Ex Parte Wittchow

Patent Trial and Appeal Board

Apr 12, 2016

12540889 (P.T.A.B. Apr. 12, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/540,889 08/13/2009 Eric Wittchow
24978 7590 04/14/2016
GREER, BURNS & CRAIN, LTD
300 S. WACKER DR.
SUITE 2500
CHICAGO, IL 60606
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.
4840.85434 2208
EXAMINER
ZISKA, SUZANNE E
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
04/14/2016 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ERIC WITTCHOW 1
Appeal2014-000341
Application 12/540,889
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and TIMOTHY G.
MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to stents that
include a gold complex in a coating or cavity filling. The claims are rejected
as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
STATEMENT OF THE CASE
Background
According to the Specification, "[t]he invention relates to a stent
coated with a bioactive and also radiopaque material and use thereof for
1 Appellant identifies the Real Party in Interest as Biotronik VI Patent AG.
(Appeal Br. 2.)
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Application 12/540,889
production of such stents." (Spec. 1.) An object of the invention is
"reducing the rate of restenosis while at the same time ensuring adequate
imageability of the stent during and after application." (Id. at 3.) "This
object is achieved by providing a stent having a coating or cavity filling
consisting of or containing an organic [Au] complex." (Id.)
Claims
Claims 6-8, 11, 17, 20, and 21 are on appeal. 2 With the exception of
claim 21, these claims depend from claim 1. Claims 1, 2, 7, 11, and 17 are
illustrative of the claims on appeal and read as follows:
1. A stent having a base body and one or more of a coating
or cavity filling comprising an organic Au complex, the one or
more of a coating or cavity filling deposited or located on the
surface of the base body of the stent.
2. The stent according to claim 1, wherein the base body
comprises a biocorrodible metallic material.
7. The stent according to claim 1, wherein the Au complex
is an Au(III) complex and has one or more multidentate N-
containing ligands.
11. The stent according to claim 1, wherein the Au complex
is embedded in an organic polymer matrix which is applied as
one or more of a coating or cavity filling to the surface of the
base body of the stent.
2 Claim 21 is to a method and depends from claim 15 (rejected, but not
challenged on appeal). For purposes of this decision, we adopt any findings
of the Examiner supporting the rejections of claims 1-5, 9, 10, 13-16, 18,
and 19, that are not challenged on appeal, and from which claims 6-8, 11,
17, 20, and 21 depend. Those unchallenged rejections are sustained. MPEP
§ 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.").
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1 7. A stent according to claim 2 wherein the at least one
cavity is provided on an interior of the stent and wherein the
one or more of a coating or a cavity filling comprises a cavity
filling contained in the interior cavity, wherein the organic Au
complex material is exposed only after the biocorrodible base
body corrodes.
(Appeal Br. (Claims App'x A-l-A-5).)
Rejections
The challenged rejections, 3 which we address in the order presented in
the briefing, are as follows:
I. Claim 11 stands rejected under 35 U.S.C. § 103(a) as obvious
over Ndondo-Lay in view of Sims;
II. Claim 17 stands rejected under 35 U.S.C. § 103(a) as obvious
over Ndondo-Lay and Sims, in view of Dave; and
III. Claims 6-8, 20, and 21 stand rejected under 35 U.S.C. § 103(a)
as obvious over Ndondo-Lay and Sims, in view ofMcKeage
and Zhang.
3 The applicable prior art is: Ndondo-Lay, U.S. 6,273,908 Bl, issued Aug.
14, 2001 ("Ndondo-Lay"); Sims et al., U.S. 7,736,687 B2, issued June 15,
2010 ("Sims"); Dave, U.S. 2008/0249608 Al, published Oct. 9, 2008
("Dave"); McKeage et al., Mechanisms of cytotoxicity and antitumor activity
of gold(!) phosphine complexes: the possible role of mitochondria, 232
COORDINATION CHEMISTRY REVIEWS 127-135 (2002) ("McKeage"); and
Christiana Xin Zhang & Stephen J. Lippard, New metal complexes as
potential therapeutics, 7 CURRENT OPINION IN CHEMICAL BIOLOGY 481--489
(2003) ("Zhang").
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Application 12/540,889
DISCUSSION - I
Issue
Has the Examiner established by a preponderance of the evidence that
claim 11 would have been obvious under 35 U.S.C. § 103(a) based on
Ndondo-Lay in view of Sims?
Findings of Fact
1. The Specification teaches that "the coating or cavity filling may
contain other ingredients, in particular an organic polymer matrix in which
the Au complex is embedded in a finely dispersed form. In other words, the
stent has a coating or cavity filling consisting of a polymer carrier matrix
with embedded Au complex." (Spec. 4.)
2. As stated by the Examiner,
Ndondo-Lay discloses stents having cavities for filling
(Abstract) on the outer surface (col 8, lines 40-52). Ndondo-
Lay discloses the cavities are capable of incorporating
biologically active agents therein (col 5, lines 5-9). Ndondo-
Lay discloses the stent can be formed from gold (col 6, line 22).
N don do-Lay discloses that the cavities are pre filled with a
biologically active agent prior to placement of the stent and that
because the biologically active agent will be released at the site
of placement the biologically active agent can have its greatest
effects directly at the desired location without prior dilution
throughout the body of the patient (col 7, lines 37--44).
(Ans. 2; see also, Final Act. 3.)
3. Ndondo-Lay teaches "the stent 1 may be dipped into or otherwise
coated with a liquid that includes the biologically active agent such that the
liquid is drawn into the cavities 5 by surface tension affects [sic]."
(Ndondo-Lay col. 8, 11. 26-29.) Moreover, Ndondo-Lay teaches that "the
biologically active agent may be combined with a polymeric material having
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controlled release properties and each of the cavities 5 carefully filled with
the mixture." (Id. at col. 8, 11. 32-35.) Ndondo-Lay further teaches "the
stent ... may include a biologically active agent-impregnated polymeric
material coating all or a portion of the appendages 3." (Id. at col. 8, 11. 53-
56.)
4. As stated by the Examiner, Sims "discloses stents made of
magnesium alloys and gold (col 14, lines 13-22) and methods of making the
stents." Sims further "discloses a pharmacologically active agent can be
loaded into the void plenums (col 17, lines 49-50) ... [and] the agent can be
auranofin (claims 4, 5, 9, and 10), an organic gold I complex (col 18, line
36)." (Ans. 2.)
Principles of Law
"[W]hen a patent claims a structure already known in the prior art that
is altered by the mere substitution of one element for another known in the
field, the combination must do more than yield a predictable result." KSR
Int'! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
Appellant contends the combination ofNdondo-Lay and Sims does
not teach or suggest the limitation "the Au complex is embedded in an
organic polymer matrix which is applied as one or more of a coating or
cavity filling to the surface of the base body of the stent." (Appeal Br. 10.)
The Examiner's response is twofold. First, the Examiner states that
"Appellant's argument appears to be based on the meaning of 'embed,"'
which the Examiner interprets as "in the matrix." (Ans. 8.) Second, the
Examiner cites "the explicit Ndondo-Lay statement that 'the biologically
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active agent [e.g., a gold complex like auranofin] may be combined with
polymeric material' (col 8, lines 31-33)." (Ans. 9.) That, plus Ndondo-
Lay's teaching that "the stent may be dipped into or otherwise coated with a
liquid that includes the active [agent] such that the liquid is drawn into the
cavities by surface tension affects [sic] (col 8, line 26-29)" satisfies the
missing element of claim 11, according to the Examiner. (Ans. 9.)
We are persuaded that claim 11 would have been obvious. A person
of ordinary skill in the art would have had a reason to use the gold complex
auranofin of Sims as the biological agent and apply that to the stent of
Ndondo-Lay (FF 2, 4)-Appellant concedes as much in not challenging the
Examiner's findings in this regard, nor the rejection of claim 1. N dondo-
Lay further teaches that such biological agents can be "embedded in an
organic polymer matrix" under any reasonable interpretation of that claim
phrase. (FF 1, 4.)4 Accordingly, we find that the combination ofNdondo-
Lay and Sims for purposes of claim 11 involves mere substitution of known
elements (e.g., combining auranofin in a polymer matrix) in a predictable
manner that would yield predictable results. KSR, 550 U.S. at 416. We,
therefore, affirm the Examiner's rejection of claim 11.
Conclusion of Law
The Examiner has established by a preponderance of the evidence that
claim 11 would have been obvious under 35 U.S.C. § 103(a) based on
Ndondo-Lay in view of Sims.
4 Sims also discloses that agents (e.g., auranofin) added to stents may be
"encapsulated ... in a polymer matrix." (See, e.g., Sims col. 18, 11. 51-53.)
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DISCUSSION - II
Issue
Has the Examiner established by a preponderance of the evidence that
claim 17 would have been obvious under 35 U.S.C. § 103(a) based on
Ndondo-Lay and Sims, in view of Dave?
Findings of Fact
5. As stated by the Examiner,
Dave discloses [0114] biodegradable implants comprising
biodegradable (the claimed biocorrodible) metallic materials
[0112] such as magnesium alloys (claims 2 and 3). Dave
discloses a material often entirely or partially consisting of the
specified magnesium alloy also satisfies the further
physiological properties, that is to say a slight inflammatory
effect and sustained prevention of tissue growth, for example,
restenosis [0114]. Dave discloses that an endoprosthesis which
entirely or partially consists of the specified magnesium alloy
satisfies many of the requirements involved in a quite particular
positive fashion, in regard to the many different desirable
properties briefly described above [0113]. Besides the
mechanical requirements, a material often entirely or partially
consisting of the specified magnesium alloy also satisfies the
further physiological properties, that is to say a slight
inflammatory effect and sustained prevention of tissue growth,
for example, restenosis [0113]. In actual fact tests have shown
that the decomposition products of the specified magnesium
alloy have only few or indeed no substantial negative
physiological effects [0113]. Therefore the specified
magnesium alloy, among the large number of conceivable
materials, represents an opportunity for degradable implantable
medical devices [0113].
(Ans. 5---6; Final Act. 7.)
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Principles of Law
A prima facie case for obviousness requires "a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
elements in the way the claimed new invention does." KSR Int 'l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
Appellant argues that the Examiner has shifted positions and confused
the record concerning the rejection of claim 17. (Reply Br. 1.) The result,
Appellant says, is that "the exact nature of the actual rejection, what
references are being relied on for what teachings, and how the references are
being combined are completely unclear." (Id.)
Appellant argues that the prior art does not teach all limitations and
cannot, in any event, be combined to satisfy the invention as claimed. (See,
e.g., Appeal Br. 16. ("Since Sims does not teach the claimed cavity, it
cannot be combined with Ndondo-Lay (or any other reference) to teach that
limitation."). The Appellant takes particular issue with the Examiner's
combination of prior art to satisfy the "at least one cavity is provided on an
interior of the stent ... wherein the organic Au complex material is exposed
only after the biocorrodible base body corrodes" limitation, and devotes the
remainder of his arguments to explaining why structures in Sims are
different from what is recited in claim 17. (Reply Br. 5-7.)
The Examiner contends the rejection of claim 17 has been consistent
and clear. According to the Examiner: (i) Ndondo-Lay discloses "stents
having cavities for filling (Abstract) on the outer surface (col 8, lines 40-52)
of the stent body"; (ii) Sims "was cited for teaching auranofin and inclusion
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of auranofin in cavities ('voids' in Sims) in base bodies of stents"; and
"Dave was cited for teaching biodegradable (biocorrodible) stents." (Ans.
10-11.) As for the rationale supporting the combination, the Examiner
writes:
Regarding claim 17, Sims discloses a pharmacologically active
agent can be loaded into the void plenums (col 17, lines 49-50),
the claimed interior cavity. It would have been obvious to one
of ordinary skill that the material in the interior cavity would
only be released when the biodegradable base body erodes.
Dave provides motivation for using a biodegradable base body.
(Ans. 6; Final Act. 7 .) The Examiner then concludes "it is apparent that one
of ordinary skill would have had a reasonable expectation of success in
producing the claimed invention." (Ans. 6.)
We are persuaded that the Examiner has not adequately explained how
the combination ofNdondo-Lay, Sims, and Dave satisfies all the elements of
claim 1 7, nor provided sufficient reasoning showing that a person of
ordinary skill would have had a reason to make the proposed combination.
KSR, 550 U.S. at 418 (2007) ("[R]ejections on obviousness grounds cannot
be sustained by mere conclusory statements; instead, there must be some
articulated reasoning with some rational underpinning to support the legal
conclusion of obviousness.")
First, the Examiner has not shown that the prior art, whether starting
with Ndondo-Lay or Sims, when combined produces a stent with a gold
complex in an interior cavity that is exposed only after the base body
corrodes as required by claim 17. Ndondo-Lay and Sims disclose cavities
with therapeutic contents that appear to be exposed irrespective of corrosion
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of a base body of the stent. 5 And although Dave discloses that biocorrodible
material may be used for a stent (FF 5), the Examiner does not explain how
the combination of its teachings with Ndondo-Lay and Sims would satisfy
the "exposed only after the base body corrodes" language of claim 17.
Second, a sufficiently detailed rationale to support the combination of
the prior art to yield a stent within the scope of claim 17 is missing. The
Examiner supplied a rationale to modify the stent ofNdondo-Lay to include
the gold complex of Sims (Ans. 3), and also explained why it would be
desirable to make the stents biocorrodible according to Dave (Ans. 6). Yet
the Examiner does not provide adequate reasoning to explain why the person
of skill in the art would have had a reason to create a modified stent with an
interior cavity filled with an organic gold complex that is released only after
the body of the stent corrodes.
For these reasons, we reverse the rejection of claim 17.
Conclusion of Law
We determine that the Examiner has not established by a
preponderance of the evidence that claim 1 7 would have been obvious under
U.S.C. § 103(a) based on Ndondo-Lay and Sims, in further view of Dave.
5 Ndondo-Lay discloses cavities/craters filled with biological agent on the
inner (lumen-facing) and outer (tissue-facing) portions of the stent.
(Ndondo-Lay col. 8, 11. 40-52). Sims, on the other hand, discloses that
active therapeutic agent may be applied to the stent as a "drug eluting layer,
or surface treatment" or the agent may be loaded into the void plenums 120.
(Sims col. 17, 11. 49---62.) Sims teaches a plurality of "openings 116" that
expose the void plenum and its contents to outside of the stent. (Sims Fig. 8;
co 1. 1 7' 11. 3 5--41.)
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DISCUSSION - III
Issue
Has the Examiner established by a preponderance of the evidence that
claims 6-8 and 20-21 would have been obvious under 35 U.S.C. § 103(a)
based on Ndondo-Lay and Sims in view ofMcKeage and Zhang?
Findings of Fact
6. As stated by the Examiner,
McKeage discloses complexes of Au(I) phosphine complexes
(title). McKeage discloses that bis ( 1,2-
bi( diphenylphosphino )ethane )gold(I) complexes (claim 5) had
significant antitumor activity in tumor models in vivo
(Abstract). McKeage discloses the gold complexes are directly
cytotoxic (Abstract). McKeage discloses auranofin has
immunosuppressive effects (page 128, right column, top
paragraph). McKeage discloses bis (1,2-bis
( diphenylphosphino )ethane) gold(I) complexes had a different
mechanism of cytotoxic action than auranofin (page 131, left
column, second paragraph).
(Final. Act. 5; Ans. 4.)
7. As stated by the Examiner, "[r ]egarding claim 6, Zhang discloses
tetrakis ( ( tris(hydroxymethyl) )phosphine) gold I complex has been reported
to be cytotoxic to several tumor cells lines (page 485, right column)." (Final
Act. 6; Ans. 4.)
8. As stated by the Examiner, "[ r ]egarding claims 7 and 8, Zhang
discloses Au(III) complexes having multidentate N-containing ligands such
as N-benzyl-N,N-dimethylamine active against human cancer cell lines
(page 486, left column, top paragraph)." (Final Act. 6; Ans. 5.)
9. As stated by the Examiner, "[ r ]egarding claim 20, Zhang discloses
auranofin has a sulfur ligand (figure 1)." (Final Act. 6; Ans. 5.)
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10. As stated by the Examiner, "[r]egarding claim 21, Zhang
discloses Au(III) compounds with multidentate ligands such as bispyridyl
ligand have demonstrate[d] cytotoxicity (page 486, left column)." (Final
Act. 6; Ans. 5.)
11. As stated by the Examiner,
Ndondo-Lay discloses a wide variety of biologically active
agents and diagnostic agents, not just those involved with
treatment of restenosis, can be used as therapeutic agents on
stents. See, Ndondo-Lay col 7, line 56 through col 8,line 22, for
example, disclosing drugs, radioactive chemical, gene therapy
vectors for use with the stent. Ndondo-Lay discloses anti-tumor
drugs such as colchicine, methotrexate, anti-metabolites, anti-
proliferative agents and cystostatic agents can be used (col 7,
line 56 through col 8, line 22).
(Ans. 17.)
Principles of Law
"In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls. . . . [A ]ny need or problem known in the field of endeavor
at the time of invention and addressed by the patent can provide a reason for
combining the elements in the manner claimed." KSR Int'! Co. v. Teleflex
Inc., 550 U.S. 398, 419--20 (2007).
Analysis
Appellant does not challenge that Zhang and McKeage disclose the
gold complexes recited in dependent claims 6-8 and 20-21. Rather,
Appellant treats these claims as a group and argues that "McKeage and
Zhang cannot properly be combined with Ndondo-Lay and Sims because
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they teach gold complexes for treating cancer and provide no motivation to
combine them with references related to stents for stenosis or imagability."
(Appeal Br. 17 .) Appellant further argues that Zhang "provides nothing
more than an abstract idea that certain gold complexes may be useful in
treating cancer, but there is no suggestion of any percent composition of a
coating or combination with a stent or similar device." (Appeal Br. 17.)
The Examiner answers that "no claim claims treatment of stenosis or
imagability" and thus, Appellant's arguments are not commensurate in scope
with the claims. (Ans. 20.) Further, the Examiner contends that Sims, not
McKeage or Zhang, was being relied upon for the teaching that an organic
gold complex could be applied to a stent, and that Zhang and McKeage are
relied upon for disclosure of additional gold complexes usable as
alternatives to the therapeutic compounds discussed in Sims and Ndondo-
Lay. (Ans. 15-16.)
As for the motivation to combine the references, the Examiner's
position is summarized as follows. The Examiner highlights that Sims and
Ndondo-Lay disclose stents that may be coated with a wide variety of
therapeutic agents, many of which are useful for immunosuppressive or
cytotoxic action. (Ans. 17.) The Examiner explains the "motivation to
include Zhang compounds Au(III) and Au(I), acknowledged by Appellants
as taught by Zhang to be useful in treating cancer, is provided in Ndondo-
Lay and Sims, disclosing inclusion of both anti-tumor and anti-restenotic
drugs with stents." (Ans. 19.) Moreover, the Examiner finds that "[d]irect
cytotoxicity would kill tumor cells or cells involved in restenosis thus
providing motivation to combine them (McKeage and Zhang) with Ndondo-
Lay and Sims." (Ans. 20.) Accordingly, the Examiner finds "it would have
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been obvious to one of ordinary skill to substitute the Au(I) and Au(III)
compounds (of Zhang) for the auranofin of Simms [sic] in order to exhibit
immunosuppressive effects and thus treat restenosis by reducing cell
growth." (Ans. 18.)
Regarding the "percent composition" argument, the Examiner states
"[i]t would have been obvious to one of ordinary skill in the art to fill the
cavity with the amount of active agent required to provide effective
treatment, lacking evidence to the contrary." (Ans. 18.) The Examiner thus,
maintains the rejection of claim 6 -the only claim on appeal to specify an
amount of the Au complex.
We conclude that the Examiner has the better position regarding the
rejections of claims 6-8 and 20-21. The prior art discloses the particular
gold complexes recited in these claims. (FF 7-10.) The Examiner has
provided reasoning with a rational underpinning showing why the skilled
artisan would have had reason to combine the prior art (e.g., to create a stent
with anti-proliferative or anti-restenotic properties on account of the gold
complexes included in a coating or cavity of the device). (FF 6, 11; Ans.
17-20.) And, as explained by the Examiner, absent evidence to the contrary,
the amount of the gold compound (claim 6) to apply to the stent would be
obvious as a matter of routine experimentation to obtain effective treatment.
(Ans. 18.) Thus, we determine that a person of ordinary skill in the art
would have had reason to combine the therapeutic gold complexes of Zhang
or McKeage with the stents ofNdondo-Lay and Sims- and would have
reasonably expected that the combination would yield a stent with beneficial
properties such as those identified by the Examiner.
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Appellant's assertions in response to the Examiner's rejection of these
claims do not supply evidence that rebuts the Examiner's prima facie case.
In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in
a brief cannot take the place of evidence."). Indeed, even if Zhang and
McKeage were focused on use of gold complexes for treatment of cancer as
Appellant argues, that is irrelevant to the language of the claims and does
not negate the reason to combine based on the rationale supplied by the
Examiner. (The Examiner discusses, for example, Ndondo-Lay's use of
known anti-cancer agents on its stents and offers a rationale for the use of
anti-cancer agents of Zhang and McKeage to limit restenosis.)
For these reasons, we affirm the rejections of claims 6-8 and 20-21.
Conclusion of Law
Claims 6-8, 20, and 21 have not been argued separately and therefore,
stand or fall together. 37 C.F.R. § 41.37(c)(l)(iv).
We determine that the Examiner has established by a preponderance
of the evidence that claims 6-8, 20, and 21 would have been obvious under
35 U.S.C. § 103(a) based on Ndondo-Lay and Sims, in view of Zhang and
McKeage.
SUMMARY
We affirm the rejection of claim 11. We reverse the rejection of claim
17. We affirm the rejections of claims 6-8, 20, and 21.
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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-IN-PART
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