Ex Parte Hatcher et al

Patent Trial and Appeal Board

Nov 3, 2016

13690538 (P.T.A.B. Nov. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/690,538 11130/2012 Brian M. Hatcher
23413 7590 11/07/2016
CANTOR COLBURN LLP
20 Church Street
22nd Floor
Hartford, CT 06103
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
UF#l4529 (UFL0009USD) 2751
EXAMINER
YOUNG, MICAH PAUL
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
11/07/2016 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):
usptopatentmail@cantorcolbum.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRIAN M. HATCHER, ANTHONY BRENNAN,
BRIAN CUEVAS, and CHARLES SEEGERT1
Appeal2015-05296
Application 13/690,538
Technology Center 1600
Before DONALD E. ADAMS, TIMOTHY G. MAJORS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a bioactive
sol-gel solution. The Examiner entered final rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses: "[ t ]he invention concerns a bioactive sol
solution, a bioactive gel, and bioactive glass (BG), each combined with a
biocompatible polymer to form a composite, and methods for producing the
1 Appellants identify the Real Party in Interest as the University of Florida.
App. Br. 2.
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Application 13/690,538
same. The BG composite can be provided in a variety of forms, including
fibers, particulates, spheres, coatings, and foamed scaffolds." Spec. ,-r 11.
"A bioactive sol-gel solution comprises a biocompatible polymer, a gelable
inorganic base material, and at least one calcium and phosphorous molecular
species." Id. at ,-r 15.
The following rejection is before us to review (Ans. 2-3):
Claims 1 and 4--10 stand rejected under 35 U.S.C. § 103(a) as obvious
over Dunn '552,2 Orefice,3 and Dunn '334.4 Claim 1 illustrates the appealed
subject matter and reads as follows:
1. A bioactive sol-gel solution, comprising:
a biocompatible polymer, a gelable inorganic base
material, wherein the gelable base material is selected from the
group consisting of alkoxysilanes, aluminates, titanates and
borates; and
at least one calcium and phosphorous molecular species;
\'l1here the calcium molecular species is calcium oxide and
where the phosphorus molecular species is phosphorus
pentoxide.
App. Br. 7, Claims App'x.
ISSUE
Does a preponderance of the evidence relied upon by the Examiner
support a conclusion of obviousness?
2 Dunn et al., US 5,599,552, issued Feb. 4, 1997 ("Dunn '552").
3 Orefice et al., Novel sol-gel bioactive fibers, October 2000, Jon Wiley &
Sons ("Orefice").
4 Dunn et al., US 5,200,334, issued Apr. 6, 1993 ("Dunn '334").
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Application 13/690,538
FACTUAL FINDINGS (FF)
FF 1. Dunn '552 discloses:
The invention is directed to a composition composed of a
thermoplastic or thermosetting polymer which is capable of
forming a biodegradable and/or bioerodible microporous, solid
or gelatinous polymer matrix. The matrix is useful as an
implant in animals for enhancing regeneration of cells and
tissue, such as bone and nerve cells, or for delivery of
biologically-active substances to tissue or organs. The
composition is administered to an implant site as a liquid. The
invention also includes a method of preventing and treating
disorders and diseases, such as bone or nerve growth disorders .
Dunn '552, Abstract.
FF 2. Dunn '552 discloses:
[T]he composition is a liquid formulation of a thermoplastic
polymer and a pharmaceutically acceptable organic solvent.
The composition is administered as a liquid to an implant site,
whereupon the solvent diffuses or dissipates into the
surrounding aqueous tissue fluids. The thermoplastic polymer
is not soluble in these aqueous fluids so that it coagulates or
solidifies to form a microporous solid or gelatinous matrix. The
matrix preferably has a two-layered pore structure composed of
a core portion and an outer surface layer or skin. The polymer
matrix is suitable for use as an in situ formed implant in an
animal, including humans and other mammals. The
composition may be administered to tissue, to a surgical
incision, or to a void space.
Id. at 2:35--48.
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FF 3. Dunn '552 discloses:
[t]he composition is a liquid formulation of a thermoset
prepolymer or copolymer, preferably an acrylic ester-
terminated biodegradable prepolymer, which is capable of
cross-linking in situ to form a polymeric or copolymeric solid
or gelatinous matrix. The composition preferably is a neat
liquid but may include a pharmaceutically acceptable organic
solvent that is miscible with water and body fluids.
Id. at 2:51-58.
FF 4. Dunn '552 discloses "[t]he composition may further contain at least
one biologically-active agent which is capable of providing a biological,
physiological or therapeutic effect in an animal." Id. at 3:50-52.
FF 5. Dunn '552 discloses:
[a]crylic pre-polymers for use in the compositions may be
synthesized according to a variety of methods including, but not
limited to, reaction of a carboxylic acid, such as acrylic or
methacrylic acid, with an alcohol; reaction of a carboxylic acid
ester, such as methyl acrylate or methyl methacrylate, with an
alcohol by transesterification; and reaction of an
isocyanatoalkyl acrylate, such as isocyanatoethyl methacrylate,
with an alcohol.
Id. at 5:21-28.
FF 6. Dunn '552 discloses "the agent may be a bone growth promoting
substance such as hydroxyapatite, tricalcium phosphate, a di- or
polyphosphonic acid, an anti-estrogen, a sodium fluoride preparation, a
substance having a phosphate to calcium ratio similar to natural bone, and
the like." Id. at 10:61-65.
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Application 13/690,538
FF 7. Orefice discloses sol-gel bioactive fibers with in vivo bioactivity.
Orefice Abstract, Fig. 11.
FF 8. Orefice discloses that sol-gel compositions containing the bioactive
fibers may be made from "a mixture of TEOS, phosphorous alkoxide and
calcium nitrate, or calcium chloride in a water ethanol solution." Id. at
Abstract.
FF 9. Orefice discloses:
[s]ol-gel ceramic materials usually are porous before the
densification step. The evolution of pore texture during heat
treatment is used frequently to follow the densification of the
material. The densification of sol-gel discontinuous bioactive
fibers was investigated in this work by studying the pore texture
of fibers heat treated at different temperatures.
Id. at p. 464, 2nd col.
FF 10. Orefice discloses fiber compositions of calcium oxide and
phosphorous pentoxide in Table 1:
TA!:ll.E l
SSS w 36
m 00 16
Id. at p. 461, 2nd col.
FF 11. Orefice discloses "[t]he in vitro bioactivity of the fibers in [simulated
body fluid] was demonstrated. Hence, the fibers described in this
publication have potential applications in both soft and hard tissue repair and
regeneration." Id. at p. 467, 2nd col.
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Application 13/690,538
FF 12. The Specification discloses "[a] bioactive sol-gel solution comprises
a biocompatible polymer, a gelable inorganic base material, and at least one
calcium and phosphorous molecular species. The base material can be an
alkoxysilane alkoxide, such as TEOS." Spec. at 4.
Principle of Law
An invention is not patentable under 35 U.S.C. § 103 if it is obvious.
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 427 (2007). Under§ 103: the
scope and content of the prior art are to be determined; differences between
the prior art and the claims at issue are to be ascertained; and the level of
ordinary skill in the pertinent art resolved. Against this background, the
obviousness or nonobviousness of the subject matter is determined.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966). A central question in
analyzing obviousness is "whether the improvement is more than the
predictable use of prior art elements according to their established
functions." KSR, 550 U.S. at 417.
OBVIOUSNESS
Based on the combination of Dunn '552 and Orefice, the Examiner
concludes that, at the time Appellants' invention was made, it would have
been "obvious to combine the prior art with an expected result of a stable
sol-gel solution capable of forming a composite material for implantation"
and to "follow the suggestions of the '552 patent to include tissue
augmentation materials including metal oxides and include the materials
described in the Orefice study, as they would be useful in achieving the
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same goal of improving tissue growth upon in situ implantation." (Ans. 4.
FF 1-11).
Initially, we note that, for the foregoing reasons, we find the subject
matter of Appellants' claimed invention prima facie obvious in view of
Dunn '552 and Orefice alone. 5 The Board may rely upon less than all the
references cited by the Examiner. See In re May, 574 F.2d 1082, 1090
(CCP A 1978). We adopt and incorporate by reference the Examiner's
findings and conclusions with respect to these references as presented in the
Final Action mailed March 3, 2014, and Answer. We address the arguments
raised by Appellants on appeal below.
Appellants argue "[t]here is[] no motivation to combine Dunn '552
with Orefice since the sol-gel material of Orefice would not a) produce pores
and b) is not soluble with water or body fluids" and that doing so would
"destroy[] the intent of the references." App. Br. 4--5. According to
Appellants:
If the Examiner intended to replace the pore formers of Dunn
'552 with the sol-gel fibers of Orefice, then it follows that the
sol-gel fibers would not be able to perform the function of the
pore formers. In addition, sol-gel materials manufactured from
alkoxysilanes are not soluble in water or body fluids, because
silica (which is obtained from alkoxysilanes as disclosed by
Orefice) is not water soluble or soluble in body fluids.
Combining the sol-gel fibers of Orefice with the composition of
5 We recognize that the Examiner relied on Dunn '334 to address elements
pertaining to Appellants' dependent claims; however, as Appellants have not
separately argued those claims, we do not address them here. 37 C.F.R.
§ 41.37(c)(l)(iv).
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Dunn '552 would therefore destroy the principle of operation of
Dunn '552 since the sol-gel fibers would not facilitate the
formation of pores that is required by Dunn '552.
Id. at 4.
The Examiner responds that the sol-gel fibers of Orefice, which are
"porous upon formation" "would not be combined with Dunn [' 552] as a
substitute for the pore forming agents, but as an agent for promoting bone
growth." Ans. 5---6. The Examiner finds it would have been obvious to
include the fibers "due to their in vitro bioactivity and compositional
similarity to compounds suggested by Dunn ['552] such as hydroxyapatite
and calcium compounds." Id. at 6. The Examiner notes that the porosity of
the fibers of Orefice would promote solubility and the existing "pore-
forming agents of Dunn '55[2] would remain." Id.
Absent evidence from Appellants to the contrary, we are not
persuaded that the sol-gel fibers of Orefice, which are porous at formation
(FF 9), would need to supplant the existing pore-forming agents of Dunn
'552 (FF 2) in the proposed combination. Appellants provide no evidence
why the proposed combination would fail in the instance where the Orefice
fibers are additions to - not substitutions for - the pore-forming agents of
Dunn '552. Specifically, Appellants have not provided any evidence in
support of their argument that the Examiner's combination of Dunn '552 and
Orefice "has destroyed the intent of the references." App. Br. 5---6. Without
evidence, this attorney argument is unpersuasive. See In re Pearson, 494
F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in a brief cannot take
the place of evidence.").
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In their Reply Brief, Appellants argue for the first time that the
combination suggested by the Examiner "would not teach all elements of the
independent claim 1" because it "does not teach the presence of an
alkoxysilane after the glass fibers are produced." Reply Br. 3--4. Although
this argument pertains to the rejection dated March 3, 2014, Appellants did
not raise it until the Reply Brief. The Board will not consider a new
argument that is "not raised in the appeal brief, or is not responsive to an
argument raised in the examiner's answer ... unless good cause is shown."
37 CPR 41.41(b)(2). Appellants did not explain why they waited until after
the Appeal Brief to raise this argument. Consequently, the Examiner has not
had the opportunity to address this argument nor do we have the benefit of
the Examiner's response. Consequently, we do not consider this new
argument.
Finally, Appellants acknowledge that "if Dunn '5[5]2 were to be
combined with Orefice prior to the production of glass fibers, one would
obtain the polymer (an acrylate), an alkoxysilane (TEOS), a pore former, a
calcium compound and a phosphate compound and a solvent" (i.e., a
composition meeting the limitations of claim 1) but argue that "the Examiner
has not spelled [out] any motivation as to why one of ordinary skill in the art
would combine Dunn '5 [ 5]2 with Orefice prior to the production of the sol
gel fibers. TEOS present in the solution would be harmful to the human
body and its presence would destroy the intent of Dunn '5[5]2." App. Br. 4.
Initially, we note that Appellants' argument that "TEOS present in the
solution would be harmful to the human body" is not persuasive in light of
Appellants' Specification, which discloses use of TEOS as a gelable
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inorganic base material used in a composition for insertion in the human
body. See FF 12 and Appellants' Specification at i-f 23: "[i]n another
embodiment of the invention, the composition is disposed on a surface of or
integrated within a medical device adapted for implantation into a patient."
Further, Appellants provide no evidence supporting this new argument or an
explanation of "good cause" for why it was raised for the first time in their
Reply Brief. We decline to consider the argument. The rejection is
affirmed.
Conclusion of Law
A preponderance of the evidence relied upon by the Examiner
supports a conclusion of obviousness. The rejection of claim 1 under
35 U.S.C. § 103(a) as unpatentable over Dunn '552 and Orefice is affirmed.
Claims 4--10 are not argued separately and fall with claim 1. 37 C.F.R.
§ 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of obviousness of claims 1 and 4--10 under
35 U.S.C. § 103(a) as unpatentable over Dunn '552 and Orefice.
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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