Ex Parte Biegun et al

Patent Trial and Appeal Board

Feb 22, 2013

10534567 (P.T.A.B. Feb. 22, 2013)

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.
10/534,567 05/12/2005 Jean-Francois Biegun CAC.P0046 6534
7590 02/22/2013
Edward G Greive
Renner Kenner Greive Bobak Taylor & Weber
Fourth Floor
First National Tower
Akron, OH 44308-1456
EXAMINER
WOODALL, NICHOLAS W
ART UNIT PAPER NUMBER
3775
MAIL DATE DELIVERY MODE
02/22/2013 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 JEAN-FRANCOIS BIEGUN and
PASCAL MARCEAUX
____________

Appeal 2011-009571
Application 10/534,567
Technology Center 3700
____________

Before DONALD E. ADAMS, JACQUELINE WRIGHT BONILLA, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims directed to a
bone rasp and a method of manufacturing a bone rasp. The Patent Examiner
has rejected the claims for containing new matter, anticipation, and
obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

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STATEMENT OF THE CASE
The Specification is directed to a bone rasp that “can only be used for
a single operation since the material rapidly wears out during the operation
to the extent that the ancillary has deteriorated too much by the end of the
operation to be able to be reused for another operation.” (Spec. 2.)
Claims 12, 13, 15-21, and 25 are on appeal, and can be found in the
Claims Appendix of the Appeal Brief (App. Br. 15-16). Claims 20 and 21
are independent claims. Claim 20 is representative of the claims on appeal,
and reads as follows:
20. A method for manufacturing a rasp for removing a part of a
bone from the bone, comprising the steps of:
providing a body having the shape of a rasp and comprising
protrusions made of a plastic material which are to come into contact
with the part of the bone and to rasp it from the bone when said rasp is
used to remove the part of the bone; and
exposing said plastic material to β or γ rays, so that after this
exposition, said plastic material is hard enough to remove the part of
the bone from the bone when said rasp is used and wears out after a
single use, and when said rasp is put into an autoclave at at least
137ºC, said rasp deteriorates itself and cannot be used anymore.
Claim 21 is directed to a rasp comprising “plastic material being hard
enough for the removal of hip bone” among other elements, but does not
recite “exposing said plastic material to β or γ rays” as required by the
method of claim 20.

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The Examiner has rejected the claims as follows:
I. claims 12, 13, and 20 under 35 U.S.C. § 112 first paragraph, as
containing new matter;
II. claims 15, 16, and 21 under 35 U.S.C. § 102(b) as being
anticipated by Geisser;1
III. claims 25 under 35 U.S.C. § 103(a) as unpatentable over
Geisser and Morgan;2 and
IV. claims 12, 13, and 20 under 35 U.S.C. § 103(a) as unpatentable
over Geisser and Morgan.

Appellants do not request review of the rejection of claims 17-19
under 35 U.S.C. § 103(a) as unpatentable over Geisser and Judd.3 (See Final
Rej. 4-5; App. Br. 5-6.) We therefore summarily affirm this rejection. See
MANUAL OF PATENT EXAMINING PROCEDURE § 1205.02 (“If a ground of
rejection stated by the examiner is not addressed in the appellant's brief, that
ground of rejection will be summarily sustained by the Board.”). The failure
to appeal is a waiver under Ex parte Frye, 2010 WL 889747 *4 (BPAI 2010)
(precedential) (“If an appellant fails to present arguments on a particular
issue--or, more broadly, on a particular rejection--the Board will not, as a

1 Albert Geisser et al., U.S. Patent No. 5,454,815, issued Oct. 3, 1995.
2 Shanon Morgan et al., U.S. Patent No. 5,910,106, issued Jun. 8, 1999.
3 Eardley C. B. Judd, U.S. Patent No. 1,396,934, issued Nov. 15, 1921.
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general matter, unilaterally review those uncontested aspects of the
rejection”).
I.
The Issue
The Examiner takes the position that the originally filed Specification
“discloses [] exposing the plastic material to radiation to sterilize the device”
but does not mention using radiation to harden the plastic material as now
claimed (Ans. 3-4).
Appellants contend that “[t]he originally filed specification clearly
teaches both that (1) the plastic material of a rasp is exposed to β or γ rays,
and (2) that the rasp is hard enough to remove bone.” (Reply Br. 6.)
The issue is whether the limitation of “exposing said plastic material
to β or γ rays, so that after this exposition, said plastic material is hard
enough to remove the part of the bone from the bone” is supported by the
original Specification.
Finding of Fact
1. The Specification provides “[t]he initial sterilisation [sic] is actually
carried out by exposure to γ or β rays. It can only be done once. A second
exposure actually degrades the plastic due to the development of free
radicals.” (Spec. 2-3.)
Principle of Law
“[I]t is the specification itself that must demonstrate possession. And
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while the description requirement does not demand any particular form of
disclosure, … or that the specification recite the claimed invention in haec
verba, a description that merely renders the invention obvious does not
satisfy the requirement.” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,
598 F.3d 1336, 1352 (2010).
Analysis
The Examiner rejected claim 20 because it “appears to imply a
limitation directed to the exposing of the plastic material to radiation hardens
the material, i.e .... so that after this exposition, said plastic material is hard
enough to remove the part of the bone from the bone when said rasp is
used.” (Ans. 3.) Appellants contend that “the Examiner seems to be finding
causation in the claim, but it is not so limited - the claim simply recites a
physical property condition for the plastic material that must be satisfied
after the step of exposing the plastic material to β or γ rays.” (App. Br. 9.)
The Specification disclosed sterilizing the rasp with radiation (FF 1).
We agree with the Appellants position that the claims do not recite a cause
and effect with respect to the β or γ rays and the hardening of the plastic
material. We find that all that is required by the claim is that the plastic,
even after the exposure to β or γ rays, still be hard enough to rasp bone. The
standard to be applied is “whether the disclosure of the application as
originally filed reasonably conveys to the artisan that the inventor had
possession at that time of the later claimed subject matter, rather than the
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presence or absence of literal support in the specification for the claim
language.” In re Kaslow, 707 F.2d 1366, 1375 (Fed. Cir. 1983).
Applying that standard, we find that the evidence supports the
Appellants’ position, for the reasons provided in the Appeal Brief, that the
claim recites a physical property condition for the plastic material. (App. Br.
9-10.) The new matter rejection is reversed.
II.
The Issue
The Examiner takes the position that “Geisser discloses a device made
from a plastic material including a carbon fiber reinforcing insert completely
embedded within the plastic material, such as polyethylenes . . . The plastic
material is hard enough to rasp the bone of the hip or knee and wears out
after a single use.” (Ans. 4.)
Appellants assert that “Geisser does not teach a rasp that is actually
hard enough to remove bone.” (App. Br. 10.) Appellants assert that the
“prior art rasp made without a pretreatment of exposition to β or γ rays is not
hard enough to rasp bone.” (App. Br. 12.)
The issue is: Has the Examiner set forth a prima facie case of
anticipation based on Geisser?
Findings of Fact
2. Geisser disclosed a “bone rasp, which can be manufactured
inexpensively, [so that] the multiple use of the rasp can be avoided. . . . The
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rasp will be discarded after single use . . . The rasp will preferably be
sterilized after manufacturing and packed to keep it sterile until use thereof.”
(Geisser col. 1, ll. 60-66; Ans. 4, 5, 7)
3. Geisser disclosed that “[t]he plastic material of the rasp can be chosen
among various known kinds of plastic types, e.g. from one of the following
types: polyoxymethylenes (POM), polyamides (PA), polyethylenes (PE),
liquid crystalline polymers (LCP), polyvinylidenfiuorides (PVDF). The
plastics can be reinforced by the addition of carbon fibers.” (Geisser col. 3,
ll. 7-12; Ans 6.)
4. Geisser’s preferred material is “is polyoxymethylene. Another
preferred material is polycarbonate, especially the type Macrolon 2805 of
the company Bayer AG.” (Geisser col. 3, ll. 13-16.)
5. The Specification provides that “[a]ccording to a favourite [sic]
production method, the plastic is a thermoplastic material, notably a
polyvinyl, polyolefin, polyamide or similar material and it deteriorates in
particular due to softening.” (Spec. 3.)
Principle of Law
Prior art references are presumed to be enabled for what they disclose,
and the burden is on Appellants to show that they are not. Amgen, Inc. v.
Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003).

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Analysis
We are not persuaded by Appellants assertion that “Geisser does not
teach a rasp that is actually hard enough to remove bone.” (App. Br. 10.)
Appellants rely on the Declaration from one of the inventors, Jean-Francois
Biegun,4 to establish that Geisser does not meet the claimed limitation. We
agree with the Examiner’s finding that “the appellant does not provide data
for all the different materials disclosed by Geisser, such as polyamides, and
therefore has not shown the Geisser reference as being incapable of
removing bone.” (Ans. 8.)
“[A] presumption arises that both the claimed and unclaimed
disclosures in a prior art patent are enabled.” Amgen Inc. v. Hoechst Marion
Roussel, Inc., 314 F.3d 1313, 1355 (Fed. Cir. 2003). Furthermore, the
MANUAL OF PATENT EXAMINING PROCEDURE section 716.07 provides that:
[E]very patent is presumed valid (35 U.S.C. 282), and since that
presumption includes the presumption of operability
(Metropolitan Eng. Co. v. Coe, 78 F.2d 199 (D.C.Cir.
1935). . . . Affidavits or declarations attacking the operability of
a patent cited as a reference must rebut the presumption of
operability by a preponderance of the evidence. In re Sasse,
629 F.2d 675 (CCPA 1980).
The Examiner takes the position that Appellants have not provided
persuasive evidence to rebut this presumption of enablement because they
have “not shown the Geisser reference being incapable of removing bone.”
(Ans. 8.) Here, the Biegun Declaration shows the manufacture of “a femoral

4 Declaration of Jean Francois Biegun, dated March 4, 2009.
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rasp in polycarbonate (Makrolon 2858 from Bayer).” (Biegun 1.) The
Declaration establishes that the Makrolon polycarbonate only becomes hard
enough to rasp bone after the exposure to β or γ rays. (Biegun 1.) What is
missing from the Declaration is a showing that the other plastic materials
listed by Geisser, for example polyamides (PA), polyethylenes (PE), liquid
crystalline polymers (LCP), and polyvinylidenfiuorides (PVDF), are also too
weak to rasp bone, i.e., are not “hard enough for the removal of hip bone” as
recited in claim 21. As acknowledged by the Examiner, the plastic materials
disclosed by Geissler include polyamides (FF 3), materials specifically
designated in the Specification as being suitable for producing a bone rasp
(FF 5). (Ans. 8.) We agree with the Examiner’s conclusion that the Biegun
Declaration does not provide persuasive evidence to show that Geisser
disclosed plastic materials are not hard enough to rasp bone.
Appellants additionally assert that Grünig5 criticizes the technology
disclosed in Geisser citing that “problems may arise with the rasp action,
particularly in hard bone material with longer application times.” (App. Br.
11.) We are not persuaded by this argument as well. Here, the claims are
silent with regards to rasping time. Additionally, Grünig does not provide
any descriptive information with respect to the hardness of the plastic
material and the suitability (or lack thereof) for the use of the plastic material
to rasp bone. All that is suggested by Grünig is that prolonged use of a
plastic rasp may cause problems, without a discussion of what those

5 Daniel Grünig et al., U.S. Patent No. 6,120,508, issued Sept. 19, 2000.
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problems are. Thus, contrary to the Appellants assertion, we find that
Grünig does not provide persuasive evidence to determine that the plastic
materials disclosed by Geisser are not hard enough to rasp bone.
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the Geisser anticipates claim 21.
We thus, affirm the rejection of claim 21 under 35 U.S.C. § 102(b) as being
anticipated. As claims 15 and 16 stand with that claim, we affirm the
rejection as to those claims as well. 37 C.F.R. § 41.37(c)(iv).

III.
The Issue
The Examiner takes the position that it would have been obvious to
take the bone rasp of “Geisser wherein the plastic material is exposed to
gamma radiation in view of Morgan in order to sterilize the device.”
(Ans. 6.)
Appellants assert that:
Morgan teaches that the instrument heater may be sterilized by
exposing it to gamma rays (column 5, lines 40-43), which
makes sense since the instrument heater is made of ‘a thin
cardboard type material’ (column 4, lines 45-49) and could not
be sterilized using conventional heat sterilization. However,
Morgan does not teach or suggest that the item actually used in
surgery (the probe) is exposed to β or γ rays.
(Reply Br. 6.)
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The issues are: Has the Examiner set forth a prima facie case of
obviousness and, if so, has Appellant provided sufficient rebuttal evidence to
overcome the prima facie case?
Additional Finding of Fact
6. Morgan disclosed that the “the instrument heater 21 is sterilized.
Sterlization [sic] normally occurs by bombarding the instrument heater 21
with Gamma-rays.” (Morgan col. 6, ll. 10-12; Ans. 7.)
Principle of Law
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993).
Analysis
Here the Examiner used Geisser for the teaching that bone rasps can
be made of plastic materials (FF 3), which allows the instruments to be
single use instruments, made of cheap material that is disposable (FF 2).
Furthermore, Geisser specifically disclosed that the instrument must be
sterilized before use (FF 2). We agree with the Examiner’s finding that
Geisser is silent with respect to the method of sterilization (Ans. 7). The
Examiner relies on Morgan to show that gamma radiation is one way
instruments can be sterilized (Ans. 7). The instrument heater on Morgan is
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made of a thin cardboard material, material that would not be suitable for
heat sterilization, a fact not disputed by Appellants (Reply Br. 6). The
ordinary artisan recognizes that there are a limited number of ways to
sterilize instruments that are not suitable for heat sterilization. Applying
KSR rational, it would be obvious choose from a finite number of predictable
solutions, with a reasonable expectation of success. KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 421 (2007).
We are not persuaded by Appellants argument that there is no
motivation to combine Geisser and Morgan. Geisser specifically teaches
that the bone rasp is sterilized after manufacturing and before use (FF 2),
and Morgan provides a method of sterilization (FF 6) that would not destroy
the plastic. Here, applying the gamma radiation sterilization method of
Morgan to the bone rasp of Geisser would have provided the predictable
result of producing a sterile bone rasp. “The combination of familiar
elements according to known methods is likely to be obvious when it does
no more than yield predictable results.” KSR at 416.
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the Geisser in view of Morgan
renders obvious claim 25. We thus affirm the rejection of claim 25 under 35
U.S.C. § 103(a) as being obvious.

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IV.
The Issue
The Examiner takes the position that it would have been obvious to
take the method of “Geisser further comprising the step of exposing the
device to gamma radiation in view of Morgan in order to sterilize the
device.” (Ans. 7.)
Appellants take the position that “Geisser does not teach a rasp that is
actually hard enough to remove bone, and Morgan does not cure this
deficiency.” (App. Br. 13)
The issue is: Has the Examiner set forth a prima facie case of
obviousness and, if so, has Appellants provided sufficient rebuttal evidence
to overcome the prima facie case?
Analysis
As discussed above (II & III) we have found no deficiency in the
Examiner’s prima facie case based Geisser or the combination of Geisser
and Morgan. We conclude that the preponderance of evidence of record
supports the Examiner’s conclusion that the combination of Geisser and
Morgan meet the claim limitations of independent claim 20. (Ans. 6-7.)
Briefly, Geisser provides a bone rasp made of plastic materials, that is
intended as a single use rasp, and that is sterilized after manufacture and
before use (FFs 2-4). Applying the gamma radiation sterilization method of
Morgan (FF 6) to the bone rasp of Geisser would provide the predictable
result of producing a sterile instrument, a bone rasp. “The combination of
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familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results.” KSR at 416.
We conclude that the preponderance of the evidence of record
supports the Examiner’s conclusion that the Geisser in view of Morgan
renders obvious claim 20. We thus, affirm the rejection of claim 20 under
35 U.S.C. § 103(a) as being obvious. As claims 12 and 13 stand with that
claim, we affirm the rejection as to those claims as well. 37 C.F.R.
§ 41.37(c)(iv).

SUMMARY
We reverse the rejection of claims 12, 13, and 20 under 35 U.S.C.
§ 112 first paragraph.
We affirm the rejection claims 15, 16, and 21 under 35 U.S.C.
§ 102(b) as being anticipated by Geisser.
We affirm the rejection of claim 25 under 35 U.S.C. § 103(a) as
unpatentable over Geisser and Morgan.
We affirm the rejection of claims 12, 13, and 20 under 35 U.S.C.
§ 103(a) as unpatentable over Geisser and Morgan.
We affirm the rejection of claims 17-19 under 35 U.S.C. § 103(a) as
unpatentable over Geisser and Judd.

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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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