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Patent Trials and Appeals Board

Nov 18, 2019

14333417 - (D) (P.T.A.B. Nov. 18, 2019)

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.
14/333,417 07/16/2014 Tammy Savage 019236.00011 1012
30256 7590 11/18/2019
SQUIRE PB (PAL Office)
275 Battery Street
Suite 2600
San Francisco, CA 94111
EXAMINER
KRISHNAN, GANAPATHY
ART UNIT PAPER NUMBER
1623
NOTIFICATION DATE DELIVERY MODE
11/18/2019 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):
sfripdocket@squirepb.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte TAMMY SAVAGE, STEPHEN WICKS, and JOHN MITCHELL
____________

Appeal 2019-004798
Application 14/333,417
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal1,2 under 35 U.S.C. § 134(a) involving claims to
substituted sulphobutyl ether β-cyclodextrin. The Examiner rejected the
claims as anticipated and obvious. We have jurisdiction under 35 U.S.C.
§ 6(b). We AFFIRM-IN-PART.

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 Curadev
Pharma Private Limited (see App. Br. 3).
2 We have considered and herein refer to the Specification of Jan. 19, 2016
(“Spec.”); Final Office Action of May 2, 2018 (“Final Act.”); Appeal Brief
of Dec. 19, 2018 (“App. Br.”); Examiner’s Answer of Apr. 2, 2019 (“Ans.”);
and Reply Brief of May 31, 2019 (“Reply Br.”).
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Statement of the Case
Background
“Sulphobutyl ether β-cyclodextrin (SBE-β-CD or SBECD) is one of a
class of polyanionic, hydrophilic water soluble cyclodextrin derivatives”
(Spec. 1:9–10). “SBE-β-CD is currently used as an effective pharmaceutical
excipient, and has been given the trade name Captisol®” (id. 1:30–31).
Known batch processes for preparing SBE-β-CD result in “a high proportion
of lower substituted SBE-β-CD” (id. 1:25–26). “[T]he continuous flow
process of the invention however results in a lower concentration of lower
substituted [SBE-β-CD] (i.e.[,] a degree of substitution value of 1–4) and
surprisingly much higher concentrations of the higher substituted . . . [SBE-
β-CD] (i.e.[,] individual degrees of substitution values of 4–13)” (id. 4:6–
10).
The Claims
Claims 21–25, 27, and 31–36 are on appeal.3 Independent claims 21
and 36 are representative and read as follows:
21. A composition comprising sulphobutyl ether β-
cyclodextrin (SBE-β-CD), wherein the average degree of
substitution (ADS) is 7.3 or more and the composition
comprises a range of individual degrees of substitution.

36. A composition comprising sulphobutyl ether β-cyclodextrin
(SBE-β-CD), wherein the average degree of substitution (ADS)
is 9 or more.

App. Br. 22–23.

3 Claims 1–3, 5, 7, 9, 10, 12, 14, 15, 17–19, 29, and 30 were withdrawn (see
App. Br. 20–23). Claims 4, 6, 8, 11, 13, 16, 20, 26, and 28 were cancelled
(see id.).
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The Issues
A. The Examiner rejected claims 21–25, 27, and 31–36 under 35 U.S.C.
§ 102(a)(1) as being anticipated by Mosher4, as evidenced by Zia5, Luna-16,
and Luna-27 (Ans. 3–5).
B. The Examiner rejected claims 21–25, 27, and 31–36 under 35 U.S.C.
§ 103 as obvious over Shah8, in view of Luna-2, Stella9, and Zia (Ans. 10–
12).
A. 35 U.S.C. 102(a)(1) over Mosher
The Examiner finds that Mosher teaches “a composition comprising
[SBE-β-CD] having an average degree of substitution of 1–21” (Ans. 3).
The Examiner finds that Mosher is an enabling reference as supported by the
evidentiary references of Zia, Luna-1, and Luna-2 (id. at 5). The Examiner
finds Zia teaches “SBE12-β-CD was produced and separated in order to
conduct a binding study” thereby showing that “SBE-β-CD compounds
having an average degree of substitution of 7.3 or more were known at least
10 years before the effective filing date of the instant invention” (id. at 4).
The Examiner finds Luna-1 and Luna-2 teach SBE-β-CD with different

4 Mosher et al., US 2010/0292268 A1, published Nov. 18, 2010.
5 Zia et al., Effect of Alkyl Chain Length and Degree of Substitution on the
Complexation of Sulfoalkyl Ether β-Cyclodextrins with Steroids, 86 J.
Pharma. Sci. 220–224 (1997).
6 Luna et al., Fractionation and characterization of 4-sulfobutyl ether
derivatives of cyclomaltoheptaose (β-cyclodextrin), 299 Carbohydrate Res.
103–110 (1997).
7 Luna et al., Evaluation of the utility of capillary electrophoresis for the
analysis of sulfobutyl ether β-cyclodextrin mixtures, 15 J. Pharma. Biomed.
Analysis 63–71 (1996).
8 Shah et al., EP 0889056 A2, published Jan. 7, 1999.
9 Stella et al., US 5,134,127, issued July 28, 1992.
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average degrees of substitution and a range of individual degrees of
substitution” (id.).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Mosher anticipates the claims?
Findings of Fact (“FF”)
1. Mosher discloses “the sodium salt of sulfobutyl ether derivative
of beta-cyclodextrin, with an average of about 7 substituents per
cyclodextrin molecule (SBE7-β-CD), is being commercialized by CyDex
Pharmaceuticals, Inc. (Kansas) as CAPTISOL® cyclodextrin” (Mosher
¶ 15).
2. Mosher discloses “[t]he SAE-CD used is available from CyDex
Pharmaceuticals, Inc. . . . [], and is described in U.S. Pat. No. 5,376,645 and
No. 5,134,127 to Stella.” (Mosher ¶ 107).
3. Mosher discloses “a composition comprising clopidogrel and a
sulfoalkyl ether cyclodextrin (SAE-CD)” “of the formula SAEx-R-CD . . . [],
wherein SAE is selected from the group consisting of . . . sulfobutyl ether
. . . and x is 1–18, 1–21, or 1–24, when R is α, β, or γ, respectively”
(Mosher 31, claim 108).
4. Zia teaches “SAE-β-CDs are a mixture of positional and
regional isomers containing from one to as many as 12 SAE groups per CD”
(Zia 220).
5. Zia teaches:
To determine the effect of degree of substitution (DS) on . . . []
binding, mixtures of SAE-β-CDs with multiple substitution
levels and varying average degrees of substitution were studied
as well as mixtures of SAE-β-CDs that contained the same
degree of substitution. Mixtures that contained SAE-β-CDs of
the same degree or substitution were isolated from the multiple
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substitution level mixtures by ion-exchange chromatography
and purified for investigation.

(Zia 220).
6. Zia teaches an electropherogram of SBE4-β-CD with an
average degree of four substitutions per CD and up to 10 degrees of
substitution (Zia 221, Fig. 2).
7. Zia teaches testing binding constants of SBE-β-CDs, including
SBE12-β-CD, to testosterone and progesterone (Zia 223, Table 1).
8. Luna-1 teaches “SBE-β-CD mixtures can be reproducibly
prepared with different average ds (i.e., 1, 4, 7) by varying . . . [] reaction
conditions” (Luna-1 104).
9. Luna-1 teaches isolating SBE-β-CD, including SBE8b-β-CD
using capillary electrophoresis (“CE”) analysis. However, “[t]he bands with
ds 9 and 10 were not detected by CE or did not elute from the Sephadex
under the experimental conditions” (Luna-1 105, Fig. 4).
10. Luna-2 teaches that changes in reaction conditions effect the
pattern of distribution of substituted SBE-β-CD products (see Luna-2 69–
70).
11. Luna-2 teaches “[n]either temperature nor reaction time
appeared to affect the distribution of the product mixture (Fig. 10a and Fig.
10b)” (Luna-2 70).
12. Luna-2 teaches:
However, changes in the amount of base caused a change in the
composition pattern (Fig. l0c). The use of 7–12 equivalents of
base produced a fairly narrow distribution pattern, but a drop to
6 equivalents of base caused a shift in the distribution from the
lower level of substitution to a higher population of
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intermediate substituted materials. A change in the distribution
pattern was also observed with the use of 14 and 21 equivalents
of base. A high base concentration produced a broader
distribution of materials with a shift of the maximum to a
slightly lower level of substitution.

(Luna-2 70).

Principles of Law
“In patent prosecution, the examiner is entitled to reject application
claims as anticipated by a prior art patent without conducting an inquiry into
whether or not that patent is enabled . . . The applicant, however, can then
overcome that rejection by proving that the relevant disclosures of the prior
art patent are not enabled.” Amgen, Inc. v. Hoechst Marion Roussel, Inc.,
314 F.3d 1313, 1355, 65 USPQ2d 1385, 1416 (Fed. Cir. 2003).
Analysis
Appellant contends that Mosher “is not enabled for the entire ADS
range of 1 to 21” (App. Br. 9). Appellant submits two declarations by
Stephen Wicks, Ph.D. and a publication by Ma10 as evidence that Mosher is
not enabled. Appellant contends that the Wicks Decl. I11 explains that
despite SBE-β-CD having “twenty-one hydroxyl groups which theoretically
could be alkylated, i.e., substituted,” “[p]revious researchers were unable to
empirically . . . make SBE-β-CD having an ADS greater than 7.1” (App. Br.
11, citing Wicks Decl. I ¶ 12.). The Declaration explains that, consistent
with the state of the art at the time, Mosher refers to Stella for a process of

10 Ma et al., The synthesis and process optimization of sulfobutyl ether b-
cyclodextrin derivatives, 72 Tetrahedron 3105–3112 (2016).
11 Declaration of Dr. Stephen Wicks, dated July 21, 2016.
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making SBE-CDs that results in SBE-CD compositions having an ADS of
7.0–7.1 (Wicks Decl. I ¶¶ 23–29). The Declaration states that “[a]t the time
of the effective filing date of the instant application, the methods in Mosher
could only produce SBECD having a maximum ADS of about 7.0” (id. ¶
32).
Appellant contends that the Wicks Decl. II12 explains that the degree
of substitution was limited by “the prior art batch methods of making SBE-
β-CD” (App. Br. 12, citing Wicks II ¶¶ 17–18). The Declaration states:
Although β-cyclodextrin has 21 hydroxyl groups available for
alkylation, researchers were unable to make a β-cyclodextrin
having an ADS greater than about 7.0–7.1 in a largely
reproducible manner and suitable for commercialization simply
by reacting β-cyclodextrin with an excess of 1,4-butane. This is
likely due to steric hindrance caused by the substituted group
on each of the glucopyranose units after each unit is alkylated
once which disfavors, thermodynamically or kinetically, further
substitution.

Wicks Decl. II ¶ 18.
Appellant contends that Ma teaches β-cyclodextrin has three hydroxyl
groups C2, C3, and C6 (multiplied by seven dextrose units for a total of 21
theoretical substitution sites) (App. Br. 12). Appellant contends that Ma
“teaches that the C3 hydroxyls are unreactive using prior art batch methods
because the amount of base (i.e., strong base conditions) required to activate
the C3 hydroxyl competitively destroys the alkyl sulfone before it can react
with the activated β-CD” (id., citing Ma 3106, 3108–3110).

12 Declaration of Dr. Stephen Wicks, dated Mar. 15, 2017.
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The Examiner responds that “[o]ut of the 21 available hydroxyls there
are only 7 hydroxyls at the C3 position. The other 14 hydroxyls are reactive
according to Ma” (Ans. 7). The Examiner finds Luna-1 “shows complete
resolution of CE peaks for DS 1–10. This shows that SBE β-cyclodextrins
having DS above 7 have been detected, which means that they were
produced” (id. see FFs 8, 9). The Examiner finds that Zia teaches the use of
SBE12-β-CD, whereby the “artisan would clearly understand that SBE12-β-
CD was produced, separated and characterized” (id. at 8, FF 7). “This
means that before SBE12-β-CD was isolated and purified, it must have been
present as a component in a mixture [of] SBE-β-CDs having a range of
individual degrees of substitution” (id.). The Examiner finds that “Figure
10c of Luna-2 shows that there is a shift toward higher degree of substitution
if base concentration is increased” and “comparing Fig. 10b with Fig. 10a
shows that there is a slight shift toward higher substitution” when
temperature is increased (id., citing Luna-2 70, Figs. 10a–c).
We find Appellant’s arguments and evidence persuasive as to the
Examiner’s rejection of anticipation by Mosher. Appellant’s claim 21
requires SBE-β-CD with an average degree of substitution (ADS) of 7.3 or
more and a range of individual degrees of substitution (IDS). Appellant’s
claim 36 requires SBE-β-Cd with an ADS of 9 or more. We find Dr. Wick’s
explanation of ADS and IDS instructive:
Two compositions of SBE-β-CD can potentially have the same
ADS but differ with respect to the distribution of, or presence
of, different IDS(s) in the composition. For example, a
composition comprising . . . [SBE-β-CD] can include a single
type of SBE-β-CD such that the IDS is equal to the ADS.
However, a composition can also include a range of SBE-β-CD
which differ with respect to the number of substituents on the
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SBE-β-CD such that certain SBE-β-CD in the composition have
an IDS not equal to the ADS.

(Wicks Decl. II ¶ 27). The Specification further provides methods for
measuring and calculating the IDS and ADS, as well as incorporating the
IDS into a calculation of ADS (see Spec. 25–30). As applied to claim 21,
we interpret the claim to require SBE-β-CD with an ADS of 7.3 or more
including multiple IDS that form a range. We interpret claim 36 to require
an ADS of 9 or more, without limitation on IDS.
We agree with the Examiner that the prior art, e.g., Luna-1, Luna-2,
and Zia, shows that individual SBE-β-CD having degrees of substitution
greater than 7 had been produced (FFs 4, 6, 7, 9, 10). This is consistent with
Mosher’s teachings of SBE-β-CD having an ADS of about 7, which would
necessarily encompass a range of IDS greater and less than 7 to obtain the
average value (FF 1). However, these isolated compounds do not establish
an ADS of more than 7.3, with a range of IDS.
Likewise, the prior art does not establish a method for practicing
Mosher’s entire ADS range of 1–21. As acknowledged by the Examiner,
Ma teaches that an IDS, and consequently ADS, of greater than 14 would
not have been expected at the time of filing. Mosher does not provide a
method of preparing SBE-β-CD, but rather cites to Stella, which produces
SBE-β-CD with an ADS of up to 7.1 (FF 2).
Moreover, we find that the art does not support the Examiner’s
conclusion as to the predictability of the method of achieving an ADS of 7.3
or more. Despite the Examiner’s interpretation of the Figures 10a–c of
Luna-2, the reference unambiguously states that “neither temperature nor
reaction time appeared to affect the distribution of the product” (FF 11).
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Moreover, Luna-2 teaches that decreasing, rather than increasing the amount
of base, “causes a shift in the distribution from the lower level of
substitution to a higher population of intermediate substituted materials” and
that the largest amounts of base equivalents “shift the maximum to a slightly
lower level of substitution” (FF 12).

Conclusion of Law
A preponderance of the evidence supports Appellant’s argument that
Mosher does not enable SBE-β-CD with an ADS range of 7.3 or more.
Consequently, we do not sustain the Examiner’s rejection of the claims as
anticipated by Mosher, and we reverse the rejection of claims 21 and 36.
The rejection of dependent claims 22–25, 27, and 31–35 falls with
independent claim 21.

B. 35 U.S.C. § 103 over Shah, Luna-2, Stella, and Zia
The Examiner finds Shah teaches that the degree of sulfoalkylation of
SBE-β-CD “can be controlled by using lower or higher amounts of
alkylsulfone depending on whether a lower or higher degree of substitution
is desired. Generally, a range of substitution of 4.5–7.5 can be achieved”
(Ans. 10). The Examiner acknowledges that Shah “does not expressly teach
SBE-β-CDs having the average degree of substitutions recited in the instant
claims” (id.). The Examiner finds “the teachings of [Shah] and [Luna-2] can
be used by one of ordinary skill in the art to optimize the reaction conditions
and order of steps to be used . . . in order to produce SBE-β-CDs having the
higher average degree of substitution as instantly claimed” (id. at 11).
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The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the claims would have been
obvious?
Findings of Fact
13. Shah teaches “a process of making a sulfoalkyl ether
cyclodextrin having a predetermined degree of substitution” (Shah 3:8–9).
14. Shah teaches the process includes the steps of: A) combining
cyclodextrin with alkyl sulfone in the presence of an alkali metal hydroxide;
B) conducting sulfoalkylation within a pH range of about 8 to about 11; C)
adding additional hydroxide to achieve the desired degree of substitution and
proceed to completion; and D) adding additional hydroxide to destroy
residual sulfone (Shah 3:26–36).
15. Shah teaches:
Once the level of residual unreacted cyclodextrin has
reached a desired level below 0.5% by weight during the pH
control stage, the pH can be raised to above 11, for example a
level above 12, by adding additional base to drive the reaction
to completion. The pH is preferably at least 12 so that the
reaction proceeds at a reasonable rate, but not so high that
unreacted alkyl sulfone is hydrolyzed rapidly rather than
reacting with cyclodextrin.

(Shah 4:24–27).
16. Shah teaches “[g]enerally the range of substitution that can be
achieved is an average of from 4.5 to 7.5, preferably 5.5 to 7.5, most
preferably 6.0 to 7.1” (Shah 5:15–16).
17. Shah teaches experimentally preparing SBE-β-CD with an
“average degree of substitution . . . [of] 7.0 by NMR and 7.1 by elemental
analysis” (Shah 7:24–32).
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Analysis
Appellant contends “Shah does not disclose how a SBE-β-CD
composition could be produced with an ADS of 7.3 or more” (Reply Br. 16).
Rather, Appellant contends that Shah’s method produces a highest ADS of
7.0 by NMR and 7.1 by elemental analysis (App. Br. 16, citing Shah ’746
8:64–65)13. Appellant contends that “[b]ecause of the competing activation
and alkylation reactions, the maximum ADS empirically possible using
prior art batch methods such as Mosher, et al. and Shah, et al., is 7.0 and
7.1, respectively” (id. at 15, citing Wicks Decl. II ¶ 18). Particularly, Dr.
Wicks states:
[I]mproved techniques resulted in methods for making SBECD
with an ADS of up to 7.0–7.1 in a largely reproducible manner,
and the process could therefore be commercialized. These
methods are disclosed in [Shah] US Patent No. 6,153,746,
which is of record in the instant case. Although β-cyclodextrin
has 21 hydroxyl groups available for alkylation, researchers
were unable to make a β-cyclodextrin having an ADS greater
than about 7.0–7.1 in a largely reproducible manner and
suitable for commercialization simply by reacting β-
cyclodextrin with an excess of 1,4-butane. This is likely due to
steric hindrance caused by the substituted group on each of the
glucopyranose units after each unit is alkylated once which
disfavors, thermodynamically or kinetically, further
substitution.

(Wicks Decl. II ¶ 18). Dr. Wicks states that “[u]ntil the disclosure of this
improved batch-continuous flow synthetic method, the aforementioned

13 Appellant refers to Shah as the U.S. publication, US 6,153,746, issued
Nov. 28, 2000 (“Shah 746”).
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thermodynamic or kinetic barriers for producing SBECD having an ADS
greater than about 7.0 were not overcome” (Wicks Decl. I ¶ 31).
The Examiner responds that although “Shah does not teach SBE-β-
CD with an ADS above 7.1 . . . one of ordinary skill in the art will recognize
that the base concentration, and therefore the pH, can be adjusted to increase
the degree of substitution while minimizing the hydrolysis of the sulfone”
(Ans. 14). The Examiner finds that “[f]rom the teachings of Shah one can
also adjust the contact time and also adjust the ratio of the CD to sulfone for
increasing the DS” (id.). The Examiner finds Luna-2 teaches “increasing
temperature shifts the ADS slightly higher toward higher value” and “[i]f
one looks at Fig. 10c, base equivalents from 6–10 show a shift toward higher
substitution values” (id.). The Examiner concludes “Applicants have not
convincingly shown that there is no reason to modify Shah, Luna-2 and Zia
in order to arrive at the instant invention” (id. at 15).
We find Appellant’s arguments and evidence persuasive as applied to
the rejection of claim 21. As discussed above, we agree that the evidence
establishes that the state of the art at the time of filing indicated the upper
limit of ADS for SBE-β-CD was 7.1 (FFs 1, 6, 8, 16, 17). We also agree
that a person of ordinary skill in the art would not have been motivated to
further increase the amount of base in Shah, as Shah cautions against
destruction of the sulfone, and Luna-2 indicates that more base decreases
rather than increases the maximum substitutions (FFs 11, 12, 15). Because
the evidence supports Appellant’s argument that SBE-β-CD having an ADS
of 7.3 or more and a range of IDS would not have been obvious at the time
the invention was made in view of the applied prior art, we do not sustain
the Examiner’s rejection of claim 21.
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We do not find Appellant’s arguments and evidence persuasive as to
the rejection of claim 36. Claim 36 recites SBE-β-CD having an ADS of 9
or more. Claim 36 lacks the limitation found in claim 21 that the
“composition comprises a range of individual degrees of substitution.”
Therefore, claim 36 is open to a composition with a single degree of
substitution.
Appellant acknowledges that Zia “is directed to purified samples in
which the IDS is equal to the ADS” (Reply Br. 11 (emphasis omitted)). Dr.
Wicks’ Declaration also explains that “a composition comprising . . . [SBE-
β-CD] can include a single type of SBE-β-CD such that the IDS is equal to
the ADS” (Wicks Decl. II ¶ 27). Zia teaches an isolated SBE12-β-CD
having an IDS of 12 (FF 7). Zia therefore teaches a purified sample in
which the IDS of 12 is equal to an ADS of 12, i.e., 9 or more, as required by
Claim 36. “It is well settled that ‘anticipation is the epitome of
obviousness.’” In re McDaniel, 293 F.3d 1379, 1385 (Fed. Cir. 2002).
Because Zia confirms and exemplifies that it was known to obtain SBE-β-
CD having an ADS of 9 or more, it would have been obvious for a person of
ordinary skill in the art to do so in view of the combination of Shah, Luna-2,
Stella, and Zia. We note the Board may rely on less than all of the
references applied by the Examiner in an obviousness rationale without
designating it as a new ground of rejection. In re Bush, 296 F.2d 491, 496
(CCPA 1961). Accordingly, we sustain the rejection of claim 36.

Conclusion of Law
A preponderance of the evidence of record does not support the
Examiner’s conclusion that claim 21 would have been obvious over the prior
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art. Consequently, we reverse the rejection of claim 21, and its dependent
claims 22–25, 27, and 31–35.
A preponderance of the evidence of record supports the Examiner’s
conclusion that claim 36 would have been obvious over the prior art.
Consequently, we affirm the rejection of claim 36.

CONCLUSION
We reverse the rejection of claims 21–25, 27, and 31–36 under
35 U.S.C. § 102(a) as anticipated by Mosher.
We reverse the rejection of claims 21–25, 27, 31–35 under 35 U.S.C.
§ 103 as obvious over Shah, Luna-2, Stella, and Zia.
We affirm the rejection of claim 36 under 35 U.S.C. § 103 as obvious
over Shah, Luna-2, Stella, and Zia.

Claims
Rejected
35 U.S.C. § Basis Affirmed Reversed
21–25, 27, 31–36 102(a)(1) Mosher 21–25, 27, 31–36
21–25, 27, 31–36 103 Shah, Luna-2,
Stella, Zia
36 21–25, 27, 31–35
Overall
Outcome
36 21–25, 27, 31–35

AFFIRMED-IN-PART