Peter Quagliano

Patent Trials and Appeals Board

Jul 26, 2021

2021000890 (P.T.A.B. Jul. 26, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/478,794 06/05/2009 Peter Quagliano 97343.00139 1140
21832 7590 07/26/2021
MCCARTER & ENGLISH, LLP
CITYPLACE I
185 ASYLUM STREET
HARTFORD, CT 06103
EXAMINER
EBRAHIM, NABILA G
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
07/26/2021 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):
hartforddocketing@mccarter.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte PETER QUAGLIANO
__________

Appeal 2021-000890
Application 12/478,794
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, JOHN G. NEW, and DAVID D. COTTA,
Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
liquid vehicle for use with an iodinated contrast agent. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Beekley
Corporation (see Appeal Br. 1). We have considered the Specification of
June 5, 2009 (“Spec.”); Final Office Action of July 18, 2019 (“Final Act.”);
Appeal Brief of May 18, 2020 (“Appeal Br.”); Examiner’s Answer of Sept.
18, 2020 (“Ans.”); and Reply Brief of Nov. 18, 2020 (“Reply Br.”). Oral
argument was heard in this case on July 15, 2021. The transcript of the
hearing will be made part of the record.
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Statement of the Case
Background
“In X-rays, the images of the patients’ body reflect the different
densities of body structures. To improve the diagnostic utility of this
imaging technique, contrast agents are employed to increase the density
difference between various structures, such as between the gastrointestinal
tract and its surrounding tissues” (Spec. ¶ 3).
The properties of an ideal oral contrast agent for CT or
MR include the following: good taste and pleasing consistency;
low cost; premixed with a long shelf life; predictable and
dependable transit time; absence of side effects or allergic
reaction; non-absorbable; chemically inert, lack of precipitation
or loss of suspension; low incidence of streak or magnet-
susceptibility artifacts; Hounsfield unit (HU) opacity (contrast
density or degree of brightness) for CT, and either
hyperintensity (“bright”) or hypointensity (“dark”) for MR,
which allow easy differentiation of bowel loops from adjacent
structures and also allow easy visualization of the contrast-
enhanced bowel wall. Unfortunately, no single agent fulfills all
of these criteria.
(id. ¶ 6). “There is, therefore, a need for a ready-mixed range of liquid
dilution vehicles” (id. ¶ 13).
The Claims
Claims 1–4, 7–9, 11–18, 21–23, and 34–41 are on appeal. Claim 1 is
an independent claim, is representative and reads as follows:
1. A liquid vehicle for use with an iodinated contrast agent
comprising: a solution for oral administration prior to computed
tomography imaging or magnetic resonance imaging to obtain
desired imaging characteristics of the gastrointestinal tract,
wherein the solution comprises (a) water; (b) between about 3
grams/liter and 22 grams/liter of at least one sugar alcohol; (c) a
buffering agent that maintains the pH between about 2 1/2 and
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about 7; (d) a sweetener; and (e) a bitterness blocker; wherein
the viscosity of the liquid vehicle is between 1 and about 20
cps, wherein the solution is suitable for combination with an
iodinated oral contrast agent.

The Rejections2
A. The Examiner rejected claims 1–4, 7–9, 11–18, 21–23, and 34–41
under U.S.C. § 103(a) as obvious over Williams III,3 Chen,4 Quagliano,5 and
Brown6 (Final Act. 7–12).
B. The Examiner rejected claims 1–4, 7–9, 11–18, and 21–24 on the
grounds of obviousness-type double patenting over the claims 1–6 of US
9,585,836, Chen, and Williams III (Final Act. 12).

A. U.S.C. § 103(a) over Williams III, Chen, Quagliano, and Brown
The issues with respect to this rejection are:
(i) Does a preponderance of the evidence of record support the
Examiner’s conclusion that the prior art renders the claims obvious?
(ii) If so, has Appellant provided evidence of unexpected results that,
when balanced with the prima facie case, supports a finding of non-
obviousness?

2 We note that the Examiner withdrew the rejections under 35 U.S.C. § 112,
first paragraph (Ans. 3).
3 Williams, III, US 2005/0074405 A1, published Apr. 7, 2005.
4 Chen et al., US 2002/0147201 A1, published Oct. 10, 2002.
5 Quagliano et al., Oral Contrast Agents for CT: A Taste Test Survey, 21 J.
Computer Assisted Tomography 720–2 (1997).
6 Brown, G., US 3,236,735, patented Feb. 22, 1966.
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Findings of Fact
1. Williams III teaches “contrast media formulations having a low
concentration of contrast agent and/or low Hounsfield value for use in
medical or diagnostic procedures, or for therapeutic use” (Williams III ¶ 9).
2. Williams III teaches “the present invention is especially suited
for use in diagnostic imaging of anatomic segments including, but not
limited to, the esophagus, the stomach and GI tract” (Williams III ¶ 16).
3. Williams III teaches, as to component a) of claim 1, completing
the volume with water (see Williams III ¶ 72 (“Qs to 100% volume with
purified water”)). In the example recited in Table 3, Williams III teaches the
use of 66.67 % water (see Williams III ¶ 77).
4. Williams III teaches, as to component b) of claim 1, that the
“formulation of the present invention may comprise about 0.005% to about
70% by weight of an osmotic agent . . . preferably about 2% of sorbitol in an
aqueous solution” (Williams III ¶ 45). We note that the range of 3
grams/liter to 22 grams/liter in claim 1 represents a 0.3 to 2.2 % range.
5. Williams III teaches, as to component c) of claim 1, a “pH
adjuster: sodium citrate and citric acid” (Williams III ¶ 72). Table 2 of
Williams III shows formulations A-D have pH values of 4.95 or 5 (Williams
III ¶ 71).
6. Williams III teaches, as to component d) of claim 1, addition of
the sweetener saccharin sodium (see Williams III ¶ 72). In the example
recited in Table 3, Williams III teaches the use of 0.0109 % saccharin
sodium (Williams III ¶ 77).
7. Williams III teaches, as to the viscosity range in claim 1 of
“between 1 and about 20 cps”, Table 2, reproduced in part below:
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The formulations in Table 2 show varying amounts of barium sulfate (0,
0.05 and 0.1 w/v%), of sorbitol, and of either 0.5226 w/v% or 0.1830 w/v %
of xanthan gum where “xanthan gum concentration difference gives high
and low viscosities solutions of approx. 720 and 130 cps” from 860 to 140
cps for otherwise identical formulations (Williams III ¶¶ 72–76).
8. Williams III teaches suitable stabilizing agents include “any
compound that appropriately modifies the viscosity of a substance so as to
facilitate the imaging process” (Williams III ¶ 37).
9. Williams III teaches compounds “to alter viscosity and lower
signal/noise ratios to improve performance in MR imaging” (Williams III
¶ 38).
10. Williams III teaches clinical evaluation of formulation D,
finding the “patient expressed no complaints about the contrast media’s
formula, flavor, viscosity or volume” (Williams III ¶ 106; cf. Williams III
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¶ 110 (For formulation C “the patient expressed no complaints about the
contrast media’s formula, flavor, viscosity or volume”)).
11. Chen teaches “methods of making water soluble and palatable
complexes and compositions and drug dosage forms incorporating such
complexes” (Chen ¶ 2). Chen explains that: “‘Active agent’ or ‘active
ingredient’ means a drug, diagnostic agent, contrast agent . . . or other agent
having a pharmacologic, biological or diagnostic effect or purpose” (Chen
¶ 27).
12. Chen teaches “for any oral dosage forms using these methods,
provisions for improving the palatability of bitter tasting drugs needs to be
provided to improve patient compliance” (Chen ¶ 18).
13. Chen teaches, as to component e) of claim 1, to use “an anionic
and palatable glycyrrhizin, to form complexes . . . An additional advantage
is that the resulting complexes can mask or lessen the bitter taste of certain
active agents” (Chen ¶ 46). Chen specifically teaches: “Glycyrrhizin can
enhance flavors, modify sweetness perception, minimize bitterness” (id.
¶ 47).
14. Table I of Quagliano is reproduced below:

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Table 1 shows a variety of different functional agents with centipoise values
of 1 and 2 for CT contrast agents (Quagliano 721, col. 2).
15. Quagliano teaches their “goal was to evaluate the palatability of
the currently available oral contrast agents for CT” (Quagliano 720, Abstr.).
16. Brown teaches “X-ray contrast media and more particularly to
barium sulfate media” (Brown 1:10–11).
17. Brown teaches a preference for “a viscosity rating not greater
than approximately 50 cps., and preferably less than 18 cps” (Brown 1:57–
58).
18. Brown teaches a composition table in Example 1, reproduced
below:

Example 1 of Brown shows a contrast agent with the highest viscosity
component having a viscosity less than 18 cps (Brown 6:29-35).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). “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).
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Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Final Act. 7–12, FF 1–18) and agree that Williams III, Chen, Quagliano, and
Brown renders the claims obvious. We address Appellant’s arguments
below.
Prima Facie Obviousness
Appellant contends “in order to reduce the viscosity of the barium
sulfate solution described in Williams III to the maximum viscosity recited
in the claims, the solution of Williams III would have to be diluted with the
Kool-Aid by a factor of greater than six” and “the impact of such a
substantial change on the imaging properties of the solution would be highly
unpredictable” (Appeal Br. 10). Appellant also cites the Quagliano
Declaration7 that “it is not possible to predict in advance whether a particular
combination and concentration of ingredients will result in a liquid vehicle
that is palatable with acceptable properties for radiographic imaging and an
acceptable level of undesirable side effects” (Quagliano Decl. 13; cf. Appeal
Br. 11). Appellant contends the “the Examiner has not provided the required
articulated reasoning to support a conclusion that the combination of
Williams III and Kool-Aid would not change the function of Williams III or
would have yielded predictable results” (Appeal Br. 12).
We find these arguments unpersuasive. William III recognizes
viscosity as an optimizable variable, teaching “to alter viscosity and lower
signal/noise ratios to improve performance in MR imaging” by using “any
compound that appropriately modifies the viscosity of a substance so as to

7 Declaration of Dr. Quagliano, dated June 27, 2018.
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facilitate the imaging process” (FF 8–9). Thus, in asserting that it would
have been obvious to optimize viscosity, the Examiner is not simply stating
that viscosity may be optimized but relying upon prior art disclosures
suggesting the optimization of viscosity in contrast agents.
The Quagliano reference demonstrates that a variety of different
viscosities for CT contrast agents are functional, ranging from 1 cps for
gastrografin, 2 cps for lipomul, and 41 cps for tomocat to higher viscosity
contrast agents as well (FF 14). Thus, the evidence reasonably suggests that
a variety of viscosity values would function in CT contrast agents.
We agree with the Examiner that, as in Brown,
the viscosity value recited in the claims is the value of the
beverage solution before adding the contrast agent while in
Williams Ill, the viscosity disclosed is the viscosity of the
solution including the barium sulfate which results in[] higher
viscosity. Thus, the viscosity of 128 cps, 130 cps and 140 cps
were evaluated while the contrast agent is included.
(Ans. 4–5). Therefore, the viscosity of the beverage solution itself, as in the
claims, will be lower than the viscosity after combination with the contrast
agent, and closer to the claimed values.
Brown, like claim 1, teaches viscosity agents with viscosities in the
range of 1 to 20 prior to mixing with the barium sulfate (FF 17–18). Indeed,
in example 1, Brown teaches a sodium CMC-XL agent with 18 cps mixed
with water and barium sulfate, thereby starting with a viscosity solution
within the claimed range (FF 18). Thus, in contrast with the bare statement
of Dr. Quagliano that it is not possible to predict whether a particular
combination and concentration of ingredients will an acceptable vehicle for
a contrast agent, the evidence in Williams III, in Quagliano, and in Brown
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supports the Examiner’s conclusion that viscosity was a well-known and
predictable optimizable variable in contrast agent solutions that could
function within a wide range of values.
Appellant contends “in view of the fact that Williams III teaches that a
six times higher viscosity is necessary to achieve acceptable imaging, the
proposed modification would render the barium sulfate solution of Williams
unfit for its intended purpose” (Appeal Br. 12).
We find these arguments unpersuasive because, as the Examiner
points out, “the viscosity range recited in the claims is the value in the
solution before adding the contrast agent” (Ans. 6). Moreover, Williams III
shows that tiny reductions in the % of the viscosity regulating agent xanthan
gum from 0.5226 to 0.1830 % w/v result in large changes in viscosity from
860 cps to 140 cps (see FF 7, formulations C and D). Thus, rather than a
six-fold dilution being necessary to reduce CPS 6.1 fold from 860 to 140
cps, all that was required was a reduction of xanthan gum by 0.3396 % w/v
or about 1/3 of 1 percent (FF 7). The teachings of Williams III, in
combination with the teachings by Quagliano and Brown of contrast agents
within the 1 to 20 cps range recited in claim 1, demonstrate that the ordinary
artisan is capable of routinely optimizing viscosity agents to obtain
viscosities that result in compositions that function for computerized
tomography (FF 7–9, 14, 18).
Appellant contends “the combination of Williams III and Kool-Aid,
though perhaps having improved palatability over the other formulations
tested in the 1997 Quagliano Publication, would not result in a liquid
formulation having the palatability characteristics of the claimed liquid
vehicle” (Appeal Br. 13).
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We find this argument unpersuasive because it fails to engage with the
rejection at issue. The rejection is not based on the addition of Kool-Aid to
the contrast agent of Williams III, but rather is based on the teachings in
Williams III to use palatability components in amounts as required by claim
1, including 2% sorbitol (FF 4, 7), pH values of about 5 (FF 7), and
sweeteners (FF 6). The Examiner then relies upon Chen to suggest
incorporating glycorrhizin, a bitterness blocker, that provides the “advantage
. . . that the resulting complexes can mask or lessen the bitter taste of certain
active agents” (FF 13). Chen explains: “Glycyrrhizin can enhance flavors,
modify sweetness perception, minimize bitterness” (FF 13). Thus, contrary
to Appellant’s characterization of the rejection, the Examiner reasonably
finds it obvious to include a bitterness blocker such as glycorrhizin into the
sweetened composition of Williams III in order to mask the bitter taste of
active agents (FF 13). “Non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references. . . . [The reference] must be read, not in
isolation, but for what it fairly teaches in combination with the prior art as a
whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellant contends
the portion of Brown cited by the Examiner does not describe
the viscosity of the contrast media of Brown, but instead
describes a characteristic of the stabilizer that may be used in
the contrast media. Brown does not describe a liquid vehicle
having a viscosity in the claimed range. The CMC itself would
raise the viscosity well above 20 centipoise, and the barium
sulfate present in Brown would further increase the viscosity.
(Appeal Br. 14).
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We find this argument unpersuasive as claim 1 is drawn to a “liquid
vehicle for use with an iodinated contrast agent” and therefore does not
include a contrast agent such as barium sulfate. So the proper comparison of
viscosity of claim 1 to Example 1 of Brown is to the sodium CMC-XL and
water composition, not the complete composition including the barium
sulfate contrast agent. Appellant points to no evidence that Brown’s
example I composition composed of 1 part sodium CMC-XL at 18
centipoise and 100 parts of 1 centipoise water would have been expected to
or necessarily result in a viscosity exceeding the highest viscosity level of
the constituents. And as noted, the addition of the barium sulfate contrast
agent is not encompassed by claim 1 and therefore does not relate to a claim
limitation. “[A]ppellant’s arguments fail from the outset because . . . they
are not based on limitations appearing in the claims.” In re Self, 671 F.2d
1344, 1348 (CCPA 1982).
Appellant contends, in the Reply Brief, that
The Examiner argues that the viscosity of the formulation
of Williams III could have been modified without dilution by
manipulating the concentrations of the stabilizing agent and the
osmotic agents, and that optimizing the ingredients in a way to
maintain good quality imaging “should be within the purview”
of those skilled in the art through routine experimentation.
(Answer at 6, 18). The Examiner’s statements are unsupported
by anything in the cited references and are contradicted by the
only evidence in the record.
(Reply Br. 6–7).
We find this argument unpersuasive because Williams III expressly
teaches to optimize viscosity, stating “any compound that appropriately
modifies the viscosity of a substance so as to facilitate the imaging process”
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(FF 8). Williams III also teaches compounds “to alter viscosity and lower
signal/noise ratios to improve performance in MR imaging” (FF 9). Thus
Williams III recognizes viscosity as an optimizable variable and identifies
reasons to modify it including to facilitate the imaging process and lower
signal/noise ratios (FF 8–9).
Secondary considerations
Appellant cites two specific secondary considerations, long felt need
and commercial success.
Long-Felt Need
To establish a long-felt need, three elements must be proven: First, the
need must have been a persistent one that was recognized by ordinarily
skilled artisans. In re Gershon, 372 F.2d 535, 538 (CCPA 1967). Second,
the long-felt need must not have been satisfied by another before Appellant’s
invention. See Newell Companies, Inc. v. Kenney Mfg. Co., 864 F.2d 757,
768 (Fed. Cir. 1988) (“[O]nce another supplied the key element, there was
no long-felt need or, indeed, a problem to be solved . . . .”). Third, the
invention must, in fact, satisfy the long-felt need. In re Cavanagh, 436 F.2d
491, 496 (CCPA 1971).
As to the persistent need, Appellant contends “[t]here has been a long-
standing, persistent problem in CT and MRI examinations due to the taste
and bitterness of iodinated oral contrast agents” (Appeal Br. 14). Appellant
cites the Lee8 and Flannery9 Declarations to show “[m]any patients have
difficulty drinking iodinated oral contrast agents when mixed with water due

8 Declaration of Jeff Lee, dated June 26, 2018.
9 Declaration of Martha Flannery, dated Apr. 11, 2019.
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to their poor taste and bitterness” and “many patients had difficulty drinking
the oral contrast agent even when mixed with Kool-Aid” (Lee Decl. ¶¶ 3–4;
cf. Flannery Decl. ¶¶ 3–4).
As to whether the need was satisfied, Appellant contends:
The claimed liquid vehicle has been formulated to provide
improved palatability while maintaining good imaging
characteristics and an acceptable level of side effects when used
with an iodinated oral contrast agent. Radiographic facilities
using the claimed liquid vehicle have seen a significant
improvement in patient compliance with drinking protocols.
Lee Decl. at ¶5; Flannery Decl. at 6-8 and Exhibits 1-2.
(Appeal Br. 16). Appellant further contends: “At the time that the claimed
liquid vehicle was introduced, there were no other liquid vehicles on the
market that addressed the long felt need” (id.).
Lastly, as to satisfying the need, Appellant contends: “Facilities that
have used Breeza for Oral Contrast Agents have found that patients are
better able to tolerate drinking the entire prescribed dose of contrast agent
within the required time frame. Lee Decl. ¶ 5; Flannery Decl. ¶¶ 7–9 and
Exhibits 1 and 2” (Appeal Br. 17).
We agree with Appellant that the Lee and Flannery Declarations
establish that there was a need for a more palatable oral contrast agent and
that the Breeza additive made oral contrast agents more palatable. Thus, two
of the three elements for long felt need are satisfied.
However, we are not persuaded that the second element was satisfied,
that the need was unrecognized by the prior art and was not already
addressed by the prior art. Indeed, Chen recognizes “provisions for
improving the palatability of bitter tasting drugs needs to be provided to
improve patient compliance” and specifically recognizes such drugs may
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include a “contrast agent” (FF 11–12). Chen further explains “[a]n
additional advantage is that the resulting complexes can mask or lessen the
bitter taste of certain active agents” and teaches: “Glycyrrhizin can enhance
flavors, modify sweetness perception, minimize bitterness” (FF 13).
“Establishing a long felt need requires evidence that an art recognized
problem existed in the art for a long period of time without a solution. The
need must have been a persistent one that was not recognized by those of
ordinary skill in the art.” Here, the evidence suggests the need was
recognized.
Not only was the need recognized, but Williams III teaches a
composition composed of a contrast agent with flavorings and artificial
sweeteners and tests two formulations, finding the “patient expressed no
complaints about the contrast media’s formula, flavor, viscosity or volume”
(FF 10). Thus, Appellant’s asserted long-felt need was already satisfied by
another before the date of Appellant’ invention (see FF 1–14; see also Ans.
10). See Newell Companies v. Kenney Mfg. Co., 864 F.2d 757, 768 (Fed.
Cir. 1988) (“[O]nce another supplied the key element, there was no long-felt
need or, indeed, a problem to be solved.”). Here, both Chen and Williams
III supply the key elements of sweeteners and bitterness masking agents that
make contrast agents more palatable (FF 6, 10, 13). None of Appellant’s
three Declarations provide evidence demonstrating that Chen and Williams
III fail to satisfy the long-felt need.
Also, we recognize that in the context of a particular product, the
Court has explained that a showing of evidence commensurate in scope
“does not mean that an applicant is required to test every embodiment within
the scope of his or her claims.” In re Huai-Hung Kao, 639 F.3d 1057, 1068
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(Fed. Cir. 2011). However, Appellant must provide “an adequate basis to
support the conclusion that other embodiments falling within the claim will
behave in the same manner.” Id. Thus, in addition to our fact based
conclusion that the evidence shows the long-felt need was already satisfied
by Chen and Williams III, we also note the claims are not commensurate in
scope with the particular Breeza composition tested by Appellant.
Commercial Success
Appellant contends “Beekley’s Breeza for Oral Contrast Agents has
been commercially successful since it was introduced to the market, and the
commercial success of the products is derived from the claimed invention”
(Appeal Br. 17). Appellant contends:
Sales of Breeza for Oral Contrast Agents increased rapidly after
the product was introduced in 2010 such that by 2012 they had
grown from zero to almost $1.5 million. Flannery Decl. at ¶ 17.
Sales have been consistently above $1.8 million each year since
2012, and were $1.9 million in 2018. Flannery Decl. at ¶ 10.
From 2010 through March 2019, a total of 1,348 radiology
facilities throughout the United States have purchased over 5.1
million bottles of Breeza for Oral Contrast Agents. Flannery
Decl. at ¶ 11.
(id. at 17–18).
We are not persuaded. We agree with concerns noted by the
Examiner that there is no evidence that the Breeza composition falls within
the scope of the claim and that commercial success must be due to claimed
features (see Ans. 29). Indeed, Flannery provides no details regarding the
pH of the Breeza composition and does not disclose what sweetener or
bitterness blockers were used (see Flannery Decl. ¶ 5).
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But more significantly, “information solely on numbers of units sold
is insufficient to establish commercial success.” In re Baxter Travenol
Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). For example, in Huang, the
Court cited Cable Electric for the proposition that “sales of 5 million units
represent a minimal showing of commercial success because ‘[w]ithout
further economic evidence . . . it would be improper to infer that the reported
sales represent a substantial share of any definable market.’” In re Huang,
100 F.3d 135, 140 (Fed. Cir. 1996) (citing Cable Elec. Prods., Inc. v.
Genmark, Inc., 770 F.2d 1015, 1026–27 (Fed. Cir. 1985).
The same reasoning applies here. While Appellant provides evidence
of $1.5 million dollars and 5.1 million bottles (units) in sales of Breeza,
Appellant does not provide any evidence of market share, even at the 1,348
facilities to which Appellant has sold Breeza (see Flanner Decl. ¶¶ 10–11).
Absent evidence of market share, this provides minimal evidence of
commercial success. Nor do the anecdotal statements regarding improved
taste establish commercial success, particularly when that improvement was
not compared to the closest prior art of Williams III or Chen. Therefore, on
the current record, we cannot determine what share of the contrast agent
market has been captured by Breeza and therefore cannot infer whether these
results show commercial success. We therefore find the commercial success
data insufficient to demonstrate whether the composition achieves
commercial success.
Conclusion of Law
(i) A preponderance of the evidence of record supports the Examiner’s
conclusion that the prior art renders the claims obvious.
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(ii) Appellant has not provided evidence of unexpected results that,
when balanced with the prima facie case, supports a finding of non-
obviousness.

B. Obviousness-Type Double Patenting
Appellant does not dispute the rejection of the claims under
obviousness-type double patenting rejections on the merits (see Appeal Br.
20). We therefore summarily affirm the obviousness-type double patenting
rejections over the claims of US 9,585,836. See Manual of Patent
Examining Procedure § 1205.02 (“If a ground of rejection stated by the
examiner is not addressed in the appellant’s brief, that ground of rejection
will be summarily sustained by the Board.”) See also Hyatt v. Dudas, 551
F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to contest a
ground of rejection to the Board . . . the Board may treat any argument with
respect to that ground of rejection as waived.”)

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–4, 7–9,
11–18, 21–
23, 34–41
103 Williams III,
Chen, Quagliano,
Brown
1–4, 7–9, 11–
18, 21–23,
34–41

1–4, 7–9,
11–18, 21–
23

Nonstatutory
Double Patenting
US 9,585,836 B2,
Chen, Williams III
1–4, 7–9, 11–
18, 21–23

Overall
Outcome
1–4, 7–9, 11–
18, 21–23,
34–41

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