GAVIN ANDREWS et al.

Patent Trials and Appeals Board

Aug 20, 2020

13043021 - (D) (P.T.A.B. Aug. 20, 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.
13/043,021 03/08/2011 GAVIN Paul ANDREWS ROVI-4-CIP 8070
24039 7590 08/20/2020
INNOVAR, LLC
P O BOX 250647
PLANO, TX 75025
EXAMINER
BARHAM, BETHANY P
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
08/20/2020 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):
innovarllc@sbcglobal.net
patents@innovarllc.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte GAVIN PAUL ANDREWS, DAVID SIMON JONES, and
SEAN PATRICK GORMAN
__________

Appeal 2019-006212
Application 13/043,021
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 a
urinary catheter or stent composed of a multilayered device comprising
plural coextensive and centrically arranged layers. The Examiner rejected
the claims as 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 Laboratorios
Farmaceuticos ROVI, S.A. (see Appeal Br. 2).
2 We have considered and refer to the Specification of Mar, 8, 2011
(“Spec.”); Final Action of Oct. 5, 2018 (“Final Act.”); Appeal Brief of Mar.
4, 2019 (“Appeal Br.”); Examiner’s Answer of June 27, 2019 (“Ans.”); and
Reply Br. of Aug. 21, 2019.
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Statement of the Case
Background
“[P]atients are often plagued by infection associated with the insertion
of a medical device and this is seen to be one of the most critical
disadvantages of an otherwise highly effective and beneficial medical
treatment” (Spec. ¶ 3). “Bacteria and pathogens which typically colonize
catheters produce urease which degrades urea in urine to form carbon
dioxide and ammonia. At increased pH associated with such degradation/
contamination, minerals in urine precipitate leading to encrustation” (id.
¶ 4).
Catheter encrustation can cause blockage of the catheter leading to an
increase in the frequency with which the catheter must be removed
and replaced. Encrustation also results in an increase in the pain of
removal of the catheter. The tissue surrounding the catheter is also far
more likely to become infected. This is particularly problematic for
patients requiring long term catheterization. Serious consequences
include septicemia, pyelonephitis and shock.
(id. ¶ 5). “The inventors have developed a device surface that is inherently
resistant to infection through the use of intelligent in vivo reactions and
preferably impregnation with antibiotics” (id. ¶ 12).
The Claims
Claims 1, 28, 63, 78, 79, 81, 82, 84–87, 90–95, and 97–109 are on
appeal. Claim 1 is representative and reads as follows:
1. A multilayered device comprising plural coextensive and
centrically arranged layers, said layers defining a lumen,
wherein:
a first coextensive layer is a structural layer that is substantially
non-degradable or non-erodible under physiological
conditions; and
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at least one second coextensive layer that is interior to the first
coextensive layer, defines a lumen, and is a pH sensitive
layer comprising 0.5 to 50% wt of functional excipient,
which is at least one organic acid, and one or more pH
sensitive linear polymers having a water solubility that
increases from a first water solubility to a second water
solubility at a pH trigger ranging from pH ≥ 5 up to about
pH 7, whereby the one or more pH sensitive linear
polymers undergoes dissolution, degradation, or erosion
in an aqueous environment at the second water solubility,
and the at least one organic acid retards the rate of
dissolution, degradation or erosion of the one or more pH
sensitive linear polymers;
wherein the layers are centrically arranged; and
the device is a urinary catheter or urinary stent.

The Issues3
A. The Examiner rejected claims 1, 28, 63, 78, 79, 81, 82, 84, 87, 90–95,
97–100, and 102–109 under 35 U.S.C. § 103(a) as obvious over Hunter4 and
Sarangapani5 (Final Act. 3–8).
B. The Examiner rejected claims 85 and 86 under 35 U.S.C. § 103(a) as
obvious over Hunter, Sarangapani, and Hanselle6 (Final Act. 8–9).

3 The Examiner required a species election on April 17, 2013. In the
response filed July 9, 2013, Appellant elected silicone as the exterior
structural layer of the device and hydroxypropylmethycellulose acetate
succinate as the pH sensitive polymer. We limit our consideration of the
merits of the appealed rejection to the elected species. See Ex parte Ohsaka,
2 USPQ2d 1460, 1461 (BPAI 1987).
4 Hunter et al., US 2005/0191331 A1, published Sept. 1, 2005.
5 Sarangapani, S., US 5,877,243, issued Mar. 2, 1999.
6 Hanselle et al., WO 2008/080932 A1, published July 10, 2008.
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A. 35 U.S.C. § 103(a) over Hunter and Sarangapani
The Examiner finds that Hunter suggests “urinary stents defining a
lumen in the form of tubes in which the devices are coated with a pH
sensitive layer comprising applicant’s elected species, HPMCAS, and
further coated with a structural layer comprising applicant’s elected species,
silicone” (Final Act. 4). The Examiner finds Hunter teaches “devices with a
pH sensitive layer interior to a structural layer where the layers are
centrically arranged on devices defining a lumen” (id. at 5).
The Examiner acknowledges that Hunter does “not teach a pH
sensitive layer comprising 0.5 to 50 wt.% of functional excipient, which is at
least one organic acid” (Final Act. 5).
The Examiner finds Sarangapani teaches “coatings and materials that
resist bacterial colonization and encrustation for use in medical devices and
urological applications” including “acidic chelating components, like
organic acids, to provide a continuous antibacterial surface” (Final Act. 5).
The Examiner finds “Sarangapani discloses incorporating EDTA and
carboxylic acids, like citric acid into its coatings . . . as set forth in instant
claims 98 and 105-109” (id. at 5–6).
The issue with respect to this rejection is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Hunter and
Sarangapani render claim 1 obvious?
Findings of Fact
1. The Specification teaches the “device of the present invention
may typically be a urinary catheter or urinary stent” (Spec. ¶ 17).
2. The Specification teaches “structural layers may be included in
the device of the present invention to provide structural support to the device
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and to provide a body (surface) upon which one or more layers of linear pH
sensitive polymer can be applied or built. . . . A structural layer can
comprise . . . silicone” (Spec. ¶ 23).
3. The Specification teaches a linear pH sensitive polymer layer
comprising a “linear pH sensitive polymer . . . selected from the group
consisting of hydroxypropyl methylcellulose acetate succinate (HPMC-
AS[)]” (Spec. ¶ 31).
4. The Specification teaches the “pH sensitive layer may comprise
one or more functional excipients . . . The functional excipients may suitably
be buffer groups (organic acids) such as citric acid, tartaric acid, succinic
acid, and fumaric acid, EDTA” (Spec. 54).
5. Hunter teaches “drug-coated implants and medical devices that
reduce the foreign body response to implantation” and that are “used to
maintain body lumens or passageways such as . . . the urinary tract” (Hunter
¶ 15).
6. Hunter teaches “a method for inhibiting scarring comprising
placing a genital-urinary stent implant and an antiscarring agent or a
composition comprising an anti-scarring agent into an animal host, wherein
the agent inhibits scarring” (Hunter ¶ 21).
7. Hunter teaches “genital-urinary (GU) stents that can benefit
from being coated with . . . polyurethane, poly(ethylene terephthalate ),
PTFE or silicone” (Hunter ¶ 652).
8. Hunter teaches:
Polymeric carriers for fibrosis-inhibiting agents can be
fashioned in a variety of forms, with desired release
characteristics and/or with specific properties depending upon
the device, composition or implant being utilized. For example,
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polymeric carriers may be fashioned to release a fibrosis-
inhibiting agent upon exposure to a specific triggering event
such as pH.
(Hunter ¶ 417).
9. Hunter teaches:
Representative examples of pH-sensitive polymers include poly
(acrylic acid) and its derivatives (including for example,
homopolymers such as poly(aminocarboxylic acid);
poly(acrylic acid); poly(methyl acrylic acid), copolymers of
such homopolymers, and copolymers of poly(acrylic acid)
and/or acrylate or acrylamide Imonomers such as those
discussed above. Other pH sensitive polymers include
polysaccharides such as cellulose acetate phthalate;
hydroxypropylmethylcellulose phthalate; hydroxypropyl-
methylcellulose acetate succinate; cellulose acetate
trimellilate; and chitosan. Yet other pH sensitive polymers
include any mixture of a pH sensitive polymer and a water-
soluble polymer.
(Hunter ¶ 417; emphasis added).
10. Hunter teaches “[n]umerous polymeric and non-polymeric
delivery systems for use in GU stents have been described” and that “[f]or
these devices, the coating process can be performed in such a manner as to
(a) coat the external surface of the stent, (b) coat the internal (luminal)
surface of the stent or (c) coat all or parts of both the internal and external
surfaces of the stent” (Hunter ¶ 659).
11. Sarangapani teaches “medical devices that are resistant to
bacterial growth or encrustation such as urological devices and more
particularly to urinary catheters constructed of, or coated with, a material
which enables the urinary catheters to inhibit urease, and to prevent calcium
and magnesium phosphate deposits on the catheters” (Sarangapani 1:6–11).
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12. Sarangapani teaches “[b]y providing a surface that kills harmful
bacteria, devices such as catheters or self-administered urethral plugs, have a
much lower probability of carrying line pathogenic bacteria to the bladder,
thus lowering the incidence of UTI” (Sarangapani 6:34–37).
13. Sarangapani teaches “certain combinations of the above
hydrophilic compounds with antibacterials, such as . . . EDTA, DPTA and
carboxylic acids give surprising effects . . . to kill E.coli on contact”
(Sarangapani 6:54–58).
14. Sarangapani teaches polymer additives for catheters comprising
1% and 2% citric acid (see Sarangapani 13:65–66) resulted in pH levels
being reduced (see Sarangapani 14:25–28, Table III-B) and the “results
showed that E. coli was consistently inhibited in synthetic and human urine
by formulated discs (1 square centimeter) containing Citric acid and
Phosphonic acids in combination with Silver” (Sarangapani 15:11–14).
15. Sarangapani teaches “a combination of acidifying chelating
compounds that partition between the plastic and the body fluids such as
urine, to provide an acidic pH on the surface” (Sarangapani 4:4–6).
16. Sarangapani teaches the “hydrophilic compounds not only
make the surface attract water molecules but also render a low pH of 4-5, on
the surface that discourages bacterial growth” (Sarangapani 6:47–50).
Principles of Law
“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
Prima facie obviousness
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3–8; FF 1–16) and agree that
Hunter and Sarangapani renders the claims obvious. We address
Appellant’s arguments below.
Appellant “submits Examiner appears to be over reading Hunter’s
disclosure . . . Hunter discloses literally tens of thousands to hundreds of
thousands of different materials” (Appeal Br. 11). Appellant contends the
“Examiner’s reasoning above fails to guide the artisan toward the claimed
invention and towards combination of its disclosure with Sarangapani,
especially if Examiner is relying upon Sarangapani solely for its motivation
to add organic acid to a polymeric coating that is already acidic” (id.).
We find this argument unpersuasive because “picking and choosing
may be entirely proper in the making of a 103, obviousness rejection.” In re
Arkley, 455 F.2d 586, 587 (CCPA 1972). Hunter teaches picking and
choosing HPMC-AS coatings for urinary stents (FF 5, 6, 9) and teaches that
silicone may also be selected (FF 7, 10), consistent with Appellant’s elected
species. We note that claim 1 broadly encompasses any non-degradable
structural layer and any pH sensitive linear polymer, and therefore would
encompass other layers and polymers disclosed by Hunter (FF 7, 9).
As to the argument regarding thousands of possible combinations,
Merck found that prior art disclosing 1200 “effective combinations does not
render any particular formulation less obvious.” Merck & Co., Inc. v.
Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Similarly, in
Corkill, an obviousness rejection was affirmed in light of prior art teachings
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that “hydrated zeolites will work” in detergent formulations, even though
“the inventors selected the zeolites of the claims from among ‘thousands’ of
compounds.” In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Perricone explains that a “specific disclosure, even in a list, makes
this case different from cases involving disclosure of a broad genus without
reference to the potentially anticipating species.” Perricone v. Medicis
Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005). In this case,
Appellant’s claim 1 “recites a combination of elements that were all known
in the prior art, and all that was required to obtain that combination was to
substitute one well-known . . . agent for another.” Wm. Wrigley Jr. Co. v.
Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012). Appellant
provides no evidence that the selection of a combination of silicone
polymers with HPMC-AS and citric acid or EDTA for use in urinary
catheters results in any unexpected result or other secondary consideration.
Appellant contends “Examiner simply argues that Hunter’s materials
are likely to exhibit the same properties as Applicant’s” (Appeal Br. 12).
Appellant “wonders how such an assertion can be true if the vast majority of
Hunter’s materials do not exhibit the same properties, in particular the same
combination of interdependent properties, as Applicant’s instant claims”
(id.).
We find this argument unpersuasive because the Examiner has
demonstrated that Hunter and Sarangapani render obvious a composition
identical in structure to that claimed by Appellant. The Examiner, in
demonstrating identity of composition, reasonably presumes that “[p]roducts
of identical chemical composition can not have mutually exclusive
properties.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990). Appellant
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provides no evidence rebutting the position of the Examiner, and such a
comparison is reasonably placed on Appellant. See In re Best, 562 F.2d
1252, 1255 (CCPA 1977).
Appellant cites Batich ’1477 and Batich ’4228 and asserts that these
references are “more relevant than Hunter” but “preferably have a pH trigger
of 8.5” and therefore “a patient using Batich’s urinary device will experience
a bacterial infection for an extended period of time before the device begins
to release drug and treat the infection” (Appeal Br. 12). Appellant also
asserts “Batich does not contemplate dissolution, erosion or degradation of
the polymeric layer” and that “[i]nclusion of a functional excipient organic
acid in Batich’s device would delay swelling of the pH dependent layer and
delay release of its antibiotic and urease inhibitor” (id. at 13). Appellant
concludes the “combination of Hunter and Batich suggests the use of water
swellable (not water soluble) pH dependent crosslinked (not linear) polymer
having a pH trigger of 8.5 or higher. Hunter and Batich, thus, teach away
from the claimed invention” (id. at 13).
We find this argument unpersuasive for several reasons. First, we
agree with the Examiner that “Appellant’s arguments regarding Batich or
any hypothetical combinations with Hunter and/or Hanselle . . . are not
relevant to the prior art currently of record” (Ans. 5). That is, Batich is not
part of the rejection nor does Batich specifically address the identical
polymers and pH sensitive layers disclosed by Hunter or the further coatings
of Sarangapani. While we do agree with Appellant that prior art not part of
the rejection might be relevant to teaching away concerns (see Reply Br. 3),

7 Batich et al., US 5,554,147, issued Sept. 10, 1996.
8 Batich et al., US 6,306, 422 B1, issued Oct. 23, 2001.
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we find the teaching away argument unpersuasive here for the reasons given
below.
Second, while Appellant contends the art suggests a pH of 8.5,
Sarangapani expressly teaches a desire for acidic pH (FF 15) and more
particularly for a pH between 4 and 5 to discourage bacterial growth (FF
16). Thus, when selecting pH sensitive polymers from the disclosure of
Hunter for use in urinary stents or catheters, Sarangapani would have
provided reason to the ordinary artisan to select pH sensitive polymers in a
range to discourage bacterial growth. As the Specification notes, this
information is easily obtainable for commercially available HPMC-AS
because “the pH value required for dissolution (the trigger pH) is as
specified. The HPMC-AS grades LF/MF/HF, having an approximate
molecular weight 18000 g/mol, are supplied by Shin-Etsu® Chemical Co.
(Tokyo, Japan) under the brand name AQOAT®” (Spec. 9).
Third, Appellant identifies no teaching in Hunter, the reference
actually relied upon by the rejection, that discourages, discredits, or
otherwise teaches away from the use of the HPMC-AS polymer or silicone
polymer in urinary stents or the use of acidic pH values. Indeed, Hunter
suggests these structural components (FF 7–9) and Sarangapani suggests
acidic pH values (FF 15–16). 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”). If a reference not of record, and not using the same
components, teaches away from the use of those different components, that
has little bearing on this obviousness rejection.
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Appellant contends “contrary to Examiner’s assertion, Sarangapani
does not teach the addition of organic acid to an already acidic pH dependent
layer. Instead, Sarangapani teaches that the coating materials should be
rendered acidic by including acidic chelating components” (Appeal Br. 14).
Appellant later contends
Sarangapani is merely additive to Hunter. In no case, does
Sarangapani suggest that organic acid should be added to the
acidic cross-linked polymer once it has been formed.
Sarangapani provides no motivation to add organic acid to an
already acidic polymer, in particular to a linear polymer that
exhibits a pH dependent water solubility.
(Appeal Br. 19).
We are not persuaded. “It is prima facie obvious to combine two
compositions each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition which is to be used for
the very same purpose. . . . [T]he idea of combining them flows logically
from their having been individually taught in the prior art.” In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980). Here, having found Hunter
reasonably renders obvious a urinary catheter with silicone and HPMC-AS
as obvious selections from within Hunter’s disclosure above (FF 5–10), we
also find it obvious to incorporate Sarangapani’s compounds such as citric
acid that inhibit bacterial growth in urinary catheters (FF 11, 14).
Moreover, “a person of ordinary skill has good reason to pursue the
known options within his or her technical grasp. If this leads to the
anticipated success, it is likely the product not of innovation but of ordinary
skill and common sense.” KSR, 550 U.S. at 421. Here, Sarangapani
demonstrates that incorporation of citric acid results in reduced growth of E.
coli in the urinary catheter context (FF 11–14), a result that would have
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reasonably motivated an ordinary artisan to include such components into
Hunter’s urinary catheter (FF 5) in order to further reduce bacterial growth.
Appellant contends that
Sarangapani merely extends the application of Wood’s
carboxylic acid group-containing HYPOL™-based crosslinked
water absorbing (but non-water-soluble and non-water-
erodible) polymers by using them in coatings for urinary
catheters. Sarangapani’s HYPOL ™-based polymers are still
crosslinked, such as with an organic acid, and still cannot erode
or dissolve in water, specifically, because they are crosslinked.
(Appeal Br. 17).
We find this argument unpersuasive because it argues the references
separately, rather than addressing the combination of Hunter’s polymers
such as HPMC-AS and silicone on a urinary stent combined with
Sarangapani’s disclosure of citric acid. Prior art “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., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
Appellant contends “the claimed invention is different than either of
Sarangapani’s solutions in at least two keys aspects . . . Neither of
Sarangapani’s polymers is water soluble or erodible . . . Neither of
Sarangapani’s coating compositions contains both a pH sensitive polymer
. . . AND additional organic acid” (Appeal Br. 18).
We find Appellant’s argument unpersuasive because it fails to
recognize that the rejection is based on the combination of Hunter and
Sarangapani, not on Sarangapani alone. “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
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1977). If Sarangapani had taught all of the elements of the claim, it would
anticipate, not be part of an obviousness rejection.
Appellant contends “even if Sarangapani were deemed to suggest
addition of organic acid to an already acidic water swellable crosslinked
polymer (which it does not), Sarangapani does not suggest how much
organic acid should be added to a water soluble linear polymer in order to
provide the claimed functionality” (Appeal Br. 19).
We are not persuaded. Sarangapani suggests the use of 1% and 2%
citric acid is effective by experimenting with both concentrations (FF 14),
demonstrating that the amount of organic acid is a results-effective variable.
To the extent that an ordinary artisan would need to determine how much
acid to add to Hunter’s polymers, “discovery 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 contends “the organic acid helps reduce the rate of erosion
or dissolution of the pH sensitive polymer and thereby of the pH dependent
layer, ultimately slowing down its erosion and extending the useful lifetime
of the instant device and providing improve antibacterial and anti-
encrustation performance as compared to a layer only including the pH
sensitive polymer” (Appeal Br. 21).
To the extent that Appellant is arguing a secondary consideration such
as unexpected results here, we find the argument unpersuasive because no
evidence is presented. “It is well settled that unexpected results must be
established by factual evidence. Mere argument or conclusory statements . .
. [do] not suffice.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). In the
instant case, Appellant relies solely on attorney argument. However,
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“attorney argument [is] not the kind of factual evidence that is required to
rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470
(Fed. Cir. 1997).
Appellant addresses claims 79, 91, and 97 separately as not disclosed
by Sarangapani (see Appeal Br. 26), but does not address Hunter, and are
therefore not persuasive because the rejection is based on the combination of
these two references.
In their Reply Brief, Appellant reiterates many of the points addressed
above (Reply Br. 2), which we find unpersuasive for the reasons given. We
have considered the prior art, including Appellant’s additional references, as
a whole, but find that the evidence of record (FF 1–16) supports the
Examiner’s conclusion of obviousness. While we are 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. Here, the evidence supports the position
that Hunter teaches a urinary tract stent/catheter where polymers may be
selected that include both silicone and HPMC-AS and Sarangapani teaches
that to improve urinary catheters, it is beneficial to include citric acid (FF 1–
16). Appellant provides no evidence that the combination would be
unpredictable or that the elected combination resulted in any unexpected
results.
Conclusion of Law
A preponderance of the evidence of record support the Examiner’s
conclusion that Hunter and Sarangapani render claims 1, 79, 91, and 97
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obvious. Claims 28, 63, 78, 81, 82, 84, 87, 90, 92–95, 98–100, and 102–109
are not separately argued and fall with claim 1.
B. 35 U.S.C. § 103(a) over Hunter, Sarangapani, and Hanselle
Appellant substantially relies upon the arguments addressed above,
which we find unpersuasive. Appellant makes one new argument specific to
the combination with Hanselle, “that Hanselle is in a field of non-analogous
art as regards Hunter and Sarangapani” (Appeal Br. 22). Appellant asserts
“an artisan working in the field of catheters would not look to art in the field
of biological sample storage for materials requiring particular functionality
as required by Hunter. Hunter and Hanselle are therefore in non-analogous
fields of art” (id. at 23).
The Examiner responds that “Hunter and Hanselle are in the same
field of Appellant’s endeavor as well as reasonably pertinent to Appellant's
problem because both references use pH dependent polymers in matrices
that release active agents” (Ans. 8).
We find that Appellant has the better position. Under the analogous
arts test, “a reference is either in the field of the applicant’s endeavor or is
reasonably pertinent to the problem with which the inventor was concerned
in order to rely on [that] reference as a basis for rejection.” In re Kahn, 441
F.3d 977, 986–87 (Fed. Cir. 2006). While Hunter and Sarangapani are both
in the polymer coated stent field of endeavor, Hanselle is drawn to matrices
for obtaining biological samples (see Hanselle 7:5–17). We are not
persuaded by the Examiner’s reasoning because Hunter is designed to
“reduce the foreign body response to implantation (FF 5) while Hanselle’s
matrix must be “suitable for the collection of a biological sample” (Hanselle
12:15). Hanselle is also not pertinent to the problem with which either the
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Specification or Hunter and Sarangapani are concerned, which is the use of
catheters and stents in the urinary tract.
CONCLUSION
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
1, 28, 63, 78,
79, 81, 82, 84,
87, 90–95,
97–100, 102–
109
103 Hunter,
Sarangapani
1, 28, 63, 78,
79, 81, 82, 84,
87, 90–95, 97–
100, 102–109

85, 86 103 Hunter,
Sarangapani,
Hanselle
85, 86
Overall
Outcome
1, 28, 63, 78,
79, 81, 82, 84,
87, 90–95, 97–
100, 102–109
85, 86

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-IN-PART