Ex Parte Ruan et al

Patent Trial and Appeal Board

May 10, 2017

13058649 (P.T.A.B. May. 10, 2017)

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.
13/058,649 03/15/2011 Tieming Ruan P-08139 (066810-01288) 2873
47058 7590 05/12/2017
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(Dickinson Wright PLLC)
1 Becton Drive, MC 110
Franklin Lakes, NJ 07417-1880
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
05/12/2017 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_kow alchuk @ bd .com
ip_docket @bd.com
DWPatents @ dickinson wright. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TIEMING RUAN, ROBERT BANK, ELIOT Z AIKEN,
MICHAEL VINCENT QUINN, and GARY SEARLE
Appeal 2015-007366
Application 13/058,649
Technology Center 3700
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PER CURIAM.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a safety
pen needle assembly. The Examiner rejected the claims on the ground of
anticipation. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
Appellants’ invention relates to “[sjafety pen needle assemblies
... for providing shielding to a used pen needle to prevent inadvertent
‘needle sticks’ therewith” (Spec. 11).
1 Appellants identify the Real Party in Interest as Becton, Dickinson and
Company (see App. Br. 2).
Appeal 2015-007366
Application 13/058,649
The Claims
Claims 1—3, 5, and 7—102 are on appeal. Independent claim 1 is
representative and reads as follows (emphasis added):
1. A safety pen needle assembly comprising:
a hub;
a needle fixed to said hub, said needle having a distal end,
formed for insertion into a patient, and a proximal end;
a shield; and,
a biasing means disposed between said hub and said shield
configured to urge said shield distally,
wherein, a protrusion extends from at least one of said hub and
said shield, a channel and locking aperture are formed in at least the
other of said hub and said shield, said channel formed to
accommodate said protrusion, said locking aperture being formed to
receive said protrusion, a ridge separating said locking aperture and
said channel,
wherein said shield is movable from a first position to a second
position, wherein, with said shield in said first position and prior to
said needle being inserted into a patient, said protrusion is seated in a
first location of said channel to retain said shield spaced from said
distal end of said needle such that said distal end of said needle is
exposed, wherein, with said shield in said second position, said
protrusion being received by said locking aperture with said shield
covering said distal end of said needle, said protrusion being received
in said locking aperture at a location more distal than said first
location, and, wherein, said channel guides said protrusion as said
shield moves from said first position to said second position;
whereby, when said shield is in said first position, a user may
visually confirm proper priming and needle placement during use.
2 Claims 6 and 11—21 are withdrawn (see Final Act. 1).
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Application 13/058,649
The Issue
The Examiner rejected claims 1—3, 5, and 7—10 under 35 U.S.C.
§ 102(b) as being anticipated Berthier3 (Final Act. 2—5).
The Examiner finds that:
Berthier discloses a safety pen needle assembly (1)
comprising a hub (2) having a needle (6) fixed thereto, said
needle having a distal end formed for insertion into a patient
and a proximal end (Fig. 1).
Berthier discloses a shield (8).
Berthier discloses a biasing means (20) disposed between
the hub and the shield configured to urge the shield distally
(Fig. 1).
Berthier discloses a protrusion (26) that extends from at least
one of the hub and the shield, a channel (22) and a locking
aperture (29) are formed in at least the other of the hub and
the shield, the channel being formed to accommodate the
protrusion, said locking aperture being formed to receive the
protrusion, a ridge (generally 28) separating said locking
aperture and the channel (See Fig. 2 or Fig. 3; note that the
bottom 28 slopes upward until it sharply drops off at recess
29 thereby forming the ridge).
Berthier discloses that the shield is moveable from a first
position (not shown) to a second position (Fig. 1), wherein
in the first position, the protrusion is seated in a first location
of the channel (i.e. at the proximal end) to retain the shield
spaced from the distal end of the needle such that the distal
end of the needle is exposed. Berthier discloses that in the
second position, the protrusion is received by the locking
aperture with shield covering the distal end of the needle
(Fig. 1), the protrusion being received in the locking
aperture at a location more distal than the first location (see
Fig. 2, note that the aperture 29 is more distal than sections
3 Berthier, US 5,429,612, issued July 4, 1995.
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Application 13/058,649
24, 25, and the majority of 23). Berthier discloses that the
channel guides the protrusion as the shield moves from the
first position to the second position, by following the shape
of the channel, whereby when the shield is in the first
position, i.e. the needle is exposed, a user may visually
confirm proper priming and needle placement during use,
i.e. since the needle is exposed a user can visualize it.
(Final Act. 2—3.)
The Examiner determines that
the phrase “prior to said needle being inserted into a patient”
constitutes functional language directed toward the intended
use of the claimed device. Examiner notes that a recitation
of intended use only limits the claims inasmuch as the
claimed invention need only be capable of performing the
specified function. In the instant case Examiner submits that
when the shield of Berthier can be induced to the first
position without insertion of the needle into a patient.
(Final Act. 3—4.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s findings that Berthier teaches the claimed invention?
Findings of Fact
1. Figure 1 of Berthier is reproduced below:
18 20 f 3 17 « f2
7 2 15
16 19 13
FIG-1
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Figure 1 shows
[a] device for an injection syringe including a cylindrical
body (2) closed at one of its ends by a transverse wall in
which the needle (6) is implanted, is such that the end of the
cylindrical body is fitted with a slideway (7) for a needle
protector (8) that includes a first tubular portion (9) of large
diameter suitable for sliding along the slideway (7) between
two positions that are axially separate from each other, and a
small diameter portion (10) that extends the large diameter
portion longitudinally, forming a moving protective sheath
for the end of the needle (6), guiding and indexing elements
(11, 12, 14, 16, 22, 26) being provided in inaccessible
manner between the slideway (7) and the large diameter
portion (9) of the protector so as to allow the needle to be
uncovered and then recovered in succession once only.
(Berthier Abstract; see also Final Act. 2—3.)
2. Figure 2 of Berthier is reproduced below:
Figure 2 shows that
the guidance and indexing means between the protector and
the slideway (which in this case is the body or needle
support 2 itself of the syringe) are constituted on the
slideway by a U-shaped groove 22 whose two branches 23
and 24 extend along two different generator lines of the
slideway and are interconnected by a circumferential groove
25 that connects them together transversely, and on the
protector by a resilient tongue 26 that projects inside the
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Application 13/058,649
protector into the branch 23 of the groove 22. Within this
branch, there is no hindrance to sliding in the needle
uncovering direction. Advantageously, particularly when a
spring such as 20 is used, the end of the branch 23 is fitted
with ratchets 27 that co-operate with the tongue 26 in a
pawl-like manner so as to prevent the protector returning
towards the needle, while leaving the tongue free to retract
and pass over the ratchets during movement in the opposite
direction. In the other branch, the bottom 28 slopes slightly
upwards towards the needle and is subsequently terminated
by a recess 29 from which the pawl cannot be extracted.
Movement of the protector is then finally prevented. To
achieve such prevention of movement, it is appropriate to
push the protector 8 towards the circumferential portion 25
of the groove 22 and to rotate it to place the tongue 26 in the
branch 24, thereby enabling the needle to be covered again
under assistance from the spring.
(Berthier 4:32—58; see also Final Act. 2—3.)
3. Berthier teaches that
[i]n a variant of this embodiment, the branch that does not
include the recess includes a plurality of ratchets each
constituting an abutment co-operating with the resilient
tongue to cause it to be retracted in the needle uncovering
direction while preventing the protector from sliding in the
needle-covering direction. This variant makes it possible to
adjust the length of the needle to be uncovered as a function
of the depth to which it is to penetrate into tissue during
injection.
(Berthier 2:48—56; see also Ans. 5.)
Principles of Law
A prior art reference can only anticipate a claim if it discloses all the
claimed limitations “arranged or combined in the same way as in the claim.”
Wm. Wrigley Jr. Co. v. Cadbury Adams USALLC, 683 F.3d 1356, 1361
(Fed. Cir. 2012).
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Analysis
We adopt the Examiner’s findings concerning the scope and content
of the prior art (Final Act. 2—5; Ans. 2—14; FF 1—3), and agree that the
claims are anticipated by Berthier. We address Appellants’ arguments.
Appellants contend that
as stated at the end of claim 1, “when said shield is in said
first position, a user may visually confirm proper priming
and needle placement during use.” This is not at all
provided in Berthier. The subject invention allows for a user
to see the exposed distal end of the needle with the shield
being retained to allow for such exposure. This permits
visual confirmation of priming and needle placement for an
injection. With Berthier, the needle is fully covered in an
initial state, thus, both: 1. preventing visual confirmation of
needle priming; and, 2. obstructing a view of needle
placement for an injection.
(App. Br. 5; see also Reply Br. 3.)
We are not persuaded. We recognize claim 1 requires that the shield
and protrusion are movable from one position to another such that in each
position, the shield or protrusion is either retained or received by a locking
aperture and that the needle is exposed in one of the positions.
Berthier teaches “a needle protector (8) that includes a first tubular
portion (9) of large diameter suitable for sliding along the slideway (7)
between two positions that are axially separate from each other” (FF 1).
Berthier teaches the protector may “be retracted in the needle uncovering
direction while preventing the protector from sliding in the needle-covering
direction. This variant makes it possible to adjust the length of the needle to
be uncovered as a function of the depth to which it is to penetrate into tissue
during injection” (FF 3). Thus, Berthier teaches a needle assembly having a
shield that can be moved to multiple positions that are at least retained or
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Application 13/058,649
locked from movement, and in at least one position, the needle is exposed
from the shield.
As the Examiner explains, “[w]hen the projection of Berthier is
disposed in such a position the shield is fully retracted and the distal end of
the needle (6) is exposed for visual confirmation and inspection by the user”
(Ans. 3; see also id. at 3—4, 8—10, 13, in which the Examiner rendered
depictions of the movement of Berthier’s needle assembly along different
positions.)
“[T]he patentability of apparatus or composition claims depends on
the claimed structure, not on the use or purpose of that structure.” Catalina
Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir.
2002). “A patent applicant is free to recite features of an apparatus either
structurally or functionally .... Yet, choosing to define an element
functionally, i.e., by what it does, carries with it a risk.” In re Schreiber, 128
F.3d 1473, 1478 (Fed. Cir. 1997).
As the Examiner explains,
such recitation of providing the device in the first position,
prior to the needle penetrating a user’s skin, constitutes a
mere intended use recitation. A recitation of intended use
only limits the claims inasmuch as the device need only be
capable of performing the specified function. Specifically,
Examiner submits that the device of Berthier, regardless of
the author’s intent, is CAPABLE of and CONFIGURED
FOR being assembled and provided to a user in a pre-use
state in the “first” position. The practitioner can then
visually confirm proper priming and needle placement
during use with the shield in the “first position”. The mere
fact that the device in intended by Berthier to be provided to
a practitioner with the needle shield extended is immaterial.
(Ans. 5.)
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The Examiner further noted that
Berthier in fact appears to contemplate providing the needle
at least partially extended prior to insertion of the needle
into the patient. For example, Berthier recites “[t]his variant
[i.e. ratchets 27] makes it possible to adjust the length of the
needle to be uncovered as a function of the depth to which it
is to penetrate into tissue during injection” (Col. 2, Ln. Ln.
48-56).
{Id.-, FF 3.)
We agree with the Examiner that the limitation “prior to said needle
being inserted into a patient” is intended use. When a user determines to
insert the needle into the patient is a choice that is not determinative of the
structure of the claimed needle assembly. For example, whether the user has
the needle exposed or retracted, prior to injection, is an intended use. Here,
the order of steps are not limited by the structural limitations of claim 1.
Appellants contend “[i]t is clear that the needle must be covered in its
initial state. As the subject rejection is an anticipation rejection, it is clear
that Berthier fails to disclose all of the limitations of the subject invention”
(App. Br. 6).
We do not find this argument persuasive because Appellants do not
define in the claims which part of these two sequences of steps constitutes
“an initial state” (see App. Br. 5 and further discussions below). More
importantly, Berthier teaches a shield structure that may move between a
needle-exposed state and a needle-protected state (FF 23). Even if there is
an additional needle-protected state prior to the needle-exposed state, that
functional use of Berthier is not excluded by apparatus claim 1 based both
on the “comprising” language that is open to additional elements and
because the term “first position” represents intended use, and does not
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impose any structural limitations on the claims as already discussed. As
long as Berthier allows exposure of the needle and the needle has not
punctured the skin, visual confirmation of priming is possible.
We recognize, but are not persuaded by, Appellants’ contention that
Berthier does not teach the shield being retained in a first location and
spaced so that the needle is exposed (see App. Br. 7). As discussed above,
Berthier teaches that the needle can be exposed, and that the needle or shield
movement is prevented based on the recess 29, the ratchets 27 interacting
with the tongue 26, or the tongue being at position 25 (see Ans. 7; see also
Ans. 8-17; FF 2-3).
Appellants argue that
[t]he retaining of the shield to be spaced from the distal end
of the needle such that the distal end of the needle is
exposed with the shield in the first position is an affirmative
structural limitation of claim 1. Relative arrangement of
elements, particularly in a retained state as claimed, does not
constitute mere method of use. Modifying Berthier to have
a distal end of the needle exposed in a retained, pre-use state
requires modification from the device as disclosed.
(App. Br. 7.)
These arguments are unpersuasive. The Examiner recognizes that the
retention of the shield at a first location is an affirmative structural claim
limitation and finds that Berthier teaches this limitation (see Ans. 10—11).
We further agree with the Examiner that “contrary to Appellant’s
allegations, NO MODIFCATION of the structure of Berthier is necessary
because the inventors of Berthier CLEARLY disclose the shield of the
disclosed device to transition by a DELIBERATE user action, i.e. ‘pushing’
and ‘rotation’ (Col. 4, Ln. 43—58)” (id. at 11).
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Appellants contend that “the Examiner has failed to take into account
Applicant’s full disclosure, as well as the perspective of those skilled in the
pen needle art” because “[t]he specification neither discloses nor suggests
any intermediate positions for the shield” (Reply Br. 1—2).
We are not persuaded. Claim 1 does not exclude intermediate
positions or require more than two positions for the shield. “[L]imitations
are not to be read into the claims from the specification.” In re Van Geuns,
988 F.2d 1181, 1184 (Fed. Cir. 1993). See also In re Self, 671 F.2d 1344,
1348 (CCPA 1982) (“[Ajppellanf s arguments fail from the outset because ...
they are not based on limitations appearing in the claims.”).
Appellants argue that ‘Tflhe Examiner Proffers New Evidence That
Should Be Ignored” in regard to the Examiner’s drawings provided in the
Examiner’s Answer (see Reply Br. 3). This argument is unpersuasive
because the Examiner’s drawings are a rendition of the movement of parts of
Berthier’s pen assembly and merely help illustrate how the pen assembly
operates for comparison to the claimed invention.
Appellants present new arguments in regard to claims 8 and 9 in the
Reply Brief and contend that “[f]or reasons unknown to present counsel, the
arguments addressed in this section were not raised by prior counsel in the
Appeal Brief. Applicant respectfully requests that these circumstances be
considered ‘good cause’ under 37 C.F.R. §41.41(b)(2) to excuse the
omission, and that the arguments be considered now” (Reply Br. 4)
Appellants are reminded that if the Examiner has not introduced new
grounds of rejection and Appellants’ later arguments are not responsive to
arguments raised by Examiner’s Answer and are without good cause, they
should not be considered.
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Any argument raised in the reply brief which was not raised in
the appeal brief, or is not responsive to an argument raised in
the examiner’s answer, including any designated new ground of
rejection, will not be considered by the Board for purposes of
the present appeal, unless good cause is shown.
(37 C.F.R. § 41.41(b)(2).) See also Ex Parte Borden, 93 USPQ2d
1473, 1473—74 (BPAI 2010) (informative opinion) (absent a showing of
good cause, the Board is not required to address an argument newly
presented in the reply brief that could have been presented in the principal
brief on appeal). Here, we do not consider arguments not raised before by a
prior counsel or a change in counsel as “good cause.”
Conclusion of Law
The evidence of record supports the Examiner’s findings that Berthier
anticipates the claimed invention.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 102(b) as being anticipated by Berthier. Claims 2, 3, 5, and 7—10 fall with
claim 1.
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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