Ex Parte Bonutti

Board of Patent Appeals and Interferences

Jul 28, 2003

09118665 (B.P.A.I. Jul. 28, 2003)

The opinion in support of the decision being
entered today was not written for publication
and is not binding precedent of the Board.
Paper No. 19
UNITED STATES PATENT AND TRADEMARK OFFICE
____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________
Ex parte PETER M. BONUTTI
____________
Appeal No. 2001-0628
Application No. 09/118,665
____________
HEARD: July 17, 2003
____________
Before COHEN, MCQUADE and NASE, Administrative Patent Judges.
MCQUADE, Administrative Patent Judge.
DECISION ON APPEAL
Peter M. Bonutti appeals from the final rejection of claims
59 through 80 and 84 through 91, all of the claims pending in the
application.
THE INVENTION
The invention relates to a “method for use in medical
imaging” (specification, page 1). Representative claim 59 reads
as follows:
59. A method of imaging a joint in a body of a patient,
said method comprising the steps of providing an imaging unit
having a chamber, positioning a joint in a patient’s body in the
chamber of the imaging unit with the patient in a seated
orientation, gripping a portion of the patient’s body adjacent to
Appeal No. 2001-0628
Application No. 09/118,665
1 The record contains an English language translation of the
Knuttel reference submitted by the appellants on August 30, 1999
(Paper No. 9).
2 The appellants submitted the Shellock and Captain Jack
materials in an Information Disclosure Statement filed July 17,
1998 (Paper No. 3) and have not challenged the examiner’s
implicit determination that these materials constitute prior art
relative to the subject matter on appeal.
2
the joint with a cuff while the joint is in the chamber of the
imaging unit and while the patient is in a seated orientation,
bending the joint in the patient’s body through at least a
portion of a range of movement while the patient is in a seated
orientation with the joint in the chamber of the imaging unit and
with the portion of the patient’s body adjacent to the joint
gripped by the cuff, and imaging the joint when the joint is bent
to each of a plurality of positions in the range of movement of
the joint while the joint is in the chamber of the imaging unit
and while the patient is in a seated orientation.
THE PRIOR ART
The references relied on by the examiner to support the
final rejection are:
Cook 5,275,174 Jan. 04, 1994
Knuttel et al., 67,933 Dec. 29, 1982
European Patent Document
(Knuttel)1
Shellock, Frank G., “Patellofemoral joint abnormalities in
athletes: Evaluation by kinematic magnetic resonance imaging,”
Topics in Magnetic Resonance Imaging, Vol. 3, No. 4, pp. 71-95
(1991) (Shellock)2
The “Captain Jack” Flyers appended to a letter dated September
12, 1991 from Pete Sullenberger to Murray Solomon, M.D. (Captain
Jack)2
Appeal No. 2001-0628
Application No. 09/118,665
3
THE REJECTIONS
Claims 59 through 68, 70, 71, 75 through 80 and 84 through
91 stand rejected under 35 U.S.C. § 112, first paragraph, as
being based on a specification which fails to comply with the
written description requirement of this section of the statute.
Claims 59 through 68, 70, 71, 75 through 80 and 84 through
91 stand rejected under 35 U.S.C. § 112, first paragraph, as
being based on a specification which fails to comply with the
enablement requirement of this section of the statute.
Claims 59 through 68, 70, 71 75, 77 through 80 and 88
through 91 stand rejected under 35 U.S.C. § 103(a) as being
unpatentable over Knuttel in view of either Shellock or Captain
Jack, and further in view of Cook.
Claims 69 and 72 through 74 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over either Shellock or Captain
Jack in view of Cook.
Attention is directed to the brief (Paper No. 12) and answer
(Paper No. 13) for the respective positions of the appellants and
examiner regarding the merits of these rejections.
Appeal No. 2001-0628
Application No. 09/118,665
4
DISCUSSION
I. The 35 U.S.C. § 112, first paragraph, written description and
enablement rejections of claims 59 through 68, 70, 71, 75 through
80 and 84 through 91
The written description and enablement requirements of 35
U.S.C. § 112, first paragraph, are separate and distinct. Vas-
Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1117
(Fed. Cir. 1991). The test for compliance with the written
description requirement is whether the disclosure of the
application as originally filed reasonably conveys to the artisan
that the inventors had possession at that time of the later
claimed subject matter, rather than the presence or absence of
literal support in the specification for the claim language. In
re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir.
1983). The content of the drawings may also be considered in
determining compliance with the written description requirement.
Id. Insofar as the enablement requirement is concerned, the
dispositive issue is whether the appellants’ disclosure,
considering the level of ordinary skill in the art as of the date
of the application, would have enabled a person of such skill to
make and use the claimed invention without undue experimentation.
In re Strahilevitz, 668 F.2d 1229, 1232, 212 USPQ 561, 563-64
Appeal No. 2001-0628
Application No. 09/118,665
5
(CCPA 1982). In calling into question the enablement of the
appellant's disclosure, the examiner has the initial burden of
advancing acceptable reasoning inconsistent with enablement. Id.
The examiner has advanced related rationales for the written
description and enablement rejections, and the appellants, in
turn, have argued the two rejections as one (see pages 10 through
13 in the brief). Hence, we too shall treat the rejections
together.
The subject matter recited in the claims so rejected is
specific to the vertically extending MRI primary coil 368
schematically illustrated in Figure 43 and briefly described in
the specification on pages 37 and 38. Of particular interest is
the passage on page 37, lines 21 through 25, which states that
[a] patient may be placed in a standing or seated
position on a support 370 for imaging in the coil 368.
A ram 372 is operable to move the patient into and out
of the coil 368. Positioning fixtures, etc. are
mounted to a support member 374.
The examiner views the appellants’ specification as failing
to comply with the written description requirement with respect
to the claimed subject matter at issue because
[t]he specification fails to disclose a method of
imaging a joint in an imaging chamber while the patient
is seated or standing while gripping a portion of the
patient’s body with a cuff. Pages 37-38 and original
claim 58 provide the only disclosure of the embodiment
which images either a seated or standing patient. The
Appeal No. 2001-0628
Application No. 09/118,665
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specification refers to “positioning fixtures” which
are mounted to the support member but fails to disclose
what those fixtures would be [answer, page 3].
In a similar vein, the examiner considers the appellants’
specification as failing to comply with the enablement
requirement with respect to the claimed subject matter at issue
because
[g]iven the structure shown in figure 43 and
appellant’s [sic] comments regarding the lack of
operability of the prior art devices in the disclosed
vertical chamber, it is unclear as to which positioning
fixtures would be used and mounted to enable them to
operate in a vertical chamber. If appellant’s [sic]
previously disclosed positioning devices are used,
appellant [sic] fails to show how the structure of such
would be modified so as to enable its use in a vertical
chamber [answer, page 4].
The appellants note that “[p]ages 8 through 36 of the
specification, taken in conjunction with Figs. 1 through 42 of
the application drawings, disclose various positioning fixtures
which grip a portion of a patient’s body adjacent to a joint with
a cuff” (brief, page 11). According to the appellants, “any one
of the positioning fixtures could be utilized with the upright
imaging unit illustrated in Fig. 43” (brief, page 12). The
appellants go on to explain that
[t]he positioning fixtures of Figs. 1 through 42
of the application have been described, prior to page
37 of the application, in conjunction with a horizontal
imaging unit 12 (Fig. 1A). At page 47 [sic, page 37],
lines 21 through 25 of the specification, it is
Appeal No. 2001-0628
Application No. 09/118,665
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disclosed that the positioning fixtures of Figs. 1
through 42 could be utilized with an imaging unit
having a vertically extending primary coil 368 (Fig.
43) rather than a horizontally extending imaging coil.
. . .
...[i]t would be apparent to a person skilled in
the imaging art that the positioning fixtures
illustrated in Figs. 1 through 42 of the application
drawings could be utilized with the upright imaging
unit of Fig. 43 rather than a horizontal imaging unit.
The Examiner has not explained why the positioning
fixtures of Figs. 1-42 can not be utilized with the
vertical imaging unit of Fig. 43 rather than the
horizontal imaging unit [brief, pages 12 and 13].
Contrary to the appellants’ assertion, the description of
the vertically extending MRI primary coil 368 on specification
pages 37 and 38 does not expressly indicate that the earlier
described “positioning fixtures” which grip a portion of a
patient’s body adjacent to a joint with a cuff could be utilized
with the vertically extending MRI primary coil. The description
of the MRI primary coil 368, however, cannot be read in a vacuum.
When the reference on page 37 to the “positioning fixtures” is
read within the context of the specification as a whole, it
becomes clear that the appellants intended it to be inclusive of
the previously described cuffs for gripping a portion of the
patient’s body adjacent to the joint. Thus, the disclosure of
the application as originally filed would reasonably convey to
the artisan that the appellants’ had possession at that time of
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Application No. 09/118,665
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the subject matter now recited in claims 59 through 68, 70, 71,
75 through 80 and 84 through 91.
Furthermore, the examiner has failed to advance acceptable
reasoning for the proposition that the appellants’ disclosure,
considering the level of ordinary skill in the art as of the date
of the application, would not have enabled a person of such skill
to effect without undue experimentation a method as recited in
claims 59 through 68, 70, 71, 75 through 80 and 84 through 91
including the step of gripping a portion of the patient’s body
adjacent to the joint with a cuff. In this regard, adapting the
gripping cuff structure disclosed by the appellants to the
vertically extending MRI primary coil 368 would appear to be a
relatively simple and straightforward enterprise.
In light of the foregoing, we shall not sustain either of
the 35 U.S.C. § 112, first paragraph, rejections of claims 59
through 68, 70, 71, 75 through 80 and 84 through 91.
II. The 35 U.S.C. § 103(a) rejection of claims 59 through 68, 70,
71, 75, 77 through 80 and 88 through 91 as being unpatentable
over Knuttel in view of either Shellock or Captain Jack, and
further in view of Cook
Appeal No. 2001-0628
Application No. 09/118,665
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Knuttel, the examiner’s primary reference in this rejection,
discloses “an electromagnet for generating the static magnetic
field needed for NMR tomography [i.e., NMR imaging], with a coil
arrangement that generates an approximately homogenous magnetic
field in the internal space defined by said coil arrangement and
in which the body to be examined is located” (translation, page
3). Figure 3 illustrates a horizontally disposed electromagnet
21 wherein a patient lies on a table 23 designed for movement
into and out of the electromagnet, and Figures 4 and 5 depict
vertically disposed electromagnets 31 and 45 adapted to be
lowered over the upper body of a standing patient (Figure 4) or a
sitting patient (Figure 5).
Claims 59 through 68, 70, 71, 75, 77 through 80 and 88
through 91 recite methods wherein the patient is in either a
seated or a standing orientation, or wherein the imaging unit has
a chamber with an upright central axis. To meet these
limitations, the examiner relies on the electromagnet embodiments
shown in Figures 4 and 5 of the Knuttel reference. As implicitly
conceded by the examiner (see pages 4 through 7 in the answer),
however, these portions of the Knuttel disclosure do not respond
to the limitations in independent claim 59, or the corresponding
limitations in independent claims 64, 69 (from which claims 70
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Application No. 09/118,665
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and 71 depend), 75 and 88, relating to the gripping and bending
steps, to the limitations in claim 69 relating to the step of
simulating joint loading by applying a tractive force, or to the
limitations in claim 88 relating to the step of positioning a
joint in a chamber of the imaging unit by maintaining the imaging
unit stationary and moving the patient along the upright central
axis of the unit. The examiner’s reliance on Shellock, Captain
Plastic and/or Cook to cure these shortcomings in Knuttel is not
well founded.
Shellock discloses the practice of using kinematic MRI
techniques on patients in prone or supine positions to analyze
knee joints flexed through a specific range of motion.
The Captain Jack flyers broadly, and somewhat ambiguously,
disclose positioning devices for use in kinematic MRI studies of
wrists, ankles and knees. The letter to which the brochures are
appended suggests that these positioning devices would be used on
patients lying in prone or supine positions.
Cook discloses a method of assessing the physiological state
of body joint by moving the joint against resistance through a
range of motion and measuring electrical activity in the muscles
controlling the joint. As shown in Figures 1 and 2, an exemplary
embodiment of this method involves a cradle 1 into which the
Appeal No. 2001-0628
Application No. 09/118,665
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forearm 2 of a subject is rigidly affixed via a strap 3,
electrical detectors 4 applied to the forearm, and a hand grip 7
mounted for rotation about an axis 6 against a selected level of
resistance.
In proposing to combine Knuttel, Shellock or Captain Jack,
and Cook to reject claims 59 through 68, 70, 71, 75, 77 through
80 and 88 through 91, the examiner concludes that it would have
been obvious in view of either Shellock or Captain Jack “to have
modified Knuttel et al such that the vertical imaging system is
combined with means for analyzing a joint” (answer, page 4), and
in view of Cook “to have further modified Knuttel et al such that
a cuff is used to grip a portion of the patient’s body adjacent
the body portion [sic, joint]” (answer, page 5) and “to have
applied a force to the joint such that it can be analyzed under
stress . . . to provide a complete analysis of the joint under
normal use conditions” (answer, page 5).
Rejections based on § 103(a) must rest on a factual basis.
In re Warner, 379 F.2d 1011, 1017, 154 USPQ 173, 177-78 (CCPA
1967). In making such a rejection, the examiner has the initial
duty of supplying the requisite factual basis and may not,
because of doubts that the invention is patentable, resort to
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Application No. 09/118,665
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speculation, unfounded assumptions or hindsight reconstruction to
supply deficiencies in the factual basis. Id.
In the present case, the disclosures by Shellock or Captain
Jack of kinematic MRI techniques for analyzing knee, wrist and/or
ankle joints would not have suggested modifying the methods
respectively depicted by Figures 4 and 5 of Knuttel to include
such kinematic techniques so as to account for the above noted
bending limitations in the claims. To begin with, and as shown
in Figures 4 and 5, Knuttel’s vertically disposed electromagnets
31 and 45, in their operative positions, do not encompass a
patient’s knee, wrist and/or ankle joints. Furthermore, these
vertically disposed electromagnets would not on their face appear
to be amenable to the sorts of fixtures or mechanisms necessary
to implement kinematic techniques for analyzing these or other
joints. Cook’s disclosure of a method of measuring electrical
activity in the muscles controlling a joint using a forearm
cradle, strap and resistance-adjustable hand grip does not cure
this basic flaw in the proposed combination of Knuttel and either
Shellock or Captain Jack, and would not have suggested further
modifying Knuttel’s MRI process to account for the above noted
gripping and tractive force limitations in the claims. The
applied references also fail to account for the recitation in
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Application No. 09/118,665
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claim 88 of the step of positioning a joint in a chamber of the
imaging unit by maintaining the imaging unit stationary and
moving the patient along the upright central axis of the unit.
Thus, the combined teachings of Knuttel, either Shellock or
Captain Jack, and Cook do not justify the examiner’s conclusion
that the differences between the subject matter recited in
independent claims 59, 64, 69, 75 and 88 are such that the
subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art.
Hence, we shall not sustain the standing 35 U.S.C. § 103(a)
rejection of claims 59, 64, 75 and 88, and dependent claims 60
through 63, 65 through 68, 70, 71, 77 through 80 and 89 through
91, as being unpatentable over Knuttel in view of either Shellock
or Captain Jack, and further in view of Cook.
III. The 35 U.S.C. § 103(a) of claims 69 and 72 through 74 as
being unpatentable over either Shellock or Captain Jack in view
of Cook
For the reasons discussed above, the combined teachings of
Shellock or Captain Jack in view of Cook do not warrant a
conclusion of obviousness with respect to the subject matter
recited in independent claim 69. Accordingly, we shall not
sustain the standing 35 U.S.C. § 103(a) of claim 69, and
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Application No. 09/118,665
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dependent claims 72 through 74, as being unpatentable over either
Shellock or Captain Jack in view of Cook.
SUMMARY
The decision of the examiner to reject claims 59 through 80
and 84 through 91 is reversed.
REVERSED
Appeal No. 2001-0628
Application No. 09/118,665
15
IRWIN CHARLES COHEN )
Administrative Patent Judge )
)
)
)
) BOARD OF PATENT
JOHN P. MCQUADE ) APPEALS
Administrative Patent Judge ) AND
) INTERFERENCES
)
)
)
JEFFREY V. NASE )
Administrative Patent Judge )
JPM/gjh
Appeal No. 2001-0628
Application No. 09/118,665
16
PAUL D. BIANCO
FLEIT, KAIN, GIBBONS, GUTMAN, BONGINI
& BIANCO
601 BRICKELL KEY DRIVE, SUITE 404
MIAMI, FLORIDA 33131