Ex Parte Svensson et al

Patent Trial and Appeal Board

May 24, 2016

12280989 (P.T.A.B. May. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/280,989 09/18/2008
23570 7590 05/26/2016
PORTER WRIGHT MORRIS & ARTHUR, LLP
INTELLECTUAL PROPERTY GROUP
41 SOUTH HIGH STREET
29THFLOOR
COLUMBUS, OH 43215
Mikael Svensson
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.
4011827-189950 6677
EXAMINER
PYLA, EVELYN Y
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
05/26/2016 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
following e-mail address( es):
ipdocket@porterwright.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MIKAEL SVENSSON and PER MATTSSON 1
Appeal2014-001845
Application 12/280,989
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN G. NEW, and RICHARD J.
SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of manufacturing a nerve regeneration device for treating a spinal cord
injury. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is BioArctic
Neuroscience AB. (Appeal Br. 1.)
Appeal2014-001845
Application 12/280,989
STATEMENT OF THE CASE
Claims on Appeal
Claims 14 and 35-38 are on appeal. (Appeal Br. 18-19.) Claim 14 is
representative and reads as follows:
14. A method of manufacturing a nerve regeneration device for treating a
spinal cord injury of a human or other vertebrate patient, wherein the device
is specially adapted for the patient's injury, said method comprising the
following steps:
imaging the spinal cord injury of the patient using an imaging
technique selected from the group consisting of computer tomography and
magnetic resonance imaging, to obtain image data related to the shape and
size of the injury,
providing a mould having a shape and size matching the imaged
spinal cord injury on the basis of said image data, said mould comprising a
bottom plate, a top plate and a centre part, each of said bottom plate and said
top plate having holes positioned to repair the imaged injured spinal cord on
the basis of said image data and to correspond to white matter points and
grey matter points in the injured spinal cord where injured nerves are to be
regenerated, and said centre part having a bore therethrough,
placing flexible threads in the bore, each flexible thread exiting the
mould through one hole in the top plate and a corresponding hole in the
bottom plate to form a descending motor pathway from a hole in the top
plate corresponding to a proximal white matter point to a hole in the bottom
plate corresponding to a distal grey matter point or an ascending sensor
pathway from a hole in the bottom plate corresponding to a distal white
matter point to a hole in the top plate corresponding to a proximal grey
matter point, wherein the formed descending pathways and ascending
pathways represent the pathways where injured nerves are to be regenerated
and are not in axial alignment with the centre part bore,
filling the mould with a biocompatible and/or biodegradable material
to produce the device,
removing the device from the mould when the biocompatible and/or
biodegradable material is solidified, and
removing the flexible threads from the device to form channels and
inserting peripheral autologous nerves from the patient into the channels.
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Application 12/280,989
Examiner's Rejection
Claims 14 and 35-38 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Hadlock,2 Fraidakis,3 and Cheng.4 (Ans. 2.)
Appellants present arguments for the patentability of claims 14 and
35-38 as a group. (Appeal Br. 8-16.) Therefore, we limit our discussion to
claim 14 as representative of those claims.
ISSUE
Does the preponderance of evidence of record support the Examiner's
conclusion of obviousness with respect to claim 14?
ANALYSIS
The Examiner finds that Hadlock teaches all of the steps of claim 14,
except that Hadlock does not specifically teach (1) imaging the spinal cord
injury, and (2) that holes provided in the top and bottom discs (plates) are
produced where one hole in a disc matches a hole in the other disc so as to
connect a hole corresponding to white matter in one disc with a hole
corresponding to grey matter in the other disc. (Ans. 2-7.) However, the
Examiner finds that Fraidakis teaches magnetic resonance imaging of spinal
cord injuries prior to the repair procedure. (Id. at 6.) In addition, the
Examiner finds that Cheng teaches a nerve regeneration device wherein
holes/channels "are prepared for directing nerves from white to grey matter
2 Hadlock et al., US 6,214,021 Bl, issued Apr. 10, 2001 ("Hadlock").
3 Fraidakis et al., Partial recovery after treatment of chronic paraplegia in
rat, EXPERIMENTAL NEUROLOGY 188, 33--42 (2004) ("Fraidakis").
4 Cheng et al., WO 98/04197, published Feb. 5, 1998 ("Cheng").
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Appeal2014-001845
Application 12/280,989
by the arrangement of the holes/channels."5 (Id. at 7.)
Appellants argue that the device resulting from the claimed method
"is specially adapted for the patient's injury, i.e., for a specific patient with a
specific injury." (Appeal Br. 9-10; Reply Br. 2-3.) Appellants also argue
that "Fraidakis specifically indicates this [MRI] information was of value in
deciding at which level to trim the stumps during the late-repair surgery"
and that "Fraidakis provides no disclosure that any of the MRI data is useful
for anything other than" that (underlined) purpose. (Appeal Br. 11-12;
Reply Br. 3--4.) Appellants argue against the Examiner's reliance on Cheng
by stating that
Cheng does not provide any teaching or suggestion of a method
of manufacturing a specific device for a specific patient based on
image data, and, particularly, Cheng teaches a device which is
configured without regard to image data of a patient's specific
injury to be repaired and without any suggestion or recognition
that the mould should be shaped and sized based on the image
data and the holes should correspond with white matter and grey
matter points of the injury for forming descending pathways
and ascending pathways as recited in claim 14.
(Appeal Br. 15.)
We adopt as our own the findings of fact set forth by the Examiner in
(1) the action from which this appeal is taken (Final Act. 10-19) and (2) the
Examiner's Answer in response to Appellants' Appeal Brief (Ans. 2-19),
and concur with the conclusions reached by the Examiner. Moreover, the
Examiner has satisfied the burden of showing "some articulated reasoning
5 For this teaching, the Examiner also refers to Appellants' acknowledgment
of a prior art nerve regeneration device. (Spec. 6, 1. 29-7, 1. 22 and Figure
1.) Figure 1 of the Specification is identical to FIG. la of Cheng.
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Appeal2014-001845
Application 12/280,989
with some rational underpinning to support the legal conclusion of
obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). As
discussed below, Appellants' arguments do not overcome that prima facie
case of obviousness.
We note at the outset that Appellants generally argue the references
separately, and particularly that (in Appellants' view) a particular reference
does not teach claim limitations that are taught by other references relied
upon by the Examiner. However, Appellants are reminded that the test for
obviousness is what the combined teachings of references would have
suggested to one of ordinary skill in the art. See In re Keller, 642 F.2d 413,
425 (CCPA 1981) (citing cases).
Specially adapted for the patient's injury
Appellants argue that they "find no teaching by Hadlock of a method
of manufacturing a nerve regeneration device for a specific patient with a
specific injury." (Appeal Br. 10.) We are not persuaded. Hadlock teaches a
molding process that "permits the fabrication of [biocompatible] and
biodegradable polymer prosthesis" and that "the lumenal architecture can be
specifically designed and controlled and that the polymer can be tailor
made." (Hadlock, col. 2, 11. 53-55; col. 10, 11. 9-11.) Furthermore, Cheng
states that the device "can e.g. be moulded to suit the subject to be treated."
(Cheng. 4, 11. 9-10.)
Imaging the spinal cord injury
Appellants argue that the mould is sized and shaped for a specific
patient with a specific injury "based on the imaging data obtained from the
injury to be treated." (Appeal Br. 9-10.) Furthermore, according to
Appellants, "Fraidakis provides no teaching or suggestion to use MRI" for
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Appeal2014-001845
Application 12/280,989
that purpose. (Id. at 11.)
We are not persuaded. Fraidakis states that "[t]he [spinal cord] lesion
extent was assessed by magnetic resonance imaging (MRI) before the repair
procedure" and that "MRI helped guide the treatment procedure," thereby
teaching that MRI can be used to assess a spinal cord injury in connection
with the repair thereof. (Fraidakis Abstract.) Moreover, an obviousness
analysis "not only permits, but requires, consideration of common
knowledge and common sense." DyStar Textilfarben GmbH & Co.
Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1367 (Fed. Cir. 2006);
see also KSR, 550 U.S. at 421 ("A person of ordinary skill is also a person of
ordinary creativity, not an automaton.").
We find that a person of ordinary skill in the art would have
determined the size and shape of the device mould, including the location of
the holes in the upper and lower plates, in the process of making the device
of Hadlock or Cheng for a specific patient with a specific injury. Moreover,
it would have been common sense to "[image] the spinal cord injury of the
patient ... to obtain image data related to the shape and size of the injury,"
such as by MRI as taught by Fraidakis, so that the device may be "specially
adapted for the patient's injury" as recited in claim 14.
White and grey matter connections
Appellants argue that Cheng teaches a device "without any suggestion
or recognition that the mould should be shaped and sized based on the image
data and the holes should correspond with white matter and grey matter
points of the injury for forming descending pathways and ascending
pathways." (Appeal Br. 15.) We are not persuaded. Appellants
acknowledge the design of the prior art device, including that "descending
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Application 12/280,989
motor pathways from proximal white were coupled to distal grey matter and
ascending pathways from distal white to proximal grey matter." (Spec. 7, 11.
12-13; see also Cheng Abstract.) Thus, it would have been common sense
for a person of ordinary skill in the art to "shape and size" the device mould
to correspond to the desired design of the device.
Hindsight
Appellants argue that the Examiner has engaged in "impermissible
hindsight." (Appeal Br. 13-14.) We are not persuaded. Rather than using
hindsight~ the Examiner points to specific disclosures in the prior art that
describe the limitations of Appellants' clairned method. (See, e.g., Ans, 2-
12.) \Ve therefore find that the Examiner's obviousness conclusion is based
on sufficiently articulated reasoning that overcomes any concerns about
hindsight bias. See KSR, 550 U.S. at 418.
CONCLUSION OF LAW
A preponderance of evidence of record supports the Examiner's
conclusion that claim 14 is obvious under 35 U.S.C. § 103(a). Claims 35-38
were not argued separately and fall with claim 14. See 37 C.F.R.
§ 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of all claims on appeal.
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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