Ex Parte Erickson et al

Patent Trial and Appeal Board

Jul 15, 2014

12492688 (P.T.A.B. Jul. 15, 2014)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte THOMAS E. ERICKSON, JAMES J. ERICKSON
and TIMOTHY A. BACHMAN
____________

Appeal 2012-002017
Application 12/492,688
Technology Center 3700
____________

Before NEAL E. ABRAMS, EDWARD A. BROWN, and
LYNNE H. BROWNE, Administrative Patent Judges.

ABRAMS, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Thomas E. Erickson et al. (Appellants) seek our review under 35
U.S.C. § 134 from the Examiner’s decision rejecting claims 2-13. We have
jurisdiction over the appeal under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
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Application 12/492,688

2
THE INVENTION
The claimed invention is directed to a dispensing strip for needle
assemblies.
Claim 2, reproduced below, is illustrative of the subject matter on
appeal.
2. A dispensing strip for needle assemblies, comprising:
a thin flexible strip having a width and a length;
a plurality of needle assemblies each having a
longitudinal axis and comprising a needle and a shield for the
needle; and
a plurality of cavities associated with the thin flexible
strip, said cavities being distributed along the length of the
strip, extending from a single face of the strip, and sized to
substantially contain a single needle assembly,
wherein each cavity substantially contains a single needle
assembly.

THE PRIOR ART
The Examiner relies upon the following as evidence of
unpatentability:
Lieberman US 4,209,091 June 24, 1980
Horii
Nguyen
Lav
US 4,436,205
US 5,944,700
US 5,971,966
Mar. 13, 1984
Aug. 31, 1999
Oct. 26, 1999

THE REJECTIONS
Claim 11 stands rejected under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement.
The following rejections stand under 35 U.S.C. § 103(a):
Claims 2-7 and 9-11 on the basis of Nguyen in view of Horii.
Claims 8 and 12 on the basis of Nguyen in view of Horii and Lav.
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Claim 13 on the basis of Nguyen in view of Horii and Lieberman.
Claims 2-7 and 9-11 on the basis of Horii in view of Nguyen.
Claims 8 and 12 on the basis of Horii in view of Nguyen and Lav.
Claim 13 on the basis of Horii in view of Nguyen and Lieberman.
OPINION
Claim 11
35 U.S.C. § 112, First Paragraph
Written Description Requirement
It is the Examiner’s view that
[t]he tube-like needle shield (NS) added to the replacement
drawing filed 1/20/2011 appears to be new matter that was not
described in the specification. The specification does not
provide sufficient details regarding the shape or size of the
tube-like needle in order to allow this element to be added to
the drawings.
Ans. 4-5.

Appellants assert that it “is well known” in the prior art that “pen
needle assemblies typically include . . . a removable tube-like shield
covering the distal portion of the hollow needle” (App. Br. 9; citing Spec. 2),
and that such a shield is disclosed in the Nguyen patent, which has been
cited as a reference in the present case (Reply Br. 2). Appellants further
argue that “[v]ariations in the shape or size of the tube-like shields which
may be found in the art are common and immaterial to the question of
whether there is proper support under 35 U.S.C. § 112, first paragraph,
within the specification for the claimed “tube-like shield . . . .” Reply Br. 2.
In the context of setting forth the background of the invention,
Appellants state that prior art pen needle assemblies typically have included
a tube-type needle shield. However, in describing the components of their
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invention, Appellants are not so precise, stating only that the term “pen
needle assembly” “be interpreted to cover (i) a complete assembly including
. . . [an] axially extending needle with associated needle shield and outer
shield, as well as (ii) the aforesaid assembly sans one or both shields and/or
the shields.” Spec. 11 (emphasis added). There is no dispute that the
original drawings fail to show any type of needle shield. Thus, Appellants’
disclosure does not provide support for the recitation of a “tube-type shield
covering the distal portion of the needle” (emphasis added) in claim 11.
We have carefully considered the arguments presented by Appellants,
however, they have not persuaded us that claim 11 meets the description
requirements of 35 U.S.C. § 112, first paragraph, and therefore this rejection
of claim 11 is sustained.
Claims 2-7 and 9-11
Obviousness – Nguyen In View Of Horii
The Examiner finds all of the subject matter recited in independent
claim 2 to be disclosed in Nguyen, except for the “dispensing strip for
holding a plurality of needle assemblies.” Ans. 5. However, the Examiner
has taken the position that Horii discloses such a strip for dispensing
elongated objects, and it would have been obvious to one of ordinary skill in
the art “to have provided a plurality of needle assemblies of Nguyen along a
strip as taught by Horii in order to transport and store a plurality of needle
assemblies together for individual dispensing and use.” Ans. 5-6.
Among the arguments presented by Appellants is “there is no apparent
problem associated with the transportation and storage of the Nguyen pen
needle assemblies” and thus there is no motivation for combining the two
references in the manner proposed by the Examiner. App. Br. 17.
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Nguyen is directed to an adjustable injection length pen needle
comprising a needle hub 40, an extender 30, a cannula 50, a cannula shield
20, and an outer cover 10. Col. 1, ll. 14-18; Fig. 1. Outer cover 10
“removably mounts to pen needle hub 40 to cover cannula 50, shield 20, and
extender 30 for shipping prior to use.” Id. at ll. 22-25.
Horii relates to improvements in containers for the storage and
transportation of ampules filled with injection fluids or the like. Col. 1, ll. 4-
37. Horii discloses a case 1 comprising bottom walls 2a and 2e, side walls
2b and 2d, and a top wall 2c (Id. at ll. 55-58). The bottoms of ampules A are
secured to the upper surface of bottom wall 2a with an adhesive. Col. 1, l.
67 – Col. 2, l. 1. To eliminate the necessity of placing information regarding
the medicinal preparation contained in the ampules on the outer surface of
the ampules themselves, Horii teaches imprinting this information on the
inner surface of the case side wall 2b. Col. 2, ll. 3-7. After attachment of
the ampules to bottom wall 2a, case 1 is erected around the ampules and then
is placed in an outer box 5 for transport or storage. Id. at 8-20; Figs. 1 and 3.
Horii explains that when the ampule is to be used, the segment of case 1 to
which the ampule is attached is separated from the rest of the case, and the
neck of the ampule is severed from the body while the ampule is held
between side walls 2b and 2d, to avoid possible injury by glass fragments.
Id. at ll. 37-42; Fig. 4. There is no explicit teaching in Horii that, once
attached, the ampules are separated from the case.
Even considering, arguendo, that Horii discloses the “thin flexible
strip” required by claim 2, we find no support in Horii for the Examiner’s
conclusion that it would have been obvious to combine the references in the
manner proposed. In this regard, Horii’s reasons for attaching the ampules
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to the strip are to protect the fragile ampules from damage during storage
and transport, to provide a location for printing information regarding the
medicinal fluid contained in the ampule, and to provide a means for allowing
the neck of the ampule to be severed safely to obtain access to the medicinal
fluids contained therein. Considering that Nguyen already protects the pen
needle from damage during storage and transport by means of an outer
sleeve, in the absence of evidence or persuasive explanation by the
Examiner, none of Horii’s reasons for attaching ampules to a strip apply to
the Nguyen pen needles, and thus support for the Examiner’s conclusion
also is not provided by Nguyen.
“[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)
(quoting In re Kahn, 441 F.39 977, 988 (Fed. Cir. 2006). The Examiner’s
rejection fails to meet this test, and therefore this rejection of independent
claim 2 and dependent claims 3-7 and 9-11 is not sustained.
Claims 8 and 12
Obviousness – Nguyen In View Of Horii and Lav
Claim 13
Obviousness – Nguyen In View Of Horii and Lieberman
Neither Lav, which was cited for disclosing removable covers for
sealing pen needle assemblies (Ans. 7), nor Lieberman, cited for holding
objects in place by means of the releasable adhesive (Ans. 7-8), overcome
the deficiency discussed supra with regard to combining Nguyen and Horii.
Thus, these two rejections also are not sustained.

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Claims 2-7 and 9-11
Obviousness – Horii In View Of Nguyen
The Examiner here concludes that it would have been obvious to one
of ordinary skill in the art “to have provided the storage/transport strip of
Horii with any elongated objects such as the needle assemblies as taught by
Nguyen in order to safely transport and store a plurality of needle assemblies
together.” Ans. 7. However, alternatively expressing the rejection with
Horii rather than Nguyen as the primary reference does not overcome the
lack of support for the conclusion that it would have been obvious to
combine the references, as expressed supra with regard to the other
exposition of the rejection based on the same references. This rejection
therefore is not sustained.
Claims 8 and 12
Obviousness – Horii In View Of Nguyen and Lav
Claim 13
Obviousness – Horii In View Of Nguyen and Lieberman
For the reasons expressed supra with regard to the other rejections of
claims 8. 12 and 13, these two rejections also are not sustained.
DECISION
The rejection of claim 11 under 35 U.S.C. § 112, first paragraph, is
affirmed.
All of the rejections under 35 U.S.C. § 103(a) are reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED-IN-PART
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