Ex Parte Schraga

Patent Trial and Appeal Board

Sep 26, 2016

11548613 (P.T.A.B. Sep. 26, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111548,613 10/11/2006
7055 7590 09/28/2016
GREENBLUM & BERNSTEIN, PLC
1950 ROLAND CLARKE PLACE
RESTON, VA 20191
FIRST NAMED INVENTOR
Steven SCHRAGA
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
P30701 5661
EXAMINER
SIMPSON, SARAH A
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
09/28/2016 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):
gbpatent@gbpatent.com
greenblum.bernsteinplc@gmail.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEVEN SCHRAGA
Appeal2014-004204
Application 11/548,613
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims 1--4, 8-33, and 35--44 which are directed
to a lancet device. The Examiner twice rejected the claims as obvious under
35 U.S.C. § 103(a) (pre-AIA). We have jurisdiction under 35 U.S.C. § 134.
The obviousness rejection is affirmed.
STATEMENT OF CASE
This is the second time claims in this application have been appealed
to the Board. The first time, the claims were rejected by the Examiner under
35 U.S.C. § 103(a) (pre-AIA) as obvious in view of Schraga (US 6,156,051,
patented Dec. 5, 2000) and Marshall et al. (US 7,087,068 Bl, patented Aug.
8, 2006) ("Marshall"). See Appeal Brief dated Mar. 10, 2010. The rejection
Appeal2014-004204
Application 11/548,613
was appealed to the Board. The Board atlirmed the rejection in a Decision
entered Mar. 23, 2012 ("First Board Decision"). In affirming the rejection,
the Board set forth a new ground of rejection pursuant to 37 C.F.R.
§ 41.50(b) based on a different claim interpretation than the Examiner's.
First Board Decision 6. In response to the new ground of rejection,
Appellant requested that prosecution be reopened. Request to Reopen
Prosecution (Apr. 26, 2012). Appellant amended the claims at the same
time. Id.
Upon return of the application to the Examiner, the Examiner
maintained the rejection over claims 1--4, 8-33, and 35--44. Office Action
dated Jan. 31, 2013. Appellant once again appealed the Examiner's
rejection of the claims. Notice of Appeal (Apr. 30, 2013).
Because the claims were not argued separately, we select claim 1 as
representative. Claims 2--4, 8-33, and 35--44 fall with claim 1.
Claim 1, with amendments underlined relative to the original appealed
claim, is reproduced below:
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 and after the
holding member moves to an extended position;
movable from an initial position to a lancet removal
position without movement of the holding member and before
the holding member moves to an extended position;
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Application 11/548,613
movable from an initial position to a lancet removal
position without movement of the holding member and when
the holding member is not in an extended position;
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.
REJECTION
The claimed invention is directed to a lancet device comprising a
body, a holding member for receiving a lancet, and a lancet ejector. The
lancet ejector is required by the claim to have at least one of five listed
functional limitations. A functional limitation is a limitation that recites a
function but not the structure for carrying out the function.
The Examiner found that Schraga describes a lancet device with the
structural limitations of independent claim 1 and the claims which depend
from it. Office Action (Jan. 31, 2013) 3-5. The Examiner found that
Schraga does not describe its device having the functional limitation of a
lancet ejector which is "movable from an initial position to a lancet removal
position without movement of the holding member and after the holding
member moves to an extended position" as required by all of the rejected
claims. Id. at 5. However, the Examiner found that Marshall describes a
lancet ejector that performs this function. Id. at 5---6. The Examiner
determined that it would have been obvious to one of ordinary skill in the art
to modify Schraga's lancet device with Marshall's lancet ejector to provide
for removal of the lancet without handling it in order to decrease the risk of
accidental puncture. Id. at 6.
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Appellant contends that the Examiner erred in finding that Marshall
describes a lancet ejector which is "movable from an initial position to a
lancet removal position without movement of the holding member and after
the holding member moves to an extended position." Appeal Br. 6 (July 1,
2013). The rejection turns on the question of whether Marshall's lancet
ejector has a structure that performs the recited function. Because this
limitation is in dispute, we first begin with claim interpretation.
CLAIM INTEPRETATION
"During [patent] examination, 'claims ... are to be given their broadest
reasonable interpretation consistent with the specification, and ... claim
language should be read in light of the specification as it would be
interpreted by one of ordinary skill in the art."' In re Am. Acad. of Sci. Tech
Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004) (cited in In re Montgomery, 677
F.3d 1375, 1379 (Fed. Cir. 2012).
The claim requires the lancet device to have a lancet ejector which is
"movable from an initial position to a lancet removal position without
movement of the holding member and after the holding member moves to an
extended position." The limitation has a two part requirement.
First, the lancet ejector must move from an "initial position" to a
"lancet removal position" without movement of the holding member. The
"lancet removal position" is the position where the lancet is removed from
the holder after it has been used to puncture the skin of a subject. Spec. 81
(i-f 150). This action is accomplished without moving the holding member.
As explained in the Specification, the structure of the lancet removal system
is such that it "operates independently of the puncturing system of the lancet
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device LD. That is, the lancet device LD can be used and reused without
ever using the lancet removal system." Id. at 82: 5-7.
Second, the lancet ejector is moved to the lancet removal position
"after the holding member moves to an extended position." This limitation
was added to the claim after the First Board Decision. Claims (dated Apr.
26, 2012). The "extended position" of the lancet "holding member" is when
the lancet is in the puncturing position. Spec. 16 (i-f 74) (Fig. 4 description),
17 (Fig. 12 description). The Specification teaches that the lancet holding
member moves from the retracted position to the extended, puncturing
position. Id. at 19 (Fig. 36 description), 20 (Fig. 41 description).
The limitation states that the ejector is moved to the removal position
"after the holding member moves to an extended [puncturing] position."
Appellant contends that the amendment "make[s] clear that ejection does not
occur when the lancet device is in the puncturing position or occurs in a
position other than the puncturing position." Appeal Br. 8. However, this
interpretation is not consistent with the plain language of the claim.
Specifically, the claim specifies the time when the ejector is moved to the
removal position, namely, "after the holding member moves to an extended
[puncturing] position," but not the position of the holding member when the
ejector is moved to the removal position. If the holding member remains in
the extended, puncturing position when the ejector is moved to the removal
position, the claim language is satisfied because the holding member has
moved to an extended position as required by the claim. If the holding
member "moves to an extended position" and then returns to the retracted or
other intermediate position, the claim language is also satisfied because the
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temporal limitation that the ejector is moved to the removal position "after
the holding member moves to an extended position" is met.
Appellant asserts that the interpretation that holder remains in the
puncturing position is not reasonable or proper, but Appellant does not
sufficiently explain how the claim language, when read in view of the
Specification, excludes such an interpretation. Appeal Br. 8. Appellant did
not identify what disclosure in the Specification mandates the interpretation
that the holding member is not in the extended, puncturing position when the
ejector is moved to the removal position.
First Board Decision and Amendment
It was clear in the First Decision that the Board construed "movable
from an initial position to a lancet removal position without movement of
the holding member" to read on the holding member in the extended,
puncturing position. First Board Decision 6. Based on this interpretation,
the Board affirmed the rejection. Id. Appellant acknowledged that the
Board had read the claim in this way. Appeal Br. 6. In response to the
Board's interpretation and rejection, Appellant amended the claim by adding
"and after the holding member moves to an extended position." Despite this
amendment, the Examiner maintained the rejection (Office Action 5---6)
because the Examiner did not consider the amendment to have changed the
interpretation of the claim by excluding the holding member from being in
the extended, puncturing position (Answer 3). As explained above, we
agree with the Examiner's interpretation and find it to be the "broadest
reasonable interpretation" of the claim language. In re Am. A cad. of Sci.
Tech Ctr., 367 F.3d at 1364.
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"An essential purpose of patent examination is to fashion claims that
are precise, clear, correct, and unambiguous. Only in this way can
uncertainties of claim scope be removed, as much as possible, during the
administrative process." In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989).
[T]he PTO gives a disputed claim term its broadest reasonable
interpretation during patent prosecution .... The "broadest
reasonable interpretation" rule recognizes that "before a patent
is granted the claims are readily amended as part of the
examination process." Burlington Indus. v. Quigg, 822 F.2d
1581, 1583 (Fed. Cir. 1987). Thus, a patent applicant has the
opportunity and responsibility to remove any ambiguity in
claim term meaning by amending the application.
In re Bigio, 381F.3d1320, 1324 (Fed. Cir. 2004).
In this case, it was evident from the Office Action of Jan. 31, 2013
that the Examiner determined that the amended claim read on the holding
member in the extended, puncturing position. Appellant did not address this
by further amending the claim or providing an adequate explanation as to
why the Examiner erred in the interpretation of the claim.
DISCUSSION
Because we have interpreted the claim to read on embodiments in
which the lancet holder is in the extended, puncturing position, the issue is
whether Marshall teaches a lancet ejector which is "movable from an initial
position to a lancet removal position without movement of the holding
member" when the holder is in the puncturing position.
The Board in the First Board Decision explained:
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
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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.
First Board Decision 6.
Finding of Fact 3 from the First Board Decision is reproduced below:
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, 11. 61-64.)
Appellant contends:
In MARSHALL, ejection (or movement of the ejector) cannot
... occur when the holding member is in the puncturing
position, as this position is a very momentary position
(occurring in a fraction of a second).
More importantly, the previous interpretation of the
Board should be considered in the context of the real world.
Appellant believes that ejection during puncturing is unsafe, to
say the least, makes no sense, is impossible in the device of
MARSHALL, and, because the puncturing position typically
occurs in a fraction of a second, is at best improbable and more
likely requires superhuman abilities. When a typical lancet
device is triggered, the lancet is moved to the puncturing
position and back - in a fraction of a second. The puncturing
position is thus achieved only momentarily. In the device of
MARSHALL, this is what appears to in fact happen. Indeed,
MARSHALL describes this action with words such as "shoots"
(see col. 2, line 24)- as in shooting the lancet forward, and
describes the trigger-set position as a "ready-to-fire position"
(see col. 4, line 8)-the word "fire" is appropriate. Such
language clearly implies a very fast puncturing movement of
the lancet - which is typical of lancet devices. This is all the
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more improbable when one considers the fact that one would
have to also remove the cover during puncturing.
Appeal Br. 7.
Appellant has not provided adequate evidence that the Board, in the
statement of the rejection in the First Board Decision, which was
subsequently adopted by the Examiner, erred.
Appellant contends that after the lancet holder "shoots" or "fires," it
moves back from the puncturing position. Id. However, Appellant has not
provided a definition of "shoots" and "fires" that would require the holding
member to move back to its original position after being fired or shot. Nor
has Appellant provided support for this argument in Marshall. Appellant
asserts what happens when a "typical lancet device is triggered," but has not
presented evidence to substantiate this assertion. An argument made by
counsel in a brief does not substitute for evidence lacking in the record.
Estee Lauder, Inc. v. L 'Orea!, S.A., 129 F.3d 588, 595 (Fed. Cir. 1997).
We do not agree with Appellant that there is no support for the
"assertion that 'the lancet would still be in the projected or puncturing
position' after use or removal of the front cover." Reply Br. 2. In Finding
of Fact 3, reproduced above, Marshall states: "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." This statement
explicitly states that lancet removal is accomplished after the lancet device is
used. The use of the lancet device would require the lancet to move into the
extended, puncturing position. Thus, absent evidence that the lancet holding
member retracts or moves to another position, the Examiner reasonably
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found that it would remain in the extended, puncturing position. Appellant
did not identify disclosure in Marshall that rebuts the Examiner's position.
Appellant also argues that the cover of the lancet device has to be
removed to eject the lancet and that the lancet cannot be used with the cover
removed. Appeal Br. 6. Appellant contends that "one of ordinary skill in
the art knows that he/she cannot use a lancet device of the type disclosed in
MARSHALL with the cover removed .... Thus, all the evidence of record
demonstrates that the lancet ejector or MARSHALL cannot and is not
designed to eject a lancet when in the puncturing position." Id.
This argument is unavailing. The lancet device is not being used
during ejection of the lancet. Appellant states that lancet cannot be removed
safely if it were in the puncturing position, but does not explain why. Reply
Br. 4--5. Handling of the lancet is not necessary because Marshall's ejector
ejects the lancet from the holder. Consequently, we do not understand why
the requirement that the cover be removed precludes the holding member
from being in the extended, puncturing position when the lancet is ejected.
In sum, the rejection of claim 1 is affirmed because Appellant did not
identify, by a preponderance of the evidence, reversible error in the
Examiner's rejection. Claims 2--4, 8-33, and 35--44 fall with claim 1
because separate reasons for their patentability were not provided. 3 7 C.F .R.
§ 41.37(c)(iv).
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)(l )(iv).
AFFIRMED
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