Kimberly A. Mcclain et al.

Patent Trials and Appeals Board

Dec 2, 2019

14591512 - (D) (P.T.A.B. Dec. 2, 2019)

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.
14/591,512 01/07/2015 Kimberly A. McClain 3712174.05106 8859
29200 7590 12/02/2019
K&L Gates LLP-Chicago
Baxter
P.O. Box 1135
Chicago, IL 60690-1135
EXAMINER
POON, ROBERT
ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
12/02/2019 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):
USpatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KIMBERLY A. MCCLAIN, MICHAEL BAKLYCKI, and
THOMAS D. MCDEVITT
Appeal 2018-007265
Application 14/591,512
Technology Center 3700
Before JOHN C. KERINS, JAMES A. WORTH, and
ARTHUR M. PESLAK, Administrative Patent Judges.
PESLAK, 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 1–6 and 9–17.2 We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. Appellant identifies the real parties in interest as Baxter International
Inc. and Baxter Healthcare SA. Appeal Br. 3.
2 Claims 7 and 8 are cancelled. Appeal Br. A2 (Claims App.).
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CLAIMED SUBJECT MATTER
The claims are directed to a packaging system and methods of alerting
a practitioner. Claim 1, reproduced below, is illustrative of the claimed
subject matter:
1. A packaging system comprising:
a container having a closed end, an open end, a
longitudinal axis running through the closed end and the open
end, and an outer surface;
a closure assembly fitted to the open end of the container
and having an access port;
a detachable cap disposed over the access port; and
a tubular label disposed about the perimeter of the
container and extending from a lower edge aligned with the
closed end of the container to an upper edge at the cap, wherein
the label has a first region having an angle relative to the
longitudinal axis between 20 and 80 degrees, the first region
consisting essentially of a name of an injectable drug product,
and
a second region having an angle relative to the longitudinal
axis between 20 and 80 degrees, the second region consisting
essentially of a concentration of the injectable drug product,
whereby the said first and second regions are angled such as to
lie in planes that make non-zero as well as non-right angles with
the longitudinal axis.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Novitch US 3,811,591 May 21, 1974
Haines US 4,312,523 Jan. 26, 1982
Kutcher US 4,540,101 Sep. 10, 1985
Willis US 4,544,073 Oct. 1, 1985
Heuer US 4,804,984 Feb. 14, 1989
Papciak US 5,284,263 Feb. 8, 1994

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REJECTIONS3
1) Claims 1–6, 10–14 are rejected under pre–AIA 35 U.S.C. § 103(a)
as unpatentable over Novitch, Willis, Haines, and Heuer.
2) Claims 9 and 15 are rejected under pre–AIA 35 U.S.C. § 103(a) as
unpatentable over Novitch, Willis, Haines, Heuer, and Papciak.
3) Claims 16 and 17 are rejected under pre–AIA 35 U.S.C. § 103(a)
as unpatentable over Novitch, Willis, Haines, Heuer, and Kutcher.

OPINION
Rejection 1
Claims 1–6
The Examiner finds that Novitch discloses many of the limitations of
claim 1 but, does not disclose, inter alia, “the label with the recited indicia at
angled orientations relative to the longitudinal axis.” Final Act. 5–6. The
Examiner relies on Haines for “a medical container . . . having a label with
indicia (18) . . . divided into regions of a name and concentration.” Id. at 6
(citing Heuer, Fig. 1). The Examiner relies on Heuer for “label packaging . .
. wherein printed indicia (14) are angled relative to the longitudinal axis of
the container(s) for allowing the indicia to be read from different
orientations.” Id. (citing Heuer, Abst., Fig. 14). The Examiner concludes
that “one of ordinary skill in the art would have found it obvious to
incorporate angled indicia to the Novitch label in order to indicate to a user
the contents of the vial and allow the indicia to be read from different

3 A rejection of claims 1–17 (Final Act. 3) on the ground of nonstatutory
double patenting has been obviated by a terminal disclaimer filed October 9,
2017 and approved on October 19, 2017.
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orientations.” Id. The Examiner also notes that “[a]lthough the prior art
does not explicitly teach the recited angles, note that printed matter . . . not
functionally related to the substrate is given little patentable weight.” Id. at
6–7.
Appellant contends the rejection is erroneous and argues that the
Examiner acknowledged that none of the references “disclose or suggest
first and second regions of a drug product container label where each of the
regions has an angle between 20 and 80 degrees relative to the longitudinal
axis of the container.” Br. 11. In the Answer, the Examiner maintains that
“appellant is relying on the indicia of the label being positioned at the recited
angles to define over the prior art,” which, according to the Examiner, is
inappropriate because the indicia “is printed matter that is not functionally
related to the product.” Ans. 9.4 For the following reasons, we do not
sustain the rejection of claim 1.
Claim 1 requires a label with a first region and a second region
wherein each region has “an angle relative to the longitudinal axis [of the
container] between 20 and 80 degrees.” Appellant’s Specification provides
an exemplary embodiment illustrating label regions 100 and 102 arranged
relative to the longitudinal axis 104 at angle ɵ. Spec. ¶ 32, Figs. 2, 5. Claim
1 further requires that the first region consists “essentially of a name of an
injectable drug product” and the second region consists “essentially of a

4 Claim 1 also requires that the “first and second regions are angled such as
to lie in planes that make non-zero as well as non-right angles with the
longitudinal axis.” Appeal Br. A1 (Claims App.). Neither the Examiner nor
Appellant specifically address this claim limitation separately from the
limitation that the regions are angled “relative to the longitudinal axis
between 20 and 80 degrees.” See generally Final Act., Br.
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concentration of the injectable drug product.” In the rejection, the Examiner
conflated these two separate requirements and found that both limitations do
not patentably distinguish the prior art because, according to the Examiner,
both limitations entail non-functional printed matter. Final Act. 6–7; see
also Ans. 9 (“The appellant is relying in the indicia of the label being
positioned at the recited angles to define over the prior art.”). We agree with
the Examiner that the actual indicia recited as appearing in the claimed
regions, i.e., the name and concentration of a drug product, cannot
patentably distinguish the prior art merely because the content of the claimed
indicia is different than the indicia appearing in the prior art labels. The
same cannot be said for the structural aspects of the claimed regions. The
first region and second region are recited to lie within certain angular ranges
relative to the longitudinal axis of the container. As noted by Appellant, the
Examiner acknowledged that “the prior art does not explicitly teach the
recited angles.” Final Act. 6–7. Further, the Examiner did not provide
persuasive evidence or technical reasoning why the recited angles of the
regions are non-functional printed matter. We, thus, do not sustain the
rejection of claim 1 and claims 2–6 which depend directly or indirectly from
claim 1.
Claims 10–14
Independent claim 10 contains limitations similar to claim 1
concerning the printed indicia and angles of “sections” of the label (as
opposed to “regions” in claim 1), however, the range of angles in claim 10 is
recited as “neither perpendicular to nor parallel with the longitudinal axis” of
the container. Br. A3 (Claims App.). Similar to its claim 1 contentions,
Appellant contends that the prior art “does not disclose or suggest a drug
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name section and a concentration section angled relative to a longitudinal
axis of a drug product container.” Br. 30 (emphases omitted). The
Examiner responds with the same positions taken as for claim 1. Ans. 15.
For the reasons discussed above, we do not sustain the rejection of claim 10
and claims 11–14 which depend directly or indirectly from claim 10.
Rejections 2 and 3
Claim 9 depends from claim 1 and claims 15–17 depend from claim
10. Br. A1–A5 (Claims App.). The Examiner does not rely on the
additional disclosure from Papciak and Kutcher to cure the deficiencies in
the rejections of claim 1 and claim 10 discussed above. Final Act. 10–11.
We, thus, do not sustain the rejections of claims 9 and 15–17 for the same
reasons.
CONCLUSION
The Examiner’s rejections of claims 1–6 and 9–17 under 35 U.S.C. §
103 are reversed.
More specifically,
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–6, 10–14 103 Novitch, Willis,
Haines, Heuer
1–6, 10–14
9, 15 103 Novitch, Willis,
Haines, Heuer, Papciak
9, 15
16, 17 103 Novitch, Willis,
Haines, Heuer, Kutcher
16, 17
Overall
Outcome
1–6, 9–17

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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
REVERSED