Ex Parte He et al

Patent Trial and Appeal Board

Jun 27, 2014

12107716 (P.T.A.B. Jun. 27, 2014)

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.
12/107,716 04/22/2008 Tom X. He 05-00658-02 1227
71422 7590 06/27/2014
VISTA IP LAW GROUP LLP/BSC - NEUROMODULATION
2040 MAIN STREET, Suite 710
IRVINE, CA 92614
EXAMINER
WU, TONG E
ART UNIT PAPER NUMBER
3766
MAIL DATE DELIVERY MODE
06/27/2014 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte TOM X. HE and MATTHEW I. HALLER
__________

Appeal 2012-002187
Application 12/107,716
Technology Center 1600
__________

Before DEMETRA J. MILLS, ERIC B. GRIMES, and JEFFREY N.
FREDMAN, Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
Implantable stimulators described in the Specification at ¶ [0006]
include a device for delivering a stimulus and a casing
having a first, metal portion and a second, portion which is
formed from a plastic or polymer. Methods of forming an
implantable stimulator described herein include preparing a coil
on a ferrite tube and molding a casing body on the coil, such
that the coil is embedded in a wall of the casing which is
formed of a plastic or polymer.

The following claims are representative.
1. An implantable nerve stimulator, comprising:
nerve stimulator circuitry configured to output electric currents suitable
for stimulating a nerve; and
an implantable casing comprising:
a first metal connector having an interior cavity, an annular cross-
section, and a first end;
a first metal ridge extending from the first end of the first metal
connector, the first metal ridge having an annular cross-section less than the
annular cross-section of the first metal connector; and
a plastic or polymeric casing body having an interior cavity, an annular
cross-section, and a first end hermetically sealed over the first metal ridge,
such that the interior cavity of the first metal connector and the interior cavity
of the plastic or polymeric casing body communicate to define a receptacle
that encases the nerve stimulator circuitry.

9. The implantable nerve stimulator of claim 1, further comprising a
coil embedded within a wall of the plastic or polymeric casing body.

10. The implantable nerve stimulator of claim 9, further comprising an
elongate ferrite tube about which the embedded coil is wrapped.

11. The implantable nerve stimulator of claim 1, further comprising a
capacitor electrically connected to the nerve stimulator circuitry, wherein at
least a portion the capacitor is embedded within a wall of the plastic or
polymeric casing.

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13. A method of forming an implantable nerve stimulator, comprising:
placing a first metal connector into a mold;
injecting a plastic or polymer into the mold to form a casing body that
contacts the first metal connector, thereby forming an implantable casing
having an interior cavity;
inserting nerve stimulator circuitry within the interior cavity of the
implantable casing; and
hermetically sealing the interior cavity of the implantable casing.

18. The method of claim 13, further comprising placing a coil within
the mold, such that the injection of the plastic or polymer into the mold
embeds the coil within the case body.

19. The method of claim 13, further comprising placing a capacitor
within the mold, such that the injection of the plastic or polymer into the
mold embeds the capacitor within the case body.

20. The method of claim 13, further comprising placing a ferrite core
within the mold, such that the injection of the plastic or polymer into the
mold forms the case body around the ferrite core.

21. The method of claim 13, wherein a metal ridge extends from one
end of the first metal connector, such that the injection of the plastic or
polymer into the mold forms the case body over the metal ridge.

22. The method of claim 21, wherein a groove, rib, or edge extends
around an outer periphery of the first metal ridge to provide additional
surface area between the metal ridge and the case body.

23. The method of claim 13, wherein the first metal connector and the
casing body have the same annular cross-section.

24. The method of claim 13, wherein the first metal connector has a
second end opposite to the first end of the first metal connector, the method
further comprising mounting a feed-through head on the second end of the
first metal connector to hermetically seal the interior cavity of the
implantable casing.

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(App. Br. Claims App’x, emphasis added. 1)

25. The method of claim 13, further comprising placing a second
metal connector into the mold, such that the injection of the plastic or
polymer into the mold form the casing body that contacts the second metal
connector.

Cited References

Schulman et al., ʼ284 US 6,164,284 Dec. 26, 2000
Schulman ʼ859 US 2002/0193859 A1 Dec. 19, 2002
Swanson US 2004/0010296 Jan. 15, 2004
Schulman et al., ʼ502 US 7,114,502 B2 Oct. 3, 2006
Kuzma US 7,174,218 B1 Feb. 6, 2007
Zart et al. US 6,817,905 B2 Nov. 16, 2004

Grounds of Rejection
1. Claims 1, 7, 27, and 28 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Schulman (US2002/0193859 A1) in view
of Kuzma.2
2. Claims 9 and 10 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859 A1) and Kuzma in
view of Swanson.

1 Claims 25-29, added March 22, 2011 are also pending. (Appellants Brief,
2, and the Examiner’s Answer, 3.)
2 Claims 7, 27 and 28 were included in this rejection in the final rejection
dated April 20, 2011, page 2, but were not included in the statement of the
rejection in the Answer. However, the Answer states that all rejections not
expressly withdrawn are maintained (Ans. 3) and both Appellants (Brief 2)
and the Examiner (Ans. 3) acknowledge that these claims remain pending
and stand rejected. We therefore conclude that the rejection applies to all of
claims 1, 7, 27, and 28.
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3. Claims 3, 11 and 12 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Schulman (US 2002/0193859 A1) and
Kuzma in view of Schulman (US 7,114,502 B2).3
4. Claims 13, 19, 23, and 25 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Schulman (US 2002/0193859 A1) in
view of Zart.
5. Claim 16 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859) and Zart in view
of Schulman (US 7,114,502).4
6. Claims 18 and 20 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859) and Zart in view
of Swanson.
7. Claims 21 and 22 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859) and Zart in view
of Kuzma.
8. Claim 24, 26, and 29 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Schulman (US 2002/0193859) and Zart or
Kuzma as combined above, and further in view of Schulman ʼ284.5

3 Claim 3 was included in this rejection in the final rejection dated April 20,
2011, page 4, but was not included in the statement of the rejection in the
Answer. However, the Answer states that all rejections not expressly
withdrawn are maintained (Ans. 3) and both Appellants (Brief 2) and the
Examiner (Ans. 3) acknowledge that claim 3 remains pending and stands
rejected. We herefore conclude that the rejection applies to all of claims 3,
11, and 12.
4 The rejection of claim 16 under 35 USC § 103 over Schulman ʼ859 in
view of Kuzma and Schulman ʼ502 is withdrawn. (Ans. 4.)
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FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages
5-11. The following facts are highlighted.
1. Figure 1 of the Specification is reproduced below.

Figure 1 shows the control circuitry and stimulator circuitry of the
implantable nerve stimulator. (Spec. 6, [0030].)
2. Figure 4 of the Specification is reproduced below.

5 Claims 26 and 29 were included in this rejection in the final rejection dated
April 20, 2011, page 9, but were not included in the statement of the
rejection in the Answer. However, the Answer states that all rejections not
expressly withdrawn are maintained (Ans. 3) and both Appellants (Brief 2)
and the Examiner (Ans. 3) acknowledge that these claims remain pending
and stand rejected. We therefore conclude that the rejection applies to all of
claims 24, 26, and 29.
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Fig. 4 illustrates a partially completed nerve stimulator in which a plastic
casing (70) has been formed, e.g., molded, to encase the coil, ferrite tube and
capacitor. As shown in Fig. 4, the coil (18), wrapped on the ferrite tube
(50), is aligned with the capacitor (15). The coil (18) and capacitor (15) may
be aligned, for example, in a mold (not shown). Figure 4 shows an
embodiment of the stimulator where capacitor 15 with coil 18 is housed
within the wall of casing 70. (Spec. p. 8, [0041].) Components of the
stimulator are housed within the wall of casing 70, and the capacitor 15 can
also function as one of the electrodes of the stimulator. (Spec. p. 9, [0044].)
The plastic in the mold encases the coil 18. When the plastic is hardened or
is cured it forms a casing 70 for the stimulator which is integrated with and
includes the coil [0043].

Discussion
ISSUE
Appellants present no arguments with respect to claim 1.
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With respect to claim 9, Appellants argue that, “Swanson does not
disclose that the telemetry coil can be embedded within the wall of a casing
body at least not one that contains electronics.” (App. Br. 6.)
With respect to claims 11 and 12, Appellants argue that there is no
disclosure in Schulman II (ʼ502) that the capacitor 183 is embedded within a
wall of the casing. (App. Br. 5.)
With respect to claim 16, Appellants argue that
The Examiner has not concluded that independent claim
13 from which claim 16 depends is unpatentable over Schulman
I and Kuzma, and thus, the Examiner has not set forth a prima
facie case that claim 16 is invalid under 35 U.S.C. §103(a), as
being obvious over Schulman I, Kuzma, and Schulman II, and
as such, Appellant respectfully requests this Board to overturn
the rejection of this claim.

(App. Br. 5-6.)

With respect to claim 19, Appellants argue that, “there is no
disclosure in Schulman I [‘859] that the capacitor is placed within the mold,
such that the injection of the plastic or polymer into the mold embeds the
capacitor within the case body.” (App. Br. 8.)
With respect to claims 13, 23 and 25, Appellants argue that, “there is
no suggestion in Zart to form the case body and metal connector in a mold
injection process.” (App. Br. 7.)
The issue is: Does the cited prior art support the Examiner’s finding
that the claimed subject matter is obvious?

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PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office). The Board “determines the scope of claims in patent
applications not solely on the basis of the claim language, but upon giving
claims their broadest reasonable construction ‘in light of the specification as
it would be interpreted by one of ordinary skill in the art.’” Phillips v. AWH
Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci.
Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
“[O]bviousness requires a suggestion of all limitations in a claim.”
CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
(citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
“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
Rejection 1
Claims 1, 7, 27, and 28 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859) in view of Kuzma. The
Appellants do not respond to this rejection on the merits and, therefore,
rejection 1 is summarily affirmed.

Rejection 2
Claims 9 and 10 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859) and Kuzma in view of
Swanson.
With respect to claim 9 (dependent upon claim 1), Appellants argue
that, “Swanson does not disclose that the telemetry coil can be embedded
within the wall of a casing body at least not one that contains electronics.”
(App. Br. 6.)
We are not persuaded. Appellants do not contest that Schulman ʼ859
discloses a casing body that encases the nerve stimulator circuitry. (Claim
1.) In Schulman ‘859 the insulating case 4 may contain a capacitor. (Page
3, [0070].) Swanson is relied on to show a ferrite coil assembly for an
implantable medical device which may be coated with polyurethane
embedding the coil within the casing, using an injection molding or other
type of molding process. (Swanson, page 3, [0022].) The Examiner
concludes that
it would have been obvious to one with ordinary skill in
the art at the time the invention was made to modify the
invention of Schulman [‘859] and Kuzma as taught by Swanson
to include a telemetry coil wrapped around an elongate ferrite
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tube embedded in a plastic or polymeric wall of the casing
body, in order to increase efficiency of the coil and lessen space
requirements.

(Ans. 6.)
Therefore, in response to Appellant’s argument, Swanson does
disclose a molded casing body that contains electronics, i.e., a telemetry coil,
and therefore embeds the telemetry coil within the casing body. (Swanson,
page 3, [0022].) Appellants do not address the Examiner’s argument that
Schulman ʼ859 also discloses a casing body that hermetically seals and
encases the nerve stimulator circuitry. (Ans. 5-6.) The preponderance of
the evidence supports the position of the Examiner.

Rejection 3
Claims 3, 11 and 12 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859) and Kuzma in view of
Schulman (US 7,114,502). We note that Swanson is not cited in this
rejection.
Claim 11 requires “at least a portion [of] the capacitor is embedded
within a wall of the plastic or polymeric casing.”
The Examiner argues that “[t]he limitation of having a portion of the
capacitor embedded within a wall, as best interpreted by the Examiner,
corresponds to the end electrodes having ridges/grooves ([Spec.] Figure 3:
#63; Figure 5: #82) which are embedded in the central plastic body in the
finished device (Figures 4 and 7).” (Ans. 11.) The Examiner finds that
Schulman ʼ859 and Kuzma as combined disclose the
casing body and end electrodes with ridges as recited in the
claims. As such, the end electrodes are shown to be embedded
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within a wall of the casing, in the same manner that the end
electrodes of Appellant are embedded in Figures 4 and 7 of the
Appellant's disclosure. … Schulman ʼ502 is then further cited
to show the capacitor can be arranged to comprise an end
electrode. Therefore, the end electrode as combined is a portion
of the capacitor which is embedded within a wall of the casing.
In addition, Examiner notes that the rejection specifically cites
Figures 10C and 10D of Schulman ʼ502, whereas Appellant
only refers to Figure 10B.

(Ans. 11-12.)

Appellants contend with respect to claims 11 and 12, that there is no
disclosure in Schulman II (ʼ502) that the capacitor 183 is embedded within a
wall of the casing. (App. Br. 5.) Appellants argue that, “Claim 11 requires
the capacitor, itself, to be embedded within the wall of the casing. The fact
that the capacitor is coupled to an element, such as the electrode, that may be
embedded in the wall of the casing is irrelevant.” (Reply Br. 2.)
We are persuaded by Appellants’ argument. Schulman ʼ502
describing Fig. 10C therein, states that
sealed housing 206 [has] the battery 104 and the circuitry
(implemented on one or more IC chips 216 to implement
electronic portions of the SCU 302) contained within. In this
presently preferred construction, the housing 206 is comprised
of an insulating 60 ceramic tube 260 brazed onto a first end cap
forming electrode 112a via a braze 262. At the other end of the
ceramic tube 260 is a metal ring 264 that is also brazed onto
the ceramic tube 260. The circuitry within, i.e., a capacitor
183 (used when in a micro stimulator mode), battery 104, IC
chips 216, and a spring 266 is attached to an opposing
second end cap forming electrode 112b. A drop of conductive
epoxy is used to glue the capacitor 183 to the end cap 112a and
is held in position by spring 266 as the glue takes hold.

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(Schulman ’502, col. 15, l. 55 to col. 16, l. 3.) The Examiner has not
established that either brazing of the ceramic tube or the use of epoxy to glue
the capacitor to the end cap meets the claim limitation of “at least a portion
the capacitor is embedded within a wall of the plastic or polymeric casing.”
Nor has the Examiner provided or pointed to specific evidence in either
Schulman ‘859 or Kuzma showing the capacitor itself embedded in the wall
of the casing.
Rejection 3 is reversed.

Rejection 4
Claims 13, 19, 23 and 25 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Schulman (US 2002/0193859) in view of Zart.
The Examiner acknowledges that Schulman ‘859 does not explicitly
disclose the method steps of placing components in a mold and injection
molding. However, the Examiner finds that
Zart teaches placing metal connector elements in a mold and
injecting plastic or polymer into the mold to form a casing body
(Col. 4, lines 60-68; Col. 5, lines 1-8, 30-43), in order to form
the connector elements integrally with the casing body.
Therefore, it would have been obvious to one with ordinary
skill in the art at the time the invention was made to form the
device of Schulman as taught by Zart to include the steps of
placing metal connector elements in a mold and injecting
plastic or polymer into the mold to form a casing body, in order
to form the connector elements integrally with the casing body.

(Ans. 7-8.)
Appellants argue that “there is no suggestion in Zart to form the case
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body and metal connector in a mold injection process.” (App. Br. 7.) We
are not persuaded.
Schulman ʼ859 teaches each element claimed, including a polymeric
casing body (Ans. 5) but does not teach that the casing body is injection
molded. Zart teaches that it was well known in the art to injection mold
implantable medical devices. (Abstract) While Zart does not teach a metal
connector as claimed, Schulman ʼ859 does.
Appellants have failed to rebut the Examiner’s prima facie case of
obviousness and the rejection of claims 13, 23 and 25 is affirmed.

Claim 19 further requires that the injection of the plastic or polymer
into the mold embeds the capacitor within the case body. Appellants
provide separate argument for claim 19 in the Brief at page 8.
Appellants argue that, “there is no disclosure in Schulman I [‘859]
that the capacitor is placed within the mold, such that the injection of the
plastic or polymer into the mold embeds the capacitor within the case body.”
(App. Br. 8.)
As discussed above with respect to claims 11 and 12, the Examiner
has failed to specifically provide evidence in Schulman ʼ859 of embedding
the capacitor within the case body. Swanson is not cited in this rejection.
For this reason, the rejection of claim 19 is reversed.

Rejection 5
Claim 16 is rejected under 35 U.S.C. § 103(a) as being unpatentable
over Schulman (US 2002/0193859) and Zart in view of Schulman (US
7,114,502).
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Appellants argue that
Schulman I [ʼ859] and Zart do not disclose, teach, or
suggest injecting a plastic or polymer into a mold to form a
casing body that contacts the first metal connector, thereby
forming an implantable casing having an interior cavity, as
required by independent claim 13 from which claim 16
depends, and Schulman II [ʼ502] does not supplement
Schulman I and Zart in a manner that would render claim 16
obvious.

(App. Br. 9.)

Having found no deficiency in the rejection of claim 13, the rejection
of claim 16 is also affirmed.

Rejection 6
Claims 18 and 20 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859) and Zart (US 6,817,905) in
view of Swanson.
Claim 18 recites that, “injection of the plastic or polymer into the
mold embeds the coil within the case body.” As discussed with respect to
the rejection of claims 11 and 12 we found that the Examiner failed to show
this limitation in Schulman ʼ859. We did find however, that Swanson
discloses embedding the coil within the case body. (Rejection 2 above.) For
this reason, the rejection of claims 18 and 20 is affirmed.

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Rejection 7
Claims 21 and 22 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859) and Zart in view of
Kuzma.
Appellants argue that
Schulman I [‘859] and Zart do not disclose, teach, or
suggest injecting a plastic or polymer into a mold to form a
casing body that contacts the first metal connector, thereby
forming an implantable casing having an interior cavity, as
required by independent claim 13 from which claims 21 and 22
depend, and Kuzma does not supplement Schulman I [‘859]
and Zart in a manner that would render claims 21 and 22
obvious.

(App. Br. 11.)
Kuzma discloses the claimed metal connector. (Claim 1.) Shulman
‘859 and Zart disclose forming an implantable medical device using
injection molding. “Appellant maintains that the Examiner erred in rejecting
claims 21 and 22 under 35 U.S.C. §103(a) as being obvious over Schulman
I, Zart, and Kuzma for at least the same reasons stated above with respect to
claim 13.” (Reply Br. 5.) Having found no deficiency in the rejection of
claim 13 (Rejection 4 above), the rejection of claims 21 and 22 is also
affirmed.

Rejection 8
Claims 24, 26, and 29 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Schulman (US 2002/0193859) and Zart or Kuzma as
combined above, and further in view of Schulman ʼ284.
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Appellants do not address this rejection in the Brief or Reply Brief
and therefore, rejection 8 is summarily affirmed.

CONCLUSION OF LAW
The rejections of claims 1, 7, 9, 10, 13, 16, 18, and 20-29 are
affirmed. The rejections of claims 3, 11, 12 and 19 are reversed.
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

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