Becton, Dickinson and Company

Patent Trials and Appeals Board

May 12, 2021

2020003074 (P.T.A.B. May. 12, 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.
14/350,969 04/10/2014 Chee Mun Kuan 3896-143109 (P-9322.US) 9827
32182 7590 05/12/2021
Becton, Dickinson and Company /
The Webb Firm
420 Ft. Duquesne Blvd., Suite 1200
Pittsburgh, PA 15222
EXAMINER
INSLER, ELIZABETH
ART UNIT PAPER NUMBER
1774
NOTIFICATION DATE DELIVERY MODE
05/12/2021 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):
ip.docket@bd.com
patents@webblaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte CHEE MUN KUAN
Appeal 2020-003074
Application 14/350,969
Technology Center 1700
Before CATHERINE Q. TIMM, BEVERLY A. FRANKLIN, and
GEORGE C. BEST, Administrative Patent Judges.
TIMM, 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 18, 19, and 26. See Non-Final Act. 1.
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 “Appellant” refers to “applicant” as defined in 37 C.F.R. § 1.42. Appellant
identifies the real party in interest as Becton, Dickinson and Company.
Appeal Br. 2.
Appeal 2020-003074
Application 14/350,969
2
CLAIMED SUBJECT MATTER
The claims are directed to a container assembly that, according to the
Specification, has improved mixing dynamics. See, e.g., claim 18; Spec. ¶ 1.
The container assembly may be an injection device or biological sample
collection container. Spec. ¶ 9.
The container assembly includes a container, such as container 41
shown in Figure 5. Spec. ¶ 44. Container 41 includes at its top end a first
closure, such as stopper 48 shown in Figure 5, and at its bottom end a second
closure, such as closure 60 shown in Figure 5. Spec. ¶¶ 45, 46, 48.
Appellant’s container assembly achieves improved mixing dynamics
by including mixing elements on the closures. As depicted in Figure 6, the
two mixing elements (cavity 63 and mixing fin 64) create vortices (w, x) that
promote thorough mixing of the fluid reservoir contents when the container
assembly (cartridge 40) is rolled. Spec. ¶ 49.
The claims require that one of the mixing elements (second mixing
element of claim 18) includes a protrusion with a substance-containing
surface that is asymmetrical about the container longitudinal axis, such as
the mixing face 91 of Figures 13 and 14. Spec. ¶¶ 54–55. Claim 18,
reproduced below with the limitation most at issue italicized, is illustrative
of the claimed subject matter:
18. A container assembly for mixing substances in
preparation for an injection or dispersion of an additive in a
biological sample, the container assembly comprising:
a container having a first end, a second end, and a
sidewall extending therebetween and defining a container
interior, the container defining a container longitudinal axis, the
container being configured to mix the substances in preparation
Appeal 2020-003074
Application 14/350,969
3
for the injection or disperse the additive in the biological
sample;
a first closure comprising a single-piece stopper having a
proximal end and a distal end, the distal end of the stopper
sealing the first end of the container;
a second closure sealing the second end of the container;
a first mixing element protruding into the container
interior, the first mixing element defining a cavity in a portion
of the first closure, the cavity opening into the container
interior; and
a second mixing element protruding into the container
interior, the second mixing element comprising a protrusion
located on a portion of the second closure, the protrusion
comprising a substance-contacting surface that contacts the
substances in the container interior, wherein the substance-
contacting surface is asymmetrical about the container
longitudinal axis, and whereby, with the container rotated about
the container longitudinal axis, the first mixing element forms
at least one vortex and the second mixing element forms at least
one vortex rotating in a direction opposite to the at least one
vortex formed by the first mixing element which effectuates
mixing of a first substance provided within the container
interior and a second substance provided within the container
interior.
Appeal Br. 21–22 (Claims Appendix) (emphasis added).
Appeal 2020-003074
Application 14/350,969
4
REFERENCES
The Examiner relies on the following prior art:
Name Reference Date
Hurscham US 3,946,732 Mar. 30, 1976
Bassarab US 8,096,971 B2 Jan. 17, 2012
Ruane2 WO 2009/043000 A1 Apr. 2, 2009
REJECTIONS
Claims 18, 19, and 26 are rejected under 35 U.S.C. § 102(b) as being
anticipated by Ruane. Non-Final Act. 2.
Claims 18, 19, and 26 are rejected under 35 U.S.C. § 103(a) as being
obvious over Ruane. Ans. 6.3
Claim 18, 19, and 26 are rejected under 35 U.S.C. § 103(a) as being
obvious over Hurscham in view of Bassarab. Non-Final Act. 4.
OPINION
Anticipation by Ruane
The Examiner rejects claims 18, 19, and 26 as anticipated by Ruane,
pointing to Ruane’s Figure 15 and paragraph 36 to support a finding that
Ruane describes the second mixing element recited in claim 18. We agree
with Appellant that the Examiner reversibly erred in finding that Ruane
describes the asymmetry required by claim 18.
Anticipation requires that a single reference “describe the claimed
invention with sufficient precision and detail to establish that the subject

2 The first named inventor is Vedrine, but because the Examiner and
Appellant refer to the reference as “Ruane,” we do as well.
3 The Examiner introduced the 35 U.S.C. § 103(a) rejection over Ruane as a
new ground in the Answer. Ans. 6.
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matter existed in the prior art.” Wasica Fin. GmbH v. Cont’l Auto. Sys., Inc.,
853 F.3d 1272, 1284 (Fed. Cir. 2017) (quoting Verve, LLC v. Crane Cams,
Inc., 311 F.3d 1116, 1120 (Fed. Cir. 2002) (emphasis in Wasica)). “For this
reason, it has long been understood that ambiguous references do not, as a
matter of law, anticipate a claim.” Id.
The required precision and detail is missing from Ruane.
Ruane discloses an injector assembly 10 (Fig. 1) for mixing a dry
component 12 and wet component 14 to form an injectable solution. Ruane
¶ 4. Ruane’s injector assembly includes a stopper 18 with a protrusion 84
and a flexible insert 22 with a complementarily sized and shaped recess 82.
Ruane ¶ 34. The recess 82 nestingly receives the protrusion 84 as shown in
Figure 13. The recess 82 and protrusion 84 may have various matched
shaped configurations as shown in Figures 12–18. Ruane ¶ 36.
In paragraph 36, Ruane discusses two examples of matched shapes,
one shown in Figure 15 and one shown in Figure 16. Both figures depict a
protrusion 84 matched to a recess 82. Figure 15 depicts an embodiment
where protrusion body 83 and recess sidewall 79 have matched right
cylindrical shapes, i.e., the cross-sectional shape being generally maintained
constant. Ruane ¶ 36. In contrast, the sidewall 79 and body 83 depicted in
Figure 16 are tapered with the cross-sectional shape being varied. Id. The
recess’s distal end 81 and protrusion’s free end 85, respectively, each may
be rounded, but may have other shapes. Id. There is no dispute that Ruane’s
exemplified configurations do not include a protrusion with a substance-
contacting surface asymmetrical about the container longitudinal axis as
required by claim 18. Ans. 8.
Appeal 2020-003074
Application 14/350,969
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Paragraph 36 ends by stating that Figures 12–18 show generally
cylindrical, arcuate, hemi-spherical, and conical shapes may be used, “as
well as other regular and irregular three-dimensional shapes.” The Examiner
focuses on the phrase “irregular three-dimensional shapes” and finds that
this is a description of a surface that is asymmetrical about the container
longitudinal axis. Non-Final Act. 3. To support this reading, the Examiner
points out that Merriam-Webster dictionary defines “irregular” as “lacking
perfect symmetry.” Ans. 9.
Ruane’s disclosure of varied symmetric shapes and bare statement
that other irregular shapes may be used is not sufficiently precise and
detailed to establish that protrusions with substance-contacting surfaces
asymmetrical about the container longitudinal axis where known in the art.
Shapes that are asymmetrical about the container longitudinal axis are but a
subset of possible irregular shapes. Ruane fails to specifically describe
asymmetry about the container longitudinal axis and, thus, the generic
reference to irregular shapes is not sufficiently precise or detailed to support
a finding of anticipation. Thus, we agree with Appellant that the Examiner
reversibly erred in finding claim 18, and by extension, claims 19 and 26
anticipated by Ruane.
Obviousness over Ruane
In the Answer, the Examiner enters a new ground of rejection in
which the Examiner concludes that claims 18, 19, and 26 are obvious over
Raune. Ans. 6. The Examiner relies on Ruane’s paragraph 36 as evidence
that Ruane’s protrusion can have a variety of shapes, including symmetrical
and asymmetrical, and concludes that it would have been obvious to modify
Ruane’s protrusion to include a variety of protrusion shapes, as taught by
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Application 14/350,969
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paragraph 36 “to better adapt to the container shape, size, and type of
ingredients for increased efficiency of mixing.” Ans. 7.
“A rejection based on section 103 clearly must rest on a factual basis,
and these facts must be interpreted without hindsight reconstruction of the
invention from the prior art.” In re Warner, 379 F.2d 1011, 1017 (CCPA
1967). Interpreting the facts without hindsight reconstruction requires the
decision maker cast the mind back to the time the invention was made and
occupy the mind of the ordinary artisan who is presented only with the
references, and who is normally guided by the then-accepted wisdom in the
art.” In re Fine, 837 F.2d 1071, 1075 (Fed. Cir. 1988).
The Examiner’s reasoning smacks of hindsight reconstruction. This is
evident from the lack of factual support in Ruane or skill of the ordinary
artisan for the Examiner’s reasoning.
First, the Examiner’s finding of a suggestion to shape the protrusion to
increase mixing efficiency is unsupported. When one considers Ruane’s
disclosure without the benefit of Appellant’s disclosure it becomes clear that
Ruane does not link the shape of either the recess or the protrusion with
mixing. Although Ruane suggests using different shapes, Ruane is mostly
concerned with forming a continuous seal when the protrusion 84 is
nestingly received in the recess 82 so the liquid is retained in the recess and
is further concerned with shaping the matching recess and protrusion to most
efficiently use the liquid between them during injection. Ruane ¶¶ 33–34.
Ruane does not disclose shaping the protrusion to increase efficiency of
mixing and the Examiner does not point to any other evidence supporting
the finding that those of ordinary skill in the art would have fashioned the
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Application 14/350,969
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protrusion with an asymmetrical shape about the container longitudinal axis
to increase mixing efficiency.
Second, Ruane’s examples all suggest using symmetrical shapes and
the passing suggestion of using other regular and irregular three-dimensional
shapes does not provide a suggestion to use shapes that are asymmetrical
about the container longitudinal axis.
Thus, a preponderance of the evidence fails to support the Examiner’s
finding of a suggestion to shape the protrusion as claimed and we agree with
Appellant that the Examiner reversibly erred.
Rejection over Hurscham and Bassarab
Turning to the Examiner’s rejection of claims 18, 19, and 26 as
obvious over Hurscham in view of Bassarab, we agree with Appellant
(Appeal Br. 14–17) that the Examiner reversibly erred in finding a
suggestion within Bassarab to change the shape of Hurscham’s conical
recess (Figure 1 at 66; Figure 6 at 406) “to better adapt to the container
shape, size, and type of ingredients for increased efficiency of mixing.”
Non-Final Act. 5–6.
Neither Hurscham nor Bassarab is concerned with how the shape of
the sealing members (Hurscham’s intermediate diaphragm 16 with conical
recess 66; Bassarab’s projections 22 on stopper 20) affect mixing. Hurscham
shapes intermediate diaphragm with conical recess 66 “to ensure that air will
be trapped in the area of the opening 35 ahead of the rising column of
medicament.” Hurscham col. 7, ll. 33–37. Bassarab uses projections 22 on
the outer surface, not on the surface-contacting surface, as support means.
Bassarab col. 16, ll. 40–48. Neither reference links the shapes they disclose
to mixing efficiency.
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Application 14/350,969
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Nor has the Examiner provided an adequate factual basis to support
the finding of incorporating Bassarab’s projections 22 into the conical recess
66 of Hurscham’s diaphragm 16 in a manner that results in a substance-
containing surface that is asymmetrical about the container longitudinal axis.
At best, the ordinary artisan would have incorporated Bassarab’s projections
22 onto the outer surface of Hurscham’s diaphragm 16 to provide support
means. The Examiner has not provided persuasive reasons for including
Bassarab’s projections 22 on the substance-contacting surface, i.e., the
conical recess 66, of Hurscham.
The Examiner reversibly erred in rejecting claims 18, 19, and 26 as
obvious over Hurscham in view of Bassarab.
CONCLUSION
The Examiner’s decision to reject claims 18, 19, and 26 is reversed.
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
18, 19, 26 102(b) Ruane 18, 19, 26
18, 19, 26 103(a) Ruane 18, 19, 26
18, 19, 26 103(a) Hurscham,
Bassarab
18, 19, 26
Overall
Outcome
18, 19, 26
REVERSED