Ex Parte Cole et al

Patent Trial and Appeal Board

Oct 26, 2016

12372328 (P.T.A.B. Oct. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/372,328 02/17/2009
26158 7590 10/28/2016
WOMBLE CARLYLE SANDRIDGE & RICE, LLP
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
Jantzen A. Cole
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.
W63747 1120.2 9469
EXAMINER
NELSON, CHRISTINE L
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
10/28/2016 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):
IPDocketing@WCSR. COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JANTZEN A. COLE, MICHAEL E. CARROLL,
JON P. MOSELEY, and KELLY C. RICHELSOPH
Appeal2014-009067
Application 12/372,328
Technology Center 3700
Before LYNNE H. BROWNE, THOMAS F. SMEGAL, and
GORDON D. KINDER, Administrative Patent Judges.
BROWNE, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Jantzen A. Cole et al. (Appellants) appeal under 35 U.S.C. § 134 from
the rejection of claims 38--41, 43--46, 48, and 49. We have jurisdiction
under 35 U.S.C. § 6(b ).
We affirm.
Appeal2014-009067
Application 12/372,328
CLAIMED SUBJECT MATTER
Claim 38, reproduced below, is illustrative of the claimed subject
matter:
38. An injectable bone graft material paste composition
comprising a mixture of a powder component, a diluent, and an
accelerant in an amount of up to 0.2% by weight, the powder
component comprising calcium sulfate hemihydrate prepared by
immersing calcium sulfate dihydrate in a solution of water and
an inorganic salt to form a mixture, and heating the mixture to
substantially its boiling point at atmospheric pressure such that
the calcium sulfate dihydrate is converted to calcium sulfate
hemihydrate, and the diluent being present in an amount
sufficient to provide a diluent to powder weight ratio between
0.19: 1 and 0.31 : 1, wherein the mixture is in the form of an
injectable bone graft material paste.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Hoggatt
Burkard
Snyders
us 2,616,789
us 3,870,538
us 5,425,769
REJECTIONS
Nov. 4, 1952
Mar. 11, 1975
June 20, 1995
I. Claims 38--41, 44--46, and 49 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Hoggatt and Snyders.
II. Claims 43 and 48 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Hoggatt, Snyders, and Burkard.
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DISCUSSION
Rejection I
Appellants argue claims 38--41, 44--46, and 49 together. Appeal Br.
6-18. We select independent claim 38 as the representative claim, and
claims 39--41, 44--46, and 49 stand or fall with claim 38.
The Examiner finds that the combined teachings of Hoggatt and
Snyders disclose or suggest all of the limitations of claim 38. See Final Act.
2-3. Appellants contend that Hoggatt is non-analogous art. Appeal Br. 6.
In support of this contention, Appellants argue that "Hoggatt ... is an
industrial patent and is not directed to the same field of endeavor of bone
graft substitute materials" and that "Hoggatt is not reasonably pertinent to
the problems addressed by the present invention, of improving working
time, injectability, or set time (particularly, with regard to a bone graft
substitute material)." Appeal Br. 7-8; see also Reply Br. 2-3.
The Examiner responds to this argument by noting that Snyders points
out that gypsum plasters having Hoggatt's composition "have long been
known to be not only suitable, but desirable, for use in ... bone graft
materials." See Ans. 4. Hoggatt is directed to a method of producing
"calcium sulphate in the form of calcium sulphate hemihydrate (CaS041/2
H20) from calcium sulphate dihydrate (CaSQ42H20)." Hoggatt 1 :2--4.
Hoggatt does not specify a use for its gypsum plaster. As noted by the
Examiner, Snyder states that "CS [calcium sulphate] alone is still unable to
mimic closely enough the mechanical properties of bone. However, I have
discovered that CS mixed in certain proportions with reconstituted fibrillar
collagen provides the desired properties and requirements of ideal bone
substitutes." Snyders 5: 20-25. Thus, Snyders provides evidence that
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Application 12/372,328
gypsum plasters, such as Hoggatt' s gypsum plaster are known to be used as
bone substitutes. Thus, Hoggatt can fairly be considered to be concerned
with this field of endeavor.
Moreover, responding to Appellants' argument that "Hoggatt is not
reasonably pertinent to the problems addressed by the present invention, of
improving working time, injectability, or set time (particularly, with regard
to a bone graft substitute material)," (Appeal Br. 7-8), the Examiner
determines that a problem with which Appellants were concerned is the
provision a gypsum plaster that in paste form is "'workable' for sufficient
time to enable precise placement and shaping of the composition in a desired
setting before the composition hardens." See Ans. 4. Appellants do not
contest the Examiner's determination. See, generally, Reply Br. Thus,
Hoggatt is analogous art under both tests for analogous art. 1
Next, Appellants argue that "the Examiner has not established initially
what the level of ordinary skill is in the pertinent art." Appeal Br. 9. "While
it is always preferable for the factfinder to specify the level of skill it has
found to apply to the invention at issue, the absence of specific findings on
the level of skill in the art does not give rise to reversible error where the
prior art itself reflects an appropriate level and a need for testimony is not
1 "Two criteria have evolved for determining whether prior art is analogous:
(1) whether the art is from the same field of endeavor, regardless of the
problem addressed, and (2) if the reference is not within the field of the
inventor's endeavor, whether the reference still is reasonably pertinent to the
particular problem with which the inventor is involved." In re Clay, 966
F.2d 656, 658-59 (Fed. Cir. 1992) (citing In re Deminski, 796 F.2d 436, 442
(Fed. Cir. 1986); In re Wood, 599 F.2d 1032, 1036 (CCPA 1979)).
Id., 966 F .2d at 659.
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Application 12/372,328
shown." Okajima v. Bourdeau 261F.3d1350, 1355 (Fed. Cir. 2001) (Citing
Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163
(Fed.Cir.1985)). In this case, the prior art reflects an appropriate level of
skill in the art. Thus, Appellants do not apprise us of error.
Appellants further argue that the rejection is "based on improper
hindsight and not on what one of skill in the art actually would have done ..
. the Examiner has relied upon the present application as a roadmap to
identify nondescript portions of the cited art to combine without any real
rational underpinning." Appeal Br. 9. However, Appellants do not identify
any knowledge relied upon by the Examiner that was gleaned only from
AppeHants' disclosure and that was not otherwise within the level of
ordinary skill at the time of the invention. See Jn re McLaughlin, 443 F .2d
1392 (CCPA 1971). Accordingly, Appellants do not apprise us of error.
In addition, Appellants contend that "[ o ]ne of skill in the art would
have no motivation to look from the industrial teachings of Hoggatt to a
reference directed to medical application to modify the materials disclosed
therein." Appeal Br. 9-10. In support of this contention, Appellants argue
that "one of skill in the art, looking to modify a medical material for
incorporating within the human body would not look to an industrial
reference for guidance in modifying that medical material." Id. at 10; see
also id. at 12-13 and Reply Br. 3. This argument is foreclosed by KSR Int'!
Co. v. Teleflex Inc., 550 U.S. 398 (2007), in which the Court rejected the
rigid requirement of a teaching or suggestion or motivation to combine
known elements in order to show obviousness. KSR, 550 U.S. at 415. The
Court noted that an obviousness analysis "need not seek out precise
teachings directed to the specific subject matter of the challenged claim, for
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Application 12/372,328
a court can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ." Id. at 418. Moreover, the Court
instructs us that "familiar items may have obvious uses beyond their primary
purposes." Id. at 550 U.S. 420. In this instance, Snyder demonstrates that
gypsum plaster (a familiar item), such as that disclosed by Hoggatt, has an
obvious use as a bone substitute material. See, e.g., Snyder 5 :20-25. Thus,
Appellants' argument is unconvincing.
In addition, Appellants argue that "the Examiner has pointed to
nothing showing that an amount of accelerant relevant to a bone substitute
material would be relevant to an amount of accelerant useful for gypsum
plasters for industrial purposes, e.g., as disclosed in Hoggatt." Appeal Br.
11 (emphasis omitted); see also Reply Br. 3. However, as discussed supra,
Snyder teaches that gypsum plasters, such as those disclosed by Hoggatt, are
known to be used as bone substitutes. See Snyder 5:20-25. Thus, Hoggatt's
discussion of the use of accelerant in its gypsum plaster is relevant to the use
of such gypsum plaster as a bone substitute.
Appellants also contend that "the Examiner is not free to pick and
choose selected teachings from a reference, while ignoring others." Appeal
Br. 11. In support of this contention, Appellants cite "Bausch & Lomb Inc.
v. Barnes-Hind Inc., 796 F.2d 443, 448 (Fed. Cir. 1986), quoting In re
Wesslau, 353 F.2d 238, 241 (C.C.P.A. 1965). Id. at 12. However, The
Supreme Court, in KSR, has provided guidance when addressing a concern
about picking and choosing.
For over a half century, the Court has held that a "patent for a
combination which only unites old elements with no change in
their respective functions ... obviously withdraws what already is
known into the field of its monopoly and diminishes the
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resources available to skillful men." Great Atlantic & Pacific Tea
Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152-153
(1950). This is a principal reason for declining to allow patents
for what is obvious. The combination of familiar elements
according to known methods is likely to be obvious when it does
no more than yield predictable results.
KSR 550 U.S. at 415-16. Thus, Appellants' argument is unconvincing.
Noting that the rejection refers to the section of Snyder from column
5, line 67 to column 6, line 7 to teach optimization of an accelerant,
Appellants argue that:
the Examiner has alleged that one of ordinary skill in the art
would view this single section as suggesting optimization of the
amount of an accelerant in a bone graft substitute composition
even though: (1) the section does not expressly mention
accelerants as a component of such compositions; and (2) the
section provides absolutely no guidance as to appropriate weight
percentages of an accelerant.
Appeal Br. 12 (emphasis omitted).
Appellants' argument is not responsive to the rejection as articulated
by the Examiner. The rejection relies upon the combination of Hoggatt's
teaching of varying amounts of accelerant as a component in a gypsum
plaster (Hoggatt 15 :45--4 7) and the optimization of the components of a
gypsum plaster discussed supra. See Final Act. 2-3. The Examiner
determines that these combined teachings render the limitation at issue
obvious. Appellants do not explain why Snyder's teachings would not apply
to Hoggatt's gypsum plaster components. Thus, Appellants do not apprise
us of error.
Next, Appellants argue that "it is not believed that the cited art
provides sufficient guidance to enable the Office to argue that it would be
mere optimization to arrive at the presently-claimed accelerant amounts,"
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Application 12/372,328
because "[w]ithout any weight percentage range taught in the cited art, there
is obviously no way to say the claimed amount overlaps or is close to the
amounts taught in the cited art." Appeal Br. 13. Responding to this
argument, the Examiner explains that:
While it is acknowledged that no specific range of percentage of
accelerant is disclosed by either Hoggatt or Snyders, clearly the
lower end of the range is 0%, since neither reference says that an
accelerant is a required component in the calcium sulfate
hemihydrate composition, which is the same lower end of the
range covered by independent claim 38.
Ans. 5. Hoggatt states:
The product produced by the process of the invention may have
a setting time generally in the range between 5 to 25 minutes
without the addition of retarders or accelerators. This product,
however, may have its setting time accelerated or retarded by the
addition thereto of accelerators or retarders which are known in
the art and which ordinarily are used in connection with gypsum
plasters.
Hoggatt 15 :41--49. Thus, the Examiner is correct that Hoggatt clearly
contemplates a range of zero to a known amount of accelerant.
Further, Hoggatt's teaching illustrates that the amount of accelerant is
a result-effective variable. The lack a specific numerical value assigned to
Hoggatt's known amount of accelerant does not negate Hoggatt's teachings.
"[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." In re Aller, 220 F.2d 454, 456 (CCPA 1955). A particular
parameter must first be recognized as a result-effective variable, i.e., a
variable which achieves a recognized result, before the determination of the
optimum or workable ranges of said variable might be characterized as
routine experimentation. In re Antonie, 559 F.2d 618 (CCPA 1977). "The
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law is replete with cases in which the difference between the claimed
invention and the prior art is some range or other variable within the claims .
. . . in such a situation, the applicant must show that the particular range is
critical, generally by showing that the claimed range achieves unexpected
results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 1578
(Fed. Cir.1990). The Examiner has shown that accelerant in a gypsum
plaster is a result-effective variable such that optimization of that variable in
not inventive. Aller, 220 F.2d at 456. Appellants have not shown that the
particular range is critical. Thus, Appellants' argument is unconvincing.
Finally, Appellants contend that "the evidence of unexpected and
surprising results should be viewed as overcoming the rejection." Appeal
Br. 14 (referring to the Declaration of Mr. Jon P. Moseley, hereinafter
"Declaration," filed August 30, 2011); see also Reply Br. 4--5. In support of
this contention, Appellants argue "the specific variables chosen for the
claimed materials lead to a composition having surprising results." Id. at 15.
However, claim 38 does not recite specific variables. See Appeal Br. 21.
Rather, claim 38 discloses a range for the percentage by weight of accelerant
and a diluent to powder weight ratio. Id.
As further evidence of unexpected results, the Declaration provides
the results of "[t]ests comparing the injectability of a composition
encompassed by the present invention and that of a MIIG® 115 composition."2
Dec. 3. "[W]hen unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art." In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
2MIIG® 115 composition is a one of the brand materials marketed by Wright
Medical Technology, Inc. the assignee of the instant invention. See Dec. 2.
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Cir. 1991 ). Here, Appellants considers a MllG® 115 composition to be the
closest prior art. See Dec. 2-5. We do not agree that a MIIG® 115
composition constitutes the closest prior art.
Although we appreciate the difficulty of determining the closest prior
art, nonetheless, "[a] comparison of the claimed invention with the
disclosure of each cited reference to determine the number of claim
limitations in common with each reference, bearing in mind the relative
importance of particular limitations, will usually yield the closest single
prior art reference." In re Merchant, 575 F.2d 865, 868 (CCPA 1978). In
this case Hoggatt, not a MIIG® 115 composition, is the closest prior art. As
noted by the Examiner, "the only difference between the composition of
Hoggatt and the composition as claimed is the upper limit of the weight
percentage of the optional accelerant recited in the claim, which upper limit
is not disclosed by Hoggatt." (Ans. 7; see also Hoggatt 16:14--19). The
MIIG® 115 composition differs from the claimed invention in that it includes
1.76% stearic acid in addition to an increased amount (0.15% rather than
0.0125%) of calcium sulfate accelerator. Dec. 4. Here, Hoggatt and the
MIIG® 115 composition have the same number of features in common with
the claimed invention, but the MIIG® 115 composition has additional features
not in common with claimed invention. Thus, Hoggatt constitutes the
closest prior art.
Appellants have not adequately explained why the alleged
improvements shown in the Declaration are significant and unexpected
relative to closest prior art, namely, Hoggatt. Moreover, Appellants have not
shown that the allegedly unexpected and surprising results in the comparison
of the instant invention and the MIIG® 115 composition are due to the
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increase in the amount of accellerant, rather than the removal of the stearic
acid. Accordingly, the Declaration does not provide a comparison of the
claimed invention to the closest prior art, and thus, does not support a
showing of unexpected or surprising results.
In the Reply Brief Appellants argue that "0% is not the lower end of
the range recited in the pending claims, as an accelerant is a required
component of the claimed compositions." Reply Br. 4. Claim 38 recites "an
accelerant in an amount of up to 0.2% by weight" which implies a range
from 0 to 0.2. The Specification, which describes, "the accelerant forming,
by weight, from 0% to 0.2% of the powder" supports this claim construction.
Spec. i-f 16. Thus, Appellants' argument is unconvincing.
In conclusion, after reviewing all of the evidence before us, including
the totality of Appellants' evidence, it is our conclusion that, on balance, the
evidence of obviousness discussed above outweighs the evidence of
nonobviousness submitted by Appellants and, accordingly, the subject
matter of claim 38 would have been obvious to one of ordinary skill in the
art within the meaning of 35 U.S.C. § 103(a) at the time Appellants'
invention was made.
Accordingly, we sustain the Examiner's decision rejecting claim 38,
and claims 39--41, 44--46, and 49, which fall therewith.
Rejection II
Appellants do not present separate arguments for the patentability of
claims 43 and 48, which depend from claim 38. Accordingly, we also
sustain the Examiner's decision rejecting these claims.
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DECISION
The Examiner's rejections of claims 38--41, 43--46, 48, and 49 are
AFFIRMED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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