Brigham Young University

Patent Trials and Appeals Board

Nov 4, 2020

15270876 - (D) (P.T.A.B. Nov. 4, 2020)

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.
15/270,876 09/20/2016 Carl Genberg 19250.42.1 7593
22913 7590 11/04/2020
Workman Nydegger
60 East South Temple
Suite 1000
Salt Lake City, UT 84111
EXAMINER
HELM, CARALYNNE E
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
11/04/2020 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):
Docketing@wnlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte CARL GENBERG, PAUL B. SAVAGE, and
RONALD L. BRACKEN
__________

Appeal 2020-002075
Application 15/270,876
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, TAWEN CHANG, and
JAMIE T. WISZ, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134 involving claims to an
implantable medical device that includes a cationic steroidal antimicrobial
compound. 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 Brigham
Young University Technology Transfer Office (see Appeal Br. 3).
2 We have considered the Specification of Sept. 20, 2016 (“Spec.”); Final
Office Action of Dec. 4, 2018 (“Final Action”); Appeal Brief of Aug. 15,
2019 (“Appeal Br.”); Examiner’s Answer of Nov. 18, 2019 (“Ans.”); and
Reply Brief of Jan. 17, 2020 (“Reply Br.”).
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Statement of the Case
Background
“[M]any medical devices are implanted into the subject, and may be
intended either as a permanent or temporary implant. However, even when
strict sterilization procedures are followed, such medical implants can be
subject to microbial contamination” (Spec. ¶ 3). “When biofouling of the
implant occurs, the implant must be removed from the subject. . . . Usually,
the fouled implant must be replaced with a new implant, adding to medical
care costs” “and can even lead to very serious and deadly conditions, such as
sepsis” (id. ¶¶ 3–4). The Specification teaches “implantable medical devices
incorporating one or more cationic steroidal antimicrobial (CSA)
compounds to provide the medical device with effective antimicrobial
properties and/or anti-inflammatory properties” (id. ¶ 9).
The Claims
Claims 1, 3, 5–11, 13–20, and 22–25 are on appeal. Claim 1 is
representative and reads as follows:
1. An implantable medical device selected from catheter,
endotracheal tube, intravenous feed line, feeder tube, drain,
prosthesis component, voice prostheses, peristaltic pump,
tympanostomy tube, and tracheostomy tube, the implantable
medical device comprising:
a structural component of the implantable medical
device formed at least in part from a thermoplastic or
thermoset polymeric material; and
a sulfonic acid addition salt of at least one cationic
steroidal antimicrobial (CSA) compound, the at least one
CSA compound having a hydrophobic sterol backbone
and a plurality of charged groups attached to the sterol
backbone, the at least one CSA compound being
incorporated into the polymeric material of the structural
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component so as to be distributed throughout the
polymeric material of the structural component,
wherein the implantable medical device provides
antimicrobial efficacy of at least two months when the
implantable medical device is implanted.

The Rejections3
A. The Examiner rejected claims 1, 3, 5, 13, 14, 20, and 22–25 under
U.S.C. § 103(a) as obvious over Jones,4 Kolobow,5 Savage,6 Ding,7 Elder,8
Mochizuki,9 and Zhao10 (Final Act. 4–8)
B. The Examiner rejected claims 6, 7, 9, 10, and 16 under U.S.C.
§ 103(a) as obvious over Jones, Kolobow, Savage, Ding, Elder, Mochizuki,
Zhao, and Terry11 (Final Act. 8–9).
C. The Examiner rejected claims 11 and 17–19 under U.S.C. § 103(a) as
obvious over Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, and
Griesbach12 (Final Act. 9–10).

3 The provisional obviousness-type double patenting rejection is moot in
view of the abandonment of US 15/406,667 on Feb. 6, 2020.
4 Jones et al., Physicochemical Characterization of Hexetidine-Impregnated
Endotracheal Tube Poly(Vinyl Chloride) and Resistance to Adherence of
Respiratory Bacterial Pathogens, 19 Pharmaceutical Res. 818–24 (2002).
5 Kolobow et al., US 5,687,714, issued Nov. 18, 1997.
6 Savage, P., US 2013/0022651 A1, published Jan. 24, 2013.
7 Ding et al., US 2002/0091433 A1, published July 11, 2002.
8 Elder et al., The Utility of Sulfonate Salts in Drug Development, 99 J.
Pharmaceutical Sci. 2948–61 (2010)
9 Mochizuki et al., JP 60-80457, issued Nov. 25, 1992 (Machine Translation
1–7).
10 Zhao, X, US 2007/0053788 A1, published Mar. 8, 2007.
11 Terry et al., US 6,329,488 B1, issued Dec. 11, 2001.
12 Griesbach, III, US 2009/0099531 A1, published Apr. 16, 2009.
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D. The Examiner rejected claims 6–8 under U.S.C. § 103(a) as obvious
over Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, Terry, and
Genberg13 (Final Act. 10–12).
E. The Examiner rejected claim 15 under U.S.C. § 103(a) as obvious
over Jones, Kolobow, Savage, Ding, Elder, Mochizuki, Zhao, and Bucki14
(Final Act. 12–13).
F. The Examiner rejected claims 17–19 under U.S.C. § 103(a) as
obvious over Jones, Kolobow, Savage, Terry, and Zhao (Final Act. 13–15).
G. The Examiner rejected claims 20 and 22–25 under U.S.C. § 103(a) as
obvious over Jones, Kolobow, Vachon,15 Savage, Elder, and Zhao (Final
Act. 15–18).
H. The Examiner rejected claim 8 under U.S.C. § 112(a) as failing to
comply with the written description requirement (Final Act. 2–3).

A. 35 U.S.C. § 103(a) over Jones, Kolobow, Savage, Ding, Elder,
Mochizuki, and Zhao
The issue with respect to this rejection16 is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Jones,
Kolobow, Savage, Ding, Elder, Mochizuki, and Zhao render claim 1
obvious?

13 Genberg et al., US 2013/0243823 A1, published Sept. 19, 2013.
14 Bucki et al., Resistance of the antibacterial agent ceragenin CSA-13 to
inactivation by DNA or F-actin and its activity in cystic fibrosis sputum, 60
J. Antimicrobial Chemotherapy 535–45 (2007).
15 Vachon et al., US 2013/0004586 A1, published Jan. 3, 2013.
16 We note that, other than claims 6–11 and 17–19, dependent claims stand
or fall with claim 1 because separate reasons for their patentability were not
provided in the Appeal Brief. 37 C.F.R. § 41.37(c)(1)(iv).
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Findings of Fact
1. Jones teaches “the incorporation of a suitable antimicrobial
agent into PVC prior to the manufacture of ET [endotracheal] tubes may
hold benefits in combating the second-most common hospital-acquired
infection, nosocomial pneumonia” (Jones 823, col. 1). Jones teaches the
“incorporation of an antimicrobial agent within the constituent polymer of a
medical device is an accepted approach in engaging the problem of medical
device-associated infection” (Jones 818, col. 2).
2. Savage teaches “hydrogel polymers useful in the present
invention include any hydrogel suitable for use in products where there is a
need to minimize microbial load. For example, the hydrogels of the present
invention may be hydrogels useful in making medical devices” (Savage
¶ 26).
3. Savage teaches:
hydrogel materials that include a hydrogel polymer that
controllably elutes a ceragenin compound from the hydrogel
polymer over time. The controlled elution of the ceragenin can
occur over days, weeks, or months at a release rate that is
within a desired range for making the hydrogel material anti-
microbial while still maintaining the desired properties of the
hydrogel material.
(Savage ¶ 7).
4. Savage teaches “[e]xamples of suitable hydrogel polymers
include . . . silicone” (Savage ¶ 27). The Specification defines “polymeric
material” as including “silicone” (Spec. ¶ 19).
5. Savage teaches: “Ceragenin compounds, also referred to herein
as cationic steroidal anti-microbial compounds (CSA) . . . act as anti-
microbial agents (e.g., anti-bacterials, antifungals, and anti-virals)” (Savage
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¶¶ 23–24). Savage teaches “[s]uitable examples of ceragenins useful in
producing a composition that will elute from a hydrogel include, but are not
limited to . . . CSA-131” (Savage ¶ 35). Savage teaches, regarding the CSA
compounds, the use of “a pharmaceutically acceptable salt thereof” (Savage
¶ 37).
6. Savage teaches “the ceragenin compound may be selected to
have a hydrophobic R17 group that non-covalently bonds to the hydrophobic
groups of the hydrogel to cause a relatively consistent elution over a period
of days or weeks” (Savage ¶ 59).
7. Savage teaches:
Examples of medical devices that can be formed from a
hydrogel containing ceragenin eluting compounds or can have
such a hydrogel coated thereon include but are not limited to
. . . endotracheal tubes . . . The hydrogel may be coated on or
form any portion of the structures of such devices and is
preferably on an outer surface and more preferably on an out
service that contacts tissue or a tissue air interface (when the
device is implanted).
(Savage ¶ 70).
8. Savage teaches “the hydrogel polymer and the ceragenin
compound are selected to yield non-covalent bonding that provides a release
rate of 0.1-100 μg/ml, 0.5-50 μg/ml, or 1-10 μg/ml at three days, one week,
or one month” (Savage ¶ 61).
9. Elder teaches “[s]alt formation with pharmaceutically
acceptable counter-ions is an extremely useful approach for the optimization
or modification of the physicochemical . . . properties of ionizable drug
substances” (Elder 2949, col. 2). Elder teaches the “greater ionic content of
strong inorganic acid salts, for example, sulfonates . . . usually ensures that
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the salt is less plastic in nature facilitating better secondary processing”
(Elder 2959, col. 2).
10. Elder teaches “sulfonates can be readily modified by
introduction of bulkier and/or longer side chains, for example . . . napsylate
. . . salts. This can be used to good effect in the development of controlled
release . . . products where decreased solubility is an important factor”
(Elder 2959, col. 2).
11. Elder teaches that an alternative name for napsylate is 1,5-
Naphthalnedisulfonate (see Elder 2950, table 1).
12. Ding teaches a “release rate profile can be altered by varying
the amount of active material, the coating thickness, the radial distribution of
bioactive materials, the mixing method, and the crosslink density of the
polymer matrix. Sufficient variation is possible such that almost any
reasonable desired profile can be simulated” (Ding ¶ 71).
13. Ding teaches “[d]rug release surface coatings on stents in
accordance with the present invention can release drugs over a period of
time from days to months” (Ding ¶ 55).
14. Figure 9 of Ding is reproduced below:

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“FIG. 9 depicts a graphical analysis . . . for the release of dexamethasone at
two different concentrations” and shows “coating layers of
polymer/bioactive species combinations for long-term release” (Ding ¶¶ 70–
71).
15. Mochizuki teaches
the silicone rubber of a urinary catheter made of silicone rubber
in which a cationic antimicrobial agent is dispersed in a silicone
rubber does not lose properties as a silicone rubber, but
relatively high concentration salts such as urine and organic
waste. It is based on the discovery that sustained release of
antimicrobial agent in urine over a long period of time and
blockage due to precipitation or deposition of calcium salt and
the like are not observed.
(Mochizuki 2).
16. Mochizuki teaches the “amount of the cationic antimicrobial
agent to be blended into the silicone rubber in the present invention varies
depending on the type and combination thereof, but is generally 0.1 to 50%
by weight . . . In this case, when the content is 0.1 % by weight or less, the
desired antibacterial activity is sufficiently obtained” (Mochizuki 5).
17. Kolobow teaches that “endotracheal tube 12 and catheter 14 are
preferably formed of a flexible plastic, such as polyvinylchloride (PVC) or
silicone rubber, which is suitable for insertion into the trachea 16 of a human
18” (Kolobow 2:59–62).
18. Zhao teaches “[t]hree primary synthetic thermoset elastomers
typically are used in medical applications: polyisoprene rubber, silicone
rubber, and butyl rubber” (Zhao ¶ 5).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
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of 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).
Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Final Act. 4–8, FF 1–18) and agree that Jones, Kolobow, Savage, Ding,
Elder, Mochizuki, and Zhao render claim 1 obvious. We address
Appellant’s arguments below.
Appellant contends
Ding fails to teach or suggest an implantable medical device
having a CSA compound or any other active component
incorporated into and dispersed throughout the polymeric
material of the structural component of the medical device.
The Examiner fails to show why Ding cures the deficiencies of
the other references or why one of ordinary skill in the art
would have been motivated to disperse the active component
throughout the polymeric structural component rather than as a
coating as expressly taught by Ding.
(Appeal Br. 14).
We find this argument unpersuasive because Ding is not cited alone
for teaching the claimed elements, but the Examiner’s rejection relies upon
other references including Savage. “Non-obviousness cannot be established
by attacking references individually where the rejection is based upon the
teachings of a combination of references.” In re Merck & Co., 800 F.2d
1091, 1097 (Fed. Cir. 1986).
Indeed, Savage and Jones motivate the ordinary artisan to incorporate
antimicrobial compounds into the body of endotracheal tubes for “benefits in
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combating the second-most common hospital-acquired infection, nosocomial
pneumonia” (FF 1, 2, 7). Savage teaches impregnation of silicone (FF 4), a
thermoset polymer as per Zhao (FF 15), with CSAs including CSA-131 (FF
5) and that the device “can be formed from a hydrogel containing ceragenin
eluting compounds” (FF 7). Thus, Savage teaches the use of a silicone as a
structural material that includes and elutes the CSA antimicrobial agent (FF
4, 5, 7).
Savage further teaches modifying the CSA with a hydrophobic
compound to allow “relatively consistent elution over a period of days or
weeks” (FF 6) and teaches “a release rate of 0.1-100 μg/ml . . . at three days,
one week, or one month” (FF 8). Elder suggests specific sulfonic acid
addition salts like 1,5-Naphthalnedisulfonate (FF 11) because they “can be
used to good effect in the development of controlled release” (FF 10).
Savage teaches that “controlled elution of the ceragenin can occur over days,
weeks, or months at a release rate that is within a desired range” (FF 3).
Thus, Savage combined with Elder and Zhao reasonably suggest
implanted endotracheal tubes formed from the thermoset material, silicone
rubber, impregnated with CSA with sulfonic addition salts (FF 1, 2, 4–11).
Savage suggests antimicrobial efficacy of controlled elution of “months” (FF
3).
The Examiner relies upon Ding to show an actual elution profile that
lasted for months (FF 14) and to further demonstrate that the underlying
parameters necessary to optimize release rate were known and exemplified,
as Ding teaches that “[s]ufficient variation is possible such that almost any
reasonable desired profile can be simulated” (FF 12).
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We therefore do not find Appellant’s argument focusing on Ding
alone persuasive because Ding is utilized in combination with Savage, Elder,
and Zhao, and it is that combination that suggests all the limitations of claim
1, including the use of the polymeric material as a structural component (FF
3, 7). “The test for obviousness . . . is what the combined teachings of the
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642, F.2d 413, 424 (CCPA 1977).
Appellant contends that “claim 1 requires the medical device to
provide ‘antimicrobial efficacy of at least two months when the implantable
medical device is implanted.’ Though [release duration and antimicrobial
efficacy] are related, they are not the same” (Appeal Br. 16). Appellant also
contends
just because a compound is actively released, in some amount,
for a given duration does not necessarily mean that it will also
provide antimicrobial efficacy across the entirety of that
duration. Antimicrobial efficacy requires more than just some
measurable presence of released antimicrobial compound. In
order to actually work to kill/deactivate microbial pathogens,
the antimicrobial compound must be present in amounts above
the minimum inhibitory concentration (MIC) threshold, and
may even need to be present in amounts above the higher
minimum bactericidal concentration (MBC) threshold.
(Appeal Br. 15).
We find this argument unpersuasive, not only because this attorney
argument is speculation without any evidentiary support (see, e.g., In re De
Blauwe, 736 F.2d 699, 705 (Fed. Cir. 1984)), but also because Savage
recognizes “controlled elution of the ceragenin can occur over . . . months at
a release rate that is within a desired range for making the hydrogel material
anti-microbial” (FF 3). Thus, the ordinary artisan would have recognized
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that retaining an amount sufficient to maintain anti-microbial activity would
be the “desired range,” and Ding teaches that this is routinely optimizable
because “release rate profile can be altered by varying the amount of active
material, the coating thickness, the radial distribution of bioactive materials,
the mixing method, and the crosslink density of the polymer matrix” (FF
12). We also agree with the Examiner’s position that the “claims do not
require any particular degree of antimicrobial efficacy, they just require
some efficacy for some type of bacteria” (Ans. 7).
Appellant contends “[f]irst, the dexamethasone corticosteroid of Ding
is not an antimicrobial compound. Second, Ding gives no indication that the
corticosteroid is released in amounts that stay above MIC and/or MBC
thresholds had an antimicrobial compound been used instead” (Appeal Br.
16).
We find this argument unpersuasive because it fails to address the
references in combination. Ding is not relied upon for the antimicrobial
agent, but rather to demonstrate that release rates may be optimized to
desired values (FF 12) and that release can extend to multiple months (FF
13–14). “[D]iscovery of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art.” In re Boesch, 617
F.2d 272, 276 (CCPA 1980). Appellant provides no evidence rebutting the
Examiner’s citation of Savage and Ding demonstrating that controlled
release of compounds, including antimicrobial compounds, may be
optimized to extend for multiple months (FF 3, 8, 12–14).
Appellant contends the Examiner’s obviousness combination
ignores the fact that Jones teaches an important interplay
between PVC and hexetidine, and that these components cannot
be simply swapped independently without potentially altering
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the important mechanical and surface properties of the resulting
device. The Examiner is thus artificially splitting the Jones
device into independent subcomponents in order to make the
substitutions necessary to arrive at the claimed inventions.
Such “picking and choosing” is improper because it is
accomplished using “knowledge gleaned only from the
applicant’s disclosure.” See In re McLaughlin, 443 F.2d 1392,
170 USPQ (CCPA 1971).
(Appeal Br. 17).
We do not find this argument persuasive because the Examiner’s
reasoning “takes into account only knowledge which was within the level of
ordinary skill at the time the claimed invention was made and does not
include knowledge gleaned only from applicant’s disclosure.” In re
McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971). We note “picking and
choosing may be entirely proper in the making of a 103, obviousness
rejection, where the applicant must be afforded an opportunity to rebut with
objective evidence” In re Arkley, 455 F.2d 586, 587 (CCPA 1972).
Therefore, while we are fully aware that hindsight bias may plague
determinations of obviousness, Graham v. John Deere Co., 383 U.S. 1, 36
(1966), we are also mindful that the Supreme Court has clearly stated that
the “combination of familiar elements according to known methods is likely
to be obvious when it does no more than yield predictable results.” KSR,
550 U.S. at 416. We agree with the Examiner that the combination of the
cited prior art would predictably result in implanted endotracheal tubes
formed from the thermoset material, silicone rubber, impregnated with CSA
with sulfonic addition salts with antimicrobial efficacy of controlled elution
of “months” (FF 1–11). Appellant provides no evidence of any secondary
considerations.
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Appellant contends:
Elder was cited as generally disclosing the use of sulfonic
addition salts such as naphthalene disulfonic acid (NDSA) salts
in making pharmaceutical compounds for oral use. Elder
makes no mention of the use of sulfonic addition salts for an
implantable medical device. Moreover, Elder does not teach or
suggest the use of sulfonic acid addition salts for an
antimicrobial compound, let alone for an antimicrobial CSA
compound that is incorporated into a polymer structure of a
medical device.
(Appeal Br. 18). Appellant contends “‘controlled-release’ benefits of
sulfonate salt in a pill/liquid pharmaceutical that is ingested (where
pharmacokinetic half-lives are typically measured in hours) has no bearing
as to the performance of a sulfonate salt in an implantable medical device
that is not ingested (and which is implanted for months at a time)” (Appeal
Br. 18–19).
We find this argument unpersuasive. Savage teaches the use of a
“pharmaceutically acceptable salt” of CSAs (FF 5). The ordinary artisan
would have looked to prior art such as Elder, who teaches “[s]alt formation
with pharmaceutically acceptable counter-ions is an extremely useful
approach for the optimization” of compound properties and specifically
suggests that sulfonate salts may be useful in processing and controlled
release compositions (FF 9–10). The ordinary artisan in the pharmaceutical
arts, a medicinal chemist, would have been aware that controlled release
drugs were notoriously well known to be useful in both oral compositions
and embedded in medical devices (see, e.g., FF 1 “incorporation of an
antimicrobial agent within the constituent polymer of a medical device is an
accepted approach in engaging the problem of medical device-associated
infection”; cf. Ding ¶ 7 the “general idea of utilizing implanted stents to
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carry medicinal agents, such as thrombolytic agents, also has been
proposed.”)
Thus, the evidence reasonably supports the Examiner’s finding that
the ordinary artisan, motivated by Savage to use pharmaceutically
acceptable CSA salts for controlled release of CSA compounds in
endotracheal tubes, would have looked to Elder to identify which salts
would optimize the synthesis and controlled release of the CSA compounds
(FF 3, 5, 7, 9, 10). These facts are analogous to Pfizer, where prior art like
Elder pointed to a particular sulfonate salt and the court found the
“references provide ample motivation to narrow the genus of 53
pharmaceutically-acceptable anions disclosed by Berge17 to a few, including
benzene sulphonate.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1363 (Fed.
Cir. 2007). And Pfizer found that selection of optimal salt was “analogous
to the optimization of a range or other variable” because “the logical line of
testing was to react benzene sulfonate with amlodipine to confirm the
presence of a salt, and then to verify that the physicochemical properties of
amlodipine besylate were adequate.” Id. at 1368. The same type of
optimization reasonably applies here, where Savage teaches the use of salts
of CSA compounds and Elder suggests sulfonate salts that improve drug
properties (FF 3, 5, 7, 9, 10). Appellant does not identify any secondary
considerations based on the selection of the salt.
Appellant contends:
Because Elder ranks NDSA salts as less water soluble than
hydrochloride salts, and because Mochizuki already identifies

17 We note, but do not rely upon the fact that Elder cites the same Berge
reference in Pfizer (see Elder 2960, reference 7).
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hydrochloride salts as being “poorly water-soluble” and
therefore less desirable, the combination of Elder and
Mochizuki teach away from selecting a sulfonic acid addition
salt for mixing within the polymer structure of a medical
device.
(Appeal Br. 19).
We are not persuaded. An “obvious composition does not become
patentable simply because it has been described as somewhat inferior to
some other product for the same use.” In re Gurley, 27 F.3d 551, 553 (Fed.
Cir. 1994). Even if we agree with Appellant that Mochizuki teaches
sulfonate salts are less water-soluble, Appellant does not identify any
teaching in either Mochizuki or Elder that criticizes, discredits, or otherwise
discourages the use of sulfonate salts. 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 of these alternatives
because such disclosure does not criticize, discredit, or otherwise discourage
the solution claimed.”) Indeed, Mochizuki teaches “particularly preferred
examples of the poorly water-soluble antibacterial agent include
hydrochloride, acetate or sulfate” salts (Mochizuki 5). Thus, Mochizuki
recognizes that a variety of salts are functional and teaches optimization of
the amount of a cationic salt blended into silicon rubber to obtain the desired
antibacterial activity (FF 16).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner’s
conclusion that Jones, Kolobow, Savage, Ding, Elder, Mochizuki, and Zhao
render claim 1 obvious.

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B.-D., F. U.S.C. § 103(a) further including Terry
Appellant separately address claims 6–11 and 17–19 in these
rejections, contending that the “cited art does not teach or suggest a medical
device that includes one or more CSA compounds distributed throughout the
polymeric device structure and, in addition, a lubricious coating that also
includes one or more CSA compounds” (Appeal Br. 20). Appellant
contends the “coating of Terry does not include a CSA compound or any
other antimicrobial agent, but the Examiner cites to Savage and argues that it
would have been obvious to add the CSA compounds of Savage to the
coating of Terry” (id.). Appellant contends:
The Examiner’s position is illogical. It cannot be true that
“there is no example [of adding an antimicrobial to a lubricious
coating] in the cited prior art,” yet simultaneously be true that
the choice to add CSA compounds to the coating of Terry is
“consistent with” the cited references regarding where to place
CSA compounds.
(id.).
We do not find this argument persuasive because Savage teaches the
“hydrogel may be coated on or form any portion of the structures of such
devices” (FF 7). That is, Savage recognizes that CSA compounds may be
either coated on or form portions of device structures, including
endotracheal tube devices (FF 7). Terry teaches regarding medical devices
such as endotracheal tubes, that it “is necessary for the surface of these
medical devices to have a low coefficient of friction to prevent injury,
irritation, or inflammation to the patient and to facilitate medical and
surgical procedures” (Terry 1:21–26). In particular, Terry teaches “[t]here is
also a need in the art for a coating having improved durability and
uniformity which retains its lubricity and will adhere to medical devices
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made from silicone” (Terry 3:30–32). Griesbach teaches “[i]n addition to
use as a lubricious coating, the coatings may be used to impart antibacterial
and anti-microbial properties to the medical device” (Griesbach ¶ 32).
We therefore agree with the Examiner that the ordinary artisan would
have had reason to use a lubricious coating on the silicone endotracheal tube
of Savage in order to have a low coefficient of friction. In addition, the
ordinary artisan would have found it obvious, based on Savage’s teaching
that CSA antimicrobial compounds may be in a device or in a device coating
and Griesbach’s teaching that a coating may have antimicrobial compounds
to incorporate CSA compounds in both the structure and coating of an
endotracheal tube because combining two known useful delivery modes into
a single device would have reasonably been obvious. In re Kerkhoven, 626
F.2d 846 (CCPA 1980). Consistent with Ding, the ordinary artisan would
have used both modes in order to optimize the elution profile as desired (FF
12).

E. and G. U.S.C. § 103(a)
Appellant does not separately argue these obviousness rejections,
instead relying upon their arguments to overcome the combination of the
primary combination of references. We do not find those arguments
persuasive for the reasons given above. The Examiner provides sound fact-
based reasoning for combining these references and we also find that the
further combinations renders the rejected claims obvious for the reasons
given by the Examiner (see Final Act. 12–13, 15–18).
Appeal 2020-002075
Application 15/270,876

19
H. U.S.C. § 112, first paragraph
Appellant does not dispute the rejection of the claim 8 as failing to
comply with the written description requirement (see Appeal Br. generally).
We therefore summarily affirm the written description rejection (see Final
Act. 2–3). 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.”)

SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 5, 13,
14, 20,
22–25
103 Jones, Kolobow,
Savage, Ding, Elder,
Mochizuki, Zhao
1, 3, 5, 13,
14, 20, 22–
25

6, 7, 9, 10,
16
103 Jones, Kolobow,
Savage, Ding, Elder,
Mochizuki, Zhao,
Terry
6, 7, 9, 10,
16

11, 17–19 103 Jones, Kolobow,
Savage, Ding, Elder,
Mochizuki, Zhao,
Griesbach
11, 17–19
6–8 103 Jones, Kolobow,
Savage, Ding, Elder,
Mochizuki, Zhao,
Terry, Genberg
6–8
15 103 Jones, Kolobow,
Savage, Ding, Elder,
Mochizuki, Zhao,
Bucki
15
Appeal 2020-002075
Application 15/270,876

20
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
17–19 103 Jones, Kolobow,
Savage, Terry, Zhao
17–19
20, 22–25 103 Jones, Kolobow,
Vachon, Savage,
Elder, Zhao
20, 22–25
8 112(a) Written Description 8
Overall
Outcome
1, 3, 5–11,
13–20, 22–
25

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