Eugene Prais et al.

Patent Trials and Appeals Board

Sep 30, 2019

14204190 - (D) (P.T.A.B. Sep. 30, 2019)

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.
14/204,190 03/11/2014 Eugene Prais BHDDX-084/US/01 1104
74144 7590 09/30/2019
Dugan & Dugan, PC
Brian M. Dugan, Ph.D.
245 Saw Mill River Road
Suite 309
Hawthorne, NY 10532
EXAMINER
MELHUS, BENJAMIN S
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
09/30/2019 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):
bdugan@duganpatent.com
duganemail@duganpatent.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EUGENE PRAIS, ROBERT S. SAMS, and SIMIN YAO
Appeal 2018-003644
Application 14/204,190
Technology Center 3700
Before JENNIFER D. BAHR, EDWARD A. BROWN, and
RICHARD H. MARSCHALL, Administrative Patent Judges.
MARSCHALL, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant,1 Bayer Healthcare LLC,
appeals from the Examiner’s decision to reject claims 1–4, 6–8, and 21–33.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “Applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as Ascensia
Diabetes Care Holdings AG. Appeal Br. 2.
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Application 14/204,190

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CLAIMED SUBJECT MATTER
The claims are directed to a lancing device. Claims 1 and 32 are
independent. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A lancet device comprising:
a base having first external threads, a first opening and a
second opening;
a lancet comprising a needle having a tip and having a
position relative to the base, the lancet received in the base
through the first opening and attached to the base via second
threads at the first opening allowing the lancet to be adjustably
positioned within the base, the tip of the needle protruding
through the second opening; and
a flexible member having an aperture, the flexible member
positioned over the second opening;
wherein the flexible member is arranged relative to the
needle so that when a sufficient force is applied to the flexible
member, the flexible member transitions from a first
configuration to a second configuration, and wherein the tip of
the needle protrudes from the aperture of the flexible member
while the flexible member is in the second configuration.
REFERENCES
The prior art relied upon by the Examiner is:
Mohammad M.B.B.S. US 6,379,337 B1 Apr. 30, 2002
Olson
Brown
Allen
US 2006/0184189 A1
US 2011/0184448 A1
US 2012/0323142 A1
Aug. 17, 2006
July 28, 2011
Dec. 20, 2012
REJECTIONS
Claims 1–4, 6, 7, and 25– 32 are rejected under pre–AIA 35 U.S.C.
§ 103(a) as being unpatentable over Olson in view of Mohammad. Final
Act. 3.
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Claims 8, 21–24, and 33 are rejected under pre–AIA 35 U.S.C.
§ 103(a) as being unpatentable over Olson in view of Mohammad, Brown,
and Allen. Final Act. 8.
OPINION
Claim 1
In the rejection of claim 1, the Examiner finds that Olson teaches the
majority of the limitations, including threaded portions 204, 206 and rear
housing portion 208 that correspond to the claimed base, and “lancet
mechanism 212” within that base. Final Act. 4; Olson ¶ 76, Fig. 12. The
Examiner also finds that Olson “does not teach attaching the lancet
mechanism to the base via second threads.” Id. The Examiner finds that
Mohammad teaches a lancet attached to a base via second threads and
“allowing the lancet to be adjustably positioned within the base.” Id. The
Examiner determined that it would have been obvious “to modify the base
and lancet mechanism of Olson by further incorporating the second threads
of Mohammad to allow removal and replacement of the lancet mechanism
should it become contaminated or damaged.” Id.
Appellant argues that Olson emphasizes how its lancet mechanism
212 moves with respect to its housing, which includes portions 204, 206,
208—the structures the Examiner relies on with respect to the claimed base.
Appeal Br. 6–7. Appellant also argues that “Olson is directed to a lancing
device wherein a lancet is ‘driven,’ ‘fired,’ or ‘launched’ to puncture a bulge
of dermal tissue created by engagement of a cap of Olson’s lancing device
against the dermal tissue.” Appeal Br. 7 (citing Olson ¶¶ 4, 9, 10, 67).
According to Appellant, attaching lancet mechanism 212 to Olson’s housing
via threads, as the Examiner proposes in the rejection, results in an
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inoperative lancing device “because lancet mechanism 212 would not be
able to be driven, fired, or launched.” Id.; see also Reply Br. 5. Appellant
further argues that the proposed modification of Olson would change its
principle of operation “from a lance that’s driven, fired, or launched to one
where the lance is stationary during a fluid sample collection procedure.”
Appeal Br. 8.
In response, the Examiner finds that “Olson’s disclosure of [the]
lancet being movable with respect to the housing is not an explicit counter-
teaching to the incorporation of threads for attaching a lancet to a housing as
taught by Mohammad.” Ans. 11. The Examiner also finds that the “state of
the pertinent art at the time the invention was made well and reasonably
contemplates the usage of threaded portions to connect a mobile component
to a stationary component; the incorporation of attachment threads does not
explicitly restrict the movement of, for example, a lancet within a housing.”
Id. The Examiner further finds that the “combination of the firing operation
of Olson and the threaded attachment of Mohammad can be accomplished in
such a way, using ordinary skill in the pertinent art, that the movement of the
lancet 212 relative to the housing of Olson is still possible.” Id.
In its Reply, Appellant argues that “attaching Olson’s lancet
mechanism 212 to its ‘base’ (i.e., either rear housing portion 208 or threaded
portion 206) via threads would likely render Olson’s lancing device at least
ineffective, if not inoperative, because lancet mechanism 212 would not be
able to be driven, fired, or launched.” Reply Br. 5. Appellant argues that
the Examiner misunderstands how Olson’s device works, and how threading
lancet mechanism 212 in place would render it ineffective and inoperable.
Id. at 5–6.
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We agree with Appellant. The Examiner’s finding that one of
ordinary skill in the art could add a threaded connection between lancet
mechanism 212 and Olson’s “base,” and maintain the relative movement of
lancet mechanism 212 necessary to preserve Olson’s function, lacks an
adequate foundation. The Examiner finds that it “is still possible” to allow
for relative movement between Olson’s lancet mechanism 212 and its base,
even after adding a threaded connection, but does not explain how one of
ordinary skill in the art would make this modification, or provide any further
explanation. Ans. 11. Olson’s pertinent disclosure describes a “spring
loaded” lancet, driven along an axis on release of the spring to puncture a
patient’s skin. Olson ¶ 4. In order to work, the lancet must be allowed to
move relative to the surrounding housing and threaded portions. See id. at
¶¶ 76–77, Figs. 12A, 12B. Adding a fixed, threaded connection between
lancet mechanism 212 and any of Olson’s surrounding structures such as
housing portion 208 would appear to fix lancet mechanism 212 in place with
respect to those structures, rendering the device inoperable for its intended
purpose as Appellant alleges. To the extent it remains “possible” to
somehow retain Olson’s required movements even after adding the threaded
connection, as the Examiner finds, the Examiner does not provide adequate
evidence and explanation to support such a finding.
Under these circumstances, where the stated basis for the proposed
combination lacks an adequate foundation, we do not sustain the rejection of
claim 1. See McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1354 (Fed.
Cir. 2001) (quoting In re Sponnoble, 405 F.2d 578, 587 (CCPA 1969)) (“If
references taken in combination would produce a ‘seemingly inoperative
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device,’ we have held that such references teach away from the combination
and thus cannot serve as predicates for a prima facie case of obviousness.”).
Remaining Claims
The pertinent limitations in independent claim 32 are nearly identical
to those in claim 1. See Appeal Br. 15 (Claims App.). For claim 32, the
Examiner relies on the same findings, and Appellant relies on the same
arguments, as those made with respect to claim 1. See Final Act. 3–5, 7–8;
Appeal Br. 10. Accordingly, we do not sustain the rejection of claim 32 for
the same reasons as claim 1.
For the remaining dependent claims, Appellant relies on the same
arguments made with respect to claims 1 and 32. See Appeal Br. 10–11.
The Examiner’s findings made with respect to the dependent claims do not
address the deficiencies in the rejection of claim 1 we addressed above. See
Final Act. 5–9. Accordingly, we do not sustain the rejections of dependent
claims 2–4, 6–8, 21–31, and 33.
DECISION
We reverse the decision of the Examiner to reject claims 1–4, 6–8,
and 21–33.

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DECISION SUMMARY
Claims
Rejected
Basis  Affirmed Reversed
1–4, 6, 7, 25–32 § 103(a) Olson,
Mohammad 
1–4, 6, 7, 25–32
8, 21–24, 33 § 103(a) Olson,
Mohammad, Brown,
and Allen 
8, 21–24, 33
Overall
Outcome
1–4, 6–8, and 21–33
REVERSED