising a polymeric material including a reaction product of
a polyol, an isocyanate and a silsesquioxane having at least two
pendant hydroxyl groups.
’461 Application Board Decision 2 (entered April 19, 2016). The finally
rejected claim 23 differs from the instant claim 38 only in that claim 38
recites “a therapeutic agent” such that “the coating is configured to release
substantially all of the therapeutic agent in less than about 200 days at body
temperature.” Appeal Br. 16.
The rejection of the ’461 Application’s claim 23 was under 35 U.S.C.
§103(a) and based on Ding and Fu (as well as the level of skill in the prior
art). See ’461 Application Board Decision 2. The Board affirmed the
rejection of claim 23. Id. at 1. Less than two months later, Appellant filed
the instant application on June 17, 2016. Appeal Br. 1 (“Filed: June 17,
2016”).
Without question, Appellant’s unsuccessful appeal of the ’461
Application is a related appeal that should have been identified in the Appeal
Brief. See 37 C.F.R. § 41.37(c)(ii). We have authority to sanction Appellant
for this omission and erroneous representation. 37 C.F.R. § 41.128(a)(1)
(“The Board may impose a sanction against a party for misconduct,
including: (1) Failure to comply with an applicable rule or order in the
proceeding.”). Pursuant to 37 C.F.R. § 41.128(b)(3), we sanction Appellant
by precluding it from contesting that the subject matter of the ’461
Application’s claim 23, and thus too the coextensive subject matter of
independent claim 38, would not have been obvious in view of Ding and Fu
(and the level of skill in the art).
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As discussed below, this sanction resolves much of the instant Appeal,
as most of Appellant’s arguments here are rehashes of its arguments in the
appeal of the ’461 Application.
Rejection 1
The Examiner rejected claims 38, 40, 42–44, 52, 54, and 56 over
Ding, Fu, and Hubbell. Final Act. 2. Appellant argues these claims
together. Appeal Br. 9–11. We select claim 38 as representative. See 37
C.F.R. § 41.37(c)(iv).
For the subject matter of claim 38 that is identical to the finally
rejected ’461 Application’s claim 23, the Examiner relied on Ding and Fu
(and the level of skill in the art). Final Act. 2–4. Appellant’s arguments to
the contrary, e.g., that a person of ordinary skill in the art would have not
combined Ding and Fu and that, even if she did, she would not have added
“at least two pendant hydroxyl groups” as recited in claim 38 (see Appeal
Br. 9–11), are arguments foreclosed by the sanction imposed above.10
The Examiner found that a third reference, Hubbell, “teaches using a
polymeric material which degrades at 37 degrees [Celsius] and a pH of 7.4
within a several days (column 25 line 48-column 26 line 52) wherein the
therapeutic agent is carried within the polymeric material thus resulting in
both being released within several days,” which is less than 100 days.11
Final Act. 4. The Examiner determined that, in view of Hubbell’s teaching,

10 The Examiner additionally cited Ding as disclosing “a therapeutic agent,”
as recited in claim 38 (but not in prior claim 23). Final Act. 3 (citing Ding
5:10–39). Appellant does not dispute this finding. See Appeal Br. 9–11.
11 Although independent claim 38 recites “less than about 200 days,”
dependent claim 50 recites “less than about 100 days.” Appeal Br. 16–17.
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it would have been obvious to a person of ordinary skill in the art to further
modify Ding and Fu “to have the polymeric material degrade within 100
days as to act as a drug.” Id. at 5.
Appellant notes that “the disclosed polymeric materials of Hubbel[l]
are gels or hydrogels,” and argues that there is “no correlation . . . between a
gel or hydrogel coating and the POSS [i.e., polyhedral oligiomeric
silsesquioxane] containing reaction product of Fu.” Appeal Br. 11. This
argument is not developed in any more detail in the Appeal Brief. Id.
However, on reply, Appellant states that further modifying the Ding and Fu
combination “to include a gel or hydrogel, which would detract from the
improved mechanical/physical properties, makes little sense and would
certainly not be obvious to one of skill in the art.” Reply Br. 7. Appellant’s
argument is not persuasive because it is not pertinent to the rejection as
articulated. The Examiner has not proposed that a person of ordinary skill in
the art would substitute Hubbell’s gel or hydrogel as the coating. Rather, the
Examiner has proposed that a person of ordinary skill in the art would have
modified the existing coating of the Ding and Fu combination to provide a
treatment duration of less than 100 days. Final Act. 5 (“It would have been
obvious to one of ordinary skill in the art at the time of the invention to have
the polymeric material degrade within 100 days as to act as a drug delivery
vehicle and delivery the drug within a limited time to a treatment site.”), 16
(“The particular teaching being used is to simply modify the duration of
treatment.”); Ans. 10 (“Hubbel[l] is simply used to teach that releasing a
drug is under 100 days is well known.”).
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For the foregoing reasons, we affirm the rejection of claim 38 as
unpatentable over Ding, Fu, and Hubbell, as well as that of claims 40, 42–
44, 52, 54, and 56, which fall therewith. See 37 C.F.R. § 41.37(c)(iv).
Rejection 2
The Examiner rejected claims 39 and 53 over Ding, Fu, Hubbell, and
Masters. Final Act. 6. Appellant argues these claims together. Appeal
Br. 11–13. We select claim 39 as representative. See 37 C.F.R.
§ 41.37(c)(iv).
Claim 39 depends from claim 38 and further recites “wherein the
therapeutic agent includes an anesthetic agent.” Appeal Br. 16. The
Examiner found that Masters teaches a stent that “includes a therapeutic
agent which is an anesthetic agent” and that “[i]t would have been obvious
to one of ordinary skill in the art at the time of the invention to include an
anesthetic agent as taught by Masters as Masters teaches said agent reduces
localized pain.” Final Act. 7 (citing Masters ¶232).
Appellant states that it “disagree[s] that one of skill in the art would
find any motivation to further modify the . . . combination of Ding, Fu and
Hubbel[l],” but does not explain or support its disagreement. Appeal Br. 12.
A statement of disagreement is not an argument, let alone a persuasive one.
Appellant argues that “Masters fails to cure any of the above-noted
deficiencies of Ding, Fu and/or Hubbel[l].” Id. However, Appellant has not
persuaded us of any such deficiencies.
For the foregoing reasons, we affirm the rejection of claim 39 as
unpatentable over Ding, Fu, Hubbell, and Masters, as well as that of claim
53, which falls therewith. See 37 C.F.R. § 41.37(c)(iv).
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Rejection 3
The Examiner rejected claims 41 and 55 over Ding, Fu, Hubbell, and
Goldberg. Final Act. 7. Appellant argues these claims together. Appeal
Br. 11–13. We select claim 41 as representative. See 37 C.F.R.
§ 41.37(c)(iv).
Claim 41 depends from claim 38 and further recites “wherein the
lumen is a ureteral lumen.” Appeal Br. 16. The Examiner found that
Goldberg shows that the “use of polyurethanes in ureteral stents is well
known,” and determined that “[i]t would have been obvious to one of
ordinary skill in the art at the time of the invention to utilize the improved
polyurethane stent of the combination of Ding, Fu, and Hubbel[l] in an
ureteral lumen as taught by Goldberg, as Goldberg teaches polyurethane
stents are soft and flexible and well suited for placement in the ureteral
lumens.” Final Act. 8 (citing Goldberg claim 1).
Appellant states that it “disagree[s] that one of skill in the art would
find any motivation to further modify the . . . combination of Ding, Fu and
Hubbel[l],” but does not explain or support its disagreement. Appeal Br. 12.
A statement of disagreement is not an argument, let alone a persuasive one.
Appellant argues that “there is no teaching or suggestion that the
polymeric materials of Goldberg . . . cure any of the above-noted
deficiencies of Ding, Fu and/or Hubbel[l].” Id. However, Appellant has not
persuaded us of any such deficiencies.
For the foregoing reasons, we affirm the rejection of claim 41 as
unpatentable over Ding, Fu, Hubbell, and Goldberg, as well as that of claim
55, which falls therewith. See 37 C.F.R. § 41.37(c)(iv).
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Rejection 4
The Examiner rejected claims 45 and 57 over Ding, Fu, Hubbell, and
Llanos. Final Act. 8. Appellant argues these claims together. Appeal
Br. 11–13. We select claim 45 as representative. See 37 C.F.R.
§ 41.37(c)(iv).
Claim 45 depends from claim 38 and further recites “wherein the
coating includes between about 1 percent by weight and about 35 percent by
weight of the therapeutic agent.” Appeal Br. 16. The Examiner found that
Llanos “teaches a known stent device with a therapeutic agent in the coating
wherein the coating includes between about 1 percent by weight and about
35 percent by weight of the therapeutic agent.” Final Act. 8 (citing Llanos
24:22–29). The Examiner concluded:
It would have been obvious to one of ordinary skill in the art at
the time of the invention to utilize a coating includes between
about 1 percent by weight and about 35 percent by weight of the
therapeutic agent as L[l]anos teaches such a range will depend
upon the particular therapeutic agent used.
Id. at 9.
Appellant states that it “disagree[s] that one of skill in the art would
find any motivation to further modify the . . . combination of Ding, Fu and
Hubbel[l],” but does not explain or support its disagreement. Appeal Br. 12.
A statement of disagreement is not an argument, let alone a persuasive one.
Appellant argues that Llanos does not “cure any of the above-noted
deficiencies of Ding, Fu and/or Hubbel.” Id. However, Appellant has not
persuaded us of any such deficiencies.
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For the foregoing reasons, we affirm the rejection of claim 45 as
unpatentable over Ding, Fu, Hubbell, and Llanos, as well as that of claim 57,
which falls therewith. See 37 C.F.R. § 41.37(c)(iv).
Rejection 5
The Examiner rejected claims 46 an 48 over Ding and Fu. Final
Act. 9. Appellant argues these claims together. Appeal Br. 13. We select
independent claim 46 as representative. See 37 C.F.R. § 41.37(c)(iv).
Claim 46 is broader than independent claim 38 and is essentially a
rewording of the finally rejected ’461 Application’s claim 23. Claim 46 is
reproduced below.
46. A method of treating a cavity or lumen in a mammal, the
method comprising:
implanting, into the lumen or cavity of the mammal, an
endoprosthesis comprising a tubular member formed at least in
part from polymeric material including a reaction product of a
polyol, an isocyanate and a silsesquioxane having at least two
pendant hydroxyl groups, and a therapeutic agent dispersed
within said polymeric material.
Appeal Br. 16–17 (paragraphing added).
The Examiner determined that claim 46 would have been obvious
over Ding and Fu (and the level of skill in the art). Final Act. 9–10.
Appellant merely argues that “the above-noted deficiencies of Ding and Fu
[in Rejection 1] apply equally to the present rejection.” Appeal Br. 13.
These arguments, however, are foreclosed by the sanctions we imposed
above.
For the foregoing reasons, we affirm the rejection of claim 46 as
unpatentable over Ding and Fu, as well as that of claim 48, which falls
therewith. See 37 C.F.R. § 41.37(c)(iv).
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Rejections 6–9
The Examiner rejected claim 47 over Ding, Fu, and Masters; claim 49
over Ding, Fu, and Goldberg; claim 50 over Ding, Fu, and Hubbell; and
claim 51 over Ding, Fu, and Llanos. Final Act. 10–13.
For all of these rejections, Appellant merely relies on its arguments
against Rejections 1–4. See Appeal Br. 13–14. All of those arguments are
either foreclosed by the sanctions we impose or are unpersuasive, as
discussed above.
Accordingly, we affirm Rejections 6–9 (i.e., the rejections of claims
47, 49, 50, and 51).
DECISION
The Examiner’s rejection of claims 38–57 is affirmed.

TIME PERIOD
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).

AFFIRMED