Ex Parte Kleiner et al

Patent Trial and Appeal Board

Oct 11, 2018

12782656 (P.T.A.B. Oct. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/782,656 05/18/2010
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.
085847.00153 5083
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 ASTAFIEVA, STEPHEN PACETTI, THIERRY GLAUSER,
JESSICA DESNOYER, and FLORIAN N. LUDWIG
Appeal2017-001475
Application 12/782,656
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.
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Application 12/782,656
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 8. 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 13; see also id. at Fig. 8. The
Specification further describes porous particles made, for example, of
magnesium alloy and discloses that such particles may include tortuous
("winding or twisting") and/or non-tortuous pores. Id. ,r,r 35, 39. According
to the Specification, "[t]ortuosity is typically controlled by the
manufacturing process of the pores." Id. ,r 36. Moreover, the Specification
explains, "the porous microparticle can be in the range of about 100nm to
about 10 µm, preferably about 1 µm to about 3 µm." Id. ,r 42.
Claims 1, 3-8, 10-16, 19, and 21-25 are on appeal. Claim 1, the only
independent claim, is illustrative:
1. A medical device for implantation or insertion into a body
of a patient, comprising:
a polymeric component;
bio-absorbable particles contained by the polymeric
component and released from the polymeric component once the
medical device is implanted or inserted into the body of the
patient; and
an agent loaded in the bio-absorbable particles;
wherein the bio-absorbable particles are particles of
porous metal, and wherein pores in the particles of porous metal
are tortuous in path to cause the agent to travel through the
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Application 12/782,656
tortuous porous path within the particles of porous metal before
being release[ d] from the particles of porous metal, and
wherein the particles of porous metal include connected
tortuous pores, and each of the particles of porous metal is of a
size of about 100 nm to about 10 µm.
App. Br. (Claims App.) ( emphasis added).
The claims stand rejected as follows:
I. Claims 1, 3, 5, 10-12, 15, 19, 21, 22, 24, and 25 under 35
U.S.C. § 103(a) as obvious over Zhong,2 Torobin, 3 and Bayer. 4
II. Claims 1, 3-5, 10-12, 15, 19, 21, 22, 24, and 25 under 35
U.S.C. § I03(a) as obvious over Zhong, Torobin, Bayer, and
Xu. 5
III. Claims 1, 3, 5, 10-13, 15, 16, 19, 21, 22, 24, and 25 under 35
U.S.C. § I03(a) as obvious over Zhong, Torobin, Bayer, and
Bosi. 6
IV. Claims 1, 3, 5, 6, 10-12, 15, 19, 21, 22, 24, and 25 under 35
U.S.C. § I03(a) as obvious over Zhong, Torobin, Bayer, and
Canham. 7
2 Zhong, US 2005/0181015 Al, published Aug. 18, 2005.
3 Torobin, US 5,212,143, issued May 18, 1993.
4 Bayer et al., DE 10361941 Al, published July 28, 2005 (English
translation of record).
5 Xu et al., US 2006/0124466 Al, published June 15, 2006.
6 Susanna Bosi et al., Fullerene derivatives: an attractive tool for biological
applications, 38 EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY 913-23
(2003).
7 Canham et al., WO 99/53898, published Oct. 28, 1999.
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V. Claims 1, 3, 5, 7, 8, 10-12, 15, 19, and 21-25 under 35 U.S.C.
§ I03(a) as obvious over Zhong, Torobin, Bayer, and Martin. 8
VI. Claims 1, 3, 5, 10-12, 14, 15, 19, 21, 22, 24, and 25 under 35
U.S.C. § I03(a) as obvious over Zhong, Torobin, Bayer, and
Hossainy. 9
VII. Claims 1, 3, 4, 6-8, 10-12, 15, 19, 21, 22, 24, and 25 for
nonstatutory obviousness-type double patenting over claims 1-
7 and 10 of US Patent No. 6,790,228, in view of Bayer and
Martin.
VIII. Claims 1, 3-8, 10-16, 19, and 21-25 are provisionally rejected
for nonstatutory obviousness-type double patenting over claims
1, 3-6, 11, 14, and 18-34 of co-pending U.S. Application No.
12/901,402 in view of Martin.
IX. Claims 1, 3, 4, 7, 10-13, 15, 16, and 21-25 are provisionally
rejected for nonstatutory obviousness-type double patenting
over claims 1, 6-9, 42, 46, 49, 51, 53, and 56 of U.S.
Application No. 11/210,344 10 in view of Xu, Bayer, and
Martin.
In the Final Rejection dated November 27, 2015 ("Final Act."), the
Examiner also provisionally rejected the pending claims for obviousness-
8 Martin et al., US 2003/0114366 Al, published June 19, 2003.
9 Hossainy et al., US 6,790,228 B2, issued Sept. 14, 2004.
10 This application issued as US 9,248,034 B2 on Feb. 2, 2016, so the
rejection is no longer provisional. See Ans. 7-8.
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type double patenting over two additional applications (U.S. Application No.
11/416,860 and U.S. Application No. 11/317,837). Final Act. 4--5, 7-8.
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-VI (OBVIOUSNESS)
Issue
For Rejection I, the Examiner concludes that independent claim 1
(and several, but not all, dependent claims) would have been obvious over
Zhong, Torobin, and Bayer. Ans. 9-12. Rejections II-VI rely and build
upon Rejection I. Ans. 12-16. Rejection II, for example, further relies on
Xu's teachings as addressing certain limitations in dependent claim 4 that
the Examiner finds are not taught by the Zhong, Torobin, Bayer
combination. Ans. 12. Likewise, Rejection III relies on the Zhong, Torobin,
and Bayer combination, along with the Bosi' s teachings, which the
Examiner finds describes certain limitations (i.e., loading the particles with
fullerene) in dependent claims 5, 13, and 16. Id. at 13.
Because each of Rejections II-VI relies on Rejection I for establishing
the obviousness of independent claim 1 over Zhong, Toro bin, and Bayer, if
Rejection I fails, so do all the other rejections under§ 103 on this record.
Accordingly, the dispositive issue here is whether the Examiner established
by a preponderance of the evidence that claim 1 would have been obvious
over Zhong, Torobin, and Bayer.
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Analysis
The Examiner finds that Zhong teaches the limitations of the
implantable medical device of claim 1 except for (i) the bioabsorbable
particles of a porous metal where the pores have a tortuous path, and further
(ii) such porous metal particles with a size of about 100 nm to about 10 µm.
Ans. 9-10; see also id. at 17-18. More specifically, the Examiner finds that
Zhong "teach[ es] a medical device for implantation and controlled drug
release comprising a release region having drug-loaded [layered] silicate
particles dispersed within a biodegradable polymer." Id. at 9-10.
According to the Examiner, Zhong teaches these silicate particles have a size
of 1 nm to 1 µm. Id. ( citing Zhong ,r 29).
Because the Examiner finds that "Zhong ... teach[ es] silicate
particles and not particles made of porous biodegradable metal wherein the
pores are connected tortuous pores," the Examiner turns to Torobin and
Bayer. Id. at 10. According to the Examiner, Bayer teaches "therapy with
stents coated with polymers comprising magnesium or magnesium alloy
particles having sizes of 5-20 µ." Id. The Examiner finds, "[ w ]hile Bayer
... do[es] not specifically teach that their particles are porous, Torobin
teaches that magnesium or mixtures of magnesium ... can be formulated
into particles comprising interconnected tortuous pores" and that "such
particles are suitable for slow release of chemical agents." Id. Moreover,
the Examiner finds, "[w]hile Torobin does not specifically teach particles
having a size of 100 nm to 10 µ, Torobin teaches that the particle size is
primarily determined by" nozzle geometry, dispersed particle viscosity,
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blowing gas pressures, and other factors. Id. at 11 ( citing, e.g., Torobin,
6:25---62, and Fig. 6).
The Examiner concludes that "one of skill in the art would have
readily recognized porous magnesium alloy as a functional equivalent of
[Zhong's] layered silicate with respect to controlled drug delivery." Id. at
11. And, the Examiner reasons, the ordinarily skilled person "would have
known to vary the parameters of Torobin's method with the reasonable
expectation that doing so would result in porous magnesium ... particles
having the sizes taught by both Zhong et al. and Bayer et al., as being
suitable for coating implantable stents." Id. According to the Examiner, it
would have been obvious to modify the prior art in this way "to achieve the
predictable result of obtaining an implantable medical device suitable for
controlled drug release." Id. at 11-12.
Appellants argue that the Zhong, Torobin, Bayer combination does
not render obvious the medical device of claim 1, particularly the
requirement that "each of the particles of porous metal is of a size in the
range of about 100 nm to about 10 µm." App. Br. 5. Appellants contend
"there is no teaching or suggestion in Torobin that would have made porous
metal microspheres in the range of about 100 nm to about 10 µm predictable
to one of ordinary skill in the art." Id. To the contrary, Appellants argue,
the size of the porous metal microspheres described in Toro bin are many
times larger than the microparticles of claim 1. Id. at 6-7. Appellants
contend that Torobin's example microspheres are 2000 µmin diameter or
larger, and even the smallest size suggested (200 µm) is twenty times larger
than the upper bound (10 µm) size recited in claim 1. Id. at 7. Further,
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Appellants point out, nothing in Torobin suggests varying process
parameters in a predictable manner to create porous microbubbles or
particles orders of magnitude smaller than described in Toro bin. Id. at 7-8;
see also Reply Br. 4 (describing a host of variables identified in Torobin for
making micro spheres).
On the record before us, Appellants have the better position. There is
an insufficient evidentiary basis to support the notion that Torobin's
manufacturing method and apparatus would be scaled down to predictably
produce metallic microparticles having connected tortuous paths and the
substantially smaller dimensions recited in the claims. Indeed, Torobin's
method and apparatus was designed to produce relatively larger
microspheres and to overcome perceived shortcomings with forming smaller
particles. See, e.g., Torobin, 3:32-35 (disclosing that "the known methods
suffer one or more shortcomings including producing very small
microspheres"), 3 :48-51 ( disclosing that "[p ]rior to the time applicant made
the present invention there was no known simple economical method of
producing relatively large hollow microspheres or hollow porous
microspheres"). 11
The Examiner challenges Appellants' position as being "just an
argument not supported by any evidence." Ans. 18. But this is not accurate.
Appellants have persuasively cited numerous disclosures in Torobin,
11 See also Toro bin, 7: 14--20 ("The process and apparatus of the present
invention as compared to the prior art sol gel microcapsule process ...
produces large uniform size spheres with uniform thin walls.") ( emphasis
added).
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including the many variables involved and Torobin's consistent teaching of
larger particles, which supports a conclusion that changing Torobin's
process in the manner proposed by the Examiner is no trivial matter that
would predictably yield functional microparticles approximately 200 times
smaller than those exemplified in Torobin. 12 App. Br. 7-8; Reply Br. 6-8.
And, in any event, it is the Examiner's burden to establish aprimafacie case
ofunpatentability, including on the issue of a reasonable expectation of
success in support of the conclusion of obviousness. In re Oetiker, 977 F.2d
1443, 1445 (Fed. Cir. 1992).
For the above reasons, we are unpersuaded on this record that the
ordinarily skilled person would have combined and modified the prior art in
the manner proposed by the Examiner with a reasonable expectation of
12 We note that, when pressed during oral hearing, Appellants' counsel was
unable to identify where the present Specification specifically describes how
the metal microparticles having the dimensions and other features (tortuous
paths) are made. Sept. 11, 2018 Hr'g Tr. 11:21-13:12. It may be that
techniques for making such microparticles are well known in the art
(potentially explaining the seeming lack of detail in the Specification). Cf
In re Epstein, 32 F.3d 1559, 1568 (Fed. Cir. 1994) ("the Board's observation
that appellant did not provide the type of detail in his specification that
[appellant] now argues is necessary in the prior art ... supports the Board's
finding that one skilled in the art would have known how to implement the
features of the references."). It may also be that the ordinarily skilled person
could ( or would) design metal microparticles having the tortuous porous
paths and the dimensions claimed through well-known techniques other than
those described in Toro bin. That, however, was not the basis of the
Examiner's rejection. And, on these issues, the record is wanting for
sufficient analysis and evidentiary support.
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success. We, thus, reverse the rejections for obviousness (Rejections I-VI)
on appeal.
REJECTIONS VII-IX (DOUBLE PA TENTING)
Appellants do not argue the obviousness-type double patenting
rejections. App. Br. 4. Instead, Appellants explain that they "do not seek
review of the double patenting rejections, as Appellants will submit a
terminal disclaimer to cure a defect in a prior-filed terminal disclaimer." Id.
Because Appellants do not contest the double patenting rejections,
those rejections are summarily affirmed. Hyatt v. Dudas, 551 F.3d 1307,
1314 (Fed. Cir. 2008) ("When the appellant fails to contest a ground of
rejection to the Board, ... the Board may treat any argument with respect to
that ground of rejection as waived ... [and] the PTO may affirm the
rejection of the group of claims that the examiner rejected on that ground
without considering the merits of those rejections.").
SUMMARY
We reverse the rejections under§ 103 for obviousness, but affirm the
uncontested 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
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