Siddarth K. Shevgoor et al.

Patent Trials and Appeals Board

Oct 18, 2019

14185831 - (D) (P.T.A.B. Oct. 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.
14/185,831 02/20/2014 Siddarth K. Shevgoor P-10098/A 7564
71562 7590 10/18/2019
Kirton McConkie
Craig Metcalf
36 S. State Street, Suite 1900
Salt Lake City, UT 84111
EXAMINER
FISHER, MELISSA L
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
10/18/2019 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):
IP_docket@bd.com
KMC-docketing@clairvolex.com
aturner@kmclaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte SIDDARTH K. SHEVGOOR, JONATHAN KARL BURKHOLZ,
HUIBIN LIU, YIPING MA, and MING ZHOU
____________

Appeal 2018-009123
Application 14/185,831
Technology Center 1600
____________

Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JOHN E. SCHNEIDER, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims 1–6, 9–16, and 21–26. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM-IN-PART, however, because our rationale differs from
Examiner’s, we designate the affirmance a new ground of rejection under
37 C.F.R. § 41.50(b).

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 Becton
Dickinson and Company (Appellant’s July 17, 2017 Appeal Brief (Appeal
Br.) 2).
Appeal 2018-009123
Application 14/185,831

2
STATEMENT OF THE CASE
Appellant’s disclosure relates “to inserts for medical devices that are
configured to elute an antimicrobial agent.” Spec.2 ¶ 1. Claims 1, 14, and 25
are representative and reproduced below:
1. An insert for a medical device, comprising:
a body comprising a distal opening, a proximal opening,
and a lumen that extends between the distal and proximal
openings, wherein the body is constructed of a base material,
wherein the base material comprises
an antimicrobial agent, wherein an outer diameter of the
body is larger than an inner diameter of a lumen of a medical
device within which the body will be placed such that the body
is compression fit within the lumen of the medical device,
wherein the body is configured to be entirely disposed within a
lumen of the medical device.
(Appeal Br. 14 (emphasis added).)
14. A medical device comprising:
a catheter adapter comprising a proximal end, a distal
end, and a lumen that extends therebetween;
an insert disposed entirely within the lumen of the
catheter adapter, wherein the insert comprises a body, wherein
the body comprises a distal opening, a proximal opening, and a
lumen that extends between the distal and proximal openings,
wherein the body is constructed of a base material, wherein the
base material comprises [an antimicrobial agent3]; and

2 Appellant’s February 20, 2014 Specification.
3 We note that the phrase “an antimicrobial agent,” present in Appellant’s
amendment filed December 12, 2016 was not reproduced in the text of
Appellant’s claim 14 as reproduced in Appellant’s Appeal Brief (see
Appellant’s December 12, 2016 Amendment 4).
Appeal 2018-009123
Application 14/185,831

3
a septum disposed within the lumen of the catheter
adapter, wherein the insert is disposed adjacent the septum to
secure the septum.
(Id. at 15 (emphasis added).)
25. An insert for a medical device, the insert comprising:
a body comprising a distal opening, a proximal opening, and a
lumen that extends between the distal and proximal openings,
wherein the body is constructed of a base material, wherein the
base material comprises an antimicrobial agent, wherein the
body is configured in a shape of a tube having an inner diameter
and an outer diameter, wherein the outer diameter of the tube is
constant along an entire length of the tube.
(Id. at 16 (emphasis added).)

Grounds of rejection before this Panel for review:
I. Claims 1–3, 5, 6, 9–16, and 21–26 stand rejected under 35 U.S.C.
§ 102(a)(1) as anticipated by Grandt.4
II. Claims 1–6, 9–16, and 21–26 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Grandt and Potter.5
III. Claims 1–4 stand provisionally rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over the claims of co-pending Application 14/606,833.

Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner’s finding that Grandt teaches Appellant’s claimed invention?

4 Grandt et al., US 2007/0083188 A1, published Apr. 12, 2007.
5 Potter, US 2008/0194707 A1, published Aug. 14, 2008.
Appeal 2018-009123
Application 14/185,831

4
FACTUAL FINDINGS (FF)
FF 1. Grandt discloses a “catheter having a first guidewire tube and a
second guidewire tube” (Grandt ¶ 4; see generally Final Act.6 3–5).
FF 2. Grandt’s Figure 1 is reproduced below:

Grandt’s “FIG. 1 is a schematic side view of a first representative
embodiment of a catheter [100] having a main body portion including a
proximal section [102], intermediate section [104], and distal section [106]
in accordance with Grandt’s . . . invention” (Grandt ¶ 23; see also id. ¶ 69
(“catheter 100 has a main body portion including a proximal section 102, a
distal section 106, and an intermediate section 104 disposed between the
proximal and distal sections. Each section having a proximal end and a
distal end” (emphasis omitted)); see Final Act. 3–4).
FF 3. Grandt’s “catheter can further include at least two overlapping
stiffening members” (Grandt ¶ 67; see id. ¶ 140 (Grandt’s “catheter 100 can
include proximal, intermediate, and distal stiffening members, 40, 42, and
44, respectively” (emphasis omitted)); id. ¶ 139 (Grandt’s “term ‘stiffening
member’ can include a filament, strand, wire, coil, or other member to

6 Examiner’s May 4, 2017 Final Office Action.
Appeal 2018-009123
Application 14/185,831

5
increase the stiffness of a section of the catheter elongate main body”); see
generally Final Act. 3–5).
FF 4. Grandt discloses that “[a] variety of materials can be used as
coatings for the stiffening member,” including “antimicrobial agents”
(Grandt ¶ 160; see Final Act. 3 and 5).
ANALYSIS
Examiner finds that Appellant’s claimed invention is anticipated by
Grandt (Final Act. 3–5). We are not persuaded.
Each of Appellant’s independent claims 1, 14, and 25 requires that the
body of the device is constructed of a base material that comprises an
antimicrobial agent. We agree with Examiner that the term “‘comprising’,
an open transitional phrase[,] . . . is inclusive or open-ended and does not
exclude additional, unrecited elements or method steps” (Ans.7 4). We note,
however, that even though the claimed base material may include additional
ingredients, Appellant’s claims require that the base material from which the
body is constructed, as opposed to a coating material on the body, contains
an antimicrobial agent.
In this regard, Examiner finds that Grandt “discloses antimicrobial
agents can be utilized” as a coating for its stiffening members (Final Act. 3
(citing Grandt ¶ 160); see also FF 4). Although Grandt discloses that an
antimicrobial agent may be used as a coating for a stiffening member (FF 4),
Examiner failed to identify, and we do not find, a disclosure in Grandt of a
body which is constructed of base material that comprises an antimicrobial
agent (see generally Appeal Br. 7, 9, and 11; see also Reply Br. 4

7 Examiner’s November 17, 2017 Answer.
Appeal 2018-009123
Application 14/185,831

6
(“Independent claims 14 and 25 include the same language as claim 1
requiring ‘the body is constructed of a base material, wherein the base
material comprises an antimicrobial agent,’ and thus, Grandt . . . does not
appear to teach each and every element of claims 14 and 25 for the same
reasons as stated with respect to claim 1”)).
In addition, we note that Appellant’s claim 13 depends from and
further limits the insert of Appellant’s claim 1 to further comprise “a
reinforcing substructure contained within the base material, the reinforcing
substructure comprising a material that is different than the base material”
(Appeal Br. 15). Examiner relied upon Grandt’s stiffening members to meet
the requirement for a reinforcing substructure as set forth in Appellant’s
claim 13 (see Final Act. 5 (“Regarding claim[] 13 . . . Grandt et al. discloses
a stiffening member”)). Thus, Examiner recognizes that Grandt’s stiffening
member is distinct from the “body” of Grandt’s device and, therefore, any
such antimicrobial coating on Grandt’s stiffening member cannot also
represent a component of the base material of Grandt’s body.
CONCLUSION
The preponderance of evidence on this record fails to support
Examiner’s finding that Grandt teaches Appellant’s claimed invention. The
rejection of claims 1–3, 5, 6, 9–16, and 21–26 under 35 U.S.C. § 102(a)(1)
as being anticipated by Grandt is reversed.

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
Appeal 2018-009123
Application 14/185,831

7
FACTUAL FINDINGS (FF)
FF 5. Grandt discloses a catheter 100 having first and second guidewire
tubes, wherein the main body portion of catheter 100 includes a proximal
section 102, intermediate section 104, and distal section 106 (see FF 1–2).
FF 6. Grandt’s catheter may also include proximal, intermediate, and distal
stiffening members coated with an antimicrobial agent (see FF 3–4).
FF 7. Grandt’s Figure 4B is reproduced below:

Grandt’s “FIG. 4B is . . . [a] cross sectional view at line 4-4 of the catheter
of FIG. 1 in accordance with . . . [Grandt’s] invention,” wherein “a portion
of catheter 100 in which second guidewire tube 30 is disposed generally
coaxially within distal tubular member 24, such that inflation lumen 24c
annularly surrounds guidewire tube 30 and guidewire lumen 30c” (Grandt
¶¶ 27 and 123 (emphasis omitted); see generally Final Act. 3).
FF 8. Grandt discloses that “distal tubular member 24 . . . includes gap 24d
along its length. Gap 24d is in fluid communication with the exterior of
catheter 100” and “can be constructed by placing two circumferential slits
through the wall of distal tubular member 24 to define a flap region” (Grandt
¶ 100 (emphasis omitted)); see Final Act. 5 (citing element 24d of Grant’s
Fig. 1) (Examiner finds that Grandt “discloses a septum”)).
Appeal 2018-009123
Application 14/185,831

8
FF 9. Examiner finds that Grandt “does not teach that the antimicrobial
agent comprises between 0.1 and 40% w/w of the insert” (Final Act. 6).
FF 10. Potter discloses:
[A] medical device capable of releasing a medically active
ingredient, said device including a blend of: (i) a carrier
polymer or a blend of carrier polymers; (ii) a medically active
ingredient; and, optionally, (iii) a water sensitive polymer for
releasing said medically active ingredient in the presence of
water and/or a pH sensitive polymer for releasing said
medically active ingredient in the presence of a solution having
a pH within a predetermined range; with the proviso that, if
component (iii) is absent, the carrier polymer includes an
ethylene vinyl alcohol copolymer.
(Potter, Abstract; see also id. ¶ 19 (Potter discloses that its “medical device
is [preferably] a urinary catheter or urinary drainage bag”); see generally
Final Act. 6.)
FF 11. Potter discloses that the “medically active ingredient may be a drug,
for example a drug to control inflammation or, preferably, an antimicrobial
agent” (Potter ¶ 13; see generally Final Act. 6).
FF 12. Potter discloses that “the blend typically comprises between about
0.1 and 20%, . . . by weight of the antimicrobial agent” (Potter ¶ 28; see
Final act. 6).
ANALYSIS
Based on the combination of Grandt and Potter, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie obvious to prepare a medical device, as disclosed in Grandt, having a
body that is constructed of a base material that comprises a blend of
ingredients including an antimicrobial agent in the amount of 0.1 and 20%
by weight, as set forth in Potter (see Final Act. 6–7; FF 5–12).
Appeal 2018-009123
Application 14/185,831

9
Appellant contends “that Grandt fails to teach the elements of
independent claims 1, 14, and 25 [as Appellant] discussed . . . with respect to
the rejection under 35 U.S.C. § 102, and that Potter fails to rectify these
deficiencies” (Appeal Br. 12). Appreciating Appellant’s separate arguments
with respect to Appellant’s independent claims 1, 14, and 25, as set forth in
the rejection under 35 U.S.C. § 102, we address Appellant’s contentions in
the context of this obviousness rejection below.
CLAIM 1
As discussed in the above analysis under 35 U.S.C. § 102, Grandt
does not teach a device having a body that is constructed of a base material
that comprises an antimicrobial agent. Potter, however, makes up for this
deficiency by disclosing a device, similar to Grandt’s device that has a body
constructed of a base material that comprises an antimicrobial agent (see FF
10–12). Thus, one of ordinary skill in the art would have had reason to
make Grandt’s body with a material comprising an antimicrobial agent as
described by Potter because Grandt teaches the presence of such agent on
the device’s body and Potter supplies one. Final Act. 6–7. Therefore, we
find that, at the time Appellant’s invention was made, it would have been
prima facie obvious to prepare a medical device, such as Grandt’s catheter
using a composition, which comprises an antimicrobial agent as taught by
Potter (see FF 2–11). Appellant did not provide adequate evidence to the
contrary. (see Appeal Br. 6–7).
We recognize that Appellant’s claim 1 requires that the
outer diameter of the body is larger than an inner diameter of a
lumen of a medical device within which the body will be placed
such that the body is compression fit within the lumen of the
Appeal 2018-009123
Application 14/185,831

10
medical device, wherein the body is configured to be entirely
disposed within a lumen of the medical device.
(Appeal Br. 14). We agree, however, with Examiner’s finding that because
“[t]here is no medical device required by the instant claim,” this limitation of
Appellant’s claim 1 is “an intended use of the claimed insert” (Ans. 5). See
Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed.
Cir. 2002) (“[T]he patentability of apparatus or composition claims depends
on the claimed structure, not on the use or purpose of that structure.”); see
also Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468
(Fed. Cir. 1990) (“[A]pparatus claims cover what a device is, not what a
device does.”). Therefore, we are not persuaded by Appellant’s contentions
regarding a body configured to be compression fit within a lumen of a
medical device or a body configured to be entirely disposed within a lumen
of a medical device, which, as Examiner’s correctly asserts, are intended use
limitations of Appellant’s claimed insert (see Appeal Br. 7–8; cf. Ans. 5
(Examiner finds the foregoing limitation to represent an intended use
limitation)).
CLAIM 14
The medical device of Appellant’s claim 14 comprises, inter alia, a
septum disposed within the lumen of a catheter adapter, wherein an insert is
disposed adjacent to the septum to secure the septum (see Appeal Br. 15).
To reach this limitation of Appellant’s claim 14, Examiner directs attention
to Grandt’s element 24d (see FF 8). Element 24d of Grandt’s device,
however, represents a “gap” that “is in fluid communication with the
exterior of catheter 100” and “can be constructed by placing two
circumferential slits through the wall of distal tubular member 24 to define a
flap region” (id.). Examiner failed to explain how this “gap” can be
Appeal 2018-009123
Application 14/185,831

11
interpreted to represent a septum (see Final Act. 4–5; see also Ans. 6–7).
Therefore, we agree with Appellant’s contention that “gap 24d appears to
allow fluid communication with the exterior of the catheter 100 and does not
appear to include a septum” (Appeal Br. 10).
CLAIM 25
As discussed above, the combination of Grandt and Potter makes
obvious a device having a body that is constructed of a base material that
includes an antimicrobial agent (see FF 5–12). Therefore, we are not
persuaded by Appellant’s contention to the contrary (see Appeal Br. 11).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness with respect to claims 1 and 25. The rejection of
claims 1 and 25 under 35 U.S.C. § 103(a) as unpatentable over the
combination of Grandt and Potter is affirmed. Claims 2–6, 9–13, 21, 22, and
26 are not separately argued and fall with claims 1 and 25, respectively. We
recognize, however, that our rationale for affirming the rejection of claims 1
and 25 differs from Examiners and, therefore, we designate the affirmance a
new ground of rejection.
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness with respect to claims 14–16, 23, and
24. The rejection of claims 14–16, 23, and 24 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Grandt and Potter is reversed.

Provisional Obviousness-type Double Patenting:
Claims 1–4 stand provisionally rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
Appeal 2018-009123
Application 14/185,831

12
the claims of co-pending Application 14/606,833. As Examiner explains,
Appellant “has provided no arguments directed to this rejection” (Ans. 9).
“If a ground of rejection stated by the examiner is not addressed in
appellant’s brief, appellant has waived any challenge to that ground of
rejection and the Board may summarily sustain it.” Manual of Patent
Examining Procedure § 1205.02 (Rev. 08.2017, January 2018). This
provisional rejection is, therefore, summarily affirmed.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed New
Ground
1–3, 5, 6,
9–16,
21–26
102(a)(1) Grandt 1–3, 5, 6,
9–16, 21–
26

1–6, 9–
16, 21–
26
103 Grandt, Potter 1–6, 9–
13, 21,
22, 25, 26
14–16,
23, 24
1–6, 9–
13, 21,
22, 25,
26
1–4 Provisional
Obviousness-type
Double Patenting
1–4
Overall
Outcome
1–6, 9–
13, 21,
22, 25, 26
14–16,
23, 24
1–6, 9–
13, 21,
22, 25,
26

TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
Appeal 2018-009123
Application 14/185,831

13
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner. . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .
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; 37 C.F.R. § 41.50(b)