Arlen D. Hanssen et al.

Patent Trials and Appeals Board

Jan 2, 2020

13619190 - (D) (P.T.A.B. Jan. 2, 2020)

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.
13/619,190 09/14/2012 Arlen D. Hanssen 4394.374US9 3286
104326 7590 01/02/2020
Schwegman Lundberg & Woessner / Zimmer
P.O. Box 2938
Minneapolis, MN 55402
EXAMINER
PREBILIC, PAUL B
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
01/02/2020 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):
SLW@blackhillsip.com
USPTO@slwip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ARLEN D. HANSSEN and DAVID LEWALLEN
Appeal 2018-001559
Application 13/619,190
Technology Center 3700
Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
JENNIFER MEYER CHAGNON, Administrative Patent Judges.
CHAGNON, Administrative Patent Judge.
DECISION ON APPEAL1
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant2 appeals from the
Examiner’s decision to reject claims 2–7, 23–31, and 34–55. We have
jurisdiction under 35 U.S.C. § 6(b). We REVERSE.

1 In this Decision, we refer to the Specification filed September 14, 2012
(“Spec.”); Final Office Action dated April 27, 2017 (“Final Act.”); Appeal
Brief filed August 9, 2017 (“Appeal Br.”); Examiner’s Answer dated
October 3, 2017 (“Ans.”); and Appellant’s Reply Brief filed November 28,
2017 (“Reply Br.”).
2 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as Zimmer, Inc.
Appeal Br. 2.
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CLAIMED SUBJECT MATTER
Appellant’s disclosure relates to “prosthetic devices for implantation
within a bone, and more particularly to support structures that are affixed to
a bone and that support prosthetic implants.” Spec. ¶ 3. Claim 2,
reproduced below, is illustrative of the claimed subject matter:
2. A prosthetic system implantable in a cavity in an end
of a bone, the prosthetic system comprising:
a prosthetic implant including a stem component;
a hollow sleeve for occupying an area in a cavity in an end
of a bone, the hollow sleeve securable to an inner surface of the
cavity, said hollow sleeve including an axial channel that extends
through the length of the hollow sleeve for accommodating said
stem component, wherein said hollow sleeve is formed
separately from said stem component for subsequent connection
to said stem component, said hollow sleeve capable of being
positioned, by itself, in the cavity in the end of the bone and
capable of being impacted and wedged, by itself, into the cavity
in the end of the bone for obtaining a press fit of the hollow
sleeve in the cavity prior to connecting the hollow sleeve to the
stem component, wherein said hollow sleeve consists essentially
of a porous metal material that is a bone ingrowth-receptive
material with a porous structure for encouraging bone ingrowth
and attachment throughout the hollow sleeve for restoring lost
bone stock in the cavity in the end of the bone in the area
occupied by the hollow sleeve when the hollow sleeve is
implanted in the cavity in the end of the bone; and
an adhesive deliverable to said axial channel for
interdigitation into said porous structure for securing said stem
component in said channel.
Appeal Br. 72–73 (emphasis added).
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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Davidson U.S. Patent 4,735,625 Apr. 5, 1988
Noiles U.S. Patent 4,790,852 Dec. 13, 1988
Kelman U.S. Patent 5,591,233 Jan. 7, 1997
Draenert U.S. Patent 5,958,314 Sept. 28, 1999
REJECTIONS ON APPEAL
The Examiner maintains the following rejections on appeal:
1. Claims 2, 3, 5–11, 14–17, 23–27, 30, 31, and 34–55 stand
rejected under 35 U.S.C. § 112, first paragraph, as failing to
comply with the written description requirement. Final
Act. 2–4.
2. Claims 7, 8, 10, 11, 14–17, 23, 24, 26, 27, 30, 31, 37–42,
44–52, 54, and 55 stand rejected under 35 U.S.C. § 102(b) as
being anticipated by Noiles. Id. at 4–5.
3. Claims 7, 8, 10, 11, 14–17, 23, 24, 26, 27, 30, 31, 37–42,
44–52, 54, and 55 stand rejected under 35 U.S.C. § 103(a) as
having been obvious over Noiles and Draenert. Id. at 4–6.
4. Claims 2, 3, 6, 9, 25, 34–36, 43, and 53 stand rejected under
35 U.S.C. § 103(a) as having been obvious over Noiles,
Draenert, and Kelman. Id. at 6–7.
5. Claim 5 stands rejected under 35 U.S.C. § 103(a) as having
been obvious over Noiles, Draenert, Kelman, and Davidson.
Id. at 7.
OPINION
We have reviewed the Examiner’s rejections in light of Appellant’s
contentions that the Examiner has erred. Further, we have reviewed the
Examiner’s response to Appellant’s arguments. We are persuaded by
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Appellant’s arguments that the Examiner erred in rejecting the claims based
on the grounds of rejection set forth above.
Written Description
Claims 2, 3, 5–11, 14–17, 23–27, 30, 31, and 34–55 stand rejected
under 35 U.S.C. § 112, first paragraph, as failing to comply with the written
description requirement. Final Act. 2–4. In particular, the Examiner
contends that the claim language “said hollow sleeve consists essentially of a
porous metal material”3, as recited in claim 2, with similar language in the
other independent claims, “lacks clear original support.” Id. at 3. According
to the Examiner, “it is not clear from the original specification what is
essential to the invention or what is the basic and novel characteristic is of
the invention.” Id. (citing MPEP 2111.03). Regarding dependent claims 43,
44, and 47, the Examiner further contends that the claim language “the
hollow sleeve is formed entirely with said porous metal material”4 “lacks
clear original support.” See id. at 4.
Appellant contends there is direct support in the Specification for
“(i) forming the sleeve from a porous metal material; and (ii) having the
entire structure of the sleeve be porous (and thus capable of receiving bone
ingrowth),” and there is, thus, “support for the sleeve being formed entirely
with a porous metal material and for the sleeve’s ability to encourage bone
ingrowth and attachment throughout itself for restoring lost bone stock in the

3 We note that the Final Office Action refers to “claim language requiring
the hemispherical support structure ‘consisting essentially of’ a porous
material,” which appears to be a clerical error, as that particular language is
not present in the rejected claims. See Final Act. 3.
4 Again, the Final Office Action recites “support structure” instead of
“hollow sleeve,” which appears to be a clerical error. See Final Act. 4.
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cavity, as claimed.” Appeal Br. 11; see also id. at 10–20 (expanding upon
this contention). We agree.
The Specification describes that “[o]ne problem commonly
encountered by surgeons replacing joints is the loss of strong bone stock
near the joint being replaced.” Spec. ¶ 4. As such, “there is a need for a
prosthetic implant system . . . that encourages bone ingrowth and attachment
over as large a surface area as possible.” Id. ¶ 10. According to the
Specification, the present invention solves this problem. See id. ¶¶ 19, 97.
As described with respect an embodiment of the invention, “the
support structure comprises a hollow porous cylindrical sleeve.” Id. ¶ 13.
Figure 8 is reproduced below.

Figure 8, above, is a cross-sectional view of the prosthetic implant support
structure (i.e., cylindrical sleeve 50) of an embodiment being placed in a
femur. Id. ¶ 28. As described, cylindrical sleeve 50 may be formed from
“a porous metal alloy.” Id. ¶ 58. Appellant contends that a person of
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ordinary skill in the art also would understand the Specification’s language
“into the porous structure of the sleeve” means the entire sleeve has a porous
structure. Appeal Br. 17 (citing Spec. ¶ 60, emphasis added by Appellant).
The Specification further describes an embodiment in which
“[a]ll surfaces against host bone . . . are available for bone ingrowth into
porous materials used for the components.” Spec. ¶ 14. Appellant presents
testimony that a porous structure that is receptive to bone ingrowth has the
ability to restore lost bone stock in an area occupied by the porous structure.
See Lewallen Decl.5 ¶ 6.
In the Answer, the Examiner contends that “restoring lost bone stock
does not necessarily means [sic] that the implant must be porous throughout
only that the implant must be capable [of] replacing the bone from a purely
structural standpoint. It does not require that the implant be porous
throughout.” Ans. 2. We agree with Appellant, however, that in
combination with the figures, e.g., Figure 8, the disclosures of at least
paragraphs 13, 55, 58, and 60 of the Specification support claims directed to
the hollow sleeve being formed entirely with a porous metal material, even if
this is not required in all of the Specification’s embodiments. See Reply
Br. 6–8; see also Appeal Br. 30 (Appellant arguing that “[w]hile it is true
that Appellant’s disclosure includes embodiments where a support structure
includes a porous outer coating but is not porous throughout, it is also true
that Appellant’s disclosure includes embodiments where the entire support
structure has a porous structure. The fact that our specification discloses the
former embodiment does not make any less valid our inventions involving

5 Declaration of David G. Lewallen under 37 C.F.R. § 1.132, executed
March 16, 2017 (“Lewallen Decl.”).
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the latter embodiment—or the reality that implanting a hollow sleeve that
encourages bone ingrowth and attachment throughout itself provides many
advantages over prior art sleeve products that are overwhelmingly non-
porous—not the least of which is the ability to actually grow new bone in
areas where it once existed rather than just filling those areas with solid/non-
porous metal.”).
Written description requires that the Specification demonstrates
Appellant had possession of the claimed invention at the time the application
was filed. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010) (en banc). Based on at least the foregoing disclosures of the
Specification and the testimony presented in the Lewallen Declaration, we
are persuaded that Appellant had possession of the hollow sleeve being
formed entirely with porous metal material. We further agree with
Appellant that, based on the disclosures above and those cited by Appellant,
a person of ordinary skill in the art would have understood the “consisting
essentially of” claim language to include a metal material hollow sleeve that
is porous throughout the structure. See Ariad, 598 F.3d at 1351. We
therefore reverse the rejection under 35 U.S.C. § 112, first paragraph, for
lack of adequate written description.
Anticipation
Claims 7, 8, 10, 11, 14–17, 23, 24, 26, 27, 30, 31, 37–42, 44–52, 54,
and 55 stand rejected under 35 U.S.C. § 102(b) as being anticipated by
Noiles. Final Act. 4–5. We select claim 7 as representative of the claims
subject to this ground of rejection.
“To anticipate a claim, a reference must disclose every element of the
challenged claim and enable one skilled in the art to make the anticipating
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subject matter.” PPG Indus. Inc. v. Guardian Indus. Corp., 75 F.3d 1558,
1566 (Fed. Cir. 1996). The Examiner relies on Noiles’s teaching of
sleeve 13 having a porous structure on the outside thereof as disclosing the
claimed hollow sleeve that “consists essentially of a porous metal material.”
See Final Act. 4–5; Noiles 7:33–43, Fig. 2. As discussed above, we agree
with Appellant that a person of ordinary skill in the art would have
understood “consisting essentially of a porous metal material,” read in light
of the Specification, to require a metal material hollow sleeve that is porous
throughout the structure. As acknowledged by the Examiner (Final Act. 5),
Noiles does not disclose this claim element because it does not disclose
porous material extending throughout the entire structure. Because Noiles
does not disclose every element of claim 7, we reverse the rejection. As the
other challenged claims similarly recite a hollow sleeve “consisting
essentially of a porous metal material,” we likewise reverse the rejection of
those claims.
Obviousness
Claims 7, 8, 10, 11, 14–17, 23, 24, 26, 27, 30, 31, 37–42, 44–52, 54,
and 55 stand rejected under 35 U.S.C. § 103(a) as having been obvious over
Noiles and Draenert. Final Act. 4–6. Claims 2, 3, 6, 9, 25, 34–36, 43, and
53 stand rejected under 35 U.S.C. § 103(a) as having been obvious over
Noiles, Draenert, and Kelman. Id. at 6–7. Claim 5 stands rejected under
35 U.S.C. § 103(a) as having been obvious over Noiles, Draenert, Kelman,
and Davidson. Id. at 7. We address these rejections together as the same
issue is dispositive to all rejections.
The Examiner relies on sleeve 13 of Noiles, which has a porous
coating on the outside thereof, as teaching the claimed hollow sleeve. See
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Final Act. 5; Noiles 7:33–43, Fig. 2. In the instance where the claims are
interpreted to require porous material throughout the hollow sleeve (as here),
the Examiner points further to Draenert. Final Act. 5. According to the
Examiner, Draenert “teaches that it was known to make similar implants out
of porous metal materials where the pores extend throughout the entire
piece.” Id. (citing Draenert, Abstract, 6:3–20, Figures). The Examiner, thus,
asserts that “it would have been considered at least clearly obvious to an
ordinary artisan to utilize porous material, as taught by Draenert, to make the
components of Noiles porous throughout for the same reasons that Draenert
utilizes the same or for the reason that it would have been a mere
substitution of one known material for another to yield a predictable result.”
Id. at 5–6 (citing MPEP 2143). Each of the rejections under 35 U.S.C.
§ 103(a) relies upon this reasoning for disclosure of a hollow sleeve
“consisting essentially of a porous metal material.” See id. at 5–7.
Appellant argues Draenert does not disclose the use of a sleeve or use
of an implant with a sleeve to connect components in a patient’s body.
Appeal Br. 42. Appellant further contends that the “overwhelming majority
of the sleeve in Noiles is completely non-porous and thus overwhelmingly
not receptive to bone ingrowth” and “Noiles fails to shed any light on how
having bone growth throughout sleeve (13) would affect the efficacy of that
particular component and/or things connected to it in the body . . . over
time.” Id. According to Appellant, a person of ordinary skill in the art
would not have modified Noiles in view of Draenert, as proposed by the
Examiner. Id. at 42–43.
We agree that a preponderance of the evidence does not support the
Examiner’s findings that the skilled artisan would have been motivated to
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combine Noiles and Draenert. A prima facie case for obviousness “requires
a suggestion of all limitations in a claim,” CFMT, Inc. v. Yieldup
International Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003), and “a reason
that would have prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention does,” KSR
International Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007).
As acknowledged by the Examiner (Final Act. 5), Noiles discloses a
porous coating on the surface of the sleeve as shown in Figure 2, reproduced
below, with annotation of the porous coating identified by the Examiner:

Annotated Figure 2 “is a magnified view of a section through the outside
surface of the sleeve of [Noiles’s] invention.” Noiles 3:37–38. Regarding
this sleeve structure, Noiles discloses:
As also shown in FIG. 2, to further enhance bone
ingrowth, the outer surface of the sleeve can be porous coated
using small balls 114 composed of the same metal as that used
to form sleeve 13, e.g., a surgically implantable alloy such as a
titanium alloy containing 6% aluminum and 4% vanadium or
chemically pure titanium (see ASTM Spec. Nos. F136-79 and
F67-83). By using a single layer of balls (see FIG. 2), the
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benefits of bone ingrowth can be achieved without sacrificing
the benefits resulting from terracing and undercutting the outer
surface of the sleeve.
Noiles 7:33–43 (emphasis added).
Draenert teaches a process
for producing a positive-material with a skeleton made of
shell-like structures and an interconnecting pore system
designed between the skeleton structures. Also disclosed is a
process for producing a negative-material made of shaped
bodies interconnected by bridges[,] a process for producing a
positive/negative-material, materials produced by this process
and their use as bone replacement materials, implants, filters
and drug delivery systems. According to this process
deformable shaped bodies in bulk are poured into a mold that
forms a negative model of the material.
Draenert Abstract. Along with the Abstract, the Examiner points to
Draenert’s Figures 1–10, which depict porous substances made by the
processes described above. See Final Act. 5.
Upon review of the disclosures identified by the Examiner, we are not
persuaded that a person of ordinary skill in the art would have found it
obvious to use the porous materials taught by Draenert such that the sleeve
of Noiles is porous throughout, as reasoned by the Examiner. In particular,
we find that Noiles’s disclosure that by using “a single layer of balls, the
benefits of bone ingrowth can be achieved without sacrificing the benefits
resulting from terracing and undercutting the outer surface of the sleeve”
teaches that full porosity is unnecessary and possibly detrimental to the
sleeve structure. We find that this disclosure would not have motivated the
artisan to make a wholly porous sleeve. And even if a wholly porous sleeve
were desired, the Examiner has not pointed us to teachings in Draenert that
suggest the artisan would have reasonably believed that the proposed
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“substitution of one known material for another to yield a predictable result”
(Final Act. 5–6) would be successful.
Appellant also submits extensive evidence of secondary
considerations (see Appeal Br. 46–67; Reply Br. 2–4), which the Examiner
contends lacks probative weight (Final Act. 12–14; Ans. 6–8). However,
given that we conclude the references do not suggest the claimed subject
matter, we find that a preponderance of the evidence does not support the
Examiner’s conclusion that the rejected claims are obvious. Because all of
the rejections are based on the Examiner’s finding that a person of ordinary
skill in the art would have found it obvious to use the porous materials
taught by Draenert such that the sleeve of Noiles is porous throughout, we
reverse all of the rejections under 35 U.S.C. § 103.
CONCLUSION
The Examiner’s rejections are reversed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
2, 3, 5–11,
14–17,
23–27, 30,
31, 34–55
112, first
paragraph
Written description 2, 3, 5–11,
14–17,
23–27, 30,
31, 34–55
7, 8, 10, 11,
14–17, 23,
24, 26, 27,
30, 31,
37–42,
44–52, 54,
55
102(b) Noiles 7, 8, 10,
11, 14–17,
23, 24, 26,
27, 30, 31,
37–42,
44–52, 54,
55
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Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
7, 8, 10, 11,
14–17, 23,
24, 26, 27,
30, 31,
37–42,
44–52, 54,
55
103(a) Noiles, Draenert 7, 8, 10,
11, 14–17,
23, 24, 26,
27, 30, 31,
37–42,
44–52, 54,
55
2, 3, 6, 9, 25,
34–36, 43,
53
103(a) Noiles, Draenert,
Kelman
2, 3, 6, 9,
25, 34–36,
43, 53
5 103(a) Noiles, Draenert,
Kelman, Davidson
5
Overall
Outcome
2–7,
23–31,
34–55

REVERSED