Ex Parte Boyd

Patent Trial and Appeal Board

Jan 18, 2013

11737050 (P.T.A.B. Jan. 18, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte THOMAS JAMES BOYD
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Appeal 2012-001965
Application 11/737,050
Technology Center 1600
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Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
SHERIDAN K. SNEDDEN, Administrative Patent Judges.

SNEDDEN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to films
comprising polymers. The Examiner has rejected the claims as obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
Appellant‟s invention relates to “films comprising polymers … for
improving the delivery of an active agent to a surface.” (Spec. 1, ¶ [0001].)
The films comprise “a mixture of a first polymer and a second polymer
having a solubility temperature that is lower than that of the first polymer.”
(Id. at 4, ¶ [0018].) “In various embodiments, the first polymer is
hydroxypropylmethylcellulose (HPMC) and the second polymer is
methylcellulose (MC).” (Id. at 3, ¶ [0013].)
Claims 1-10, 17, 18 and 25-27 are on appeal. Claim 1 is
representative and reads as follows:
1. A film comprising:
(a) a first polymer;
(b) a second polymer having a solubility temperature
lower than that of the first; and
(c) a therapeutic active selected from the group
consisting of abrasives, anticaries agents, anticaluclus agents,
antiplaque agents, antisensitivity agents, occluding agents,
periodontal actives, breath freshening agents, malodor control
agents, whitening agents, stain prevention actives, salivary
stimulants, and combinations thereof;
wherein the breaking strength of the film is greater than
750 psi (5,171 kPa);
wherein the first polymer has a solubility temperature of
greater than about 100° F. (37.8°C.);
wherein the first and second polymers are cellulose
ethers; and
wherein the film dissolves in water in 506 seconds or
less.

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The sole rejection before us for review is the Examiner‟s rejection of
claims 1-10, 17, 18 and 25-27 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Barkalow
1
as evidenced by Leung.
2

I.
Issue
The Examiner finds that Barkalow discloses compositions comprising
a film forming agent and a thickening agent, where both the film forming
agent and thickening agent may be a cellulose ether (Ans. 5, citing Barkalow
at ¶¶ [0008], [0013], [0014], and [0025]), where cellulose ethers include
methylcellulose and hydroxypropyl methylcellulose (id., citing Barkalow at
¶ [0043]), and where “[m]ethylcellulose is … art recognized for use as a
thickener in edible films” (id., citing Leung at ¶ [0043]). The Examiner
finds that “the edible films of Barkalow . . . are comprised of substantially
the same film forming polymers as the instant claims” (Ans. 7).
While recognizing that Barkalow fails to disclose a specific example
of a composition comprising a first and second polymer in the manner now
claimed, and thus fails to anticipate claim 1, the Examiner finds that
it would have obvious to have selected … a combination of
hydroxypropylmethylcellulose and methyl cellulose and oral
care agents for treating plaque and gingivitis or breath
freshening agents from within a prior art disclosure, to arrive
[at] compositions “yielding no more than one would expect
from such an arrangement”

(Ans. 6, quoting KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007)).

1
Barkalow et al., US 2002/0131990 A1, published Sep. 19, 2002.
2
Leung et al., US 2001/0022964 A1, published Sep. 20, 2001.
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Regarding the properties of the films recited in claim 1, the Examiner
finds that the desired properties “can be optimized through routine
experimentation by varying the amount of each polymer in the film forming
polymer combination based on the concentration range of total film forming
agent of about 10% to about 90% by dry weight of the film taught by
Barkalow.” (Id. at 7.) Moreover, the Examiner finds that because “the films
of Barkalow . . . provide similar desirable properties as pullulan-based films
such as rapid dissolution, they would reasonably be expected to possess the
ability to dissolve in 30 seconds” (id.).
Appellant contends that “Barkalow does not disclose particular
combinations of cellulose ethers, or the use of solubility temperature as „a
result effective variable‟ for their selection” (App. Br. 9) and that “[t]he
films of Barkalow … are not disclosed as having the breaking strength or
dissolution properties of the instantly claimed films” (id.). Appellant further
contends that
it is unreasonable to suppose that one could readily select and
optimize combinations of cellulose ethers from this generic
disclosure, without identifying result-effective variables as
criteria for selection, it is equally unreasonable to suppose that
all combinations of film forming agents within this huge class
will have “substantially the same film strength” as asserted by
the Examiner

(id. at 11).
The issue presented is: Does the evidence of record support the
Examiner‟s findings that Barkalow renders claim 1 obvious?
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Findings of Fact
The following findings of fact (“FF”) are supported by a
preponderance of the evidence of record.
FF1. The Specification discloses that, “[i]n various embodiments, the
first polymer is hydroxypropylmethylcellulose (HPMC) and the second
polymer is methylcellulose (MC).” (Spec. 3, ¶ [0013].)
FF2. Barkalow discloses that an “advantage of the present invention
is to provide a pullulan free edible film composition that exhibits rapid
dissolution, flexibility, non-hygroscopity, clean mouth feel, clean flavor and
ease of manufacture” (Barkalow 2, ¶ [0032]).
FF3. The edible film formulations disclosed in Barkalow “comprise
effective amounts of at least one film forming agent; at least one bulk filler
agent; at least one plasticizing agent; and optionally at least one thickening
agent” (Barkalow, Abst.) (emphasis added).
FF4. Barkalow discloses that the film forming agent may be
cellulose ether (id. at 1, ¶ [0008]).
FF5. Barkalow discloses that the thickening agent may be cellulose
ether (id. at 3, ¶ [0051]).
FF6. Barkalow discloses that “[e]xamples of cellulose ethers include,
but are not limited to, methylcellulose; ethylcellulose;
hydroxymethylcellulose; hydroxyethylcellulose;
hydroxypropylmethylcellulose; carboxymethylcellulose; derivatives thereof
and combinations thereof” (id. at 3, ¶ [0043]) (emphasis added).
FF7. The compositions of Barkalow rapidly dissolve within the oral
environment (p. 5, ¶[0079]).
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FF8. Leung discloses “fast dissolving orally consumable films …
used to deliver breath deodorizing agents, antimicrobial agents and salivary
stimulants to the oral cavity . . . [as well as] pharmaceutically active agents.”
(Leung 1, ¶ [0001].)
FF9. Leung discloses methylcellulose as a preferred thickening agent
for use in fast dissolving orally consumable films (id. at 3, ¶ [0043]).

Principles of Law
“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).
A reference inherently discloses an element of a claim “if that missing
characteristic is necessarily present, or inherent, in the single anticipating
reference.” Schering Corp. v. Geneva Pharms., 339 F.3d 1373, 1377 (Fed.
Cir. 2003) (citation omitted). “Inherency, however, may not be established
by probabilities or possibilities. The mere fact that a certain thing may result
from a given set of circumstances is not sufficient.” Therasense, Inc. v.
Becton, Dickinson and Co., 593 F.3d 1325, 1332 (Fed. Cir. 2010) (citing
Cont’l Can Co. USA, Inc. v. Monsanto Co., 948 F.2d 1264, 1269 (Fed. Cir.
1991)).
The Examiner has the burden of providing reasonable proof that a
claim limitation is an inherent characteristic of the prior art. In re Best, 562
F.2d 1252, 1254–55 (CCPA 1977) (“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
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fairness is evidenced by the PTO‟s inability to manufacture products or to
obtain and compare prior art products.”); see also Crown Operations Int'l,
Ltd. v. Solutia Inc., 289 F.3d 1367, 1377 (Fed. Cir. 2002). The Examiner
meets this “burden of production by „adequately explaining the
shortcomings it perceives so that the applicant is properly notified and able
to respond.‟” In re Jung, 637 F.3d 1356, 1362 (Fed. Cir. 2011) (quoting
Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007)). The burden of proof
then shifts to the applicant “to prove that the subject matter shown to be in
the prior art does not possess the characteristic relied on.” Best, 562 F.2d at
1254–55 (“Where … the claimed and prior art products are identical or
substantially identical, … 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.”); In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990)
(“[W]hen the PTO shows sound basis for believing that the products of the
applicant and the prior art are the same, the applicant has the burden of
showing that they are not.”).
Analysis
We find that the Examiner has presented a sound rationale as to why a
person of ordinary skill in the art would have used HPMC and MC in
forming the films disclosed in Barkalow and why these films would be
expected to have the properties set forth in the claims, and thus has provided
sufficient evidence to support a prima facie case of obviousness. (See, e.g.,
Ans. 4-7.) We adopt the Examiner‟s rationale as our own. Having provided
a sound basis for believing that the claimed films are substantially the same
as obvious variants to the films disclosed in Barkalow, Appellant has the
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burden of showing that they are not. Best, 562 F.2d at 1254–55. Appellant
has not met this burden.
We are not persuaded by Appellant‟s arguments that the Examiner
needed to explain “[w]hy a person skilled in the art would have been
motivated to measure and optimize the relative solubility temperature as „a
result effective variable‟ for optimizing the film's strength and dissolution
properties.” (App. Br. 10.) On the evidence of record, the Examiner finds
the “solubility temperature”, in the context of claim 1, to be an inherent
property of the polymers encompassed by claim 1 (e.g., HPMC and MC),
and provides evidence that the same polymers are disclosed by Barkalow.
(Ans. 7.) Appellants have not provided evidence that the solubility
temperatures of the HPMC and MC polymers disclosed in Barkalow are not
the same as those claimed, as required by In re Best.
Moreover, the recitation of a new property in a claimed composition
does not render a known composition patentable. See, e.g., In re Spada, 911
F.2d at 708 (“The discovery of a new property or use of a previously known
composition, even when that property and use are unobvious from the prior
art, can not impart patentability to claims to the known composition.”).
Nor are we persuaded by Appellant‟s arguments that the Examiner has
not explained why a person of skill in the art would have selected cellulose
ethers out of the various polymers disclosed in Barkalow. (See, e.g., App.
Br. 11.) Barkalow discloses film compositions that may comprise a
therapeutic agent and one or more of a finite number of cellulose ethers that
include HPMC and MC (FF3-FF6; see also, Ans. 4-7). Having done so, the
burden shifted to Appellant to provide evidence that the claimed
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combination of known elements would do more than more than yield
predictable results, KSR, 550 U.S. at 416 (2007), or that the compositions in
the prior art did not possess the claimed properties.
Conclusion of Law
The preponderance of evidence on this record supports the
Examiner‟s findings that Barkalow renders claim 1 obvious. Claims 2-10,
17, 18 and 25-27 fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
SUMMARY
We affirm the rejection of claims 1-10, 17,18 and 25-27 are rejected
under 35 U.S.C. § 103(a) as being unpatentable over Barkalow as evidenced
by Leung.
AFFIRMED

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