Ex Parte Grunert et al

Patent Trial and Appeal Board

Jun 13, 2017

12666967 (P.T.A.B. Jun. 13, 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.
12/666,967 12/28/2009 Lothar Grunert MERCK-3664 3091
23599 7590 06/15/2017
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BLVD.
SUITE 1400
ARLINGTON, VA 22201
EXAMINER
ANDERSON, DON M
ART UNIT PAPER NUMBER
3781
NOTIFICATION DATE DELIVERY MODE
06/15/2017 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):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte LOTHAR GRUNERT, ANDREAS MRASS,
PETER MUELLER, KEMAL ERAY,
THORSTEN HASSENZAHL, and KLAUS OSWALD
Appeal 2015-006096
Application 12/666,967
Technology Center 3700
Before JENNIFER D. BAHR, JAMES P. CALVE, and
ANTHONY KNIGHT, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Lothar Grunert et al. (Appellants)1 appeal under 35 U.S.C. § 134(a)
from the Examiner’s decision, set forth in the Non-Final Action, dated
August 29, 2014, rejecting claims 1 and 9-13, which are the only pending
claims. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the real party in interest is Merck Patent GmbH.
Appeal Br. 1.
Appeal 2015-006096
Application 12/666,967
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is the only independent claim and is
illustrative of the claimed subject matter.
1. A closure (2) for sealing an opening of a container (1) for the
storage and removal of sterile or moisture-sensitive media
having a closure cap (3) which can be connected to the container
(1) in a liquid-tight manner and having a piercable, self-sealing
septum (20) which seals an off-center removal opening (7) in the
closure cap (3) in a liquid-tight manner, wherein the closure (2)
has a rotatable mounted protective cap (4) having only one cut­
out (5) for uncovering the removal opening (7), and wherein the
cut-out (5) in the protective cap (4) is matched to the dimension
of the removal opening (7), and
wherein closure cap (3) has a plurality of off-center
removal openings (7) each of which is sealed by a septum (20)
and wherein the rotation of the protective cap (4) positions the
cut-out (5) to match the dimensions of each of the removal
openings (7) in order to uncover it.
REJECTIONS
I. Claims 1, 9, 10, and 13 stand rejected under 35 U.S.C. § 103(a) as
unptatentable over Blank (US 2,459,304, iss. Jan. 18, 1949) and
Claessens (US 2004/0217082 Al, pub. Nov. 4, 2004).
II. Claim 11 stands rejected under 35 U.S.C. § 103(a) as unptatentable
over Blank, Claessens, and Pherigo (US 5,183,171, iss. Feb. 2,
1993).
III. Claim 12 stands rejected under 35 U.S.C. § 103(a) as unptatentable
over Blank, Claessens, and Mayo (US 1,189,465, iss. July 4,
1916).
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DISCUSSION
Rejection I
Claims 1, 10, and 13:
In rejecting independent claim 1, the Examiner finds that Blank
discloses a closure as claimed, with the exception of a closure cap having a
plurality of removal openings. Ans. 2. The Examiner finds that Claessens
teaches a closure comprising a protective cap (overcap 8) and closure cap 7,
wherein the protective cap has at least one cut-out (defined by weakening
line 29 after removal of tear-open tabs 22), the closure cap has a plurality of
removal openings (holes 18) arranged off-center, and the at least one cut-out
is matched to the dimensions of each of the removal openings. Ans. 2—3
(citing Claessens, Figs. 2, 3; paras. 29-36).
The Examiner determines it would have been obvious to provide
Blank’s closure with a closure cap having a plurality of openings arranged
off-center, with the dimensions of the cutout in the protective cap being
matched to the dimensions of the removal openings, as taught by Claessens,
“in order to ensure a needle is used in selective piercing regions.” Ans. 3.
More specifically, the Examiner explains that, in accordance with the
proposed modification, “the septum of Blank would be replaced with the
closure cap and septum of Claessens” and “[t]he cut-out in the protective cap
would be rotated to align with one of the removal openings so that a needle
could pierce the septum and gain access to the contents of the vial.” Id. at 6.
Appellants argue that neither Blank nor Claessens teaches “the
combination of one opening in the protective cap and a plurality of off-
center removal openings in the septum.” Appeal Br. 3 (pointing out that
Blank discloses no openings in the septum, and Claessens teaches a 1:1 ratio
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of openings in the cap and in the septum). This argument is not persuasive
because it attacks each of Blank and Claessens individually, rather than as
combined in the rejection. Nonobviousness cannot be established by
attacking the references individually when the rejection is predicated upon a
combination of prior art disclosures. See In re Merck & Co., 800 F.2d 1091,
1097 (Fed. Cir. 1986) (citing In re Keller, 642 F.2d 413, 425 (CCPA 1981).
The Examiner relies on Blank for the cut-out in the protective cap (window
41 in disk 40) and on Claessens for the off-center removal openings in the
closure cap (holes in closure cap 7) to ensure a needle is used in selective
piercing openings. Ans. 2—3.
Appellants submit that Claessens’s cap 7 is specifically designed not
to rotate relative to overcap 8, thus requiring Claessens’s protective cap to
have the same number of openings as the septum. Appeal Br. 3^4. Thus,
Appellants contend that “[t]he Examiner’s attempt to separate the alignment
aspect of Claessens from its teaching of a fixed protective cap and septum
with matching openings which results in the alignment aspect misrepresents
the actual teachings of. . . Claessens and is clear use of impermissible
hindsight.” Id. at 4.
We do not agree with Appellants that the Examiner misrepresents the
teachings of Claessens. Claessens teaches providing closure cap 7 with
holes 18 in top 12 thereof circumscribing distinct piercing regions 17 to
define discrete areas (disk-like filler bodies 20) of the top surface of the
septum (sealing part 1) to be pierced. Claessens, paras. 32—35. The
Examiner’s rejection proposes incorporating this feature into the closure of
Blank. Ans. 3, 6.
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Appellants are correct that Claessens also teaches retaining overcap 8
on closure cap 7 such that it is secured against rotation, in order to ensure
alignment of piercing region 17 and tear-open tab 22. Id., paras. 49-50.
However, Claessens employs this non-rotating alignment arrangement
because the intact tear-open tabs 22 serve to identify piercing regions which
have not yet been punctured; if Claessens’s overcap 8 were rotatable relative
to closure cap 7, the presence of an intact tear-open tab would not
necessarily be indicative of a new, unpunctured piercing region
therebeneath. By contrast, rotatable disk 40 of Figures 11 and 12 of Blank
(the embodiment relied on by the Examiner) comprises only a single cut-out
(window 41), which is rotated successively, in one direction only, to uncover
sterilized, unpunctured areas of the stopper. Blank, col. 4,11. 31—51. A
closure cap with a plurality of off-center openings as taught by Claessens
would perform the same function in Blank’s closure that it performs in
Claessens—defining discrete areas of the septum to be pierced. Thus, it
would have been reasonable for one of ordinary skill in the art to incorporate
the closure cap with holes feature of Claessens into the closure of Blank
without also incorporating the particular alignment features taught by
Claessens—namely, providing a number of cut-outs in the protective cover
equal to the number of holes in the closure cap and fixing the protective cap
to the closure cap such that it is secured against rotation.
Further, the Examiner’s articulated reason for incorporating the
closure cap with holes feature of Claessens into Blank’s closure—to have
designated piercing regions, leading to better sanitation and prolonged life of
the stopper—is grounded in teachings of Blank, and not in Appellants’
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disclosure. Ans. 5 (citing Blank, col. 1,11. 28—51). Thus, the Examiner does
not use impermissible hindsight.
Appellants also contend that Blank and Claessens teach away from the
claimed subject matter. Appeal Br. 5—6. In particular, Appellants argue that
Claessens’s teaching of fixing the cap (overcap 8) to the septum and Blank’s
teaching of a movable cap would have discouraged one of ordinary skill in
the art from combining them. Id. at 5. This argument is unconvincing.
Prior art does not teach away from claimed subject matter merely by
disclosing a different solution to a similar problem unless the prior art also
criticizes, discredits or otherwise discourages the solution claimed. See In re
Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). As discussed above, Blank
(Figures 11 and 12) and Claessens disclose two different approaches for
identifying sterilized, unpunctured areas of the septum to be pierced, but a
closure cap with openings would serve the same function in a closure using
either approach. Appellants do not point to any teaching in either Blank or
Claessens that would have discouraged a skilled artisan from employing
such a feature in Blank’s closure.
Appellants also argue that if Blank were modified “to include an
actual opening on the stopper like the removable openings of the claims, the
stopper would no longer fulfill its function of sealing the container,” thereby
rendering it unsatisfactory for its intended purpose. Appeal Br. 5 (emphasis
added); see also Reply Br. 2 (referencing removal openings in Claessens that
“have to be removed”). Thus, Appellants contend that “Blank teaches away
from such a modification.” Appeal Br. 5. This argument is unavailing
because it is not commensurate with either claim 1 or the rejection
articulated by the Examiner. Claim 1 requires “removal openings,” not
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removable openings. Id. at 10 (Claims App.). Moreover, Claessens does not
teach openings in sealing part 1, and the Examiner does not propose to
incorporate openings in the stopper of Blank’s closure. Rather, as set forth
above, Claessens teaches, and the Examiner proposes to incorporate in
Blank’s closure, a closure cap with openings defining piercing regions
exposing areas of the sealing part to be pierced.
Appellants assert that Blank’s disk 40 does not prevent piercing of the
rubber seal when not properly aligned, and that Blank fails to provide
protection for the area of the stopper located under the cut-out of the
protection cap in its initial location (i.e., surface area 42). Id. at 6 (citing
Blank, col. 4,11. 41—45). These assertions are unavailing because they attack
Blank individually, rather than as combined in the rejection, and because
they are directed to features not recited in claim 1. See In re Self, 671 F.2d
1344, 1348 (CCPA 1982) (limitations not appearing in the claims cannot be
relied upon for patentability).
Appellants argue that Claessens “teaches away from providing a
rotatably mounted protective cap with a single cut-out as required by [claim
1]” because “[t]he protective cap in Claessens is not rotatably mounted to
the bottle, i.e.., ‘the overcap 8 is secured against rotation on the closure cap
7.’” Appeal Br. 6. We appreciate that Blank and Claessens teach different
approaches for identifying and exposing sterilized, unpunctured areas of the
septum, as discussed above. However, Appellants do not point to, nor do we
discern, any disclosure in Claessens which criticizes, discredits, or otherwise
discourages the approach taught by Blank, which uses a rotatable protective
cap (disk 40) with a single cut-out, rather than a plurality of tear-open tabs
permanently aligned with piercing areas.
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Appellants additionally argue that Blank and Claessens “teach two
alternative structural arrangements” and that, “[sjhould either reference be
modified to include the other, it would be rendered inoperative for its
original purpose.” Appeal Br. 6—7. This argument essentially rehashes the
arguments discussed above, and is unpersuasive for the same reasons.
For the above reasons, Appellants fail to apprise us of error in the
rejection of claim 1. Accordingly, we sustain the rejection of claim 1 and
claims 10 and 13, for which Appellants do not present any separate
arguments for patentability, under 35 U.S.C. § 103(a) as unpatentable over
Blank and Claessens.
Claim 9:
The Examiner finds that detent elements 45 and projecting elements
46 of Blank satisfy the latch mechanism limitations of claim 9. Ans. 3; see
Appeal Br. 10 (Claims App.). Appellants take issue with this finding.
Appeal Br. 8. According to Appellants, the section of Blank disclosing these
features “teaches a one-way rotating protective cap but fails to teach that
rotation is in any way, ‘aligned either flush with the or a removal opening
(7) in the closure cap (3) or alternatively at a distance from the removal
openings (7).’” Id. Appellants add that “Blank teaches merely a mechanism
to avoid repeated piercings of the same spot of the septum” and that
“Claessens specifically teaches no rotation of either cap and therefore
teaches away from such a feature.” Id.
Appellants’ arguments attack Blank and Claessens individually, rather
than as combined as proposed in the rejection. In the proposed combination,
the one-direction rotation effected by detent elements 45 engaging projecting
elements 46 is suitable for arranging the protective cap (disk 40) relative to
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the closure cap so that the cut-out (window 41) of Blank is aligned either
flush with or alternatively at a distance from each successive removal
opening (hole 18), thereby satisfying this limitation of claim 9. Further, for
the reasons set forth above, although Blank and Claessens teach different
approaches for identifying and exposing sterilized, unpunctured areas of the
septum, Claessens does not teach away from the rotatable protective cap
approach taught by Blank.
For the above reasons, Appellants fail to apprise us of error in the
rejection of claim 9. Accordingly, we sustain the rejection of claim 9 under
35 U.S.C. § 103(a) as unpatentable over Blank and Claessens.
Rejection II
Claim 11 depends from claim 1, and further recites that “the
protective cap (4) is connected to the closure cap (3) in a detachable manner
and wherein the detachment of the protective cap (4) from the closure cap
(3) for the first time is visually evident to a user.” Appeal Br. 10 (Claims
App.). In addressing this additional limitation, the Examiner relies on
Pherigo’s teaching of connecting a protective cap (cap 21) to a closure cap
(fitment 20) via weld 50 in order to reduce shipping costs. Ans. 4 (citing
Pherigo, Figs. 1—5; col. 3,1. 54—col. 4,1. 2). The Examiner determines it
would have been obvious to modify the closure of the Blank/Claessens
combination by connecting the protective cap to the closure cap in a
detachable manner as taught by Pherigo, “in order to reduce shipping costs.”
Id. The Examiner finds that detachment of the protective cap from the
closure cap for the first time, in this further modified combination, would be
evident. Id. The Examiner explains that “[i]t would clearly be visually
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evident to a user when the protective cap and closure cap are detached for
the first time because they will no longer be in contact.” Id. at 7.
Appellants submit that because weld 50 is located between the cap
and the fitment, it “would not be visually evident to a user.” Appeal Br. 9.
Appellants add that “the [Specification makes clear that this claim feature is
a tamper proofing feature” and “[t]hat once the cap has been put back on, it
will still be visually evident to a user that [it] had been removed.” Reply Br.
4. According to Appellants, “[t]his is not equivalent to simply a state
wherein the caps are not physically connected as alleged by the Examiner.”
Id. at 4—5.
Appellants do not persuade us that the Examiner’s finding that the
detachment for the first time of a connection as taught by Pherigo between
the protective cap and the closure cap would be visually evident to the user
is unreasonable when claim 11 is read in light of the Specification. Notably,
Appellants’ detachable connection between protective cap 4 and closure cap
3 consists of latch elements 14, which, like weld 50 taught by Pherigo, is
disposed between protective cap 4 and closure cap 3. See Spec. 10,11. 4—15;
Fig. 7. The detachment for the first time of the protective cap from the
closure cap at a weld connection, as taught by Pherigo, would yield a broken
connection that is as visually evident to the user as the bent or broken off
latch elements of Appellants’ invention. Moreover, the detachment would
permit rotation of Blank’s closure cap (disk 40) relative to closure cap 7 in
the closure of the combination, rendering the detachment for the first time
visually evident to the user. Notably, claim 11 does not specify the
conditions under which such detachment must be visible.
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For the above reasons, Appellants fail to apprise us of error in the
rejection of claim 11. Accordingly, we sustain the rejection of claim 11
under 35 U.S.C. § 103(a) as unptatentable over Blank, Claessens, and
Pherigo.
Rejection III
In contesting the rejection of claim 12, Appellants submit that Mayo
does not overcome the asserted deficiencies in the combination of Blank and
Claessens discussed above. Appeal Br. 9. For the above reasons, we discern
no such deficiencies, and, thus, the argument fails to apprise us of error in
the rejection of claim 12.
Appellants additionally point out ostensible errors in the citations to
Mayo in the Examiner’s rejection of claim 12. Id. (referencing page 5 of the
Final Action). In response, the Examiner concedes that the parenthetical
citations in the Final Action were in error, and replaces them with correct
citations. Ans. 7; compare Final Act. 5, with Ans. 4. Appellants do not
point out error in the Examiner’s application of Mayo with the corrected
citations.
Accordingly, Appellants fail to apprise us of error in the rejection of
claim 12 under 35 U.S.C. § 103(a) as unptatentable over Blank, Claessens,
and Mayo, which we, thus, sustain.
DECISION
The Examiner’s decision rejecting claims 1 and 9—13 is 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). See 37 C.F.R.
§ 1.136(a)(l)(iv).
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AFFIRMED
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