Ex Parte McDown et al

Patent Trial and Appeal Board

Sep 29, 2016

12866768 (P.T.A.B. Sep. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/866,768 11/29/2010
47058 7590 10/03/2016
David W, Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(Dickinson Wright PLLC)
1 Becton Drive, MC 110
Franklin Lakes, NJ 07417-1880
FIRST NAMED INVENTOR
Christopher McDown
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.
P-8221 (66810-1292) 4301
EXAMINER
PATEL, SHEFALI DILIP
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
10/03/2016 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):
lorraine_kowalchuk@bd.com
ip_docket@bd.com
DWPatents@dickinsonwright.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHRISTOPHER McDOWN, ELIOT ZAIKEN, and
TIEMING RUAN
Appeal2014-008567
Application 12/866,768
Technology Center 3700
Before ERIC B. GRIMES, ULRIKE W. JENKS, and
ROBERT A. POLLOCK, Administrative Patent Judges.
PERCURIAM.
DECISION ON APPEAL
This is a decision on appeal 1 under 35 U.S.C. § 134 from the
Examiner's rejection of claims 1-9 and 13. We have jurisdiction under 35
U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
Claims 1 and 7 are representative of the claims on appeal and read as
follows (emphasis and formatting added):
1. A safety needle assembly for an injector comprising:
a needle having a distal end formed for an injection;
1 Appellants identify the Real Party in Interest as Becton Dickinson and
Company (App. Br. 2).
Appeal2014-008567
Application 12/866,768
a carrier for supporting said needle, said carrier being
configured for mounting onto the injector; and,
a shield for selectively covering the distal end of the
needle, said shield having at least one through aperture
formed therein, wherein said at least one through aperture is
superimposed over the distal end of the needle in an initial
state prior to the injection as viewed along an axis disposed
perpendicularly to the needle.
7. A safety needle assembly for an injector comprising:
a needle having a distal end formed for an injection;
a carrier for supporting said needle, said carrier being
configured for mounting onto the injector; and,
a shield for selectively covering the distal end of the
needle, said shield having a proximal end, a distal end and a
sidewall extending therebetween,
said sidewall defining a first outer diameter at said
distal end of said shield,
said sidewall defining a greatest outer diameter, greater
than said first outer diameter, at a location closer to said
proximal end of said shield than said distal end of said shield,
said greatest outer diameter being greater than all outer
diameters defined by said sidewall between said location and
said first outer diameter,
wherein said outer diameter of said shield gradually
increases from said first outer diameter to said greatest outer
diameter.
The claims stand rejected under 35 U.S.C. § 102(b) as follows:
~ Claims 1---6 in view of Perez;2
~ Clairns 7, 8, and 13 in view of Asbaghi;3
2 US 6,171,283 Bl, issued Jan. 9, 2001.
3 US 5,688,241, issued Nov. 18, 1997.
2
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Application 12/866,768
~ Clairns 7, 9, and 13 in view of Stewart;4 and
411 Claims 7 and 13 in view of Hirsiger. 5,6
I.
Issue
The Examiner has rejected claims 1---6 under 35 U.S.C. § 102(b) as
anticipated by Perez (Final Act. 5---6, Ans. 2).
The issue presented is: Does a preponderance of the evidence support
the Examiner's finding that Perez discloses a safety needle assembly that
comprises a shield with an "aperture [that] is superimposed over the distal
end of the needle in an initial state prior to the injection as viewed along an
axis disposed perpendicularly to the needle"? (Claim 1, emphasis added)
Findings of Fact
1. Perez discloses a "syringe guard ... including a shield for
covering the needle thereof after medication is dispensed from the syringe"
(Perez, col. 1, 11. 6-9).
4 US 6,485,469 Bl, issued Nov. 26, 2002.
5 US 7,147,624 B2, issued Dec. 12, 2006.
6 The Examiner's statement of the rejection included claim 10 (Final Act. 8),
although claim 10 has been canceled (App. Br. 14 (Claims App'x)).
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Application 12/866,768
2. Figure 4 of Perez is shown below:
Figure 4 shows a the syringe guard about to receive a syringe (id. at col. 4,
11. 32-34). Shield 60 "includes an elongate opening or window 64
therethrough" (id. at col. 6, 11. 28-29). Perez states that "[t]he distal end 94
of the syringe 90 is inserted into the open proximal end 22 of the body 20.
The syringe 90 ... progresses distally until the distal end 94 of the syringe
90 engages the distal end 24 of the body 20." (Id. at col. 7, 11. 16-20.)
3. Figure 6A of Perez is shown below:
Figure 6A shows "the syringe guard holding a syringe, with the shield
locked in a guarded position after medication has been dispensed from the
syringe" (id. at col. 4, 11. 39--42).
4
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Application 12/866,768
4. Perez discloses that, when '"the needle 95 is withdrawn from the
patient , .. the self-shielding foature of the guard 10 is engaged ... [by]
sliding the shield 60 distally until it reaches the guarded position'~ (id. at
col. 7, 11. 53---62).
Analysis
The Examiner finds that Perez discloses a safety needle assembly that
meets all of the elements of claim 1, including a shield that has "at least one
through aperture (windows [64]) formed therein" (Final Act. 5). The
Examiner finds that the "through aperture is superimposed over the distal
end of the needle in an initial state (almost position of Figure 6A right before
shield is permanently locked in the guarded position) prior to the injection as
viewed along an axis disposed perpendicularly to the needle" (id.).
Appellants argue that window 64 "is moving in a distal direction from
the initial state ... to the final state of Figure 6A ... [and] is at its furthest
distal location in the final state of Figure 6A. Any position prior to that is
located further back proximally from the needle" (App. Br. 7). Appellants
argue that Figure 6A shows that "window 64 is not superimposed over the
distal end of the needle as viewed along an axis disposed perpendicularly to
the needle" because it shows that a "portion of the shield, not the window 64
... [is] in superimposed alignment with the distal end of the needle" (id. at
7-8). Appellants argue that, "prior to reaching the state of Figure 6A, the
window 64 is even further out of superimposed alignment with the distal end
of the needle since the window 64 is located further proximally away from
the distal end of the needle" (id. at 8).
5
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Application 12/866,768
The Examiner responds that Figure 6A of Perez "shows the front
window [64] of the shield [60] in superimposed alignment with the distal
end of the needle [95]" (Ans. 3). The Examiner states that the "shield
position right before the shield is permanently locked in the guarded position
of Figure 6A is capable of being an initial state prior to the injection" (id.).
We agree with the Examiner's reasoning and conclusions.
"Description for the purposes of anticipation can be by drawings alone as
well as by words." In re Mraz, 455 F.2d 1069, 1072 (CCPA 1972). As
recognized by the Examiner, Figure 6A of Perez shows that the distal end of
the needle is located within the boundaries of the front facing window 64.
Also as recognized by the Examiner, immediately before the shield shown in
Figure 6A is locked in position could be construed as an initial state prior to
injection; and the distal end of the needle would also be located within the
boundaries of the front facing window 64. Thus, irmnediately before the
shield is locked into place, "at least one through ape1iure is superimposed
over the distal end of the needle in an initial state prior to the injection as
viewed along an axis disposed perpendicularly to the needle," as recited in
claim 1.
Moreover, Perez discloses that, prior to injection, the syringe (and
needle) are inserted into the shield. Thus, the distal end of the needle passes
from the proximal end of the shield to the distal end and necessarily passes
in front of the window. That position also meets the claim limitation of a
through aperture "superimposed over the distal end of the needle in an initial
state prior to the injection as viewed along an axis disposed perpendicularly
to the needle."
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Application 12/866,768
Thus, we affirm the rejection of claim 1under35 U.S.C. § 102(b).
Claims 2---6 have not been argued separately and therefore fall with claim 1.
See 37 C.F.R. § 41.37(c)(l)(iv).
II.
Issue
The Examiner has rejected claims 7, 8, and 13 under 35 U.S.C.
§ 102(b) as anticipated by Asbaghi (Final Act. 6-7, Ans. 2).
The issue presented is: Does a preponderance of the evidence support
the Examiner's finding that As bag hi discloses a shield having a sidewall that
gradually tapers from a first outer diameter at its distal end to "a greatest
outer diameter, greater than said first outer diameter, at a location closer to
said proximal end of said shield than said distal end of said shield"?
(Claim 7 (emphasis added).)
Findings of Fact
5. Asbaghi discloses "a safety needle guard apparatus" (Asbaghi~
coL 1 ~ lL 6----7).
6. Figure 2 of Asbaghi is shown below:
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Application 12/866,768
Figure 2 shows a view of the needle guard '"with the outer cylinder cut
awai~ (id. at col. 3, 11. 34----35). "[ \V]ithin the outer cylinder 20 is an inner
cylinder 26 having a proximal end 28 and a distal end 30 .. , . The distal end
30 of inner cylinder 26 has a decreasing diameter portion 44"' (id. at coL 4,
1L 22-38).
7. The Specification states:
It is preferred that the outer diameter of the shield 14 be greatest
(Dmax) at a location closer to the proximal end 36 of the shield
14 than the distal end 18 of the shield 14. The shield 14 may
define a constant section having the greatest outer diameter
Dmax, such that a cylinder 33 is defined having the greatest outer
diameter Dmax. The cylinder 33 may extend from the proximal
end 36 of the shield 14. It is further preferred that the outer
diameter of the shield 14 gradually increase from the reduced
outer diameter D 1 to the greatest outer diameter Dmax.
(Spec. 8, 11. 4--10.)
Analysis
The Examiner finds that Asbaghi discloses a safety needle assembly
that comprises a shield having a sidewall defining a first outer diameter at
the distal end and "a greatest outer diameter, greater than said first outer
diameter, at a location closer to said proximal end (proximal end [28]) of
said shield than said distal end" (Final Act. 7).
Appellants argue that "Asbaghi does not provide a 'greatest outer
diameter' as set forth ... [in] claim 7" (App. Br. 9). Appellants argue that,
"in Asbaghi, the 'greatest outer diameter' would be defined at the juncture of
the portions 44 and 56 .... [T]his location is not closer to the proximal end
28 than the distal end. Rather, it is closer to the distal end than the proximal
end---opposite of what is claimed" (icL at 10).
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Application 12/866,768
In response, the Examiner provides the following annotated version of
Asbaghi's Figure 2:
.• -:~ ~X:):..:::~::'i~i X::J:::::
..... ~-1""'{.·
(Ans. 5.) The Examiner's annotations of Figure 2 point to the uniform
diameter portion 56 of the inner cylinder as corresponding to the location
having the greatest outer diameter, and the Examiner labels part of uniform
diameter portion 56 near the proximal end as "portion." The Examiner
concludes that Asbaghi thus discloses a location having a greatest outer
diameter (uniform diameter portion 56) having a portion ("portion") that is
closer to the proximal end of a shield inner cylinder than its distal end (id. at
4).
Appellants argue that "[t]he Examiner's interpretation of a 'location'
is not consistent with the subject specification or the claims" (Reply Br. 3).
However, we agree with Examiner's reasoning. "[D]uring examination
proceedings, claims are given their broadest reasonable interpretation
consistent with the specification." In re Hyatt, 211F.3d1367, 1372 (Fed.
Cir. 2000).
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Application 12/866,768
Here, the uniform diameter portion 56 of Asbaghi's inner cylinder 20
corresponds to the claim limitation of a "sidewall defining a greatest outer
diameter, greater than said first outer diameter, at a location closer to said
proximal end of said shield than said distal end of said shield." As shown in
Asbaghi's Figure 2, part of uniform diameter portion 56 is closer to the
proximal end of inner cylinder 20, than the distal end (FF 6). The
Specification states that "[t]he shield 14 may define a constant section
having the greatest outer diameter Dmax, such that a cylinder 33 is defined
having the greatest outer diameter Dmax" (FF 7). Interpreting the claim
language to encompass a shield that includes a cylinder with a greatest outer
diameter, as shown in Asbaghi, is therefore consistent with the Specification.
Thus, we affirm the rejection of claim 7 under 35 U.S.C. § 102(b).
Claims 8 and 13 fall with claim 7. See 37 C.F.R. § 41.37(c)(l)(iv).
III.
Issue
The Examiner has rejected claims 7, 9, and 13 under 35 U.S.C.
§ 102(b) as anticipated by Stewart (Final Act. 7-8, Ans. 2).
The issue presented is: Does a preponderance of the evidence support
the Examiner's finding that Stewart discloses a shield having a sidewall that
gradually tapers from a first outer diameter at its distal end to "a greatest
outer diameter, greater than said first outer diameter, at a location closer to
said proximal end of said shield than said distal end of said shield"?
(Claim 7 (emphasis added).)
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Application 12/866,768
Findings of Fact
8. Stewart discloses "a shielded dental safety needle" (Stewmi,
coL 1, lL 8-----9).
9. Figure 1 of Stewart is shown below:
FIG. 1
Stewart discloses that Figure 1 illustrates "a shielded safety needle 20'' that
"includes a sliding outer shield 30 having a distal frustoconical or tapered
shield crown 34'' (Stevvart, coL 5~ IL 15-19),
Analysis
The Examiner finds that Stewart discloses a safety needle assembly
that comprises a sidewall with "a first outer diameter at said distal end (next
to distal opening [36])" (Final Act. 8). The Examiner finds that the outer
diameter of the sidewall gradually increases to "a greatest outer diameter,
greater than said first outer diameter, at a location closer to said proximal
end of said shield than to said distal end of said shield" (id}
Appellants argue that,
[a]s with Asbaghi, the "location" with the "greatest outer
diameter" in Stewart et al. is defined at the juncture of the straight
cylindrical portion (marked with numeral 30) and the tapered
portion (marked with numeral 34). However, this juncture is
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Appeal2014-008567
Application 12/866,768
located closer to the distal end of the device rather than the
proximal end of the device.
(App. Br. 11.)
The Examiner responds that the "[t]he 'location' of Stewart et al is
the entire straight cylindrical portion. A portion ... of the location is closer
to the proximal end than to the distal end" (Ans. 7-8).
We agree with the Examiner's finding that Stewart discloses the
disputed limitation for essentially the same reasons as discussed above with
regard to Asbaghi. That is, with reference to Stewart's Figure 1, the
cylindrical portion of shield 30 corresponds to the claim limitation that the
sidewall defines "a greatest outer diameter, greater than said first outer
diameter, at a location closer to said proximal end of said shield than said
distal end of said shield" (FF 9). As shown in Figure 1, part of the
cylindrical portion is closer to the proximal end of shield 30 than the distal
end. As discussed above for the rejection in view of Asbaghi; the broadest
reasonable interpretation of claim 7 that is consistent with the Specification
does not exclude a cylinder having a constant greatest outer diameter.
Thus, we affirm the rejection of claim 7 under 35 U.S.C. § 102(b).
Claims 9 and 13 fall with claim 7. See 37 C.F.R. § 41.37(c)(l)(iv).
IV.
Issue
The Examiner has rejected claims 7 and 13 under 35 U.S.C. § 102(b)
as anticipated by Hirsiger (Final Act. 8-9, Ans. 2).
The issue presented is: Does a preponderance of the evidence support
the Examiner's finding that Hirsiger discloses a shield having a sidewall that
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Application 12/866,768
gradually tapers from a first outer diameter at its distal end to "a greatest
outer diameter, greater than said first outer diameter, at a location closer to
said proximal end of said shield than said distal end of said shield"?
(Claim 7 (emphasis added).)
Findings of Fact
10. Hirsiger discloses "a needle protecting device" (Hirsiger, col. 1,
11. 14--16).
11. Figure 1 of Hirsiger is shown below:
Figure l shows "the needle protecting device in an initial position , .. [in
which] needle cover 10 can be shortened. , . such that the injection needle 3
protrudes through the needle cover Hr (id, at coL 5, 1L 36-37, 44-50).
"[N]eedle cover 10 comprises bellows 11 and a functional body lr' (id, at
coL 6~ lL 5-----6).
12. Hirsiger discloses that "locking means 20 comprises . , . locking
elements 21, 22 and 23 [that] are formed by coaxially arranged sleeve bodies
of equal 1ength"' (id, at coL 6, 1L 51-59),
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Application 12/866,768
Hirsiger discloses that as the bellows 11 is shortened) the
"needle cover 10 and the proximal locking element 23 are then hooked to
each other with respect to the longitudinal direction of the injection needle 3
by [a] latching connection)' (id. at coL 8. lL 41-44}
14. figure 4 ofHirsiger is shown below:
'--' "--''
!3
~--
Figure 4 shm:vs "the needle protecting device in a protecting and locking
position" (id, at col. 5~ 11. 23----24), "The locking elements 21 to 23 form a
1ocking te1escope which, when extended, . , assumes a locking position'~ (id,
at coL 6, IL 60-62} "[T]he outermost locking element. , , [is] the dista1
kicking element 21 and the hmennost locking element [is] the proxima1
locking element 23'' (i(l at coL 6, lL 65----67).
15. Hfrsiger discloses that ''the locking e1ements 21 to 23 are
fr.-nmed bv cvlindrical ... sleeves which surround each other and are " ..
arranged coaxially'' (ill at coL 8, lL 63-66). "Forming the 1ocking te1escope
using sleeve bodies which , , , are linearly guided on each other via
cylindrical surface areas results in a particularly stabile [sic] arrangement
during relative shifting and .. , in the extended locking position'' (id. at
coL 9, lL 4----8).
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16. Hirsiger discloses that~ after the product has been administered,
"the needle cover 10, i.e.~ the bellows 11, are relieved of pressure and
elongated into the protecting position shown in FIG. 4 as a result of their
own elastic restoring force9' (id. at coL 9~ IL 9-14). "In the protecting
position ... the needle cover 10 protects against handling and injury. If the
locking elements 21 to 23 are formed cylindricaHy, the locking means 20
can instead also protect against handling and injury, Advantageously~ double
protection is realized'~ (id. at coL 9~ lL 51----56).
Analysis
The Examiner finds that Hirsiger discloses a safety needle assembly
comprising "a shield (locking means [20]) for selectively covering the distal
end of the needle" (Final Act. 8-9). The Examiner finds that the shield has a
sidewall that defines "a first outer diameter at said distal end (outer diameter
of innermost locking element [23]) of said shield" (id. at 9). The Examiner
finds that the sidewall also gradually increases to "a greatest outer
diameter, greater than said first outer diameter, at a location closer to said
proximal end of said shield than said distal end of said shield" (id.).
Appellants argue that, "[i]n Hirsiger et al., the needle cover 10 must
be taken to correspond to the claimed 'shield'. The needle cover 10 has its
outer diameters defined by the bellows 11 with no correspondence to the
specific claimed geometry" (App. Br. 12). Appellants argue that the
"locking means 20 of Hirsiger et al. cannot be taken alone as the claimed
'shield.' ... The locking means 20 is not a 'shield' by itself for covering a
distal end of a needle since the locking means 20 cannot act as a shield"
(id,).
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Application 12/866,768
The Examiner responds that Hirsiger's "the locking means selectively
covers the distal end of a needle" and "is composed of coaxially arranged
sleeve bodies [21] [22] [23] that form a telescope about the needle. Hence,
the locking means [20] shields the needle, including the distal end of the
needle" (Ans. 8).
We agree with the Examiner's finding that Hirsiger discloses the
safety needle assembly of claim 7, including a "shield for selectively
covering the distal end of the needle." Hirsiger discloses that locking
elements 21, 22, and 23 of locking means 20 form a locking telescope of
cylindrical elements when in the extended position (FFs 14 and 15).
1--Hrsiger~s locking element 23 has a first diameter at the distal end of the
shield and locking element 21 has a greatest outer diameter_ greater than the
fi mt diameter, at a location that is closer to the prox ima1 end of the shield
than the distal end (FF 14). 'fhe greatest outer diameter of locking element
21 is greater than all outer diameters between locking element 21 and
locking element 23, and the shield gradually increases in diameter from
locking element 23 to locking element 21.
Appellants' argument that locking means 20 is not by itself a shield is
not persuasive because claim 7 uses open claim language and therefore does
not exclude an assembly with more than one shield. Hirsiger specifically
recites that both the needle cover 10 and locking elements 21----23 oflocking
means 20 protect the needle and device against handling and injury and that
"double protection is realized" (FF 16 ).
Thus, we affirm the rejection of claim 7 under 35 U.S.C. § 102(b).
Claim 13 falls with claim 7. See 37 C.F.R. § 41.37(c)(l)(iv).
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SUMMARY
We affirm all of the rejections on appeal.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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