Ex Parte Yu

Patent Trial and Appeal Board

May 10, 2016

12476600 (P.T.A.B. May. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/476,600 0610212009
33357 7590 05/12/2016
ABBOTT MEDICAL OPTICS INC
1700 E. ST. ANDREW PLACE
SANTA ANA, CA 92705
FIRST NAMED INVENTOR
Zhi-Jian Yu
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.
27768USO 5782
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
05/12/2016 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):
PatentMGR@abbott.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ZHI-JIAN YU
Appeal2013-004196 1
Application 12/476,6002
Technology Center 1600
Before DONALD E. ADAMS, LORA M. GREEN, and
FRANCISCO C. PRATS, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to an
ophthalmic topical liquid composition in the form of an oil-in-water
emulsion. The Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b ). We affirm.
STATEMENT OF THE CASE
As background, the Specification explains that oil-in-water emulsions
"generally comprise an aqueous phase having suspended therein discrete oil
droplets (particles) surrounded by a layer of at least one water soluble
1 The Real Party in Interest is Abbott Medical Optics, Inc. App. Br. 3.
2 As related appeals, Appellant identifies applications 12/476,547 (Appeal
2013-005893) and 12/476,579 (Appeal 2013-005894). App. Br. 3.
Appeal2013-004196
Application 12/476,600
surfactant." Spec. i12. The Specification states that "[t]he term 'particle' as
used herein refers to a spherical oil droplet suspended in the aqueous phase
of an oil-in-water emulsion." Id. i-f 28.
As further background, the Specification explains that, because
emulsion stability is primarily a function of particle size, oil-in-water-
emulsions with particle sizes exceeding 1 µm in diameter "tend to be less
stable and undergo creaming, coagulation and phase separation upon
storage. Therefore, for most applications it is desirable to reduce particle
size which generally results in significant increases in aqueous phase
surfactant concentration." Id. i-f 2. When used in emulsions for ophthalmic
use, however, the increased amount of surfactant required to reduce particle
size can exacerbate conditions such as dry eye. Id. i-f 3.
The Specification discloses that "[ s ]urprisingly, the present inventor
has discovered that by closely matching the surfactant system with the oil
component, the adverse effects resulting from excessive amounts of free
surfactant can be avoided while simultaneously achieving the desired
particle size and thus improving the therapeutic emulsion's overall
performance." Id. i-f 39. More specifically, the Specification discloses:
The present inventor surprisingly discovered that [by]
combining an oil soluble/water insoluble surfactant
(hydrophobic surfactant) with a hydrophilic surfactant the total
amount of free hydrophilic surfactant in the aqueous phase was
remarkably reduced; but only in combination with a non-polar
oil. In fact, the present inventor discovered that merely adding
a hydrophobic surfactant to the prior art combination of castor
oil and a hydrophilic surfactant actually increased the amount to
free hydrophilic surfactant in the aqueous phase and thus
exacerbated eye irritation.
Id. i-f 40.
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Claims 1 and 4 are representative of the appealed subject matter and
read as follows (App. Br. 29-30):
1. A stable oil-in-water emulsion ophthalmic topical liquid
composition having an average particle size less than 1 µm
compnsmg:
0.5 to 3.0 %w/w of at least one plant-derived oil selected
from sesame oil, cherry kernel oil, pumpkin seed oil, hemp seed
oil, flax seed oil, perilla seed oil and blackcurrant seed oil;
0.1 to 5.0 %w/w of a hydrophilic surfactant selected from
a polyethylene glycol ester having an HLB value between
approximately 10 and 14;
0.1 to 3.0 %w/w of a hydrophobic non-co-block
surfactant selected from a polyoxyethylene oleyl ether and a
polyoxyethylene stearyl ether, having an HLB value between
approximately 4 and 6; and
0.01to0.15 %w/w of cyclosporine A.
4. A stable oil-in-water emulsion ophthalmic topical liquid
composition having an average particle size less than 0.6 µm
consisting essentially of:
0.5 to 3.0 %w/w of at least one plant-derived oil selected
from sesame oil, cherry kernel oil, pumpkin seed oil, hemp seed
oil, flax seed oil, perilla seed oil and blackcurrant seed oil;
0.1 to 5.0 %w/w of a hydrophilic surfactant selected from
a polyethylene glycol ester having an HLB value between
approximately 10 and 11;
0.1 to 3.0 %w/w of a hydrophobic non-co-block
surfactant selected from a polyoxyethylene oleyl ether and a
polyoxyethylene stearyl ether, having an HLB value between
approximately 4 and 6; and
0.01to0.15 %w /w of cyclosporine A.
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The sole rejection before us for review is the Examiner's rejection of
claims 1-7 under 35 U.S.C. § 103(a) for obviousness over Dor, 3 Chang
'692, 4 Chang '710, 5 Chen, 6 and Weimer. 7 Final Action 5-10.
OBVIOUSNESS
The Examiner cited Dor as teaching oil-in-water emulsions having
nano-sized or micro-sized droplets of a solvent, as recited in the rejected
claims. Final Action 6. The Examiner found that Dor taught also that its
emulsions could contain, in concentrations overlapping those recited in the
rejected claims, each of the ingredients recited in the claims, including
cyclosporine A as a therapeutic agent, sesame oil as the solvent, hydrophilic
surfactants with an HLB greater than 10, hydrophobic surfactants with an
HLB below 10, and that Dor taught that different surfactants could be used
in combination. Id. at 6-7.
The Examiner found that, although Dor did not teach the use of
certain surfactants recited in the rejected claims, the Weimer and Chang
'710 references reference taught that the claimed surfactants were useful in
ophthalmic formulations useful for treating dry eye, including formulations
that included plant-derived oil solvents. Id. at 7-8. The Examiner cited
Chang '692 as evidence that cyclosporine A was known to be useful in dry
eye-treating ophthalmic formulations. Id. at 8. The Examiner cited Chen as
teaching that sesame oil was known in the art to be useful as a solvent for
3 U.S. Patent Appl. Pub. No. 2006/0182771 Al (published Aug. 17, 2006).
4 U.S. Patent Appl. Pub. No. 2007/0015692 Al (published Jan. 18, 2007).
5 U.S. Patent Appl. Pub. No. 2007/0015710 Al (published Jan. 18, 2007).
6 U.S. Patent Appl. Pub. No. 2002/0032171 Al (published Mar. 14, 2002).
7 U.S. Patent Appl. Pub. No. 2002/0009507 Al (published Jan. 24, 2002).
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solubilizing therapeutic agents in compositions containing a plurality
surfactants.
Based on the references' teachings, the Examiner concluded:
[A ]ll of the claimed elements were known in the prior art
for use as ophthalmic topical compositions, and one skilled in
the art could have combined the elements as claimed for use as
the very same purpose (eye drops) with no change in their
respective functions, and the combination would have yielded
predictable results to one of ordinary skill in the art at the time
of the invention.
Id. at 9.
In traversing the Examiner's rejection, Appellant states that, "[f]or the
purposes of this appeal, claims 1-3 stand or fall together, and claims 4--7
stand or fall together." App. Br. 5.
We select claim 1 as representative of the first group of claims, and
claim 4 as representative of the second group of claims. 3 7 C.F .R.
§ 41.37(c)(l)(iv).
As stated in Jn re Oetiker, 977F.2d1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability ....
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
Appellant's arguments do not persuade us that a preponderance of the
evidence fails to support the Examiner's prima facie case as to either claim
1, or claim 4. In addition, for the reasons discussed below, we are not
persuaded that Appellant has advanced evidence of unexpected results
sufficient to outweigh the evidence of prima facie obviousness.
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As to the Examiner's prima facie case regarding claim 1, Dor
describes self-emulsifying formulations useful for topically treating a variety
of eye disorders, including dry eye. Dor i-fi-130, 39, 77. Dor discloses that its
self-emulsifying formulations may include "a therapeutic agent, a solvent,
and a surfactant. The surfactant component may comprise a single
surfactant or a combination of surfactants. The solvent component may
comprise a single solvent or a combination of solvents." Id. i143.
As the Examiner found, and as recited or encompassed by claim 1,
Dor discloses, as suitable in its formulations, cyclosporine A as a therapeutic
agent (id. i165), sesame oil as a solvent for solubilizing the therapeutic agent
(id. i-f 113), and hydrophilic surfactants with an HLB greater than 10,
including polyethoxylated hydrogenated castor oil (id. i-f 128). As the
Examiner also found, Dor discloses that hydrophobic surfactants with an
HLB below 10 may be used in its compositions, "optionally ... in
combination with other surfactants as co-surfactants." Id. i-f 132. As the
Examiner found, Dor discloses that Brij type emulsifiers are suitable in its
compositions. Id. i-f 130.
While it might be true that Dor does not expressly describe using
precisely the surfactants recited in claim 1 in its formulations, as the
Examiner pointed out, Weimer discloses that polyethoxylated hydrogenated
castor oil compounds, which are undisputedly hydrophilic surfactants
encompassed by claim 1, are useful for treating dry eye, because they are
thought to mimic or enhance tear composition. Weimer i-f 11, 12. As the
Examiner pointed out also, when preparing oil-containing cyclosporine
formulations for treating dry eye (Chang '710 i-f l, 11), Chang '710 teaches
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that Brij 78, a hydrophobic polyoxyethylene stearyl ether surfactant
undisputedly encompassed by claim 1, was a suitable surfactant (id. i-f 1594).
As the Examiner pointed out, beyond the disclosure in Dor that
sesame oil was a suitable solvent for solubilizing therapeutic agents, Chang
'692 teaches that when preparing surfactant-containing cyclosporine
formulations for treating dry eye (Chang '692 i-f 1, 11 ), sesame oil is among
suitable oils for use in such compositions (id. i-f 1 7). Further as to sesame
oil, as the Examiner also pointed out, Chen discloses that sesame oil is a
preferred source of triglycerides (Chen i-f 49) to be used with a combination
of surfactants to solubilize therapeutic agents, thereby producing
"homogeneous, single-phase aqueous dispersions that are
thermodynamically stable and optically clear. The optical clarity is
indicative of a very small particle size within the aqueous dispersions, and
this small particle size substantially reduces lipolysis dependence of the rate
of bioabsorption, and other disadvantages of conventional triglyceride-
containing formulations" (id. i-f 32).
Given the cited references' teachings, we find that a preponderance of
the evidence supports the Examiner's prima facie case of obviousness as to
claim 1. In particular, given Dor' s disclosure of compositions suitable for
treating dry eye, the disclosed compositions including a therapeutic agent
(which may be cyclosporine A), a solvent (which may be sesame oil), and a
combination of surfactants, we agree with the Examiner that an ordinary
artisan would have been prompted to combine those ingredients, as recited
in claim 1. We agree with the Examiner also that an ordinary artisan would
have been particularly prompted to combine cyclosporine A and sesame oil
as recited in claim 1, given the teachings in Chang '692 that dry eye-treating
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topical ophthalmic compositions suitably contain a combination of
cyclosporine and sesame oil.
We also agree with the Examiner that, in view of Weimer's disclosure
that the hydrophilic surfactants recited in claim 1 were advantageous in dry
eye-treating topical compositions, and in view of Chang '710' s disclosure
that the hydrophobic surfactant recited in claim 1 was suitable for use in
oil-containing dry eye-treating topical compositions, an ordinary artisan
would have been particularly prompted to include that surfactant in a topical
dry eye-treating composition, such as that described in Dor or Chang '692.
Lastly, given Chen's disclosure that sesame oil was useful in therapeutic
compositions using a combination of surfactants to solubilize a therapeutic
agent, we further agree with the Examiner that an ordinary artisan would
have been particularly prompted to use sesame oil as the solvent in a topical
dry eye-treating composition, such as that described in Dor, or Chang '692.
In sum, because the cited combination of references, for the reasons
discussed, suggest as a whole that the combination of ingredients recited in
claim 1 would have been useful in an oil-in-water topical composition for
treating dry eye, the formulation having a particle size of less than 1 µm, we
find that a preponderance of the evidence supports the Examiner's prima
facie case of obviousness as to claim 1.
Appellant's arguments do not persuade us to the contrary. We
acknowledge, as Appellant argues (App. Br. 8-22; Reply Br. 4--8), that
claim 1 's solvent, surfactants, and active agent, appear as single items in
long lists in Dor, and also in Chang '710.
As our reviewing court has explained, however, that the prior art
"discloses a multitude of effective combinations does not render any
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particular formulation less obvious. This is especially true because the
claimed composition is used for the identical purpose taught by the prior
art." Merck & Co. Inc. v. Biocraft Labs. Inc., 874 F.2d 804, 807 (Fed. Cir.
1989).
Thus, that the ingredients in claim 1 's composition were known in the
prior art to be among many other useful alternatives included in topically
applied therapeutic ophthalmic emulsions does not persuade us that an
ordinary artisan lacked motivation to select the claimed ingredients,
particularly given the teachings, discussed above, that the specific
ingredients recited in claim 1 were known to be useful in topically applied
ophthalmic emulsions for the common purpose of treating dry eye.
Moreover, given that the motivation for combining the ingredients recited in
claim 1 would have been derived only from the prior art, Appellant's
arguments (App. Br. 25-26; Reply Br. 5-8), do not persuade us that the
Examiner's prima facie case is based improperly on hindsight.
We acknowledge our reviewing court's interpretation of the fact
situation in KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398 (2007), as "posit[ing]
a situation with a finite, and in the context of the art, small or easily
traversed, number of options that would convince an ordinarily skilled
artisan of obviousness." Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
520 F.3d 1358, 1364 (Fed. Cir. 2008) (emphasis added).
In the context of the art involved in this case, topically applied
therapeutic ophthalmic oil-in-water emulsions, the prior art recognizes that
numerous different active agents, numerous different oil solvents, and
numerous different surfactants are useful in such formulations, as evidenced
by Dor, Chang '692, and Chang '710, discussed above. That an ordinary
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artisan on the relevant date had many useful options from which to choose
when preparing such a formulation does not persuade us that choosing a
particular set of known useful options would have been unobvious, absent
some showing that the resulting combination had properties that would not
have been expected. See KSR, 550 U.S. 398 at 417 ("[W]hen a patent
'simply arranges old elements with each performing the same function it had
been known to perform' and yields no more than one would expect from
such an arrangement, the combination is obvious.") (quoting Sakraida v. Ag
Pro, Inc., 425 U.S. 273 (1976)).
Taken to its logical extension, Appellant's interpretation of Ortho-
McNeil would mean that in an art such as this, which recognizes numerous
suitable alternative ingredients, no formulation composed of known useful
ingredients could be considered obvious under§ 103, absent some emphasis
in the art of the formulation's particular ingredients, such as an expressed
preference or disclosure of working examples. As our reviewing court has
pointed out, however, "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 v. Biocraft, 874 F.2d at 807 (internal quotations
omitted); see also In re Mills, 470 F.2d 649, 651 (CCPA 1972) ("All the
disclosures in a reference must be evaluated, including nonpreferred
embodiments, and a reference is not limited to the disclosure of specific
working examples." (citations omitted)). Indeed, we note that inMerckv.
Biocraft the court concluded that the claimed combination was obvious,
despite the fact that the obviating reference disclosed a "multitude of
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effective combinations," and despite the fact that there was no emphasis on
the claimed combination at issue. 87 4 F. 2d at 807.
Appellant's arguments (App. Br. 24--25; Reply Br. 2) also do not
persuade us that, under Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352
(Fed. Cir. 2011 ), all obviousness determinations relating to pharmaceutical
compositions must proceed from an identified reference composition. As
the court explained in that decision, the reference composition analysis is
appropriate only in certain infringement contexts, which are not applicable
here:
In the context of a composition or formulation patent where the
patented formulation was made to mimic a previously FDA-
approved formulation, the functional and pharmaceutical
properties of the "lead compound" can be more relevant than
the actual chemical structure (though not always mutually
exclusive). Thus, the term "reference composition" is more
appropriate than "lead compound" when considering
obviousness for a chemical composition that the infringer
deliberately imitates.
Unigene, 655 F.3d at 1361-62 (emphasis added).
Appellant's arguments (App. Br. 10-11; Reply Br. 6-7) also do not
persuade us that an ordinary artisan would have failed to look to Chen when
considering suitable solvents for use in ophthalmic oil-in-water emulsions.
We acknowledge that Chen refers to its compositions as "dispersions" rather
than emulsions. See Chen i-f 32. Chen, nonetheless, describes its
compositions as aqueous dispersions that contain small particles of
triglyceride solvent-solubilized therapeutic agents. See id. Given that this
description is consistent with an ordinary artisan's understanding of the
composition of oil-in-water emulsions as advanced by Appellant (see Spec.
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il 2), Appellant does not persuade us that an ordinary artisan preparing
topical ophthalmic oil-in-water emulsions such as those described in Dor,
Weimer, or the Chang references, would have failed to look to Chen when
considering suitable solvents.
Appellant's arguments (App. Br. 22) also do not persuade us that the
Examiner erred in finding that Dor suggests preparing therapeutic topical
ophthalmic oil-in-water emulsions with a particle (oil droplet) size of less
than 1 µm as recited in claim 1. As Appellant acknowledges, and as the
Examiner found, Dor teaches that, in such formulations, the "droplets in the
emulsion may generally be of any size, including but not limited to those up
to 5,000 nm." Dor i-f 31; see also id. at i-f 42 ("The droplets in the emulsion
may generally be of any size. Emulsions formed by the self-emulsifying
formulation may be of any type, including but not limited to micro- and
nano-emulsions.") (emphasis added).
Appellant "respectfully submits that these very brief statements
regarding particle size do not provide one skilled in the art with sufficient
guidance to render obvious the claimed range of less than 1 µm." App. Br.
22. Appellant does not, however, explain with any specificity why Dor's
express teaching of emulsion particle sizes of less than 5,000 nm, as well as
micro- and nano-emulsions, both of which encompass particle sizes less than
1 µm, would have failed to direct an ordinary artisan to particles having a
size encompassed by claim 1. Accordingly, we do not find Appellant's
argument on this issue persuasive.
In sum, for the reasons discussed, Appellant's arguments do not
persuade us that a preponderance of the evidence fails to support the
Examiner's prima facie case of obviousness as to claim 1. We are also
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unpersuaded that Appellant has advanced evidence of unexpected results
sufficient to outweigh the evidence of prima facie obviousness.
Specifically, Appellant contends that, as shown in the Specification,
the inventor found it surprising that the total amount of free hydrophilic
surfactant in the aqueous phase could be significantly reduced by combining
a hydrophobic surfactant with a hydrophilic surfactant, and that reduction
occurred only in the presence of a non-polar oil. App. Br. 23 (citing Spec.
i-f 40). In particular, Appellant contends, despite the alleged suggestion in
the prior art that sesame oil and castor oil would have been considered
equivalents, the unexpected benefits alleged to flow from the claimed
compositions inhere only to sesame oil, and not castor oil. App. Br. 23-24;
Reply Br. 3--4.
It is well settled, however, that "when unexpected results are used as
evidence of nonobviousness, the results must be shown to be unexpected
compared with the closest prior art." In re Baxter-Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991).
In the instant case, in arguing that the reduction in the amount of
hydrophilic surfactant was unexpected, Appellant does not identify which
prior art embodiment is considered to be closest to claim 1. Nor does
Appellant direct us to a comparison between (a) the hydrophilic surfactant
concentration in a specific prior art embodiment and (b) the hydrophilic
surfactant concentration recited in claim 1. Indeed, Appellant does not
dispute the Examiner's contention (Final Act. 7), that the suitable
concentration of hydrophilic surfactant taught in Dor overlaps the
concentration of that component recited in claim 1. We note further the
following teaching in Chen, suggesting that it was known in the art that one
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could reduce the hydrophilic surfactant concentration in the type of
composition recited in claim 1 by including a hydrophobic surfactant:
To achieve a high level of fully-solubilized triglyceride
would require an amount of the hydrophilic surfactant
exceeding that which would be bioacceptable. The
pharmaceutical compositions of the present invention, however,
solve these and other problems of the prior art by adding a
third component, a hydrophobic surfactant or a second
hydrophilic surfactant. The solubilization of the triglyceride in
the aqueous system is thereby unexpectedly enhanced.
Conversely, it is also true that solubilization of a hydrophobic
surfactant or a second hydrophilic surfactant is unexpected
enhanced based on the presence of the triglyceride in the
formulation. Of course, the relative amounts of the
hydrophobic surfactant or the second hydrophilic surfactant in
the formulation will depend on the type of formulation that is
desired, actual components used, nature of the therapeutic
agent, and so forth. These and other factors are routinely
considered by those of skill in the art in determining the amount
of each component to be added to a formulation. In addition, a
suitable amount of each component to form the desired
formulations can be readily determined by routine
experimentation.
Chen, i-f 220 (emphasis added).
As to the data presented in Table 3 of the Specification, which
Appellant asserts as showing an unexpected reduction in particle size (App.
Br. 23-24), we note that the only comparison was between a composition
having both a hydrophilic (Lumulse GRH-40) and hydrophobic (Brij 72)
surfactant, and a composition having only the hydrophilic surfactant. Spec.
i-fi-163---65. As noted above, however, Chang '710 discloses an embodiment
that contains only Brij 78, a hydrophobic surfactant, in combination with
cyclosporine A and a plant-derived oil solvent. Chang '710 i-f 1594.
Moreover, as also noted above, Dor discloses the use of surfactant
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combinations (Dor ilil 43, 132), and Chen discloses that particle size can be
significantly reduced using a combination of surfactants (Chen i-f 32). Thus,
we are again not persuaded that Appellant has shown a comparison between
the claimed invention and the closest prior art.
As to the data in Tables 6 and 6a of the Specification, advanced by
Appellant to show significantly increased delivery of cyclosporine A to eye
tissues (App. Br. 24), we note that the inventive compositions (Test
Solutions #1, #2, and #3) were compared to a commercial castor oil product
that did not include any surfactant, and a castor oil control solution
containing only a hydrophilic surfactant (Lumulse GRH-40). Spec. i-fi-174--
77. As noted above, however, the cited prior art not only discloses the
combination of cyclosporine A with surfactants, but in fact teaches that
cyclosporine A is desirably combined with both a surfactant and sesame oil.
See Chang '692 i-fi-1 11-1 7. Thus, we are again not persuaded that Appellant
has shown a comparison between the claimed invention and the closest prior
art.
Lastly we note that the compositions alleged as showing unexpected
results have specific amounts of each of the claimed ingredients, whereas
claim 1 recites relatively broad ranges for each of the claimed ingredients.
Accordingly, we are not persuaded that Appellant has established that the
showing of unexpectedness it alleges is commensurate in scope with the
claimed subject matter. See In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir.
2003) ("[A]pplicant's showing of unexpected results must be commensurate
in scope with the claimed range.").
In sum, as discussed above, Appellant's arguments do not persuade us
that a preponderance of the evidence fails to support the Examiner's prima
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facie case of obviousness as to claim 1. For the reasons discussed, we are
also not persuaded that the evidence advanced by Appellant to show
unexpected results is sufficient to outweigh the evidence of prima facie
obviousness. Accordingly we affirm the Examiner's obviousness rejection
of claim 1. Because they were argued in the same claim grouping, claims 2
and 3 fall with claim 1. 37 C.F.R. § 41.37(c)(iv).
As to claims 4--7, Appellant contends that those claims are not
obvious over the cited references for the same reasons as advanced to claims
1-3, and further contends that an ordinary artisan would have been not have
arrived at a composition "consisting essentially of the recited components
based on any of the cited references. Each of the references describes
compositions that include components that may affect the basic and novel
properties of the claimed compositions. To arrive at the compositions of
claims 4--7, one would have needed to exclude such components." App. Br.
26.
We are not persuaded. As noted above, we select claim 4 as
representative of this group of claims. 37 C.F.R. § 41.37(c)(iv).
We note that claim 4 recites its composition using the transitional
phrase "consisting essentially of." App. Br. 29. We note also that "[b]y
using the term 'consisting essentially of,' the drafter signals that the
invention necessarily includes the listed ingredients and is open to unlisted
ingredients that do not materially affect the basic and novel properties of the
invention." PPG Indus. Inc. v. Guardian Indus. Corp, 156 F.3d 1351, 1354
(Fed. Cir. 1998). Appellant, however, bears the burden of establishing that
the ingredients present in the prior art composition are excluded by the
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"consisting essentially of' claim language. In re De Lajarte, 337 F.2d 870,
874 (CCPA 1964).
In the instant case, Appellant does not advance any clear or specific
evidence supporting its assertion that non-claimed ingredients in the
compositions of the prior art affect the basic and novel properties of the
compositions recited in claim 4. Nor does Appellant identify any specific
ingredient in any of the cited prior art that would affect the basic and novel
properties of the composition recited in claim 4. Accordingly, Appellant's
arguments do not persuade us that that the Examiner erred in concluding that
the composition recited in claim 4 would have been obvious to an ordinary
artisan. We, therefore, affirm the Examiner's rejection of claim 4. Because
they were argued in the same claim grouping, claims 5-7 fall with claim 4.
37 C.F.R. § 41.37(c)(iv).
SUMMARY
For the reasons discussed, we affirm the Examiner's rejection of
claims 1-7 under 35 U.S.C. § 103(a) for obviousness over Dor, Chang '692,
Chang '710, Chen, and Weimer.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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