Ex Parte Nie

Patent Trial and Appeal Board

Mar 28, 2018

13784721 (P.T.A.B. Mar. 28, 2018)

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.
13/784,721 03/04/2013 Weiyan Nie P-10089 (66810-739) 6983
47058 7590
Dickinson Wright - BD
1825 Eye St., NW
Suite 900
WASHINGTON, DC 20006
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
03/30/2018 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 WEIYAN NIE
Appeal 2016-008363
Application 13/784,721
Technology Center 3700
Before BRETT C. MARTIN, BEVERLY M. BUNTING, and
PAUL J. KORNICZKY, Administrative Patent Judges.
KORNICZKY, Administrative Patent Judge.
DECISION ON APPEAL
Appeal 2016-008363
Application 13/784,721
STATEMENT OF THE CASE
Appellant Weiyan Nie1 appeals under 35 U.S.C. § 134(a) from the
Examiner’s decision, as set forth in the Final Office Action dated April 29,
2015 (“Final Act.”), rejecting claims 1—6, 11, 12, 15—19, and 26—30.2 We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
THE CLAIMED SUBJECT MATTER
The claims are directed to a single-step removal of a cannula guard
and an adhesive liner in a medical device. Spec. (Title). Claims 1 and 26
are the independent claims on appeal. Claim 1, reproduced below with
disputed limitations italicized for emphasis, is illustrative of the claimed
subject matter:
1. A medical device, comprising:
a body;
a cannula extending from the body, for insertion into a
patient's skin;
a guard covering the cannula, the guard being open at
opposing ends thereof,
an adhesive for securing the medical device to the patient's
skin; and
an adhesive liner covering the adhesive;
wherein the guard is connected to the adhesive liner to
enable conjoint and at least partial removal of the guard and the
adhesive liner.
1 Appellant identifies Becton, Dickinson and Company as the real party
in interest. Appeal Brief, dated October 29, 2015 (“Appeal Br.”), at 3.
2 Claims 7—10, 14, 20—25, and 31 are withdrawn from consideration,
and claim 13 is cancelled. Appeal Br. 15—18 (Claims App’x.).
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Application 13/784,721
REFERENCES
In rejecting the claims on appeal, the Examiner relied upon the
following prior art:
Mogensen
Johansson
Moberg
Shaw
US 7,621,395 B2
US 7,935,096 B2
US 8,317,759 B2
US 2012/0004621 A1
Nov. 24, 2009
May 3, 2011
Nov. 27, 2012
Jan. 5, 2012
REJECTIONS
The Examiner made the following rejections:
1. Claims 1—5, 11, 12, 15—19, and 26—30 stand rejected under 35
U.S.C. § 103(a) as being unpatentable over Mogensen, Moberg, and Shaw.
2. Claim 6 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Mogensen, Moberg, Shaw, and Johansson.
Appellant seeks our review of these rejections.
DISCUSSION
The Rejection of Claims 1—5, 11, 12, 15—19, and 26—30
as Unpatentable Over Mogensen, Moberg, and Shaw
Independent Claims 1 and 26
Appellant argues claims 1 and 26 as a group. Appeal Br. 9-11. We
select claim 1 as the representative claim, and claim 26 stands or falls with
claim 1. 37C.F.R. § 41.37(c)(l)(iv)
The Examiner finds that Mogensen discloses all of the limitations of
claims 1 and 26 except for the limitation reciting that the guard is “open at
opposing ends thereof.” Final Act. 3—A. The Examiner finds that a cannula
guard open at opposing ends is disclosed by Moberg and Shaw. Id. at 3
(citing Moberg Fig. 8 (e.g., guard 34 covering cannula 65) and Shaw (e.g.,
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Application 13/784,721
guard 260 covering cannula 236 in Fig. 15)). The Examiner determines it
would have been obvious “to form the guard of Mogensen to be open at
opposing ends, as disclosed by Moberg, in order to [1] allow the guard to
breathe, [2] permit sterilizing of the cannula with the guard in place, and [3]
simplify the manufacture of the guard by permitting injection molding core
pins to be removed from both ends thereof as disclosed by Shaw.” Id. at 3—
4.
Appellant contends that the Examiner failed “to articulate reasoning
with sufficient rational underpinning to support the legal conclusion of
obviousness” for several reasons. Appeal Br. 9. First, Appellant argues that
“Mogensen discloses that the packaging (impenetrable part 7 combined with
removable part 8) delivers an infusion set and an insertion needle under
sterile conditions” {id. (citing Mogensen 1:12—20, 6:57—60, Abstract)), and
“that modifying the circular center part 7a and the support part 9 of the
impenetrable part 7 of the packaging of Mogensen to be open at opposing
ends thereof, as suggested by the Examiner, would render the device
inoperable for its intended purpose of maintaining the sterility of the internal
contents of the packaging” {id. at 10).
We agree with the Examiner that “while [Mogensen’s] device should
be delivered under ‘sterile conditions’ and ‘placed inside a packaging
according to the invention under sterile conditions, ’ Mogensen does not link
the closed end of the cannula guard (7a and 9) with maintaining such
sterility.” Answer, dated February 10, 2016 (“Ans.”), at 3 (citing Mogensen
Abstract, 6:57—60).
The three Mogensen excerpts cited by Appellant (i.e., Mogensen
1:12—20, 6:57—60, Abstract) state, in relevant part:
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Application 13/784,721
The insertion of the infusion part will be performed with an
insertion needle which is delivered together with the infusion
part under sterile conditions. The packaging includes an
impenetrable part protecting the surroundings from the insertion
needle and a removal part which is to be removed by the user
before applying the infusion part.
Mogensen Abstract.
The insertion of the infusion part will be performed with an
insertion needle which is delivered together with the infusion
part under sterile conditions.
Id. at 1:18-20.
In FIG. 8a the combination of needle hub 1 and infusion part 2
is placed inside a packaging according to the invention under
sterile conditions, and the impenetrable part 7 protects the
surroundings from contact with the insertion needle 3.
Id. at 6:57—60. Thus, Mogensen discloses that the device and needle should
be delivered under sterile conditions and the purpose of the guard is to
prevent the needle from inadvertently sticking the surroundings.
As the Examiner explains, these three
recitations by Mogensen do not preclude the use of additional
wrappers (such as those disclosed by Shaw) to maintain sterility,
only indicating that the device is provided under ‘sterile
conditions’ (e.g.[,] which could include an additional wrapper
and indicate that the device is interfaced with a patient under the
sterile field of a medical theater) and that the device is placed
inside the packaging ‘under sterile conditions’ (which only
indicates that the device is assembled in a clean, sterile
environment and could certainly include the use of a sterile
wrapper as disclosed by Shaw).
Ans. 4—5. The Examiner correctly notes that Moberg discloses “a
substantially similar infusion part which an ordinary artisan would
reasonably recognize and appreciate should be similarly sterilized and
installed during sterile conditions,” and “the guard [has] an open distal end
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Application 13/784,721
and such a construction does not render the device of Moberg unsuitable for
interfacing with a patient[,] thereby demonstrating that providing a closed
end to the guard is not itself required for maintaining sterility of the system.”
Ans. 5.
Appellant does not identify any portion of Mogensen that explicitly
states that the intended purpose of the guard is to maintain needle sterility,
and merely “submits that one of ordinary skill in the art would understand
that both parts of the outer packaging (i.e., impenetrable part 7 combined
with removable part 8) in combination are structures for maintaining the
sterility of the infusion device,” and that “Mogensen does not promote one
intended purpose over another. Instead, both seem to be important intended
purposes for outer packaging to deliver a medical device to an end user.”
Reply Brief, dated April 12, 2016 (“Reply Br.”), at 2. However, Appellant’s
“attorney argument [is] not the kind of factual evidence that is required to
rebut a prima facie case of obviousness.” In re Geisler, 116 F.3d 1465, 1470
(Fed. Cir. 1997); see In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974)
(Appellant’s arguments do not take the place of evidence); In re De Blauwe,
736 F.2d 699, 705 (Fed. Cir. 1984) (lawyer arguments and conclusory
statements which are unsupported by factual evidence are entitled to little
probative value). In this regard, Appellant does not persuasively rebut the
Examiner’s finding that there are other well-known methods to maintain
sterility of Mogensen’s device. See, e.g., Ans. 3.
Second, Appellant argues that if Mogensen’s device is modified with
an open end to “allow the guard to breathe” and “permit sterilizing of the
cannula with the guard in place,” as suggested by the Examiner, “the
modified device would not maintain the sterility of the cannula after
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Application 13/784,721
sterilization . . . unless an additional sterile wrapper were provided.”3
Appeal Br. 10. Appellant argues that the “Examiner has articulated no
reasoning to include this extra step and expense, particularly if the un­
modified packaging of Mogensen already accomplishes its intended
purpose” and “submits that the suggested combination would involve such
additional effort that no one of ordinary skill would have undertaken it
without a recognized reason to do so.” Id. at 11. As discussed above,
however, Appellant does not identify any portion of Mogensen that states
the guard’s purpose is to maintain sterility of the device, and Mogensen does
not preclude the well-known use of sterile wrappers.
In response to Appellant’s argument, the Examiner explains that Shaw
states that the open end permits the needle to breathe (Ans. 5 (citing Shaw
54, 58), and an ordinary artisan “would also recognize that such an open end
permits the device to be sterilized with the needle guard in place, as opposed
to requiring assembly under sterile conditions and prior to insertion of the
needle into the guard” (id.). The Examiner finds that “[sjterilizing of
medical devices is commonly performed by either steam sterilization (e.g.
via an autoclave) or gas sterilization (e.g. ethylene oxide gas, ozone, or the
like),” and “[i]n either case a gas or vapor sterilizing media must be
permitted to communicate and make contact with the structure to be
sterilized.” Id. Thus, the Examiner concludes that an “ordinary artisan
would reasonably recognize and appreciate (based particularly on the
teachings of Shaw) that providing the guard with an open distal end would
3 The Examiner also correctly notes that “Moberg and Shaw both
disclose open ended needle guards wherein the sterility of the device is not
compromised.” Ans. 6.
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Application 13/784,721
permit the device to be assembled under ordinary, non-sterile conditions
(thereby simplifying manufacture and reducing costs by not requiring the
manufacturing facility and equipment to be maintained to rigorous sterile
conditions).” Id.
In response to the Examiner’s explanation, Appellant argues that
Mogensen does not disclose the irradiation, steam, and gas sterilization
methods (Reply Br. 3), but does not address the substance of the Examiner’s
finding that these sterilization methods are well-known to the ordinary
artisan (e.g., Ans. 5). Thus, Appellant does not identify error in the
Examiner’s findings and reasoning.
Third, Appellant argues that because Mogensen does not disclose the
manufacturing process of the impenetrable part 7 or mold core pins, “the
Examiner has not provided sufficient evidence to support the allegation that
a design (such as that of Shaw) that permits improved removal of mold core
pins would decrease costs or allow for faster, simpler manufacture of the
impenetrable part 7.” Reply Br. 3. We agree with Appellant, but this does
not detract from the Examiner’s other alternate findings and reasoning
discussed above.
For the reasons discussed above, the rejection of independent claims 1
and 26 is sustained.4
4 We note that Moberg discloses most of the limitations in independent
claims 1 and 26 including an adhesive or an adhesive pad for securing the
medical device to the patient's skin may be applied to base 14. See, e.g.,
Moberg 5:6—16, Fig. 8. Moberg does not disclose an adhesive liner covering
the adhesive, or a guard that is connected to the adhesive liner to enable
conjoint and at least partial removal of the guard and the adhesive liner.
Mogensen, however, discloses an adhesive liner (i.e., release layer 6a)
covering the adhesive (i.e., adhesive 6), and a guard (i.e., part 7) that is
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Dependent Claims 2—6, 11, 15—19, and 26—30-
“Appellant submits that claims 2—6, 11, 15—19, and 26—30, which
ultimately depend from one of independent claims 1 or 26, should be
allowable for at least the same reasons as claims 1 and 26, as well as for the
additional features recited therein.” Appeal Br. 11. Because the rejection of
claims 1 and 16 is sustained, Appellant’s argument is not persuasive. The
rejection of claims 2—6, 11, 15—19, and 26—30 is sustained.
Dependent Claim 12
Claim 12 recites that “the adhesive liner has a slit; the connecting
portion is connected to the adhesive liner at or adjacent to the slit; and the
shape of the slit corresponds to the shape of the connecting portion.”
The Examiner finds that “Mogensen discloses that the shape of the slit
corresponds to the shape of the connecting portion, see Fig. 21b, note that
connected to the adhesive liner 6a to enable conjoint and at least partial
removal of the guard 7 and the adhesive liner 6a, as recited in claims 1 and
26. See, e.g., Mogensen 62:6; 2:4—10 (stating the release layer 6a is
removed from the adhesive when the body 1 and guard 7a are detached from
each other). Because the release liner is attached to the guard 7, both the
release liner and the guard are removed when the guard 7 is removed from
the device, and body/cannula may be applied to the patient. See, e.g., id. at
6:48—54, Fig. 7. It would have been obvious for a person having ordinary
skill in the art at the time the invention was made to modify Moberg’s
adhesive so that Mogensen’s release liner covers Moberg’s adhesive and is
attached to Moberg’s guard 34 in order to protect the adhesive and prevent
uncovered adhesive to pick up particles and other contaminants and to
permit the guard to remove the liner for easy application of the cannula to
the patient.
5 In Rejection 2, claim 6 is rejected as being obvious over Mogensen,
Moberg, Shaw, and Johansson. Because Appellant addressed claim 6 as
part of Rejection 1, we address claim 6 here for completeness.
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the slit forms a spiral shape that radiates outwardly from a center so as to be
concentric with the connecting portion (i.e. corresponding in shape).” Final
Act. 5.
In response to the Examiner’s rejection of claim 12, Appellant argues
that
although Mogensen does indeed disclose that the slit of the
release layer 6a, 6b can be spiral-shaped (see Mogensen, e.g., at
Fig. 21 b), Mogensen neither discloses nor suggests that the
support part 9 (alleged to correspond to the claimed connecting
portion) is spiral-shaped, and therefore, the slit does not have a
shape that corresponds to the shape of the support part 9. Further,
a square and a circle can be drawn about the same center (i.e.
they can be concentric), but that does not mean that the circle and
the square correspond in shape. Thus, contrary to the Examiner's
allegation, concentricity does not mean correspondence in shape.
Appeal Br. 12.
Relying on the ordinary dictionary definition of “corresponding,”6 the
Examiner explains that the shape of Mogensen’s slit broadly “corresponds”
with the shape of the connecting portion 9 because
both the liner and the connecting portion are a circular shape
(Fig. 7, 20, and 21b) and are concentric about the needle. The
spiral shape of the slit radiates outwardly from this common
center (see Fig. 21 b) to a common outer periphery of the
connecting portion (see Fig. 7 and 20) thereby “corresponding”
in shape to the connecting member.
6 The Examiner states “that ‘corresponding’ does not require the slit
and the connecting portion to have the SAME shape, rather a shapes [sic] be
‘related’ or ‘accompanying’ and ‘having or participating in the same
relationship (as kind, degree, position, correspondence, or function)
especially with regard to same or like wholes (as geometric figures or sets)
Corresponding parts of similar triangles>.” Ans. 8 (citing Merriam-
Webster’s Online Dictionary).
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Ans. 8. The Examiner correctly concludes that “[b]oth shapes are not
required to be spirals to “CORRESPOND”, but rather need only be related
to one another (which the common center and outer circumference
achieve).” Id. We agree with the Examiner that Mogensen’s “spiral slit
forms a generally circular shape which is similar in size and shape to the
[circular] connecting part.” Id. at 9.
For the reasons above, Appellant’s argument is not persuasive, and the
rejection of claim 12 is sustained.
DECISION
For the above reasons, the Examiner’s rejections of claims 1—6, 11,
12, 15-19, and 26-30 are 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)(l)(iv).
AFFIRMED
11