Ex Parte Murphy

Board of Patent Appeals and Interferences

May 21, 2008

09594685 (B.P.A.I. May. 21, 2008)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte KIERAN P.J. MURPHY
____________

Appeal 2008-1756
Application 09/594,685
Technology Center 3700
____________

Decided: May 21, 2008
____________

Before ERIC GRIMES, RICHARD M. LEBOVITZ, and FRANCISCO C.
PRATS, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal from the final rejection of claims 1-23.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.

STATEMENT OF THE CASE
The claims are directed to a tray comprising vertebroplasty
components. Vertebroplasty is a surgical procedure in which a biomaterial
is injected into a vertebral body of the spine to strengthen it (Spec. 1-2).
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Claims 1-23 are pending (App. Br. 3). Appellant appeals the
following rejections:
1) Claims 17-19 as anticipated under 35 U.S.C. § 102(b) by Lazarus
(U.S. Pat. No. 4,128,173, Dec. 5, 1978) (Ans. 5);
2) Claims 1-16, 20, and 21 as obvious under 35 U.S.C. § 103(a) over
Vagley (U.S. Pat. No. 6,158,437, Dec. 12, 2000) (Ans. 5);
3) Claims 1-16, 20, and 21 as obvious under 35 U.S.C. § 103(a) over
Vagley, Shanley (U.S. Pat. No. 5,626,230, May 6, 1997), MacLeod (U.S.
Pat. No. 5,506,257, Apr. 9, 1996), Smith (U.S. Pat. No. 5,690,618, Nov. 25,
1997), Arlers (U.S. Pat. No. 3,910,273, Oct. 7, 1975), Racz (U.S. Pat. No.
5,817,074, Oct. 6, 1998), Jiang (U.S. Pat. No. 5,847,046, Dec. 8, 1998),
Singer (U.S. Pat. No. 5,147,308, Sep. 15, 1993), Draenert (U.S. Pat. No.
5,645,347, Jul. 8, 1997), Haynie (U.S. Pat. No. 5,240,415, Aug. 31, 1993),
Hertzmann (U.S. Pat. No. 5,084,043, Jan. 28, 1992), and Baker (U.S. Pat.
No. 4,554,686, Nov. 26, 1985) (Ans. 6); and
4) Claims 22 and 23 as indefinite under 35 U.S.C. § 112, second
paragraph (Ans. 4)
We select claims 1, 17, and 22 as representative of the appealed
subject matter. Claims 1, 17, and 22 read as follows:
1. A tray of vertebroplasty components for use in performing
vertebroplasty, said tray comprising:
a local anaesthesia assembly for producing a reversible
loss of sensation in a surgical area proximate to a vertebral
body;
a bone cement assembly for preparation of a hardenable
liquid biomaterial for strengthening said vertebral body;
a surgical cutting instrument for providing cutaneous
incision in said surgical area proximate to said vertebral body;
and
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a device for injection of said hardenable liquid
biomaterial into said vertebral body.

17. A vertebroplasty kit for use in performing vertebroplasty,
said vertebroplasty kit comprising:
a first tray of vertebroplasty injection components for
performing a first vertebroplasty injection through a first
pedicle of a vertebral body;
a second tray of vertebroplasty injection components for
performing a second vertebroplasty injection through a second
pedicle of said vertebral body, such that said second tray of
vertebroplasty injection components can remain sterile for use
in another vertebral body if said first vertebroplasty injection
sufficiently strengthens said vertebral body.

22. The kit according to claim 17, wherein the vertebroplasty
injection components comprise:
a local anaesthesia;
a local anaesthesia aspiration syringe;
a local anaesthesia aspiration needle;
a local anaesthesia injection needle;
a liquid monomer;
a monomer aspiration needle;
a monomer aspiration syringe;
a mixing bowl;
a mixing spatula;
a polymer powder;
an opacifier;
a scalpel; and
a vertebroplasty needle.

ANTICIPATION OVER LAZARUS
Claims 17-19 stand rejected as anticipated under 35 U.S.C. § 102(b)
by Lazarus.

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Issue
The Examiner finds that Lazarus discloses a kit which comprises first
and second trays, individually assembled and packaged (Ans. 5). The
Examiner states that the Lazarus’s tray 10b includes a syringe and needle
and that tray 10a includes a cannula for injecting or aspirating fluid, each of
which are capable of being used in a spinal surgical procedure (Ans. 8) and
therefore which meet the limitations of claim 17 of “vertebroplasty injection
components.”
Appellant contends that the phrase “vertebroplasty injection
components” as recited in claim 17 requires the kit to comprise needles
which are “sufficiently robust for injection of bone cement” in a vertebral
body (App. Br. 16).
Thus, the issues to be considered in this rejection are as follows:
1) whether the claimed “vertebroplasty injection components” requires
components which must be capable of injecting a biomaterial (“bone
cement”) into the pedicle of a vertebral body; and 2) if so, whether the
components in the Lazarus kit are capable of meeting this limitation.
Claim interpretation
The first issue is one of claim interpretation. Thus, we turn to the
language of claim 17.
Claim 17 is directed to a “vertebroplasty kit” for performing
vertebroplasty. Vertebroplasty is surgical procedure in which a biomaterial
is injected into a vertebra to strengthen it (Spec. 1-2). The kit comprises
“first” and “second” trays of “vertebroplasty injection components for
performing a . . . vertebroplasty injection through a [first and second,
respectively] pedicle of the vertebral body.” The second tray of components
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“can remain sterile for use in another vertebral body if” the first injection,
using the components of the first tray, is sufficient to strengthen the vertebral
body.
Each tray comprises “vertebroplasty injection components” which are
“for performing a vertebroplasty injection through a . . . pedicle of a
vertebral body.” These terms indicate an intended use of the claimed
components which do not necessarily limit their structure. However, in this
case, we find that the phrase “vertebroplasty injection components” is also a
description of the component structure. According to the Specification,
vertebroplasty injection involves inserting a “vertebroplasty needle” into a
vertebral pedicle and body (Spec. 9: 26-28). Once inserted into the desired
location, a bone cement material is injected through the needle into the
vertebral body (Spec. 10: 6-8) to strengthen it. The needles utilized to inject
the material are described as preferably 11 and 13 gauge (Spec. 6: 2-6).
Thus, we interpret “vertebroplasty injection components” to include
components which have a structure enabling them to be utilized to inject a
bone cement,1 e.g., an 11 or 13 gauge needle (to pierce the pedicle), as well
as a syringe or other means to hold the cement for injection through the
vertebroplasty needle.

1 We have focused here on the vertebral body injection function of the
claimed “vertebroplasty injection components” because this function is in
dispute in the rejection. However, we note that claim 22, which depends on
claim 17, comprises “vertebroplasty injection components” in which this
function is not necessary, such as “local anaesthesia.”
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The Lazarus patent
1. Lazarus describes a package 10, for peritoneal cavity treatment (Lazarus,
at col. 1, ll. 9-13), comprising two halves, 10a and 10b, “each separately
sealed and openable” (id. at col. 7, ll. 41-42; Fig. 1).
2. First half 10a is shown as having a catheter 12 and cannula 16; the second
half 10b is shown as having a syringe 36 and needle 38 (Lazarus, at col. 7, ll.
36-41; Ans. 8).
3. Cannula 16 is sized in length and diameter for inserting into the
peritoneal cavity (Lazarus, at col. 5, l. 67 to col. 6, l. 21).
4. The needle 38 is for injecting a local anesthetic into the skin and is 26
gauge (Lazarus, at col. 3, ll. 35-39).
Analysis
We have interpreted each tray of the kit of claim 17 to require
components, such as an injection needle or a syringe, which are capable of
injecting a bone cement through a pedicle of a vertebral body. The
Examiner finds that
Lazarus’s tray 10b includes a syringe 36 and needle 38 and they
are capable of being used in a spinal surgical procedure, e.g. for
injecting anesthesia. Lazarus’s tray 10a includes a cannula for
injecting and/or aspirating fluid and it is capable of being used
in a spinal surgical procedure, e.g. for injecting or aspirating
nucleus pulpous [sic, pulposus2].
(Ans. 8). The Examiner concludes that Lazarus meets all the limitations of
claim 17, and thus anticipates the claim, because “each tray includes an

2 The nucleus pulposus is “central portion of intervertebral disks, consisting
of a pulpy elastic substance” (Murphy Dec. ¶ 9)
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injection component [that] . . . can perform a function in spinal surgery if
one so desire[s]” (id.).
The PTO does not have the ability “to manufacture products or to
obtain and compare prior art products.” In re Best, 562 F.2d 1252, 1255
(CCPA 1977). Thus, once “the PTO shows sound basis for believing that
the products of the applicant and the prior art are the same, the applicant has
the burden of showing that they are not.” In re Spada, 911 F.2d 705, 708
(Fed. Cir. 1990). In this case, because halves 10a and 10b (FF 1) contain
components that could be utilized for injection – the catheter and cannula in
10a (FF 2, 3) and the syringe and needle in 10b (FF 2, 4) – we find that the
Examiner has “sound basis for believing that the products of the applicant
and the prior art are the same,” shifting the burden to Appellant to provide
rebuttal arguments or evidence.
To rebut anticipation, the named inventor, Dr. Kieran P.J. Murphy,
provided a declaration under 37 C.F.R. § 1.132 (“Murphy Dec.”). Dr.
Murphy states that needle 38 in 10b of Lazarus is “thin-walled and not
suitable for vertebroplasty injection” (Murphy Dec. ¶ 8). Dr. Murphy
explains that a “bone-cement injection needle suitable for vertebroplasty
injection is much more robust (typically eleven gauge or thirteen gauge, see
my Application at page 6, lines 3-6, although sometimes a 14 gauge needle
would be used) than the needles described by Lazarus (26 gauge, see
Lazarus at column 1, lines 37-39)” (id.).
With regard to the cannula 16 in 10a of Lazarus, Dr. Murphy states
that it “would be too small for injecting or aspirating nucleus pulposus (the
central portion of intervertebral disks, consisting of a pulpy elastic
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substance” (Murphy Dec. ¶ 9). The inventor also states that “injecting or
aspirating nucleus pulposus . . . is not vertebroplasty injection (id.)
“[P]atentability is determined on the totality of the record, by a
preponderance of the evidence.” In re Oetiker, 977 F.2d 1443, 1445 (Fed.
Cir. 1992). In this case, we find that the Examiner has met the burden of
establishing prima facie anticipation and that Appellant has not provided
adequate evidence to rebut it.
In determining that Lazarus anticipates claim 17, the Examiner made
the finding that 10b of the Lazarus package contains a syringe 36 and a
syringe needle 38 which could be used in a spinal surgical procedure (Ans.
8). Dr. Murphy, the inventor, and also a surgeon who has performed over
“500 vertebroplasty injection surgeries” (Murphy Dec. ¶ 1), declares that
needle 38 is not “suitable for vertebroplasty injection” because it is thin-
walled and has a smaller gauge (id. at ¶ 8; see also fn. 1).
The Examiner rejects this evidence because “the declaration is
directed to an opinion from applicant and not to evidence” (Ans. 8). We do
not agree. Dr. Murphy provides a factual basis for his opinion: Lazarus’s
syringe needle is described as 26 gauge (FF 4) which would make it thin-
walled and insufficiently robust for injection into a pedicle in comparison to
the lower gauge needles described in the Specification (Murphy Dec. ¶ 8).
We agree that there is a conflict of interest, and hence potential bias, when
an inventor provides a declaration distinguishing the claimed invention from
the prior art; however, in this case, we can guard against it by scrutinizing
the underlying factual basis for the opinion. Since we see no defect in the
facts presented by Dr. Murphy, and the Examiner has failed to unveil any,
we conclude that Appellant has rebutted the Examiner’s assertion that needle
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38 can be used for injection through a pedicle of a vertebral body as required
by claim 17.
For the syringe 36, Dr. Murphy states that “[i]n my opinion, the
syringe” is not a “vertebroplasty component[]” (Murphy Dec. ¶ 12; see also
¶ 7). In this case, Dr. Murphy does not identify a reason, or point to facts, as
to why the syringe could not carry bone cement to be injected into a pedicle
when attached to a vertebroplasty needle.3 Thus, we do not find the
declaration to be persuasive on this point – and conclude to the contrary –
that syringe 36 is a vertebroplasty component as in claim 17.
Dr. Murphy also states that “Lazarus's preferred Becton-Dickinson
18G23/4 thin wall catheter cannula 16 [in half 10b of Lazarus] would be too
small for injecting or aspirating nucleus pulposus” (Murphy Dec. ¶ 9). He
asserts that “injecting or aspirating nucleus pulposus . . . is not
vertebroplasty injection, and a cannula for injecting or aspirating nucleus
pulposus is not a vertebroplasty injection component” (id.).
We are not persuaded by this evidence. The requirement in claim 17
that the “vertebroblasty injection components” are “for performing a
vertebroplasty injection” imposes the structural requirement that the
component be capable of piercing a pedicle. While the Lazarus cannula is
for inserting into a peritoneal cavity (FF 1, 3), this does not preclude it from
also being capable of injecting into a vertebral pedicle – thus meeting the
limitation of claim 17. Dr. Murphy states that “cannula 16 is too small for

3 Claim 22, which depends on claim 17, lists “a local anaesthesia aspiration
syringe” and “a monomer aspiration syringe” as “vertebroplasty injection
components.” Thus, syringes appear to meet the claimed limitation of
vertebroplasty injection components, even if not used to inject cement into
the vertebral body.
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injecting or aspirating nucleus pulposus,” but he also states that “a cannula
for injecting or aspirating nucleus pulposus is not a vertebroplasty injection
component” (Murphy Dec. ¶ 9). Thus, there is no statement in the
declaration that cannula 16 could not be used to inject through a pedicle as
required by claim 17.
In sum, we conclude that Appellants have not provided sufficient
evidence to rebut the Examiner’s prima facie case. Thus, we affirm the
rejection of claim 17 as anticipated by Lazarus. Claims 18 and 19 fall with
claim 17 because separate reasons for their patentability were not provided.
See 37 C.F.R. § 41.37(c)(1)(vii).

OBVIOUSNESS OVER VAGLEY
Claims 1-16, 20, and 21 stand rejected under 35 U.S.C. § 103(a) over
Vagley.
Claims 1-16, 20, and 21 stand rejected under 35 U.S.C. § 103(a) over
Vagley, Shanley, MacLeod, Smith, Arlers, Racz, Jiang, Singer, Draenert,
Haynie, Hertzman, and Baker.
Issue
We have selected claim 1 as representative of the appealed subject
matter. See 37 C.F.R. § 41.37(c)(vii)(1). Claim 1 is directed to a tray of
vertebroplasty components comprising: a local anesthesia assembly, a bone
cement assembly, a surgical cutting instrument, and a device for injecting
biomaterial into a vertebral body.
The Examiner finds that Vagley describes an instrument support tray
having a plurality of surgical instruments (Ans. 5). The Examiner also finds
that Vagley states that the “tray can be customized” for performing specific
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surgical procedures (id.). Based on this suggestion, the Examiner contends
that it would have been obvious to assemble in a single instrument tray all
the components for vertebroplasty as recited in claim 1 (id. at 6). Additional
references (Shanley, MacLeod, Smith, Arlers, Racz, Jiang, Singer, Draenert,
Haynie, Hertzman, and Baker) are cited by the Examiner as evidence that
vertebroplasty components were known in the art.
Appellant contends that Vagley does not teach or suggest the claimed
combination of components recited in claim 1.
Thus, the issue in these rejections is whether Vagley’s teaching would
have suggested the claimed tray of known vertebroplasty components.

The Vagley patent
5. Vagley describes an instrument supporting tray which includes
instruments in specific positions “to establish a sequence which corresponds
generally to the sequence in which the surgical instruments will be
employed” in a surgical procedure (Vagley, Abstract).
6. A “surgical procedure” is defined by Vagley as “procedure performed on
a patient by a physician, dentist, veterinarian or other legally authorized
health care professional which procedure involves a plurality of hand-held
instruments and is at least partially invasive (Vagley, at col. 3, ll. 5-10; see
Ans. 12).
7. Vagley provides a specific example of a tray of instruments for a
rhinoplasty (Vagley, at col. 4, ll. 32-35).
8. Vagley states that the tray may be
customized to cater to the preference of a specific surgeon
during a specific procedure and in such case may also provide
additional equipment preferences of the surgeon. All of this is
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directed toward enhanced efficiency in the surgical suite and
more accurate and prompt delivery of the correct instrument to
the surgeon and return of the same to the tray after use.
(Vagley, at col. 5, ll. 43-50; see Ans. 11-12).
Analysis
In making an obviousness determination, the Examiner must first
identify the scope and content of the prior art and then ascertain the
differences between the prior art and the claimed invention. Graham v. John
Deere Co., 383 U.S. 1, 17 (1966). Once the differences between the prior
art and the claimed invention have been identified, the next step is to
identify motivation or a reason why persons of ordinary skill in the art would
have been prompted to combine the prior art to have made the claimed
invention. KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007).
Vagley describes a kit comprising different components for
performing surgery, but does not contain the specific components recited in
claim 1. However, the Examiner finds that Vagley teaches that the “tray can
be customized” for performing specific surgical procedures, providing a
reason to have assembled the components recited in claim 1 into a single
tray in order to perform vertebroplasty, which is a surgical procedure (Ans.
5). The Examiner also provides evidence that the surgical components for
vertebroplasty were known in the art.
Appellant contends the “Examiner has used Applicant’s claims as a
shopping list to find patents that teach each element” of claim 1 (App. Br.
17). Appellant argues that the “Vagley patent discloses a tray and says things
other than vertebroplasty components should be on the tray. So Vagley does
not teach or suggest Applicant’s combination, Vagley teaches a different
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combination” (App. Br. 17). Dr. Murphy makes similar statements in his
declaration (Murphy Dec. ¶ 14).
The Examiner has the better argument. As noted by the Examiner,
Vagley is not limited to a rhinoplasty instrument tray (FF 5, 6, 8). Vagley
explicitly states that the instrument tray may be “customized to cater to the
preference of a specific surgeon during a specific procedure” (FF 8).
Further, Vagley defines surgical procedures broadly to include “at least
partially invasive” procedures performed by “physician, dentist, veterinarian
or other legally authorized health care professional” (FF 6). Thus, the
Examiner’s finding that Vagley’s teachings suggest utilizing the surgical
tray for other surgical procedures, including vertebroplasty (Ans. 6-7, 11), is
supported by the evidence of record.
We do not agree with Appellant that the Examiner has used claim 1 as
“shopping list” (App. Br. 17). The Examiner relies on Vagley’s teaching of
an instrument tray containing a plurality of instruments used in a single
surgical procedure as suggesting a tray of components for vertebroplasty, all
of which were known in the art. Appellant does not rebut the Examiner’s
findings that the specific components recited in claim 1 are those used in a
typical single vertebroplasty procedure; thus, there is no evidence that the
Examiner has used claim 1 as shopping list. To the contrary, the Examiner’s
position – which is unrebutted – is that the components recited in claim 1 are
those which would normally be used to perform vertebroplasty.
We also do not find Dr. Murphy’s declaration persuasive. Dr.
Murphy states:
In my opinion, neither the Vagley Patent alone, nor the Vagley
Patent in combination with the 11 other references upon which
the Examiner relies, would suggest to a person of ordinary skill
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in the art, the combinations claimed in my Claims 1-16, 20 and
21.
(Murphy Dec. ¶ 14).
While objective factual evidence going towards a §103
determination is preferable to statements of opinion on the
issue, the nature of the matter sought to be established, as well
as the strength of the opposing evidence, must be taken into
consideration in assessing the probative value of expert opinion.
In re Oelrich, 579 F.2d 86, 91 (CCPA 1978). Opinion
testimony rendered by experts must be given consideration, and
while not controlling, generally is entitled to some weight. See
FED.R. EVID, 701-704; Orthopedic Equipment Co. v. United
States, 702 F.2d 1005, 1012 (Fed. Cir. 1983). Lack of factual
support for expert opinion going to factual determinations,
however, may render the testimony of little probative value in a
validity determination. Cf. In re Altenpohl, 500 F.2d 1151,
1158 (CCPA 1974).
Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294
(Fed. Cir. 1985).
In this case, there are no factual underpinnings for Dr. Murphy’s
statement that “the Vagley Patent alone, nor the Vagley Patent in
combination with the 11 other references” (Murphy Dec. ¶14) would not
have suggested the subject matter of claim 1. In contrast, the Examiner has
provided adequate evidence to support his position (i.e., the fact that
vertebroplasty was a known procedure and the teaching that the components
to accomplish the procedure were known in the art). Thus, when we
consider the totality of evidence in the record before us, we conclude that the
Examiner did not err in concluding that claim 1 would have been obvious
over Vagley alone, or in combination with the cited prior art. We affirm the
rejection of claim 1. Claims 2-16, 20, and 21 fall with claim 1 because
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separate reasons for their patentability were not provided. See 37 C.F.R.
41.37(c)(1)(vii).

INDEFINITENESS
Claims 22 and 23 stand rejected under 35 U.S.C. § 112, second
paragraph, as indefinite. We have selected claim 22 as representative.
Claim 22 depends on claim 17, and further requires that the vertebroplasty
injection components of claim 17 comprise thirteen specifically recited
components (i.e., local anaesthesia, local anaesthesia aspiration needle, etc.).
The Examiner contends that the claim is indefinite because it is not clear
whether all thirteen of the recited components are represented in each of the
first and second trays, or whether a specific component in the list is either in
the first or second tray, but not in both (Ans. 4).
Appellant contends that the claims are clear because there is
antecedent basis for “the vertebroplasty injection components” in both lines
3 and 5 of claim 17 (App. Br. 14), for the first and second trays,
respectively.
We agree with Appellant. Because there is antecedent basis in claim
17 for both a first and second tray of “vertebroplasty injection components”,
persons of skill in the art would understand that each tray comprises all of
the components recited in claim 22.
We reverse the rejection of claims 22 and 23.

CONCLUSION
We affirm the prior art rejections of claims 1-21, but reverse the
rejection of claims 22 and 23 under 35 U.S.C. § 112, second paragraph.
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TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED-IN-PART

Ssc:

BRINKS HOFER GILSON & LIONE
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