Ex Parte Imwinkelried et al

Patent Trial and Appeal Board

Dec 20, 2017

13213213 (P.T.A.B. Dec. 20, 2017)

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.
13/213,213 08/19/2011 Thomas Imwinkelried 104525.006127 7842
53443 7590 12/22/2017
Raker & Hostetler T T P
EXAMINER
CIRA CENTRE, 12TH FLOOR WOODALL, NICHOLAS W
2929 ARCH STREET
PHILADELPHIA, PA 19104-2891 ART UNIT PAPER NUMBER
3775
NOTIFICATION DATE DELIVERY MODE
12/22/2017 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
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 THOMAS IMWINKELRIED, ELLIOTT GRUSKIN,
ANDREA MONTALI, and STEFAN BECK
Appeal 2017-001214
Application 13/213,21s1
Technology Center 3700
Before ERIC B. GRIMES, JOHN G. NEW, and
KRISTI L. R. SAWERT, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state that the real party-in-interest is Depuy Synthes Products,
Inc. App. Br. 1.
Appeal 2017-001214
Application 13/213,213
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1, 2, 15-18, and 23-25. Specifically,
claims 1, 2, and 15-17 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Tepic (US 2008/0200955
Al, August 21, 2008) (“Tepic”), Del Medico (US 2005/0010225 Al,
January 13, 2005) (“Del Medico”) and Lozier et al. (US 2009/0198286 Al,
August 6, 2009) (“Lozier”).
Claim 18 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Tepic, Del Medico, Lozier, and
Dixon et al. (US 2002/0082603 Al, June 27, 2002) (“Dixon”).
Claim 24 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being obvious over the combination of Tepic, Del Medico, Lozier, and
Isaccsson et al. (US 6,673,469 B2, January 6, 2004) (“Isaccsson”).
Claims 23 and 25 stand rejected as unpatentable under 35 U.S.C.
§112, first paragraph, as failing to comply with the written description
requirement.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to a degradation controlled metal
implant and methods of controlling the degradation of the implant. Abstract.
REPRESENTATIVE CLAIM
Claim 1 is representative of the claims on appeal and recites:
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Application 13/213,213
1. An implant system comprising:
a plate consisting essentially of a first material and having a
plurality of apertures;
a fastener configured to be disposed within at least one of the
plurality of apertures and capable of securing the plate to a tissue;
and
a fastener blank configured to be disposed within at least one
aperture and to substantially fill the aperture without protruding
from the plate, the fastener blank consisting essentially of a
second material that is less noble than the first material.
App. Br. 18.
ISSUES AND ANALYSES
We are not persuaded that the Examiner has established a prima facie
case of unpatentability and we therefore decline to adopt the findings and
conclusions of the Examiner. We address the arguments raised by
Appellants below.
A. Rejection of claims E 2, and 15-18 and 24 under 35 U.S.C. $ 103(a)
Issue
Appellants argue the Examiner erred in finding that the combined
cited prior art teaches or suggests “a plate consisting essentially of a first
material” and a “fastener blank consisting essentially of a less noble second
material,” as recited in claim 1. App. Br. 8-9.
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Analysis
The Examiner finds Lozier teaches a device comprising a body and a
blank, in which the body consists essentially of a first material, such as cold-
sprayed metallic coating comprising at least one cobalt-chrome alloy, gold,
gold alloy, silver, or silver alloy and the blank consists essentially of a
second, less noble, material, such as titanium, titanium alloy, or stainless
steel, to prevent galvanic corrosion of the metals. Final Act. 4 (citing Lozier
10, 11). The Examiner concludes that it would have been obvious to a
person of ordinary skill in the art to replace the plate for treating bone
fractures of Tepic, with a device in which the body consists essentially of a
first material, such as a cold-sprayed metallic coating, and in which the
blank consists essentially of a second less noble material, such as titanium,
titanium alloy, or stainless steel, as taught by Lozier, to prevent galvanic
corrosion of the metal. Id.
Appellants argue that the Examiner mistakenly equates the cold-
sprayed metallic coating taught by Lozier with the plate claimed by
Appellants. Ans. 9. According to Appellants, this is inconsistent with the
teachings of Lozier, which expressly describes three compositions: (1) a
plate having a first composition; (2) a metallic fastener having a second
composition; and (3) a cold-sprayed metallic coating having a third
composition. Id. (citing Lozier 10). Appellants contend Lozier teaches
that the cold-sprayed metallic coating is to be applied within an opening of
the plate or on the metallic fastener. Id. Furthermore, Appellants argue, the
separate nature of the coating with respect to the material of the plate and
fastener is further emphasized at paragraph [0026] of Lozier, which teaches
that: “the coating 26 resides between the metal (or alloy thereof) of the
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metallic bone plate 12 and the metal (or alloy thereof) of the metallic
fastener 16, particularly at all surfaces where the metallic fastener 16 is in
direct contact with the metallic bone plate 12.” Id. Therefore, Appellants
assert, it is the coating, and not the plate of Lozier, that is taught as having
an electrical resistance greater (i.e., is more noble) than the stainless steel of
the metallic fastener. Id. at 4-5 (citing Lozier 12).
In contrast, Appellants argue, the claims on appeal recite a plate that
consists essentially of a first material and a fastener blank that consists
essentially of a second material that is less noble than the first material.
App. Br. 5. Appellants contend that Examiner’s finding that the coating
taught by Lozier is essentially the first material of the plate is inconsistent
with the definitions and teachings of Lozier. Id. Moreover, Appellants
argue, even if one ignores Lozier’s teaching of a separate and distinct
coating layer, the coating layer on the plate would only make up a small part
of the overall plate material — Appellants assert that the plate could not be
said to consist essentially of the coating layer and thereby read on the
corresponding limitation of claim 1. Id. Rather, Appellants argue, and to
the extent the coating is applied to the plate, it is said to be formed on the
surface of an opening of the plate. Id. at 10 (citing Lozier 10, 26).
Appellants therefore argue that a plate with a surface coating within one or
more of its openings would not consist “essentially” of that surface coating,
rather, the phrase “consisting essentially of’ defines the overall makeup of
the plate. Id. This contention, Appellants argue, is further supported by the
Specification’s disclosure that the body of their claimed plate 110 is said to
“substantially consist of’ a material having a first nobility. Id. (citing Spec.
142).
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The Examiner responds that, for the purposes of searching for and
applying prior art under 35 U.S.C. §§ 102 and 103, absent a clear indication
in the specification or claims of what the basic and novel characteristics
actually are, “consisting essentially of’ is to be construed as equivalent to
“comprising.” Ans. 9 (citing, e.g., PPG Indus, v. Guardian Indus. Corp.,
156 F.3d 1351, 1355 (Fed. Cir. 1998)). The Examiner also points out that
Appellants have the burden of showing that the introduction of additional
steps or components would materially change the characteristics of the
Appellants’ invention. Id. (citing MPEP § 2111.03).
The Examiner finds that Appellants’ Specification does not provide a
clear indication that providing additional materials in either the plate or the
fastener blank would materially change the characteristics of the Appellants’
invention. App. Br. 9-10. Therefore, the Examiner construes the phrase
“consisting essentially of’ as being the equivalent of the claim term
“comprising.” Id. at 10.
We are not persuaded by the Examiner’s reasoning. Lozier teaches:
The present invention provides a bone fracture fixation
system comprising (i) a metallic bone plate having a first
composition comprising titanium or a titanium alloy and an
opening for receiving a fastener, (ii) a metallic fastener, having a
second composition comprising titanium, a titanium alloy, or a
stainless steel, is sized to be received in the opening, and (iii) a
cold-sprayed metallic coating either within the opening or on the
metallic fastener. The cold-sprayed metallic coating comprises
a biocompatible metallic material having a third composition that
is different than the first and second compositions. When the
metallic fastener is inserted into the opening of the metallic bone
plate to stabilize a bone fracture, the cold-sprayed metallic
coating substantially prevents bonding and corrosion between
the metallic fastener and the metallic bone plate.
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Lozier]} 10 (emphasis added). Lozier elaborates:
[T]he cold-sprayed metallic coating 26 may be formed on
a surface of the opening 18 or on a surface of head 28. Therefore,
the coating 26 resides between the metal (or alloy thereof) of the
metallic bone plate 12 and the metal (or alloy thereof) of the
metallic fastener 16, particularly at all surfaces where the
metallic fastener 16 is in direct contact with the metallic bone
plate 12.
Lozier ]} 26.
Claim 1 recites: “[A] plate consisting essentially of a first material and
having a plurality of apertures” and that: “[T]he fastener blank consisting
essentially of a second material [...] is less noble than the first material.”
For the teachings of Lozier to read on these limitations of the claim, the
Examiner must select the embodiment of Lozier that teaches the more noble
spray coating (e.g., of cobalt-chrome alloy, gold, gold alloy, silver, or silver
alloy) be applied to the plate (rather than the fastener) because the limitation
requires that the blank inserted into the aperture be less noble than the first
material of the plate.
The Examiner finds that, because Lozier teaches that the cold-sprayed
metallic coating forms a portion of the plate, the requirement that the plate
“consist essentially of’ a more noble first material than the blank is satisfied,
because the Examiner considers the phrase “consists essentially of’ to be
equated with comprising. See Ans. 9-10. We disagree. The transitional
term “comprising” “creates a presumption that the recited elements are only
a part of the device, [and] that the claim does not exclude additional,
unrecited elements.” Crystal Semiconductor Corp. v. TriTech
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Microelectronics Int 7, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001).
However, the transitional phrase “consisting essentially of’ typically:
[PJrecedes a list of ingredients in a composition claim or a series
of steps in a process claim. By using the term “consisting
essentially of,” the drafter signals that the invention necessarily
includes the listed ingredients and is open to unlisted ingredients
that do not materially affect the basic and novel properties of the
invention. A “consisting essentially of’ claim occupies a middle
ground between closed claims that are written in a “consisting
of’ format and fully open claims that are drafted in a
“comprising” format.
PPG, 156 F.3d at 1354.
Lozier teaches that the cold spray coating is applied only to the
“surface in the opening [i.e., the aperture]” of the plate and that the plate
itself typically consists of “titanium or a titanium alloy.” Lozier 10. We
find, contrary to the Examiner, that the basic character of the plate itself,
with the exception of the cold spray coating applied the interior surface of
the aperture to prevent corrosion, consists of the “first composition
comprising titanium or a titanium alloy,” and is of substantially the same
material as the fastener. Id. We therefore do not agree with the Examiner’s
finding that Lozier, upon which the Examiner expressly relies, teaches a
plate consisting essentially of a first material that is more noble than that of
the fastener (or blank) disposed within the aperture. We therefore reverse
the Examiner’s rejection of the claims on this ground. Furthermore, because
we find this issue to be dispositive of the rejections under 35 U.S.C.
§ 103(a), we do not reach Appellants’ additional arguments.
Appellants argue claim 18 and 24 separately, providing additional
arguments that the claim is nonobvious over the cited prior art. However,
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Application 13/213,213
claims 18 and 24 depend from claim 1 and therefore, for the same reasons
explained supra, we also reverse the Examiners’ rejection of these claims.
B. Rejection of claim 23 under 35 U.S.C. $ 112, first paragraph
Issue
Appellants argue the Examiner erred in rejecting claims 23 as lacking
written descriptive support. App. Br. 15.
Analysis
The Examiner finds that claim 23 contains subject matter which was
not described in Appellants’ Specification in such a manner as to reasonably
convey to one skilled in the relevant art that the inventors, at the time the
application was filed, were in possession of the claimed invention. Final
Act. 2. Specifically, the Examiner finds claim 23 recites “wherein the plate
and the fastener do not include a coating layer.” Id. The Examiner finds this
limitation is not supported by Appellants’ Specification as originally filed.
Id. Furthermore, finds the Examiner, any negative limitation or exclusionary
proviso must have basis in the original disclosure and, if alternative elements
are positively recited in the Specification, they may be explicitly excluded in
the claims. Id. However, the Examiner finds, the mere absence of a positive
recitation is not a basis for exclusion. Id. (citing MPEP § 2173.05(i)).
Appellants argue that the Examiner’s finding that “the components
lacking a coating cannot be distinguished by the figures of the specification
as originally filed” is unclear and suggests that the Specification’s Figures
do, in fact, support an embodiment that does not include a coating. App. Br.
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16 (quoting Final Act. 6-7). Appellants disagree, however, that, to the
extent that the Examiner is asserting that the Figures do not support
embodiments of the disclosed implant systems that do not have a coating.
Id.
Appellants point to Figure 4 of their Specification, which illustrates
“an exemplary cross-sectional view of the tissue implant of FIG. 3 fastened
to a tissue (e.g., bone) according to one embodiment of the present
invention.” App. Br. 16. (quoting Spec. ^ 25). Appellants assert that, as
shown in Figure 4, here is no coating on the implant 100 or the fastener
blank 130. Id. Therefore, Appellants contend, Figure 4 supports an
embodiment of the claimed implant systems in which neither the plate nor
the fastener blank have a coating. Id.
Appellants contend that it is clear from the context of their
Specification that the inventors had possession of an embodiment where the
plate and fastener blank do not include a coating layer, as recited in claim
23. App. Br. 17. According to Appellants: “[t]he specification describes
and illustrates various uncoated embodiments.” Id. Moreover, Appellants
argue, in alleging that the separate coating layer of Lozier is relevant, the
Examiner evidently takes the position that the instant specification supports
claims encompassing both coated and uncoated embodiments and that
dependent claim 23 is simply directed to an uncoated embodiment. Id.
We are not persuaded by the Examiner’s reasoning. Claim 23 recites:
“The implant system of claim 1, wherein the plate and the fastener do not
include a coating layer.” Claim 23 thus recites a negative limitation, i.e.,
that the plate and fastenings do not include a coating layer.
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Appellants’ Specification discloses several embodiments in which the
implant consists of a layer of less noble second material that is “plated” over
a more noble first material:
In one embodiment, illustrated in Fig. 6, implant 100 (e.g.,
a plate) includes a main body 630 having a plurality of apertures
120 at least substantially surrounded by the first material 610 and
a prolongation 605 substantially comprising a second material.
In one embodiment, prolongation 605 consists essentially of the
second material. In one embodiment, prolongation 605 includes
second material that is plated over first material.
Spec. ^ 48 (emphasis added). Similarly, with respect to the embodiment
depicted in Appellants’ Figure 7, the Specification discloses:
[IJmplant 700 (e.g., a plate) includes a main body 730 having a
plurality of apertures 120 at least substantially surrounded by
first material 610. Implant 700 may also include segments 705
comprising or consisting essentially of a second material. In one
embodiment, main body 730 comprises or consists essentially of
first material. In one embodiment, second material is plated over
the main body at segments 705.
Spec. ^ 49 (emphasis added). We find that, in these contexts, having a
second material “plated over” a first material corresponds to “a coating
layer,” as recited in claim 23.
Furthermore, we find the Specification discloses embodiments in
which the first and second materials are segregated to different components
of the invention. For example, Appellants’ Specification discloses that:
[I]n one embodiment, body 110 may comprise or substantially
consist of a material having a first nobility and a fastener blank
130 comprising or consisting essentially of a second material
having a nobility that is different from the first material. In one
embodiment, the first material ... is more noble than the second
material. In another embodiment, the second material is more
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noble than the first embodiment [sic, material]. In one
embodiment, the second material is an alloy of the first material.
In a further embodiment, the second material is not an alloy of
the first material.
Spec. ^ 42. In this instance, there is no layer of less noble material plated
over, or coating, the first material of the base, as in the embodiments
disclosed with respect to Figures 6 and 7. Nor can any such plated layer be
contemplated within the transitional phrase “consisting essentially of’
because it would necessarily have a material effect upon the basic property
of the material of the plate - i.e., it would confer upon it the properties of the
less noble second layer described in Figures 6 and 7. Rather, in this
embodiment (see, e.g., Figs. 1-3 and 5) the more- and less-noble materials
are segregated to different elements of the invention (i.e., the plate and the
fastener blanks). We consequently conclude that the Specification provides
written descriptive support for embodiments of the invention both with and
without a coating layer (the latter as required by claim 23) and we reverse
the Examiner’s rejection of the claim.
C. Rejection of claim 23 under 35 U.S.C. $ 112, first paragraph
Issue
Appellants argue the Examiner erred in rejecting claim 25 as lacking
written descriptive support. App. Br. 15.
Analysis
The Examiner finds claim 25 recites, in relevant part: “[A] plate
consisting of a first material ... [and] a fastener consisting of a second
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material.” Final Act. 2-3.2 The Examiner finds this limitation is not
supported by Appellants’Specification. Id. at 3. The Examiner finds
Appellants’ Specification uses only the terms “consisting essentially of’
when directed towards the materials for the plate and the fastener (blank).
Id. Therefore, the Examiner finds, the claim as presented is not supported
and is new matter. Id.
Appellants point to paragraph [0042] of the Specification, which
discloses: “body 110 may comprise or substantially consist of a material
having a first nobility and a fastener blank 130 comprising or consisting
essentially of a second material having a nobility that is different from the
first material.” App. Br. 13. Appellants also argue that the Specification
discloses “a body including a first material” and that “the fastener blank
includes a second material that is less noble than the first material.” Id.
(quoting Spec. 6, 8). Appellants point to Section 2111.03 of the MPEP,3
which states that: “[t]he transitional term ‘comprising’ ... is synonymous
with ‘including.’” Id. Therefore, argue Appellants, the Specification
supports the use of claim terms “comprising” and “consisting essentially of.”
Id.
Appellants disagree with the Examiner’s finding that the use of
“comprising” or “consisting essentially of’ does not provide written support
for the use of “consisting of’in claim 25. App. Br. 13. Appellants contend
2 The Examiner appears to be referring the claim language defining the
material of the fastener blank, since claim 25 does not include any limitation
on the material of the fastener itself.
3 Appellants actually cite MPEP § 211.03, but that section does not exist.
MPEP § 2111.03 addresses the interpretation of transitional phrases.
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that, although the term “comprising” is open-ended and does not exclude
additional, unrecited elements, use of the term does not mean that it must
include additional, unrecited elements. Id. Appellants point out that our
reviewing court has expressly stated that: “[although ‘comprising’ language
is not limiting and may include features not recited in the claim, such
language cannot be read to require other structure.” Id. at 13-14 (citing
Versa Corp. v. Ag-Bag Intern. Ltd, 392 F.3d 1325, 1329 (Fed. Cir. 2004)).
Appellants therefore contend that, if “comprising” cannot be read to
require additional elements, it can be read to either include or exclude
additional elements and that a reading that would exclude other elements
(i.e., not require other elements) is consistent with the use of the phrase
“consisting of.” Id. at 14.
The Examiner responds that Appellants’ Specification provides no
support for an embodiment of the invention in which the plate is made of
only the first material and wherein the fastener blank is made of only the
second material. Ans. 11. Furthermore, finds the Examiner, the phrase
“consisting of’ does not appear in the application as originally filed. Id.
The Examiner finds the use of the transitional phrase “consisting of’ creates
a criticality regarding the presence of the plate being made from only the
first material and the fastener blank being made from only the second
material which is not present in the Specification and therefore introduces
new matter. Id. at 11-12.
We are persuaded by Appellants’ arguments. We agree with
Appellants that our reviewing court has held that the claim term
“comprising” cannot be read to require other structures. See Versa Corp.,
392 F.3d at 1329. By logical extension, we conclude that the more limited
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transitional phrase “consisting essentially of’ similarly does not require the
inclusion of additional elements. See PPG, 156 F.3d at 1354. We
consequently disagree with the Examiner’s conclusion that the embodiments
recited in the Specification disclosing plates and blanks “consisting
essentially of,” respectively, first and second materials fails, as a matter of
law, to provide written descriptive support of claim 25 ’s recitation of “[A]
plate consisting of a first material ... [and a] fastener blank consisting of a
second material.” We consequently reverse the Examiner’s rejection of
claim 25.
DECISION
The Examiner’s rejection of claims claims 1, 2, and 15-18 and 24
under 35 U.S.C. § 103(a) is reversed.
The Examiner’s rejection of claims claims 23 and 25 under 35 U.S.C.
§112, first paragraph is reversed.
REVERSED
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