Ex Parte 8070957 et al

Patent Trial and Appeal Board

Dec 21, 2015

95001986 (P.T.A.B. Dec. 21, 2015)

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.
95/001,986 05/10/2012 8070957 12100.1005 REX 8699
25099 7590 12/22/2015
DAVID M. QUINLAN, P.C.
P.O. Box 8088
22 Monterey Drive
PRINCETON, NJ 08543
EXAMINER
XU, LING X
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
12/22/2015 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

BIOTAGE AB
Requester

v.

Patent of SCIENTIFIC PLASTIC PRODUCTS, INC.
Patent Owner and Appellant
____________

Appeal 2015-000196
Reexamination Control 95/001,986
Patent 8,070,957 B2
Technology Center 3900
____________

Before RICHARD M. LEBOVITZ, JEFFREY B. ROBERTSON, and
RAE LYNN P. GUEST, Administrative Patent Judges.

ROBERTSON, Administrative Patent Judge.

DECISION ON APPEAL
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Patent Owner Scientific Plastic Products, Inc. (“Patent Owner”)
appeals under 35 U.S.C. §§ 134(b) and 315(a) (pre-AIA) the Examiner’s
final decision to reject claims 1–4.1 Third-Party Requester Biotage AB
(hereinafter “Requester”) urges that the Examiner’s decision must be
affirmed.2 We have jurisdiction under 35 U.S.C. §§ 134(b) and 315(a)
(pre-AIA).
We affirm the Examiner’s decision to reject claims 1–4. However,
because our reasoning differs from that of the Examiner’s, we designate our
affirmance of the rejection of claims 3 and 4 as a new ground of rejection
under 37 C.F.R. § 41.77(b).

STATEMENT OF THE CASE
United States Patent 8,070,957 B2 (hereinafter the “’957 Patent”),
which is the subject of the current inter partes reexamination, issued to
Samuel A. Ellis and Jeffrey L. Harlan on December 6, 2011 from
Application 12/152,166. The ’957 Patent claims to be a continuation of
United States Patent 7,410,571 B2 (hereinafter the “’571 Patent”), which
issued August 12, 2008 from Application 11/476,292. Application
11/476,292 claims to be a divisional of United States Patent 7,138,061,
(hereinafter the “’061 Patent”), which issued on November 21, 2006 from
Application 10/842,288, filed May 10, 2004.

1 See Patent Owner’s Appeal Brief 1 (filed February 4, 2014) (hereinafter
“App. Br.”); Examiner’s Answer (mailed March 21, 2014) (hereinafter
“Ans.”); Right of Appeal Notice (mailed September 13, 2013) (hereinafter
“RAN.”).
2 See Requester’s Respondent Brief (filed March 4, 2014) (hereinafter
“Resp’t Br.”).
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The ’571 Patent was the subject of reexamination control 95/000,496
(Appeal No. 2012-012468). The ’061 Patent was the subject of
reexamination control 95/000,497 (Appeal No. 2012-007322). United States
Patent 7,381,327 (hereinafter the “’327 Patent”) is also related and was the
subject of reexamination control 95/000,495 (Appeal No. 2012-007321).
Decisions were rendered by the Board in each of the appeals on November
30, 2012 affirming the Examiners’ rejection of the claims. The Court of
Appeals for the Federal Circuit affirmed the Board’s decisions. Scientific
Plastic Products, Inc. v. Biotage AB, 766 F.3d 1355 (Fed. Cir. 2014), cert
denied.
We are also informed that the ’327 Patent, the ’061 Patent, and the
’571 Patent are the subject of litigation styled Scientific Plastics Products,
Inc. v. Biotage AB et al., Case No. 3:09-cv-00677 (S.D. Cal.), which has
been stayed. (App. Br. 1.)
United States Patent 8,066,875 B2 (hereinafter “the ’875 Patent”) is
also related and is currently the subject of reexamination control 95/001,985
(Appeal No. 2015-004633), a decision on which will be mailed concurrently
herewith.
We are also informed that the ’875 Patent and the ’957 Patent are the
subject of litigation styled Scientific Plastics Products, Inc. v. Biotage AB et
al., Case No. 11-cv-2778 (S.D. Cal.), which has been stayed. (PO App. Br.
1.)

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We heard oral arguments from Patent Owner and Requester on April
15, 2015, a transcript of which was entered into the record on May 15,
2015.3
The ’957 Patent relates to low pressure liquid chromatography.
(Col. 1, ll. 15–17.) Claims 1 and 3, which are illustrative of the appealed
subject matter, read as follows:
1. A method for low pressure liquid chromatographic
analysis of a material using a liquid chromatographic cartridge
kit assembled by a user of the kit, said kit including a hollow
cylindrical polymer container and a polymer cap with a fluid
inlet for attachment to one end of said container by the user to
form a chromatographic cartridge, wherein said container
includes a fluid outlet at another end thereof and has a
chromatographic packing material placed therein before said kit
is obtained by the user, said packing material having a surface
spaced from said one end of said container to form a
predetermined volume between said surface and said cap
sufficient to hold a sample for chromatographic analysis when
said cap is attached to said container, and said container further
includes a threaded portion on an external surface thereof
proximate to said one end and said cap comprises a depending
skirt having a threaded portion on an internal surface thereof for
engaging said threaded portion on said container, the method
comprising:
placing the sample in said volume;
thereafter screwing said cap onto said container into a
final position by engaging said respective threaded portions to
provide a seal between said container and said cap capable of
withstanding pressures up to about 100 psi, said seal being
formed between (a) an inner surface of said container proximate
to said upstream end thereof, said container including an

3 Pursuant to 37 C.F.R. § 41.73(e)(1), the arguments considered in rendering
this decision are those which were relied upon in the briefs.
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inclined lip portion surrounding said inner surface of said
upstream end, and (b) a cap flange disposed for accepting said
container between said skirt and said flange with said inclined
container lip portion contacting said cap flange to urge said
flange inwardly toward said longitudinal axis as said cap is
screwed onto said container and into said final position;
attaching a low pressure liquid chromatographic
apparatus to said inlet for introducing chromatographic process
fluid into said inlet under a pressure up to about 100 psi; and
introducing said chromatographic process fluid from said
outlet to said low pressure liquid chromatographic apparatus for
analysis.
3. A method for low pressure liquid chromatographic
analysis as in claim 1, wherein said cap includes a single said
cap flange that depends from the interior of said cap and
contacts said container when said cap is in said final position,
said flange extending beyond the most upstream end of said
threaded portion on said skirt, and wherein said inclined lip
portion presents a flat surface extending to the upstream end of
said container.
(App. Br. 30, Claims App’x.)

Patent Owner contests the Examiner’s final decision to reject the
claims as follows:
I. Claims 1-4 under 35 U.S.C. § 103(a) as obvious over Yamada
et al. (U.S. Patent No. 5,693,223, issued December 2, 1997)
(“Yamada”), King (WO 02/42171 A1, published May 30, 2002)
and Hargro et al. (U.S. Patent No. 6,139,733, issued October
31, 2000) (“Hargro”);
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II. Claims 1-4 under 35 U.S.C. § 103(a) as obvious over Yamada,
King, and Argonaut (International Sorbent Technology,
Catalogue of Sample Preparation Products and Services
(2001));
III. Claims 3 and 4 under 35 U.S.C. § 103(a) as obvious over
Yamada, King, Hargro or Argonaut, Aichinger (U.S. Patent No.
4,033,472, issued July 5, 1977) or Victor et al. (U.S. Patent No.
4,057,160, issued November 8, 1977) (“Victor”);
IV. Claims 3 and 4 under 35 U.S.C. § 103(a) as obvious over
Yamada, King, Hargro or Argonaut, and any of Husar et al.
(U.S. Patent No. 5,916,525, issued June 29, 1999) (“Husar”),
Omi et al. (JP H10-35699, published February 10, 1998,
English Translation of record) (“Omi”), or Odajima et al. (JP
2001-114310A, published April 24, 2001, English Translation
of record) (“Odajima”);
V. Claim 4 under 35 U.S.C. § 103(a) as obvious over Yamada,
King, Hargro or Argonaut, and Hawkins (U.S. Patent No.
4,844,273, issued July 4, 1989); and
VI. Claim 4 under 35 U.S.C. § 103(a) as obvious over Yamada,
King, Hargro or Argonaut, any of Aichinger, Victor, Husar,
Omi, or Odajima, and further in view of Hawkins.

Patent Owner additionally relies on the following as evidence:
Declaration of Barry C. Holwerda executed October 16, 2012 (App.
Br., Ex. MM, Ex. A.)
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Declaration of Suhas Kulkarni executed October 16, 2012 (App. Br.,
Ex. MM, Ex. B)
Declaration of Samuel A. Ellis executed October 16, 2012 (App. Br.,
Ex. MM, Ex. C)
Second Declaration of Barry C. Holwerda executed June 28, 2013
(App. Br., Ex. OO, Ex. G)
Second Declaration of Suhas Kulkarni executed June 28, 2013 (App.
Br., Ex. OO, Ex. H)
Second Declaration of Samuel A. Ellis executed June 28, 2013 (App.
Br., Ex. OO, Ex. I)
Declaration of Daniel C. Hill executed June 26, 2013 (App. Br., Ex.
OO, Ex. J)

Requester additionally relies on the following as evidence:
Declaration of Bob Towill executed May 2, 2012 (See App. Br., Ex.
LL)
First Declaration of Juha Esala executed April 3, 2012
(See App. Br., Ex. LL)
Second Declaration of Juha Esala executed November 13, 2012
(See App. Br., Ex. NN)
Third Declaration of Juha Esala executed July 30, 2013
(See App. Br., Ex. PP)
First Declaration of William H. Pearson executed March 29, 2012
(See App. Br., Ex. LL)
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Second Declaration of William H. Pearson executed November 15,
2012 (See App. Br., Ex. NN)
Third Declaration of William H. Pearson executed July 31, 2013 (See
App. Br., Ex. PP)
ISSUES
Patent Owner has limited the issues on appeal to the rejections of
independent claim 1 and dependent claim 3 (App. Br. 4), which are included
in Rejections I-IV. Rejections IV-VI are directed only to claims 3 and 4.
Accordingly, we confine our discussion to claims 1 and 3, with claims 2 and
4 standing or falling with claims 1 and 3, respectively. (See App. Br. 4, n.
1.)
Patent Owner contends that the Examiner is relying solely on the prior
art apparatus in rejecting the claims and thus erred by not giving weight to
the method limitations in the appealed claims. (App. Br. 4-5.) Patent Owner
argues that the relevant inquiry is whether it would have been obvious to
have modified Yamada’s apparatus and method to perform the method
recited in the claims. (Id. at 7.) Specifically, Patent Owner argues that
Yamada is directed solely to the analysis of physiologically active materials,
and as a result, one of ordinary skill in the art would not incorporate a
method step of placing a sample in a volume above the chromatographic
packing material before screwing on the head portion. (Id. at 6, 8-9.) Patent
Owner argues further that contrary to the Examiner’s finding, Yamada does
not disclosed pre-packed chromatographic columns. (Id. at 7-8.) Patent
Owner contends that any empty volume in Yamada would have been
insufficient to receive a sample. (Id. at 8.)
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Regarding claim 3, Patent Owner argues that the prior art does not
disclose the structure of the seal recited in the claim. (App. Br. 20.) In
particular, Patent Owner contends that the Examiner erred in construing
claim 3 to allow for more than one cap flange depending from the interior of
the cap. (Id. at 20-21.) Patent Owner argues that King, Omi, and Odajima
disclose multiple cap flanges, and thus do not disclose a single cap flange as
recited in claim 3. (Id. at 22-23.) Patent Owner argues that Aichinger does
not disclose that the portion of the container relied on by the Examiner to
disclose an inclined lip portion having a flat surface does not contact the cap
flange as required in claim 3. (Id. at 23–24.) Patent Owner contends that
Victor does not disclose a threaded cap, such that even if combined with
Yamada, the combination would not meet the recited method step of
screwing the cap onto the container recited in claim 1, from which claim 3
depends. (Id. at 24.) Patent Owner also argues that Husar discloses a
chamfer that contacts a sealing lip and not an inclined surface that extends to
the upstream end of the container as required by claims 1 and 3. (Id. at
25-26.)
Patent Owner argues that there is objective evidence of
nonobviousness including industry praise and commercial success, which is
unopposed by evidence, and must be given proper weight. (App.Br. 26–28.)
Patent Owner contends also that King and other references to bottle
caps are not analogous art and that the Examiner did not identify sufficient
reason to modify Yamada’s seal structure with the seal structure disclosed in
King. (App. Br. 9–20.) We previously addressed similar arguments by
Patent Owner regarding non-analogous art and modification of Yamada
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based on King in the previous decisions on appeals (see, e.g., Decision on
Appeal mailed November 20, 2012, in Appeal No. 2012-007322, Reexam
Control No. 95/000,497, pages 11–16), which as indicated above, was
affirmed by the Federal Circuit. Scientific Plastic Products, 766 F.3d at
1359–1361. For the same reasons to those discussed in detail in our
previous decisions, we are not persuaded by Patent Owner’s arguments. We
need not repeat that our analysis here.
Accordingly, the dispositive issues for this appeal are:
1. Did the Examiner err in concluding that the method recited in
claim 1 would have been obvious to one of ordinary skill in the art in view
of the evidence of record?
2. Did the Examiner err in concluding that the cap flange structure
recited in claim 3 would have been obvious in view of the prior art of
record?
FINDINGS OF FACT (“FF”)
1. Yamada discloses a plastic column and column device for low
pressure-high speed liquid chromatography “to be used for
separating and purifying materials, particularly physiologically
active materials . . . .” (Col. 1, ll. 10-15, col. 2, ll. 15-20.)
2. Yamada discloses that a “variety of materials may be separated
and purified by using the column for the low pressure-high
speed liquid chromatography according to the present
invention.” (Col. 7, ll. 36-38.)
3. Yamada discloses:
The maximum flow rate of the gear pump
assembled into the chromatography system used was 50
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ml/min., and the separating and purifying operation was
effected at the treating flow rate of 80 column volume/hr.
In that case, a column having a column volume up to
37.5 ml can be fitted to the system. An amount of the
granular filler can be selectively determined, based on the
adsorbing volume of the granular filler and the amount
(treating amount) of the intended material contained in
the liquid to be treated.
(Col. 13, ll. 16-24.)
4. Figure 2 of King is reproduced below:

Figure 2 depicts a cross section view of the lip region of a
container with the closure at the sealing position including
inwardly tapered surface 7 of the container neck adjacent to the
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lip and cylindrical sealing plug 8 including continuous sealing
ribs 9. (Page 7, ll. 30-32, page 8, ll. 21-30.)
5. King discloses a threaded cap having a cylindrical sealing plug
8 that projects downwardly from the base of the closure cap and
is tapered. (Page 8, ll. 21-25, Figs. 2, 3.)
6. Figure 9 of Husar is reproduced below:

Figure 9 depicts a diagrammatic partial cross-section of a
closure 11, having a sealing lip 20 (the unlabeled flange of the
cap/closure 11) and a lip sealing surface 21, and vessel 1 having
a wall with a vessel sealing surface 23, wherein lip sealing
surface 21 contacts vessel sealing surface 23. (Col. 4, ll. 44-62;
col. 5, ll. 46-62; col. 6, ll. 6-36.)
7. Regarding the length of the sealing lip, Husar discloses only
that the “length of the sealing lip is selected so that its lip
sealing surface is urged against the vessel sealing surface due to
an overpressure within the vessel as caused by the vapor
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pressure of the fluid probe within the vessel.” (Col. 3,
ll. 27-33.)
8. The ’957 Patent discloses that the threads of the container mate
with the internal threads of the skirt in a variety of
configurations. (Col. 4, ll. 23–30.)
9. The ’957 Patent discloses that “the threads represent one
specific form of inclined mating surfaces, and other means for
fastening the cap to the container include the broader use of
inclined mating surfaces.” (Col. 8, ll. 39-43.)

PRINCIPLES OF LAW
As stated by the Supreme Court in KSR, “any need or problem known
in the field of endeavor at the time of [the] invention and addressed by the
patent can provide a reason for combining the elements in the manner
claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007). KSR
instructs that “familiar items may have obvious uses beyond their primary
purposes.” Id. at 420–421. It is not necessary that the prior art suggest the
combination for the same reason as contemplated by Appellants. In re
Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006).

ANALYSIS
All of the rejections on appeal rely on the base combination of
Yamada and King. The Examiner found that Yamada discloses a similar
method as recited in claims 1 and 2, but Yamada does not disclose applying
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the sample to the column before sealing the column with the cap as required
by the claims. (RAN 7, 9.)
Claim 1
Yamada-Physiologically Active Materials
Much of Patent Owner’s contentions on appeal rely on the premise
that Yamada’s disclosure is limited to physiologically active materials, such
that the one of ordinary skill in the art would not have modified the structure
of Yamada’s column to allow for a space of a sufficient volume to hold a
sample for chromatographic analysis. According to Patent Owner, the
presence of such a space would compromise a physiologically active sample
due to “unpredictable mixing.” (App. Br. 6, 8-9.) We are not persuaded by
Patent Owner’s contentions. Initially, we observe that Yamada disclosed
that the materials for separation are “particularly” physiologically active
materials, but more generally describes separating a “variety of materials”.
(FF 1, 2.) Thus, on its face, Yamada contemplates that the column apparatus
would be used to separate other materials.
In addition, even accepting Patent Owner’s position that Yamada is
directed exclusively to physiologically active materials, Patent Owner has
not provided sufficient evidence that all physiologically materials either
would need to remain hydrated or would be compromised by a mixing
space. (App. Br. 8-9; First Holwerda Decl. ¶¶ 19, 20 and 22; Second
Holwerda Decl. ¶ 27.) In this regard, Dr. Pearson, who holds a Ph.D. in
organic chemistry and has extensive experience with molecules of biological
interest and in the field of liquid chromatography, declared that
“physiologically active materials” is a very broad term, which may
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encompass small-molecule drugs, “which are often rather normal organic
compounds.” (First Pearson Decl. ¶¶ 1-3; Second Pearson Decl. ¶ 10.)
While Patent Owner’s declarant Dr. Holwerda implies that Dr. Pearson’s
characterization of small-molecule drugs as physiologically active materials
is inappropriate, Dr. Holwerda fails to explain why Dr. Pearson’s
understanding of the term is too broad and fails to offer a definition of
“physiologically active material” that would exclude the organic compounds
identified by Dr. Pearson. (First Holwerda Decl. ¶ 19; Second Holwerda
Decl. ¶ 22.) Accordingly Patent Owner’s position that one of ordinary skill
in the art would have understood Yamada’s disclosure to be limited to the
particular types of physiologically active material is not supported by a
preponderance of the evidence.
Space for introducing a sample
Regarding the structure of the cartridge as claimed, the Examiner
found that, inter alia, Yamada discloses a predetermined volume between
the surface of the packing material and the head portion. (RAN 7.) The
Examiner explained that in Figures 1, 2, and 4 of Yamada, the granular filler
or packing material does not fully occupy the column chamber such that
there is sufficient volume between the head portion and the granular fillers
to hold a sample. (Id. at 28.) The Examiner stated further that Yamada
discloses that the amount of granular filler can be determined based on the
adsorbing volume of the granular filler and the amount of material in the
liquid sample to be treated. (FF 3; RAN 28.) To support this statement, the
Examiner pointed to an example in Yamada, where there was a 2 milliliter
volume space between the head portion and the surface of the granular filler,
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which the Examiner found was sufficient to hold a sample for
chromatographic analysis. (RAN 28-29.)
Requester agrees with the Examiner, arguing that Yamada’s described
empty space is evidence that it would have been obvious to one of ordinary
skill in the art to selectively dictate the amount of free space left in the
column for adding a sample. (Resp’t Br. 7, citing Second Pearson Decl. ¶ 9
and Yamada, col. 13, ll. 15-34.) Requester contends also that it was
common in the LPLC (low pressure liquid chromatography) field for
columns to be supplied pre-packed by the manufacturer as evidenced by
Argonaut and declaration evidence of record. (Id., citing Argonaut ¶ 87;
Second Holwerda Decl. ¶¶ 20, 31; Pearson Decl. ¶ 6-7.)
Initially, we disagree with the Examiner and Requester that Figures 1
and 2 of Yamada show a space within a column sufficient to add a sample.
Figure 2 of Yamada is reproduced below.

Figure 2 depicts a sectional view of an embodiment according to the
patent in an assembled state. (Col. 4, ll. 31-37.) Yamada discloses that a
head portion 2 is inserted into cylindrical column body 1 to define a column
chamber 7. (Col. 8, ll. 1–9.) Yamada discloses that a pair of filters 8, 8’ are
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fitted at opposite ends of the column chamber 7, and granular filler 9 is
charged between the pairs of filters. (Col. 8, ll. 9–12.) Yamada is silent as
to how much filler is “charged” into the column chamber 7 as depicted in
Figure 2. As a result, we do not interpret Figure 2 as showing actual
amounts of filler in the column chamber, but rather Figure 2 provides an
illustration that filler is present in it. In addition, when the column is in the
assembled state as depicted in Figure 2, no space is shown between the end
of the head portion 2 and filter 8, nor does the disclosure describe the
presence of any space. Thus, even if there is space remaining in the filler
area, it would not be accessible to be filled with sample in the assembled
state.
The Examiner relies also on Yamada’s disclosure of an example
having a 2 milliliter empty space for support. (RAN 28-29 (citing Yamada,
col. 13, ll. 15-34).) However, as pointed out by Patent Owner, the particular
example relied on in Yamada was conducted using a column device in
accordance with Figure 3, which is generally the same as the embodiments
depicted in Figures 1 and 2. (Reb. Br. 5; Yamada, col. 9, ll. 21-32.) As
explained by Patent Owner:
while there may be a space under the filter 8, there is none into
which a sample can be placed prior to affixing the head portion,
as required by claim 1. Yamada explicitly states that Test No.1
was performed using the column device shown in Figure 3,
which Yamada says is the same as the Figures 1 and 2
embodiment except for stepped portions on the column body
and head portion that mesh to prevent leakage. Yamada, col. 9,
lines 22-32. As Dr. Holwerda pointed out, the Figure 3
embodiment also has no space for a sample. Second Holwerda
Declaration, at para. 25, citing Yamada, col. 2, lines 55-58.
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(Reb. Br. 5.)
Accordingly, we cannot agree with the Examiner that Yamada
describes sufficient space in the columns disclosed in Figures 1 and 2 to
allow for the addition of a sample, as recited in claim 1.
Figure 4 of Yamada is reproduced below.

Figure 4 of Yamada depicts a sectional view of an alternative embodiment in
an assembled state. (Col. 4, ll. 41-44.)
Yamada discloses an “axially inwardly conical shape 22,” which
results in a space in order to “facilitate removal of bubbles.” (Col. 9, ll.
42-46.) Requester contends that the space depicted in Figure 4 would be
suitable for preloading small samples in need of separation. (Resp’t Br. 6-7;
Second Pearson Decl. ¶ 9.) Patent Owner argues that the space depicted in
Figure 4 is not sufficient to hold a sample. (App. Br. 8, citing First
Holwerda Decl. ¶ 19.) Further, Patent Owner’s expert, Dr. Holwerda
clarified that the space in Figure 4 may have been theoretically capable of
receiving small samples, but Yamada would not have suggested using the
space in Figure 4 for holding a sample, because Yamada expressly stated the
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purpose of the space was to facilitate removal of bubbles. (Second
Holwerda Decl. ¶ 26.)
We do not find Patent Owner’s argument to be persuasive. As the
Supreme Court has stated, “familiar items may have obvious uses beyond
their primary purposes.” KSR, at 420–421. Thus, the fact that Yamada
refers to the purpose of the space as related to bubble removal is not fatal to
an obviousness determination. Accordingly, we agree with the Examiner
and Requester that Figure 4 of Yamada depicts a space sufficient to hold a
sample for chromatographic analysis as recited in claim 1. However, the
issue is still whether it would have been obvious to have placed a sample
into this volume, which is discussed below.

Method Steps
The claim also requires a step of placing a sample in the volume prior
to sealing the column with the cap. The Examiner found that Hargro
discloses a liquid chromatographic method including pre-absorbing a sample
onto a packing material in a column prior to sealing the column and then
carrying out the chromatographic separation. (RAN 9, citing Hargro col. 1,
ll. 29-40 “The pre-absorbed media is then placed at the head of a pre-packed
glass, metal or plastic chromatography column . . . .”)
The Examiner concluded that it would have been obvious to use
Hargro’s method of introducing the sample into the column before sealing
the column as an alternative method of introducing sample in the column,
because both Yamada and Hargro disclose LPLC methods and disclose
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equivalent processes of introducing samples into columns for separation.
(RAN 9-10.)
The Examiner similarly found that Argonaut discloses a
chromatographic column with additional volume for sample loading as well
as the pre-absorption of liquid samples. (RAN 11, citing Argonaut, p. 87
“The ISOLUTE Flash-XL (4x 22 cm) incorporates additional volume above
the top frit for dry loading of samples.”) The Examiner concluded that it
would have been obvious to have used Argonaut’s method of introducing a
sample for similar reasons as with respect to Yamada and Hargro. (Id. at
12-13.)
As discussed above, a preponderance of the evidence supports the
Examiner’s position that Yamada’s teachings are not limited to
physiological materials that require hydration or that would be compromised
by a mixing space. Therefore, we agree also with the Examiner’s position
that it would have been obvious to have applied the method of pre-absorbing
samples disclosed in Hargro or Argonaut using the column apparatus
disclosed in Yamada as a predictable substitution of equivalent sample
loading process steps in low pressure liquid chromatographic analysis.
Pre-packing
Patent Owner contends that there is no disclosure in Yamada
indicating that the columns disclosed therein are pre-packed. (App. Br. 7,
citing RAN 26-27.) Thus, according to Patent Owner, Yamada does not
disclose the limitation in claim 1 of a chromatographic cartridge that “has a
chromatographic packing material placed therein before said kit is obtained
by the user.” We agree with Patent Owner that Yamada alone does not
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sufficiently describe this limitation. The passage in Yamada relied on by the
Examiner as teaching a pre-packed column, is a description in Yamada of
Figure 11 with reference to a low pressure-high speed liquid
chromatography system manufactured by Millipore, Inc. under the name
Consep LC100. (RAN 26-27, citing Yamada, col. 10, ll. 19–26.) However,
Yamada does not describe explicitly that such a system includes a pre-
packed column, and the Examiner points to no additional evidence for
support of this position.
In addition, we agree with Patent Owner that Dr. Pearson’s view that
the limitation in claim 1 would read on a column that is received by one lab
technician and packed prior to being used by another worker is
unreasonable. (App. Br. 7; Third Pearson Decl. ¶ 7.) Claim 1 clearly recites
that the packing material is placed in the chromatographic cartridge before
the kit is obtained by the user and the ’957 patent clearly distinguishes a user
from the manufacturer. (’957 Patent, col. 7, ll. 30-35.) The notion that the
user would be only the person actually running the column and would not
include a person in the same lab preparing for the experiment is simply
without merit.
However, the Examiner also relies on Argonaut for teaching pre-
packing LPLC columns before sale to the user. (RAN 27, citing Argonaut
pages 83-84.) Patent Owner does not persuasively challenge the Examiner’s
finding in this regard. Accordingly, a preponderance of the evidence
supports the Examiner’s position that pre-packing the columns of Yamada
would have been obvious to one of ordinary skill in the art in view of the
prior art of record.
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Claim 3
Regarding claim 3, the Examiner found that Yamada discloses a
single flange structure that depends from the cap as well as an O-ring in an
annular groove at the head portion to ensure liquid tightness. (RAN 10.)
The Examiner found also that King discloses a single flange extending
below the most upstream end of the threads of the cap skirt and an incline lip
portion structure such that the sealing surface between the cap and the
container is a flat surface extending to the upstream end of the container.
(Id.) The Examiner concluded that it would have been obvious to have
incorporated the sealing configuration of King with the threaded cap and
column configuration of Yamada to achieve a resealing/sealing function
between the LPLC cap and column. (Id.) The Examiner also found that
Aichinger, Victor, Husar, Omi, or Odajima disclose the seal structure recited
in claim 3, and that it would have been obvious to have incorporated the seal
structure disclosed in any of the cited prior art into the LPLC device of
Yamada. (Id. at 16-17, 19-20.)
Patent Owner contends that the Examiner incorrectly interpreted the
recited “said cap includes a single said cap flange” to allow for the presence
of other cap flanges. (App. Br. 20-22.) Thus, Patent Owner contends that
King, Omi, and Odajima are distinguished from the seal structure of claim 3
because they have multiple cap flanges. (Id. at 22-23.) Patent Owner
acknowledges that Aichinger, Victor, and Husar disclose a single cap flange,
but argues that each of these references is distinguished for other reasons.
(Id. at 22, 23-26.)
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ANALYSIS
After reviewing the evidence of record, we conclude that the seal
structure recited in claim 3 would have been obvious to one of ordinary skill
in the art in view of King and Husar, and that it would have been obvious to
have incorporated such a seal structure based on the combined teachings of
Yamada in view of Hargro or Argonaut.
We acknowledge that with respect to Husar, the argument centers
around Figures 11-13. (App. Br. 25-26; Resp’t Br. 18; RAN 19-20, 45-46.)
Figure 11 of Husar is reproduced below.

Figure 11 depicts a longitudinal cross section of an alternative vessel
33 and closure 26 assembly, having sealing lip 30. (Col. 4, ll. 66-67; col. 6,
ll. 47-51.) We agree with Patent Owner that Figures 11-13 fail to disclose
all the requirements of the recited seal structure, because claim 3, as a result
of depending from claim 1, also requires that the seal is formed between a
single cap flange and a container lip portion “proximate to said upstream
portion thereof.”
Husar expressly discloses that, as shown in Figure 11, contact is made
between the cap flange and the container at chamfer 38, and Figure 11
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shows a gap between the cap flange 30 and the container lip portion 34
proximate to the upstream end of container lip portion 34. (Husar, Fig. 11,
Col. 6, ll. 36-65.) Similarly, Husar discloses a gap 40 (not labeled in Fig.
11) between the sealing lip 30 and the vessel wall 36 that extends to the
vessel mouth as depicted in Figures 12 and 13. (Id. at Figures 12, 13, Col. 7,
ll. 10-13.) Accordingly, Figures 11-13 fail to disclose that the seal is formed
between a single cap flange and a container lip portion “proximate to said
upstream portion thereof.”
However, Husar discloses another embodiment of a sealing
configuration as depicted in Figures 7-9. (See FF 6.) In this embodiment,
the sealing surface 23 of vessel 1 is an inclined flat surface, and as shown in
Figure 9, forms a seal with the sealing surface 21 of single sealing lip 20
proximate to the upstream end of the inner surface of the container. (FF 6.)
In Husar, the single sealing lip 20 does not extend downstream beyond the
most upstream end of the threaded portion of the cap skirt as required by
claim 1. Regarding the length of the sealing lip, Husar discloses only that
the length is selected so that the lip sealing surface is urged against the
vessel sealing surface. (FF 7.)
In view of the evidence of record, it would have been obvious to have
provided a cap with a single flange extending downstream beyond the most
upstream end of the threaded portion of the cap skirt, either by extending the
length of the cap flange or by configuring the threads of the skirt to extend
further toward the upstream end of the cap skirt in combining the teachings
of Husar and King with Yamada and Hargro or Argonaut. That is, both
King and Husar provide evidence that sealing arrangements having cap
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flanges extending beyond the threaded portions of cap skirts were known in
the art. (See FF 4, 5; Husar Figs. 11–13, Resp’t. Br. 17, 18.)
In addition, the ’957 Patent discloses that the configurations of threads
on the cap skirt and container may be varied, and also that other mechanisms
besides threads may be used to lock the container and cap together. (FF 8,
9.) Thus, the ’957 Patent does not assign any particular criticality to the
relationship between the extent of the threads on the cap skirt and the length
of the cap flange.
Accordingly, it would have been obvious to have incorporated the
sealing arrangement of Figures 7-9 of Husar into the combination of
Yamada in view of Hargro or Argonaut to provide a seal between a
container lip portion with an inclined flat inner surface decreasing in
thickness and extending to the upstream end of the lip portion and a single
cap flange depending from the interior of a cap. The reason would have
been that Husar discloses that such arrangements provide for effective
sealing between containers and caps with threaded portions. It would also
have been obvious to configure the sealing arrangement such that the single
cap flange extends downstream beyond the most upstream end of the
threaded portion. The reason would have been that Husar and King provide
evidence that such arrangements are known design alternatives for caps and
containers with fluid tight seals. KSR, 550 U.S. at 417 (“[I]f a technique has
been used to improve one device, and a person of ordinary skill in the art
would recognize that it would improve similar devices in the same way,
using the technique is obvious unless its actual application is beyond his or
her skill.”).
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In view of the rejection set forth above, we are not persuaded by
Patent Owner’s arguments that the claims would not have been obvious
because King and other references of record disclose multiple cap flanges.
(App. Br. 22-23.) The Examiner interpreted the word “includes” of the
phrase “said cap includes a single said cap flange” as synonymous with the
open language “comprising,” which does not exclude unrecited elements,
including additional flanges. RAN 40. Even if we were to agree with Patent
Owner that the Examiner’s interpretation renders the recitation of a specific
number of cap flanges to be meaningless (see App. Br. 20-21), Husar
demonstrates that caps having an effective sealing surface formed from a
single flange “proximate to said upstream portion thereof” was well known
in the art. Patent Owner’s arguments focus on the individual teachings of
these references, rather than the prior art as a whole. “[T]he test for
combining references is not what the individual references themselves
suggest but rather what the combination of disclosures taken as a whole
would suggest to one of ordinary skill in the art.” In re McLaughlin, 443
F.2d 1392, 1395 (CCPA 1971).

Secondary Considerations
Patent Owner contends that the record includes evidence of industry
praise of the claimed methods and commercial success of the cartridges used
in the claimed methods, which is unopposed by any contrary evidence.
(App. Br. 26-28.)
The Examiner determined that the evidence of peer recognition and
commercial success presented in the First Ellis Declaration does not show
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that all of the features of the claims are present in the commercial products,
including the sealing configuration and that LPLC analysis was performed
according to the claimed methods. (RAN 47-48.) The Examiner also found
that the e-mails referred to in the Second Ellis Declaration were insufficient
to show that the SINGLE StEP® columns possess all the claimed features.
(Id. at 48-49.) The Examiner further found that there is no evidence that the
Thompson columns referred to in the Hill Declaration contain the sealing
configuration recited in the claims. (Id. at 50.) Regarding the sales figures
presented in the Second Ellis Declaration, the Examiner found that there is
no evidence of a nexus between the sales figures and the claimed invention,
or of any market share. (Id. at 50-51.) As a result, the Examiner determined
that Patent Owner had not established a nexus between the merits of the
claimed invention and the evidence of secondary considerations, and as
such, the evidence provided by Patent Owner was insufficient to overcome
the obviousness rejections presented. (Id. at 51-52.)
Requester agrees with the Examiner that Patent Owner’s evidence is
unsubstantiated and does not overcome the strong evidence weighing in
favor of obviousness. (Resp’t Br. 19-22.)

DISCUSSION
The ultimate determination of whether a claimed invention would
have been obvious or non-obvious is a legal conclusion, which is made
based on considering and weighing all of the facts in evidence. See In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
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A “nexus” must be established between the merits of the claimed
invention and the evidence of secondary considerations in order for the
evidence to be given substantial weight. See In re GPAC, Inc., 57 F.3d
1573, 1580 (Fed. Cir. 1995).
We have reviewed the evidence of record and we are not persuaded
that the evidence of nonobviousness outweighs the evidence of obviousness
present in the record. That is, the solicited e-mail feedback attached to the
First Ellis Declaration, while being complimentary of the SINGLE StEP®
columns, discusses sample loading accuracy and tighter packed silica as well
as convenience. (First Ellis Decl. ¶ 4.) The First Ellis Declaration relates
these features to the ability to remove and reseal the cap. Id. However,
resealable caps were known in the art as discussed above. In addition, we
have also reviewed the Hill article attached to the First Ellis Declaration and
discussed in the Second Ellis Declaration, which also refers to the SINGLE
StEP® column. (Second Ellis Decl. ¶ 8; First Ellis Decl., Ex. 3.) According
to the Hill Declaration (the author of the Hill article), cartridges with
removable caps and headspace for accepting a sample provided equivalent
performance to permanently sealed cartridges. (Hill Decl. ¶¶ 2, 5.) While
the Second Ellis Declaration stated that the SINGLE StEP® columns
possess the seal structure recited in claim 1 (Second Ellis Decl. ¶ 6), the two
e-mails discussed in the First and Second Ellis Declarations contain no
further explanation that the particular seal arrangement recited in the claims
contributed to the testimonials related to the SINGLE StEP® columns
expressed in the e-mails.
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Regarding commercial success, the Second Ellis Declaration provides
sales figures for the SINGLE StEP® cartridge between 2005 and 2013.
(Second Ellis Decl. ¶ 9.) While the sales in the reported period range from
$93,000 to $881,000 dollars per year, we agree with the Examiner that the
magnitude of sales by itself is insufficient to assess the overall success in the
market of the SINGLE StEP® cartridge. Id. That is, no comparison is made
with the number of units of other LPLC cartridges sold in the market over
the same period. Thus, this evidence alone does not establish market share
or whether the cartridges were indeed successful as compared to other
competing cartridges sold at the same time.
Thus, the evidence of industry praise and commercial success, while
providing some evidence that customers using the SINGLE StEP® cartridge
were happy with its results and that Patent Owner was able to sell a
significant number of the cartridges, does not sufficiently outweigh the
evidence of obviousness on the record discussed above.

CONCLUSION
To be clear, we affirm the Examiner’s rejection of claims 1 and 2 as
detailed in Rejection I and II. We reverse the Examiner’s rejection of claims
3 and 4 as applied in Rejections I and II. We affirm the Examiner’s
rejections of claims 3 and 4 as set forth in Rejections IV and VI based on the
rejection of claim 3 over Yamada, King, Hargro or Argonaut, and Husar as
discussed above. Because our reasoning differs from that of the Examiner’s
we designate the affirmance of Rejections IV and VI as a new ground of
rejection. In view of the discussion above, we find it unnecessary to discuss
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the remaining references applied against claims 3 and 4 in Rejections IV and
VI, and we do not reach Rejections III and V.

DECISION
The Examiner’s decision to reject claims 1–4 is affirmed.
Pursuant to 37 C.F.R. § 41.77(a), the above-noted affirmance includes
a new ground of rejection. Section 41.77(b) provides that “[a] new ground
of rejection . . . shall not be considered final for judicial review.” That
section also provides that Patent Owner, WITHIN ONE MONTH FROM
THE DATE OF THE DECISION, must exercise one of the following two
options with respect to the new grounds of rejection to avoid termination of
the appeal proceeding as to the rejected claims:
(1) Reopen prosecution. The owner may file a response
requesting reopening of prosecution before the examiner. Such a
response must be either an amendment of the claims so rejected
or new evidence relating to the claims so rejected, or both.

(2) Request rehearing. The owner may request that
the proceeding be reheard under § 41.79 by the Board
upon the same record. The request for rehearing must
address any new ground of rejection and state with
particularity the points believed to have been
misapprehended or overlooked in entering the new
ground of rejection and also state all other grounds
upon which rehearing is sought.

In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the
appeal may file a request for rehearing of the decision within one month of
the date of: . . . [t]he original decision of the Board under § 41.77(a).” A
request for rehearing must be in compliance with 37 C.F.R. § 41.79(b).
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Comments in opposition to the request and additional requests for rehearing
must be in accordance with 37 C.F.R. § 41.79(c)–(d), respectively. Under
37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a)
of this section, for requesting further rehearing under paragraph (c) of this
section, and for submitting comments under paragraph (b) of this section
may not be extended.
An appeal to the United States Court of Appeals for the Federal
Circuit under 35 U.S.C. §§ 141–144 and 315 and 37 C.F.R. § 1.983 for an
inter partes reexamination proceeding “commenced” on or after November
2, 2002 may not be taken “until all parties’ rights to request rehearing have
been exhausted, at which time the decision of the Board is final and
appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See
also MPEP § 2682 (8th ed., Rev. 8, July 2010).
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
Requests for extensions of time in this inter partes reexamination
proceeding are governed by 37 C.F.R. § 1.956. See 37 C.F.R. § 41.79.
In the event neither party files a request for rehearing within the time
provided in 37 C.F.R. § 41.79, and this decision becomes final and
appealable under 37 C.F.R. § 41.81, a party seeking judicial review must
timely serve notice on the Director of the United States Patent and
Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983.

AFFIRMED; 37 C.F.R. § 41.77(b)

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bar

PATENT OWNER:

DAVID M QUINLAN, PC
32 NASSAU STREET
SUITE 300
PRINCETON, NJ 08542

THIRD-PARTY REQUESTER:

FOLEY AND LARDNER, LLP
3000 K STREET NW
SUITE 600
WASHINGTON, DC 20007