Ex Parte Schraga

Board of Patent Appeals and Interferences

Mar 21, 2012

11548613 (B.P.A.I. Mar. 21, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte STEVEN SCHRAGA
__________

Appeal 2011-000742
Application 11/548,613
Technology Center 3700
__________

Before LORA M. GREEN, STEPHEN WALSH, and
ERICA A. FRANKLIN, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) from the rejection of
claims directed to a lancet device and a method of puncturing a skin surface.
The Patent Examiner rejected the claims for obviousness. We have
jurisdiction under 35 U.S.C. § 6(b). We affirm-in-part.
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STATEMENT OF THE CASE
Claims 1-47 are on appeal. Claim 1 is representative and reads as
follows (emphasis added):
1. A lancet device comprising:
a body;
a holding member movably mounted within the body and comprising
a front end and a rear end;
the front end being configured to receive a lancet having a lancet
needle; and
a lancet ejector at least one of:
movable from an initial position to a lancet removal position
without movement of the holding member;
movable from an initial position to a lancet removal position
while the holding member is in an initial position defined as a position
between a trigger-set position and an extended puncturing position; and
movable from an initial position to a lancet removal position
while the holding member is in a trigger-set position.

The Examiner rejected claims 1-47 under 35 U.S.C. § 103(a) as
unpatentable over Schraga (US 6,156,051, Dec. 5, 2000) and Marshall
(US 7,087,068 B1, Aug. 8, 2006).

OBVIOUSNESS
The Issue
The device of claim 24 comprises a lancet ejector having “at least one
of” three listed features. The rejection focuses on the first of the three listed
features, i.e., that the ejector be “movable from an initial position to a lancet
removal position without movement of the holding member.”
The Examiner’s position is that Schraga described a lancet device and
method having the features of Appellant’s device and method except that
Schraga’s device did not include a lancet ejector movable from an initial
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position to a lancet removal position without movement of the holding
member. (Ans. 6.) The Examiner found that Marshall described a lancet
device wherein the lancet could be removed without the holder member
being moved (id. at 6-7, citing Marshall at col. 3, ll. 14-17), and concluded
that it would have been obvious to modify Schraga’s device with this feature
because “[d]oing so would provide a method for removing and disposing of
the contaminated tip after use without handling it and for decreasing the risk
of inadvertently puncturing yourself during removal” (id. at 7).
Appellant contends that
no proper combination of [the Schraga and Marshall] documents
discloses or suggests: inter alia, a lancet ejector at least one of
movable from an initial position to a lancet removal position without
movement of the holding member, . . . .

(App. Br. 6-7.) Appellant (i) agrees that Marshall does teach a lancet ejector
that can eject a lancet, but (ii) disagrees that Marshall’s ejector can eject the
lancet without moving the lancet holder, and (iii) further contends that
Marshall appears to teach the opposite, i.e., causing the holding member to
move during ejection of the lancet. (Id. at 7-8.)
The Examiner responds that “the spring 22 of Marshall is positioned
specifically to prevent movement of the holder 20 during ejection,” and “the
only movement of the lancet holder 20 disclosed by Marshall is via the
hammer 29 and ring 30, during activation of the lancet 24.” (Ans. 8-9.)
Appellant replies that “[t]he Examiner can point to no disclosure in
MARSHALL which describes or shows how the lancet ejector can eject the
lancet 24 while the holding member 20 remains static. MARSHALL
specifically does not teach this feature. The Examiner has simply assumed or
opined that this occurs.” (Reply Br. 3.) Appellant contends that Marshall’s
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“spring 22 cannot prevent movement of the holder 20 if the force causing the
holder 20 to move is sufficient to cause compression of the spring 22. While
the spring 22 can prevent forward movement of the holder 20 when, for
example, the lancet device is not being used, this would not necessarily (or
likely) occur when the ejector is activated.” (Id. at 4.)
The issue with respect to this rejection is whether Marshall’s spring
22 prevents movement of the holder 20 during ejection.

Findings of Fact
1. Marshall described “a medical skin piercing device comprising a
barrel, means for carrying a lancet in the forward part of the barrel to
allow the tip of the lancet to advance from a retracted to a projection
position.” (Marshall, col. 1, ll. 22-26.)
2. Marshall’s “lancet carrying means may be a generally tubular member
with limited axial movement, into which a lancet fits from the forward
end and spring urged rearwardly normally to maintain a lancet tip
retracted.” (Id. at col. 1, ll. 56-60.)
3. Marshall explained: “To avoid handling a lancet after use, an ejector
rod can extend lengthwise of the barrel through the barrier and the
hammer and be movable forwards to eject a lancet from the carrying
means when the nose section is removed.” (Id. at col. 1, ll. 61-64.)
4. In Marshall’s device, “[a]n ejector rod 27 extends co-axially through
the barrel and beyond to the rear, and when the collar 13, with the
nose piece 15, is removed it can be pressed by rear end knob 28 to
snap the lancet forward out of the holder 20.” (Marshall, col. 3, ll. 14-
17.)
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5. Marshall’s Figure 7 is reproduced here:

{Figure 7 is a longitudinal section of Marshall’s lancet device.}
6. In Marshall’s Figure 7, 24 is the lancet, 20 is the lancet holder, and 22
is a light spring. The holder is “allow[ed] limited axial travel.”
(Marshall, col. 3, ll. 5-12.)

Analysis
A. Claim 1
The claim limitation in dispute reads:
a lancet ejector at least one of:
movable from an initial position to a lancet removal position
without movement of the holding member.

The phrase “an initial position” is critical but neither the Examiner nor
the Appellant provided an interpretation of this phrase. In our view, the
word “initial” refers to the position at the time ejection is initiated. Marshall
states that its lancet can be in a retracted position or in a projection position.
(FF 1.) It appears that in the ordinary course, a user could choose to eject
Marshall’s lancet from either position. Because the ordinary meaning of the
indefinite article “an” is plural, the claim covers at least two initial positions,
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i.e., ejection initiated when the lancet is retracted, and ejection initiated
when the lancet is projected.
Prior to use, Marshall’s lancet would be in the retracted position. (FF
2.) The retracted position is illustrated in Marshall’s Figure 7. (See FF 5.)
Thus, if ejection is initiated when the lancet is in the retracted position, the
holder 20 will also be in a retracted position as shown in Marshall’s Fig. 7,
and spring 22 would be in an extended state as shown in Fig. 7. Appellant
provides a cogent and concise explanation of how Marshall’s ejection device
works to eject the lancet from the retracted position. (Reply Br. 4-5.) We
find Appellant’s explanation more convincing than the Examiner’s
counterarguments. Nevertheless, the explanation is incomplete because it
fails to account for Marshall’s ejection from the lancet projection position.
Marshall explains how to eject the lancet from its carrying means after
use (FF 3), and it appears that after use the lancet would be in the projected
position. In the lancet projected position, spring 22 would be compressed,
and lancet holder 20 would be at the limit of its axial motion in the projected
direction, against a stop, with further motion blocked. When knob 28 is
pressed, ejector rod 27 will push against the lancet, but holder 20 will not
move because further axial travel in the projected direction is not possible,
and Appellant’s claimed limitation is met. Because Appellant’s claim refers
to “an” initial position, the claim covers plural initial positions from which
ejection can be initiated. The evidence is that Marshall’s device operates as
claimed when the lancet projected position is the initial position. We affirm,
but designate the affirmance as a new ground of rejection because the plural
position claim interpretation was not part of the rejection of record, and the
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rejection did not apply the evidence taking that embodiment of Marshall into
account.
Claims 2-4, 8-33, and 35-44 have not been argued separately and
therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
B. Claim 45
Claim 45 defines “[a] lancet device comprising . . . a biasing member
biasing the lancet ejector wherein the biasing member is one of: arranged
within the holding member; and biases a mechanism for setting a trigger.”
We agree with Appellant that the evidence does not support finding that the
references relied on taught or suggested either biasing member. (See App.
Br. 8-10.) The rejection of claim 45 is reversed.
C. Claims 46 and 47
Appellant argues each of claim 46 and claim 47 separately, but only
reapplies the arguments presented for claim 1 to each of claim 46 and 47.
(App. Br. 10-12 and 12-13, respectively.) The arguments remain
unpersuasive for the reasons discussed in part A above.
D. Claim 5
Claim 5 recites “an intermediate member non-removably connected to
the body and wherein the front cover is movably and removably connected
to the intermediate member.”
The rejection found that Schraga’s device included “a body 20C; . . .
and an intermediate member 20A.” (Ans. 4.) The rejection later stated that
“[m]ember 20C can be regarded as the intermediate member and 20A can be
regarded as the body.” (Id. at 5.) Appellant disagrees. (App. Br. 14.) The
Examiner responds that “the body member and the intermediate member
may be defined as the same piece of the device that is divided into two
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separate portions. . . . A single element of a device may have different
portions as well as many different uses.” (Ans. 9-10.) Elements 20A and
20C are shown in Schraga’s Figure 16. It is not apparent how the front
cover is connected to either. We therefore reverse.
E. Claim 6
Claim 6 recites “movement of the intermediate member adjusts a
depth of penetration of the lancet needle.”
Appellant argues that Schraga’s “body member 20A is not properly
characterized as the recited intermediate member,” and “it is member 20C
which moves for depth adjustment and not member 20A.” (App. Br. 15.)
The rejection identified both 20A and 20C as the intermediate member.
(Ans. 4-5.) As it is unclear which disclosures of Schraga were applied to
this claim, we reverse.
F. Claim 7
Claim 7 recites “a front cover removably mounted to an intermediate
member.” The rejection identified Schraga’s “front cover 50” (Ans. 4), and
found that “cover 50 can be threadingly attached to the body (20A in this
case; col. 10, lines 18-26)” (id. at 5.) Appellant contends that “the body
member 20A is not properly characterized as the recited intermediate
member” (App. Br. 16), and that Schraga “uses a body 20A and a front
cover 50 without any intermediate member” (id. at 17). We reverse the
rejection of claim 7 as unsupported by evidence.
G. Claim 34
Claim 34 recites “a front cover that rotates about an axis that runs
through a lancet opening and the holding member without changing an
overall length of the lancet device.” Appellant contends that Schraga
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“teaches a front cover 50 which does not rotate,” and although Marshall
“teaches a front cover 15 that can rotate, it appears that the overall length of
[Marshall’s device] would change upon rotation of the front cover 15.”
(App. Br. 17.) The Examiner responds that Schraga disclosed “cover 50 can
be threadingly attached to the body (20A in this case; col. 10, lines 18-26).”
(Ans. 10.) Schraga’s column 10, lines 18-26 does not state that cover 50 can
be threadingly attached to the body. We therefore reverse the rejection of
claim 34 for lack of evidence.

37 CFR § 41.50(b)
Regarding the affirmed rejection(s), 37 CFR § 41.52(a)(1) provides
“[a]ppellant may file a single request for rehearing within two months from
the date of the original decision of the Board.”
In addition to affirming the examiner's rejection(s) of one or more
claims, this opinion contains a new ground of rejection pursuant to 37 CFR
§ 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960 (August 12,
2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)). 37 CFR
§ 41.50(b) provides “[a] new ground of rejection pursuant to this paragraph
shall not be considered final for judicial review.”
37 CFR § 41.50(b) also provides that the appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
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(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the proceeding
will be remanded to the examiner. . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record. . . .

Should the appellant elect to prosecute further before the examiner
pursuant to 37 CFR § 41.50(b)(1), in order to preserve the right to seek
review under 35 U.S.C. §§ 141 or 145 with respect to the affirmed rejection,
the effective date of the affirmance is deferred until conclusion of the
prosecution before the examiner unless, as a mere incident to the limited
prosecution, the affirmed rejection is overcome.
If the appellant elects prosecution before the examiner and this does
not result in allowance of the application, abandonment or a second appeal,
this case should be returned to the Board of Patent Appeals and Interferences
for final action on the affirmed rejection, including any timely request for
rehearing thereof.

SUMMARY
We affirm the rejection of claims 1-4, 8-33, 35-44, 46, and 47 under
35 U.S.C. § 103(a) as unpatentable over Schraga and Marshall.
We reverse the rejection of claims 5-7, 34, and 45 under 35 U.S.C.
§ 103(a) as unpatentable over Schraga and Marshall.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
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AFFIRMED-IN-PART

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