Cochlear Limited

Patent Trials and Appeals Board

Aug 10, 2021

2021000453 (P.T.A.B. Aug. 10, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/165,165 05/26/2016 Kristien Johanna Maria Verhoeven 3065.0250C 1082
110239 7590 08/10/2021
Edell Shapiro & Finnan LLC
9801 Washingtonian Blvd., Suite 750
Gaithersburg, MD 20878
EXAMINER
ZAMORY, JUSTIN L
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
08/10/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
epatent@usiplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte KRISTIEN JOHANNA MARIA VERHOEVEN,
DANIEL SMYTH, MARCUS ANDERSSON,
CLAUDIU G. TREABA, and FYSH DADD

Appeal 2021-000453
Application 15/165,165
Technology Center 3700
____________

Before MICHAEL C. ASTORINO, JAMES A. WORTH, and
ROBERT J. SILVERMAN, Administrative Patent Judges.

ASTORINO, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 1–6, 11, 12, 19, 30–32, and 34–37.
Claims 7–10, 13–18, 20, and 22 are cancelled. Appeal Br., Claims App.
Claims 21 and 23–29 are withdrawn. Appeal Br. 3. The Examiner

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. The Appellant identifies the real party in interest as
Cochlear Limited. Appeal Br. 3.
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determined that claim 33 includes allowable subject matter. Final Act. 7.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

STATEMENT OF THE CASE
Claimed Subject Matter
Claim 1, the sole independent claim, is representative of the subject
matter on appeal and is reproduced below.
1. A securable inner ear drug delivery plug, comprising:
a body for insertion into an opening in an inner ear of a
recipient, wherein the body has an elongate frustoconical shape;
at least one passive drug delivery mechanism configured
to deliver one or more drugs directly into the inner ear via the
body; and
screw threads extending along an outer surface of the
body and configured to be screwed into the inner ear opening to
mechanically mate with a surface of an inner ear structure
surrounding the inner ear opening to fluidically seal the inner
ear opening to prevent egress of inner ear fluid through the
inner ear opening past the screw threads.
Appeal Br., Claims App.

References
The prior art relied upon by the Examiner is:
Name Reference Date
Woods US 4,353,364 Oct. 12, 1982
Arenberg et al.
(“Arenberg”)
US 6,685,697 B1 Feb. 3, 2004
Wen US 2007/0077270 A1 Apr. 5, 2007
Muni et al. (“Muni”) US 2008/0319424 A1 Dec. 25, 2008

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Rejections
Claims 1, 2, 4, 5, 11, 12, and 30–32 are rejected under 35 U.S.C.
§ 103 as unpatentable over Muni and Woods.
Claims 3, 19, and 34–37 are rejected under 35 U.S.C. § 103 as
unpatentable over Muni, Woods, and Wen.
Claim 6 is rejected under 35 U.S.C. § 103 as unpatentable over Muni,
Woods, and Arenberg.

ANALYSIS
The Appellant argues that the Examiner’s rejection of independent
claim 1 lacks articulated reasoning with some rational underpinning to
support the legal conclusion of obviousness. See, e.g., Appeal Br. 11–13.
The Appellant contends that the Examiner fails to explain “why it would be
desirable to add the fluidically sealing capabilities[, i.e., the claimed ‘to
fluidically seal the inner ear opening to prevent egress of inner ear fluid
through the inner ear opening past the screw threads,’] (allegedly taught by
Woods) to the device of Muni.” Appeal Br. 25; see Appeal Br. 27. The
Appellant’s argument is persuasive.
The Examiner finds Muni teaches substantially all of claim 1’s
securable inner ear drug delivery plug. Final Act. 4. Specifically, the
Examiner finds that Muni’s tube or elongate shaft 104 and exterior surface
of substance reservoir 106 corresponds to the claimed “body,” and that
substance reservoir 106 corresponds to the claimed “at least one passive
drug delivery mechanism.” See Final Act. 4 (citing Muni ¶¶ 95, 122,
Fig. 6A′). The Examiner finds that Muni’s inner ear drug delivery plug
includes a securement feature; namely, “one or more anchoring features
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(e.g., deployable arms 338 as depicted in Figure 6A′) disposed at the body
and configured to mechanically engage a surface of the inner ear at the inner
ear opening to secure the body within the inner ear opening.” Final Act. 4
(citing Muni ¶ 144).
The Examiner finds that Muni fails to disclose the claimed
“frustoconical shape” of the body and “screw threads extending along an
outer surface of the body.” Final Act. 4. To remedy this deficiency, the
Examiner turns to Woods’ teachings. Final Act. 4 (citing Woods col. 6,
ll. 11–43, col. 7, ll. 35–44, Fig. 1). Specifically, the Examiner finds that
“Woods teaches (Figure 1) a securable device for an ear comprising a body
having a frustoconical shape (Figure 1) and further comprising screw threads
(web 14) disposed on an outer surface of the body.” Final Act. 4. The
Examiner determines that “[i]t would have been obvious to one of ordinary
skill in the art . . . to modify the securement features of the device of Muni
by providing the threaded engagement features and body shape of Woods so
as to sufficiently secure the device in the inner ear via a well-known means
such as the elastomeric screw threads.” Final Act. 4.
After carefully considering the Examiner’s rejection, we are unable to
discern an adequately supported reason or rationale for the Examiner’s
determination that one of ordinary skill in the art would have modified the
securement/anchoring features of Muni’s device with the teaching of a
“frustoconical shape” of the body and “screw threads extending along an
outer surface of the body” as taught by Woods. See also Manual of Patent
Examining Procedure (“MPEP”) § 2143, Examples of Basic Requirements
of a Prima Facie Case of Obviousness (9th ed., rev. 10.2019, last rev. June
2020).
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In the Answer, the Examiner adds:
it would have been obvious for one of ordinary skill in the art at
. . . to utilize the screw thread retention means of [W]oods with
the inner ear drug delivery device [of Muni] as it is a known
means of retaining a device within a patient’s ear and would
further apply [(1)] a known technique to a known device via
[(2)] an obvious to try retention means with the yielding of
predictable results via the securement of the device within the
target space. For this reason the Examiner maintains that the
references provide sufficient motivation as it is understood that
one anchoring means would work equally as well as another
and therefore no hindsight is require for such a [(3)]
substitution given the disclosures of Muni and Woods.
Ans. 7–8. Similarly, after carefully considering the foregoing addition in the
Answer, we are unable to discern an adequately supported reason or
rationale for the Examiner’s determination that one of ordinary skill in the
art would have modified the securement/anchoring features of Muni’s device
with the teaching of a “frustoconical shape” of the body and “screw threads
extending along an outer surface of the body” as taught by Woods. The
Examiner’s proposed reason/rationale may be conflating three rationales for
combining the teachings of Muni and Woods; namely: (1) “[a]pplying a
known technique to a known device (method, or product) ready for
improvement to yield predictable results;” (2) “‘[o]bvious to try’ – choosing
from a finite number of identified, predictable solutions, with a reasonable
expectation of success; and (3) “[s]imple substitution of one known element
for another to obtain predictable results.” See MPEP § 2143. Nonetheless,
by themselves or in combination none of these rationales adequately
articulate reasoning with some rational underpinning as to why one of
ordinary skill in the art would have included the teaching of a “frustoconical
shape” of the body and “screw threads extending along an outer surface of
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the body” of Woods’ ear canal plug into the securement/anchoring features
of Muni’s device.
As for the first and second rationales –– i.e., “applying a known
technique to a known device” and “obvious to try” –– the Examiner plainly
conflates these two distinct rationales into one. Nonetheless, the Examiner
fails to set forth the necessary factual findings to support either rationale.
See MPEP § 2143(I)(D)–(E). For example, the Examiner does not offer a
useful comparison between the structural aspects of the securing features of
Woods’ ear plug in relation to the ear canal and Muni’s modified device in
relation to a location where Muni’s device would have been secured. See
Appeal Br. 21; compare Woods Fig. 4 (showing Woods’ ear plug inserted
into a user’s ear canal) with Muni Figs. 4A′–4E′ (showing delivery of an
implantable substance delivery device through nasal passages, to a middle
ear of a patient), 6A′ (showing Muni’s device deployed in the sphenoid
sinus). Rather, the Examiner refers to a non-descript “target space” where
Muni’s modified device may be situated. Ans. 7. Accordingly, we
determine that the Examiner’s rejection fails to adequately articulate
reasoning with rational underpinning as to why one of ordinary skill in the
art would have modified the securement/anchoring features of Muni’s device
with the teaching of a “frustoconical shape” of the body and “screw threads
extending along an outer surface of the body” as taught by Woods’ ear canal
plug.
As for a third rationale –– i.e., “simple substitution” –– the
Examiner’s proposed rejection adds a feature to the securement/anchoring
features in Muni’s inner ear drug delivery plug that was not present prior to
the modification; namely, “to fluidically seal the inner ear opening to
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prevent egress of inner ear fluid through the inner ear opening past the screw
threads.” See Ans. 8. Because the combination adds this feature, the
rationale cannot be considered a “simple substitution.” And, similar to the
above analysis, the Examiner fails to adequately articulate reasoning with
some rational underpinning as to why one of ordinary skill in the art would
have modified the securement/anchoring features of Muni’s device to add
this feature.
Thus, we do not sustain the Examiner’s rejection of independent
claim 1 and dependent claims 2, 4, 5, 11, 12, and 30–32. Additionally, the
Examiner fails to rely on Wen or Arenberg in any manner that would
remedy the deficiency in the Examiner’s rejection as discussed above.
Therefore, we likewise do not sustain the Examiner’s rejections of
dependent claims 3, 6, 19, and 34–37.

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 2, 4, 5,
11, 12,
30–32
103 Muni, Woods

1, 2, 4, 5,
11, 12,
30–32
3, 19,
34–37
103 Muni, Woods, Wen 3, 19, 34–37
6 103 Muni, Woods,
Arenberg
6
Overall
Outcome
1–6, 11, 12,
19, 30–32,
34–37

REVERSED