Giare-Patel, Kamma et al.

Patent Trials and Appeals Board

Dec 12, 2019

14357440 - (D) (P.T.A.B. Dec. 12, 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.
14/357,440 05/09/2014 Kamma Giare-Patel 40792.21543 3771
30734 7590 12/12/2019
BakerHostetler
Washington Square, Suite 1100
1050 Connecticut Ave. N.W.
Washington, DC 20036-5304
EXAMINER
FUBARA, BLESSING M
ART UNIT PAPER NUMBER
1613
NOTIFICATION DATE DELIVERY MODE
12/12/2019 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):
edervis@bakerlaw.com
eofficemonitor@bakerlaw.com
patents@bakerlaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KAMMA GIARE-PATEL, NISHA GUPTA,
GREG ETTER, KEVIN SECHRIST, MOLLY STEWART,
IGOR TENTLER, and AL WILLIAMS 1
____________

Appeal 2019-005102
Application 14/357,440
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies Arroaw International, Inc. as the real
party-in-interest. App. Br. 3.

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Application 14/357,440

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SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 8–11, 28–31, 33, 34, and 37–45 as
unpatentable under 35 U.S.C. § 103(a) as being obvious over Modak et al.,
(US 6,872,195 B2, March 29, 2005) (“Modak”).2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to a coated medical device wherein
the interior surface of the device is treated with a first formulation and the
exterior of the device is treated with a different second formulation. Spec.
¶¶ 4–5.
REPRESENTATIVE CLAIM
Claim 8 is representative of the claims on appeal and recites:
8. A medical device comprising an interior surface that
defines a cavity or lumen, and an exterior surface, wherein the
interior surface is treated with a first formulation consisting
essentially of:

methyl-ethyl-ketone (50–70 wt%); methanol (10–20
wt%); acetone (15–25 wt%); chlorhexidine diacetate (0.5–10
wt%); and chlorhexidine free base (0.5-10 wt%) resulting in a
coating or impregnation with an antimicrobially effective
amount of chlorhexidine,

2 Claims 8–11, 28–31, 33, 34, and 37–45 were also rejected as unpatentable
under 35 U.S.C. § 112, first paragraph, for lack of written description. Final
Act. 6. That rejection has been withdrawn by the Examiner. Ans. 9–10.
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and wherein the exterior surface of the medical device is
treated with a second formulation consisting essentially of:

tetrahydrofuran (THF) (70–90 wt%); methanol (5–15
wt%); polyurethane (1–15 wt%); and chlorhexidine diacetate
(0.5–10.0 wt%) resulting in a coating or impregnation with an
antimicrobially effective amount of chlorhexidine,

wherein chlorhexidine has not been bulk incorporated into
the medical device and the medical device has an internal volume
portion having a concentration of chlorhexidine that is greater
than 4 mM.

App. Br. 14.

ISSUES AND ANALYSIS
We agree with, and expressly adopt, the Examiner’s findings,
reasoning, and conclusion that the claims are prima facie obvious over the
cited prior art. We address below the arguments raised by Appellant.

Issue 1
Appellant argues that the Examiner erred in finding that Modak
teaches a medical device having “concentration of chlorhexidine that is
greater than 4 mM.” App. Br. 10.

Analysis
The Examiner finds that Modak teaches a medical device, e.g., a
catheter, having internal and external surfaces impregnated with a treatment
solution containing 1–5% chlorhexidine. Ans. 6 (citing Modak col. 19, ll.
56–57 (claims 1, 2); col. 20, ll. 13–19 (claims 10, 11)). The Examiner finds
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that Modak teaches the chlorhexidine treatment solution may include
polyurethane (claims 6, 7), but does not necessarily include triclosan or a
silver salt. Id. (citing Modak at col. 19, ll. 1–57, 60–63; col. 20, ll. 1–61).
Because Modak teaches embodiments of the medical device that do not
include triclosan, the Examiner finds that Modak teaches coatings
“consisting essentially of” chlorhexidine. See id.
The Examiner explains that, because the claims recite a medical
device “wherein the interior surface is treated with a first formulation” and
“wherein the interior surface is treated with a second formulation,” “the
claims have been examined as [a] product by process” claim. Ans. 12.
Accordingly, the Examiner determines “the first and second solutions used
to impregnate the chlorhexidine onto the medical device are composition[s]
used in the process and do[ ] not limit the medical device.” Id. Applying
this interpretation, the Examiner finds that the solvents recited in the claimed
formulations evaporate after coating and are not required elements of the
claimed medical device. Id. at 13–14.
The Examiner acknowledges that “Modak does not specifically teach
that the concentration of chlorhexidine is greater than 4 mM in the internal
surface.” Ans. 7. Rather Modak teaches a “local concentration of
chlorhexidine at between 100 and 2000 μg/mL,” i.e., 0.00198–3.96 mM. Id.
at 6–7. However, the Examiner finds that Modak teaches a treatment
solution containing 1–5% chlorhexidine, wherein “at 1 % the mM for
chlorhexidine is about 1.98 and at 5% the mM chlorhexidine is at 9.89.” Id.
at 6 (citing Modak col. 3, ll. 45–51; col. 4, ll. 36–40). The Examiner finds:
[I]t is reasonable to expect that treating the internal surface with
composition comprising from 1–5 % (claim 1) and from 1–10%
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(claim 13) would result in the adsorption of certain amount of the
chlorhexidine onto the internal surface. Since, for example, local
concentration of chlorhexidine at between 100 and 2000 μg/mL
(0.00198–3.96 mM) was provided [] on the medical device, it
would be reasonable to expect that the concentration of the
chlorhexidine on the catheter would approximate the
concentration of the chlorhexidine in the internal surface at
between 1.98 mM … to 19.78 mM. These disclosed ranges allow
for concentration of greater than 4 mM as required by claim 8 for
the concentration of chlorhexidine.

Id. at 7. The Examiner concludes that the claimed range of greater than 4
mM lies inside the prior art range, and therefore it would have been obvious
to a person of ordinary skill in the art to discover the optimum or workable
ranges by routine experimentation. Id. at 8 (citing In re Aller, 220 F.2d 454,
456 (CCPA 1955)).
Appellant argues that Modak “does not teach medical devices having
the concentration of chlorhexidine recited by the present claims.” App. Br.
9. Particularly, Appellant contends that “the chlorhexidine concentration
(100 and 2000 μg/ml) disclosed by Modak is less than the presently claimed
chlorhexidine concentration greater than 4 mM.” Id.
We are not persuaded. The Examiner acknowledges that Modak does
not expressly teach a local concentration greater than 4 mM. Ans. 7.
However, Modak teaches coating compositions containing 1–10%
chlorhexidine, equating to a range of 1.98–19.78 mM, which overlaps with
the claimed range of 4 mM. Id. Moreover, Modak’s chlorhexidine diacetate
and free base concentration of 1–10% overlaps with the Appellant’s claimed
ranges of chlorhexidine diacetate (0.5–10 wt%) and chlorhexidine free base
(0.5–10 wt%). Modak col. 20, ll. 31–37. The Examiner has shown it is
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reasonable to expect that treating the internal surface of a medical device
with a composition containing the same concentration of chlorhexidine
would result in the claimed concentration. It is Appellant’s burden,
therefore, to demonstrate that the concentration of chlorhexidine in Modak’s
compositions would not result in an internal volume portion having a
concentration of chlorhexidine that is greater than 4 mM.
Where, as here, 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, or “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 (C.C.P.A. 1977). Appellant adduces no
evidence to show that Modak’s coated medical devices do not necessarily
and, thus, inherently possess the characteristics of the claimed product. As
such, we do not find Appellant’s argument in this respect persuasive.

Issue 2
Appellant argues that Modak does not disclose either the first
formulation or the second formulation. App. Br. 10.

Analysis
Appellant argues that “Modak fails to disclose the solvent mixture in
the first formulation” and “the combination of the components claimed in
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the second formulation.” App. Br. 10–11. With respect to the first
formulation, Appellant argues Modak does not teach acetone as a suitable
solvent, nor a combination of methyl ethyl ketone (“MEK”) and methanol.
Id. With respect to the second formulation, Appellant argues that “Modak
does not disclose any compositions that do not include chlorhexidine free
base,” unlike the second formulation which uses chlorhexidine diacetate
alone. Id. at 11. Appellant contends that “Modak even explains the need for
chlorhexidine free base because it forms a complex with triclosan for
improved solubility and increased uptake.” Id. (citing Modak col. 8, ll. 11–
18). With respect to both first and second formulations, Appellant argues
that Modak does not teach the specific combinations and claimed weight
percentages of the components. Id. at 10–11.
We are not persuaded. We begin with Appellant’s characterization
Modak. Appellant’s distinguishes Modak by highlighting specific examples,
e.g., the combination of chlorhexidine free base and triclosan. “But in a
section 103 inquiry, ‘the fact that a specific [embodiment] is taught to be
preferred is not controlling, since all disclosures of the prior art, including
unpreferred embodiments, must be considered.’” Merck & Co. Inc. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
Contrary to Appellant’s argument, Modak teaches medical articles
with coatings on “their external surface, internal surface, or both.” Modak
col. 5, ll. 55–66; col. 20, ll. 14–15. Modak teaches various formulations,
including formulations containing chlorhexidine diacetate (CHA) without
chlorhexidine free base (CHX). See id. at col. 9, ll. 52; col. 19, ll. 40.
Modak additionally teaches first and second coating solutions, wherein the
second solution includes a polymer. Id. at col. 20, ll. 40–42. With respect to
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the solvents, Modak teaches “[s]uitable solvents include, but are not limited
to,” tetrahydrofuran (“THF”), methanol, MEK, and mixtures thereof. Id. at
col. 6, ll. 33–39. Accordingly, considering Modak’s teachings as a whole,
we do not agree with Appellant’s characterization of the reference.
Furthermore, Appellant’s argument does not address the Examiner’s
rejection. The Examiner interprets the claims as product-by-process, in
which the solvent mixture is evaporated, resulting in a medical device with
an interior surface impregnated with chlorhexidine diacetate and
chlorhexidine free base, and an exterior surface impregnated with
polyurethane and chlorhexidine diacetate. Ans. 13–14. Appellant does not
argue against the Examiner’s interpretation of the claims as product-by-
process. Rather, as noted by the Examiner, Appellant acknowledges that
“the solvents evaporate after the coating or impregnation is formed.” App.
Br. 11. In the Reply Brief, Appellant argues, “Modak fails to disclose
different interior and exterior coatings in general and, more particularly, fails
to disclose the specific coating solutions and resulting coatings as recited.”
Reply Br. 2. However, as discussed supra, Modak teaches medical devices
with different internal and external surface coatings that may include
combinations of chlorhexidine diacetate and chlorhexidine free or
polyurethane and chlorhexidine diacetate. Because picking and choosing
from the various disclosures of a reference may be entirely proper in the
making of an obviousness rejection, we are not persuaded that the Examiner
erred in determining the claims are prima facie obvious. See in re Arkley,
455 F.2d 586, 587 (C.C.P.A. 1972)

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Issue 3
Appellant argues the solvent mixtures are critical components
resulting in internal and external surfaces with different properties. App. Br.
11.

Analysis
Appellant argues that “[a]lthough the solvents evaporate after the
coating or impregnation is formed, the solvents selected in the claimed
formulations and their respective amounts are not trivial and ultimately
determine the amount of chlorhexidine in the treated device.” App. Br. 11.
Appellant contends the solvent system determines the solubility of
chlorhexidine as well as the ability of chlorhexidine to coat or impregnate
the surface of the medical device. Id. at 11–12. Appellant contends that
“even after the solvents in the interior coating solution and exterior coating
solutions have volatilized, the resultant interior coating and exterior coating
are different from one another and optimized for their environments.” Reply
Br. 2.
We are not persuaded. The Examiner has shown that the general
conditions of the claimed product were known in the prior art, and that it
would have been obvious to discover the optimum or workable ranges by
routine experimentation. Final Act. 11, citing Aller, 220 F.2d at 456.
Appellant adduces no evidence to show that the claimed amounts of
components are critical or result in different products than those taught by
the prior art. Consequently, Appellant’s conclusory statements are no more
than attorney argument, to which we assign little probative value. In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
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Accordingly, we affirm the Examiner’s rejection of claim 8. Because
Appellant does not argue the dependent claims separately (see App. Br. 12),
we affirm the Examiner’s rejection of claims 9–11, 28–31, 33, 34, and 37–
45.

CONCLUSION

The Examiner’s rejection of claims 8–11, 28–31, 33, 34, and 37–45 as
unpatentable under 35 U.S.C. § 103(a) is affirmed.
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).

AFFIRMED
Claims
Rejected
35 U.S.C. §  Basis Affirmed Reversed
8–11, 28–31,
33, 34, 37–45
103(a) Modak 8–11, 28–31,
33, 34, 37–45