Bjoern Klocke et al.

Patent Trials and Appeals Board

Jul 24, 2019

13191647 - (D) (P.T.A.B. Jul. 24, 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.
13/191,647 07/27/2011 Bjoern Klocke 4840.103795 4500
24978 7590 07/24/2019
GREER, BURNS & CRAIN, LTD
300 S. WACKER DR.
SUITE 2500
CHICAGO, IL 60606
EXAMINER
LOPEZ, LESLIE ANN
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
07/24/2019 ELECTRONIC
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UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BJOERN KLOCKE and ALEXANDER BORCK
____________

Appeal 2017-010475
Application 13/191,647
Technology Center 3700
____________

Before MICHELLE R. OSINSKI, SUSAN L. C. MITCHELL, and
GEORGE R. HOSKINS, Administrative Patent Judges.

HOSKINS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Bjoern Klocke and Alexander Borck (“Appellants”)1 appeal under
35 U.S.C. § 134 from the Examiner’s decision rejecting claims 1–3, 5, 7, 8,
11–16, 19, 21, and 22 in this application. The Board has jurisdiction over
the appeal under 35 U.S.C. § 6(b).
A hearing was held on June 11, 2019. See Transcript (entered July 10,
2019) (“Tr.”).
We REVERSE.

1 Biotronik AG is identified as the real party in interest. Br. 2.
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CLAIMED SUBJECT MATTER
Claims 1, 16, and 22 are independent. Claims 1 and 12 illustratively
recite:
1. An implant having a base body comprised of a
biocorrodible magnesium alloy and a corrosion-inhibiting
polylactide coating, and wherein the corrosion-inhibiting
polylactide coating contains a polylactide polymer and a
compound selected from lipophilic substances, wherein the
lipophilic substance is selected from the group consisting of
squalene and squalane,
wherein the compound is distributed homogeneously in
the corrosion-inhibiting polylactide coating, and
wherein the corrosion-inhibiting polylactide coating is
applied directly over the biocorrodible magnesium alloy base
body; and
wherein the corrosion-inhibiting polylactide coating
results in the implant having a non-linear corrosion rate and a
support time that is increased by at least 2 weeks after the
implantation as compared to an uncoated implant having a base
body comprised of a biocorrodible magnesium alloy.
12. An implant according to Claim 1, wherein the
corrosion-inhibiting polylactide coating is hydrophobic and
contains the lipophilic substances having a weight fraction of
0.5–10% by weight, relative to the total weight of the polylactide
coating.
Br. A-1, A-3 (Claims App.) (emphases added).
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REJECTIONS ON APPEAL2
Claims 1, 3, 8, and 12–14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Dave (EP 1 977 722 A1, pub. Oct. 8, 2008) and Eldridge
(US 2007/0014739 A1, pub. Jan. 18, 2007).
Claims 2, 5, 11, and 22 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Dave, Eldridge, and Wang (US 2009/0248147 A1, pub.
Oct. 1, 2009).
Claims 7, 16, and 19 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Dave, Eldridge, and Heublein (US 2004/0034409 A1,
pub. Feb. 19, 2004).
Claim 21 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Dave, Eldridge, Heublein, and Wang.
OPINION
A. Obviousness Over Dave and Eldridge (claims 1, 3, 8, and 12–14)
In rejecting independent claim 1, the Examiner finds Dave discloses,
as illustrated in Figures 3 and 9, stent implant 100 having base body 902
comprised of a biocorrodible magnesium alloy, and corrosion-inhibiting
polylactide coating 904 (i.e., PLLA). Final Act. 4 (citing Dave, Abstract,
¶¶ 101–102, 111, 119). The Examiner finds Dave fails to disclose that
coating 904 contains a lipophilic substance, such as squalene. Id. at 5. The
Examiner finds Eldridge discloses a stent implant “having squalene in a

2 The Examiner has withdrawn a rejection of claim 15 under 35 U.S.C.
§ 103(a) as unpatentable over Dave, Eldridge, Wang, and Heublein. See
Final Act. 11–12 (rejection); Ans. 2 (withdrawal). Thus, there is no
rejection of claim 15 presently before us on appeal.
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polymer carrier on the stent . . . as part of [a] pentacy[c]lic acid treatment
layer.” Id. (emphases added) (citing Eldridge ¶¶ 37, 78, 95, 117).
The Examiner determines it would have been obvious to modify Dave
by incorporating squalene into Dave’s polylactide coating 904, “as part of a
pentacy[c]lic acid treatment layer,” to prevent infection as taught by
Eldridge. Id. (citing Eldridge, Abstract). According to the Examiner, the
resultant coating, which would include a polylactide polymer component as
disclosed by Dave and a squalene component as disclosed by Eldridge,
would satisfy the corrosion rate and support time requirements of claim 1,
because “these properties are a result . . . of the [claimed] composition,” and
“as the composition is met [by the combination of Dave and Eldridge], the
properties claimed are met” as well. Id. at 5–6 (citing MPEP § 2112.01(II)).
In particular, according to the Examiner, squalene “is present in” Eldridge’s
pentacyclic acid treatment layer, in the concentration range recited in
Appellants’ claim 12 for example3, so the modified coating “therefore has all
the physical properties inherent chemically of squalene.” Id. at 2–3 (citing
Eldridge ¶ 78); Ans. 4.
Appellants argue Eldridge teaches away from using squalene, so Dave
and Eldridge taken together as a whole do not render the invention of
claim 1 obvious. Br. 8–9, 10–11. Appellants particularly contend Eldridge
describes squalene as an impurity that might be present in Eldridge’s
beneficial pentacyclic acid triterpene compound, if that compound is
obtained via purification from natural plant sources rather than via synthetic
preparation. Id. (citing Eldridge ¶¶ 44–45, 78–84); Tr. 3:6–19.

3 We understand the Examiner’s reference to claim 10 in this regard to be a
typographical error.
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The Examiner agrees Eldridge “teaches the pentacyclic acid triterpene
compound or composition contains ‘no or less than 1% by weight
hydrocarbon’” such as squalene. Ans. 3 (quoting Eldridge ¶ 78).
Nonetheless, the Examiner maintains it would have been known to be
beneficial to add Eldridge’s pentacyclic acid triterpene compound to Dave’s
polylactide coating to prevent infection, and concludes that “[a]s the
pentacyclic acid triterpene compound or composition is added, so are its
impurities, in the tolerable levels as disclosed by Eldridge (less than 1%).”
Id. (citing Eldridge, Abstract). The Examiner points out that claim 1
“merely claims squalene’s presence” without specifying a minimum amount
of squalene within the coating. Id.
Based on our review of the foregoing, we conclude the rejection
presently before us is not sustainable. In particular, the Examiner’s
conclusion that it would have been obvious, in light of Eldridge, to add a
pentacyclic acid triterpene compound including a squalene impurity to
Dave’s polylactide coating is not supported by a preponderance of the
evidence.
“A reference may be said to teach away when a person of ordinary
skill, upon reading the reference, would be discouraged from following the
path set out in the reference, or would be led in a direction divergent from
the path that was taken by the applicant.” Polaris Indus., Inc. v. Arctic Cat,
Inc., 882 F.3d 1056, 1069 (Fed. Cir. 2018) (quoting Ricoh Co., Ltd. v.
Quanta Comput. Inc., 550 F.3d 1325, 1332 (Fed. Cir. 2008)). Further, “a
reference ‘must [be] considered for all it taught, disclosures that diverged
and taught away from the invention at hand as well as disclosures that
pointed towards and taught the invention at hand.’” Id. (quoting Ashland
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Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 296 (Fed. Cir.
1985)). Thus, “even if a reference is not found to teach away, its statements
regarding preferences are relevant to a finding regarding whether a skilled
artisan would be motivated to combine that reference with another
reference” in the manner claimed. Id. (citing Apple Inc. v. Samsung Elecs.
Co., 839 F.3d 1034, 1051 n.15 (Fed. Cir. 2016) (en banc)).
Here, we conclude the rejection presently before us errs in not
considering Eldridge for everything that it teaches, including disclosures that
diverge or teach away from Appellants’ claimed invention. It is undisputed
that Eldridge considers squalene to be an impurity that may be found in
Eldridge’s beneficial pentacyclic acid triterpene compounds, when those
compounds are obtained via “methods of purification from plant sources”
described in Eldridge. Eldridge ¶ 78. In particular, Eldridge states a
preference for “an essentially pure preparation of a pentacyclic acid
triterpene[],” which Eldridge defines as containing “no or less than 1.0% by
weight” of hydrocarbons such as squalene. Id. (emphases added). The
Examiner does not cite, and we cannot find, any disclosure in Eldridge of
circumstances under which it would be beneficial for squalene to be
included in Eldridge’s pentacyclic acid triterpene compounds. Thus, a
person of ordinary skill in the art would understand that Eldridge’s
preference is to have no squalene impurities present in Eldridge’s
pentacyclic acid triterpene compounds, but squalene may nonetheless be
present as an impurity of less than 1.0% by weight within the compound, as
an undesired by-product of obtaining the compound from natural plant
sources. Id.
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Further, Eldridge discloses alternative methods of obtaining the
pentacyclic acid triterpene compounds, which would appear to avoid the
squalene impurities that may be present in Eldridge’s natural plant
purification processes. Specifically, Eldridge indicates “[t]he pentacyclic
acid triterpene compounds disclosed herein may be obtained from either
[1] natural sources, [2] direct synthesis or [3] purchased from commercial
vendors.” Id. ¶¶ 70–71; see also id. ¶¶ 72–78 (obtaining from natural
sources), 79–83 (obtaining from direct synthesis), 84 (obtaining from
commercial vendors). There is no suggestion in Eldridge that direct
synthesis of pentacyclic acid triterpene compounds will be subject to the
disadvantage of containing impurities, such as squalene, that Eldridge
identifies in relation to the natural plant purification process. Id. ¶¶ 70–84.
Thus, a person of ordinary skill in the art would understand that there were
alternative methods of obtaining the infection-fighting pentacyclic acid
triterpene compounds of Eldridge that would not have any squalene
impurities, which would be preferred.
The rejection presently before us does not address, in any fashion
other than simply acknowledging them, Eldridge’s teachings that squalene is
an undesired impurity within Eldridge’s infection-fighting pentacyclic acid
triterpene compounds, and that such compounds may be obtained without
the impurity. See Final Act. 2–3, 4–6; Ans. 3–4. For example, the Examiner
does not provide a reason why it would have been obvious to a person of
ordinary skill in the art to obtain Eldridge’s infection-fighting pentacyclic
acid triterpene compound via plant purification, rather than through some
other means that would avoid the squalene impurity problem identified in
Eldridge. See In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (Examiner
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bears burden to provide a rational underpinning sufficient to support the
legal conclusion of obviousness), cited with approval in KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
We, therefore, do not sustain the rejection of claim 1 as having been
obvious over Dave and Eldridge. The Examiner’s additional consideration
of claims 3, 8, and 12–14, each of which depends from claim 1, does not
cure the noted deficiency in connection with claim 1. See Final Act. 4–7.
We, therefore, likewise do not sustain the rejection of claims 3, 8, and 12–14
as having been obvious over Dave and Eldridge.
B. Obviousness Over Dave, Eldridge, and One or Both of Wang and
Heublein (claims 2, 5, 7, 11, 16, 19, 21, and 22)
The rejections of the other independent claims 16 and 22 rely upon the
same analysis of Dave and Eldridge discussed above in connection with
independent claim 1. See Final Act. 10–11 (claim 16), 8–9 (claim 22). The
Examiner’s additional reliance on Heublein as disclosing the coating
thickness of claim 16, and on Wang as disclosing the seed crystals of
claim 22, does not cure the deficiency noted above. See id. at 9–11
(claim 16), 7–9 (claim 22).4 Further, the Examiner’s additional

4 We additionally note claim 16 specifies that the coating contains a
lipophilic substance such as squalene “in a concentration of between
0.5–10% (wt)” in the coating. Br. A-5 (Claims App.). The Examiner finds
Eldridge discloses that limitation, because Eldridge indicates the pentacyclic
acid triterpene compound may contain “no or less than 1.0% by weight” of
squalene. Final Act. 2; Ans. 3. However, the Examiner does not explain
why the squalene, in the combination of Dave’s polymer with Eldridge’s
pentacyclic acid triterpene compound (including a squalene impurity) to
form the claimed coating, would comprise at least 0.5% by weight of the
combined coating.
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consideration of dependent claims 2, 5, 7, 11, 19, and 21 also does not cure
the deficiency noted above. See id. at 7–8, 9, 11, 13. Therefore, we do not
sustain the rejections of claim 2, 5, 7, 11, 16, 19, 21, and 22 as having been
obvious over Dave, Eldridge, and one or both of Wang and Heublein.
DECISION
The Examiner’s decision to reject claims 1–3, 5, 7, 8, 11–16, 19, 21,
and 22 is reversed.
REVERSED