Ex Parte Schraga

Patent Trial and Appeal Board

Apr 19, 2018

13458468 (P.T.A.B. Apr. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/458,468 04/27/2012
7055 7590 04/23/2018
GREENBLUM & BERNSTEIN, P.L.C.
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.
P41730 3763
EXAMINER
FERNANDES, PATRICK M
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
04/23/2018 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 1
Appeal2017-005835
Application 13/458,468
Technology Center 3700
Before ERIC B. GRIMES, RYAN H. FLAX, and TIMOTHY G. MAJORS,
Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a fluid
collection/injection device, which have been rejected as anticipated or
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification states that the "invention relates generally to
devices used to collect fluid samples from and/or inject fluids into patients.
More specifically, this invention relates to a device which utilizes a holder
1 Appellant identifies the Real Party in Interest as Stat Medical Devices, Inc.
Br. 3.
Appeal2017-005835
Application 13/458,468
having a double-ended needle that can be released or removed from the
holder in a more safe and easy manner." Spec. i-f 2.
Claims 1-17, 21, and 22 are on appeal. Claim 1 is illustrative and
reads as follows (emphasis added to disputed limitation):
1. A fluid collection/injection device comprising:
a body having a front end, a back end, and a main hollow section
arranged between the front and back ends;
a needle hub securing section arranged on the front end and being
structured and arranged to receive therein a needle member;
the fluid collection/injection device is structured and arranged to
utilize at least an installation mode, an operational mode, and a post-use
mode;
in the installation mode, the needle member being coupled to the body
via the needle hub securing section;
in the operational mode, fluid passing through the needle member and
into or out of a receptacle inserted into the main hollow section; and
in the post-use mode, a safety cover at least one of:
prevents removal of the needle member from the fluid
collection/injection device;
prevents removal of the needle member from the needle hub
securing section;
activates release of the needle member from the body such that
when the safety cover is in a position covering a needle of the needle
member, the needle member can fall out of the needle hub securing section;
activates release of the needle member from the body such that
when the safety cover is in a position covering a needle of the needle
member, the needle member is no longer securely retained to the needle hub
securing section;
releases a securing engagement between the needle member and
the needle hub securing section;
unlocks a locking connection between the needle member and
the needle hub securing section; and
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Application 13/458,468
moves a mechanism arranged in an area of the needle hub
securing section which releases a connection between the needle member
and the needle hub securing section.
Claims 21 and 22 are the only other independent claims. Claim 21 is
directed to a fluid collection device and claim 22 is directed to a needle
assembly. Claims 21 and 22 recite the same functions of the safety cover as
recited in claim 1.
The claims stand rejected as follows:
Claims 1-17, 21, and 22 under 35 U.S.C. § 102(b) as anticipated by
Leong2 (Ans. 2) and
Claims 3-9 under 35 U.S.C. § 103(a) as obvious based on Leong and
Payne 3 (Ans. 4).
DISCUSSION
The Examiner has rejected all of the claims on appeal as anticipated
by Leong, and has rejected claims 3-9 as obvious based on Leong and
Payne. The same issue is dispositive for both rejections.
The Examiner finds that Leong discloses a device meeting all of the
limitations of independent claims 1, 21, and 22. Ans. 2-3. In particular, the
Examiner finds that "in the post-use mode, a safety cover ( 60) ... activates
release of the needle member from the body such that when the safety cover
is in a position covering a needle of the needle member, the needle member
can fall out of the needle hub securing section (Figure 5)." Id. at 3.
2 Leong et al., US 7,163,526 B2, issued Jan. 16, 2007.
3 Payne et al., US 6,551,288 B2, issued Apr. 22, 2003.
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Application 13/458,468
Appellant argues that
moving the safety cover 60 of LEONG to the closed position
shown in Fig. 5 causes or actuates nothing which would result
in release or removal of the needle member. Instead, it merely
results in the safety cover 60 covering the needle 30 so that a
user can thereafter safely remove (by unthreading) the needle
member 10 from the holder 86. In other words, in LEONG,
moving the safety cover to the needle covering position
accomplishes or results in only the safe covering of the needle
whereas, in the invention, moving the safety cover to the needle
covering position accomplishes or results in both the safe
covering of the needle and activation of release of the needle
member.
Br. 11.
We agree with Appellant that the rejections on appeal are based on an
unreasonably broad claim interpretation. The Examiner reasons that
Leong's device includes a safety cover that "activates release of the needle
member from the body such that when the safety cover is in a position
covering a needle of the needle member, the needle member can fall out of
the needle hub securing section," as recited in the independent claims,
because "the cover of Leong moving into the closed position causes the
ability for the needle member to fall out of the needle hub securing section
by allowing it the ability to start being unthreaded and be removed and thus
'fall out'." Ans. 6.
The Specification states that the disclosed device includes "a
deflectable element 20 having an activatable portuion [sic] AP and a
movable jaw or retaining portion 25 . ... [W]hen the user moves the
deflectable portion 21, the movable jaw 25 coupled thereto moves to the
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Appeal2017-005835
Application 13/458,468
open position so that needle assembly NA can disengage from the interface
NRS and fall out of the body 10." Spec. i-f 35.
The Specification similarly states that, to put the disclosed device in
the post-use position, "the user simply grips the shield 60 and rotates or
pivots it." Id. i-f 3 7. This movement of the shield
Id.
simultaneously and/or automatically causes the portion 25 of
the body 10 retaining the needle assembly NA to disengage
there from. This is as a result of the shoulder or wall 63
contacting and causing movement of the activating projection
AP .... The needle assembly NA can now be removed safely
from the body 10 by simply pulling it off or allowing it to drop
out (under the force of gravity).
Read in light of the Specification, therefore, the claim limitation
stating that the safety cover activates release of the needle member "such
that when the safety cover is in a position covering a needle of the needle
member, the needle member can fall out of the needle hub securing section"
requires the cover, when closed, to release the needle member so that it can
fall out of the device under the force of gravity. The Examiner's
interpretation of "fall out" as allowing the needle "the ability to start being
unthreaded and be removed" (Ans. 6) is broader than is reasonable when the
claim language is read in light of the Specification.
Leong discloses a "shieldable fluid collection needle assembly" that
includes a hinged shield. Leong 2:38-39, 3:27-28. "[T]he shield can be
rotated from the open position to a closed position where the shield
surrounds the distal cannula," or needle. Id. at 3 :35-37.
Leong describes use of its device as follows: "Needle assembly 10 is
used by first separating NP [non-patient] shield 84 from collar 50 and then
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Application 13/458,468
threading distal end 14 of housing 12 into a needle holder 86. Shield 60 then
is rotated into the fully open position." Id. at 6:33-36. "After collecting the
last sample of blood, the phlebotomist ... exerts pressure with a thumb or
forefinger on top wall 68 of shield 60. As a result, shield 60 rotates about
hook 56 into a closed position." Id. at 6:55-59. Shield 60 locks in the
closed position and "[ t ]he safely shielded needle assembly then can be
discarded in a sharps receptacle." Id. at 6:64 to 7:3.
We agree with Appellant that Leong' s description indicates that
"moving the safety cover to the needle covering position accomplishes or
results in only the safe covering of the needle." Br. 11. The Examiner has
not pointed to any disclosure in Leong indicating that closing the safety
cover (or shield) of its device activates release of the needle member such
that the needle member can fall out of the needle hub securing section. Nor
has the Examiner provided a persuasive explanation of why that limitation,
under the broadest reasonable interpretation, is inherently met by Leong' s
device.
In summary, the Examiner has not shown that independent claims 1,
21, and 22 are anticipated by Leong. See Verdegaal Bros., Inc. v. Union Oil
Co., 814 F .2d 628, 631 (Fed. Cir. 1987) ("A claim is anticipated only if each
and every element as set forth in the claim is found, either expressly or
inherently described, in a single prior art reference."). We therefore reverse
the rejection of those claims, and dependent claims 2-17, under 35 U.S.C.
§ 102(b) based on Leong.
With regard to the rejection of claims 3-9 under 35 U.S.C. § 103(a),
the Examiner cites Payne only for limitations of the dependent claims, and
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does not point to any disclosure in Payne that makes up for the deficiency in
Leong discussed above. See Ans. 4--5. We therefore reverse the rejection of
claims 3-9 under 35 U.S.C. § 103(a) based on Leong and Payne for the
reasons discussed above.
SUMMARY
We reverse both of the rejections on appeal.
REVERSED
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