Gerhard Schmidmaier et al.

Patent Trials and Appeals Board

Oct 23, 2019

15091812 - (D) (P.T.A.B. Oct. 23, 2019)

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.
15/091,812 04/06/2016 Gerhard Schmidmaier 104525.007046 1093
53443 7590 10/23/2019
BakerHostetler
Cira Centre, 12th Floor
2929 Arch Street
Philadelphia, PA 19104-2891
EXAMINER
SINGH, RANDEEP
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
10/23/2019 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):
eofficemonitor@bakerlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte GERHARD SCHMIDMAIER, MICHAIL RASCHKE, and
AXEL STEMBERGER
__________

Appeal 2019-002654
Application 15/091,8121
Technology Center 1600
__________

Before RICHARD M. LEBOVITZ, DEBORAH KATZ, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
fracture fixation device, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
Appellant’s Specification explains that implants to stabilize a fracture
and promote healing are known as are implants which are permanently
bonded to the bone. (Spec. ¶ 3.) Appellant’s invention is directed to a

1 We use the word “Appellant” to refer to “Applicant” as defined in 37
C.F.R. § 1.42. Appellant is DePuy Synthes Products, Inc. who identifies the
real party in interest as the named inventors. (Appeal Br. 1.)
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fracture fixation implant that has a biodegradable polymer coating that
contains a biocidal or anti-infection substance. (Spec. ¶¶ 7, 35, and claim 9.)
Claims 9–28 are on appeal. Claim 9 is representative and reads as
follows:
9. A fracture fixation device comprising:
a nail comprising a non-degradable metal or alloy base
material having an outer surface;
a polymer coating adhesively bonded on the outer surface
of the nail, the polymer coating comprising a polylactide
or polylactide interpolymer, or a blend thereof, wherein
the coating has an average thickness of less than 30
microns; and,
a biocidal or anti-infective active agent dispersed within
the coating.
(Appeal Br. 20.)

The following ground of rejection by the Examiner is before us on
review:
Claims 9–28 under 35 U.S.C. § 103(a) as unpatentable over Fox,2
Kummer,3 Davidson,4 and Sinclair.5
DISCUSSION
The Examiner finds that Fox teaches infection resistant medical
devices that are prepared by dissolving a polymer matrix such as poly (L) or
(D)-lactide in an organic solvent to form a dispersion, incorporating at least
one antimicrobial agent therein, and coating the device with the polymer

2 Fox, Jr. et al., US 5,019,096, issued May 28, 1991.
3 Kummer et al., US 4,338,926, issued July 13, 1982.
4 Davidson, US 5,458,653, issued Oct. 17, 1995.
5 Sinclair et al., US 5,502,158, issued Mar. 26, 1996.
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matrix, which the Examiner finds meets the recited limitation of “a biocidal
or anti-infective active agent dispersed within the coating” and that the
coating be adhered to the outer surface. (Final Action 2–3; Ans. 4.) The
Examiner finds that Fox teaches “that an advantage of using biodegradable
polymers such as poly(L-lactide) and poly(D-lactide) in their coating matrix
is to allow improved tissue ingrowth simultaneously with a prolonged
antimicrobial effect as the biodegradable polymer degrades (see column 12,
lines 13–17).” (Ans. 4.) The Examiner explains that while Fox does not
specifically recite that the device is a fracture fixation device, it nevertheless
discloses that the medical devices can be implants and the surfaces that can
be coated can be metal. (Id. (citing Fox 3: 6–19).)
To meet the corresponding limitations in the claim regarding the type
of fracture fixation device, the Examiner further finds that Kummer teaches
bone prostheses for use in healing a bone fracture such as nails, screws, and
plates, that have their surface covered by a biologically absorbable element
affixed or molded thereto. (Final Action 4.) The Examiner concludes that it
would have been obvious to one of ordinary skill in the art to use the method
of coating described in Fox to produce a coated infection-resistant
orthopedic fracture fixation device like nails, screws, or plates as taught in
Kummer with a reasonable expectation of success. (Id.)
Regarding the claimed limitation that the polymer coating have a
thickness of less than 30 microns, the Examiner recognizes that Fox does not
explicitly recite polymer coatings having a thickness of less than 30 microns.
(Final Action 4.) However, the Examiner finds that Fox teaches the
thickness of the coating can be varied to achieve a desired thickness. (Id. at
3 (citing Fox 14:63–65).) Moreover, the Examiner finds that Fox teaches
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the antimicrobial particles are 5 microns or less (Ans. 7–8 (citing Fox 13:61–
68).) The Examiner also finds that Fox teaches “applying a powdered
antimicrobial agent to an adhesive surface in micro layers so that minimum
loss of adhesiveness occurs while imparting a high level of protection
against growth of microorganisms to the surface.” (Id. at 8 (citing 15: 5–9).)
The Examiner finds that Davidson teaches load-bearing skeletal replacement
prostheses that are coated with a bioabsorbable polymer such as polylactide
and that antibiotics may be added to the coating. (Final Action 5.) The
Examiner further finds that Davidson teaches that “the selection of a
polymer of a particular average molecular weight or range of molecular
weights, copolymerization, and selection of coating thickness will fix the
‘life’ of the coating.” (Id.) Thus, the Examiner concludes that Davidson and
Fox teach coating thickness is a known result effective variable and that one
of ordinary skill in the art would have found it obvious to formulate via
routine experimentation the coating layer thickness to be 30 microns or less
to optimize the life of the coating. (Id.; Ans. 8).
We disagree that the Examiner has established a prima facie case of
obviousness, but solely on the limitation requiring the coating to have “an
average thickness of less than 30 microns.” We will address Appellant’s
other arguments first.
Appellant’s argument that Fox as a whole does not suggest the
specifically claimed metal fixation devices with polylactide coatings because
it teaches a “narrower application of the disclosed [laundry list of] coatings”
and surfaces onto which the coating may be applied and “denigrates such
expansive lists disclosed in the prior art” (Appeal Br. 6) is not persuasive.
Fox discloses that it determined combinations of polymeric coatings that
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were “superior to all other known polymeric coating materials” in the ability
to provide an antimicrobial agent on the surface of a medical device to be
retained and released in an active state over an appreciable period of time.
(Fox 3:67–4:4, 7:22–25, 8:49–52 (“The superior characteristics of the
biomedical polyurethanes, lines 20 and 21, are surprising, since the prior art
does not hint or suggest that any one of the above polymer matrices is any
better than any other.”).) Such a disclosure is not a denigration of a broad
disclosure of the capability of polymers to adhesively bond to a surface, but
rather an indication that some polymers may bond better than others.
Appellant’s claim 9 simply requires that the polylactide that has the biocidal
or anti-infective agent dispersed in it be adhesively bonded to the outer
surface of the metal or alloy nail. We agree with the Examiner that Fox’s
disclosure renders such a coating obvious because it discloses that
polylactide polymers are suitable surface coatings (Fox 11:35–12:52) and
expressly teaches devices made of metals (Fox 3:17–19) as required by all
the claims. In re Longi, 759 F.2d 887, 897 (Fed. Cir. 1985) (“The fact that
some titanium compounds function more effectively, and that the exact
magnitude of the increased catalytic activity might not be predictable, does
not preclude a conclusion of obviousness.”).
It is true that Table II of Fox demonstrates that the adhesion of
polymeric coatings on the surfaces of polyurethane catheters and latex
catheters is not the same (Appeal Br. 8–9 (noting “GOOD” adhesion to
urethane catheter but “POOR” adhesion to latex catheter)), and Fox teaches
that “[s]election of the coating vehicle depends upon the specific
composition of the surface of the device to be coated, and the characteristics
sought” (Fox. 4: 5–7) and indicates that “[c]ertain solvent solutions
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containing certain polymers do not adequately wet latex surfaces” thereby
resulting in a coating that is discontinuous or not adherent (id. at 13:10–16).
However, Fox describes a method for determining polymers that would form
stable coatings on a medical device that will contact an area of the human
body either externally or internally. (Id. at 5:31–7:25.) Thus, we disagree
with Appellant that “Fox does not provide the methodology to determine
which surfaces, solvents and coatings successfully work with each other”
(Appeal Br. 8).
Appellant’s argument that Fox teaches the adhesive bonding required
by the claims is unpredictable (Appeal Br. 10–12; Reply Br. 1), is not
persuasive of the non-obviousness of the claimed invention. It is true that
Example 5 demonstrates that polytetrafluoroethylene arterial graft material
(Goretex) could not be adequately surface coated with polyurethane mixed
with PLA and an antibacterial while polyethylene terephthalate arterial graft
material (Dacron) could be, and that no explanation is provided as to why
that is the case. (Fox 19–20.) However, such evidence does not
demonstrate unpredictability of coating a non-degradable metal or alloy with
a polylactide or polylactide interpolymer, or a blend thereof as claimed.
In light of the fact that Fox teaches that the method of coating a
medical device with a biodegradable polymer such as polylactide can be
applied to medical implants and metal surfaces, we agree with the Examiner
that one of ordinary skill in the art, using routine experimentation, would
have had a reasonable expectation of success in using that method to coat a
metal nail. “Reading a list and selecting a known compound to meet known
requirements is no more ingenious than selecting the last piece to put into
the last opening in a jig-saw puzzle. It is not invention.” Sinclair & Carroll
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Co. v. Interchemical Corp., 325 U.S. 327, 335 (1945); see also Merck & Co.
Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
Furthermore, Kummer indicates that such a polylactide coating is
compatible with metal nails used in the fixation of bone fractures. (Kummer
1–2; see also Kummer 3:22–31, 4:18–27.) Kummer differentiates between a
coating that is molded onto a metallic structural member as opposed to a
layer that is separable from the metallic structure and placed between the
metallic structure and the bone surface to which the structural element is in
abutment. (Compare id. 3:22–31 with id. 3:62–4:16.) While Kummer does
not describe the polylactide coating that is molded to the metallic nail as one
that is adhered to the metal so as to be molded onto it, Fox teaches that one
can adhere such a coating to a metal surface using the described process.
Thus, we agree with the Examiner that Kummer supports the conclusion that
the claimed invention would have been obvious.
Appellant argues that Kummer’s disclosure of the coating being “held
under compression” does not provide any “basis for the examiner to allege
equivalence between the claimed ‘adhesively bonded’ and ‘affixing’ or
‘molding’ disclosed in Kummer.” (Appeal Br. 12.) It is true that Kummer
describes the coating being “held” under compression between the nail or
plate and the bone fragments sought to be rejoined when the “prosthesis . . .
is secured to the fragments” (Kummer 3:31–34, 4:34–40), just as a separable
polylactide washer layer is described to be “held” under compression
between the fixation device and bone fragment, but being so “held” so as to
achieve compression does not preclude adherence of the polylactide
continuous layer on the nail or plate. That is because the reference merely
requires that polymeric material be compressed against the bone, which
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allows for “all of the stresses transmitted between bone fragments 8 and 9
[to be] transmitted through” the polylactide rather than “across the fracture
line” and carried by the plate or nail. (Id. 3:36–41, 4: 37–46.) There is no
evidence that the stresses would not be transmitted through the polylactide if
it were adhered as a layer rather than simply being molded on.
Appellant’s argument that Kummer employs polylactide coatings for a
different purpose than the purpose provided in Appellant’s Specification
(Appeal Br. 12) is also not persuasive. First, as the Examiner notes, the
claims do not recite a functional purpose for the polylactide coating. (Ans.
6.) Moreover, it is not necessary that references be combined or modified
for the same reasons as Appellant’s. “As long as some [reason,] motivation
or suggestion to combine the references is provided by the prior art taken as
a whole, the law does not require that the references be combined for the
reasons contemplated by the inventor.” In re Beattie, 974 F.2d 1309, 1312
(Fed. Cir. 1992). Fox teaches that a polylactide composition can be a matrix
to support an antimicrobial that can be coated on a medical device to prepare
an infection resistant device. Kummer teaches the polylactide would serve
as a stress-shield when the coating is applied to a nail or plate used in
fracture fixation. We agree with the Examiner “that a skilled artisan would
have readily appreciated, based on the teachings of Fox and Kummer, that it
would be beneficial for a stress-shielding coating to incorporate an
antimicrobial composition for infection treatment and resistance upon
implantation.” (Ans. 6.)
Turning now to the thickness of the coating limitation. Appellant
argues that Davidson, while discussing thickness in the context of stress
shielding and retarding bone growth does not recite any thickness values for
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the coating and the Examiner has admitted that Fox fails to disclose a
coating thickness of less than 30 microns. (Appeal Br. 13–16.) We agree
with Appellant that “[n]either Fox nor Davidson teach or provide any further
guidance that narrows the universe of ‘variable’ thicknesses to what would
motivate one skilled in the art to the particularly recited thickness range
currently claimed.” (Id. at 16.) “[W]here there is a range disclosed in the
prior art, and the claimed invention falls within that range, there is a
presumption of obviousness.” Iron Grip Barbell Co. v. USA Sports, Inc.,
392 F.3d 1317, 1322 (Fed. Cir. 2004). It is true, as the Examiner notes, that
Fox teaches application of “micro layers” of the “powdered antimicrobial
agent to an adhesive surface so that minimum loss of adhesiveness occurs
while imparting a high level of protection against growth of microorganisms
to the surface. (Fox 15: 5–9.) However, that teaching does not establish a
range for the thickness of the adhesive layer. Even though Fox also teaches
the use of micronized particles in coatings of 5 microns or less (id. at 13:65–
67), the size of micronized particles does not equate to the thickness of the
micro layers. At best, Fox teaches a layer thickness range of greater than 5
microns. Thus, even accepting that Davidson suggests that the thickness of
the polylactide coating is a result effective variable, there is no teaching of a
thickness range in the prior art with an upper limit of less than 30 microns as
required by all the rejected claims. Thus, there is no presumption of
obviousness for the claimed range. Each of the independent claims has this
same coating thickness layer limitation.
Consequently, we reverse the Examiner’s rejection of claims 9–28 as
being obvious over Fox, Kummer, Davidson and Sinclair.

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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
9–28 103 Fox, Kummer,
Davidson, Sinclair
9–28

REVERSED