Ex Parte SCHRAGA

Patent Trial and Appeal Board

Apr 4, 2016

13100838 (P.T.A.B. Apr. 4, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/100,838 05/04/2011
7055 7590 04/06/2016
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.
P39896 3791
EXAMINER
SCHMIDT, EMILY LOUISE
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
04/06/2016 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
Appeal2014-002892
Application 13/100,838
Technology Center 3700
Before CHARLES N. GREENHUT, MICHAEL L. HOELTER, and
ERIC C. JESCHKE, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from a final
rejection of claims 1-24. App. Br. 3. We have jurisdiction under 35 U.S.C.
§ 6(b ).
We AFFIRM-IN-PART.
THE CLAIMED SUBJECT MATTER
The disclosed subject matter "relates generally to syringes, e.g.,
hypodermic syringes, such are utilized for injection of medicament into the
body tissues of human and animal patients." Spec. i-f 2. Claims 1, 15, 16,
Appeal2014-002892
Application 13/100,838
21, and 22 are independent. Claim 1 is reproduced below and is illustrative
of the claims on appeal:
1. A single-use injection device comprising:
a barrel;
a plunger having a portion structured and arranged to
move within the barrel and a frangible member arranged within
the plunger at a location that is axially spaced from a proximal
end of the plunger;
a needle connecting arrangement that comprises a needle
connecting interface adapted to mate with a needle interface, a
biasing member, and a body; and
said body one of:
containing at least one deflectable member
movable between an initial position and a position
allowing the needle connecting interface to retract into
the barrel under action of the biasing member;
being capable of being installed on the barrel by a
user prior to use; and
being capable of being non-removably connected
with the barrel by a user.
REFERENCES RELIED ON BY THE EXAMINER
Botich US 4,994,034 Feb. 19, 1991
Kaufuold US 5, 125,898 June 30, 1992
Tenhuisen US 2003/0004491 Al Jan. 2, 2003
Crawford US 2005/0159705 Al July 21, 2005
THE REJECTIONS ON APPEAL
Claims 1--4, 6-14, and 20 are rejected under 35 U.S.C. § 102(b) as
anticipated by Botich.
Claim 5 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Botich and Tenhuisen.
Claims 15, 16, 19, and 21-24 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Botich and Crawford.
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Application 13/100,838
Claims 17 and 18 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Botich, Crawford, and Kaufhold.
ANALYSIS
The rejection of claims 1--4, 6-14, and 20 as anticipated by Botich
Independent claim 1 (and hence dependent claims 2--4, 6-14, and 20)
includes limitations directed to a "frangible member" and a "plunger." The
Examiner correlates these structures, respectively, to Botich's "frangible end
65" and "plunger 59." Final Act. 2; see also Botich 7:40--42. Claim 1
further specifies that the frangible member is "arranged within the plunger."
Appellant contends that Botich's "frangible member 65 is arranged outside
of the plunger 73 (see Fig. 4) and is not arranged within the plunger" as
recited. 1 App. Br. 9; see also Reply Br. 2-3. Appellant draws this
conclusion because Botich teaches that the plunger has a cavity 71 and that
this cavity allows "a frangible end 65 to enter the cylindrical cavity 71."
Botich 7: 19-24; App. Br. 9. According to Appellant, "[t]his language
implies that the member 65 is not already disposed within the cylindrical
cavity to start with." App. Br. 9 (referencing Botich Fig. 4).
The Examiner relies on figure 3 of Botich as disclosing this limitation
(Final Act. 2) and although Appellant references figure 4 of Botich (App. Br.
9), they both disclose the same arrangement. These figures illustrate
frangible member 65 connected to an end of plunger 59 via a frangible
circumferential groove 69. See also Botich Figs. 1 and 2. Member 65 is
shown in these figures as being, at best, flush with and extending beyond the
1 Appellant seems to confuse item 73 with item 59. We will presume
Appellant is referencing Botich's plunger when employing numeral 73. See
Botich 7:50-54; Figs. 1-3.
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Application 13/100,838
end of plunger 59. The Examiner states that Botich meets this limitation
because Botich figure 3 "shows the frangible member to be connected within
the walls of the plunger." Ans. 3. In other words, it appears the Examiner is
equating an end connection, even if flush with the end, with the limitation of
the "member arranged within the plunger." The Examiner does not
elaborate further and we are not persuaded that this is, indeed, the case.
As if to emphasize this "within" limitation, claim 1 also includes the
limitation that the frangible member is "at a location that is axially spaced
from a proximal end of the plunger. "2 The Examiner finds the frangible
member located as claimed by reasoning that the recited proximal end is
"generally in the area of 61." Ans. 3. However, piston 61 is located along
the plunger in an area that is inset or spaced from the proximal end of the
plunger. See Botich Figs. 1--4. The Examiner does not explain how
Botich's member 65, located at an end of the plunger, can be said to meet
the limitation of being "at a location that is axially spaced from a proximal
end of the plunger."
Based on the record presented, we agree with Appellant that
"BOTICH clearly lacks these features." App. Br. 10. We reverse the
Examiner's rejection of claim 1 and dependent claims 2--4, 6-14, and 20 as
being anticipated by Botich.
The rejection of claim 5 as unpatentable over Botich and Tenhuisen
Claim 5 depends from claim 1 and includes the additional limitation
of employing a "synthetic resin material." The Examiner relies on
Tenhuisen for disclosing this limitation. Final Act. 4. The Examiner does
2 The proximal end of the plunger is adjacent the needle. See Spec. i-f 35.
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Appeal2014-002892
Application 13/100,838
not rely on Tenhuisen for curing the defect of Botich discussed supra with
respect to claim 1. We reverse the rejection of claim 5 as being unpatentable
over Botich and T enhuisen.
The rejection of claims 15, 16, 19, and 21-24
as unpatentable over Botich and Crawford
Appellant addresses each of these claims separately. We likewise
address each of these claims.
Claim 15
Independent claim 15 includes a limitation directed to "a needle
member having a standard needle connecting interface." Emphasis added.
The Examiner acknowledges that Botich "does not specifically teach how
the needle is attached within 11" and finds that Crawford teaches "various
equivalent means for attaching a needle within a hub including various
standard interfaces, for example, friction fit ([0026])." Final Act. 5. The
Examiner concludes that it would have been obvious "to use friction fit as
the needle interface in Botich et al. because Crawford et al. teach[ es] it is
one of several equivalent needle connecting means." Final Act. 5.
Appellant states that the claim term "standard needle connecting
interface" has been defined in the Specification. App. Br. 14. Appellant's
Specification states:
In embodiments, the standard needle interface is a luer-
lock interface. In embodiments, the standard needle interface
relies substantially only upon contact between tapered surfaces.
In embodiments, the standard needle interface relies
substantially only upon friction fit contact.
Spec. i-f 18. Hence, according to Appellant's Specification, at least one type
of standard needle interface relies substantially upon friction fit contact. It is
not disputed that Crawford teaches a method of attachment using "friction
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Application 13/100,838
fit." Crawford if 26. Based on Crawford, the Examiner "maintains a friction
fit is a standard connection." Ans. 4. Appellant disagrees with the
Examiner clarifying that a "standard connecting interface is one that [] has
been adopted in the art or industry as a standard." Reply Br. 4. However,
this interpretation of "standard" by Appellant in the Reply Brief is not
consistent with how this term is employed in Appellant's Specification. In
Appellant's Specification, the term "standard" is treated as being equivalent
to "universal." Spec. if 64 ("universal or standard receiving interface").
Accordingly, the Examiner's reliance on Crawford for disclosing a standard
(or universal) means of needle attachment involving a friction fit is not
unreasonable.
Appellant further contends that "[h ]owever reasonable it may be to
interpret Fig. 5 of BOTICH as teaching a so-called interface 33, this opening
33 is manifestly not a standard needle connecting interface." App. Br. 14.
However, as stated by the Examiner with respect to the rejection of claim 1,
"[t]he Examiner does not find member 33 to be the needle connecting
interface" but instead "the Examiner finds the needle connecting interface to
be member 11." Ans. 3. Hence, Appellant's focus on item 33 in disputing
the Examiner's rejection is not persuasive of Examiner error.
Appellant also contends that Botich and Crawford do not "appreciate
an advantage" of the claimed "standard needle connecting interface." App.
Br. 14. However, Appellant does not identify where any such advantage is
specifically recited and as such, Appellant's identification of an "advantage"
arising from such an interface is not persuasive of Examiner error.
We sustain the Examiner's rejection of independent claim 15 as being
unpatentable over Botich and Crawford.
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Appeal2014-002892
Application 13/100,838
Claims 16 and 19
Independent claim 16 includes the limitation of a needle "having an
interface adapted to mate with a standard needle interface." Appellant
focuses on the "standard needle interface" claim language and relies on
arguments similar to those previously discussed with respect to claim 15
supra. App. Br. 15. Appellant also repeats the "appreciate an advantage"
argument which was also found not to be persuasive of Examiner error.
Of particular interest, claim 19 depends from claim 16, and claim 19
includes the additional limitation "wherein the standard needle interface
relies substantially only upon friction fit contact." See also Ans. 4. Because
parent claim 16 is directed to a "standard needle interface," then this claimed
phrase must encompass, via claim differentiation, an interface that "relies
substantially only upon friction fit contact." This determination is consistent
with the Examiner's finding that "a friction fit is a standard connection."
Ans. 4. Accordingly, we sustain the Examiner rejection of independent
claim 16 and dependent claim 19 as being unpatentable over Botich and
Crawford.
Claims 21 and 22
Both independent claims 21 and 22 include the limitation of "a needle
unit comprising a standard interface." With respect to both claims,
Appellant relies on arguments previously presented and which have not been
found to be persuasive. App. Br. 16-18. We sustain the Examiner's
rejection of claims 21 and 22 as being unpatentable over Botich and
Crawford.
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Application 13/100,838
Claim 23 and 24
Claim 23 depends from claim 22 and includes the further limitation
"wherein the needle assembly is instable by the user at a time of use."
Appellant contends that "no apparent way exists for a user to install the
needle assembly." App. Br. 19. Claim 24 also depends from claim 22 and
includes the further limitation "wherein the needle assembly is non-
removably instable by the user." Appellant again contends that "no apparent
way exists for a user to install the needle assembly." App. Br. 19-20.
Regarding both claims, the Examiner "finds the limitations regarding
the installation of the needle to be functional and that the needle as provided
by the references is capable of being installed." Ans. 4. More specifically
with respect to claim 23, the Examiner finds that "the needle can be installed
by a user at a time of use." Final Act. 7. With respect to claim 24, the
Examiner references Botich column 7, lines 1-13. This cited section of
Botich discusses the assembly of the needle component to the plunger
component via bayonet tabs 4 7 on the one and mating slots 49 on the other.
See also Botich Figs. 2--4. In summary, we are not persuaded the Examiner
erred in finding that Botich's syringe is capable of being installed in
accordance with how we understand claims 23 and 24. See also Botich
8: 11-13. Accordingly, we sustain the Examiner's rejection of claims 23 and
24 as being unpatentable over Botich and Crawford.
The rejection of claims 17 and 18
as unpatentable over Botich, Crawford, and Kaufhold
Appellant presents no arguments to the effect that Kaufhold was
improperly employed by the Examiner. Instead, Appellant only contends
that these claims are allowable because they depend from claim 16 "and are
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Application 13/100,838
believed to be allowable based at least on their dependence to this
independent claim." App. Br. 20. This is not persuasive of Examiner error.
We sustain the Examiner's rejection of claims 17 and 18 as unpatentable
over Botich, Crawford, and Kaufhold.
DECISION
The Examiner's rejections of claims 1-14 and 20 are reversed.
The Examiner's rejections of claims 15-19 and 21-24 are affirmed.
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-IN-PART
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