Ex Parte Miyasaka

Patent Trial and Appeal Board

Jul 25, 2017

13700361 (P.T.A.B. Jul. 25, 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.
13/700,361 05/31/2013 Susumu Miyasaka H-NS-01219
(1502-798PCTUS
4361
54964 7590 07/27/2017
rVwiHie.n f.Senniaer Powers;^
EXAMINER
Attn: IP Legal Department
15 Hampshire Street
KLEIN, BENJAMIN JACOB
Mansfield, MA 02048 ART UNIT PAPER NUMBER
3761
NOTIFICATION DATE DELIVERY MODE
07/27/2017 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):
iplegalus@covidien.com
uspatents @ senniger.com
medtronic_mitg-pmr_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SUSUMU MIYASAKA1
Appeal 2015-003799
Application 13/700,361
Technology Center 3700
Before WILLIAM A. CAPP, SCOTT A. DANIELS, and
SEAN P. O’HANLON, Administrative Patent Judges.
DANIELS, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Susumu Miyasaka (Appellant) appeals under 35 U.S.C. § 134(a) from
the Final Rejection of claims 1—20. Appeal Br. 3. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellant the Real Party In Interest is Covidien LP. App.
Br. 1.
Appeal 2015-003799
Application 13/700,361
CLAIMED SUBJECT MATTER
Appellant claims a connector cap “used in priming of a transfusion
line which conducts a fluid such as liquid medicine to a patient.” Spec. 11.
Priming of a transfusion line ensures that any gas, air for example, is
removed from the delivery line prior to the liquid medicine being dispensed
to a patient. See id. 1 52, (“When the fluid . . . enters the reservoir 13, air
from the tube 5 and the flow path of the male connector 40 is exhausted.”).
Appellant’s cap 10 includes cylindrical housing 11 having septum 21 at one
end and hydrophobic filter 31 at the other end defining reservoir 13 within
the cap. Id. 143 44.
i o
FIG. 3D
Figure 3D, above, illustrates connector cap 10 for use in priming of a
transfusion line. Septum 21 is made of an elastic material having slit 22
formed in it. Id. 143. Slit 22 accepts tube part 43 of male connector 40 as
shown below in Figure 4 from the ’361 application. Id. 1 50.
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Application 13/700,361
Figure 4 shows a schematic cross-sectional diagram illustrating the
connected state of a male connector and connector cap. Id. 119.
In use, when tube part 43 of male connector 40 is inserted through
septum 21 as illustrated above in Figure 4 of the ’361 application, fluid can
flow between tube part 43 and reservoir 13. Id. 143. Also, air can pass
through hydrophobic filter 31, but liquid cannot. Id. When tube part 43 is
removed from septum 21, the nature of the septum’s elastic material permits
slit 22 to close, thus sealing fluid drawn into the cap within reservoir 13. Id.
154.
Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A connector cap which can be removably attached to a male
connector, comprising:
a container including a first opening and a second opening and
having an inside and an outside;
a seal member disposed in the first opening so as to separate the
inside and the outside of the container, the seal member
including an insertion passage formed therethrough whereby
an inserted body can be inserted from the outside to the inside
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Application 13/700,361
of the container, the insertion passage of the seal member
elastically sealed after removal of the inserted body; and
a hydrophobic filter which is disposed in the second opening.
REJECTION
Claims 1—20 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Ramsey (US 2007/0156118 Al, pub. July 5, 2007), in
view of Miyasaka (US 2008/0103487 Al, pub. May 1, 2008).
ANALYSIS
Unpatentability of claims 1—20 over Ramsey and Miyasaka
Appellant argues the two independent claims 1 and 7 as a group. See
App. Br. 8—12. Appellant does not present separate arguments as to
dependent claims 2—6 and 8—20, which depend respectively from claim 1
and claim 7. Id. at 12. We select claim 1 as representative of the group
where claim 7 stands or falls with claim 1. See 37 C.F.R. 41.37(c)(l)(vii)
(2011).
Claims 1 and 7
The Examiner found that Ramsey discloses a removable connector
cap for priming a medical intravenous line for example, including
container 68 having seal member(s) 92, 94 and insertion passage 70 at one
end for accepting a male member and a hydrophobic filter at the opposite
end of the container. Final Act. 4. The Examiner determined that seal
member 92, 94 “separate [s] the inside and the outside of the container” as
recited in claim 1. Id.', Ans. 3. According to the Examiner, Miyasaka
teaches use of an elastic septum seal 27 that is widely known in the art.
Ans. 4. The Examiner states that a person of ordinary skill in the art would
have known “to replace the O-ring seal of Ramsey with any alternative type
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Application 13/700,361
of seal, including the septum seal of Miyasaka,” because it is merely the
replacement of one well know element for another that achieves the same
functionality and predictable outcome. Id.
Appellant makes three specific arguments: first, that the Examiner’s
analysis fails to address each element of the claims; second, that the
Examiner has not identified an articulated reason with evidentiary
underpinnings to support the combination of Ramsey and Miyasaka; and
lastly, that the modification of Ramsey with Miyasaka’s septum seal would
render Ramsey unsatisfactory for its intended purpose. App. Br. 3, 8—12.
We address each of the arguments, below, in turn.
Appellant argues specifically that Ramsey’s O-ring seal 94 fails to
meet the limitation of a seal that “separate^]” the inside and outside of the
container. Id. at 8. Appellant’s position is also that Ramsey’s O-ring seal 94
is disposed around opening 70, “and is not disposed in the opening 70.” Id.
The clause at issue in claim 1 recites “a seal member disposed in the
first opening so as to separate the inside and the outside of the container.”
Observing Figures 5—8 of Ramsey we observe certain end structure (no
specific reference number) located, i.e. disposed, in a first end of container
68 and O-ring seal 94 formed on an outer surface of that end structure. We
have highlighted in yellow the end structure to which we refer, in Ramsey’s
Figure 8, as reproduced below.
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Application 13/700,361
Figure 8 from Ramsey, as annotated above, illustrates priming cap 66
and container 68 with end structure highlighted in yellow, including O-ring
seal 94.
The Examiner takes the position that this end structure which includes
O-ring seal 94 is “disposed in the first opening” as called for in claim 1.
Ans. 2—3. We are persuaded that the Examiner’s position is more reasonable
because the claimed “opening,” as the noun in this prepositional phrase, is
really nothing more than a temporal reference to an end of the container that
is not in fact “open” but has the seal member positioned in it. Also, we
understand from a plain reading of the claim that the seal member is
“disposed in the first opening,” with no further elucidation of the relative
structural arrangement of the “opening” and “seal member.”
Appellant’s argument does not persuasively address the Examiner’s
complete analysis which points to the end structure as well as O-ring seal 94
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Application 13/700,361
(as highlighted above) being located in the first end of Ramsey’s container.
A reasonable reading of the claim language does not differentiate
sufficiently the recited opening and seal member from Ramsey’s end
structure and O-ring seal 94 at the end of container 68. In this same vein, we
agree with the Examiner that the claim language “does not require that the
separation completely and totally isolates the inside from the outside of the
container.” Id. at 3. Ramsey arguably has an opening 70 which is not
elastic and does not self-seal; however, observing Figure 8, above, Ramsey’s
end structure and O-ring seal 94 forms the end of container 68 and mostly
separates the inside from the outside of container 68. See Ramsey 129,
Figs. 5—8.
We are also not persuaded that the Examiner has provided insufficient
reasoning and evidence that one of ordinary skill in the art would have
combined Ramsey and Miyasaka. See App. Br. 9—10. Appellant argues that
the “Examiner failed to cite to any portion of Ramsey that would provide
motivation” for utilizing a septum in Ramsey. Id, at 9. There is, however,
no legal requirement that the Examiner’s reasoning or rationale be
predicated on “a suggestion” in the references. See KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 419 (2007) (“The obviousness analysis cannot be
confined by a formalistic conception of the words teaching, suggestion, and
motivation, or by overemphasis on the importance of published articles and
the explicit content of issued patents.”). Moreover, the Examiner pointed to
paragraph 33 of Ramsey which, after describing the embodiment of Figure
5, states that “[w]ith this configuration, the seal may be formed as an integral
part of the reservoir device. However, other types of seals may be devised
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Application 13/700,361
and used.” See Ans. 4 (citing Ramsey 133). Thus, Ramsey expresses the
evidentiary foundation that alternative seal structures were known in the art.
Also, the Examiner explained that “[sjeptum seals are extremely well
known in the art and clearly taught by Miyasaka.” Final Act. 2. The
Examiner reasoned persuasively that
[t] he use of a septum type seal provides for a sealed space prior
to the introduction of any medical fluids, thereby maintaining a
sterile and uncontaminated environment. One of ordinary skill
would recognize that the septum seal of Miyasaka would provide
additional protection against contamination, while still providing
a suitable seal engageable by the distal end of a syringe or other
male sealing element.
Id. In light of the record, Appellant’s arguments do not apprise us of any
lack of reasoning or failure on the part of the Examiner to provide sufficient
evidentiary foundation for the combination of Ramsey and Miyasaka.
Appellant’s argument that Miyasaka’s septum seal would prevent
fluid from flowing into the reservoir device 68 of Ramsey’s priming cap,
during priming, and therefore Ramsey’s priming cap would thereupon be
made unfit for its intended purpose, is unpersuasive. See App. Br. 10-11.
Appellant’s argument presumes that one of ordinary skill in the art would
not have known, or gleaned from Miyasaka, to insert male member through
slit 27a of septum 27 to allow fluid to flow into Ramsey’s reservoir device
68. See id. We find the Examiner’s position here the more persuasive one
where he explained that
[u] se of the septum seal of Miyasaka would only require that the
seal be penetrated by the male member prior to the beginning of
priming, and would remain in that configuration for the duration
of priming, thereby allowing fluid flow between the luer element
(50) and the reservoir.
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Ans. 6. Indeed, in the Final Office Action the Examiner stated the specific
teaching from Miyasaka, and that one of ordinary skill in the art would have
understood from such teaching, to use a penetrating member with an elastic
septum seal:
Miyasaka et al. teaches a connection structure for a transfusion
line set comprising an elastic septum (27) defining an inside and
an outside of a connector element, designed to allow the passage
of a penetrating element of a male connector from the outside to
the inside, and which elastically seals before and after insertion
of the penetrating element.
Final Act. 9. Appellant’s argument does not substantively address, nor
provide persuasive evidence, why use of a penetrating member as shown in
Miyasaka used with an elastic seal, for example in Figure 4, would have
been outside the experience or knowledge of one of ordinary skill in the art.
Besides the fact that a penetrating member in cooperation with the elastic
septum seal is expressly disclosed in Miyasaka, we are not apprised of any
evidence that using such a penetrating member was beyond the level of
ordinary skill in the art. See KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398,
416—19 (2007) (holding obvious the inclusion of a known device because
there was no evidence presented that the inclusion of the known device in
the combined device was “uniquely challenging or difficult for one of
ordinary skill in the art” or “represented an unobvious step over the prior
art”).
The Examiner’s position is supported by a preponderance of the
evidence and the Examiner’s legal conclusion of obviousness is well
founded and articulated. We sustain the rejection of claim 1.
Appellant does not raise what amounts to a separate argument for the
patentability of claim 7. See Appeal Br. 8—12. We sustain the rejection of
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claim 7 for the same reasons as stated for claim 1. See 37 C.F.R. §
41.37(c)(iv) (failure to separately argue claims).
Claims 2—6 and 8—20
Appellant argues that dependent claims 2—6 are allowable due to their
dependency from claim 1, and that claims 8—20 are allowable due to their
dependency from claim 7. App. Br. 12. As we sustain the rejection of
claims 1 and 7, these arguments are not persuasive. Accordingly, we sustain
the rejection of claims 2—6 and 8—20.
DECISION
We AFFIRM the rejection of claims 1—20.
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
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