Ex Parte Ou-Yang

Patent Trial and Appeal Board

Jan 24, 2017

12397760 (P.T.A.B. Jan. 24, 2017)

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.
12/397,760 03/04/2009 David Tien-Tung Ou-Yang P-8518/1 8792
71562 7590 01/26/2017
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(Kirton & McConkie)
1 Becton Drive, MC 110
Franklin Lakes, NJ 07417-1880
EXAMINER
COHEN, MICHAEL P
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
01/26/2017 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):
ip_docket @bd.com
cmetcalf@kmclaw.com
khaley@kmclaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID TIEN-TUNG OU-YANG
Appeal 2015-007106
Application 12/397,7601
Technology Center 1600
Before ERIC B. GRIMES, RYAN H. FLAX and DAVID COTTA,
Administrative Patent Judges.
COTTA, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
infusion therapy medical device, or a component of an infusion therapy
medical device, that comprises a coating. The Examiner rejected the claims
on appeal as unpatentable under 35 U.S.C. § 103(a) and on the grounds of
non-statutory obviousness-type double patenting.
We affirm.
STATEMENT OF THE CASE
1 According to Appellants, the real party in interest is Becton Dickinson and
Company. App. Br. 1.
Appeal 2015-007106
Application 12/397,760
Claims 1, 3, 5, 7, 9, 10, and 12—23 are on appeal. Claim 1 is
illustrative and reads as follows (emphasis added):
1. An infusion therapy medical device or a component of an
infusion therapy medical device that comprises a coating,
comprising:
a liquid ultraviolet (UV) curable coating matrix
comprising;
from 10% to 90% by weight an acrylate oligomer having
two or more functional groups and selected from the group
consisting of acrylated aliphatic urethanes, acrylated aromatic
urethanes, acrylated polyesters, unsaturated polyesters, acrylated
polyethers, and acrylated acrylics; and
from 5% to 90% by weight an acrylate monomer having
two or more acrylated functional groups and selected from the
group consisting of 2-ethyl hexyl acrylate, isooctyl acrylate,
isobomylacrylate, 1,6-hexanediol diacrylate, diethylene glycol
diacrylate, triethylene glycol diacrylate, pentaerythritol tetra
acrylate, pentaerythritol tri acrylate, dimethoxy phenyl
acetophenone hexyl methyl acrylate, and 1,6-hexanediol
methacrylate;
from 1 to 10 parts by weight a photoinitiator, the
photoinitiator selected from the group consisting of benzoin
ethers, acetophemones, benzoyl oximes, acyl phosphine oxide,
Michler’s ketone, thixanthone, anthroguionone, benzophenone,
methyl diethanol amine, and 2-N-butoxyethyl-4-
(dimethylamino) benozoate;
from 0.1 to 30 parts by weight a rheological modifier in
100 parts UV curable composition, the rheological modifier
selected from the group consisting of organic clay, castor wax,
polyamide wax, polyurethane, and fumes silica; and
from 0.5 to 50 parts by weight an antimicrobial agent in
100 parts UV curable composition, the antimicrobial agent
selected from the group consisting of aldehydes, anilides,
biguanides, bis-phenols, and quaternary ammonium compounds,
and excluding metal salts, wherein the antimicrobial agent is
configured to diffuse out of the cured matrix when the cured
matrix is softened by a fluid, and wherein upon exposure to a UV
source, the liquid UV curable coating matrix cures to form a
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Appeal 2015-007106
Application 12/397,760
solid, clear, substantially colorless hydrophilic material that is
capable of permanently coating an infusion therapy medical
device or component.
The claims stand rejected as follows:
Claims 1, 3, 5, 7, 12—17, and 23 as unpatentable under 35 U.S.C.
§ 103(a) over the combination of Krongauz,2 Elton,3 and Ong.4
Claims 9, 10, and 18—22 as unpatentable under 35 U.S.C. § 103(a)
over the combination of Krongauz, Elton, Ong, andNishtala.5
Claims 1,3,7, 9, 10, and 12—23 were rejected on the ground of non-
statutory obviousness-type double patenting over claims 1—19 of US Patent
No. 8,691,887. Appellant does not address the Examiner’s double patenting
rejection. We therefore summarily affirm the obviousness-type double
patenting rejection. See Manual of Patent Examining Procedure § 1205.02
(“If a ground of rejection stated by the examiner is not addressed in the
appellant’s brief, that ground of rejection will be summarily sustained by the
Board.”).
REJECTION OF CLAIMS 1,3,5, 7, 12-17, AND 23 OVER THE
COMBINATION OF KRONGAUZ, ELTON, AND ONG
Appellant argues claims 1, 3, 5, 7, 12—17, and 23 together as a group.
We designate claim 1 as representative of the group.
2 Krongauz et al., US Patent Publication No. 2009/0324666 Al, published
Dec. 31, 2009 (“Krongauz”).
3 Elton, US Patent No. 5,077,352, issued Dec. 31, 1991 (“Elton”).
4 Ong et al., US Patent Publication No. 2005/0080158 Al, published Apr.
14, 2005 (“Ong”).
5 Nishtala et al., WO 2009/012336 Al, published Jan. 22, 2009 (“Nishtala”).
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Application 12/397,760
The Examiner found that Krongauz taught methods for making
antimicrobial resins comprising all of the elements of claim 1 with the
exception that it did not teach the inclusion of a rheological modifier such as
fumed silica and did not teach the claimed antimicrobial compounds. Ans.
2—A. The Examiner found that Elton taught the missing element of using
fumed silica gel as a rheological modifier and that Ong taught the claimed
antimicrobial compounds. Id. at 4. The Examiner concluded:
[I]t would have been obvious to a person of ordinary skill in the
art at the time of the instant invention to add fumed silica to the
composition of Krongauz, and to substitute a biguanide or
bisphenol antimicrobial for silver salts to form a material which
is capable of permanently coating an infusion therapy medical
device or component since Krongauz teaches a coating
comprising monomers, oligomers, and photoinitiators that are
essentially identical to the claimed ingredients, Elton teaches
that fumed silica gel functions as a rheological modifier to
obtain a composition with the desired thickness, and Ong
teaches that biguanide or bisphenol compounds can substitute
in the acrylate-urethane coating for the silver salts of Krongauz.
Id. at 4—5.
Appellant argues that Ong is not analogous art and thus does not
quality as prior art for purposes of an obviousness determination. App. Br.
9. “Whether a reference in the prior art is ‘analogous’ is a fact question.” In
re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992) (citing Panduit Corp. v.
Dennison Mfg. Co., 810 F.2d 1561, 1568 n.9 (Fed. Cir. 1987)). “Two
tests define the scope of analogous prior art: (1) whether the art is
same field of endeavor, regardless of the problem addressed and,
(2) if the reference is not within the field of the inventor's endeavor, whether
the reference still is reasonably pertinent to the particular problem with
which the inventor is involved.” In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir.
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Application 12/397,760
2004). “A reference is reasonably pertinent if, even though it may be in a
different field from that of the inventor’s endeavor, it is one which, because
of the matter with which it deals, logically would have commended itself to
an inventor’s attention in considering his problem.” In re Clay, 966 F.2d at
659.
The problem addressed by Appellant was to provide an antimicrobial
coating for medical devices. See Specification % 13 (“there is a need for an
effective antimicrobial coating that can be easily applied to medical devices
constructed of polymeric materials and metals”). Ong addresses a similar
problem, as reflected in the following discussion from Ong’s “Background
of the Invention”:
What is needed is an antimicrobial agent that can be
incorporated, or embedded, into a polymeric coating
prior to polymerization, where that antimicrobial agent
survives polymerization. In particular, what is needed is
an antimicrobial agent incorporated into a polymeric
coating that is applied to surfaces, and that is free from
toxic effects and is durable over the lifespan of the
polymer coating.
Ong 110. The solution disclosed by Ong is a radiation cured antimicrobial
coating. Id. at Abstract. Ong’s antimicrobial agent is non-toxic {id. at 119),
“migrates to the coated surface” and is “durable over the lifespan of the
polymer coating.” Id. at 121. Ong’s coating is taught to be “suitable for
coating flooring, furniture, cabinetry and other products that are susceptible
to bacterial/microbial contamination” {id. at 122) and can be incorporated
“on surfaces in health care and food service facilities where bacteria and
bioburdens pose a health hazard.” Id. at 123.
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Application 12/397,760
Both Ong and Appellant sought to develop a durable, non-toxic anti­
microbial coating. Given this similarity in purpose, the pertinence of the
properties of Ong’s antimicrobial agent, and Ong’s teaching that its coating
can be incorporated on surfaces in health care facilities, we find that Ong
would have “commended itself’ to an inventor considering the problem
addressed by Appellant.
We acknowledge, but are not persuaded by, Appellant’s contention
that the present invention “addresses problems related to Catheter Related
Blood Stream Infection (CRBSI)” (see App. Br. 10) because the
Specification describes the problems addressed by Appellant more broadly,
(see Specification 113), and discusses CRBSI only as an example of type of
problem faced. See id. at || 7 and 14. Moreover, the claims are not limited
to CRBSI and Appellant has not provided persuasive evidence or argument
to establish that the person of ordinary skill in the art would have found Ong
inapplicable to CRBSI-related problems. See Johnston v. IVAC Corp., 885
F.2d 1574, 1581 (Fed. Cir. 1989) (“Attorneys’ argument is no substitute for
evidence.”); In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
Accordingly, we affirm the Examiner’s rejection of claim 1 over the
combination of Krongauz, Elton, and Ong. Because they were not argued
separately, claims 3, 5, 7, 12—17, and 23 fall with claim 1.
REJECTION OF CLAIMS 9, 10, AND 18-22 OVER THE
COMBINATION OF KRONGAUZ, ELTON, ONG, AND NISHTALA
Claims 9, 10 and 18—22 require various antimicrobials that the
Examiner found were not disclosed in Ong. The Examiner found that these
antimicrobials were obvious in view of Nishtala, because Nishtala disclosed
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Application 12/397,760
that they were known equivalents of the antimicrobials disclosed in Ong.
The Examiner explained:
[I]t would have been obvious to a person of ordinary skill
in the art at the time of the instant invention to substitute
cetyl pyridinium chloride (claims 9 and 20), alexidine
(claims 10 and 19), chlorhexidine diacetate (claim 21), or
benzalkonium chloride (claim 22) for the antimicrobial
taught in the combination of Krongauz, Elton, and Ong
since Nishtala teaches that cetyl pyridinium chloride,
alexidine (claims 10 and 19), chlorhexidine diacetate
(claim 21), or benzalkonium chloride are known as
equivalents which perform the same function as triclosan
or bisguanide antimicrobials, as taught by Ong, in a
polyacrylate coating material on a medical device
inserted into a human patient.
Ans. 6—7.
Appellant argues that Nishtala teaches away from the claimed
invention because “while Nishtala may teach the inclusion of various non-
metal salt antimicrobial agents, the polymeric coatings of Nishtala require
that at least one of the components be ‘a colloid comprising a salt or oxide of
one or more oligodynamic metals.’” App. Br. 11. Appellant contends that
Nishtala’s teaching that a metal salt or oxide is required is contrary to the
limitation of claims 9, 10, and 18—22 requiring “an antimicrobial agent. . .
excluding metal salts.” We are not persuaded.
The Examiner relied upon Nishtala for its teaching that the
antimicrobials recited in claims 9, 10, and 18—22 were “known as
equivalents which perform the same function as triclosan or biguanide
antimicrobials.” Ans. 6—7. Appellant’s argument that Nishtala requires
metal salts is not persuasive because it does not establish that Nishtala’s
teaching of known equivalence among antimicrobials was incorrect.
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Application 12/397,760
In addition, it is not clear that Nishtala does, in fact, require a metal
salt or oxide. Appellant argues that “Nishtala teaches a polymeric coating
‘that includes at least one polymer and a colloid comprising a salt or oxide
of one or more oligodynamic metals, wherein the salt or oxide of one or
more oligodynamic metals inhibits microbial adherence of one or more
organisms to the composition.’” App. Br. 11. However, even assuming that
Nishtala does require a metal salt or oxide, the claims at issue exclude only
the use of metal salts. They do not exclude the use of metal oxides. The use
of Nishtala’s equivalent antimicrobials together with a metal oxide would
thus not be inconsistent with language of claims 9, 10, and 18—22.
Accordingly, we affirm the Examiner’s rejection of claims 9, 10, and
18—22 over the combination of Krongauz, Elton, Ong and Nishtala.
SUMMARY
For these reasons and those set forth in the Examiner’s Answer, and
the Final Office Action, the Examiner’s final decision to reject claims 1,3,
5, 7, 9, 10, and 12—23 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
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