Ex Parte Murphy

Patent Trial and Appeal Board

Apr 26, 2017

12713305 (P.T.A.B. Apr. 26, 2017)

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.
12/713,305 02/26/2010 Kieran Murphy P2350US01 4432
54640 7590 04/28/2017
PERRY + CURRIER INC.
1300 YONGE STREET
SUITE 500
TORONTO, ON M4T-1X3
CANADA
EXAMINER
PYLA, PAUL D
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
04/28/2017 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):
docketing @pckip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KIERAN MURPHY
Appeal 2016-002805
Application 12/713,305
Technology Center 1600
Before JEFFREY N. FREDMAN, RACHEL H. TOWNSEND, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a method
of treating scoliosis. The Examiner rejected the claims as obvious and on
the grounds of obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b). We reverse.
Statement of the Case
Background
“Scoliosis is a condition in which the vertebral column 10 presents an
abnormal lateral curvature . . . Due to the imbalance caused by the lateral
curvature 50, a potentially debilitating compression of one side of the body
1 Appellant identifies the Real Party in Interest as Kieran Murphy LLC (see
App. Br. 3).
Appeal 2016-002805
Application 12/713,305
may result, often leaving the afflicted person with pain and reduced mobility
usually proportional to the degree of the deformity” (Spec. 110).
“In the various embodiments presented herein, disproportionate
growth across the transverse plane of the epiphyseal growth plate ... is
treated through the introduction or application of at least one agent having
the effect of modulating growth” (Spec. 113).
The Claims
Claims 1—6 and 20 are on appeal. Claim 1, the sole independent
claim, is representative and reads as follows:
1. A method of treating scoliosis, comprising injecting a
therapeutically acceptable amount of a growth modulator into a
first epiphyseal growth plate of a first vertebra for altering the
growth of the first epiphyseal growth plate to correct or
compensate for disproportionate growth.
The issues
A. The Examiner rejected claims 1—6 and 20 under 35 U.S.C. § 103(a) as
obvious over Boyce2 and Tobinick3 (Ans. 4—12).
B. The Examiner rejected claims 1—6 and 20 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1, 4, 5, and 26 of U.S. 8,852,240 (Ans. 13—15).
A. 35 U.S.C. § 103(a) over Boyce and Tobinick
The Examiner finds “Boyce teaches a method of repairing bone with a
load-bearing osteoimplant that comprises the implantation at a bone repair
site” and “[bjioactive substances which can be readily combined within the
2 Boyce et al., US 2001/0043940 Al, published Nov. 22, 2001.
3 Tobinick, US 2009/0130019 Al, published May 21, 2009.
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Application 12/713,305
osteoimplant include human growth hormone” but “Boyce does not
expressly teach epiphyseal growth plates as the express site of injection”
(Ans. 4—5). The Examiner finds that “delivery of human growth hormone
locally into the growth plate (Fig. 2b) (as well as systemically) will
inherently cause the growth plates to grow based on the inherent properties
(i.e., its mechanism of action) of human growth hormone” (Ans. 5).
The Examiner finds “Tobinick teaches methods of administration of
large molecules, utilizing perispinal administration, which results [in]
increased effectiveness compared with systemic administration” (Ans. 6).
The Examiner finds “the types of administration, either by implant or
via an injectable form are results effective variables that are routinely
optimizable” and that a “person of ordinary skill in the art would easily pick
and choose the form of administration based on the circumstances in terms
of administration (delivery) of the composition into the site of repair since
the composition is taught as being administered by both routes to the same
affected areas for the same purpose” (Ans. 10).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the prior art renders the
claims obvious?
Findings of Fact
1. Boyce teaches “a load-bearing osteoimplant which contains
pores or cavities which permit the osteoimplant to be properly
revascularized and incorporated by the host” (Boyce 1 8).
2. Boyce teaches the “osteoimplant herein is applied at a bone
repair site, e.g., one resulting from injury, defect brought about during the
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course of surgery, infection, malignancy or developmental malformation,
which requires mechanical support” (Boyce 1 87).
3. Boyce teaches the “osteoimplant can be utilized in a wide
variety of orthopaedic, periodontal, neurosurgical and oral and maxillofacial
surgical procedures such as . . . scoliosis, lordosis and kyphosis treatments”
(Boyce 1 87).
4. Boyce teaches: “Specific bones which can be repaired or
replaced with the bone-derived implant herein include the . . . cervical
vertebra, thoracic vertebra, lumbar vertebra” (Boyce 1 87).
5. Boyce teaches: “Bioactive substances which can be readily
combined with the bone particles include . . . human growth hormone
(HGH)” (Boyce 1 64).
6. Figure 2b of Boyce is reproduced below:
FIG. 2 b
\
“In FIG. 2b, osteoimplant 70 is configured and dimensioned as a threaded
cylinder ... to be inserted into the intervertebral site 72 on the anterior side
of vertebral column 84” (Boyce 1 89).
7. The Examiner finds “delivery of human growth hormone
locally into the growth plate (Fig. 2b) (as well as systemically) will
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Application 12/713,305
inherently cause the growth plates to grow based on the inherent properties
(i.e., its mechanism of action) of human growth hormone” (Ans. 5).
8. Tobinick teaches:
Perispinal administration involves anatomically localized
delivery performed so as to place radio labeled etanercept or
another tagged biologic directly in the vicinity of the spine, and
thereby facilitate delivery of the large molecule to the brain, the
eye, the retina, the auditory apparatus, the cranial nerves, the
spinal nerve roots, the intervertebral discs, the spinal nerve
roots, the dorsal root ganglia, the spinal cord or the head.
(Tobinick 194).
9. Tobinick teaches: “Perispinal administration . . . includes the
use of interspinous injection carried through the skin in the midline of the
neck or back, directly overlying the spine, so that the large molecule is
delivered into the interspinous space” (Tobinick 194).
10. Tobinick teaches: “Perispinal administration for delivery of
neuroactive molecules other than etanercept. . . may be performed. The
neuroactive compounds include . . . Humatrope®” (Tobinick 1131).
11. The Specification teaches
To achieve the desired growth characteristics, the growth
modulator may be directly injected into the target tissue.
Alternatively, the growth modulator may be incorporated into
pharmaceutically acceptable matrix suitable for depot into the
target area. For example, the matrix can be formed into a pellet
from which the growth modulator diffuses into the surrounding
tissue.
(Spec. 136).
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Application 12/713,305
Principles of Law
A prima facie case for obviousness “requires a suggestion of all
limitations in a claim,” CFMT, Inc. v. Yieldup Int’l Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) and “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 contends: “Placing an implant between two vertebrae is
clearly not equivalent to injecting a substance into one of those vertebrae
(specifically, into a growth plate of one of those vertebrae)” (App. Br. 10).
The Examiner responds: “Claim 1 as presently written recites
injecting a therapeutically acceptable amount of a growth modulator into a
first epiphyseal growth plate, which is broadly interpreted to include a direct
injection as well as an indirect injection” (Ans. 16).
We find that the Appellant has the better position. We interpret the
phrase “inject. . . into” in claim 1 in light of the Specification, which teaches
the “growth modulator may be directly injected into the target tissue” or “the
growth modulator may be incorporated into pharmaceutically acceptable
matrix suitable for depot into the target area[,]” such as by diffusion (FF 11).
Thus, the Specification specifically distinguishes between direct injection
into a target area and indirect incorporation into the target area.
Consequently, the Examiner’s interpretation is not consistent with the
reasonable interpretation of “injecting . . . into” when read in light of the
Specification. “The protocol of giving claims their broadest reasonable
interpretation during examination does not include giving claims a legally
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Application 12/713,305
incorrect interpretation.” In re Skvorecz, 580 F.3d 1262, 1267 (Fed. Cir.
2009).
Moreover, claim 1 requires that the injection be “into a first
epiphyseal growth plate”, not anywhere in the body or more narrowly,
anywhere in a vertebra. The Examiner has not established that either Boyce
or Tobinick suggest injection “into a first epiphyseal growth plate” as
distinguished from other locations in the body or vertebra. Even if we
agreed that Tobinick’s suggestion of spinal injection rendered injection of
Boyce’s growth hormone-containing osteoimplant into the vertebra obvious,
these references do not suggest injection into the epiphyseal growth plate,
which Appellant specifies for the purpose of delivering growth modulator to
the actively growing area of the vertebra.
We recognize, but find unpersuasive, the Examiner’s finding that
since there are growth hormone receptors on or near the
epiphyseal growth plates on bones, the osteoimplant, which
provides long term delivery of human growth hormone into the
scoliosis affected vertebrae, the delivery of human growth
hormone locally into the growth plate (Fig. 2b) (as well as
systemically) will inherently cause the growth plates to grow
based on the inherent properties (i.e., its mechanism of action)
of the human growth hormone.
(Ans. 16). In particular, the Examiner relies upon the inherent delivery of
human growth hormone to the epiphyseal growth plate, but the Examiner
provides no evidence that a depot, remote from the epiphyseal growth plates,
will necessarily operate to “correct or compensate for disproportionate
growth” as required by claim 1. “Inherency . . . may not be established by
probabilities or possibilities. The mere fact that a certain thing may result
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Application 12/713,305
from a given set of circumstances is not sufficient.” MEHL/Biophile Int 7.
Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).
These are also not circumstances similar to In re Best, 562 F2.d 1252,
1255 (CCPA 1977) where the Examiner has shifted the burden to Appellant,
because even if Boyce and Tobinick render insertion of an osteoimplant into
vertebra containing growth hormone obvious, there is no reason to expect
that growth of the epiphyseal growth plate in only the correct orientation
would occur sufficiently to compensate for disproportionate growth as
required by claim 1. Moreover, the Specification also teaches
“disproportionate growth of a defective vertebrae 60 is addressed by
modulating the growth of an adjacent vertebrae 62” (Spec. 16). However,
insertion of an osteoimplant that released growth hormone systemically
would not have any inherent expectation of modulating only vertebrae 62
and not vertebrae 60 as well.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the prior art renders the claims obvious.
B. Obviousness-type Double Patenting
The Appellant contends the “co-pending application is directed to
systemic injection of bone augmentation agents, while the claims of the
present application are directed to injection of a growth modulator into a
vertebra. As discussed above, the effects obtained by these two modes of
delivery are quite different” (App. Br. 9).
The Examiner responds “instant claim 1 is a species claim to U.S.
Patent No. 8,852,240 claim 1 since instant claim 1 is directed to the species
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of injecting into the epiphyseal growth plate, while U.S. Patent No.
8,852,240 claim 1 [is] directed [to] a generic systemic injection” (Ans. 20).
We find that the Appellant has the better position. Claim 1 of US
8,852,240 teaches augmenting bone by “systemically administering” an
agent, not local injection to an epiphyseal growth plate. We agree with the
Appellant that local injection into an epiphyseal growth plate is not a
“species” of systemic injection, but rather a different approach, and is not
rendered obvious by a teaching of systemic injection. None of the claims of
US 8,852,240 suggest injection into an epiphyseal growth plate nor do they
suggest treatment of the patient population with scoliosis.
SUMMARY
In summary, we reverse the rejection of claims 1—6 and 20 under 35
U.S.C. § 103(a) as obvious over Boyce and Tobinick.
We reverse the rejection of claims 1—6 and 20 on the ground of
nonstatutory obviousness-type double patenting as being unpatentable over
claims 1, 4, 5 and 26 of U.S. 8,852,240.
REVERSED
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