Ex Parte Goodwin

Patent Trial and Appeal Board

Sep 23, 2014

11012573 (P.T.A.B. Sep. 23, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
11/012,573 12/15/2004 Mark R. Goodwin CES 100 DIV CON 8447
23579 7590 09/23/2014
Pabst Patent Group LLP
1545 PEACHTREE STREET NE
SUITE 320
ATLANTA, GA 30309
EXAMINER
BOR, HELENE CATHERINE
ART UNIT PAPER NUMBER
3768
MAIL DATE DELIVERY MODE
09/23/2014 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 MARK R. GOODWIN
__________

Appeal 2012-003350
Application 11/012,573
Technology Center 3700
__________

Before DONALD E. ADAMS, LORA M. GREEN, and
TINA E. HULSE, Administrative Patent Judges.

PER CURIAM

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 24, 25, 27, 31–39, and 41–54. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 The Real Party in Interest is Cutting Edge Surgical, Inc. (App. Br. 2).
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STATEMENT OF THE CASE
The Specification discloses an “IntraOsteal UltraSound (IOUS) based
system [that] is used for the placement of implants . . . and for [the]
detection and characterization of bone” (Spec. 5:2–4). The Specification
discloses that “a titanium screw or pin . . . is implanted into a channel
created by channeling a probe through the cortical bone into the cancellous
bone” (id. at 6:14–15). The Specification discloses that the “system includes
a device for sensing and alerting via an auditory or visual signal the absence
of bone (cortical, cancerous, cartilaginous)” (id. at 5:8–10).
Claim 24, the only independent claim, reads as follows:
24. A probe suitable for insertion into bone and real time interrogation
comprising
(a) a transducer and a receiver for ultrasound or audio signals for
interrogation of a tissue, and
(b) input and output connections for transmitting and receiving data
from the probe to a central processing unit, to provide real time interrogation
and feedback to an operator via an external electrical processing and
monitoring means, allowing real time manipulation and navigation of the
probe.

The claims stand rejected as follows:
I. Claims 32–37 under 35 U.S.C. § 112, second paragraph (Ans.
5, 12–13);
II. Claims 24, 25, 27, 32–36, 38, 39, 41–46, and 49–54 under
35 U.S.C. § 102(a) as anticipated by Kleffner2 (Ans. 6–9); and

2 DE 199 21 279 C1, pub. Nov. 30, 2000. (All citations to Kleffner are to
the certified English translation, PTO 11-3860.)
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III. Claims 31, 37, 47, and 48 under 35 U.S.C. § 103(a) over the
combination of Kleffner and Wheeless3 (Ans. 10–11).
I.
The Examiner has rejected claims 32–37 under 35 U.S.C. § 112,
second paragraph, as being indefinite “for failing to particularly point out
and distinctly claim the subject matter which applicant regards as the
invention” (Rejection I) (Ans. 5, 12–13).
The Examiner sets forth a new ground of rejection with regard to
claims 32–37, in which the Examiner cites language in claims 32 and 33
(Ans. 12). Claims 34–37 depend from claim 33. Appellant has not
presented arguments to dispute this rejection, and thus we summarily
dismiss the appeal as to claims 32–37. 37 C.F.R. § 41.39(b).
II.
Issue
The Examiner has rejected claims 24, 25, 27, 32–36, 38, 39, 41–46,
and 49–54 under 35 U.S.C. § 102(a) as anticipated by Kleffner (Rejection II)
(Ans. 6–9). The Examiner has also rejected claims 31, 37, 47, and 48 under
35 U.S.C. § 103(a) as obvious over the combination of Kleffner and
Wheeless (Rejection III) (Ans. 10–11). As we have dismissed the appeal as
to claims 32–37, we do not address those claims further.

3 Wheeless’ Textbook of Othropaedics, “Duke University School of
Medicine,” Sept. 27, 2007, available at
http://www.wheelessonline.com/ortho/screws.
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The issue with respect to this rejection is: Has the Examiner
established by a preponderance of the evidence that Kleffner discloses a
probe suitable for insertion into bone and real time interrogation comprising
(a) a transducer and a receiver for ultrasound or audio signals and (b) input
and output connections for transmitting and receiving data from the probe to
a central processing unit?
Findings of Fact
FF1. The Examiner finds that Kleffner discloses a “probe comprising
means for interrogation of a tissue comprising a transducer and a receiver for
ultrasound or audio signals,” wherein the transducer sends the ultrasound
signal and the receiver receives the ultrasound signal (Ans. 6 (citing Kleffner
at Fig. 1)).
FF2. The Examiner finds that Kleffner “teaches input and output
connections for transmitting and receiving data from the probe to a central
processing unit . . . to provide real time interrogation and feedback to an
operator via an external electrical processing and monitoring means” (id.,
(citing Kleffner at Fig. 1)).
FF3. The Examiner finds that the Kleffner system allows for “real
time manipulation and navigation of the probe” (id. (citing Kleffner at Fig.
1)).
FF4. The Examiner finds that Kleffner teaches that the probe further
comprises “means for creating a lumen or channel into the bone at a desired
site” (id. (citing Kleffner at Fig. 2)).
FF5. The Examiner finds that Kleffner teaches that the means for
creating a pilot hole in bone includes a “hollow drill bit comprising the
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FF9. Figure 2 of Kleffner is shown below:

Figure 2 shows an “enlarged cut-away view in area A in Figure 1 with a drill
tool equipped with an ultrasound converter” (id.).
FF10. Kleffner discloses that spiral drill 2 comprises “an interior
channel 6 . . . which terminates in a receptacle area 7 that is located directly
behind the cone-shaped cutting area 8 of the spiral drill 2” (id. at 9).
FF11. Kleffner discloses that an “ultrasound converter 9 is positioned
in this receptacle area 7 . . . [and] can radiate ultrasound radiation . . .
perpendicular to the cutting surface 8 and . . . accept ultrasound radiation
impacting on it from this direction” (id.).
FF12. Kleffner discloses that the “ultrasound converter is connected
with a line 10 . . . [to] a transmission and receiving device 11 that . . . is
connected via line 12 with a display device 13” (id.).
FF13. Kleffner discloses that that the “transmission and receiving
device 11 . . . can produce and receive ultrasound radiation . . . [that] is sent
in the form of an impulse through the ultrasound converter 9 into the
surrounding bone 4” (id.).
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FF14. Kleffner discloses that the “reflected radiation then impacts
again on the ultrasound converter 9 and is converted there into an electric
signal that is sent to the transmission and receiver device 11” (id. at 10).
FF15. Kleffner discloses that “the reflected ultrasound radiation
produces signals that are a measure of the nature of the bone material in the
direction of radiation” (id. at 3).
FF16. Kleffner discloses that the “[t]he signals accepted by the
transmission and receiver device 11 can be . . . displayed on the viewing
device 13 . . . so that the operating physician receives an optical display of
how the bone material around the spiral drill 2 is constituted” (id. at 11). As
taught by Kleffner, that “makes it possible for the operating physician to . . .
aim the spiral drill . . . [such] that during further penetration into the bone
. . . it can always be as accurately centered in the bone material as possible
and keep a sufficient separation from the boundary surfaces of the bone”
(id.).
FF17. Kleffner discloses that the “ultrasound converter rotates
together with the spiral drill 2 and thus . . . can scan a cone-shaped shell
which is formed by a cone positioned coaxially to the rotation axis of spiral
drill 2” (id. at 10).
FF18. Appellant’s Specification discloses that “a titanium screw or
pin . . . is implanted into a channel created [in the bone] by channeling a
probe through the cortical bone into the cancellous bone within the bone to
be immobilized” (Spec. 6:14–16).
FF19. Appellant’s Specification discloses that instruments that “can
be used to create the images and pilot holes for the surgeon . . . [include]
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drill bits currently in use, [which are] modified to include a transducer” (id.
at 9:3–6).
FF20. According to Appellant’s Specification, such instruments “may
be made by modifying existing ultrasound probes to include a hard pointed
end” (id. at 9:8–9).
Analysis
Appellant argues that Kleffner does not disclose or suggest a probe as
required by claim 24, but that “Kleffner discloses a drill, not a probe” (App.
Br. 9). Appellant argues that Kleffner “discloses a mechanically rotating
surgical power tool for cutting bone material . . . [but] does not disclose or
suggest any device other than a mechanically rotating surgical tool, such as a
drill, milling cutter, reamer, trephine, etc.” (id. at 8).
Appellant’s argument is not persuasive. The Specification discloses
that a channel is created in a bone by channeling a probe through the cortical
bone into the cancellous bone (FF 18). The Specification discloses that
instruments that can be used to create the pilot holes for the surgeon include
drill bits that have been modified to include a transducer (FF 19). Thus, one
of skill in the art would have understood that the probe of claim 24 that
comprises a transducer could be a drill bit that comprises a transducer, which
Kleffner discloses (FF 11).
Claim 24 is directed to a probe comprising “(a) a transducer and a
receiver for ultrasound or audio signals” and “(b) input and output
connections for transmitting and receiving data from the probe to a central
processing unit, to provide real time interrogation and feedback to an
operator . . . [to allow for] real time manipulation and navigation of the
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probe .” Appellant concedes that Kleffner teaches part (a) of claim 24,
stating that “Kleffner discloses a drill which contains an ultrasonic
transducer,” wherein the “transducer sends out a signal . . . which is reflected
and received by the transducer” (App. Br. 10).
Appellant, therefore, only argues that Kleffner does not teach part (b)
of claim 24. Specifically, Appellant argues that Kleffner’s device does not
contain “a means of transmitting and receiving signals both from the tissue
being interrogated AND with a central processer that returns signals to the
probe which then acts in response thereto - i.e., real time interrogation”
(App. Br. 10). Appellant argues that Kleffner’s drill contains a transducer
that “sends out a signal, such as ultrasonic radiation, which is reflected and
received by the transducer” (id.). Appellant argues that the reflected “signal
is converted to an electronic signal which is fed to the transmitter and
receiver” (id.). Appellant argues that the “transmitter and receiver are not
located within the surgical drill, but rather, distal in a separate drilling
machine or power supply component” (id.). Appellant argues, therefore,
“there can be no interaction between the distant separate drilling machine or
power supply [of Kleffner] and the drill, only transmission of signal” (id.).
Appellant’s arguments are not persuasive because Kleffner’s
transducer/receiver is connected by line 10 to a transmission and receiving
device 11 (FF 12–13). Kleffner discloses that the reflected radiation impacts
ultrasound converter 9 and is converted into an electric signal that is sent to
the transmission and receiver device 11 (FF 14). Kleffner also discloses that
the ultrasound signals received by the transmission and receiver device 11
are displayed on viewing device 13 so that the physician receives an optical
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display of the bone material constitution that surrounds around the drill, and
can thus accurately aim the drill for further penetration into the bone (FF
16). Thus, contrary to Appellant’s argument, Kleffner discloses a probe the
comprises “input and output connections for transmitting and receiving data
from the probe to a central processing unit, to provide real time interrogation
and feedback to an operator,” as required by part (b) of claim 24.
Thus, we affirm the rejection of claim 24 as being anticipated by
Kleffner. Claims 25, 27, 38, and 39 have not been argued separately and
therefore fall with claim 24. 37 C.F.R. § 41.37(c)(1)(vii).
Appellant also argues the rejection of claim 41 (App. Br. 15). Claim
41 is directed to a
method for diagnosing bone disease, bone thickness, absence of
bone, cartilage interface, failed spinal fusions, detection of bone
to avascular necrosis interface, fractures, neoplasms, osteoid
osteoma, and vascular lesions comprising inserting the probe of
claim 24 into a bone or tissue and detecting defined differences
in acoustical impedence signal.

Appellant argues that “Kleffner only discloses an ability to determine ‘the
condition of bone and the thickness of bone’ in the area adjacent to the drill
. . . [but] does not disclose or suggest a method of diagnosing or detecting
the specific conditions recited in claim 41” (App. Br. 15).
The Examiner responds that claim 41’s recitation of a “method of
diagnosing or detecting the specific conditions . . . has not been given
patentable weight because the recitation occurs in the preamble” (Ans. 20).
The Examiner responds that a “preamble is generally not accorded any
patentable weight where it merely recites the purpose of a process or the
intended use of a structure, and where the body of the claim does not depend
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on the preamble for completeness” (id.). The Examiner reasons that,
because the claim body “fully and intrinsically sets forth all of the
limitations . . . and the preamble merely states . . . the purpose or intended
use of the invention, rather than any distinct definition of any of the claimed
invention’s limitations,” the preamble is not a limitation (id.).
We agree with the Examiner that Kleffner discloses the invention of
claim 41. “It is a general rule that merely discovering and claiming a new
benefit of an old process cannot render the process again patentable.” In re
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). Further, “[a]n intended use
or purpose usually will not limit the scope of the claim because such
statements usually do no more than define a context in which the invention
operates.” Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp.,
320 F.3d 1339, 1345 (Fed. Cir. 2003). Claim 41 recites:
A method for diagnosing bone disease, bone thickness, absence
of bone, cartilage interface, failed spinal fusions, detecting of
bone avascular necrosis interface, fractures, neoplasms, osteoid
osteoma, and vascular lesions comprising inserting the probe of
claim 24 into a bone or tissue and detecting defined differences
in acoustical impedance signal.
As found by the Examiner, Kleffner teaches the method step of inserting a
probe that meets the limitations of claim 24 into bone or tissue and detecting
defined differences in the acoustic impedance signal (Ans. 7). Kleffner
teaches also that such a method may be used to determine bone thickness
and structural changes of the bone material (Ans. 7 (citing Kleffner, 4, first
paragraph of translation)). Thus, Kleffner teaches all of the steps required
by claim 41, that is, Kleffner teaches inserting the probe into bone or tissue
and detecting defined differences in acoustical impedance signal. The
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recitation of the conditions in the preamble of claim 41 do not add additional
steps to the method steps recited, and thus are a benefit of the process of
Kleffner not specifically recognized by Kleffner, or, as argued by the
Examiner, an intended use of the process of Kleffner. Moreover, Kleffner
specifically notes that the disclosed method can be used to determine bone
thickness, which is one of the items recited in the preamble of claim 41.
Thus, we affirm the rejection of claim 41 as being anticipated by Kleffner.
Appellant also argues the rejection of claims 42–44 (App. Br. 15-16),
which depend from claim 41 and further recite the following: in claim 42,
“the video signal is used to measure or provide analysis of one or more
factors or variables in bone selected from the group consisting of Bone
mineral density (BMD), disease, lesion or neoplasm, vascular defects, or
areas of avascular necrosis;” in claim 43, “the method is used to determine
areas of bony non-union, fracture, or regions between bone;” and in claim
44, “the method is used to determine water content or cartilage
composition.”
Appellant argues that Kleffner does not disclose the particular method
uses recited in claims 42, 43, and 44 (App. Br. 16). The Examiner responds
that the “appellant did not positively recite the steps of determining areas of
bony unions or determine water content” and that “[p]atentability does not
rely on what the method is used for” (Ans. 21). The Examiner also notes
that Kleffner teaches that it is possible to determine inhomogeneities in the
bone, as well as boundary areas, and thus may be used as a measure for bone
condition (id. (citing Kleffner, 10)).
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We agree with the Examiner that Kleffner discloses the methods of
claims 42–44. As discussed above with regard to claim 41, claims 42-44 do
not add any additional method steps, and thus would be a benefit not
recognized by Kleffner of the disclosed process of Kleffner. Thus, we
affirm the rejection of claims 42–44 as being anticipated by Kleffner.
Appellant also argues the rejection of claim 45 (App. Br. 16–17).
Claim 45 is directed to a
method for guiding and placing an implant within a region of
tissues or bone characterized by defined differences in video
signal or acoustical impedence comprising introducing into the
region the probe of claim 24 and monitoring differences in
video signal or acoustical impedence as the probe including the
transducer and receiver are moved through the region.

Appellant argues that “Kleffner discloses a mechanically rotating surgical
power tool for cutting bone material” (App. Br. 17). Appellant argues that
“[w]hile Kleffner suggests that the drill may be useful for preparing ‘drill
holes for receiving bone screws,’ Kleffner does not disclose or suggest any
method of guiding and placing an implant within these drill holes” (id.,
(emphasis deleted)).
The Examiner responds that the recitation of a method “for guiding
and placing an implant within a region of tissues or bone characterized by
defined differences in video signal or acoustical impedence” has not been
given patentable weight (Ans. 20). The Examiner reasons that the cited
language occurs in the preamble and is not considered a limitation because
the body of the claim “fully and intrinsically sets forth all of the limitations
of the claimed invention, and the preamble merely states . . . the purpose or
intended use of the invention” (id.).
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We agree with the Examiner that Kleffner discloses the method of
claim 45. As discussed above with regard to claim 41, the broadest
reasonable interpretation of claims 45 is that the preamble claim language
that is directed to a particular use of the claimed method steps is merely a
statement of intended use that defines a context in which the invention
operates. Thus, Appellant’s arguments are not persuasive, and we affirm the
rejection of claim 45 as being anticipated by Kleffner.
Claims 46 and 49–54 have not been argued separately and therefore
fall with claim 45. 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner has also rejected claims 31, 47 and 48 under 35 U.S.C.
§ 103(a) as obvious over the combination of Kleffner and Wheeless
(Rejection III) (Ans. 10–11). Appellant argues that, “for at least the reasons
set forth with respect to claims 24 and 45, claims 31, 37, 47, and 48 are non-
obvious in view of Kleffner” (App. Br. 17). That argument is not persuasive
because, as discussed above, we have found that Appellant’s arguments with
regard to claims 24 and 45 were not persuasive.
Conclusion of Law
A preponderance of the evidence supports the Examiner’s finding that
Kleffner discloses a probe suitable for insertion into bone and real time
interrogation comprising (a) a transducer and a receiver for ultrasound or
audio signals and (b) input and output connections for transmitting and
receiving data from the probe to a central processing unit.
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SUMMARY
We summarily dismiss the appeal as to claims 32–37. We also affirm
the rejection of claims 24, 25, 27, 38, 39, 41–46, and 49–54 under 35 U.S.C.
§ 102(a) and the rejection of claims 31, 47, and 48 under 35 U.S.C. § 103(a).
TIME PERIOD FOR RESPONSE
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

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