Bo Radmer et al.

Patent Trials and Appeals Board

Sep 29, 2021

2021002268 (P.T.A.B. Sep. 29, 2021)

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.
12/865,048 11/01/2010 Bo Radmer 7751.204-US 9924
155895 7590 09/29/2021
Novo Nordisk Inc.
Intellectual Property Department
800 Scudders Mill Road
Plainsboro, NJ 08536
EXAMINER
PATEL, SHEFALI DILIP
ART UNIT PAPER NUMBER
3783
NOTIFICATION DATE DELIVERY MODE
09/29/2021 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):
NNIPATENT@NOVONORDISK.COM
kisw@novonordisk.com
lklw@novonordisk.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte BO RADMER, JAKOB OEST WIELANDT,
FRANK ANDREAS JESPERSEN, TOM HEDE MARKUSSEN, and
JACOB KOLLERUP JENSEN
____________

Appeal 2021-002268
Application 12/865,048
Technology Center 3700
____________

Before MICHAEL J. FITZPATRICK, BRANDON J. WARNER, and
MICHAEL L. WOODS, Administrative Patent Judges.

WARNER, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1 and 14, which are all the pending
claims. Appeal Br. 2; Non-Final Act. 1 (Office Action Summary). We have
jurisdiction over the appeal under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to the “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as NOVO
NORDISK A/S of Bagsvaerd, Denmark. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
Appellant’s disclosed invention “relates to a variable connection for
an injection device and preferably for a variable connection between the
parts of an injection device determining the distance between the movable
element in the container and the part moving the movable part.” Spec., p. 1,
ll. 5–7. Claims 1 and 14 are independent. Claim 1, reproduced below with
emphasis added, is illustrative of the subject matter on appeal.
1. A disposable prefilled injection device for performing
medical injections comprising[:]
a cartridge having a predetermined and non-replaceable
amount of a medicine, the cartridge permanently embedded in
the prefilled injection device containing a piston rod structure,
such that when the predetermined and non-replaceable amount
of the medicine has been injected the entire prefilled injection
device is discarded and a new injection device is used for
subsequent injections,
wherein the cartridge comprises a distal end closed by a
membrane and a proximal end closed by a movable plunger
which is movable in a distal direction by the piston rod
structure in order to expel the medicine contained between the
membrane and the movable plunger, wherein a relative axial
position between the piston rod structure and the plunger is
determined during assembly of the prefilled injection device,
the piston rod structure comprises a piston rod and a
piston rod foot,
wherein the piston rod foot is a separate part
permanently attachable to the piston rod,
wherein the piston rod foot has a variable connection
allowing the piston rod foot and the piston rod to slide axially
relative to one another, and
wherein a relative axial distance between the piston rod
foot and the plunger is individually determined during the
assembly such that when the piston rod and the piston rod foot
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are slid into a position where the piston rod foot and the
movable plunger abut each other, the piston rod and the piston
rod foot are configured to be permanently connected to each
other, and
wherein the piston rod foot has a number of resilient
attaching wings pointing in a proximal direction which wings
are received in a number of recesses in the piston rod.2

EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Glazier US 4,883,466 Nov. 28, 1989
Chanoch US 5,688,251 Nov. 18, 1997

2 We question precisely when in the manufacturing or assembly stage
the disposable prefilled injection device of claim 1 is to be considered to fall
within the scope of the claim. For example, recitations such as “the piston
rod foot is a separate part permanently attachable to the piston rod,” and
“the piston rod foot has a variable connection allowing the piston rod foot
and the piston rod to slide axially relative to one another,” imply features
that would seem to exist only prior to final assembly. However, other
recitations such as “a relative axial position between the piston rod structure
and the plunger is determined during assembly of the prefilled injection
device,” where the components are permanently connected to each other
after such determination, imply features that would seem to exist only after
final assembly of the disposable prefilled injection device. We leave to the
Examiner to consider whether the device of claim 1 (as compared with the
method of assembling of claim 14) meets the requirements for definiteness
of the subject matter recited.
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REJECTION
The following rejection is before us for review: Claims 1 and 14
stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Chanoch
and Glazier. Non-Final Act. 3–7.

ANALYSIS
Claims 1 and 14 are both directed to a disposable prefilled injection
device, specifically reciting that the device includes a cartridge filled with “a
predetermined and non-replaceable amount of a medicine,” which is
“permanently embedded in the prefilled injection device,” such that the
entire device is discarded upon use of the medicine. Appeal Br., Claims
App. The rejection of these claims starts with Chanoch for disclosing such a
disposable prefilled injection device. Non-Final Act. 3–4 (claim 1), 5–6
(claim 14). Both claims also recite a piston rod structure that includes a
piston rod and a piston rod foot that can initially “slide axially relative to one
another” until a relative distance therebetween is “individually determined
during the assembly,” such that the piston rod foot abuts a moveable plunger
of the cartridge, whereafter the piston rod and the piston rod foot are to be
“permanently connected” (claim 1) or “permanently attached” (claim 14) to
each other in an assembled device. Appeal Br., Claims App. For disclosure
of these features of the piston rod structure, the rejection turns to Glazier.
Non-Final Act. 4–5 (claim 1), 6–7 (claim 14).
Appellant argues that the cited references are deficient in teaching the
claimed features for which they are relied on—specifically that Chanoch
does not teach a disposable prefilled injection device, where a prefilled
cartridge is permanently embedded therein (see Appeal Br. 7–9), and that
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Glazier does not teach a permanent connection or attachment between a
piston rod and a piston rod foot as claimed (see id. at 9–11). In short, we
agree with Appellant.
With regard to Chanoch, Appellant is correct that this reference
discusses both disposable and reusable injection devices in its background
section, and then expressly discloses an invention directed to the latter
(namely, a mechanism for loading and priming cartridges with a reusable
injection device). See, e.g., Chanoch, col. 2, l. 25 – col. 3, l. 12; see also
Appeal Br. 7–9 (making the same point). We note that this same distinction
is also drawn in Appellant’s Specification, where it is stated that the present
invention is directed to a disposable injection device. See, e.g., Spec. p. 1,
ll. 16–32; see also Reply Br. 2–3 (making the same point).
The Examiner attempts to expand the disclosure of Chanoch to cover
a disposable injection device by urging that the reusable injection device “is
capable of being disposed of or thrown away at any point in time,” but such
an expansion would effectively render the distinction meaningless, which is
contrary to the evidence of record. Ans. 3–4. Similarly, the Examiner’s
consideration of the recited cartridge being “permanently embedded in the
prefilled injection device” being met by Chanoch’s changeable cartridge
being embedded in the reusable injection device “during use” of the device
is unreasonable as it effectively reads out the claim’s requirement of
permanence. Id. at 5.
In sum, we agree with Appellant that Chanoch is deficient in teaching
a disposable prefilled injection device, where a cartridge filled with “a
predetermined and non-replaceable amount of a medicine” is “permanently
embedded in the prefilled injection device,” as claimed. It is clear from
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Appellant’s disclosure that disposable prefilled injection devices are known
in the art. See Spec., p. 1, l. 26 – p. 2, l. 28 (discussing assembly issues due
to tolerances within these known devices, and identifying two patent
documents for such devices). But it is also clear that Chanoch, as relied on
in the rejection, does not teach this type of injection device.
Turning to Glazier, Appellant is correct that this reference does not
teach components of a piston rod and a piston rod foot that are to be
“permanently connected” or “permanently attached” to one another, as
recited in the claims. See Appeal Br. 9–11. In particular, Glazier discloses a
syringe that is non-reusable (single-use or self-destroying). As Appellant
explains, the components relied on by the Examiner as being the claimed
piston rod and piston rod foot are removably connected to one another
(operably connected only during a first use), but are then disconnected from
one another, which is necessary for Glazier’s device to achieve its disclosed
purpose of being single-use. See Appeal Br. 10; see also Glazier, col. 3,
l. 56 – col. 6, l. 19 (discussing operation of these components to be operably
connected only as the syringe is filled and emptied “once and only once,”
after which it is rendered non-reusable).
Somewhat similar to the interpretation issue discussed above, the
Examiner considers “permanently connected” or “permanently attached” to
encompass the operable connection of Glazier’s components “during . . . the
point in time of use” of the injection device in a way that effectively reads
out the claim’s requirement of permanence, which is unreasonable in light of
Appellant’s disclosure and the plain meaning of the term. Ans. 7–9. We
agree with Appellant that Glazier is deficient in teaching components of a
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piston rod structure that are to be “permanently connected” or “permanently
attached,” as claimed.
Accordingly, because the Examiner’s rejection is premised on
findings that are not supported by a preponderance of the evidence, we do
not sustain the rejection.

DECISION
We REVERSE the Examiner’s rejection of claims 1 and 14 under
35 U.S.C. § 103(a) as being unpatentable over Chanoch and Glazier.

CONCLUSION
In summary:

Claim(s)
Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 14 103(a) Chanoch, Glazier 1, 14

REVERSED