Ex Parte Fallin

Patent Trial and Appeal Board

Sep 25, 2017

13444231 (P.T.A.B. Sep. 25, 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
13/444,231 04/11/2012 T. Wade
51640 7590 09/27/2017
SPINE
LERNER, DAVID, et al.
600 SOUTH AVENUE WEST
WESTFIELD, NJ 07090
INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
Fallin SPINE 3.0-500 DIV 1759
EXAMINER
BRAY, STUART SAMUEL
ART UNIT PAPER NUMBER
3733
NOTIFICATION DATE DELIVERY MODE
09/27/2017 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):
eOfficeAction @ ldlkm. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte T. WADE FALLIN
Appeal 2015-005637
Application 13/444,231
Technology Center 3700
Before JOHN C. KERINS, WILLIAM A. CAPP, and
BRENT M. DOUGAL, Administrative Patent Judges.
KERINS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
T. Wade Fallin (Appellant) seeks our review under 35 U.S.C. § 134 of
the final rejection of claims 1—27. We have jurisdiction under 35 U.S.C.
§ 6(b). An oral hearing was conducted on September 20, 2017.
We REVERSE.
Appeal 2015-005637
Application 13/444,231
THE INVENTION
Appellant’s claimed invention is directed to a method for configuring
or selecting one or more implants for implantation into a patient. Claim 1,
reproduced below, is illustrative:
1. A method for configuring or selecting one or more implants
for implantation in an implanted position in a body of a patient,
the method comprising:
positioning a distal portion of a first extender proximate a first
anatomic point within the body, through which the one or more
implants are to pass in the implanted position, the first extender
projecting the first anatomic point to a first projected point
outside the body, the first projected point being located at a
proximal portion of the first extender;
positioning a distal portion of a second extender proximate a
second anatomic point within the body, through which the one or
more implants are to pass in the implanted position, the second
extender projecting the second anatomic point to a second
projected point outside the body, the second projected point
being located at a proximal portion of the second extender;
arranging the first and second extenders such that the first and
second projected points mimick the relative positioning of the
first and second anatomic points; and
configuring or selecting the one or more implants based on
locations of the first and second projected points.
THE REJECTION
The Examiner has rejected:
(i) claims 1—4, 6, 9-11, 13—17, and 21—27 under 35 U.S.C. § 102(e) as
being anticipated by Iott (US 7,758,617 B2, issued July 20, 2010);
(ii) in the alternative, claims 1—4, 6, 9-11, 13—17, and 21—27 under 35
U.S.C. § 103(a) as being unpatentable over Iott and Simonson (US
2006/0030858 Al, published Feb. 9, 2006);
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Application 13/444,231
(iii) claim 7 under 35 U.S.C. § 103(a) as being unpatentable over Iott
and Simonson;
(iv) claims 5, 8, 18, and 19 under 35 U.S.C. § 103(a) as being
unpatentable over Iott, Simonson, and Jackson (US 2006/0293680 Al,
published Dec. 28, 2006); and
(v) claims 12 and 20 under 35 U.S.C. § 103(a) as being unpatentable
over Iott, Simonson, Jackson, and Altarac (US 2007/0043359, published
Feb. 22, 2007).
ANALYSIS
Claims 1—4, 6, 9—11, 13—17, and 21—27—§ 102(e)—Iott
The Examiner finds that Iott discloses positioning first and second
extenders proximate first and second respective anatomic points within the
body, with the first and second extenders projecting those first and second
anatomic points to first and second projected points outside the body at
proximal portions of the first and second extenders. Final Act. 2. The
Examiner additionally finds that Iott discloses constraining the first and
second extenders by coupling them to a bridge to maintain the extenders
parallel to one another while permitting substantially free relative translation
between them. Id. at 3. The Examiner takes the position that Figure 1 of
Iott discloses that the so-called projection points mimic the anatomic points
at the distal ends of the extenders. Id. Finally, the Examiner maintains that:
The step of configuring or selecting the one or more implants
based on the locations of the first and second extender is not
disclosed by Iott, rather it is considered an inherent step in a
surgical procedure. Once the surgeon prepares the insertion site
and attaches the anchors and extenders, it is an inherent step to
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Application 13/444,231
select an implant that will fit with the location/position of the
extenders and the projected points on those extenders.
Final Act. 5.
Responding to arguments advanced by Appellant that the step of
configuring or selecting an implant as claimed is not necessarily performed
in Iott, and is therefore not inherently disclosed in Iott, the Examiner
additionally maintains that:
In this case a person ordinarily skilled in the art would be likely
an orthopedic surgeon. It is asserted that an orthopedic surgeon
would recognize that the projected points of extenders, attached
to pedicle screws in a spine, would necessitate a specific shape,
curve, or orientation of a required spinal implant.... Because
the points of the extenders outside of the body are projections
that mimic the points of the extenders connected to the spine,
the locations of these projected points would be clearly
recognized as representing the associated points on the spine.
Therefore, a surgeon would be capable of recognizing that
he/she could use the projected points as a reference guide to
select an appropriate implant suitable for the patient’s anatomy.
Ans. 9—10. According to the Examiner, if the surgeon did not use the
projected points, it would be necessary to estimate/calculate the shape of the
implant based on the attached points of the extenders. Id. at 10.
This last statement by the Examiner, which identifies a viable
approach to configuring or selecting an implant different than that claimed,
highlights the absence of an inherent disclosure in Iott of employing the
locations of first and second projected points to configure or select one or
more implants. “Under the principles of inherency, if the prior art
necessarily functions in accordance with, or includes, the claimed
limitations, it anticipates.” In re Cruciferous Sprout Litig., 301 F.3d 1343,
1349 (Fed. Cir. 2002) (citations and internal quotation marks omitted).
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Application 13/444,231
Moreover, an inherent disclosure may anticipate a method claim. See id.;
see also Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1378 (Fed. Cir.
2005). “Inherency, however, may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set
of circumstances is not sufficient.” In re Oelrich, 666 F.2d 578, 581 (CCPA
1981).
Iott is essentially silent as to what step or steps are employed to
configure or select the implant or implants to be used. Appellant’s claimed
step is one approach, the Examiner identifies a different approach, and
Appellant identifies even another different approach used in a patent to
Landry. Appeal Br. 11—13. As such, the Examiner has failed to establish
that Appellant’s claimed step of using first and second projected points is
necessarily used in Iott.
Further, even the Examiner’s premise that an orthopedic surgeon
would recognize that points on the proximal ends of the extenders in Iott
could be used in configuring or selecting an appropriate implant, is based on
a flawed finding. The Examiner, as mentioned above, points to Iott as
disclosing constraining the first and second extenders by coupling them to a
bridge to maintain the extenders parallel to one another. Final Act. 3.
Although Figure 1 shows the extenders positioned essentially parallel to one
another, the discussion of the alignment tool notes that it is used only to
constrain the extenders in a common plane. Iott, col. 7,11. 33—35.
Figure 18, which is the focus of that discussion, evidences that the extenders
are not necessarily maintained in parallel relationship. The positions of the
proximal ends of the extenders in such orientations do not mimic the relative
positioning of first and second anatomic points at the distal ends of the
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extenders. As such, it is not at all certain, or even likely, that an orthopedic
surgeon would happen to realize that points on the proximal ends of the Iott
extenders could be used to configure or select the implant or implants to be
installed at the distal ends thereof.
Each of independent claims 1, 14, and 15 includes the limitation
directed to using the projected points in configuring or selecting the one or
more implants. As such, the rejection of these claims, as well as of
dependent claims 2-4, 6, 13, 16, 17, and 21—27, as being anticipated by Iott
is not sustained.
Claims 1—4, 6, 9—11, 13—17, and21—27—,§ 103(a)—lott/Simonson
The Examiner alternatively finds, in the event that Iott is found to not
inherently disclose the claimed implant selection step, that Simonson
discloses selecting a properly sized implant, in the form of cannula 100,
based on an implantable object, in the form of implant 50, and its location on
the spine. Final Act. 5. According to the Examiner, it would have been
obvious to modify the method of Iott with a step of selecting an implant
based on the location of another implant on the spine, in order to have a
properly fitted spinal implant. Id. at 5—6. Appellant further explains that
Simonson is cited for the proposition that “one may choose the proper size
of a device (here a cannula) based on the physical characteristics (location,
shape) of another device (an implant).” Ans. 10. The Examiner finds
applicability of this to Iott in the sense that it would therefore have been
obvious “to select something, not based on direct measurements of the
patient, but rather the dimensions/characteristics of an intermediate or
associated device,” that “’projects’ characteristics necessary for selecting the
first device. Id. at 11.
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These characterizations and explanations as to the alleged relevance
of Simonson to Iott appear to be intended to buttress the Examiner’s position
that an orthopedic surgeon would recognize that the necessary size and
shape of the implant in Iott can be divined from looking to points of
reference other than the actual location where the implant is to be fitted and
secured. As noted above, however, Iott does not appear to be concerned
with positioning its extenders such that points on the proximal ends thereof,
so-called projected points for the purpose of meeting the claim language,
mimic the positions of the anatomic points at the location where the implant
or implants are to be installed. Simonson’s teaching of selecting a cannula
having a sufficiently large inner opening to accommodate the size of the
implant to be inserted therethrough has no particular relevance to
establishing a plurality of reference points located remotely from the
patient’s body by which an implant can be configured or selected.
The rejection of claims 1—4, 6, 9-11, 13—17, and 21—27 as being
unpatentable over Iott and Simonson is not sustained.
Claim 7—§ 103(a)—lott/Simonson
The rejection of claim 7 is not sustained for the reasons noted in the
preceding section.
Claims 5, 8, 18, and 19—§ 103(a)—lott/Simonson/Jackson
The Examiner does not rely on Jackson in any manner that remedies
the deficiencies of the teachings in Iott and Simonson. The rejection of
clams 5, 8, 18, and 19 as being unpatentable over these references is not
sustained.
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Claims 12 and 20—§ 103(a)—Iott/Simonson/Jackson/Altarac
The Examiner does not rely on Jackson or Altarac in any manner that
remedies the deficiencies of the teachings in Iott and Simonson. The
rejection of clams 12 and 20 as being unpatentable over these references is
not sustained.
DECISION
The rejection of claims 1—4, 6, 9-11, 13—17, and 21—27 under
35 U.S.C. § 102(e) as being anticipated by Iott is REVERSED.
The rejection of claims 1—4, 6, 9-11, 13—17, and 21—27 under
35 U.S.C. § 103(a) as being unpatentable over Iott and Simonson is
REVERSED.
The rejection of claim 7 under 35 U.S.C. § 103(a) as being
unpatentable over Iott and Simonson is REVERSED.
The rejection of claims 5, 8, 18, and 19 under 35 U.S.C. § 103(a) as
being unpatentable over Iott, Simonson, and Jackson is REVERSED.
The rejection of claims 12 and 20 under 35 U.S.C. § 103(a) as being
unpatentable over Iott, Simonson, Jackson, and Altarac is REVERSED.
REVERSED
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