Ex Parte Hughes et al

Patent Trial and Appeal Board

May 30, 2017

13087284 (P.T.A.B. May. 30, 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.
13/087,284 04/14/2011 Michael Dean Hughes PT-3763-US-NP 5887
23715 7590 06/01/2017
SARRTNA fTT A MRFRS
EXAMINER
SMITH & NEPHEW, INC. BATES, DAVID W
1450 EAST BROOKS ROAD
MEMPHIS, TN 38116 ART UNIT PAPER NUMBER
3775
NOTIFICATION DATE DELIVERY MODE
06/01/2017 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
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL DEAN HUGHES and
JEFFREY A. SHARP
Appeal 2015-003017
Application 13/087,2841
Technology Center 3700
Before LINDA E. HORNER, JASON W. MELVIN, and
BRENT M. DOUGAL, Administrative Patent Judges.
MELVIN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal arises under 35 U.S.C. § 134(a), from final rejections of
claims 1—5 and 28—38. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 Appellants identify Smith & Nephew, Inc., as the real party in interest.
Appeal Br. 2.
Appeal 2015-003017
Application 13/087,284
BACKGROUND
The claims are directed to a system for patient-based computer-
assisted surgical procedures. Claim 1, reproduced below, is representative:
1. A patient-matched surgical guide for registering a location
of a patient’s bone, the surgical guide comprising:
an inner surface that conforms to the patient’s bone; and
a registration site formed in a non-bone contacting surface
that receives a registration tool of a medical device for
communicating the location of that registration tool to a
processor,
wherein the registration site includes a registration point that
corresponds to a reference marker described in an image
of the patient’s bone, and
wherein the registration site does not extend to the inner
surface.
App. Br. A1 (Claims App’x).
REJECTIONS
Appellants seek review of the following rejections:
1. Claims 1—3 and 28—36 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Tschakaloff (U.S. Pat. No. 5,290,281, iss. Mar. 1,
1994). Final Act. 2—5.
2. Claims 1—5 and 28—36 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Tschakaloff and Metzger (U.S. Pat. Pub. No.
2007/0288030 Al, pub. Dec. 13, 2007). Final Act. 6.
3. Claims 37 and 38 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Tschakaloff and Bainville (U.S. Pat. No.
5,564,437, iss. Oct. 15, 1996). Final Act. 7.
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4. Claims 37 and 38 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Tschakaloff, Metzger, and Bainville. Final
Act. 7.
DISCUSSION
Tschakaloff’s teachings
The Examiner finds that Tschakaloff teaches the surgical guide of
claim 1 and reasons that multiple aspects of the claim, such as the processor
and medical device are “not positively recited.” Final Act. 2-3. As to other
aspects of the claim, the Examiner reasons that the “corresponds to”
language is “essentially non-limiting requiring only that some sort of
relationship exists between components.” Id. The Examiner further reasons
that the “‘reference marker described in an image’ does not require any
particular object other than the image.” Id. at 4.
Appellants argue first that Tschakaloff does not teach a “patient-
matched” surgical guide because the component in Tschakaloff is generic
until it is heated to cause it to conform to a patient’s bone during a
procedure. App. Br. 6—8. According to Appellants, a person of skill in the
art would understand a patient-matched guide “to be customized to match
the unique anatomy of a specific patient.” Id. at 7. The Examiner, however,
finds that Tschakaloff teaches such a device. Final Act. 2 (“matched by
conforming it to the underlying bone”). Although Appellants argue that a
patient-matched guide must be preoperatively matched to a specific patient
(App. Br. 7 (contrasting intraoperative customization)), that requirement
does not appear in claim 1 and Appellants do not offer persuasive evidence
that a person of skill would only understand “patient-matched surgical
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Application 13/087,284
guide” as a preoperatively matched patient guide. Accordingly, we do not
agree that the Examiner fails to show that Tschakaloff teaches a patient-
matched guide.2
Appellants argue next that the Examiner errs in finding that
Tschakaloff teaches a registration site corresponding to a reference marker
in an image. App. Br. 8—11. We agree with Appellants. As Appellants
note, Tschakaloff does not teach an image. App. Br. 12; see Ans. 11. In
some aspects of the rejection, the Examiner appears to agree that the claims
require an image. See Final Act. 4 (“The limitation ‘reference marker
described in an image’ does not require any particular object other than the
image.”). The Examiner “takes official notice of use of bone imaging . . .
prior to any orthopedic surgery and considers the presence of such an image
to be essentially inherent to any surgical procedure.” Final Act. 3.
As an initial matter, “official notice” is not proper in an anticipation
rejection. See In reMorsa, 803 F.3d 1374, 1380 (Fed. Cir. 2015) (Newman,
J., dissenting) (explaining that official notice cannot substitute for the
required inherency analysis). Further, the Examiner offers no evidence to
support a finding that orthopedic surgeries necessarily involve imaging. See
Continental Can Co. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991)
(“[Ejvidence [supporting inherency] must make clear that the missing
descriptive matter is necessarily present in the thing described in the
reference, and that it would be so recognized by persons of ordinary skill.”).
2 The Examiner further reasons that a “patient-matched” guide would also
read on a “generally linear plate” because it would match a “hypothetical
generally linear piece of bone.” Ans. 9. While we need not decide the issue,
we do not agree that the claim reads on such generic, noncustomized plates.
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Application 13/087,284
Thus, the Examiner has not adequately shown that Tschakaloff teaches an
image of the patient’s bone.
Beyond concluding that Tschakaloff inherently teaches an image, the
Examiner also appears to interpret claim 1 as broadly reciting a surgical
guide with registration points that are merely capable of corresponding with
reference markers in an image. See Ans. 10—12. We do not agree with this
interpretation. Rather, the claim requires that registration points (and thus
the registration sites in the claimed guide) actually correspond to reference
markers in an image. The Specification supports this understanding. E.g.,
Spec. 1110 (“registration points chosen so as to correspond to related
reference markers of the three-dimensional model,” “The surgeon selects the
reference marker site in the graphical computer image of the bone then
generates the guide body with a point that corresponds to that site.”), 52
(“locations of these markers 59a-f are selected to correspond with certain
anatomic landmarks or articulating surfaces of the femur 51 and tibia 55”).
Accordingly, without teaching an image, Tschakaloff cannot anticipate
claim 1, and we therefore do not sustain the rejection of claim 1 under § 102.
The Examiner’s rejection of dependent claims 2, 3, and 28-36 under
§102 and rejection of claims 37 and 38 under § 103 based on Tschakaloff
and Bainville rely on the same findings regarding Tschakaloff discussed
above. Accordingly, for the same reasons, we do not sustain those
rejections.
The combination of Tschakaloff and Metzger
The Examiner finds that Metzger teaches use of CT or MRI imaging
for a bone and joint involved in an orthopedic procedure. Final Act. 6. The
Examiner further finds that a person of skill would have used the image of
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Application 13/087,284
Metzger because it would “provide the surgeon with a view of the patient’s
bones prior to the surgery to permit the surgeon to plan for the particular
situation of the procedure to be performed.” Id. The Examiner reasons that
although claim 1 does not “positively recite” an image, the rejection under
§103 includes a reference teaching an orthopedic image so that “provision
of some image is now provided for.” Ans. 12.
Appellants argue that simply adding an image of the patient’s bone
“does not mean that one of skill would take the next step: forming a
registration site in a patient-matched surgical guide that corresponds to a
reference marker in that image.” App. Br. 13—14. We agree with Appellants
that simply including an image does not account for the limitation requiring
that the claimed guide have a registration point that corresponds to a
reference marker in an image. Id. Thus, the language of claim 1 does not
read on the combination applied by the Examiner. Accordingly, we do not
sustain the rejection of claim 1 under § 103 based on a combination of
Tschakaloff and Metzger.
The Examiner’s rejection of dependent claims 2-5 and 28-36 based
on the combination of Tschakaloff and Metzger, and rejection of claims 37
and 38 based on Tschakaloff, Metzger, and Bainville both rely on the same
findings regarding Tschakaloff and Metzger discussed above. Accordingly,
for the same reasons, we do not sustain those rejections.
DECISION
For the above reasons, the Examiner’s rejections of claims 1—5 and
28—38 are reversed.
REVERSED
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