Ex Parte McCombs

Patent Trial and Appeal Board

May 3, 2016

12944799 (P.T.A.B. May. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/944,799 11/12/2010 DANIELL. McCOMBS
30559 7590 05/03/2016
SABRINA CHAMBERS
SMITH & NEPHEW, INC.
1450 BROOKS ROAD
MEMPHIS, TN 38116
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
0131-0940 6413
EXAMINER
SKIBINSKY, ANNA
ART UNIT PAPER NUMBER
1631
MAILDATE DELIVERY MODE
05/03/2016 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 DANIEL L. McCOMBS
Appeal2013-009552
Application 12/944, 799
Technology Center 1600
Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and JOHN G.
NEW, 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).
We affirm-in-part.
Appeal2013-009552
Application 12/944,799
STATEMENT OF CASE
The following claims are representative.
14. A system for planning a custom surgical procedure
compnsmg:
a user interface that receives input for planning the
custom surgical procedure, wherein the custom surgical
procedure comprises cutting a bone via one or more resections
at non-standard locations or orientations using a custom cutting
guide or a custom cutting block, wherein cutting the bone
according to the custom surgical procedure allows attachment
of a custom medical implant having an internal bone contacting
geometry to the bone, wherein the user interface receives
information about sensitivity of the surgical procedure with
respect to the resections at non-standard locations;
a display component that outputs a visual representation
of the custom medical implant-relative to the bone; and
wherein the user interface is configured to receive and
display a planned adjustment to the one or more resections to
the bone on the outputted visual representation and to display a
planned change to the internal bone contacting geometry of the
medical implant based on the planned adjustment to the one or
more resections, wherein the system determines whether the
planned adjustment is acceptable based at least in part on the
sensitivity of the surgical procedure with respect to the one or
more resections.
22. The system of claim 14 further comprising a
component for comparing a custom medical implant to
available standard implants to identify an acceptable standard
implant.
23. The system of claim 14 wherein the system is
configured to generate manufacturing instructions.
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Cited References
Rybicki et al.
Masini
Mire et al.
Zaddem et al.
us 4,011,602
us 5,885,296
US 2004/0171924 Al
US 6,827,723 B2
US 2006/0058575 Al,
Mar. 15, 1977
Mar. 23, 1999
Sept. 2,2004
Dec. 7, 2004
Mar. 16, 2006
Michael C. Durkin, MD, Sensitivity and Error Anaylysis in Conjutction with
Tibial Intramedullary Guides in Total Knee Arthroplasty, 13 J. OF
PROSTHETICS AND ORTHOTICS (2) (2001).
Grounds of Rejection
3-17.
1. Claims 14--17 and 21 are rejected under 35U.S.C.§103(a) as
being unpatentable over Carson in view of Durkin.
2. Claim 18 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Carson in view of Durkin and Zaddem.
3. Claim 19 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Carson in vie\~1 of Durkin and P'"-ybicki.
4. Claim 20 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Carson in view of Durkin and Masini.
5. Claims 22-23 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Carson in view of Durkin and Mire.
FINDINGS OF FACT
The Examiner's findings of fact are set forth in the Answer at pages
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
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Serial No. 12/944,799
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
"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).
"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'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Rejection 1
We select claim 14 as representative of Rejection 1, as Appellant
provides no separate argument for other claims in Rejection 1. We agree
with the Examiner's fact finding, statement of the rejection and responses to
Appellant's arguments as set forth in the Answer. We find that the
Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment to the
Examiner's argument set forth in the Final Rejection and Answer.
The Examiner relies on Carson for the disclosure of each claim
limitation (Ans. 6-9), except the Examiner finds that, "Carson do[ es] not
teach accepting adjustments by taking into account (i.e. based on) the
sensitivity of the surgical procedure with respect to the resections at non-
standard locations, as in claim 14." Ans. 8. Thus, the Examiner relies on
Durkin for teaching sensitivity and error analysis in conjunction to knee
surgery guides. Ans. 9.
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The Examiner concludes that
It would have been obvious to one of ordinary skill in the art at
the time the invention was made to have implemented the
surgical anatomy and implant imaging system of Carson with
the measurements of error as a result of skewed implant
placement (i.e. surgical sensitivity) as taught by Durkin et al.
Durkin et al. provide motivation by teaching that knowledge of
measured error can reduce component malpositioning
(Abstract). One of skill in the art would have had a reasonable
expectation of success at utilizing the systems of Carson and
Durkin because both teach surgical image systems.
Ans. 9--10.
Appellants argue that
It is clear that the sensitivity referred to in the last clause of claim 14
refers back to and derives antecedent basis from the earlier introduced
"sensitivity of the surgical procedure with respect to the resections at
non-standard locations." Thus, it is clear that claim 14 requires a
system that determines whether a planned adjustment to a resection is
acceptable based at least in part on the sensitivity of the surgical
procedure with respect to the locations of the one or more resections.
Neither Carson nor Durkin teach or suggest such a
determination.
App. Br. 6. In response, the Examiner argues that
The instant specification does not provide a definition of
"sensitivity" and only describes the term in relation to "the sensitivity
of the surgical procedure to changes in technique and implant
attributes, and the sensitivity of the medical device's performance to
changes in implant attributes and surgical procedure" (par. 9, page 3,
specification filed 11/12/2010), which provides support for the
examiner's interpretation of sensitivity as applied to the
procedure/technique itself. The specification also discloses
"sensitivity of the surgical procedure to changes in specialists and "the
sensitivity of the implant's performance to changes in implant
dimension" (par. 18, amendments to the Specification filed
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11/12/2010). Nowhere does the instant specification describe
sensitivity as being related to a location (nonstandard or standard) of
an implant.
Ans. 14-15. Furthermore, the Examiner finds that
Carson teaches that the system is used during surgery and that the
system suggests modifications to implant size (i.e. which reads on
changes in implant dimensions and custom implant), positioning (i.e.
acceptable design parameters) and techniques (i.e. changes in surgical
technique) to optimize the kinematics (motion) (col. 8, lines 35-34).
This suggests that the system is "sensitive" to the needed implant
dimensions, positions (i.e. parameters) and surgical techniques for
optimal knee motion, as in claims 15, 16, and 17.
Ans. 8. According to Carson,
Such systems and processes, among other things, allow surgeons to
navigate and perform unicompartmental knee arthroplasty using
images that reveal interior portions of the body combined with
computer generated or transmitted images that show surgical
implements, instruments, trials, implants, and/or other
devices located and oriented properly relative to the body
part. Such systems and processes allow, among other things,
more accurate and effective resection of bone, placement
and assessment of trial implants and joint peiformance, and
placement and assessment of performance of actual implants
and joint peiformance.
Carson, col. 1, 11. 28-40 (emphasis added). Durkin provides a method for
making potential rod implant alignment error calculations noting that proper
orientation of the prosthetic components is critical for the longevity of the
total knee arthroplasty. Durkin, p. 56-57. The model allows for accurate
cuts, including tibial bony cuts, in knee arthroplasty. Id., at 59.
In view of the above, it would reasonably appear that the Examiner
has provided evidence to support knowledge in the prior art of a custom
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surgical procedure system displaying a planned changed of the internal bone
contacting geometry of the medical implant based on the planned adjustment
to the one or more resections (more accurate and effective resection of
bone), wherein the system determines whether the planned adjustment is
acceptable based at least in part on the sensitivity of the surgical procedure
with respect to the one or more resections. Durkin does disclose making
potential rod implant alignment error calculations using a mathematical
model prior to implant insertions in order to insure longevity of the
arthroplasty.
The Appellant's Specification does not specifically define
"sensitivity" but does indicate that,
The user interface may further allow medical device manufacturing
specialists and others to participate in the planning process and/or
contribute by providing information about the sensitivity of the
surgical procedure to changes in technique and implant dimensions,
the sensitivity of the implant's performance to changes in implant
dimensions and surgical procedure.
Spec. i-f 18 (emphasis added). Carson as modified by Durkin would
reasonably appear to disclose a surgical computer navigation system for
knee arthroplasty which compensates for implant size (dimensions) to avoid
implant location insertion error and allow for more accurate and effective
resection of bone (i.e., proper resection location of bone based on implant
size). We further note that Appellant does not specifically define the term
"non-standard locations or orientations" in the claim. A procedure, such as
that of Carson or Durkin, which takes into account varying implant size
(custom implants) would reasonably appear to accommodate any size,
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location or orientation of the implant and attendant bone resection, including
non-standard locations or orientations.
We further acknowledge that both the Examiner and Appellant have
presented claim interpretation argument regarding alleged "intended use"
language in claim 14. We need not reach this argument as it would
reasonably appear that one of ordinary skill in the art reading and aware of
the combination of Carson and Durkin, would have found that the cited prior
art discloses a system as in claim 14, providing, "display[ing] a planned
change to the internal bone contacting geometry of the medical implant
based on the planned adjustment to the one or more resections, wherein the
system determines whether the planned adjustment is acceptable based at
least in part on the sensitivity of the surgical procedure with respect to the
one or more resections." In other words, the cited prior art meets the
intended use claimed.
Rejection 1 is affirmed for the reasons discussed above and set forth
in the Final Rejection and Examiner's Answer.
Re} ections 2-4
Appellant essentially presents the same arguments for Rejections 2-5,
as presented for Rejection 1. Br. 13-16. Having found Appellant's
arguments with respect to Rejection 1 unconvincing, for essentially the
reasons discussed above and set forth in the Final Rejection and Answer, we
affirm Rejections 2-5.
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Rejection 5
Claims 22 and 23 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Carson in view of Durkin and Mire.
The Examiner finds that Carson and Durkin et al. do not teach
comparing a custom implant to available implants to identify an acceptable
standard implant, as in claim 22. Ans. 13. The Examiner finds that Carson
and Durkin et al. do not teach manufacturing instructions, as in claim 23. Id.
The Examiner relies on Mire for teaching the selection of an implant based
on an image acquired of a patient and various measurements relating to the
implant to be placed (i-f 8 and claim 28), as in claim 22. Id. Mire is argued
by the Examiner to teach manufacturing specifications for the implant (i-f
81), as in claim 23. Id.
The Examiner concludes that
It would have been obvious to one of ordinary skill in the art at
the time the invention was made to have implemented the system
\~1hich suggests implants as taught by Carson in vie\~1 of Durkin et al.
with the system which compares image and measurement information
to an implant storage system to select an implant as taught by Mire et
al. It would have been obvious to one of skill in the art to substitute
the anatomical image and measurement information used to select the
implant as taught by Mire with the suggested implant information as
taught by Carson wherein the predictable result would be the
matching of data to a database of implants to select the closest implant
that matched the data. One of skill in the art would have had a
reasonable expectation of success at utilizing the system of Carson
and Mire because both teach computerized surgical systems.
Ans. 13-14. Appellants, instead argue that
Paragraph 0081 of Mire, however, does not disclose a system that is
"configured to generate manufacturing instructions," rather, it
discloses the use of "manufacture specifications, such as tolerance
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range of the instruments or positions for implants." The "manufacture
specifications" referred to in paragraph 0081 of Mire appear to be
information such as tolerance ranges supplied by a manufacturer to
specify safe use of an instrument or implant, and have nothing to do
with a system for planning a custom surgical procedure where the
system is configured to "generate manufacturing instructions."
App. Br. 15.
The Examiner does not respond to Appellant's arguments concerning
claims 22 and 23, to further explain how the use of safe zones determined by
manufacture specifications in Mire would have suggested to one of skill in
the art to substitute the anatomical image and measurement information used
to select the implant as taught by Mire with the suggested implant
information as taught by Carson wherein the predictable result would be the
matching of data to a database of implants to select the closest implant that
matched the data.
Accordingly, because the preponderance of the evidence does not
support the Examiner's rejection and Rejection 5, claims 22 and 23, are
reversed.
CONCLUSION OF LAW
The cited references support the Examiner's obviousness rejections
1--4, which are affirmed for the reasons of record. Rejection 5, claims 22
and 23, is reversed.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a).
AFFIRMED-IN-PART
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