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.
15/336,662 10/27/2016 Charles Roger Leigh 5441-601 1167
111614 7590 01/04/2021
Pilloff Passino & Cosenza LLP
2000 Duke Street
Suite 300
Alexandria, VA 22314
EXAMINER
LEVICKY, WILLIAM J
ART UNIT PAPER NUMBER
3792
NOTIFICATION DATE DELIVERY MODE
01/04/2021 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):
mail@pilloffpassino.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________
Ex parte CHARLES ROGER LEIGH and PADRAIG HURLEY
____________
Appeal 2020-004189
Application 15/336,662
Technology Center 3700
____________
Before DANIEL S. SONG, EDWARD A. BROWN, and
CHARLES N. GREENHUT, Administrative Patent Judges.
BROWN, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Appellant1 seeks review under 35 U.S.C. § 134(a) of the Examiner’s
decision rejecting claims 1, 4, 5, 7, 9, 11, 12, 17–19, and 24–37, which are
all the pending claims. Appellant’s representative presented oral argument
on December 10, 2020. We have jurisdiction under 35 U.S.C. § 6(b).2
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 Cochlear Limited as the real party in
interest. Appeal Br. 2.
2 We lack jurisdiction as to the procedural matters raised in the Reply Brief
and those matters are not addressed herein. Reply Br. 2; 37 C.F.R.
§ 41.40(a).
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CLAIMS
Claims 1, 12, 32, and 36 are independent, claims 4, 5, 7, 9, 11, 24–27,
34, 35, and 37 depend from claim 1, claims 17–193 and 28–31 depend from
claim 12, and claim 33 depends from claim 32. Appeal Br. 128–133
(Claims App.). Claim 1, reproduced below, is illustrative.
1. An apparatus comprising:
an implantable stimulator unit;
an implantable power source;
an implantable coil assembly configured to wirelessly
couple the implantable stimulator unit with an external
component of an auditory prosthesis; and
a releasable connector disposed between the implantable
coil assembly and the implantable stimulator unit, wherein the
releasable connector is configured to electrically connect the
implantable coil assembly to the implantable stimulator unit.
Id. at 128 (Claims App.).
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Gibson ’680 US 2003/0050680 A1 Mar. 13, 0050680 A1
Gibson ’629 US 2005/0004629 A1 Jan. 6, 2005
Hochmair US 2008/0221641 A1 Sept. 11, 2008
Leigh US 2012/0022647 A1 Jan. 26, 2012
Thenuwara US 2014/0343626 A1 Nov. 20, 2014
Meadows US 2016/0008601 A1 Jan. 14, 2016
3 The preamble of claim 19 recites “[t]he apparatus of claim 16, claim 12.”
Appeal Br. 130 (Claims App.). Claim 16 has been cancelled. The Examiner
treats claim 19 as depending from claim 12, as we will also. Ans. 3.
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REJECTIONS4
1. Claims 19 and 29 are rejected under 35 U.S.C. § 112(a) as
failing to comply with the written description requirement5. Final Act. 11–
12.
2. Claims 11, 12, 17–19, 25, 28–31, and 34–37 are rejected under
35 U.S.C. § 112(b) as being indefinite6. Final Act. 14–16.
3. Claims 1, 4, 5, 7, 11, 12, 17, 19, 24–34, 36, and 37 are rejected
under 35 U.S.C. § 103 as unpatentable over Gibson ’629 and Meadows.
Final Act. 18–34.
4. Claim 9 is rejected under 35 U.S.C. § 103 as unpatentable over
Gibson ’629, Meadows, and Gibson ’680. Final Act. 34.
5. Claims 17 and 18 are rejected under 35 U.S.C. § 103 as
unpatentable over Gibson ’629, Meadows, and Hochmair. Final Act. 35.
6. Claim 29 is rejected under 35 U.S.C. § 103 as unpatentable
over Gibson ’629, Meadows, and Leigh. Final Act. 36.
7. Claim 35 is rejected under 35 U.S.C. § 103 as unpatentable
over Gibson ’629, Meadows, and Thenuwara. Final Act. 36–38.
4 The rejection of claims 11 and 17–19 under 35 U.S.C. § 112(d) has been
withdrawn. Ans. 3; Final Act. 17–18.
5 The rejection of claim 35 under this ground has been withdrawn. Ans. 3;
Final Act. 13.
6 The rejection of claim 1 (and dependent claims 4, 5, 7, 9, 11, 12, 24–27,
and 37), claim 28, and one of the two stated bases for rejecting claim 35
have been withdrawn. Ans. 3; Final Act. 14–16. The Examiner also
indicates that claims 17–19 and 28–31 inherit the same deficiency as claim
12. Final Act. 15. Accordingly, we treat claims 17–19 and 28–31 as also
being subject to this rejection.
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ANALYSIS
Rejection 1—Written Description
The Examiner rejects claims 19 and 29 as failing to comply with the
written description requirement of 35 U.S.C. § 112(a).
Claim 19
Claim 19 recites, in part, that “the first coil assembly includes a
module that when connected to the stimulator connector part forms an
upgraded auditory prosthesis.” Appeal Br. 130 (Claims App.) (emphasis
added). The Examiner determines that claim 19 fails to comply with the
written description requirement because it
requires a module that forms an upgraded auditory prosthesis,
without reciting any structure for the module. This means that
the claim includes subject matter not yet disclosed or invented,
such as any new/future modules that would be used on an
implantable apparatus to form an upgraded auditory prosthesis.
Final Act. 11–12 (emphasis added).
Appellant contends that one of ordinary skill in the art would
understand that Appellant had possession of the claimed subject matter from
reading the Specification. Appeal Br. 27 (quoting Spec. ¶ 43). Additionally,
Appellant disagrees that claim 19 does not recite any structure for the
module. Id. at 28. Appellant also contends that the recited “module” is a
functional limitation, asserting that “functional limitations may be used to
claim a structure capable of performing a recited function, and . . . functional
limitations connote structure that must be taken into account in
distinguishing a claim from the prior art.” Id. Appellant further contends
that the Examiner’s “assertions about the claim including subject matter not
yet disclosed are speculative.” Id. at 29.
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Appellant’s contentions are unpersuasive. The test for sufficiency
under the written description requirement of 35 U.S.C. § 112(a) “is whether
the disclosure of the application relied upon reasonably conveys to those
skilled in the art that the inventor had possession of the claimed subject
matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (en banc). To have “possession,” “the
specification must . . . show that the inventor actually invented the invention
claimed.” Id.
The purpose of the written description requirement is to
prevent an applicant from later asserting that he invented that
which he did not; the applicant for patent is therefore required
to “recount his invention in such detail that his future claims
can be determined to be encompassed within his original
creation.”
Amgen Inc. v. Hoechst Marion Roussel Inc., 314 F.3d 1313, 1330 (Fed. Cir.
2003) (citing Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1561 (Fed. Cir.
1991)).
We agree with the Examiner that claim 19 does not recite any
structure of the module. Rather, the claim recites the effect or result of
connecting the module to the stimulator connector part, that is, “form[ing] an
upgraded auditory prosthesis.” Appellant does not identify what structure is
purportedly connoted by the term “module.” We note that paragraph 43 of
the Specification describes connecting module 814 to connector 808 to form
an upgraded auditory prosthesis 800A. See Spec. ¶ 43, Figs. 8A, 8B. As
described, “the module 814 may include a sound processor, microphone, and
other required or desired components.” Spec. ¶ 43 (emphasis added). This
disclosure merely states what the module may include, and fails to indicate
what the “other required or desired components” might be. We agree with
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the Examiner that claim 19 appears to encompass “any new/future modules
that would be used on an implantable apparatus to form an upgraded
auditory prosthesis.” Final Act. 11–12.
We have also considered Appellant’s contentions presented in the
Reply Brief and do not find them persuasive of Examiner error. Reply Br.
8–14. We determine that Appellant’s disclosure fails to reasonably convey
to persons skilled in the art that the inventors had possession of the full
scope of subject matter of claim 19 as of the filing date. Thus, we sustain
the rejection of claim 19 under the written description requirement.
Claim 29
Claim 29 recites, “wherein the first coil connector part and/or the
stimulator connector part are configured to control and/or prevent a growth
of biofilm at an interface therebetween.” Appeal Br. 131 (Claims App.).
The Examiner determines that the claim “requires the first coil connector
part or the stimulator connector part are configured to control and/or prevent
a growth of biofilm at an interface therebetween.” Final Act. 12. The
Examiner notes that paragraph 29 of the Specification “states the spacing
between the stimulator unit 302C and coil assembly 304C (e.g., at the
interface 324C) can be minimal in the configuration of FIG. 3C. This can
help prevent the growth of biofilm at the interface 324C.” Id. The
Examiner determines that “this is not the same as the first coil connector part
is configured to control and/or prevent a growth of biofilm at an interface
therebetween.” Id. According to the Examiner, “[t]he disclosure appears to
teach that the closeness of the two components are required for controlling
and preventing biofilm growth and not that one or the other components is
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solely responsible for controlling or preventing biofilm growth.” Id. at 12–
13.
Appellant disagrees with the Examiner, pointing out that the
Specification further discloses:
Additional configurations to control or eliminate the growth of
biofilm are known and can include the outer surfaces (upper,
lower, perimeter, etc.) of the stimulator unit 302C and coil
assembly 304C being formed with a smooth finish.
Appeal Br. 32 (quoting Spec. ¶ 29). Appellant contends that this passage
“disclose[s] a feature that can be present on one or the other or on both.” Id.
We agree with Appellant that the Specification discloses
configurations to control or eliminate growth of biofilm at the interface in
addition to the first coil connector part and stimulator connector part having
a minimal spacing between them. However, paragraph 29 describes that
both stimulator unit 302C and coil assembly 304C are formed with a smooth
finish to control or eliminate biofilm growth. This paragraph does not
disclose that forming only one of stimulator unit 302C and coil assembly
304C with a smooth finish would be effective to control or eliminate biofilm
growth at an interface between them, as required by claim 29. We have also
considered Appellant’s contentions presented in the Reply Brief and do not
find them persuasive of Examiner error. Reply Br. 14–17. We agree with
the Examiner that Appellant’s disclosure fails to reasonably convey to those
skilled in the art that the inventor had possession of the subject matter of
claim 29 as of the filing date. Thus, we sustain the rejection of claim 29
under the written description requirement.
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Rejection 2—Indefiniteness
The Examiner rejects claims 11, 12, 17–19, 25, 28–31, and 34–37
under 35 U.S.C. § 112(b) as being indefinite.
In examining an application under 35 U.S.C. § 112(b), the PTO is
obliged to test the claims for “reasonable precision.” In re Packard, 751
F.3d 1307, 1313 (Fed. Cir. 2014). “A claim [in an application] is indefinite
when it contains words or phrases whose meaning is unclear.” Id. at 1314;
see Ex parte McAward, No. 2015-006416, slip op. at 11 (PTAB Aug. 25,
2017) (precedential) (same). The test for definiteness under 35 U.S.C.
§ 112, is whether “those skilled in the art would understand what is claimed
when the claim is read in light of the specification.” Orthokinetics, Inc. v.
Safety Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (citations
omitted). Section 112 places the burden of precise claim drafting on the
applicant. See In re Morris, 127 F.3d 1048, 1056–57 (Fed. Cir. 1997).
Claim 11
Claim 11 recites, in part, that “the apparatus is configured such that
removing the coil assembly causes the controller to enter an MRI
compatibility state.” Appeal Br. 129 (Claims App.). The Examiner
determines that the meaning of this recitation “is unclear because there
appears to be missing elements necessary for the controller to enter an MRI
state.” Final Act. 14. The Examiner questions “How does the apparatus
know the coil assembly has been removed?” and “What changes result as the
controller enters the MRI state?” Id.
Appellant contends that the rejection is based on claim breadth,
because the claim does not recite how claimed components function.
Appeal Br. 45.
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The Examiner does not determine that any specific term in claim 11 is
unclear. To the extent it is the Examiner’s position that the claim is
incomplete because it omits some unidentified essential element(s), this
position is not clearly stated. As for the Examiner’s questions, the
Specification describes the disconnection of coil assembly 506 from
stimulator unit 504, as follows:
Once disconnected, as depicted in FIG. 5C, the stimulator unit
504 enters an MRI compatibility mode, where operation of the
stimulator unit 504 ceases and wherein, due to removal of the
coil assembly 506 (more specifically the magnet 512 therein),
patient comfort and reduced artifacts are ensured. A controller
within the stimulator unit 504 can include a physical or
electronic switch that can automatically shut down the
stimulator unit 504 and open the circuit or circuits associated
with the stimulating electrodes (described elsewhere herein),
thus preventing stimuli from being sent to the recipient. As
such, the cochlear implant 500 is now in an MRI compatibility
mode and the recipient can undergo an MRI procedure, at any
field strength.
See Spec. ¶ 36 (emphasis added), Figs. 5A–5C. This passage describes how
the apparatus “knows” the coil assembly has been removed, as well as that
this causes the controller to enter the MRI compatibility mode. In light of
this disclosure, we disagree with the Examiner that those skilled in the art
would have been unable to understand what is claimed in light of the
specification. Thus, we do not sustain the rejection of claim 11 under 35
U.S.C. § 112(b).
Claim 12
Claim 12 recites, in part, “a controller configured to deactivate the
stimulator portion when the first coil assembly is disconnected.” Appeal Br.
129–30 (Claims App.). The Examiner determines that “[i]t is unclear how
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the controller identifies the disconnection.” Final Act. 14–15. The
Examiner also questions whether this claim recitation is an intended use. Id.
at 15.
Appellant contends that the controller would identify the
disconnection, such as by an open circuit, no electricity, or nor signal.
Appeal Br. 46. Appellant also contends that the rejection appears to be
based on claim breadth, because the claim does not recite how claimed
components function. Id. at 47–48.
The Examiner does not determine that any specific term in claim 12 is
unclear. As discussed above, paragraph 36 of the Specification discloses
that the controller can include a physical or electronic switch to deactivate
the stimulator portion and open the circuit(s) associated with the stimulating
electrodes. This disclosure indicates sufficiently how the controller
identifies the disconnection. In light of this disclosure, the Examiner has not
shown persuasively that those skilled in the art would have been unable to
understand what is claimed when claim 12 is read in light of the
Specification. Thus, we do not sustain the rejection of claim 12, and claims
17–19 and 28–31 depending therefrom, under 35 U.S.C. § 112(b).
Claim 25
Claim 25 recites that “the apparatus is configured such that the area
associated with the releasable connector enables flexibility such that the
apparatus conforms to the skull more than that which would be the case in
the absence of the flexibility.” Appeal Br. 131 (Claims App.) (emphasis
added). The Examiner determines that there is insufficient antecedent basis
for “the area.” Final Act. 15. Appellant contends that the “area” is an
inherent recitation. Appeal Br. 48.
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“[C]laims are not necessarily invalid for a lack of antecedent basis.”
Microprocessor Enhancement Corp. v. Texas Instruments Inc., 520 F.3d
1367, 1376 (Fed. Cir. 2008). If the scope of a claim would be reasonably
ascertainable by those skilled in the art, then the claim is not indefinite.
Energizer Holdings, Inc. v. Int’l Trade Comm’n, 435 F.3d 1366, 1370–71
(Fed. Cir. 2006) (citation omitted). Appellant does not explain what the
recited phrase “area associated with the releasable connector” means. We
do not disagree with Appellant that the releasable connector would have an
“area”; however, claim 25 does not recite “the area of the connector.” It is
unclear whether the recited phrase means, for example, the entire connector
alone, or the entire connector combined with some portion of the coil
assembly and/or stimulator unit. Further, we note the recited phrase is not
described in the Specification, which thus, provides no clear guidance as the
phrase’s meaning. Accordingly, we agree with the Examiner that the claim
language is indefinite.
The Examiner also determines that it is unclear what structure of the
apparatus is further limited by the recited requirement that “the apparatus is
configured such that the releasable connector area enables flexibility.” Final
Act. 15. Appellant contends that “anything that enables flexibility is
covered.” Appeal Br. 49. Appellant also contends that the rejection appears
to be based on claim breadth. Id. at 49–50.
We agree with the Examiner that the meaning of the recited
requirement is unclear. Claim 25 recites that “the apparatus is configured
such that the area associated with the releasable connector enables
flexibility.” Appeal Br. 131 (Claims App.) (emphasis added). We note that
the Specification discloses that “[t]he configuration of the connection
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elements at the interface 234 enables flexibility at the interface 234, which
allows the stimulator/receiver unit 202 to more easily conform to the skull.”
See Spec. ¶ 23 (emphasis added). Claim 25 does not, however, recite that
the releasable connector is configured to enable flexibility. We agree with
the Examiner that it is unclear what structure of “the apparatus is configured
such that the area associated with the releasable connector enables
flexibility.” For example, is a portion or the entire connector alone, or the
entire connector in addition to some portion of the coil assembly and/or
stimulator unit so “configured”?
We have also considered Appellant’s contentions presented in the
Reply Brief and do not find them persuasive of Examiner error. Reply Br.
27–31. Accordingly, we agree with the Examiner that claim 25 is indefinite
for this additional reason. Thus, we sustain the rejection of claim 25 under
35 U.S.C. § 112(b).
Claim 34
Claim 34 recites that “the magnet chassis has a diameter nearly the
same as that of an outer perimeter of the encapsulant.” Appeal Br. 132–133
(Claims App.) (emphasis added). The Examiner determines that “nearly” is
a relative term, rendering the claim indefinite. Final Act. 16. The Examiner
submits that “nearly” “is not defined by the claim, the specification does not
provide a standard for ascertaining the requisite degree, and one of ordinary
skill in the art would not be reasonably apprised of the scope of the
invention.” Id. In contrast, Appellant contends that terms of degree are not
automatically indefinite and the Examiner has not provided the required
analysis. Appeal Br. 51.
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In claim 34, the term “nearly” is a term of degree or approximation.
MPEP § 2173.05(b) (9th ed., rev. 08.2017, Jan. 2018) (Section I Terms of
Degree, Section III Approximations). “Claim language employing terms of
degree has long been found definite where it provided enough certainty to
one of skill in the art when read in the context of the invention.” Interval
Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370 (Fed. Cir. 2014).
Accordingly, “[t]he claims, when read in light of the specification and the
prosecution history, must provide objective boundaries for those of skill in
the art.” Id. at 1371 (citing Nautilus, Inc. v. Biosig Instruments, Inc., 572
U.S. 898, 911 & n.8 (2014)).
We understand that claim 34 corresponds to the cochlear implant 600
depicted in Figure 6. Paragraph 38 of the Specification describes this figure,
stating, “in this example, the magnet chassis 616 has a diameter nearly the
same as that of the outer perimeter of the coil encapsulant 618” (emphasis
added). The Specification does not provide a specific definition of “nearly.”
We note that a dictionary definition of “nearly” is “almost but not quite
.” See Merriam-Webster’s Collegiate Dictionary 828 (11th ed.
2003). As shown in Figure 6, the diameter of magnet chassis 616 can be
considered “almost but not quite” the same as that of the outer perimeter of
coil encapsulant 618. We agree with Appellant that the meaning of the term
“nearly” would be sufficiently clear to one of ordinary skill in the art when
read in the context of the Specification. Accordingly, we do not sustain the
rejection of claim 34 under 35 U.S.C. § 112(b).
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Claim 35
Claim 35 recites, in part:
a magnet chassis that encases the magnet and is
embedded in the encapsulant, wherein the magnet chassis has a
diameter nearly the same as that of an outer perimeter of the
encapsulant, wherein the magnet chassis has a diameter slightly
smaller than a smallest diameter of the coil.
Appeal Br. 133 (Claims App.) (emphasis added). The Examiner determines
that the terms “nearly” and “slightly” are both relative terms, rendering
claim 35 indefinite for the same reasons as claim 34. Final Act. 16.
Additionally, the Examiner determines:
It is unclear how the encapsulant is nearly the same diameter as
the chassis, while the coil is embedded in the encapsulant that
has a larger diameter than the chassis. It is unclear how the
encapsulant can be simultaneously nearly the same size as the
chassis and have a diameter that allows the coil to be
embedded.
Id. Appellant provides the same argument for claim 35 as discussed above
for claim 34. Appeal Br. 51.
Paragraph 38 of the Specification describes that “chasses can have
diameters slightly smaller than the smallest diameter of the coil. In such an
example, the coil may be wrapped tightly about the outer perimeter of the
chassis.” Spec. ¶ 38. The Specification does not provide a specific
definition of “slightly.” We note that a dictionary definition of the term
“slight” is “small of its kind or in amount
.” See Merriam-
Webster’s Collegiate Dictionary 1173 (11th ed. 2003). We construe the
final “wherein” clause of claim 35 to mean that the coil is located between
the magnet chassis and the encapsulant’s outer perimeter. As such, we agree
with the Examiner that it is unclear how the magnet chassis has both “a
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diameter nearly the same as that of an outer perimeter of the encapsulant”
and “a diameter slightly smaller than a smallest diameter of the coil,” as
required by claim 35. Appellant does not persuasively address this issue.
We have also considered Appellant’s contentions presented in the Reply
Brief and likewise find them unpersuasive. Reply Br. 32–34. Accordingly,
we sustain the rejection of claim 35 under 35 U.S.C. § 112(b).
Claim 36
Claim 36 recites, in part, “a controller within the stimulator unit
including a physical and/or electronic switch that can automatically shut
down the stimulator unit, thus preventing stimuli from being sent to a
recipient.” Appeal Br. 133 (Claims App.) (emphasis added). The Examiner
determines there is insufficient antecedent basis for “a recipient.” Final Act.
16.
We note, for example, that the Specification describes Figure 1 as
showing “a behind-the-ear auditory prosthesis worn on a recipient.” See
Spec. ¶ 9, Fig. 1. A “recipient,” then, is the wearer or user of the claimed
apparatus to which the stimuli are prevented from being sent. Thus, the
claim’s scope would be reasonably ascertainable by one skilled in the art.
Thus, we do not sustain the rejection of claim 36 under 35 U.S.C. § 112(b).
Claim 37
Claim 37 recites that “the apparatus is configured such that the area
associated with the releasable connector enables rigidity.” Appeal Br. 133
(Claims App.) (emphasis added). The Examiner determines there is
insufficient antecedent basis for “the area.” Final Act. 16.
For claim 37, Appellant relies on the same argument that “the area” is
an inherent recitation as discussed above for claim 25. Appeal Br. 48–50.
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This argument is likewise unpersuasive for claim 37. Thus, we sustain the
rejection of claim 37 under 35 U.S.C. § 112(b).
Requirements of a Prima Facie Case
All pending claims 1, 4, 5, 7, 9, 11, 12, 17–19, and 24–37 are rejected
as being obvious over the prior art. Appellant contends that the Examiner
has failed to establish a prima facie case of obviousness against any claim,
as a matter of procedure. Appeal Br. 13. Specifically, Appellant asserts:
Nowhere on the record does the Examiner develop the
broadest reasonable interpretation of the claim phrases
pursuant to proper procedure. In fact, nowhere does the
Examiner even explain the broadest reasonable interpretation of
any claim phrase at issue. Instead, there are simply assertions
about the teachings in the prior art, followed by a decree that
such corresponds to what is claimed.
Id. Appellant lists numerous phrases recited in claims 1, 11, 12, 17–19, 24–
27, 31–33, 36, and 37 (id. at 21–25), and states: “It is submitted that no case
of anticipation or obvious can be established until the BRI of these phrases is
placed on the record and support for such meeting MPEP 2111 and In re
Smith is presented.” Id. at 21.
We disagree as to the requirements of a prima facie case of
obviousness. As explained in In re Jung, 637 F.3d 1356, 1362 (Fed. Cir.
2011):
As this court has repeatedly noted, “the prima facie case
is merely a procedural device that enables an appropriate shift
of the burden of production.” Hyatt v. Dudas, 492 F.3d 1365,
1369 (Fed. Cir. 2007) (citing In re Oetiker, 977 F.2d 1443,
1445 (Fed. Cir. 1992)). See also In re Piasecki, 745 F.2d 1468,
1472 (Fed. Cir. 1984). The Patent and Trademark Office
(“PTO”) satisfies its initial burden of production by “adequately
explain[ing] the shortcomings it perceives so that the applicant
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is properly notified and able to respond.” Hyatt, 492 F.3d at
1370. In other words, the PTO carries its procedural burden of
establishing a prima facie case when its rejection satisfies 35
U.S.C. § 132, in “notify[ing] the applicant ... [by] stating the
reasons for [its] rejection, or objection or requirement,
together with such information and references as may be useful
in judging of the propriety of continuing the prosecution of
[the] application.” 35 U.S.C. § 132. That section “is violated
when a rejection is so uninformative that it prevents the
applicant from recognizing and seeking to counter the grounds
for rejection.” Chester v. Miller, 906 F.2d 1574, 1578 (Fed.
Cir. 1990).
(Emphasis added).
We agree with Appellant that claims are to be given their broadest
reasonable interpretation (“BRI”) consistent with the specification during
examination. Appeal Br. 14; see, e.g., In re Montgomery, 677 F.3d 1375,
1379 (Fed. Cir. 2012). But this does not mean that the Examiner must make
on-the-record claim constructions that apply this standard to establish a
prima facie case. In fact, the court in Jung refused “to impose a heightened
burden on examiners beyond the notice requirement of § 132,” stating:
There has never been a requirement for an examiner to make
an on-the-record claim construction of every term in every
rejected claim and to explain every possible difference between
the prior art and the claimed invention in order to make out a
prima facie rejection. This court declines to create such a
burdensome and unnecessary requirement.
Jung, 637 F.3d at 1363 (emphasis added). Rather, the court explained,
all that is required of the office to meet its prima facie burden of
production is to set forth the statutory basis of the rejection and
the reference or references relied upon in a sufficiently
articulate and informative manner as to meet the notice
requirement of § 132.
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Id. In Jung, the court determined that the examiner had put applicant on
notice, stating “the [Examiner’s] specific column and line cites to the prior
art reference would have put any reasonable applicant on notice of the
examiner’s rejection.” Id. at 1362. Once the notice requirement has been
met, the burden shifts to the applicant to rebut the prima facie case, requiring
the applicant to provide specific reasons why the prior art teachings do not
correspond to each claim element. See Packard, 751 F.3d at 1312; Jung,
637 F.3d at 1364; 35 U.S.C. § 132.7
As for Appellant’s reliance on MPEP § 2111 and “In re Smith,” first,
MPEP § 2111 describes the broadest reasonable interpretation standard
applied to pending claims during patent examination. Second, we
understand Appellant is referring to In re Smith International, Inc., 871 F.3d
1375 (Fed. Cir. 2017). In Smith, the court addressed the issue of “[t]he
correct inquiry in giving a claim term its broadest reasonable interpretation
in light of the specification,” that is, how to apply this claim construction
standard. Id. at 1382–83. We disagree with Appellant that MPEP § 2111 or
Smith requires the Examiner to make an express on-the-record claim
construction to establish a prima facie case of obviousness.
7 Further, as explained in In re Google Technology Holdings LLC, No. 2019-
1828, 2020 WL 6685948, at *5 (Fed. Cir. Nov. 13, 2020): “Once an
examiner has made a prima facie case for rejecting the application claims,
the applicant is provided with an opportunity to submit any saving claim
construction it believes may be grounds for reversing the rejection both to
the examiner and potentially again, to the Board. The burden lies with the
applicant to present this argument in the initial instances.”
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Rejection 3—Gibson ’629 and Meadows
The Examiner rejects claims 1, 4, 5, 7, 11, 12, 17, 19, 24–34, 36, and
37 under 35 U.S.C. § 103 as unpatentable over Gibson ‘’629 and Meadows.
Claims 1, 4, 5, 7, 11, 24–27, 34, and 37
For claim 1, the Examiner finds that Gibson ’629 discloses an
implantable stimulator unit (stimulator device 104), an implantable coil
assembly (receiver coil 102), and a releasable connector (pin and socket
arrangement 105), as recited. Final Act. 18–19 (citing Gibson ’629 ¶¶ 71,
81, 82, Figs. 8A, 8B). The Examiner concedes that Gibson ’629 does not
disclose an implantable power source, as claimed. Id. at 19.
The Examiner relies on Meadows as teaching an implantable device
comprising a battery and a controller to disconnect connections to lead
contacts to protect tissue from effects of an MRI. Final Act. 19 (citing
Meadows ¶¶ 7, 26, Fig. 5). The Examiner determines that it would have
been obvious to modify Gibson ’629 with “an implantable device
compris[ing] a battery and a controller,” as taught by Meadows, to provide
this same tissue protection. Id.
Appellant contends that “[a]dding a battery, which is optional in
Meadows, will do nothing to protect from the effects of an MRI” and “the
bit in Meadows about stimulation protection has nothing to do with the
battery. The MRI can cause electrical current to flow irrespective of the
battery.” Appeal Br. 98 (emphasis omitted). In that regard, Appellant
contends that Meadows suggests the absence of a battery in a device that
might have this stimulation problem. Id. at 98–99 (quoting Meadows ¶ 26).
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Appellant contends that Zimmerling8 provides evidence that “it is known
that MRI fields create magnetic fields that can cause stimulation in an
implant via interaction of the field with an inductance coil.” Id. at 100. In
support, Appellant quotes several passages in Zimmerling, including the
following:
Another potentially dangerous effect may occur when RF
pulses emitted by the MR unit induce voltages in the implant
coil, implant circuit and/or electrode circuit. These voltages
may generate unwanted stimulation, especially in implants with
analog electronic circuitry. Additionally, over-voltages may be
generated, which could destroy the implant electronics.
Zimmerling, col. 1, ll. 46–52; see also Appeal Br. 101–102.
The Examiner responds that “the addition of the battery with the
controller allows the controller to properly function by disconnecting
connections to lead contacts to protect tissue from effects of an MRI.” Ans.
11.
Initially, as discussed above, we disagree with Appellant’s position as
to the requirements of the Examiner’s initial burden in establishing a prima
facie case of obviousness. Particularly, we disagree that the Examiner has
failed to establish a prima facie case by not placing on the record broadest
reasonable interpretations of specified claim language recited in claim 1.9
See Appeal Br. 21–22. However, we agree with Appellant that the Examiner
has not established that it would have been obvious to modify Gibson ’629
in view of Meadows, as proposed, to result in the apparatus recited in claim
1, for the following reasons.
8 US 6,838,963 B2, issued Jan. 4, 2005.
9 This same comment applies equally to the Examiner’s initial burden in
rejecting independent claims 12, 32, and 36, as discussed below.
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The rejection proposes to modify Gibson ’629 by adding both a
battery and a controller. Paragraphs 7 and 26 of Meadows cited by the
Examiner describe a battery. However, these paragraphs of Meadows do not
appear to describe a battery that provides power to a “controller.” These
paragraphs do not describe a controller and the Examiner does not otherwise
show that a controller is implicitly disclosed. Nor does the Examiner
identify any element in Fig. 5 that corresponds to the “controller.” As such,
the Examiner does not establish that this disclosure in Meadows teaches a
controller that disconnects connections to lead contacts. Consequently, the
Examiner does not establish with evidence that such purported battery and
controller are disclosed in Meadows. Nor does the Examiner rely on any
additional prior art to support this finding.
Additionally, we agree with Appellant that Zimmerling shows that it
is known in the art that MRI units can cause unwanted stimulation in
cochlear implants. The Examiner does not directly respond to Appellant’s
position, and thus, does not provide any persuasive evidence that adding a
battery to Gibson ’629’s cochlear implant would be sufficient to avoid this
problem.
For these reasons, the Examiner has not articulated an adequate reason
with a rational underpinning to modify Gibson ’629 by adding both a battery
and a controller. Thus, we do not sustain the rejection of claim 1, and claims
4, 5, 7, 11, 24–27, 34, and 37 depending therefrom, as unpatentable over
Gibson ’629 and Meadows.
Claims 12, 17, 19, and 28–31
For independent claim 12, the Examiner finds that Gibson ’629
discloses an implantable device comprising a stimulator portion including a
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stimulator connector part 104, and a first coil assembly including a first coil
connector part releasably connectable to the stimulator connector part 105,
as recited in claim 12. Final Act. 23–24 (citing Gibson ’629 ¶¶ 81, 82, Figs.
8A, 8B). The Examiner concedes that Gibson ’629 does not disclose a
controller to deactivate the stimulator portion when the first coil assembly is
disconnected, as claimed. Id. at 24.
The Examiner relies on Meadows as teaching a battery and a
controller to disconnect connections to lead contacts to protect tissue from
effects of an MRI. Final Act. 24 (citing Meadows ¶¶ 7, 26, Fig. 5). The
Examiner determines that it would have been obvious to modify the system
of Gibson ’629 with “an implantable device compris[ing] a battery and a
controller,” as taught by Meadows, to provide this known tissue protection.
Id.
Appellant contends that the passages in Meadows cited by the
Examiner do not disclose a controller, let alone a controller that deactivates
leads. Appeal Br. 81–82. We agree with Appellant for the reasons
discussed above for claim 1. Additionally, claim 12 includes the further
requirement that the controller is “configured to deactivate the stimulator
portion when the first coil assembly is disconnected.” Id. at 130 (Claims
App.) (emphasis added). Appellant notes correctly that the Examiner’s
rationale does not address the recitation “when the first coil assembly is
disconnected.” Id. at 83; see Final Act. 23–24. Moreover, the Examiner
does not identify any disclosure in Meadows of any controller that meets this
requirement.
Accordingly, the Examiner has not established by a preponderance of
the evidence that the proposed combination would include all limitations
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recited in claim 12. Because the Examiner’s conclusion that it would have
been obvious to modify Gibson ’629 to result in the claimed apparatus is not
supported by an adequate factual basis, the legal conclusion is in error. See
In re Warner, 379 F.2d 1011, 1017 (CCPA 1967). Thus, we do not sustain
the rejection of claim 12, and claims 17, 19, and 28–31 depending
therefrom, as unpatentable over Gibson ’629 and Meadows.
Claims 32 and 33
For independent claim 32, the Examiner finds that Gibson ’629
discloses an implantable stimulator unit 104, an electrode array including
stimulating electrodes in signal communication with the implantable
stimulator unit (element 3010), and an implantable coil assembly 102
configured to wirelessly couple the implantable stimulator unit with an
external component of an auditory prosthesis, the coil in signal
communication with the stimulator unit. Final Act. 29–30 (citing Gibson
’629 Figs. 1, 8A, 8B). The Examiner concedes that Gibson ’629 does not
disclose a controller, as claimed. Id. at 30.
The Examiner finds that Meadows teaches “an implantable device
compris[ing] a battery . . . and a controller within the stimulator unit
including a physical and/or electronic switch that can automatically shut
down connections to lead contacts . . . to . . . protect[] tissue from effects of
an MRI.” Final Act. 30 (citing Meadows ¶¶ 7, 26, Fig. 5). The Examiner
determines that it would have been obvious to modify Gibson ’629 with an
10 We understand that element 30 should be element 18 based on the
Examiner’s findings for claim 36 and Gibson ’629’s depiction of electrode
array 18 in Figure 1. See also Final Act. 32–33; Gibson ’629 ¶ 49.
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implantable device comprising a battery and a controller, as taught by
Meadows, to provide this same tissue protection. Id.
Appellant contends that the passages in Meadows cited by the
Examiner do not disclose a controller as recited in claim 32. We agree. As
discussed above for the rejection of claim 1, the Examiner does not identify
any disclosure of a controller in the cited portions of Meadows. Further,
claim 32 requires that the controller is “within the stimulator unit.” The
Examiner does not identify the stimulator unit in Meadows, let alone a
controller within such stimulator unit. Additionally, claim 32 requires that
the controller within the stimulator unit “includ[e] a physical and/or
electronic switch that can automatically shut down the stimulator unit and/or
open a circuit or circuits associated with the stimulating electrodes, thus
preventing stimuli from being sent to the recipient.” The Examiner also
does not identify any disclosure in Meadows as to shutting down a
stimulator unit, as claimed.
Accordingly, the Examiner has not established by a preponderance of
the evidence that the proposed combination would include all limitations
recited in claim 32. Thus, we do not sustain the rejection of claim 32, and
claim 33 depending therefrom, as unpatentable over Gibson ’629 and
Meadows.
Claim 36
Claim 36 differs from claim 32 in that claim 36 requires “a controller
within the stimulator unit including a physical and/or electronic switch that
can automatically shut down the stimulator unit, thus preventing stimuli
from being sent to a recipient.” Appeal Br. 133 (Claims App.). The
Examiner makes the same findings for Gibson ’629 as discussed for claim
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32, and relies on Meadows as teaching the controller limitation. Final Act.
32–33. The Examiner determines that it would have been obvious to modify
the Gibson ’629 system with an implantable device comprising a controller,
as taught by Meadows, for the same reason stated for claim 32. Id. at 33.
Appellant contends that the Examiner finds that Meadows discloses
shutting down connections to lead contacts, but does not address shutting
down a stimulator unit, as claimed. Appeal Br. 85. Appellant also contends
that the passages in Meadows cited by the Examiner do not disclose a
controller, as recited in claim 32. Id. at 87. Thus, Appellant further
contends, Meadows does not disclose a controller within a stimulator unit, as
claimed. Id. at 88. We agree with Appellant.
Thus, for reasons similar to those discussed above for the rejection of
claim 32 over Gibson ’629 and Meadows, we likewise do not sustain the
rejection of claim 36 under this same ground.
Rejections 4–7
Claims 9, 17, 18, 29, and 35 respectively depend from claim 1 or 12.
In rejecting these dependent claims, the Examiner additionally applies
teachings of Gibson ’680 (Final Act. 34), Hochmair (id. at 35), Leigh (id. at
36), and Thenuwara (id. at 36–38). The Examiner’s application of each of
these respective references fails, however, to cure the deficiency in the
rejection of claim 1 or 12 over Gibson ’629 and Meadows. Thus, we
likewise do not sustain the rejections of: claim 9 as unpatentable over
Gibson ’629, Meadows, and Gibson ’680, claims 17 and 18 as unpatentable
over Gibson ’629, Meadows, and Hochmair, claim 29 as unpatentable over
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Gibson ’629, Meadows, and Leigh, or claim 35 as unpatentable over Gibson
’629, Meadows, and Thenuwara.
CONCLUSION
In summary:
Claim(s)
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
19, 29 112(a) Written
Description
19, 29
11, 12, 17–
19, 25, 28–
31, 34–37
112(b) Indefiniteness 25, 35, 37 11, 12, 17–
19, 28–31,
34, 36
1, 4, 5, 7, 11,
12, 17, 19,
24–34, 36,
37
103 Gibson ’629,
Meadows
1, 4, 5, 7, 11,
12, 17, 19,
24–34, 36, 37
9 103 Gibson ’629,
Meadows, Gibson
’680
9
17, 18 103 Gibson ’629,
Meadows,
Hochmair
17, 18
29 103 Gibson ’629,
Meadows, Leigh
29
35 103 Gibson ’629,
Meadows,
Thenuwara
35
Overall
Outcome
19, 25, 29,
35, 37
1, 4, 5, 7, 9,
11, 12, 17,
18, 24, 26–
28, 30–34, 36
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED IN PART
