Ex Parte Ritchey et al

Patent Trial and Appeal Board

Oct 11, 2017

13123792 (P.T.A.B. Oct. 11, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/123,792 10/06/2011 Nicholas S. Ritchey 8178SN3684 1033
96878 7590 10/13/2017
Smith & Nephew, Inc. - KDB
1450 Brooks Road
Memphis, TN 38116
EXAMINER
BRUTUS, JOEL F
ART UNIT PAPER NUMBER
3786
NOTIFICATION DATE DELIVERY MODE
10/13/2017 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):
Patents.Dept.US@smith-nephew.com
docketing @ kbdfirm. com
mbotnaru @kdbfirm.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NICHOLAS S. RITCHEY, SIED W. JANNA,
CHARLES C. HEOTIS, and HOA LA WILHELM
Appeal 2015-0007771
Application 13/123,7922
Technology Center 37003
Before MICHAEL C. ASTORINO, PHILIP J. HOFFMANN, and
KEVIN W. CHERRY, Administrative Patent Judges.
CHERRY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Nicholas S. Ritchey et al. (“Appellants”) seek review under
35 U.S.C. § 134(a) of a Non-Final Rejection of claims 1—13 and 15—21, the
only claims pending in the application on appeal. We have jurisdiction over
1 Our decision references the Appellants’ Appeal Brief (“Br.”), filed July 9,
2014, a Non-Final Action (“Non-Final Act.”), mailed October 9, 2013, and
the Examiner’s Answer (“Ans.”), mailed August 13, 2014.
2 Appellants’ Appeal Brief identifies Smith & Nephew, Inc. as the real-
party-in-interest (Br. 1).
3 The record includes a transcript of the oral hearing held May 16, 2017
(“Tr.”).
Appeal 2015-000777
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the appeal pursuant to 35 U.S.C. § 6(b). Appellants appeared for oral
hearing on May 16, 2017.
We AFFIRM.
Appellants’ claimed invention “relates to identification of blind
landmarks on orthopaedic implants” (Spec. 12).
Claims 1,16, and 20 are the independent claims at issue in this appeal.
Claim 1 is illustrative of the subject matter on appeal and is reproduced
below.
1. A system for targeting a landmark on an orthopaedic implant
comprising:
an autoclavable device comprising:
an autoclavable housing comprising an outer covering; and
a field generator for generating an electromagnetic field, the
field generator
comprising a plurality of magnetic field generating elements
disposed within the outer covering of the housing;
wherein the autoclavable device is configured to be operable
after being subjected to autoclave sterilization;
a first electromagnetic sensor for disposition at a set distance
from the landmark that generates sensor data in response
to the generated electromagnetic field; and
an element removably coupled to the housing, the element
defining a longitudinal axis that represents one axis of the
generated electromagnetic field, wherein the system is
configured to use the one axis of the generated
electromagnetic field to determine the position of the
element relative to the landmark.
(Br. 15, Claims App.).
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Rejections
Claims 1—13 and 15—21 stand provisionally rejected on the ground of
non-statutory double patenting as being unpatentable over claim 1 of co­
pending Application No. 12/758,7474 in view of Feine (US 2008/0015551
Al, pub. Jan. 17, 2008). Non-Final Act. 2—6.
Claims 1—7, 9—13, 16, 18, and 19 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Govari (US 2004/0034355 Al,
pub. Feb. 19, 2004), Feine, and Jensen (US 2007/0162018 Al, pub. July 12,
2007). Id. at 6-14.
Claim 8 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Govari, Feine, Jensen, and Cho (US 2003/0135211 Al,
pub. July 17, 2003). Id. at 15.
Claim 15 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Govari, Feine, Jensen, and Milbocker (US 2008/0221628
Al, pub. Sept. 11, 2008). Id. at 15—16.
Claims 17, 20, and 21 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Govari, Feine, Jensen, and Protopsaltis
(US 2008/0154266 Al, pub. June 26, 2008). Id. at 16-19.
ANALYSIS
I. Double Patenting
Claims 1—13 and 15—21 stand provisionally rejected on the ground of
non-statutory double patenting as being unpatentable over claim 1 of co­
pending Application No. 12/758,747 in view of Feine. Non-Final Act. 2—6.
4 Now US 9,031,637 B2, issued May 12, 2015 to Ritchey.
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Appellants do not traverse the double patenting rejection. Accordingly, we
summarily sustain the double patenting rejection.
II. Obviousness
A. Obviousness over Govari, Feine, and Jensen
Claims 1—7 and 9—13
Independent claim 1 recites “an autoclavable device comprising: an
autoclavable housing” that includes an “outer covering.” The autoclavable
device also includes “a field generator for generating an electromagnetic
field,” with the field generator including “a plurality of magnetic field
generating elements” (claim 1) within the outer covering. Claim 1 recites
that “the autoclavable device is configured to be operable after being
subjected to autoclave sterilization.” Appellants argue that it would not have
been obvious to combine Govari with Feine because the proposed
modifications to Govari would render Govari inoperative for its intended
purpose (Br. 5—6). Specifically, Appellants argue that Feme’s moveable pin
transducer 100 is not capable of enabling surgical positioning in Govari’s
system (id. at 6). We disagree.
As the Examiner explained Feine is relied on for its teaching of an
autoclavable device with a plurality of magnetic field generating elements
disposed within the housing and an outer covering (Ans. 20). As the
Examiner found, a person of ordinary skill would have been motivated to
substitute Feme’s magnetic field generating elements disposed in the
housing and outer cover into the device of Govari “in order to generate
magnetic fields simultaneously; therefore, reducing the procedure time and
having the autoclave device configured to be operable after being subjected
to autoclave sterilization and to use an outer covering; in order to protect the
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electronics from corrosion and to reduce contamination and to facilitate
sterilization” (Ans. 9). It is not required that the features of Feine be deemed
equivalent for the purposes of substitution into Govari’s device. See In re
Mouttet, 686 F.3d 1322, 1332 (Fed. Cir. 2012) (“It is well-established that a
determination of obviousness based on teachings from multiple references
does not require an actual, physical substitution of elements.” (Collecting
cases)). “Rather, the test for obviousness is what the combined teachings of
the references would have suggested to those having ordinary skill in the
art.” Id. at 1333. We agree with the Examiner that Feine teaches coils
located in the housing and outer covering (see Feine | 51, Fig. 3). Feine
further teaches that “electromagnetic fields in each coil (304A-304D) can be
precisely manipulated” and that “[s]uch manipulation of magnetic fields is
well known by one of ordinary skill in the art” (Feine | 54), which
contradicts Appellants’ contentions about the limitations of Feme’s coils.
The only evidence that Appellants cite for supporting their argument
that the combined device would be inoperable is the declaration of one of the
named inventors, Mr. Charles Heotis (see Br. 6 (citing Declaration of
Charles C. Heotis (“Heotis Decl.”) Tflf 7—10)). However, we do not find the
Heotis Declaration persuasive because it rests mainly on arguments and is
unsupported by sufficient evidence in the record. See Heotis Decl. 117-10;
see also In re Am. Acad. ofSci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir.
2004) (“[T]he Board is entitled to weigh the declarations and conclude that
the lack of factual corroboration warrants discounting the opinions expressed
in the declarations.” (Citations omitted)); In re Etter, 756 F.2d 852, 860
(Fed. Cir. 1985) (en banc) (opinion affidavit asserting the reference
disclosed obsolete technology was correctly characterized by the board “as
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merely representing opinion[] unsupported by facts and thus entitled to little
or no weight” (citations omitted)); Ashland Oil, Inc. v. Delta Resins &
Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985) (“Lack of factual
support for expert opinion going to factual determinations, however, may
render the testimony of little probative value in a validity determination.”).
In particular, the declaration does not provide any experimental results or
cite to any verifiable sources as the bases for Mr. Heotis’s opinions and
disagreement with the Examiner’s analysis and factual findings.
Appellants further argue that “it would not have been obvious to use
Feme’s outer covering in Govari’s system because a covering designed to
limit electromagnetic interference (EMI)[] would impede the transmission of
electromagnetic fields necessary for Govari’s system to operate” (Br. 7).
Appellants assert that there is no evidence to support the Examiner’s finding
that Feme’s cover would not impede the transmission of magnetic fields,
which are necessary for the operation of Govari (id.). We do not find this
argument persuasive. Contrary to Appellants’ assertions, Feine expressly
discloses that the elastomeric covering allows the transmission of
electromagnetic fields (see Feine 156). As Appellants explain, Feine
requires that magnetic rod within the well of the handpiece vibrate through
its interaction with the electromagnetic fields generated by the coils (Br. 6
(citing Feine 151)). As the Examiner noted, Feine teaches that the well that
holds the magnetic rod is lined with the elastomer (Ans. 20—21 (citing Feine
156)). Thus, the magnetic field has to be transmitted through the elastomer
to reach the magnetic rod (see Feine H 51, 56). The testimony of
Mr. Heotis to the contrary is not persuasive because it is conclusory and
contradicts the plain disclosure of Feine that the magnetic field can pass
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through the elastomeric coating and reach the magnetic rod. See Network
Commerce, Inc. v. Microsoft Corp., 422 F.3d 1353, 1361 (Fed. Cir. 2005)
(“[Ejxpert testimony at odds with the intrinsic evidence must be
disregarded.”).
Appellants also argue that it “would not have been obvious to modify
Govari’s system to include an autoclavable device that includes a field
generator and that is ‘configured to be operable after being subjected to
autoclave sterilization,’ because of the difficulty of maintaining a proper
arrangement of magnetic field generating elements under autoclave
conditions” (Br. 8). Appellants contend that “[o]ne of ordinary skill would
have recognized that autoclave sterilization would cause thermal expansion
and contraction and other detrimental effects that would tend to shift the
location and orientation of the magnetic field generator modules 30” {id.
(citing Declaration of Nicholas S. Ritchey (“Ritchey Decl.”) Tflf 5, 11—15)).
Appellants further argue that “others in the field teach away from autoclave
sterilization of distal targeting equipment” {id.). Appellants point to the user
manual of the “Ekliptik LIDIS system” as “explicitly wam[ing] against
using autoclave sterilization for its electromagnetic components” {id. at 8—9
(citing Ritchey Decl. 18—23, Exhibit C, 7, 32)).
We do not find these arguments persuasive. Appellants’ arguments
rely on the testimony of Mr. Ritchey, one of the named inventors, that
autoclaving would damage the electrical elements of the electrical elements
of the field generator {see id. at 9 (citing Ritchey Decl. Tflf 5, 11—15)).
However, we do not find the Ritchey Declaration persuasive because it rests
mainly on argument and is unsupported by sufficient evidence in the record.
See Ritchey Decl. 25, 11—15; see also In re Am. Acad, of Sci. Tech Ctr.,
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367 F.3d at 1368; In re Etter, 756 F.2d at 860; Ashland Oil, 776 F.2d at 294.
In particular, the affidavit does not provide any experimental results or cite
to any verifiable sources as the bases for Mr. Ritchey’s opinions and
disagreement with the Examiner’s analysis and factual findings.
Appellants also cite the Ekliptik LIDIS system user manual, but this
user manual does not cure the problems with Mr. Ritchey’s testimony for
several reasons. First, as Appellants conceded, the Ekliptik LIDIS system is
not the system described in Govari (Tr. 12:1—11). At best, Appellants
argued that the Ekliptik LIDIS system is “something similar” (id.), but there
is no evidence provided to support this contention that it is “something
similar” (see Ritchey Decl. ]Hf 18—23 (discussing the Ekliptik LIDIS
system)). Second, although the Ekliptik LIDIS system user manual does
caution against autoclaving certain parts of the system, no explanation or
reason is given in the cited portions of the user manual for why that is the
case. Thus, the Ekliptik LIDIS system user manual fails to provide
persuasive support for Mr. Ritchey’s contention that autoclaving will
damage the electrical elements of the field generator.
Accordingly, Appellants fail to persuade us that the Examiner erred in
rejecting claim 1, and we sustain the rejection of claim 1.
Claims 2—7 and 9-13 all depend from claim 1. Appellants do not
argue claims 2—7 and 9—13 separately apart from the arguments considered
above with respect to claim 1. Thus, for the reasons stated above with
respect to claim 1, we sustain the rejection of claims 2—7 and 9—13.
Claims 16, 18, and 19
As an initial matter, Appellants also argue that rejections of claims 16,
18, and 19 should be reversed for the reasons discussed above with respect
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to claim 1. Just as with claim 1, independent claim 16 recites “an
autoclavable device comprising: an autoclavable housing” that includes an
“outer covering.” The autoclavable device also includes “a field generator
for generating an electromagnetic field,” with the field generator including
“at least three induction coils” (claim 16) within the outer covering.
Claim 16 also recite that “the autoclavable device is configured to be
operable after being autoclaved multiple times.” Although there are
differences between claim 1 and claim 16, Appellants do not contend that
those differences affect the arguments considered with respect to claim 1,
regarding the inoperability of the combination, the lack of a reason to
modify Govari, or the technical challenges of the proposed combination.
Thus, for the same reasons discussed above with respect to claim 1, we find
those arguments unpersuasive.
In addition the arguments considered above, Appellants also argue
that the rejections of claims 16—19 should be reversed for the additional
reason that the combination of Govari, Feine, and Jensen does not teach or
suggest “an autoclavable internal mounting structure formed of a non­
magnetic material” where induction coils are “mounted to the autoclavable
internal mounting structure” (Br. 9—11). Appellants argue that the
Examiner’s rejection is based on “at least three flawed and misleading
interpretations of [Feine]” {id. at 10). Appellants contend that (1) “[Feine]
does not disclose that any internal mounting structure is formed of
elastomeric material;” (2) “[Feine] does not disclose that [Feme’s] ‘outer
covering’ is formed of elastomeric material;” and (3) “[Feine] does not
disclose that elastomeric material can ‘limit electromagnetic interference’ as
the Examiner alleges” {id.). Appellants argue that, instead, Feine only
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discloses the well can be lined with an elastomeric material (id.). Appellants
further assert that “[Feine] does not indicate what material forms the
handpiece body 306 . . . [and] [t]here is no evidence to support the
Examiner’s assertion that the handpiece body 306 is formed of a non­
magnetic material” (id.).
We do not find Appellants’ argument persuasive. As the Examiner
explained, paragraph 56 of Feine describes that “well 302 can be [lined] with
[an] elastomeric material,” and Figure 3 shows well 302 formed of a single
piece of material (Ans. 13, 20—22). Thus, we agree with the Examiner that
Feine suggests that well 302 can be formed of an elastomeric material.
Further, Feine teaches that the coils “can be formed within the handpiece
body 306 and/or disposed at least partially within the well 302” (Feine 1 56).
We further agree with the Examiner that Feine suggests that the coils can be
formed into and supported by an elastomeric material. Feine also discloses
that the handpiece 300 can be formed of a single material (id.). In view of
Feme’s suggestion that the well can be formed of an elastomeric material,
we agree with the Examiner’s inference that the entire body can be formed
of an elastomeric material (Ans. 12—13, 20—22). Furthermore, we agree with
the Examiner that Feine discloses that the entirety of the handpiece can be
autoclavable and can include an outer covering to limit electromagnetic
interference (EMI) (id. at 12—13 (citing Feine 1 56). Appellants do not
dispute that an elastomer is a non-magnetic material. Appellants identify no
evidence, other than Feine, that the Examiner’s findings are in error.
However, as we have explained, we agree with the Examiner’s reading and
understanding of what Feine would suggest to a person of ordinary skill in
the art. Accordingly, although Appellants are correct that Feine does not
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expressly state that the body is formed of an elastomeric material that is
autoclavable, we find that the Examiner’s reading of Feine and reasoning are
reasonable and supported by paragraph 56 Feine. Appellants have failed to
point to any persuasive evidence showing that the Examiner’s reading of
Feine is incorrect. Thus, we sustain the rejection of claims 16, 18, and 19.
B. Obviousness of Claim 8 over Govari, Feine, Jensen, and Cho
Aside the arguments raised regarding independent claim 1, from
which claim 8 depends, Appellants do not argue the rejection of claim 8 over
Govari, Feine, Jensen, and Cho separately. For the reasons stated above
regarding the rejection of claim 1, we sustain the rejection of claim 8.
C. Obviousness of Claim 15 over Govari, Feine, Jensen, and
Milbocker
Aside the arguments raised regarding independent claim 1, from
which claim 15 depends, Appellants do not argue the rejection of claim 15
over Govari, Feine, Jensen, and Milbocker separately. For the reasons stated
above regarding the rejection of claim 1, we sustain the rejection of
claim 15.
D. Obviousness of Claims 17, 20, and 21 over Govari, Feine, Jensen,
and Protopsaltis
Claims 20 and 21
As an initial matter, Appellants also argue that rejections of claims 20
and 21 should be reversed for the reasons discussed above with respect to
claim 1. Just as with claim 1, independent claim 20 recites “an autoclavable
device comprising: an autoclavable housing” that includes an “outer
covering.” The autoclavable device also includes “a field generator for
generating an electromagnetic field,” with the field generator including “at
least three induction coils” (claims 20) within the outer covering. Claim 20
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also recite that “the autoclavable device is configured to be operable after
being autoclaved multiple times.” Although there are differences between
claim 1 and claim 20, Appellants do not contend that those differences affect
the arguments considered with respect to claim 1, regarding the inoperability
of the combination, the lack of a reason to modify Govari, or the technical
challenges of the proposed combination. Thus, for the same reasons
discussed above with respect to claim 1, we find those arguments
unpersuasive.
In addition to the arguments presented with respect to all of the
combinations based on Govari, Appellants also argue that the rejections of
claims 20 and 21 should be reversed because the combination of Govari,
Feine, Jensen, and Protopsaltis does not teach or suggest an “autoclavable
outer covering formed of silicone” having “at least three induction coils and
the autoclavable internal mounting structure being encapsulated in the
autoclavable outer covering,” as recited in claim 20 (Br. 11—12). Appellants
argue that it would not have been obvious to modify Govari and Feine to
include the “autoclavable outer covering formed of silicone” based on
Protopsaltis {id. at 11). Appellants assert “[t]he primary functions of
Protopsaltis’ sheath are irrelevant to the devices of Govari and [Feine],”
because “[t]he devices of Govari and [Feine] have no ‘curable material’ that
needs to be contained, and have no need for shape to be controlled ‘prior to
completion of curing’ as Protopsaltis’ implant does” {id. (citing Protopsaltis
1 52)). Appellants further contend that the “devices of Govari and [Feine]
are surgical instruments, not implants, and so have no need to be suitable for
long-term implantation” {id. at 12). We do not find these arguments
persuasive. As the Examiner explained, Feine discloses that “coils 304A-
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304D . . . can be formed . . . within well 302 which can be made with
elastomeric material” (Ans. 17 (citing Feine 1 56, Fig. 3)). Protopsaltis is
only relied upon to support the Examiner’s contention that it was well-
known in the medical arts to construct medical devices that have outer
coverings made of silicone, a type of elastomer, which can be sterilized {id.
at 18 (citing Protopsaltis 1110, claim 17)). The fact that Protopsaltis is not
directed to same precise device as Govari and Feine is beside the point. “A
reference may be read for all that it teaches, including uses beyond its
primary purpose.” In re Mouttet, 686 F.3d at 1331 (citing KSR Int’l Co. v.
Teleflex, Inc., 550 U.S. 398, 418—21 (2007)). Protopsaltis teaches that outer
coverings for medical devices that can be sterilized can be made from
silicone. The Examiner relies on Govari, Feine, and Jensen to teach or
suggest the other limitations of the claims. As for Appellants’ contention
that there is reason to combine the references, we disagree. As the Examiner
explained and we discussed above with respect to claim 16, Feine suggests
that its coils can be housed in an elastomeric material (Feine 156). Silicone
is a type of elastomeric material, and is well-known for its use in medical
devices (see Ans. 22). The Examiner further reasoned that a person of
ordinary skill would be motivated use such a covering because these
materials allow the feeding of energy and such a material is well-known
(id.). This type of reasoning is sufficient because the use of silicone as a
covering of a medical device is, as demonstrated by Protopsaltis, simply
using a known technique to improve a device in a known way with
predictable results. See KSR, 550 U.S. at 416.
Finally, Appellants argue that the Examiner’s proposed modification
in view of Protopsaltis represents impermissible hindsight (Br. 12). We
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disagree. As we explained above, the Examiner has provided articulated
reasoning with rational underpinnings to support the combination of Govari,
Feine, Jensen, and Protopsaltis. Moreover, Appellants do not identify any
knowledge relied upon by the Examiner that was gleaned only from
Appellants’ disclosure and that was not otherwise within the level of
ordinary skill at the time of the invention. See In re McLaughlin, 443 F.2d
1392 (CCPA 1971). As such, we are not persuaded by Appellants’ assertion
that the Examiner relied on impermissible hindsight in reaching the
determination of obviousness. Thus, we sustain the rejection of claims 20
and 21.
Claim 17
Appellants argue that, in addition to the arguments discussed above
regarding independent claim 16, from which claim 17 depends, claim 17 is
also patentable because the combination of Govari, Feine, Jensen, and
Protopsaltis does not teach or suggest that an “autoclavable outer housing
body is formed of silicone,” as recited in claim 17. For the reasons
discussed above with respect to the same limitation in claims 20 and 21, we
are not persuaded that the combination fails to teach or suggest that an
“autoclavable outer housing body is formed of silicone.” Thus, we sustain
the rejection of claim 17.
DECISION
The Examiner’s decision to reject claims 1—13 and 15—21 is affirmed.
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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)(l)(iv).
AFFIRMED
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