Ex Parte Schutte et al

Patent Trial and Appeal Board

Sep 5, 2018

12746276 (P.T.A.B. Sep. 5, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/746,276 06/04/2010 Grant Schutte
62127 7590 09/07/2018
VALSPAR SOURCING, INC.
PO Box 1461
MINNEAPOLIS, MN 55440-1461
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
06-1924-0101 7761
EXAMINER
SANDERSON, LEE E
ART UNIT PAPER NUMBER
1782
NOTIFICATION DATE DELIVERY MODE
09/07/2018 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):
PATENTS@VALSPAR.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN I. SHIPP
Appeal 2016-007589
Application 12/746,276
Technology Center 1700
Before LINDA M. GAUDETTE, MONTE T. SQUIRE,
and JANEE. INGLESE, Administrative Patent Judges.
GAUDETTE, Administrative Patent Judge.
DECISION ON APPEAL 1
Appellant2 appeals under 35 U.S.C. § 134(a) from the Examiner's decision
finally rejecting claims 1, 5, 7, 9, 10, 12, 17, 20, 22, 23, 28, 29, and 31-39. We
have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 This Decision includes citations to the following documents: Specification filed
June 4, 2010 ("Spec."); Final Office Action dated July 2, 2015 ("Final"); Appeal
Brief filed Jan. 4, 2016 ("Appeal Br."); Examiner's Answer dated June 2, 2016
("Ans."); and Reply Brief filed Aug. 2, 2016 ("Reply Br.").
2 Appellant identifies the real party in interest as Valspar Sourcing, Inc. Appeal Br.
3.
Appeal 2016-007589
Application 12/746,276
"[T]he invention relates to polymer coating compositions suitable for use on
surfaces intended for contact with a medicament." Spec. ,r 2. Claim 1 is
representative of the claims on appeal, and is reproduced below.
1. A coated article, comprising:
a pressurized metered dose inhaler, comprising:
a pressurized container filled with a propellant-based
medicament composition including a drug and a liquefied gas
propellant, wherein the pressurized container has a coating applied on
at least a portion of an interior metal surface such that the coating is in
contact with the medicament composition; and
wherein the coating is formed from an aqueous coating
composition that comprises a water-dispersible resin system that
includes at least about 10% by weight, based on total solids, of an
emulsion polymerized acrylic latex polymer, and wherein the aqueous
coating composition is substantially free of bound BP A and aromatic
glycidyl ether compounds.
Appeal Br. 19 (Claims Appendix).
The claims stand rejected as unpatentable under 35 U.S.C. § I03(a) as
follows:
1. Claims 1, 5, 7, 9, 10, 12, 17, 20, 22, 23, 29, 31, 32, 34, and 37-39
over Tzou (US 5,776,433, issued July 7, 1998) in view of O'Brien (US
2006/0100366 Al, published May 11, 2006 ("O'Brien '366"));
2. Claim 35 over Tzou and O'Brien '366 in view of Concannon (US
4,335,030, issued June 15, 1982); and
3. Claims 1, 5, 7, 9, 10, 12, 20, 22, 23, 28, 29, 31-34, and 36-39 over
Chan (US 2004/0134824 Al, published July 15, 2004) in view of Wind (US
2006/0141261 Al, published June 29, 2006) and O'Brien (US 2004/0259989 Al,
published Dec. 23, 2004 ("O'Brien '989")).
2
Appeal 2016-007589
Application 12/746,276
Grounds of Rejection Based on Tzou and O'Brien '366
The Examiner finds Tzou discloses the invention as recited in claim 1, with
the exception that Tzou does not disclose that the coating on the interior of the
container comprises an acrylic polymer. Final 2-3. Rather, Tzou discloses that
"[ s Jui table resins for coating the formulation chamber include materials commonly
employed as interior can coatings, such as epoxy resins (e.g., epoxy-phenolic
resins and epoxy-urea-formaldehyde resins)." Tzou, 4: 10-14; see Final 3.
The Examiner finds O'Brien '366 "discloses an aqueous, bisphenol A
(BP A)/aromatic glycidyl ether free, coating composition that is useful for coating
the interior surfaces of aluminum cans." Final 3. The Examiner further finds
"[ t ]he composition contains a resin system comprising an emulsion polymerized
acid-functional acrylic latex polymer which is present in the resin system in
amounts of 5 to 95 wt%," and "[t]he cured coating produced from the coating
composition exhibits excellent adhesion, blush resistance, and has a low
extractable content." Id. The Examiner finds the coating composition of O'Brien
'366 "is suitable for use in containers that contain substances for human
consumption as it [is] substantially free of potentially harmful compounds such as
BPA or aromatic glycidyl ethers." Id. The Examiner finds one of ordinary skill in
the art would have coated the interior of Tzou's container with the coating
composition of O'Brien '366 because "it was known to be useful for coating the
interior of cans" and has "excellent adhesion and blush resistance properties and
provides corrosion resistance without comprising potentially harmful BPA." Id. at
3--4.
Appellant argues the Examiner's rejection is based on an obvious-to-try
rationale and, as such, the Examiner must identify evidence to support findings
that, at the time of the invention, there were a finite number of identified,
3
Appeal 2016-007589
Application 12/746,276
predictable solutions to a recognized problem or need in the art, and that the
ordinary artisan would have had a reasonable expectation of success in pursuing
these known solutions. Appeal Br. 9; see Rolls-Royce, PLC v. United
Technologies Corp., 603 F.3d 1325, 1339 (Fed. Cir. 2010) ("The important
question is whether the invention is an 'identified, predictable solution' and an
'anticipated success."'). Appellant argues the Examiner has failed to meet this
burden and, instead, relies on improper hindsight reasoning in concluding the
claimed invention would have been obvious. See Appeal Br. 9-14. Appellant's
argument is persuasive for the reasons discussed below.
Appellant relies on the Declaration of Joseph Groeger under 37 C.F.R.
§ 1.132 ("Deel.") in support of its contention that the ordinary artisan would not
have had a reasonable expectation of success in using a food contact coating in a
metered dose inhaler ("MDI") container. Mr. Groeger testified that he has an M.S.
in Metallurgy and has completed the coursework and research for a PhD in
Materials Science. Deel. ,r 2. Mr. Groeger testified that he has over 10 years of
experience in the designing, processing and coating of MDI cans, and is a named
inventor on multiple patents and patent applications directed to MDI cans for use
in storing and administering medicaments. Id. Notably, Mr. Groeger testified that
he is not an employee of Appellant or any of its corporate affiliates, and was not
compensated for time spent in preparing his Declaration. Id. ,r 3. We find Mr.
Groeger is qualified to testify as to the knowledge and skill level of the ordinary
artisan at the time of the invention, and accord weight to Mr. Groeger' s testimony
that
[ t ]he food or beverage can coating area is a unique end use area,
which requires its own balance of end-use-specific coating properties
that is distinct from that of the MDI coating area. For example, the
chemical make-up of a packaged medicament product is appreciably
4
Appeal 2016-007589
Application 12/746,276
different from that of a food or beverage product[] ( e.g., certain oils,
biologically-active compounds, propellants, etc.) that make it difficult
to design or select an acceptable MDI coating.
Id. ,r 9. We also give weight to Mr. Groeger's testimony that "polymer coatings
designed for other coating end uses do not typically exhibit the balance of stringent
coating properties that [are] required in the demanding MDI end use area," id. ,r 8,
and that one of ordinary skill in the art at the time of the invention would not have
expected the coating composition of O'Brien to "have exhibited the necessary
balance of stringent properties to be suitable for use in the demanding MDI end use
area," id. ,r 9.
We have considered the Examiner's position that we should give little
weight to Mr. Groeger's testimony because the claims do not recite "the properties
and balance thereof which [ A Jppellant asserts are critical for a coating to be
suitable for use in an MDI container" and Mr. Groeger does not cite evidence in
support of his testimony. Ans. 17. We find, however, that Mr. Groeger's
testimony has probative value with respect to the issues of whether an ordinary
artisan would have looked to food and beverage cans out of the numerous types of
cans that have interior coatings, and whether the ordinary artisan would have had a
reasonable expectation of success in using the food can coating of O'Brien '3 66.
See Velander v. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003) (stating that it is
"within the discretion of the trier of fact to give each item of evidence such weight
as it feels appropriate"). Moreover, Mr. Groeger's testimony is consistent with the
teachings of Tzou and O'Brien '366.
Tzou provides a very general statement that "resins ... commonly employed
as interior can coatings" are suitable for coating the interior of a metered dose
inhaler ("MDI") canister used with Tzou's inventive flunisolide aerosol
formulation. See Zhou, 4: 10-12. As argued by Appellant, "[t]here are many types
5
Appeal 2016-007589
Application 12/746,276
of cans other than food or beverage cans - e.g., paint cans, industrial solvent cans,
cans containing cleaning products or other industrial products, and the like."
Reply Br. 8. Tzou does not provide direction to select from among coatings used
in a particular type of can, see id.; rather, Tzou expresses a preference for using "a
glass aerosol vial or an aluminum aerosol vial having an interior formulation
chamber coated with a resin that is inert to flunisolide and preferably does not
absorb flunisolide from the formulation," Tzou 4:2-10. Tzou indicates that
coatings comprising epoxy resins such as epoxy-phenolic resins and epoxy-urea-
formaldehyde resins meet these requirements. Id. at 4: 10-14; see also id. at 9: 18-
45 (Table 8, epoxy coated aluminum).
While Tzou is concerned with the problem of the coating absorbing
flunisolide, i.e., the active drug ingredient in a propellant-based pharmaceutical
aerosol formulation, O'Brien '366 is concerned with the opposite problem of
bisphenol A and/or other aromatic glycidyl ether compounds used to coat the
interior of food and beverage cans being released into the food or beverage, which
presumably are not aerosol formulations. Compare Tzou 4:1-10, with O'Brien
'366 ,r,r 36, 120. O'Brien '366 discloses that the inventive "latex polymers ... are
suitable for use in food contact situations," id. ,r 36, but does not indicate that the
coating is suitable for any other purpose. The Examiner has not identified a
disclosure in O'Brien '366, or other evidence of record, to support a finding that
one of ordinary skill in the art reasonably would have expected that a food contact
coating that does not contain extractible quantities of BP A or aromatic glycidyl
ether compounds would meet MDI canister coating requirements, which according
to both Tzou and the present inventor, are that the coating is inert to the active drug
in the formulation, and does not absorb the active drug from the medicament
formulation. See Tzou 4:2-10; Spec. ,r 3, Background (emphasis added) ("[D]rug-
6
Appeal 2016-007589
Application 12/746,276
dispensing articles such as metered dose inhalers ('MDis') typically have a
container for storing aerosol medicaments. Traditionally, these containers have
been formed from metal (e.g., aluminum) and have a bare metal inner surface for
contacting the medicament. These metal surfaces have typically suffered from
several drawbacks which include, for example, adsorption of drug onto the metal
surfaces (which can result in inconsistent or reduced drug delivery), reduced drug
stability, and possible contamination of the drug ( e.g., through extraction of
residual organic compounds present on the metal surface)."
In sum, Appellant has argued persuasively that the Examiner has not
identified sufficient evidence to support findings that the ordinary artisan would
have selected O'Brien '366's interior coating for a food and beverage can, from
among the numerous interior coatings used in other types of cans, for use in Tzou' s
MDI canister, and had a reasonable expectation of success in so doing. See Reply
Br. 8-9. Accordingly, we do not sustain the rejection of claims 1, 5, 7, 9, 10, 12,
17, 20, 22, 23, 29, 31, 32, 34, and 37-39 over Tzou in view of O'Brien. Because
the Examiner does not cite to teachings in Concannon that cure the above-noted
deficiencies in the Examiner's combination of Tzou and O'Brien, we also sustain
the rejection of claim 35 over Tzou and O'Brien in view of Concannon.
Ground of Rejection Based on Chan, Wind, and O'Brien '989
The Examiner finds Chan discloses the invention as recited in claim 1, with
the exception that Chan does not disclose that the coating on the interior of the
container is formed from a water-dispersible resin system comprising an acrylic
polymer. Final 10. The Examiner finds Wind discloses a composition suitable for
coating drug packaging, the composition comprising an aqueous dispersion
containing an epoxide-functional resin that may be EPON 1007 or EPON 1009 and
an acid-functional acrylic resin. Id. The Examiner finds Wind describes the
7
Appeal 2016-007589
Application 12/746,276
coating composition as exhibiting good adhesion to metal substrates and low
volatile organic compound ("VOC") content. Id. The Examiner determines one of
ordinary skill in the art at the time of the invention would have used Wind's
coating composition to coat the inner surface of Chan's MDI container "because it
was known to be suitable for coating drug containers and exhibits a good adhesion
to metal substrate while being SP A/aromatic glycidyl ether free and having a low
VOC content." Id. at 11.
The Examiner finds O'Brien '989 "teaches that there is a perception that
BPA and aromatic glycidyl ether compounds pose a risk to human health." Id.
The Examiner finds O'Brien 989 discloses a coating composition, useful for
coating the interior surfaces of aluminum cans, comprising an aqueous dispersion
composed of an oxiranefunctional acrylic polymer (i.e. an epoxide-functional
acrylic polymer) and an acid-functional acrylic polymer that is said to "mimic" or
"exceed" the properties of traditional epoxy resin such as EPON 1007 and EPON
1009. Id. (quoting O'Brien '989 ,r 47). The Examiner determines one of ordinary
skill in the art at the time of the invention
would have utilized the oxirane-functional acrylic polymer of the
coating composition of O'Brien 989 as the epoxide-functional
polymer of the coating composition of MDI of Chan modified with
Wind because it was known to mimic or exceed the properties of the
EPON 1007 and EPON 1009 resin which are taught by Wind as being
suitable as the epoxide-functional polymer component,
and "because it was known to be a suitable epoxide-functional polymer in aqueous
epoxy/acrylic coating compositions with the benefit of not comprising potentially
harmful BPA and/or aromatic glycidyl ether compounds." Id. at 11-12.
Appellant presents arguments similar to those made in support of
patentability over the combination of Tzou and O'Brien '3 66, and also relies on the
Groeger Declaration. We find these arguments persuasive.
8
Appeal 2016-007589
Application 12/746,276
Like Tzou, Chan discloses that coatings are used in MDI canisters for the
purpose of preventing "drug losses due to deposition of drug substances on the
canister walls" and "the possibility of interaction between the formulation and the
canister walls." Chan ,r 6. Chan lists numerous materials for possible use as the
coating. See id. ,r,r 47-71. As argued by Appellant, see Appeal Br. 14--15,
although Wind discloses coatings that may be used on drug bottles as well as food
and beverage containers, the Examiner has not identified any disclosure in Wind
that suggests the coatings would meet MDI canister coating requirements, i.e., that
the coatings are inert to the active drug in an MDI formulation, and do not absorb
the active drug from the formulation. See Wind ,r,r 2, 4, 5 (noting there is a need in
the art to provide a coating composition for beverage and other sanitary cans with
reduced VOC content to address environmental concerns); Chan ,r 6; Spec. ,r 3.
Likewise, the Examiner has not identified evidence to support a finding that the
ordinary artisan at the time of the invention reasonably would have expected the
coatings of O'Brien '989 to meet MDI canister coating requirement. See Appeal
Br. 15. Similar to O'Brien '366, O'Brien '989 is directed to coatings for food and
beverage cans that do not liberate BP A or aromatic glycidyl ether compounds into
the food or beverage. O'Brien '989 ,r,r 2, 47. We again credit Mr. Groeger's
testimony that "polymer coatings designed for other coating end uses do not
typically exhibit the balance of stringent coating properties that [are] required in
the demanding MDI end use area," Deel. ,r 8, and that one of ordinary skill in the
art at the time of the invention would not have expected the coating composition of
Wind to "have exhibited the necessary balance of stringent properties to be suitable
for use in the demanding MDI end use area," id. ,r 9.
Accordingly, because the Examiner has not cited sufficient evidence to
support a conclusion of obviousness, we do not sustain the rejection of claims 1, 5,
9
Appeal 2016-007589
Application 12/746,276
7, 9, 10, 12, 20, 22, 23, 28, 29, 31-34, and 36-39 over Chan in view of Wind and
O'Brien '989.
REVERSED
10