Ex Parte Levengood et al

Patent Trial and Appeal Board

Jun 21, 2017

13770046 (P.T.A.B. Jun. 21, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
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APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/770,046 02/19/2013 Sheeny K.L. Levengood P110341US01
(3004049-0017
1789
130832 7590 06/23/2017
Stinsinn T ennarrl Street T T P fWARF ^00404Q^
EXAMINER
7700 Forsyth Blvd.
Suite 1100
MIKNIS, ZACHARY J
St. Louis, MO 63105 ART UNIT PAPER NUMBER
1675
NOTIFICATION DATE DELIVERY MODE
06/23/2017 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHEENY K.L. LEVENGOOD, SABRINA H. BROUNTS,
WILLIAM L. MURPHY, and JAE SUNG LEE1
Appeal 2016-008578
Application 13/770,046
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS,
and JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for coating bone tissue, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Bone and joint diseases account for half of all chronic conditions in
people over 50 resulting in an increased need for bone repair and
1 Appellants identify the Real Party in Interest as Wisconsin Alumni
Research Foundation. Appeal Br. 1.
Appeal 2016-008578
Application 13/770,046
replacement therapies. Spec. 1 6. One such therapy is bone grafts including
autografts and allografts. Spec. 1 7. While bone autograft is the gold
standard for bone graft transplants, its use is often limited by the availability
and potential donor site morbidity from bone graft harvesting. Spec. 8.
The Specification describes
modular biologically active molecules for binding native bone.
Particularly preferred modular biologically active molecules
may include modular cytokines, growth factors, hormones,
nucleic acids, and fragments thereof. Of particular importance
in this disclosure are modular growth factors having improved
non-covalent binding to native bone and being capable of
initiating osteogenesis, angiogenesis, and/or osteogenic
differentiation.
Spec. 13.
Claims 1 and 3—12 are on appeal. Claim 1 is the sole independent
claim and reads as follows:
1. A method of coating native bone with a modular
peptide, the method comprising:
exposing native bone selected from the group consisting
of a bone autograft, a bone allograft, and a bone xenograft to a
solution comprising a modular peptide, wherein the modular
peptide comprises a bone-binding portion and a biomolecule-
derived portion and wherein the modular peptide is non-
covalently bound to the native bone in the absence of a
synthetic HA-based material.
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Application 13/770,046
Claims 1 and 3—12stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Murphy2 in view of Clarke3 and Jahangir.4
DISCUSSION
Issue
The issue is whether a preponderance of evidence supports the
Examiner’s conclusion that claims 1 and 3—12 would have been obvious
over Murphy combined with Clarke and Jahangir.
The Examiner finds that Murphy teaches a method of coating a
hydroxyapatite (“HA”) containing biomaterial with a modular protein. Final
Act. 3. The Examiner finds that one skilled in the art would understand HA
containing biomaterial to include bone. Id. The Examiner finds that
Murphy teaches the use of a modular protein has a HA-binding portion. Id.
The Examiner finds that while Murphy does not disclose binding to “native
bone,” the Examiner concludes that
Given the binding of the peptide of Murphy to “bone-like”
materials (see e.g. 11 [0009], [0092]), one of ordinary skill in the
art would have a high expectation that it would also bind to bone,
i.e. the process of binding to and/or coating bone instead of HA
or synthetic HA-based biomaterial would be highly predictable
given the teachings of Murphy.
Final Act. 4.
2 Murphy et al., US 2011/0129611 Al, published June 2, 2011 (“Murphy”).
3 Bart Clarke, Normal Bone Anatomy and Physiology, 3 Clin. J. Am. Soc.
Nephrol. S131-39 (2008) (“Clarke”).
4 Jahangir et al., Bone-graft substitutes in orthopeadic surgery, AAOS Now
9, published Jan. 2008,
http://www.aaos,orq/news/aaosnowhan08/reimbursement2.asp (“Jahangir”).
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Application 13/770,046
The Examiner also finds that Clarke teaches that bone is comprised of
50—70% mineral which is mostly HA. Id. The Examiner finds that Jahangir
teaches that autograft is the gold standard for bone repair. Id.
The Examiner concludes that
Thus it would have been obvious to one of ordinary skill
in the art at the time of the invention at arrive at the claimed
method of coating native bone with a modular peptide based on
the teachings of Murphy of the modular peptide, the ability to
bind to HA-based biomaterials, and the levels of HA in bone;
the teachings of Clarke that the mineral composition of bone is
largely HA; and the teachings of Jahangir that bone autografts
are considered the gold standard for bone repair, based at least
on the KSR rationale. . . . The process would be highly
predictable given that the peptides of Murphy are demonstrated
to bind to HA-based materials and promote osteogenesis,
osteoconduction, angiogenesis, and osteogenic differentiation,
and the skilled artisan would merely be changing the material
coated from a generic "biomaterial" (including synthetic HA-
based materials) to a specific material (bone autografts
containing natural HA).
Final Act. 6—7.
Appellants contend that the references do not teach or suggest
modifying the method of Murphy to used native bone in lieu of HA
containing synthetic biomaterial. Appeal Br. 5. Appellants contend that
while both Murphy and Clarke teach that natural bone contain HA, neither
reference teaches or suggests substituting natural bone for a HA containing
biomaterial. Id. at 5—6. Appellants argue that while Jahangir teaches that
native bone grafts are the gold standard, Jahangir teaches that there are
problem associated with natural bone and discusses alternative materials for
bone grafts. Id. at 6. Appellants argue that nothing in Jahangir teaches
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Application 13/770,046
substituting natural bone for the biomaterial of Murphy. Id. Appellants also
argue that one skilled in the art would not have a reasonable expectation of
success in substituting natural bone for the HA containing biomaterial of
Murphy as the art teaches that there are different forms of hydroxyapatite
having different chemical and physical properties. Id. at 7—8.
Analysis
“[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result.” KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), citing United States v.
Adams, 383 U.S. 39, 50-51 (1966). “The combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results.” Id. As to motivation to combine separately
disclosed subject matter, “the question is whether there is something in the
prior art as a whole to suggest the desirability, and thus the obviousness, of
making the combination, not whether there is something in the prior art as a
whole to suggest that the combination is the most desirable combination
available.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) (citation
omitted).
It is prima facie obvious to combine two [things] each of
which is taught by the prior art to be useful for the same
purpose, in order to form a third [thing] which is to be used for
the very same purpose. . . . [T]he idea of combining them flows
logically from their having been individually taught in the prior
art.
In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
We have identified claim 1 as representative; therefore, all claims fall
with claim 1. We find that, under the above-cited precedent, the Examiner
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Application 13/770,046
has established that claim 1 would have been obvious over Murphy
combined with Clarke and Jahangir. The Examiner provides a detailed and
well-reasoned explanation as to how the prior art combination teaches and
suggests the claimed subject matter. Final Action 3—7; Ans. 3—7. Further,
we agree that there would have been motivation to combine the cited prior
art, at least because Jahangir teaches the desirability to use natural bone as
opposed to synthetic biomaterials. Jahangir 1. Appellants have not
produced evidence showing, or persuasively argued, that the Examiner’s
determinations are incorrect. We address Appellants’ arguments below.
Appellants contend that there is no motivation to substitute natural
bone for the synthetic biomaterial of Murphy. Appeal Br. 5. We are
unpersuaded. As the Examiner points out, Murphy and Clarke both teach
that native bone comprises significant amounts of HA making it similar to
the biomaterial of Murphy. Ans. 11. Jahangir teaches that native bone is
preferred over substitutes. Id. Thus, while no single references provides a
motivation to make the substitution, the combined teaching of the references
would motivate on skilled in the art to treat natural bone with the peptides
disclosed in Murphy.
Appellants contend that one skilled in the art would not have a
reasonable expectation of success in substituting native bone for the
synthetic biomaterial of Murphy. Appeal Br. 7. Appellants argue that the
mere fact that native bone contains HA would not lead one skilled in the art
to expect application of the peptides to native bone to be successful. Id. In
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support of this argument Appellants point to Rey5 which teaches that there
significant structural and chemical differences between the many synthetic
hydroxyapatites and apatite found in native bone. Appeal Br. 8.
We are unpersuaded by Appellants’ argument. We agree with the
Examiner that “Appellant has provided no evidence that the structure of the
apatite found in bone that Rey teaches is sufficiently different from the HA
of Murphy such that binding of peptide to HA within native one would not
be expected.” Ans. 17. Appellants have submitted nothing more that
attorney argument that the differences in the HA found in native bone versus
the HA in the synthetic material of Murphy are critical to the binding of the
peptide to HA. “Attorneys’ argument is no substitute for evidence.”
Johnston v. IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 would have been obvious over Murphy
combined with Clarke and Jahangir.
Claims 3—12 have not been argued separately and therefore fall with
claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a).
5 Rey et al., Bone mineral: update on chemical composition and structure,
20 Osteoporos 1013 (2009) (“Rey”).
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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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