Ex Parte Blum

Patent Trial and Appeal Board

Sep 8, 2017

12413099 (P.T.A.B. Sep. 8, 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.
12/413,099 03/27/2009 Michael F. Blum GLRCG005A 8366
26409 7590 09/12/2017
The Cache Law Firm, P.C.
4943 Coshatt Drive
BIRMINGHAM, AL 35244
EXAMINER
SNOW, BRUCE EDWARD
ART UNIT PAPER NUMBER
3738
NOTIFICATION DATE DELIVERY MODE
09/12/2017 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):
russ@gachelaw.com
russgache@gmail.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MICHAEL F. BLUM
Appeal 2015-0012131
Application 12/413,0992
Technology Center 37003
Before MICHAEL C. ASTORINO, PHILIP J. HOFFMANN, and
KEVIN W. CHERRY, Administrative Patent Judges.
CHERRY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Michael Blum (Appellant) seeks review under 35 U.S.C. § 134(a) of a
Final Rejection of claims 1—20 and 26—29, the only claims pending in the
1 Our decision references the Appellant’s Appeal Brief (“Appeal Br.”), filed
June 11, 2014, Appellant’s Reply Brief (“Reply Br.”), filed October 10,
2014, the Final Action (“Final Act.”), mailed October 16, 2013, and the
Examiner’s Answer (“Ans.”), mailed August 15, 2014.
2 Appellant’s Appeal Brief identifies Appellant Dr. Michael F. Blum as the
real-party-in-interest (Appeal Br. 3).
3 The record includes a transcript of the oral hearing held May 16, 2017
(“Tr.”).
Appeal 2015-001213
Application 12/413,099
application on appeal. We have jurisdiction over the appeal pursuant to
35 U.S.C. § 6(b). Appellant appeared for oral hearing on May 16, 2017.
We REVERSE.
Appellant’s claimed invention “relates generally to prosthetic knee
implants and corresponding surgical methods used to replace the total knee
joint in a mammal” (Spec. 1,11. 6—7).
Claims 1,17, and 26—29 are the independent claims at issue in this
appeal. Claim 17 is illustrative of the subject matter on appeal and is
reproduced below.
17. A prosthetic knee implant for replacing a knee joint and an
associated anterior cruciate ligament connecting a mammalian
femur and a mammalian tibia, comprising:
a. means for replacing a lower portion of the mammalian
femur, said femoral replacement means including means
for replacing a medial and lateral condyle;
b. means for replacing an upper portion of the mammalian
tibia, said tibial replacement means including an upper
surface;
c. wherein said femoral replacement means includes a recess
between said medial and lateral condyles means defining
an access way into said femur;
d. wherein said upper surface of said tibial replacement
means further comprises a bearing surface for
cooperatively supporting and slidably engaging said
medial and lateral condyle means, and wherein said
bearing surface defines an aperture through the center of
said bearing surface of said tibial replacement means; and,
e. wherein said femoral access way and said aperture in said
tibial replacement means are aligned along an axis
generally parallel to the axis of said associated anterior
cruciate ligament and extending along said axis, wherein
said access way is further adapted to define a tunnel in said
femur, said tunnel adapted to cant laterally and have one
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end disposed adjacent to said access way and the other end
disposed through said lateral condyle.
(Appeal Br. 48, Claims App.).
Rejections
Claims 17—20 and 29 stand rejected under 35 U.S.C. § 101 and
Section 33(a) of the Leahy-Smith America Invents Act (“ALA”), Pub. L.
112-29, 125 Stat 284, 340 (Sept. 11, 2011), as encompassing a human
organism.
Claims 18, 27, 28, and 29 stand rejected under 35 U.S.C. § 112,
second paragraph, as indefinite for failing to particularly point out and
directly claim the subject matter the applicant regards as his invention.
Claims 1—17, 19, 20, and 26—29 stand rejected under 35 U.S.C.
§ 102(b) as being unpatentable as being anticipated by Metzger
(US 2005/0187635 Al, pub. Aug. 25, 2005).
Claims 1—20 and 26—29 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Metzger and Hanslik (US 4,440,663, iss. Sept. 13,
1988), as further evidenced by Skiba (US 6,482,210 Bl, iss. Nov. 19, 2002).
ANALYSIS
Section 101 andAIA Section 33(a) Rejection
The Examiner rejected independent claims 17 and 29, and claims 18—
20 that depend from claim 17, as directed to unpatentable subject matter for
claiming a human organism. Claim 17 recites, in relevant part: “wherein
said femoral access way and said aperture in said tibial replacement means
are aligned along an axis generally parallel to the axis of said associated
anterior cmciate ligament and extending along said axis[.]” The Examiner
explained that “for the femoral access way and the aperture in the tibial
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replacement means to be aligned with the associated ACL, they must be
implanted within the knee, and, therefore claim[] the knee.” Ans. 10.
Similarly, with respect to claim 29, the Examiner noted that “[cjlaim 29
claims the femoral component ‘positioned to be affixed to the femur’ and ‘to
match the angle of the original ACL.’” Id. The Examiner found that “this is
claiming the femoral component within the knee and, therefore, positively
claiming the knee.” Id. at 10—11.
We agree with Appellant that the recitations in claims 17 and 29 of
the “femoral access way” and “femur,” respectively, serve only to define the
correct relative position of the implant and do not encompass a human
organism nor “positively claim[] the knee” as the Examiner contends.
Appeal Br. 17—20; Reply Br. 1—4. Accordingly, the rejection of claims 17—
20 and 29 under 35 U.S.C. § 101 and AIA § 33(a) is reversed.
Indefiniteness Rejections
The Examiner rejected claims 18, 27, 28, and 29 under 35 U.S.C.
§112, second paragraph, as indefinite, for different, but similar reasons.
Final Act. 4. We consider each below.
Claim 18
Claim 18 depends from claim 17. Claim 18 additionally recites
“wherein said aperture is canted medially through said tibia replacement
means and defines a passage way having an angle aligned with said axis
such that said ligament substitute is adapted to be canted laterally with
respect to a sagittal plane bisecting said knee joint.” The Examiner
determined that the limitation that the “aperture is canted medially” is
indefinite. Ans. 4. The Examiner explains that the natural anterior cruciate
ligament cants laterally from the tibia, but claim 18 claims the opposite. Id.
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at 11. The Examiner further notes that this limitation opposes the language
“said tunnel adapted to cant laterally” recited in independent claim 17 and
“said ligament substitute is adapted to be canted laterally” recited in
claim 18. Id. Appellant argues that “canted medially” indicates the medial
direction, which in Appellant’s drawings “means angled to the right which is
in the direction toward the inside of the knee since the example knee joint in
the figures is a right knee. . . .” Appeal Br. 21. Appellant asserts that “when
the entire ligament substitute is installed through tunnels 46 and 64 and
aligned along the angle of the original [anterior cruciate ligament] (see
Fig. 10) the angle of the ligament substitute with respect to the sagittal plane
bisecting the knee joint has a lateral angle (i.e., angled to the left and away
from a vertical plane extending directly forward and backward in a human
body and bisecting the knee joint; see attached Exhibit 3).” Id. Appellant
contends that “there is no conflict between the recited language of ‘canted
medially’ and ‘canted laterally’ because the reference points are different.”
Id. at 21—22. We find Appellant’s argument persuasive. In the May 26,
2011 Amendment to the Specification, Appellant defined the directions
lateral and medial with respect to axes 31 and 32 shown in Figure 1. We
determine that a person of ordinary skill reviewing this definition, the
drawings, and the other disclosure of the Specification would understand the
medial direction refers to the aperture canting to the right from the center of
the tibial replacement. Thus, we cannot sustain the rejection of claim 18.
Claim 27
With respect to claim 27, the Examiner determined that the claim’s
recitation of “a tibial component. . . including an upper surface portion that
defines an aperture through said tibial component at its center and adapted to
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be canted laterally relative to said knee joint” was indefinite. Ans. 4. The
Examiner further explains that an aperture can be canted or not canted, and it
was unclear how an aperture could be “adapted to be canted.” Id. at 11. The
Appellant responds that the language is clear. Appeal Br. 22. We agree
with Appellant. Importantly, claim 27 is a drafted as a “method of
consuming the components of a surgical kit,” and the “tibial component”
that is recited is a component that has not been implanted yet into a patient.
We agree with Appellant that a person of ordinary skill reading the claim in
light of the Specification would understand that the aperture is adapted such
that once it is implanted in the patient it can be canted in a particular
direction. Thus, we agree with Appellant that the language is sufficiently
clear, and that the rejection of claim 27 as indefinite cannot be sustained.
Claim 28
With respect to claim 28, the Examiner determined that claim 28’s
recitation of an “aperture canted to match the angle of the original anterior
cruciate ligament” conflicts with recitation that the “ligament substitute
forms an axially aligned segment angled to approximately match the angle
of the original anterior cruciate ligament in the knee joint” rendering the
claim indefinite. Ans. 4. Appellant argues that there is no conflict because
these are two different elements of the claim. Appeal Br. 22. Appellant
submits that “[wjhile these angles are similar, they do not necessarily need
to be identical because the former [i.e., the aperture] has a much shorter
length relative to the latter segment recitation [i.e., the ligament
replacement] allowing for small variations in angle of the segment relative to
the aperture.” Id. We find this argument persuasive and agree with
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Appellant that there is no conflict between the two limitations. Thus, we
cannot sustain the Examiner’s indefmiteness rejection of claim 28.
Claim 29
With respect to claim 29, the Examiner determined that the claim
limitation “a femoral component positioned to be affixed to the femur at its
lower end,” was indefinite. Ans. 4 (emphasis added). Appellant argues that
“the relative position of the femoral component 41 in its anatomical
environment of a human knee joint is clear” and that “[t]he femur is not
positively recited in the claim . . . but the relative position of femoral
component 41 in its operating environment is clear . . . .” Appeal Br. 22—23.
Appellant’s argument is persuasive. The claim language, when read in light
of the Specification, merely recites where the relative position that the
“femoral component” of the implant is implanted. A person of ordinary skill
in the art would understand this limitation. Thus, we cannot sustain the
rejection of claim 29 as indefinite.
Anticipation Rejection
Appellant argues that Metzger does not disclose:
wherein said femoral access way and said tibial aperture are
aligned along an axis generally parallel to the axis of said
associated anterior cruciate ligament and positioned to receive a
ligament substitute extending along said axis
as recited in independent claim 1. Appeal Br. 29—35. Appellant contends
that Metzger, instead, discloses an Anterior Cruciate Ligament (ACL)
replacement that is vertical or zero degrees with respect to the sagittal plane
bisecting the knee and 90 degrees with respect to the transverse plane. Id.
at 30; Reply Br. 6. In contrast, Appellant argues that the ACL implant
claimed is generally along the axis of the original ACL, which is
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approximately 27 degrees with respect to the sagittal plane and 63 degrees
with respect to the transverse plane. Reply Br. 6. The Examiner
acknowledges this difference, but reasons that the claim only requires that
the replacement be “generally” parallel and that Metzger “clearly meets
‘generally.’” Ans. 12.
We agree with Appellant that Metzger does not meet the “generally
parallel” limitation of the claims. Although “generally” means that it does
not have to be exactly parallel, we do not agree with the Examiner that a
ACL replacement positioned at 0 degrees with respect to the sagittal plane
and 90 degrees with respect to the transverse plane is “generally parallel”
to 27 degrees and 63 degrees, respectively. We agree with Appellant that
such a wide difference is not within the scope of “generally parallel” when
read in light of the Specification. Thus, we cannot sustain the anticipation
rejection of claim 1, and claims 2—16 that depend from claim 1.
The remaining independent and dependent claims have a similar
limitation to this limitation. Thus, for the reasons stated above with respect
to claim 1, we cannot sustain the anticipation rejection of claims 17, 19, 20,
and 26—29.
Obviousness Rejection
Appellant argues that the Examiner has failed to show that it would
have been obvious to modify Metzger to have an ACL replacement angle
that is generally parallel with the axis of the original ACL, as shown in
Hanslik. Appeal Br. 36—37. We agree. The Examiner’s rationale for the
modification to Metzger was that it is “obvious to try and make a prosthetic
device which copies the body portion they are replacing in both form and
function,” and that “one skilled in the art would be able to use the knee
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prosthesis of Metzger such that the ACL more closely conformed to the
natural conditions of the knee.” Ans. 14—15. However, Metzger explains
that his graft is configured so the bearing component may articulate while
still allowing clearance for the graft. Metzger 140. The Examiner’s
rationale is insufficient to explain why a person of ordinary skill would
relocate the graft of Metzger such that it would no longer clear Metzger’s
bearing surface despite Metzger’s teaching that would interfere with the
operation of Metzger’s prosthesis. See In re Kahn, 441 F.3d 977, 988 (Fed.
Cir. 2006) (“[R]ejections on obviousness grounds cannot be sustained by
mere conclusory statements; instead, there must be some articulated
reasoning with some rational underpinning to support the legal conclusion of
obviousness.”). The remaining independent and dependent claims have a
similar limitation to this limitation. Thus, for the reasons stated above with
respect to claim 1, we cannot sustain the anticipation rejection of claims 17,
19, 20, and 26-29.
DECISION
The Examiner’s decision to reject claim 1—20 and 26—29 is reversed.
REVERSED
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