Ex Parte Kleiner et al

Patent Trial and Appeal Board

Oct 11, 2018

12901402 (P.T.A.B. Oct. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/901,402 10/08/2010
45159 7590 10/15/2018
SQUIRE PB (Abbott)
275 BATTERY STREET, SUITE 2600
SAN FRANCISCO, CA 94111-3356
FIRST NAMED INVENTOR
Lothar W. Kleiner
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.
085847.00155 9978
EXAMINER
POPA, ILEANA
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
10/15/2018 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):
sfripdocket@squirepb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LOTHAR W. KLEINER, SYED HOSSAINY,
IRINA ASTAFIEV A, STEPHEN PACETTI, THIERRY GLAUSER,
JESSICA DESNOYER, and FLORIAN N. LUDWIG
Appeal2017-000165
Application 12/901,402
Technology Center 1600
Before RICHARD J. SMITH, TA WEN CHANG, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134 involving
claims to a medical device for implantation into a patient's body. The
Examiner rejected the claims as obvious and for obviousness-type double
patenting. We have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Abbott Cardiovascular
Systems Inc. App. Br. 1.
Appeal2017-000165
Application 12/901,402
STATEMENT OF THE CASE
Appellants' invention relates to "devices for the sustained release of
treatment agent to treat an occluded blood vessel and affected tissue and/or
organs." Spec. ,r 7. As the Specification explains, according to some
embodiments, "a device comprising a polymeric implantable medical
device[,for example, a stent,] includ[ es] one of at least one bioabsorbable
metal, glass or ceramic carrier [and] includes the carrier embedded within at
least a portion of the device." Id. ,r 12; see also id. at Fig. 8. The
Specification further describes porous particles for carrying and release of a
treatment agent, which particles are made, for example, of magnesium alloy.
Id. ,I,I 33-37.
Claims 1, 4---6, 11, 14, and 18-34 are on appeal. Claim 1, the only
independent claim, is illustrative:
1. An implantable medical device comprising:
a stent;
smaller particles contained in larger particles and
configured to be released from the larger particles when the
device is implanted in a patient, wherein the smaller particles are
made of bioabsorbable metal, glass or ceramic, and the smaller
particles are non-porous; and
a substance carried by the smaller particles,
wherein the larger particles disposed over or in the stent,
the larger particles are embedded within a biodegradable
polymer matrix, and the substance comprises at least one of a
treatment agent and an image-enhancing agent, and
wherein the larger particles are made of bioabsorbable
metal, and the bioabsorbable metal comprises one of a
magnesium allow, a zinc alloy and an iron alloy.
2
Appeal2017-000165
Application 12/901,402
App. Br. (Claims App'x.) (emphases added to reflect elected species and
limitations particularly relevant to this appeal).
In response to an election/restriction requirement, Appellants elected:
"metal (species Group A); treatment agent (species group B); and non-
porous smaller particles." Response to Election/Restriction dated Nov. 26,
2012, 1. We limit our analysis of the claims to the patentability of the
elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BP AI 1987).
The claims stand rejected as follows:
I. Claims 1, 4---6, 11, 14, 18, 20-29, and 31-34 under 35 U.S.C.
§ I03(a) as obvious over Zhong,2 Gao, 3 and Heublein. 4
II. Claims 1, 4---6, 11, 14, 18-345 under 35 U.S.C. § I03(a) as
obvious over Zhong, Torobin, Bayer, and Navab. 6
2 Zhong, US 2005/0181015 Al, published Aug. 18, 2005.
3 Gao, US 2006/0286379 Al, published Dec. 21, 2006.
4 B. Heublein et al., Biocorrosion of magnesium alloys: a new principle in
cardiovascular implant technology?, 89 HEART 651-56 (2003).
5 In the heading related to this rejection, the Examiner omits claim 30; but
claim 30 is addressed in the body of the rejection so the omission in the
heading appears to have been unintentional. Ans. 6-7; Final Act. 17-18.
6 Mohamad Navab, G.M. et al., Apolipoprotein A-I Mimetic Peptides, 25
ARTERIOSCLER. THROMB. V ASC. BIOL. 1325-31 (2005).
3
Appeal2017-000165
Application 12/901,402
III. Claims 1, 4---6, 11, 14, and 18-34 for nonstatutory obviousness-
type double patenting over claims 1-7 and 10 of US Patent No.
6,790,228,7 in view ofHirsch8 and Heublein.
IV. Claims 1, 4---6, 11, 14, and 18-34 are provisionally rejected for
nonstatutory obviousness-type double patenting over claims 1,
3-8, 10-12, 15, 19, and 21-25 of co-pending U.S. Application
No. 12/782,656, in view of Hirsch and Heublein.
V. Claims 1, 4---6, 11, 14, and 18-34 are provisionally rejected for
nonstatutory obviousness-type double patenting over claims 1-
17, 19, 20, and 22 of U.S. Application No. 11/210,3449 in view
of Hirsch and Heublein.
In the Final Rejection dated April 16, 2015 ("Final Act."), the
Examiner's§ 103 rejections also relied on Hakamatsuka10 in combination
with the other references. Final Act. 4. As the Examiner explains, however,
Hakamatsuka was relied upon only as teaching certain limitations of
dependent claim 3, which has since been canceled. Ans. 3 ("Cancellation of
claim 3 renders Hakamatsuka ... moot because the reference was only cited
for teaching the limitation of claim 3 (i.e., porous ceramic larger
7 Hossainy et al., US 6,790,228 B2, issued Sept. 14, 2004.
8 L. R. Hirsch et al., Targeted Photothermal Tumor Therapy using Metal
Nanoshells, Proceedings of the Second Joint EMBS/BMES Conference
530-31 (2002).
9 This application issued as US 9,248,034 B2 on Feb. 2, 2016, so the
rejection is no longer provisional. See Ans. 11-12.
10 Hakamatsuka et al., US 5,318,779, issued June 7, 1994.
4
Appeal2017-000165
Application 12/901,402
particles)."). Hence, as acknowledged by the Examiner, "this reference
[Hakamatsuka] is removed from the instant rejections." Id.
In addition to the double-patenting rejections described above, the
Examiner also provisionally rejected the pending claims for obviousness-
type double patenting over two additional applications (U.S. Application No.
11/416,860 and U.S. Application No. 11/317,837). Final Act. 10-13. Those
applications, however, have since gone abandoned. So, the provisional
rejections over those applications are moot.
An oral hearing before the Board related to this appeal took place on
September 11, 2018, and a transcript of that hearing is included in the
prosecution record.
REJECTIONS I-II (OBVIOUSNESS)
Issue
For Rejection I, the Examiner concludes that independent claim 1
(and all the dependent claims except claims 19 and 30) would have been
obvious over Zhong, Gao, and Heublein. Ans. 4---6. Rejection II relies and
builds upon Rejection I. Id. at 6-7. More specifically, Rejection II cites
Navab's teachings only to address limitations of claims 19 and 30 that the
Examiner finds are not taught or suggested by the Zhong, Gao, Heublein
combination. Id. ( describing N avab 's teachings of Apo A-1 mimetic
peptides as therapeutic agents).
Because Rejection II relies on Rejection I for establishing the
obviousness of independent claim 1 over Zhong, Gao, and Heublein, if
Rejection I fails, so does Rejection II. Accordingly, the dispositive issue
5
Appeal2017-000165
Application 12/901,402
here is whether the Examiner established by a preponderance of the evidence
that claim 1 would have been obvious over Zhong, Gao, and Heublein.
Analysis
Claim 1 generally recites a stent with smaller non-porous
bioabsorbable metal particles contained within larger bioabsorbable metal
particles. The larger particles are, in tum, embedded in a polymer matrix
and disposed over or in the stent. And, the smaller metal particles carry a
treatment agent (e.g., a drug).
The Examiner finds that Zhong teaches the limitations of the
implantable medical device of claim 1 except for (i) bioabsorbable
magnesium alloy particles (i.e., the "larger particles" as claimed) and
(ii) that such magnesium alloy particles carry non-porous smaller metal
particles. Ans. 5. More specifically, the Examiner finds that Zhong
"teach[ es] a medical device for implantation comprising a release region
having drug-loaded layered silicate particles embedded within a
biodegradable polymer." Id. at 4 (citing, e.g., Zhong, Abstract, ,r,r 17, 29,
32, 39). According to the Examiner, Zhong teaches these silicate particles
may further include drugs and/or imaging agents (e.g., to make the device
visible on an MRI). Ans. 4 (citing, e.g., Zhong ,r,r 22, 58, 71-72).
In an effort to remedy Zhong' s deficiencies related to the other
limitations of claim 1, the Examiner turns to Gao and Heublein. Ans. 5---6.
The Examiner finds that Gao teaches polymer-coated iron alloy
nanoparticles usable as MRI imaging agents. Id. And the Examiner finds
that Heublein teaches stents formed of magnesium alloy and that
"magnesium alloy is biodegradable and thus it can be used for drug
6
Appeal2017-000165
Application 12/901,402
delivery." Id. at 5 (citing Heublein, Abstract, 653 (col. 2), 655 (col. 2).
According to the Examiner, "[a]lthough Heublein et al. does not specifically
teach pores, one of skill in the art would readily understand that drug
delivery necessarily entails the presence of pores to be loaded with the
drug." Ans. 5.
Based on the combined teachings of Zhong, Gao, and Heublein, the
Examiner concludes claim 1 would have been obvious. Id. at 6. The
Examiner reasons that the ordinarily skilled person "would have found
obvious to specifically use Gao' s iron alloy nanoparticles as the MRI
imaging agents," and that it would be "obvious to associate the therapeutic
agents with iron alloy nanoparticles and load them in the pores of the
magnesium alloy particles ... [thus] obtaining a composition for both
sustained delivery and detection of MRI." Id.
We are unpersuaded the Examiner has met the burden to demonstrate
by a preponderance of the evidence on this record that claim 1 would have
been obvious over Zhong, Gao, and Heublein. Heublein does not disclose
porous magnesium alloy particles loaded with a treatment agent ( e.g., drug),
or magnesium alloy particles within which other treatment-agent loaded
particles - metal or otherwise - are present. As Appellants point out,
Heublein teaches stents made of a biodegradable metal, such as magnesium
alloy, and specifically describes stents formed from extruded rods of
magnesium alloy. App. Br. 9; Heublein 651 ("Tubes (wall thickness
between 150-200 µm, length 10 mm, outer diameter 2 mm) were drilled
from extruded AE21 [ magnesium alloy] rods."). Heublein generally
describes that drug delivery is possible with certain implants, such as
7
Appeal2017-000165
Application 12/901,402
polymer-coated metallic ("hybrid") stents, and hypothesizes that
biocorrosion of magnesium alloys "may be a promising new technology for
improving cardiovascular implants as effective temporary systems with
inherent or hybrid local drug delivery functions." Heublein 654--55. But
there is an insufficient evidentiary basis on this record to support the
Examiner's assertion that Heublein inherently discloses (or the skilled
person would "readily understand" Heublein as disclosing) porous particles
of magnesium alloy in which other particles - much less drug-carrying
metal particles- are carried. Ans. 5, 16-17; see Reply Br. 4--5 ("In sum,
there is no description in Heublein that particles of magnesium alloy could
be formulated to have pores, much less loading a drug in pores to control
delivery of the drug."). 11
In short, on this record, the Examiner has not demonstrated a teaching
or suggestion in the cited art of all the limitations of claim 1. Claim 1
requires, inter alia, smaller, treatment agent ( e.g., drug) carrying metal
particles that are contained within larger metal particles. At least this feature
of claim 1 is, however, missing in the cited teachings of Zhong, Gao, and
Heublein - whether the references are considered alone or in combination.
For that reason, the rejection of claim 1 as obvious over Zhong, Gao, and
Heublein (Rejection I) is reversed. Navab, insofar as the Examiner relies on
that reference for Rejection II, does not cure the deficiencies of Rejection I.
11 Claim 1 does not specifically recite that the larger particles include
"pores" but instead recite that smaller, treatment agent-loaded metal
particles are "contained in" the larger metal particles.
8
Appeal2017-000165
Application 12/901,402
REJECTIONS III-V (DOUBLE PATENTING)
Appellants failed to argue the substance of the obviousness-type
double patenting rejections as presented. For each such rejection,
Appellants do not address, nor grapple with, the disclosures of the claims of
the underlying patents and/or applications that are being relied upon by the
Examiner (US Patent No. 6,790,228; US Appl. No. 12/782,656; US Appl.
No. 11/210,344) to support the rejections. See App. Br. 13-15; Reply Br. 8-
10. Moreover, Appellants conceded this point at oral argument and further
stated that Appellants, thus, were withdrawing their contentions related to
the double patenting rejections and were prepared to file terminal
disclaimers. Sept. 11, 2018 Hr'g Tr. 10:5-12:10. We, therefore, consider
Appellants' arguments to have been waived and the double patenting
rejections (Rejections III-V) are affirmed.
SUMMARY
We reverse the rejections under§ 103 for obviousness, but affirm the
rejections for obviousness-type double patenting.
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
9