Ex Parte Chudik

Patent Trial and Appeal Board

Mar 18, 2013

11585041 (P.T.A.B. Mar. 18, 2013)

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.
11/585,041 10/24/2006 INV001Steven C. Chudik 5181-1000.1 6748
7590 03/18/2013
Gregory B. Beggs
Law Offices of Gregory B. Beggs
928 Warren Avenue
Downers Grove, IL 60515
EXAMINER
PELLEGRINO, BRIAN E
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
03/18/2013 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte STEVEN C. CHUDIK
__________

Appeal 2012-001262
Application 11/585,041
Technology Center 3700
__________

Before TONI R. SCHEINER, LORA M. GREEN, and ULRIKE W. JENKS,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claim 1. We have jurisdiction under 35 U.S.C.
§ 6(b).
Appeal 2012-001262
Application 11/585,041

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STATEMENT OF THE CASE
The Specification teaches a method of repairing the rotator cuff (Spec.
44, ¶161
1
). Figure 33 is reproduced below.

Figure 33 is a schematic of “tying the passed suture of the suture pin device
after removing the pin component” (id. at 14-15, ¶ 98).
As taught by the Specification
The bore tip 150 is extended into the lateral humeral 20 cortex
under direct or arthroscopic visualization (Figure 30). An
arthroscopic retractor 136 may assist the process. Directed by
an insertional guide 134 a flexible pin 140 is advanced by a
drill through the greater tuberosity of the proximal humerus to
exit into an anteromedial supraspinatus rotator cuff footprint.

1
As amended July 22, 2010.
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The next step is to reduce the torn edge of the supraspinatus
tendon with a soft tissue grasper 138A. The flexible pin 140 is
advanced through the cuff (Figure 31) and out through the
superior soft-tissue and the skin using a pin director 142 as
needed (Figure 32). The suture-pin devices 141 may pass
through the acromion or deltoid as necessary. These steps,
namely, advancing the suture pin through the greater tuberosity
of the humerus, the supraspinatus rotator cuff tendon and out of
the shoulder through the superior soft tissue and skin, are done,
as described, in a single unidirectional pass. The drill is
switched to a suture pin leading tip and the flexible pin
component 140 is removed from the body. The flexible pin 140
is cut from the suture 144. The above steps may be repeated as
often as necessary to provide sufficient sutures 144 to secure
the torn rotator cuff. For the arthroscopic technique, a tying
cannula 146 is then inserted for tensioning and securing suture
144 outside of the humerus inside the shoulder (Figure 33).
The sutures 144 are retrieved and passed in modified Mason-
Allen fashion if desired, using free needles (open technique) or
an arthroscopic suture passing device. The sutures 144 are tied
and the tying steps are repeated. The repair may be reinforced
with lateral suture anchors as needed before or after tying the
transosseous sutures 144 (Figure 33).

(Id. at ¶161).
Claim 1 reads as follows:
1. A method of arthroscopic or open rotator cuff repair comprising the
steps of
a) inserting an insertional guide into a humerus of a shoulder;
b) inserting a suture pin carrying a suture into said insertional guide;
c) advancing said suture pin through the greater tuberosity of said
humerus, the supraspinatus rotator cuff tendon and out of said shoulder
through the superior soft tissue and skin in a single unidirectional pass;
d) removing said insertional guide and suture pin; and
e) tensioning and securing said suture outside of the humerus inside the
shoulder.

Appeal 2012-001262
Application 11/585,041

4
The following grounds of rejection are before us for review:
2

I. Claim 1 stands rejected under 35 U.S.C. § 112, first paragraph, for
scope of enablement (Ans. 4).
II. Claim 1 stands rejected under 35 U.S.C. § 112, second paragraph,
as being indefinite (Ans. 5).
III. Claim 1 stands rejected under 35 U.S.C. § 102(b) as being
anticipated by Bennett.
3
(Ans. 6.)

We reverse.

ANALYSIS
Enablement
The Examiner concludes that the Specification, “while being enabling
for passing a suture pin through the tissues of the humerus, rotator cuff, soft
tissue and skin in a single pass, . . . does not reasonably provide enablement
for the delivery to be limited to unidirectional” (Ans. 4).
According to the Examiner, Figure 33, relied upon by Appellant to
demonstrate enablement, “is not of sufficient quality to discern that a suture
pin with the suture does not get delivered only in one direction since the

2
Appellant requests review of the Examiner‟s refusal to enter Appellant‟s
Amendment After Final (App. Br. 20). The Examiner‟s refusal to enter the
amendment after final, however, is a petitionable matter under 37 C.F.R.
§ 1.181 and not within the jurisdiction of the Board. 37 C.F.R. § 1.127; In
re Berger, 279 F.3d 975, 984 (Fed. Cir. 2002) (citing In re Hengehold, 440
F.2d 1395, 1403-1404 (CCPA 1971)); see also MPEP § 715.08.
3
Bennett, US 6,013,083, issued Jan. 11, 2000.
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Application 11/585,041

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lines are sketchy and not clear to distinguish and permitting the best search
and examination on what [Appellant] is doing in the claimed method” (id.).
The Examiner further notes that the while the Specification is enabled
for pushing the suture pin out of the humerus, the Specification “does not
reasonably provide enablement for the exact location of the suture pin to
tension and secure” (id. at 5). According to the Examiner, while Figure 33
shows the suture outside of the humerus, the description fails to explain if
the suture is outside of the skin. According to the Examiner:
Applicant‟s amendment to the specification (paragraph 161) to
clarify issues fails to make it clear because the added recitation
is maybe implying outside the skin by adding the clause
“advancing the suture pin through the greater tuberosity of the
humerus, the supraspinatus rotator cuff tendon and out of the
shoulder through the superior soft tissue and skin” because then
also it was added that “tensioning and securing suture outside
of the humerus and inside the shoulder” would mean that it is
not advanced out the soft tissue and beyond the skin. Thus
there is ambiguity and contradiction to the location where
securing is to occur.

(Id.)
Appellant responds that Figure 33 “unmistakably shows the legs of
suture 144 being engaged inside the skin of a patient‟s shoulder by a tying
cannula 146” (App. Br. 18). Appellant asserts further that ¶ 161 of the
Specification teaches that a tying cannula is inserted, and the only place a
tying cannula can be inserted is through the skin (id.).
“When rejecting a claim under the enablement requirement of section
112, the PTO bears an initial burden of setting forth a reasonable explanation
as to why it believes that the scope of protection provided by that claim is
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not adequately enabled by the description of the invention provided in the
specification of the application.” In re Wright, 999 F.2d 1557, 1561-62
(Fed. Cir. 1993). “„The enablement requirement is met if the description
enables any mode of making and using the invention.‟” Johns Hopkins
Univ. v. CellPro, Inc., 152 F.3d 1342, 1361 (Fed. Cir. 1998) (quoting Engel
Indus., Inc. v. Lockformer Co., 946 F.2d 1528, 1533 (Fed. Cir. 1991)).
We agree with Appellant that the Examiner has not established by a
preponderance of the evidence that the Specification fails to enable the full
scope of the method of claim 1.
The Examiner notes that the Specification is enabling “for passing a
suture pin through the tissues of the humerus, rotator cuff, soft tissue and
skin in a single pass,” but it is not enabling for limiting the delivery to be
unidirectional (Ans. 4). But if the suture pin is passed through all of those
tissues in a single pass, the Examiner has not explained how that single pass
through those tissues would not be in a single direction.
Moreover, as to the Examiner‟s concern that the disclosure does not
provide enablement for the exact location of the suture pin to tension and
secure, as noted by Appellant, as taught by the Specification at ¶ 161, the
suture pin is removed from the suture and the suture is secured inside the
shoulder but outside the humerus. It appears as if the Examiner is equating
the suture pin with the suture, but that is not supported by ¶ 161 of the
Specification, as just noted. The Examiner has not explained as to why that
description provided by the Specification would not enable the skilled
artisan to practice the claimed method.
The enablement rejection is thus reversed.
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Indefiniteness
According to the Examiner:
If the suture pin carrying suture is “advanced out of the
shoulder through the superior soft tissue and skin ....” as recited
in step c of the claim, how then is “tensioning and securing the
suture outside of the humerus inside the shoulder”
accomplished as recited in step e?

(Ans. 5.)
Appellant argues that the Examiner‟s rejection “assumes that the pin
remains connected to the suture while the suture is being tensioned and
secured” (App. Br. 18). Appellant argues that is not the case, as ¶ 161 of the
Specification explains that the pin is removed from the suture once the pin
exits the shoulder (id. at 18-19). Appellant asserts that the “Examiner‟s
assumption that the pin and suture are somehow reinserted into the shoulder
simply has no basis in the appellant‟s specification or claim” (id. at 19).
“The standard of indefiniteness is somewhat high; a claim is not
indefinite merely because its scope is not ascertainable from the face of the
claims.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342
(Fed. Cir. 2003). Rather, “[a] claim is indefinite if, when read in light of the
specification, it does not reasonably apprise those skilled in the art of the
scope of the invention.” Id.
For the reasons set forth by Appellant, as well as set forth in the
analysis of the enablement rejection, we agree with Appellant. The
indefiniteness rejection is thus reversed.

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Anticipation
The Examiner finds that element 32 as shown in Figure 5B of Bennett
reads on the suture pin (Ans. 6). The Examiner later notes that figures 5B
has multiple pins as shown by elements 27 and 32 (id. at 7). With respect to
the step of “advancing said suture pin through the greater tuberosity of said
humerus, the supraspinatus rotator cuff tendon and out of said shoulder
through the superior soft tissue and skin in a single unidirectional pass” of
claim 1, the Examiner finds that as “Bennett discloses passing the suture pin
apparatus through all of the claimed tissues, it meets this step” (id. at 6).
Specifically, the Examiner notes that “[s]ince the language of the method
claim is not clear as to direction, it can be said that Bennett establishes the
claimed steps and does have the pins pass through the claimed tissues” (id.
at 7).
Appellant argues that Bennett is drawn to a different method of
shoulder repair, wherein an anchor is sent through the humoral head to
engage the downward outer surface of the bone, and a suture is held in place
behind the anchor (App. Br. 13). According to Appellant, the suture pin of
Bennett “does not perform appellant‟s step c because it does not „pass
through the greater tuberosity of said humerus, the supraspinatus rotator cuff
tendon and out of said shoulder through the superior soft tissue and skin,‟ as
Figures 5B, 6C, 6D, and 6E of the Bennett patent unmistakably show” (id.).
Specifically, according to Appellant, neither the protuberances 32 or the
anchor 27 of Bennett read on the suture pin required by the claim, as neither
of them are removed from the body as required by the claimed method
(Reply Br. 4-5).
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Step (c) of the claimed method requires “advancing said suture pin
through the greater tuberosity of said humerus, the supraspinatus rotator cuff
tendon and out of said shoulder through the superior soft tissue and skin in a
single unidirectional pass.” The step requires advancing the suture pin, to
which, as explained by ¶ 161 of the Specification, the suture is attached,
through the recited tissues and out of the shoulder through the skin in a
single pass. Thus, step (c) requires the pin to leave the shoulder through the
skin.
Figures 5A and 5B of Bennett are reproduced below:

Figure 5A shows a suture button as with a conventional suture, and Figure
5B shows a suture button with a conventional suture (Bennett, col. 3, ll. 42-
45).
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As taught by Bennett, as shown in Figure 5A, a conventional suture
30 may be secured to the eyelet 28 of the anchor, and as shown in Figure 5B,
a pair of special suture strands 31 that have a plurality of longitudinally
spaced protuberances may be attached to eyelet 28 (id. at col. 4, ll. 42-50).
Thus, the ordinary artisan would not understand the protuberances 32 of the
suture 31 in Figure 5B to read on the suture pin of the claim.
As to element 27, as seen in Figures 5A and 5B of Bennett, it is
attached to anchor 29. As shown in Figure 6E of Bennett, the anchor is
pulled up against the bone (see also Bennett, col. 5, ll. 40-50), and thus
element 27 does not pass out of the shoulder through the skin.
The Examiner has thus not demonstrated by a preponderance of the
evidence that Bennett anticipates claim 1, and the anticipation rejection is
thus reversed.

Appeal 2012-001262
Application 11/585,041

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SUMMARY
The rejections of:
Claim under 35 U.S.C. § 112, first paragraph, for scope of
enablement;
Claim 1 under 35 U.S.C. § 112, second paragraph, as being indefinite;
and
Claim 1 under 35 U.S.C. § 102(b) as being anticipated by Bennett;
are reversed.

REVERSED

cdc