Ex Parte Ogilvie

Patent Trial and Appeal Board

Jan 28, 2015

11259941 (P.T.A.B. Jan. 28, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte JAMES W. OGILVIE
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Appeal 2012-004925
Application 11/259,941
Technology Center 3700
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Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims directed to
a method of distracting vertebrae in a scoliotic spine. The Patent Examiner
rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

1 Appellant states that the Real Party in Interest is Axial Biotech, Inc. (App.
Br. 2.)
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Application 11/259,941

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STATEMENT OF THE CASE
Claims 55–133 and 135–146 are on appeal,2 and can be found in the
Claims Appendix of the Appeal Brief (App. Br. 21–35). Claim 55 is
representative of the claims on appeal, and reads as follows:
55. A method for distracting a first vertebra from a second
vertebra of an orthotic-unresponsive scoliotic spine having at
least one year of growth remaining, said method comprising:
(a) joining a first fastener to a posterior portion of said first
vertebra and a second fastener to a posterior portion of said
second vertebra on a concave side of a curve formed in said
spine; (b) joining an implant with said first fastener and said
second fastener; (c) expanding said implant between said first
vertebra and said second vertebra; and (d) allowing angular
movement of at least one of said first fastener and said second
fastener with respect to said implant.
Independent claims 63, 74, 93, 106, 120, and 132 also recite a
preamble that includes “an orthotic-unresponsive scoliotic spine having at
least one year of growth remaining.”
The Examiner rejects the claims as follows:
1. claims 55–58, 61, 62, 67, 70, 73–81, 90, 93, and 95–98 are rejected
under 35 U.S.C. § 103(a) as being unpatentable over Ogilvie3 in
view of Martin4 and further in view of Panjabi5 (Ans. 4);

2 Claims 55–146 are pending (Office Action mailed Apr. 28, 2011) and
although Appellant (Appeal Br. 2) and the Examiner (Ans. 3) agree that all
of the claims stand rejected, the rejections set out in the Office Action
mailed Apr. 28, 2011 and in the Answer do not include claim 134. Thus,
there is no rejection of claim 134 on appeal.
3 J. W. Ogilvie, Diagnosis and treatment of spinal deformities: What to do
for the patient with scoliosis; 84 Postgraduate Medicine 147 (1988).
4 J. R. Martin, US 5,672,175, issued Sept. 30, 1997.
5 M. M. Panjabi, US 2004/0236329 A1, published Nov. 25, 2004.
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2. claims 63–66, 68, 69, and 84–89 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Ogilvie in view of Martin and
(Ans. 9);
3. claims 59, 60, 82, 83, 94, 102–105, 107, 108, 110–112, 121, 122,
124–126, 133, and 136–138 are rejected under 35 U.S.C. § 103(a)
as being unpatentable over Ogilvie in view of Martin, Panjabi and
further in view of Dodge6 and furthermore in view of Calhoun7
(Ans. 10);
4. claims 71, 72, 91, 92, 106, 109, 116–120, 123, 130–132, 135, and
142–146 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Ogilvie in view of Martin and further in view of
Dodge and furthermore in view of Calhoun (Ans. 13);
5. claim 99 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Ogilvie in view of Martin, Panjabi and
furthermore in view of Atkinson8 (Ans. 14);
6. claim 100 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Ogilvie in view of Martin, Panjabi, Atkinson
and furthermore in view of Paul9 (Ans. 15);
7. claim 101 is rejected under 35 U.S.C. § 103(a) as being
unpatentable over Ogilvie in view of Martin, Panjabi, Atkinson,
Paul and furthermore in view of Losken10 (Ans. 16);

6 G. R. Dodge et al., US 7,206,638 B2, issued Apr. 17, 2007.
7 C. J. Calhoun et al., US 2003/0185874 A1, published Oct. 2, 2003.
8 R. E. Atkinson et al., US 2002/0095154 A1, published July 18, 2002.
9 D. C. Paul et al., US 2004/0236327 A1, published Nov. 25, 2004.
10 H. W. Losken et al., US 6,033,412, issued Mar. 7, 2000.
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8. claims 113, 127, and 139 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Ogilvie in view of Martin, Panjabi,
Dodge, Calhoun and furthermore in view of Atkinson (Ans.16);
9. claims 114, 128, and 140 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Ogilvie in view of Martin, Panjabi,
Dodge, Calhoun, Atkinson and furthermore in view of Paul (Ans.
17); and
10. claims 115, 129, and 141 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Ogilvie in view of Martin, Panjabi,
Dodge, Calhoun, Atkinson, Paul and furthermore in view of
Losken (Ans. 18).

The Issue: Obviousness
The Examiner relies on the disclosure of Ogilvie for teaching the
application of surgical intervention on patients with “an orthotic-
unresponsive scoliotic spine having at least one year of growth remaining.”
(Ans. 5, 19–20.) The Examiner looks to Martin for teaching “a method for
distracting a first vertebra from a second vertebra of scoliotic spine . . . for
correcting scoliotic spine” with a first and second fastener. (Ans. 5.) The
Examiner concludes that “[i]t would have been obvious to a person of
ordinary skill in the art at the time of the invention was made to use the
method of correcting scoliotic spine of Ogilvie JW. with a surgical treatment
in view of Martin for providing an effective treatment for progressive or
painful scoliosis.” (Ans. 6, 10.)
Does the preponderance of evidence of record support the Examiner’s
conclusion that Ogilvie teaches the application of surgical treatment to
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patients with “an orthotic-unresponsive scoliotic spine having at least one
year of growth remaining”?
Findings of Fact
FF 1. The Specification provides that “the present apparatus and
methods may be used in cases where the patient has a flexible spine
deformity which is unresponsive to orthotic treatment.” (Spec. 38.)
FF 2. Ogilvie disclosed that “[s]pinal deformities occurring before
skeletal maturity is achieved have greater potential to be progressive and
often call for more active intervention.” (Ogilvie, p. 147.) “Among the
cases of scoliosis seen in skeletally immature patients, 90% are of the
adolescent idiopathic type.” (Id. at p. 148.) For treatment purposes “[o]ther
factors that must also be considered are the age of the patient and the
location and severity of the deformity.” (Id. at p. 149.) “[T]he consulting
physician has a strong responsibility to be up to date about currently
available orthotic and surgical options.” (Id.)
FF 3. Ogilvie disclosed that “[i]n the pediatric age-group, a brace is
used to retard progression of the curve until skeletal maturity occurs.” (Id.
at. 150.) Furthermore,
In pediatric patients with adolescent idiopathic curves
ranging between 20° and 40°, orthotic treatment in the form of
either a Milwaukee brace or a low-profile plastic body jacket is
indicated if at least one year of skeletal growth remains. A
muscle stimulator worn during the night is also an option.
When a scoliotic deformity exceeds 40° and more than one year
of skeletal growth remains, surgical treatment is often the
primary consideration.
(Id. at p. 149–150.)
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FF 4. Ogilvie disclosed
In pediatric patients with adolescent idiopathic scoliosis,
observation is the best approach to curves of less than 20°.
Since curves rarely progress more than 1° to 2° per month,
follow-up visits can be scheduled according to this formula:
number of months times maximum progression rate. For
example, if examination reveals a 10° curve, the follow-up visit
could be scheduled for five months later because even at a
progression rate of 2° per month, the curve would not exceed
20°.
(Id. at p. 149.)
FF 5. Ogilvie disclosed “[r]egardless of the patient’s age, however,
progressive or painful scoliosis may necessitate surgical treatment.” (Id. at
p. 153, summary (emphasis omitted).)
Analysis
The Examiner rejects all claims under 35 U.S.C. § 103(a) based on
Ogilvie in various combinations with Martin, Panjabi, Dodge, Calhoun,
Atkinson, Paul, and Losken (see above 1–10). Appellant argues the
disclosure of Ogilvie. (App. Br. 7–20.)
The Board’s role in an appeal is to “review[ ] the obviousness
rejection for error based upon the issues identified by appellant, and in light
of the arguments and evidence produced thereon.” Ex parte Frye, 94
USPQ2d 1072, 1075 (BPAI 2010) (precedential). Therefore, we look to
Appellant’s Brief to show error in the proffered prima facie case. Only
those arguments actually made by Appellant have been considered in this
decision. Arguments which Appellant could have made but choose not to
make in the Brief have not been considered and are deemed to be waived.
See 37 C.F.R. § 41.37(c)(1)(vii). See also Frye, 94 USPQ2d at 1075
(“Filing a Board appeal does not, unto itself, entitle an appellant to de novo
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review of all aspects of a rejection. If an appellant fails to present arguments
on a particular issue . . . the Board will not, as a general matter, unilaterally
review those uncontested aspects of the rejection.”).
Appellant’s arguments are directed solely at the disclosure of Ogilvie
(App. Br. 7–20), thus, the same issue is dispositive for all rejections.
Appellant contends that
Nowhere in Ogilvie is there a teaching that the scoliotic spine is
“orthotic-unresponsive.” . . . Ogilvie’s motivation in
suggesting surgical treatment is not attributed to orthotic-
unresponsiveness, appellant respectfully points that surgical
treatment may be for instance to correct the curvature of an
orthotic-responsive scoliotic spine wherein the curvature prior
to the use of an orthosis progressed to a stage sufficient to
warrant surgical treatment in spite of subsequent use of an
orthosis.
(App. Br. 7.) Appellant repeats the same argument with respect to each
ground of rejection (id. at 8–20). Specifically, Appellant contends that
“Ogilvie did not distinguish between orthotic-responsiveness and orthotic-
unresponsiveness.” (Reply Br. 2.)
The Examiner finds that Ogilvie “suggests to one of ordinary skill that
a spinal orthosis does not always prevent progression (‘may prevent’) and
that progressive scoliosis may require surgery. If it did not PREVENT
progression, and the patient then required surgery, one of ordinary skill
would consider it to be unresponsive [to the orthosis] at least at that time.”
(Ans. 19.)
Claim interpretation is at the heart of patent examination because a
claim cannot be compared to the prior art before its scope is properly
ascertained. In re Abbott Diabetes Care Inc., 696 F.3d 1142, 1146 (Fed. Cir.
2012)). In this case, Appellant contests the limitation of “orthotic-
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unresponsive” as interpreted by the Examiner. During prosecution, claim
terms are given their broadest reasonable interpretation as they would be
understood by persons of ordinary skill in the art in the light of the
Specification. In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed.
Cir. 2004). Therefore, we first turn to the Specification to interpret the term
“orthotic-unresponsive.” The Specification provides that the methods are
applied to “patient[s] [that] have a flexible spine deformity which is
unresponsive to orthotic treatment” (FF 1).
The Examiner has interpreted the term an “orthotic-unresponsive”
spine as being a patient group that continues progression of the spinal
deformity despite the use of an orthotic device by the patient (Ans. 19). We
find that this interpretation is reasonable, and consistent with the
Specification that provides surgical intervention is indicated when orthotic
treatment is not responsive (FF 1; see also Reply Br. 2).
Ogilvie describes treatment protocols based on the severity of the
curvature of the spine (FF 2–5). The treatment categories are observation
(FF 4), application of an orthotic (FF 3), and surgical intervention (FF 3).
Ogilvie acknowledges that spinal deformities in the pediatric or adolescent
age group tend to be progressive (FF 2) and surgical intervention is indicated
when the scoliosis is either progressive beyond 40° or painful (FF 4, 5).
We are not persuaded by Appellant’s contentions that “Ogilvie did not
distinguish between orthotic-responsiveness and orthotic-unresponsiveness.”
(Reply Br. 2.). The claims recite applying a distraction method to vertebrae
in a scoliotic spine that is orthotic-unresponsive. The Examiner finds, and
Appellant does not contest, that Ogilvie recognizes that the use of an
orthosis may prevent progression of a spinal deformity in a child or
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adolescent (Ans. 19; see also Reply Br. 2 (“Ogilvie taught two possible
outcomes of the use of an orthosis, namely prevention of spinal deformity
progression (e.g. orthotic-responsiveness) and non-prevention of spinal
deformity progression (e.g. orthotic-unresponsiveness)”). Specifically, the
Examiner’s position is that if the application of the orthosis “did not
PREVENT progression, and the patient then required surgery, one of
ordinary skill would consider it to be unresponsive [to the orthotic] at least at
that time.” (Ans. 19–20.)
We agree with the Examiner’s position that Ogilvie’s disclosure
includes a patient population in which the application of the orthotic “did not
PREVENT progression” and this patient population requires surgery when
the curvature reaches above 40 degrees or is painful. (Ans. 19.) We find no
error in the Examiner’s interpretation that Ogilvie teaches a treatment
protocol for patients, specifically those in the child or adolescent age group
having at least one year of growth remaining, suffering with a spinal
deformity that is not responsive to the application of an orthosis (FF 2–5).
We conclude that the cited references support a prima facie case of
obviousness with respect to claim 55. Appellant’s rebuttal is not sufficient
to overcome the Examiner’s prima facie case. Claims 56–58, 61, 62, 67, 70,
73–81, 90, 93, and 95–98 have not been argued separately and therefore fall
with claim 55. 37 C.F.R. § 41.37(c)(1)(vii).
Appellant has waived arguments with respect to claims 60, 63–66, 68,
69, 71, 72, 82–89, 91, 92, 94, and 99–146 that are based on various
combinations of Ogilvie with Martin, Panjabi, Dodge, Calhoun, Atkinson,
Paul, and Losken. See Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir.
2008.)
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SUMMARY
We affirm all rejections 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

cdc