Ex Parte Campbell et al

Patent Trial and Appeal Board

Jun 28, 2013

11453161 (P.T.A.B. Jun. 28, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SHANNON E. CAMPBELL
and JOEL C. COLBURN
__________

Appeal 2012-003725
Application 11/453,161
Technology Center 3700
__________

Before DEMETRA J. MILLS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).

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Application 11/453,161

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STATEMENT OF CASE
Claims 1 and 2 illustrate the appealed subject matter (emphasis added):
1. A medical device comprising:
an inflatable balloon cuff;
an endotracheal tube associated with the balloon cuff,
wherein the endotracheal tube passes through a proximal
opening and a distal opening of the balloon cuff; and
a mucoadhesive disposed on a tissue-contacting surface
of the balloon cuff.

2. The medical device, as set forth in claim 1, wherein
the mucoadhesive comprises an acrylic acid polymer, a methyl
vinyl copolymer, or a polyvinyl pyrrolidone.

Cited References

Young US 2008/0283052 A1 Nov. 20, 2008
Wilkins US 2002/0150707 A1 Oct. 17, 2002
Furst US 2006/0206189 A1 Sep. 14, 2006
Palmer US 6,951,546 B2 Oct. 4, 2005

Grounds of Rejection
Claims 1-4, 6-7, 10-14, 17-22 and 25 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Young in view of Wilkins.
Claims 8 and 23 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Young in view of Wilkins and Furst.
Claims 9, 15-16 and 24 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Young in view of Wilkins and Palmer.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 5-
9. The following facts are highlighted.
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1. Young Fig. 2 is reproduced below.

Young Fig 2 shows the artificial airway device or apparatus 19
takes the form of an endotracheal tube (ETT). The ETT 19
includes a tube, or tubular member 19a, and a cuff, or balloon,
20 mounted near the distal end of tube 19a. Tube 19a and cuff
20 are both made of silicone. Young, page 2.

Discussion
ISSUE
The Examiner concludes that
in fig. 2 Young discloses an inflatable balloon cuff (20, Page 3,
para 48, II. 9), an endotracheal tube (19, Page 3, para 48, II. 1)
associated with the balloon cuff, and the endotracheal tube
passes through a proximal opening and a distal opening of the
balloon cuff. Young is silent regarding polyvinyl pyrrolidone
mucoadhesive disposed on a tissue-contacting surface,
however, Wilkins teaches polyvinyl pyrrolidone mucoadhesive
disposed on a tissue-contacting surface of a balloon cuff (Page
1, para 2, Page 7, para 68). Therefore, it would have been
obvious to one of ordinary skill in the art at the time the
invention was made to modify Young's cuff to be coated with
polyvinyl pyrrolidone, as taught by Wilkins, for the purpose of
providing ease of intubation and removal of the balloon catheter
and to prevent damage to a user's trachea.

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(Ans. 5.)

Appellants argue that Wilkins fails to disclose a mucoadhesive. Appellants
contend that
Wilkins discloses that the catheter balloons "may be coated
with pharmaceutical compounds (e.g., heparin) and non-
thrombogenic lubricants (e.g., polyvinyl pyrrolidone)."
Wilkins, paragraph [0068] (emphasis added). However, Wilkins
appears silent as to a catheter balloon coated with a
mucoadhesive. Instead, the Examiner has asserted that the
polyvinyl pyrrolidone lubricant of Wilkins is a mucoadhesive.
Final Office Action, p. 3.

(App. Br. 8.) Appellants further argue that the addition of lubricant PVP
reduces the tension of mucoadhesive material as evidence by Appendixes A-
C of the Brief. Br. 10. Appellants argue that the combination of references
is improper hindsight. (App. Br. 10.)
The issue is: Does the cited prior art teach or suggest the invention as
claimed?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
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issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“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).
Moreover:

Where . . . the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed product.
Whether the rejection is based on “inherency” under 35 U.S.C.
§ 102, on “prima facie obviousness” under 35 U.S.C. § 103,
jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO’s inability to manufacture
products or to obtain and compare prior art products.

In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added) (citation
omitted).
“From the standpoint of patent law, a compound and all of its
properties are inseparable; they are one and the same thing.” In re Papesch,
315 F.2d 381, 391 (CCPA 1963).
The motivation to combine references does not have to be identical to
the applicants’ to establish obviousness. In re Kemps, 97 F.3d 1427, 1430
(Fed. Cir. 1996).
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
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However, “[a]ny judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning ….” In re McLaughlin, 443
F.2d 1392, 1395 (CCPA 1971).
Obviousness requires more than a mere showing that the prior art
includes separate references covering each separate limitation in a claim
under examination. KSR, 550 U.S. at 418. Rather, obviousness requires the
additional showing that a person of ordinary skill at the time of the invention
would have selected and combined those prior art elements in the normal
course of research and development to yield the claimed invention. Id. at
421. See also Unigene Laboratories, Inc. v. Apotex, Inc., 655 F.3d 1352,
1360 (Fed. Cir. 2011).

ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellants’ arguments as set forth in the Answer. We find
that the Examiner has provided adequate evidence to support a prima facie
case of obviousness. We provide the following additional comment to the
arguments in the Answer.
Appellants’ principal argument is that the polyvinylpyrrolidone
(PVP) coated on the catheter balloons in Wilkins (page 7, [0068]) is a
lubricant and is not mucoadhesive, as claimed. We are not persuaded. The
Examiner finds that “[a]lthough Wilkins teaches polyvinyl pyrrolidone
coated catheter balloons and lists PVP as a lubricant, it still has
mucoadhesive properties, which are not mutually exclusive properties.”
(Ans. 10.) We agree with the Examiner that PVP can possess both
mucoadhesive and lubricating properties. See also Appellants’ Specification
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page 11, and claim 2, indicating that PVP is a mucoadhesive within the
scope of the invention. Appellants have not come forth with evidence
showing that PVP alone has no mucoadhesive properties.
While Appellants put forth evidence in Appendices A-C to the Brief
that PVP under some circumstances may have decreased mucoadhesive
properties, particularly if it is combined with other polymers or ingredients,
Wilkins discloses only PVP as a catheter balloon covering. Thus, under the
principles of In re Best, the burden of proof has shifted to Appellants to
show that that PVP alone has no mucoadhesive properties. This Appellants
have not done.
Appellants argue that the combination of Young and Wilkins is
hindsight reconstruction of Appellants’ invention. (Reply Br. 4.) We are
not persuaded. The Examiner finds that “it would have been obvious to one
of ordinary skill in the art at the time the invention was made to modify
Young's cuff to be coated with polyvinyl pyrrolidone, as taught by Wilkins,
for the purpose of providing ease of intubation and removal of the balloon
catheter and to prevent damage to a user's trachea.” (Ans. 5.) The
motivation to combine references does not have to be identical to the
applicants’ to establish obviousness. In re Kemps, 97 F.3d at 1430. We find
that the Examiner has provided a sufficient reason or rationale to combine
the cited references based on the references alone, and the cited claim
language, and without regard to hindsight reconstruction of Appellants’
invention.
Appellants traverse the obviousness rejections of dependent claims
over Young and Wilkins, and further in view of Furst or Palmer for the same
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reasons as put forth for the primary combination of Young and Wilkins.
(App. Br. 11-12.)
We thus affirm all the obviousness rejections for the reasons of
record.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejections.
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

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