Ex Parte Faasse et al

Board of Patent Appeals and Interferences

Aug 2, 2010

10985709 (B.P.A.I. Aug. 2, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte ADRIAN L. FAASSE, STEVEN RICHARD KLEMM,
GLEN EDWARD GROENEWEG, and ALAN GENE THELEN
__________

Appeal 2010-000143
Application 10/985,709
Technology Center 1600
__________

Before DONALD E. ADAMS, MELANIE L. McCOLLUM, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to a device
for delivering an oral care agent. The Examiner has rejected the claims as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a
civil action, as recited in 37 C.F.R. § 1.304, or for filing a request
for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from
the “MAIL DATE” (paper delivery mode) or the
“NOTIFICATION DATE” (electronic delivery mode) shown on
the PTOL-90A cover letter attached to this decision.
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Statement of the Case
The Claims
Claims 1-7, 10-58, 60-69, 84-86, 88-98, 100-102, and 110-119 are on
appeal. Claims 1, 46, 48, 49, 50, 60, 64, and 102 are separately argued. The
remaining claims have not been argued separately and therefore stand or fall
together. 37 C.F.R. § 41.37(c)(1)(vii). Claims 1, 46, 48, 49, 50, 60, 64, and
102 are representative and read as follows:
1. A device for delivering an oral care agent,
wherein the device is sized to fit over a plurality of
teeth in an upper or lower dental arch in a subject,
the device comprising:
a permanently deformable backing layer;
a non-woven binding material comprising a
first part and a second part; and
an oral care layer comprising at least one
oral care agent and at least one hydrophilic
polymer, wherein the first part of the binding
material is substantially invested in at least a
portion of the oral care layer, and the second part
of the binding material is substantially invested in
at least a portion of the backing layer, and
wherein the oral care layer has an
adhesiveness when hydrated relative to the surface
of the teeth of the subject that is sufficient to retain
the device on the user’s teeth when placed thereon.

46. The device of claim 1, wherein the
adhesiveness of the oral care layer with respect to
the surface of the user’s teeth is from about 200
N/m to about 400 N/m.

48. The device [of claim 1, wherein the at least
one oral care agent is entrapped within the oral
care layer], wherein the at least one oral care agent
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is released from the hydrophilic polymer upon
hydration of the oral care layer.

49. The device of claim 1, wherein the at least
one oral care agent is activated upon hydration of
the oral care layer.

50. The device of claim 1 wherein the oral care
layer comprises a pressure- sensitive adhesive
comprising at least one oral care agent, at least one
hydrophilic polymer, and at least one water-
soluble plasticizer that is miscible with the
hydrophilic polymer.

60. The device of [claim 50], wherein the oral
care layer comprises crosslinked or non-
crosslinked polyvinyl pyrrolidone.

64. The device [of claim 60, wherein the oral
care layer is a sustained release oral care layer]
wherein the sustained-release oral care layer
releases the at least one oral care agent at a rate of
approximately 0.2 mg/cm2-min to 1 mg/cm2-min.

102. The device of claim 1, further comprising a
scrim embedded in the oral care layer.

The prior art
The Examiner relies on the following prior art references to show
unpatentability:
Singh et al. US 2003/0152528 A1 Aug. 14, 2003
Jones et al. US 2005/0260544 A1 Nov. 24, 2005

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The issues
A. The Examiner rejected claims 1-6, 10, 11, 14, 19-20, 22-33, 36, 46-
58, 61, 62, 65-69, 84-86, 88-96, 102, and 110-119 under 35 U.S.C. § 103(a)
as obvious over Jones (Ans. 3-6).
B. The Examiner rejected claims 7, 12, 13, 15-18, 21, 34, 35, 37-45, 60,
63, 64, 96-98, and 101 under 35 U.S.C. § 103(a) as obvious over Jones and
Singh (Ans. 6-8).
C. The Examiner rejected claims 1-7, 10-58, 60-69, 84-86, 88-98, 100-
102, and 110-119 on the ground of provisional nonstatutory obviousness-
type double patenting over claims 1-11, 15-32, 36-58, 60-81, 83-85, 87-97,
100, 101, 107, and 109-118 of U.S. Application 10/187,666.

A. 35 U.S.C. § 103(a) over Jones
The Examiner finds that “Jones et al. disclose oral care devices
comprising several layers. The first layer is a backing layer which may be
made from a plastically deformable material such as wax” (Ans. 3). The
Examiner finds that Jones “teaches the same polymers are used in the
disclosed oral care compositions as those disclosed by the instant
specification that provide the adhesive function and further teaches the
polymers are used to adhere the oral care substance to the teeth” (Ans. 9).
The Examiner finds that “the strip of material, which is the backing layer, is
forced among the fibers of the fabric to bond them together” (Ans. 13).
Appellants contend that “Jones repeatedly teaches away from using an
oral care substance as an adhesive and repeatedly states that the combination
of an oral care substance and an adhesive is the very problem it is trying to
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overcome” (App. Br. 5). Appellants contend that “any reasonable
interpretation of oral care layer must include that the layer has an
adhesiveness throughout” (App. Br. 7). Appellants also contend that “Jones
fails to disclose a binding material ‘substantially invested in’ both a backing
layer and an oral care layer” (App. Br. 10).
The issues with respect to this rejection are: Does the evidence of
record support the Examiner’s conclusion that Jones teaches and suggests
(i) “an oral care layer comprising at least one oral care agent and at
least one hydrophilic polymer . . . wherein the oral care layer has an
adhesiveness when hydrated . . . that is sufficient to retain the device on the
user’s teeth” and
(ii) “wherein the first part of the binding material is substantially
invested in at least a portion of the oral care layer, and the second part of the
binding material is substantially invested in at least a portion of the backing
layer”?
Findings of Fact
1. The Specification teaches that the “oral care layer comprises at
least one oral care agent and at least one hydrophilic polymer” (Spec. 7 ¶
0026).
2. The Specification teaches that:
The non-woven binding material preferably comprises a
spun bonded polypropylene. The material and structure of
the first part and the second part are preferably the same.
The primary basis for the distinction between the first part
and the second part is the layer into which the individual
layer is invested. The first part of the binding material is
substantially invested in the oral care layer. The second part
of the binding material is substantially invested in the
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backing layer. Preferably, the first part of the binding
material comprises about one half of the binding material
and the second part of the binding material comprises about
one half of the binding material.

(Spec. 17 ¶ 0070).
3. The Specification teaches that in “some embodiments, the oral
care agent is entrapped within the oral care layer by a matrix formed by the
hydrophilic polymer. The oral care agent is released from the hydrophilic
polymer matrix upon hydration and swelling of the hydrophilic polymer,
whereupon the agent is delivered to the teeth” (Spec. 21 ¶ 0087).
4. The Specification teaches that “the oral care layer comprises a
pressure-sensitive adhesive comprising an oral care agent and a hydrophilic
polymer that is made tacky (i.e., it is rendered pressure-sensitive) at room
temperature by addition of a water-soluble plasticizer that is miscible with
the polymer” (Spec. 21 ¶ 0089).
5. The Specification teaches that “[h]ydrophilic polymers useful in
the oral care layer . . . include polysaccharides (e.g. starches and starch
derivatives, cellulose-derivatives such as sodium carboxymethyl cellulose or
‘Na-CMC’) . . . carboxylic acid polymers such as the Carbopols and
Carbomers . . . and natural gums such as xanthan gum, karaya gum, and
gelatin” (Spec. 21 ¶ 0090).
6. The Specification teaches that “[p]lasticizers useful in the oral
care layer are characterized as being liquid at room temperature . . . Suitable
plasticizers include glycerin, sorbitol, any of the glycols, polysorbate 80,
triethyl titrate, acetyl triethyl titrate, and tributyl titrate” (Spec. 22 ¶ 0091).
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7. Jones teaches “a delivery device for delivering an oral
healthcare substance to the oral surfaces of the teeth, gingival and/or
mucosal tissues . . . , comprising; a strip of an orally acceptable flexible
material, having a strip surface capable of being applied to a tooth surface
and/or adjoining soft tissue” (Jones 1 ¶¶ 0005-0006).
8. Jones teaches a strip with “an oral healthcare substance
deposited upon a strip surface thereof, and/or impregnated into its bulk, the
substance being capable of transference from the strip surface to the tooth
surface and/or adjoining soft tissue” (Jones 1 ¶ 0007).
9. Jones teaches a strip which is “capable of adhesion to a tooth
surface and/or adjoining soft tissue to which the strip is applied, the adhesion
function being provided independent of the oral healthcare substance” (Jones
1 ¶¶ 0008-0009).
10. Jones teaches that the strip may adapt by “permanent
deformation i.e. in which the strip undergoes plastic deformation with little
or no tendency to return to its original shape after adaptation to a tooth
surface” (Jones 1 ¶ 0012).
11. Jones teaches:
[A] layer of absorbent fabric may then be attached to the
laminated wax strips by known methods, for example by
bringing the fabric into contact with a surface of the first
sheet opposite to the first surface, and applying pressure. For
example the laminated sheets of wax and the fabric may be
rolled together between rollers. In this way the plastically
deformable material may be forced among the fibres of the
absorbent fabric to thereby generate a bond.

(Jones 5 ¶ 0056).
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12. Jones teaches that the “oral healthcare substance of the present
invention can be in a dry form e.g. solid particles, or in a fluid form e.g. in
the form of a viscous liquid, paste, gel, solution or any other suitable form”
(Jones 3 ¶ 0035).
13. Jones teaches that “[p]referably, the substance is in the form of
a gel, which may be an aqueous or non-aqueous (e.g. based on glycerol) gel,
and may also include a gelling or thickening agent. It may be necessary to
add additional gelling agents in the formula to help the active ingredients
adhere to the tissues of the oral cavity” (Jones 3 ¶ 0035).
14. Jones teaches that “Suitable gelling agents useful in the present
invention include . . . carboxymethyl cellulose, carboxypropyl cellulose . . .
and natural gums such as . . . xanthan gum, guar gum . . . A preferable
gelling agent for use in the present invention is . . . Carbopol®” (Jones 3 ¶
0035).
15. Jones teaches that an “additional carrier material may also be
added to the oral care substance or composition. These materials are
generally humectants and include glycerin, sorbitol, polyethylene glycol”
(Jones 3 ¶ 0037).
16. Jones teaches that “capsules of oral healthcare substance and
adhesive may be attached to the surface of the strip, e.g. by means of a
second adhesive or by embedding the capsules in the strip material” (Jones 6
¶ 0064).
17. Jones teaches that “[f]or example a thin layer of the adhesive
may be deposited on the surface of the strip, and capsules of the oral
healthcare substance may be embedded at least partly if not completely
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within this adhesive layer, or may sit upon the surface of this adhesive layer”
(Jones 6 ¶ 0064).
18. Jones teaches that “the strip material may be inherently
adherent to a tooth surface . . . The oral healthcare substance may be
deposited upon a surface of such a strip, for example in spots, patches, lines,
or as a layer e.g. a porous or perforated layer on the surface through which
the adhesive may pass” (Jones 6-7 ¶ 0070).
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
(2) the level of ordinary skill in the art; (3) the differences between the
claimed invention and the prior art; and (4) secondary considerations of
nonobviousness, if any. Graham v. John Deere Co., 383 U.S. 1, 17 (1966).
The Supreme Court has emphasized that “the [obviousness] analysis need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” KSR Int’l v.
Teleflex Inc., 550 U.S. 398, 418 (2007). As noted by the Court in KSR, “[a]
person of ordinary skill is also a person of ordinary creativity, not an
automaton.” 550 U.S. at 421.
Claim terms are interpreted using the broadest reasonable
interpretation in light of the Specification. See, e.g., In re Hyatt, 211 F.3d
1367, 1372 (Fed. Cir. 2000) (“[D]uring examination proceedings, claims are
given their broadest reasonable interpretation consistent with the
specification.”).
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Analysis
Claim Interpretation
Claim interpretation is at the heart of patent examination because
before a claim is properly interpreted, its scope can not be compared to the
prior art. In this case, Appellants challenge the Examiner’s interpretation of
two different phrases in Claim 1. First, Appellants contend that “any
reasonable interpretation of oral care layer must include that the layer has an
adhesiveness throughout” (App. Br. 7). Second, Appellants contend that
“Jones fails to disclose a binding material ‘substantially invested in’ both a
backing layer and an oral care layer” (App. Br. 10).
During prosecution, claim terms are given their broadest reasonable
interpretation as they would be understood by persons of ordinary skill in the
art in the light of the Specification. Therefore, we first turn to the
Specification to determine whether the meanings of the phrases “oral care
layer” and “substantially invested” can be discerned.
“Oral care layer”
The Specification teaches that the “oral care layer comprises at least
one oral care agent and at least one hydrophilic polymer” (Spec. 7 ¶ 0026;
FF 1). The Specification teaches that “the oral care layer comprises a
pressure-sensitive adhesive comprising an oral care agent and a hydrophilic
polymer that is made tacky (i.e., it is rendered pressure- sensitive) at room
temperature by addition of a water-soluble plasticizer that is miscible with
the polymer” (Spec. 21 ¶ 0089; FF 4).
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Appellants do not identify any portion of the Specification which
specifically defines the term “oral care layer” (see App. Br. 5-8). Instead,
Appellants point to dependent claim 48 and argue that for “the oral care
agent to be ‘released from the hydrophilic polymer,’ it must have been
mixed with the hydrophilic polymer originally” (App. Br. 7). Appellants
also argue that the “plain meaning of the recited ‘oral care layer’ also
requires adhesiveness throughout the layer. Claim 1 recites that the oral care
layer, not merely a portion thereof, has an adhesiveness when hydrated”
(App. Br. 7).
The Examiner finds that Jones “teaches the same polymers are used in
the disclosed oral care compositions as those disclosed by the instant
specification that provide the adhesive function” (Ans. 9).
We find that the Examiner has the better position here. Both Claim 1
and the Specification require “an oral care layer comprising at least one oral
care agent and at least one hydrophilic polymer” (see Claim 1; Spec. 7 ¶
0026; FF 1). The transitional term “comprising” is “inclusive or open-
ended and does not exclude additional, unrecited elements or method steps.”
Georgia-Pacific Corp. v. United States Gypsum Co., 195 F.3d 1322, 1327,
(Fed. Cir. 1999). Therefore, applying the broadest reasonable interpretation
to Appellants use of the term “comprising” in Claim 1 results in a claim
which can encompass oral care agents, hydrophilic polymers and other
components such as adhesives desired by Jones.
Jones certainly teaches that the adhesive layer may be mixed into the
oral care layer, noting that “[f]or example a thin layer of the adhesive may
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be deposited on the surface of the strip, and capsules of the oral healthcare
substance may be embedded at least partly if not completely within this
adhesive layer, or may sit upon the surface of this adhesive layer” (Jones 6 ¶
0064; FF 17). If the oral health care substance is completely embedded in
the adhesive layer, Jones is reasonably interpreted as teaching a layer which
is both an oral health care layer and an adhesive layer (FF 16-18).
We disagree with Appellants that Jones teaches away from the
claimed invention. The teaching in Jones which desires separate adhesive
function from the oral healthcare substance does not teach away from these
two functions being in the same layer, only that the adhesive is not the same
as the oral healthcare substance (which is true of Appellants’ invention as
well, since the adhesive is not being provided by the peroxide or other
healthcare components, but rather by the layer in which these components
are embedded (see FF 3-4)). See In re Fulton, 391 F.3d 1195, 1201 (Fed.
Cir. 2004) (“The prior art’s mere disclosure of more than one alternative
does not constitute a teaching away from any … alternatives because such
disclosure does not criticize, discredit, or otherwise discourage the solution
claimed.…”).
We also are not persuaded by Appellants argument that the “plain
meaning of the recited ‘oral care layer’ also requires adhesiveness
throughout the layer” (App. Br. 7). There is no such requirement in the
claim, nor do Appellants identify any teaching in the Specification which
defines an “oral care layer” as requiring adhesiveness throughout the layer.
“[L]imitations are not to be read into the claims from the specification.” In
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re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993) (citing In re Zletz, 893
F.2d 319, 321 (Fed. Cir. 1989)).
Therefore, we conclude that the phrase “oral care layer” reasonably
encompasses the layer disclosed by Jones where “capsules of the oral
healthcare substance may be embedded at least partly if not completely
within this adhesive layer” (Jones 6 ¶ 0064; FF 17).
“Substantially invested”
The Specification teaches, regarding the meaning of the
Claim term “substantially invested”, that:
The non-woven binding material preferably comprises a
spun bonded polypropylene. The material and structure of
the first part and the second part are preferably the same.
The primary basis for the distinction between the first part
and the second part is the layer into which the individual
layer is invested. The first part of the binding material is
substantially invested in the oral care layer. The second part
of the binding material is substantially invested in the
backing layer. Preferably, the first part of the binding
material comprises about one half of the binding material
and the second part of the binding material comprises about
one half of the binding material.

(Spec. 17 ¶ 0070; FF 2).
Appellants argue that “Jones fails to disclose a binding material
‘substantially invested in’ both a backing layer and an oral care layer” (App.
Br. 10). Appellants argue, based on the disclosure of figures 5 and 10, that
“‘substantially’ means the binding material extends into the oral care layer
and into the backing layer such that all or almost all portions of the binding
material are immersed in one of those other two layers” (App. Br. 10).
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The Examiner finds that Claim 1 recites “‘the second part of the
binding material is substantially invested in at least a portion of the backing
layer.’ The term ‘a portion’ includes any size portion and therefore when a
‘portion of the backing layer is bound to a ‘portion’ of the binding material,
the claim[] limitation is met” (Ans. 12).
We find that the Examiner has the better position. While Appellants
urge that “substantially invested” is limited to the case in the Specification
and figures where almost all portions of the binding material are immersed
in one of the other two layers, there is no definition in the claims or
Specification which requires this narrow interpretation of “substantially
invested”. Consistent with Zletz, an “essential purpose of patent
examination is to fashion claims that are precise, clear, correct, and
unambiguous. Only in this way can uncertainties of claim scope be
removed, as much as possible, during the administrative process.” In re
Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).
In this case, where the term “substantially invested” may not be
indefinite, it is reasonably interpreted as broadly encompassing a range of
investments which may overlap “minimally invested” to “fully invested”.
Jones teaches that “the plastically deformable material may be forced among
the fibres of the absorbent fabric to thereby generate a bond” (Jones 5 ¶
0056; FF 11).
Therefore, we conclude that the Examiner reasonably interpreted
Jones’ teaching as satisfying the claim requirement that the binding material
was “substantially invested in at least a portion of the backing layer” (FF
11).
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Obviousness
Claim 1
Applying the claim interpretations discussed above, Jones teaches and
suggests a device for delivering an oral care agent with a permanently
deformable backing layer (FF 7-10), with a non-woven binding material, an
oral care layer comprising at least one oral care agent and at least one
hydrophilic polymer (FF 12-16) where the binding material is reasonably
interpreted as “substantially invested” in the oral care layer and backing
layer (FF 11) and where the oral care layer has an adhesiveness that is
sufficient to retain the device on the user’s teeth (FF 16-18).
Claim 46
Appellants argue that Jones “discloses an adhesiveness separate and
apart from the oral care function, which means that the oral care layer in
Jones cannot have an adhesiveness from about 200 N/m to about 400 N/m”
(App. Br. 11).
The Examiner finds that “the oral care compositions recited in the
instant claims comprise the same polymers as the oral care compositions of
the reference and therefore it is reasonable to conclude that the compositions
of the reference have the same adhesiveness” (Ans. 13). The Examiner finds
that “changes in result effective variables are not patentable where the
difference involved is one of degree, not of kind; experimentation to find
workable conditions generally involves the application of no more than
routine skill in the art” (Ans. 5).
We find that the Examiner has the better position. For the reasons
discussed above, we agree with the Examiner that Jones teaches an oral care
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device with an oral care layer which satisfies the requirements of claim 1,
from which claim 46 depends. We also agree with both of the Examiner’s
points, that Jones suggests component elements for the oral care layer which
are identical to those taught in Appellants’ Specification (FF 5, 6, 12-15),
and that the discovery of an optimum value of a results-effective variable in
a known process is normally obvious. In re Antonie, 559 F.2d 618, 620
(CCPA 1977); In re Aller, 220 F.2d 454, 456 (CCPA 1955). Appellants have
provided no evidence or argument to rebut the finding that the amount of
adhesiveness is a results-effective variable or to demonstrate unexpected
results with the claimed adhesiveness range.
Claims 48 and 49
Appellants argue that “[c]laim 48 recites that at least one oral care
agent is released from the hydrophilic polymer upon hydration of the oral
care layer. Claim 49 recites that at least one oral care agent is activated
upon hydration of the oral care layer. Jones fails to disclose either of those
elements” (Ans. 11).
The Examiner finds that Jones teaches that when “the device is
applied to the teeth the oral care substance migrates through the holes 103 of
the adhesive, thus the oral care agent and the adhesive are a part of one layer
mixed together and the hydrophilic polymer is releasing the oral care
substance as recited in claim 48” (Ans. 12).
We find that the Examiner has the better position. As the Examiner
points out, Jones suggests release of the oral care agent through the oral care
layer (FF 16). To the extent that Appellants argument is based on a method
step of “hydration”, the “patentability of a product does not depend on its
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method of production. If the product in a product-by-process claim is the
same as or obvious from a product of the prior art, the claim is unpatentable
even though the prior product was made by a different process.” In re
Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985). Therefore, Jones teaching of a
hydrated layer such as a gel satisfies the claim whenever the hydration
occurs (FF 12-13).
Claim 50
Appellants argue that Jones “teaches away from an oral care substance
having adhesiveness, let alone a pressure sensitive adhesive that includes an
oral care agent as recited in present claim 50. In addition, Jones fails to
disclose an adhesive that includes at least one hydrophilic polymer and at
least one water-soluble plasticizer that is miscible with the hydrophilic
polymer” (App. Br. 12).
The Examiner finds that “the oral care composition [of Jones] may
comprise additional carriers such as glycerin (paragraph 0037). Further
when a whitening gel is formulated, carriers [are] used for the gel
composition includ[ing] glycerol (paragraph 0038)” (Ans. 14). The
Examiner finds that “Jones teaches an oral care agent mixed with
hydrophilic polymers . . . and also teaches addition agents may be used to
adhere the oral care substance to the oral cavity, thus encompassing claim
50” (Ans. 14).
We find that the Examiner has the better position. Appellants’
argument uses oral care substance and oral care layer interchangeably, but
they are different. Claim 50 requires that the oral care layer, and not the oral
care substance, comprise a pressure sensitive adhesive (see Claim 50).
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Thus, as the Examiner points out (Ans. 14), Jones teaches oral care layers
which comprise hydrophilic polymers and miscible water-soluble
plasticizers combined with an oral care agent (FF 9, 12-16) which satisfy the
structural requirements of claim 50.
Claim 102
Appellants argue that “Jones fails to disclose a scrim, let alone a scrim
embedded in the oral care layer” (App. Br. 12). Appellants argue that “even
if one were to assume that Jones discloses a binding layer, the rejection is
still improper. Claim 102 includes a binding material . . . and a scrim as two
separate elements. The Examiner has failed to demonstrate how Jones
teaches those two separate elements” (Ans. 13).
The Examiner finds that “Jones discloses the devices may comprise a
backing with multiple layers including one or more open or closed cell
foamed layers . . . The absorbent carrier would be a scrim when the oral care
agent is completely absorbed into the carrier” (Ans. 14).
We find that Appellants have the better position. As Appellants
correctly note, the Examiner’s argument makes the binding material and
scrim a single element, when claim 102 clearly “further comprises a scrim”,
requiring the scrim in addition to the binding material.
Conclusion of Law
The evidence of record support the Examiner’s conclusion that Jones
teaches and suggests
(i) “an oral care layer comprising at least one oral care agent and at
least one hydrophilic polymer . . . wherein the oral care layer has an
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adhesiveness when hydrated . . . that is sufficient to retain the device on the
user’s teeth” and
(ii) “wherein the first part of the binding material is substantially
invested in at least a portion of the oral care layer, and the second part of the
binding material is substantially invested in at least a portion of the backing
layer”.
The evidence of record does not support the Examiner’s conclusion
that Jones teaches and suggests “a scrim embedded in the oral care layer”.

B. 35 U.S.C. § 103(a) over Jones and Singh
Appellants separately argue only Claim 64 in this obviousness
rejection. The remaining claims are not separately argued from Claim 1, and
we therefore affirm the rejection of these claims for the reasons given for
affirming Claim 1.
Appellants argue that “the Examiner fails to show how the elements
of the pressure sensitive adhesive recited in claim 50 can be adjusted to
achieve the release rate recited in claim 64” (App. Br. 14). Appellants argue
that “the Examiner fails to show how the polyvinyl pyrrolidone recited in
claim 60 can be adjusted to achieve the release rate recited in claim 64”
(App. Br. 14).
The Examiner finds that “[b]ecause these polymers are the same as
those used in Jones, it is reasonable to conclude that the oral care substance
of the reference [would] have the same rate as those of the instant claims”
(Ans. 15). The Examiner finds that “it would be in the relative skill of one of
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ordinary skill in the art to have adjusted the amounts of components in the
carrier to obtain the desired rate of release” (Ans. 15).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the specific release rate of an oral
care agent in Claim 64 of 0.2 mg/cm2-min to 1 mg/cm2-min would have
been obvious?
Additional Findings of Fact
19. Singh teaches “hydrogel compositions for dental care,
and more particularly relates to novel hydrogel compositions
useful in whitening of an individual’s teeth” (Singh 1 ¶ 0002).
20. Singh teaches that the “properties of the composition
of the invention are readily controlled by adjusting one or more
parameters during fabrication” (Singh 7 ¶ 0078).
21. Singh teaches that the “degree to which the hydrogel
composition will swell upon contact with water can be varied by
selecting different water-swellable polymers, and, in those
compositions containing a continuous hydrophilic phase, by
adjusting the ratio of the water-swellable, water-insoluble polymer
to the hydrophilic polymer/complementary plasticizer blend”
(Singh 7 ¶ 0078).
22. Singh teaches that the “release of whitening agents
‘loaded’ into the present hydrogel compositions typically involves
both absorption of water and desorption of the agent via a
swelling-controlled diffusion mechanism” (Singh 7 ¶ 0079).
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Analysis
We find that the Examiner has the better position. We agree with the
Examiner that Jones suggests component elements for the oral care layer
which are identical to those taught in Appellants’ Specification (FF 5, 6, 12-
15).
We also note that Singh expressly teaches that the “properties of the
composition of the invention are readily controlled by adjusting one or more
parameters during fabrication” (Singh 7 ¶ 0078; FF 20). In particular, Singh
also teaches that the degree to which the composition swells is adjustable
(FF 21) and that the degree of swelling is related to the release of active
agent (FF 22). The discovery of an optimum value of a results-effective
variable in a known process is normally obvious. In re Antonie, 559 F.2d
618, 620 (CCPA 1977); In re Aller, 220 F.2d 454, 456 (CCPA 1955).
Appellants have provided no evidence or argument to rebut the finding that
the rate of release is a result-effective variable or to demonstrate unexpected
results with the claimed release rate.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
specific release rate of an oral care agent in Claim 64 of 0.2 mg/cm2-min to
1 mg/cm2-min would have been obvious.

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C. Provisional nonstatutory obviousness-type double patenting over U.S.
Application 10/187,666.
Appellants argue that a “device having a binding material
substantially invested in an oral care layer is not even remotely similar to an
oral care layer minimally invested in an anchor layer” (App. Br. 15).
The Examiner finds that the “instant claims recite a portion of the
binding layer is substantially invested, which may encompass a small
portion of the binding layer and therefore encompasses the copending claims
‘minimally invested’” (Ans. 16).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the instant claims are obvious over
the designated claims of U.S. Application 10/187,666?
Additional Findings of Fact
23. Claim 1 of U.S. Application 10/187,666 is reproduced below:
1. A device for delivering an oral care agent, wherein the
device is sized to fit over a plurality of teeth in an upper or
lower dental arch in a subject, comprising:
a permanently deformable backing layer;
an anchor layer having a first side and a second side
opposite said first side, the first side in contact with the
backing layer, the backing layer penetrating into the first
side of the anchor layer and
an oral care layer comprising at least one oral care
agent and at least one hydrophilic polymer, wherein the oral
care layer is in contact with the second side of the anchor
layer and forms an adhesive bond thereto,
and wherein the oral care layer is minimally invested
in the anchor layer and has an adhesiveness when hydrated
relative to the surface of the teeth of user that is sufficient to
retain the device on the user's teeth when placed thereon.
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24. The Specification of U.S. Application 10/187,666 teaches that
“[a]s used herein, ‘minimally invested’ means that the oral care layer fills
only the surface depressions in the anchor layer foam, but does not
appreciably penetrate below the surface of the anchor layer” (Spec.
10/187,666 19, ll. 8-11).
Analysis
The element of claim 1 of U.S. Application 10/187,666 which differs
from the instant claim 1 is that the oral care layer is “minimally invested” in
the anchor layer of the former, while the oral care layer is “substantially
invested” in the binding material of the latter.
While the Specification of U.S. Application 10/187,666 defines the
term “minimally invested”, unlike the instant Specification which does not
define “substantially invested”, that definition permits the oral care layer to
fill surface depressions in the anchor layer and penetrate below the surface,
just not “appreciably” (FF 24).
The obviousness question then depends upon whether the lowest
amount of “investment” of the range of “substantially invested” overlaps the
highest amount of “investment” of the range of minimally invested.
Without any measurable or quantitative standard for determining
“substantially invested” or “minimally invested”, we conclude that using the
broadest reasonable interpretation of these terms, it is reasonable to interpret
“substantially invested” as broadly encompassing a range of investments
which overlaps “minimally invested”. It is the Appellants’ burden to
precisely define the invention, not that of the United States Patent and
Trademark Office. In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997).
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Conclusion of Law
The evidence of record supports the Examiner’s conclusion that the
instant claims are obvious over the designated claims of U.S. Application
10/187,666.
SUMMARY
In summary, we affirm the rejection of claims 1, 46 and 48-50 under
35 U.S.C. § 103(a) as obvious over Jones. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 2-6, 10, 11, 14,
19, 20, 22-33, 36, 47, 51-58, 61, 62, 65-69, 84-86, 88-96 and 110-119 as
these claims were not argued separately.
We reverse the rejection of claim 102 under 35 U.S.C. § 103(a) as
obvious over Jones.
We affirm the rejection of claim 64 under 35 U.S.C. § 103(a) as
obvious over Jones and Singh. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 7, 12, 13, 15-
18, 21, 34, 35, 37-45, 60, 63, 96-98, and 101 as these claims were not argued
separately.
We affirm the rejection of claims 1-7, 10-58, 60-69, 84-86, 88-98,
100-102, and 110-119 on the ground of provisional nonstatutory
obviousness-type double patenting over claims 1-11, 15-32, 36-58, 60-81,
83-85, 87-97, 100, 101, 107, and 109-118 of U.S. Application 10/187,666.
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)(iv)(2006).

AFFIRMED
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