9376305 et al.

Patent Trials and Appeals Board

Jul 30, 2020

2020004624 (P.T.A.B. Jul. 30, 2020)

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.
96/000,272 10/08/2018 9376305 A259 7000US.REX 1011
26158 7590 07/30/2020
WOMBLE BOND DICKINSON (US) LLP
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
EXAMINER
DAWSON, GLENN K
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
07/30/2020 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SARTORIUS STEDIM NORTH AMERICA, INC.
Patent Owner and Appellant

Appeal 2020-004624
Reexamination Control 96/000,2721
Patent 9,376,305
Technology Center 3900
BEFORE JEFFREY B. ROBERTSON, DANIEL S. SONG, and
JEREMY M. PLENZLER, Administrative Patent Judges.
SONG, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(b) and 306, the Appellant2 appeals from
the final rejection of claims 1, 2, 4–7, 10–13, 17–22, and 24–27.3 We have

1 This reexamination stems from a Request for Supplemental Examination
Under 37 CFR 1.601 et seq., filed October 8, 2008.
2 Appellant identifies the real party in interest as Sartorius Stedim North
America, Inc. Appeal Br. 1.
3 Claims 3, 8, 9, 15, 16, 23, and 28–31 are objected to, and claim 14 has
been cancelled. Final Act. 20.
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

2
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
The claims are directed to a fluid transfer interface. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. A fluid transfer interface for use with a vessel comprising:
a body, wherein one or more apertures extend through the
body,
one or more fluid transfer conduits secured to the body,
and
a cast seal within an interior of the body and surrounding
the fluid transfer conduits, the fluid transfer conduits extending
continuously and axially through the one or more apertures, the
cast seal being cured after the one or more fluid transfer conduits
are inserted through the one or more apertures,
wherein when the fluid transfer interface is affixed to a
vessel with an interior and exterior, the cast seal and body forms
a closed aseptic seal between the interior of the vessel and the
exterior of the vessel,
wherein the fluid transfer interface further comprises at
least one fluid control device connected to at least one or more
fluid transfer conduits, and wherein the cast seal comprises
silicone.
Appeal Br. 14, Claims App. (emphasis added).
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Smith US 2,460,542 Feb. 1, 1949
Ryo US 4,715,359 Dec. 29, 1987
Crook US 2002/0162648 A1 Nov. 7, 2002

Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

3
REJECTIONS
1. Claims 1, 2, 4–7, 10–13, 17–22, and 24–27 are rejected under
35 U.S.C. § 103 as unpatentable over Ryo in view of Crook. Final Act. 12.
2. Claims 25–27 are rejected under 35 U.S.C. § 103 as
unpatentable over Ryo in view of Crook and Smith. Final Act. 18.
OPINION
Rejection 1
The Appellant argues independent claims 1, 24, and 25 together as a
group. Appeal Br. 5. Accordingly, we select claim 1 as representative, and
claims 24 and 25 stand or fall with claim 1. See 37 C.F.R. § 41.37(c)(1)(iv).
In addition, the Appellant merely relies on dependency for patentability of
the remaining dependent claims 2, 4–7, 10–13, 17–22, 26, and 27. Appeal
Br. 11. Accordingly, these dependent claims stand or fall with their
respective independent claims.
The Examiner rejects claim 1 finding that Ryo discloses the invention
substantially as claimed except for a silicone cast seal that is cured after the
conduits are inserted through the apertures of the cap. Final Act. 12. The
Examiner finds that Crook discloses sealing of fluid conduits extending
through apertures in a body by using a cast silicone seal that is cured after
the conduits are inserted through the apertures as claimed. Final Act. 12,
citing Crook ¶ 22; see also Crook, Abstract, Figs. 1A–1D, 4; ¶¶ 22, 54, 59,
72. The Examiner concludes that it would have been obvious to one of
ordinary skill in the art to have “provided the cast seal of Crook instead of
the seal 58 of Ryo, and to have provided it after the conduits were placed
through the apertures in the body, as such was known to provide a flexible,
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

4
bonded, liquid tight joint of fluid conduits in a body.” Final Act. 12–13,
citing Crook ¶ 22.

Non-Analogous Art
The Appellant argues that “Crook is not analogous art.” Appeal Br. 5.
There does not appear to be any dispute between the Appellant and the
Examiner that Crook is not within the same field of endeavor in accordance
with the first prong of the analogous art test. See Ans. 13 (“While the
examiner might agree that Crook is not in the same field of endeavor as the
claimed invention, the examiner contends that Crook is reasonably pertinent
to a problem faced by the inventor.”) (quoting Advisory Action mailed Oct.
8, 2019 (“Advisory Act.”)); Reply Br. 2 (“With respect to the first prong (1),
Appellant agrees with the Examiner that Crook is not in the same field of
endeavor as the claimed invention and notes that the Examiner did not
present arguments to the contrary.”). In that regard, the Examiner does not
respond to arguments of the Appellant in its Appeal Brief that Crook is not
in the same field of endeavor, but instead, only addresses the “reasonably
pertinent” prong of the analogous art test in the Examiner’s Answer, stating
that “[t]he examiner explained in the Advisory Action that the teachings of
Crook are indeed reasonably pertinent to problems facing the inventor.”
Ans. 14.
The second prong of the analogousness test requires consideration of
“whether the reference . . . is reasonably pertinent to the particular problem
with which the inventor is involved.” In re Clay, 966 F.2d 656, 659 (Fed.
Cir. 1992) (emphasis added). “A reference is reasonably pertinent if, even
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

5
though it may be in a different field from that of the inventor’s endeavor, it
is one which, because of the matter with which it deals, logically would have
commended itself to an inventor’s attention in considering his problem.” In
re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379–80 (Fed. Cir. 2007).
As to this second prong of the analogousness art test, the Appellant
argues that “Crook is not reasonably pertinent to the problem solved by the
disclosure and claims of the ’305 Patent.” Appeal Br. 7. In particular, the
Appellant argues that the problem confronting the inventor of the ’305
Patent is explained in the Background portion of the ’305 Patent, which
states:
What is further needed is a low cost, disposable fluid transfer
interface that is connected to a vessel . . . that creates a
substantially aseptic fluid pathway into and out of the vessel
that does not suffer from the shortcomings of a barbed or luer
termination, or other means of joining fluid pathways.
Appeal Br. 7, quoting the ’305 Patent, col. 2, ll. 1–7; see also Reply Br. 3.
The Appellant submits numerous arguments in support of its
contention that “Crook is not ‘reasonably pertinent’ to creating a ‘low cost’,
disposable, or ‘substantially aseptic’ fluid pathway as described in the ’305
Patent.” Appeal Br. 7–8; see also Reply Br. 3. In that regard, the Appellant
argues that “there is not a need or a desire to form a seal that would be
aseptic” for a heat exchanger. Appeal Br. 8; see also Reply Br. 5. The
Appellant also argues that Crook does not pertain to addressing the
shortcomings of barbed or luer terminations. Appeal Br. 8; see also Reply
Br. 4.
The Examiner responds that Crook is “reasonably pertinent to the
problem faced by the Patentee of how to attach tubes (fluid transfer
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

6
conduits) to a body with holes therethrough which is then attached to a
vessel for providing transfer of fluid to and from that vessel without the need
for tube connections.” Ans. 14.
The Appellant responds that “the Examiner’s analysis is based on an
incorrect or incomplete understanding of the problem faced by the inventor,”
and that it is “unsure of what the Examiner is citing to formulate the problem
faced by the inventor” because the ’305 Patent “does not recite or frame the
problem as alleged by the Examiner.” Reply Br. 3.
We agree with the Examiner. The Examiner stated that the problem
confronting the inventor was “how to attach tubes (fluid transfer conduits) to
a body with holes therethrough which is then attached to a vessel for
providing transfer of fluid to and from that vessel without the need for tube
connections.” Ans. 14. Although the Appellant relies on the ’305 Patent,
col. 2, ll. 1–7 in support of its articulation of the problem, which focuses on
a “further need[]” based on low cost, disposability, aseptic pathway, and
avoiding barbed or luer termination, the ’305 Patent also specifically
discloses that:
Thus, what is needed is a fluid transfer interface with a body
from which continuous fluid transfer conduits extend, whereby
the conduits extend through and are secured to the body, and to
which a fluid control device may be connected.
’305 Patent, col. 1, ll. 64–67.
This passage articulates the main problem confronting the inventor,
and is stated immediately before the later “further needed” passage relied
upon by the Appellant, which articulates other problems confronting the
inventor. Accordingly, the Examiner’s articulation of the problem faced by
the inventor is supported by the ’305 Patent’s disclosure of a need for “a
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

7
fluid transfer interface with a body from which continuous fluid transfer
conduits extend, whereby the conduits extend through and are secured to the
body.” ’305 Patent, col. 1, ll. 64–67.
Moreover, Crook discloses “[a] heat exchanger and method of making
a heat exchanger which includes providing a header having openings
adapted to receive a plurality of tubes,” wherein the tubes extend through the
wall of the heat exchanger, and are sealed thereto. See, e.g., Crook,
Abstract; Figs. 1A–1D, 4; ¶¶ 22, 54, 59, 72. As such, Crook provides a fluid
transfer interface with the body of the heat exchanger through which
continuous tubes or conduits extend and are secured thereto. Thus, the
Examiner has adequately set forth how the Crook is “reasonably pertinent to
the particular problem with which the inventor is involved,” and “logically
would have commended itself to an inventor’s attention in considering his
problem.” In re Clay, 966 F.2d at 659; In re Icon Health and Fitness, Inc.,
496 F.3d 1379–80.
The Appellant also argues that Crook is not reasonably pertinent
because it is directed to providing a flexible joint for heat exchangers “as an
improvement over the rigid connections” between a rigid metal header and
rigid metal tubes. Appeal Br. 7–8, citing Crook ¶¶ 6–7, 9. According to the
Appellant, “[a]s both of the elements being joined by the flexible joint of
Crook are rigid and one of the elements, i.e., the rigid metal header, is fixed
to an engine that vibrates, there is a need for flexibility in the joint to make
the joint [] durable over an extended period.” Reply Br. 4. The Appellant
argues that in contrast, “the cast seals of the ’305 Patent are formed between
a fluid transfer interface and flexible tubes as a replacement for separable or
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

8
temporary connections, e.g., barbed or luer termination.” Appeal Br. 8; see
also Reply Br. 4.
However, the Appellant’s arguments appear to be directed toward
establishing that Crook is not within the same field of endeavor as the
claimed invention, and this point has already been conceded by the
Examiner. In addition, as discussed above, the fact that Crook does not
specifically address the problem associated with barbed or luer termination
does not detract from its reasonable pertinence to the main problem
confronting the inventor. To the extent that the Appellant’s argument is
focusing on the fact that the tubes of Crook are metal, and thus, presumably
rigid, we observe that such tubes are nonetheless conduits that extend
continuously to provide a fluid transfer interface though a wall, addressing
the main problem confronted by the inventor. Moreover, we further observe
that claim 1 does not require the conduits to be flexible, or otherwise
preclude conduits that are rigid.
In view of the above, we are not persuaded by the Appellant’s
arguments that Crook is non-analogous art.

Rational Underpinnings
The Appellant does not challenge the Examiner’s finding that Crook
discloses a cast silicone seal that is cured after the fluid transfer conduits are
inserted through the apertures. See also Crook, Abstract. Instead, the
Appellant argues that “there is no rational underpinning for the proposed
combination of the flexible joint of Crook with the Safety Bottle and Cap of
Ryo.” Appeal Br. 9. According to the Appellant, “Ryo already discloses
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

9
that the mounting and sealing member 58 fixes the straws 40 and 42 in the
cap 10. There is nothing in Ryo to suggest that having a flexible joint as
disclosed in Crook would be preferred or even suitable for the disclosed
application.” Appeal Br. 10–11.
However, the Examiner is correct that “there is no requirement that a
modification must provide a preference over that which is already disclosed
in the primary reference in order to be combined with the primary
reference.” Ans. 15. Our reviewing court has explained that “just because
better alternatives exist in the prior art does not mean that an inferior
combination is inapt for obviousness purposes.” In re Mouttet, 686 F.3d
1322, 1334 (Fed. Cir. 2012); see also In re Gurley, 27 F.3d 551, 553 (Fed.
Cir. 1994).
In addition, the Examiner also explained that the suggested
combination of the rejection would likely improve the sealed joint in that it
would result in “a flexible, bonded, long-life, liquid-tight sealing joint,” and
that a person of ordinary skill in the art would have understood that:
a sealed joint between components which is flexible would be
beneficial over one that is not flexible because any relative
movement of one relative to another could cause an inflexible
joint to fissure or break. In Ryo the straws will constantly be
moved relative to the seal and container in its normal use.
Ans. 15, citing Crook, col. 2, ll. 56–59, col. 6, ll. 46–61.
The Examiner is also correct that “[a] mere alternative has been
recognized as being a valid rationale for combination.” Ans. 15. As the
Examiner explains, the rejection is replacing the seal Ryo with the silicone
seal as disclosed in Crook, which is cast in the manner recited in claim 1.
Ans. 15. In that regard, “when a patent claims a structure already known in
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

10
the prior art that is altered by the mere substitution of one element for
another known in the field, the combination must do more than yield a
predictable result.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Moreover,
if a technique has been used to improve one device, and a
person of ordinary skill in the art would recognize that it would
improve similar devices in the same way, using the technique is
obvious unless its actual application is beyond his or her skill.
Id. at 417.
The Appellant’s invention of claim 1 substitutes one type of seal
disclosed in Ryo for another type that is known as evidenced by Crook,
using the technique disclosed therein, i.e., sealing of fluid conduits
extending through apertures in a body using a cast silicone seal that is cured
after the conduits are inserted through the apertures.
The Appellant argues that “[a]s the straws 40, 42 [of Ryo] are flexible,
there is no need for the flexible joint of Crook with the cap 10 of Ryo.”
Appeal Br. 11. In addition, as to suitability, the Appellant argues that the
flexibility of the seal as proposed in the rejection “would inherently allow
some removal of the straws from the container in contrast to the teachings of
Ryo” regarding prevention of any accidental removal of the straws, and thus,
would render Ryo unsuitable for its intended purpose. Reply Br. 7.
However, as discussed above, in addition to substitution reasoning,
the Examiner has already provided reasoning with rational underpinnings as
to why it would have been obvious to provide a flexible joint in view of the
disclosure in Crook. See Ans. 15, citing Crook, col. 2, ll. 56–59, col. 6, ll.
46–61. In addition, it is not apparent how the straws/conduits of Ryo would
be removable once the silicone seal cures around the circumferences thereof.
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

11
In that regard, the Appellant does not provide evidence or persuasive
reasoning in support of its assertion that the suggested combination allows
for some removal of the straws of Ryo so as to render it unsuitable for its
intended purpose. Attorney argument is no substitute for such evidence.
Enzo Biochem, Inc. v. Gen-Probe, Inc., 424 F.3d 1276, 1284 (Fed. Cir.
2005); In re Schulze, 346 F.2d 600, 602 (CCPA 1965) (“Argument in the
brief does not take the place of evidence in the record.”).
Therefore, we also find the Appellant’s arguments asserting
deficiencies in the Examiner’s rationale to be unpersuasive. Accordingly, in
view of the above, we affirm the Examiner’s rejection of claim 1, and claims
2, 4–7, 10–13, 17–22, and 24–27 fall with claim 1.

Rejection 2
Claims 25–27 are also rejected as unpatentable over Ryo in view of
Crook and Smith, the Examiner relying on Smith for its disclosure of clips
for “attaching or connecting a straw to the glass.” Final Act. 18–19. The
Appellant relies on the same arguments submitted with respect to Rejection
1 for the patentability of independent claim 25, and relies on dependency on
claim 25 for patentability of claims 26 and 27. Appeal Br. 12. Accordingly,
having found the Appellant’s arguments directed to Rejection 1
unpersuasive, we affirm this rejection as well.
CONCLUSION
The Examiner’s rejections are affirmed. More specifically,
1. The rejection of claims 1, 2, 4–7, 10–13, 17–22, and 24–27 as
unpatentable over Ryo in view of Crook is affirmed.
Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

12
2. The rejection of claims 25–27 as unpatentable over Ryo in view
of Crook and Smith is affirmed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 2, 4–7,
10–13, 17–
22, 24–27
103 Ryo, Crook 1, 2, 4–7,
10–13, 17–
22, 24–27

25–27 103 Ryo, Crook, Smith 25–27
Overall
Outcome
1, 2, 4–7,
10–13, 17–
22, 24–27

REQUESTS FOR EXTENSIONS OF TIME
Requests for extensions of time in this ex parte reexamination
proceeding are governed by 37 C.F.R. § 1.550(c). See 37 C.F.R. § 41.50(f).
AFFIRMED

em

Appeal 2020-004624
Reexamination Control 96/000,272
Patent 9,376,305

13
For Appellant:

WOMBLE BOND DICKINSON (US) LLP
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037