Ex Parte Hacking et al

Patent Trial and Appeal Board

Jun 12, 2015

11871633 (P.T.A.B. Jun. 12, 2015)

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.
11/871,633 10/12/2007 Adam S. Hacking HAC 0001 PA 7190
23368 7590 06/12/2015
DINSMORE & SHOHL LLP
FIFTH THIRD CENTER, ONE SOUTH MAIN STREET
SUITE 1300
DAYTON, OH 45402-2023
EXAMINER
WATKINS, MARCIA LYNN
ART UNIT PAPER NUMBER
3774
MAIL DATE DELIVERY MODE
06/12/2015 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 ADAM S. HACKING and EDWARD J. HARVEY1
__________

Appeal 2012-009451
Application 11/871,633
Technology Center 3700
__________

Before ERIC B. GRIMES, MELANIE L. McCOLLUM, and
ELIZABETH A. LaVIER, Administrative Patent Judges.

McCOLLUM, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a bone
graft. The Examiner has rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 7, 10, 11, and 31–34 are on appeal (App. Br. 2).2 Claims 7,
10, and 11 are illustrative and read as follows:

1 Appellants identify the real party in interest as Adam S. Hacking (App.
Br. 1).
2 Claims 1–6 and 13–30 are also pending but have been withdrawn from
consideration (App. Br. 2).
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7. A bone graft having a surface contactable with a host bone for
promoting regeneration of the host bone, wherein at least a portion of the
surface includes macrostructures and microstructures, where the
macrostructures comprise peaks which are randomly distributed across the
bone graft surface and have a peak-to-peak spacing less than about 180 μm.
10. A bone graft according to claim 7, wherein the peak-to-peak
spacing is between about 0.1 and about 180 μm.
11. A bone graft according to claim 7, wherein the surface roughness,
as defined by Ra, is between about 0.1 and 400 μm.
Claims 7, 10, 11, and 31–34 stand rejected under 35 U.S.C. § 103(a)
as obvious over Khandkar et al. (US 6,846,327 B2, Jan. 25, 2005) in view of
Petersson et al. (US 2006/0154206 A1, July 13, 2006) (Ans. 4).
The Examiner relies on Khandkar for disclosing a “bone graft having
a surface contactable with a host bone for promoting regeneration of the host
bone . . . , wherein at least a portion of the surface includes rough-textured
pattern capable of aiding in the promotion of boney ingrowth” (id.).
The Examiner relies on Petersson for teaching “a means for enhancing
the promotion of ingrowth using a roughened exterior surface” (id. at 5).
Specifically, the Examiner finds that “Petersson teaches the surface includes
macrostructures and microstructures . . . , where the macrostructures
comprise peaks which are randomly distributed . . . across the surface” (id.).
The Examiner concludes:
It would have been obvious to one of ordinary skill in the art at
the time of the invention to implement the parameters of
exterior surface texture taught by Petersson in the invention of
Khandkar in order to optimize the capability of boney ingrowth
in the graft by using specific surface morphology that gives a
very resistant new bone in-growth that does not easily fracture
from the old bone.
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(Id.) In addition, the Examiner concludes:
[I]t is clearly within the skill of a worker in the art to discover
optimized and workable ranges for size dimensions of
macrostructures including: peak-to-peak spacing between about
0.1 and about 30 µm [and] surface roughness between about 0.1
and 400 µm . . . since where the general conditions of a claim
are disclosed in the prior art, discovering the optimum or
workable ranges involves only routine skill in the art.
(Id. at 5–6.)
FINDINGS OF FACT
1. The Specification discloses that “the term ‘bone graft’ includes
the whole or any part of a graft derived from natural bone, such as cortical or
cancellous bone” (Spec. ¶ 42).
2. The Specification also discloses that “the terms
‘macroroughness’, ‘macrotexture’ or ‘macrofeatures’ refer to larger surface
features within the micron range” (id. ¶ 46).
3. In addition, the Specification discloses that “the terms
‘microroughness’, ‘microtexture’ or ‘microfeatures’ refer to smaller surface
features within the micron scale and which are smaller than the
macrofeatures” (id. ¶ 47).
4. Khandkar discloses a “bone graft 10 compris[ing] a bio-
compatible ceramic substrate having a porous construction to define an open
lattice conducive to interbody bone ingrowth and fusion” (Khandkar, col. 5,
ll. 18–22).
5. Khandkar also discloses that the “open-celled ceramic substrate
is coated internally and externally with a bio-active surface coating selected
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for relatively strong osteoconductive and osteoinductive properties” (id. at
col. 5, ll. 24–27).
6. In particular, Khandkar discloses a “bone graft in the form of an
improved spinal fusion cage 10 . . . , in the shape of a generally cylindrical
body” (id. at col. 5, ll. 33–37).
7. Khandkar also discloses that the “cylindrical body is shown
further to include a laterally open recess or bore 24 for receiving and
supporting morselized bone graft material 26 (FIG. 2), such as allograft bone
material from a third party donor, or autograft bone material from the
patient” (id. at col. 5, ll. 44–48).
8. Petersson discloses “an implant for implantation into bone
tissue having an implant surface, wherein at least a part of the implant
surface . . . comprises . . . a microroughness” (Petersson ¶ 30).
9. Petersson also discloses that “the term ‘microroughness’ refers
to a surface roughness comprising pores having a pore diameter equal to or
less than 1 µm and a pore depth equal to or less than 1 µm” (id. ¶ 45).
10. In addition, Petersson discloses that “the term
‘macroroughness’ refers to a surface roughness comprising surface
irregularities having dimensions greater than 1 µm” (id. ¶ 46).
11. Petersson also discloses:
This specific surface morphology gives a very resistant bone in-
growth. With this specific morphology, newly formed bone,
which grows into the surface irregularities of the implant
surface, does not easily fracture from the old bone. In addition,
the peaks of the implant surface do not easily fracture from the
implant.
(Id. ¶ 64.)
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12. In addition, Petersson discloses: “Preferably, the method
further comprises providing a macroroughness on the implant surface . . .
prior to providing the microroughness. Thus, an implant having a
microroughness superimposed on the macroroughness is obtained.” (Id.
¶ 91.)
13. Petersson Figure 1 is set forth below:

Figure 1 depicts “a microroughness . . . superimposed on a macroroughness”
(id. ¶ 53). Figure 1 “defines the terms ‘pore diameter’ (D) [i.e., D1 and D2],
‘pore depth’ (h) [i.e., h1 and h2] and ‘peak width at half the pore depth’ (x)
[i.e., x1 and x2]” (id. ¶ 32).
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ANALYSIS
Khandkar discloses a bone graft having a surface contactable with a
host bone for promoting regeneration of the host bone (Findings of Fact (FF)
4–7). Petersson discloses an implant having a surface including
macrostructures and microstructures, where the macrostructures comprise
peaks that are randomly distributed (FF 8 & 12–13). Petersson also
discloses that its “surface morphology gives a very resistant bone in-growth”
(FF 11). We agree with the Examiner that it would have been obvious to
include Petersson’s surface morphology on the surface of Khandkar’s bone
graft to provide resistant bone ingrowth (Ans. 5). In addition, we agree with
the Examiner that it would have been obvious to include Petersson’s
macrostructures with a peak-to-peak spacing of less than about 180 µm (id.
at 5–6). See In re Aller, 220 F.2d 454, 456 (CCPA 1955) (“[W]here the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation.”).
We are not persuaded by Appellants’ arguments to the contrary
substantially for the reasons set forth in the Examiner’s Answer (Ans. 6–14).
However, we include the following additional comments.
As noted by the Examiner (id. at 11), Khandkar specifically refers to
its device as a “bone graft” (FF 4). In addition, the Specification merely
states that “the term ‘bone graft’ includes the whole or any part of a graft
derived from natural bone, such as cortical or cancellous bone” (FF 1
(emphasis added)). We do not agree with Appellants that this definition
clearly recites that the surface of a “bone graft” must be derived from natural
bone (Reply Br. 4 & 7). Thus, we do not agree with Appellants that
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Khandkar’s “bone graft” is excluded by this definition (id.). Furthermore,
Appellants have not provided sufficient evidence to support their position
that “a skilled person would understand that adding morselized bone to a
ceramic implant does not make it a ‘bone graft’ as understood in the art”
(App. Br. 13).
As also noted by the Examiner (Ans. 5), Petersson discloses “an
implant having a microroughness superimposed on the macroroughness”
(FF 12). Petersson also discloses that “the term ‘microroughness’ refers to a
surface roughness comprising pores having a pore diameter equal to or less
than 1 µm and a pore depth equal to or less than 1 µm” (FF 9). Appellants
argue that “[t]here is no disclosure in Petersson of microfeatures as defined
in the present specification: ‘smaller surface features within the micron
[scale]’ . . . i.e. more than 1 micron” (App. Br. 15). However, we do not
agree with Appellants that the definition of microfeatures provided in the
Specification (FF 3) clearly indicates that the claimed microstructures are
larger than one micron.
In addition, the Examiner finds that Petersson’s “figure 1 clearly
teaches and suggests the random distribution of peaks (i.e., more than one
peak of differing configuration)” (Ans. 13). Petersson Figure 1 depicts “a
microroughness . . . superimposed on a macroroughness” (FF 13).
Appellants argue that “Figure 1 of Petersson illustrates a single peak but
there is no disclosure of the orientation of the peaks across a surface” (App.
Br. 15). However, this Figure appears to depict more than one peak, the
peaks having different shapes (FF 13). Thus, it is not clear to us why this
Figure fails to support the Examiner’s position.
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With regard to the claimed peak-to-peak spacing, Appellants argue
that “[i]t would not have been obvious to discover the claimed peak-to-peak
spacing . . . by ‘routine experimentation’ as there is no motivation in the
cited prior art to conduct such experimentation on bone surfaces” (App.
Br. 16). However, for the reasons discussed above, we do not agree that
claim 7 requires the formation of peaks on bone surfaces and instead
encompasses a bone graft comprising a porous ceramic substrate, as
disclosed in Khandkar (FF 4). Appellants do not adequately explain why it
would not have been obvious to determine workable ranges of peak-to-peak
spacing for Khandkar’s bone graft.
In addition, Appellants argue that the “claims on appeal are directed to
the promotion of host bone regeneration, and not bone ingrowth” (Reply
Br. 3). We recognize that claim 7 recites a surface “for promoting
regeneration of the host bone” (App. Br. 19). However, Appellants admit
that Khandkar’s surface is osteoconductive, which is a known mechanism
for the promotion of host bone regeneration (Reply Br. 3–4; see also FF 5).
Thus, Khandkar’s surface is for promoting host bone regeneration.
We also recognize that claim 7 does not specifically recite bone
ingrowth. However, we agree with the Examiner that providing resistant
bone ingrowth is a reason to combine Khandkar with Petersson. “In
determining whether the subject matter of a patent claim is obvious, neither
the particular motivation nor the avowed purpose of the patentee controls.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419 (2007). Instead, “any need
or problem known in the field of endeavor at the time of invention and
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addressed by the patent can provide a reason for combining the elements in
the manner claimed.” Id. at 420.
Appellants also argue that “the implant of Petersson cannot result in
bone ingrowth due to the sizes of its surface features” (Reply Br. 5).
However, Petersson specifically recites that its “surface morphology gives a
very resistant bone in-growth” (FF 11). In addition, although Petersson
discloses pores with a diameter of ≤ 1 µm (FF 8–9), Petersson discloses that
these pores are superimposed on macroroughness, which comprises “surface
irregularities having dimensions greater than 1 µm” (FF 12 & 10).
Appellants do not adequately demonstrate that this structure would not allow
for bone ingrowth.
With regard to claim 10, Appellants additionally argue that “the
Examiner has provided no evidence, only unsupported speculation, that
Petersson teaches the claimed spacing or that the claimed ranges could have
been achieved by routine experimentation” (App. Br. 17). However, “where
the general conditions of a claim are disclosed in the prior art, it is not
inventive to discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955). In the
present case, Petersson discloses “an implant having a microroughness
superimposed on . . . macroroughness” (FF 12). In addition, Petersson refers
to the “macroroughness” as “a surface roughness comprising surface
irregularities having dimensions greater than 1 µm” (FF 10). Based on
Petersson’s disclosure, we agree with the Examiner that peak-to-peak
spacing between about 0.1 and about 180 µm would have been prima facie
obvious. “Only if the ‘results of optimizing a variable’ are ‘unexpectedly
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good’ can a patent be obtained for the claimed critical range.” In re Geisler,
116 F.3d 1465, 1470 (Fed. Cir. 1997) (quoting In re Antonie, 559 F.2d 618,
620 (CCPA 1977)).
With regard to claim 11, Appellants additionally argue that “the
references are silent with regard to the claimed surface roughness” (App.
Br. 17). However, Appellants do not explain why it would not have been
obvious, as asserted by the Examiner, to provide a surface roughness
between about 0.1 and 400 µm (Ans. 5–6). As noted above, “where the
general conditions of a claim are disclosed in the prior art, it is not inventive
to discover the optimum or workable ranges by routine experimentation.” In
re Aller, supra.
CONCLUSION
The evidence supports the Examiner’s conclusion that Khandkar and
Petersson suggest the bone graft of claims 7, 10, and 11. We, therefore,
affirm the obviousness rejection of claims 7, 10, and 11. Claims 31–34 have
not been argued separately and therefore fall with claim 7. 37 C.F.R.
§ 41.37(c)(1)(vii).
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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