Edouard Bouvier et al.

Patent Trials and Appeals Board

Dec 15, 2020

2019006868 (P.T.A.B. Dec. 15, 2020)

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.
13/512,751 12/21/2012 Edouard S.P. Bouvier 10450US.PCT
(W-654-US1)
8969
13871 7590 12/15/2020
WOMBLE BOND DICKINSON (US) LLP / Waters
ATTN: IP DOCKETING
P.O. BOX 7037
ATLANTA, GA 30357-0037
EXAMINER
PEO, KARA M
ART UNIT PAPER NUMBER
1777
NOTIFICATION DATE DELIVERY MODE
12/15/2020 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):
BostonDocket@wbd-us.com
IPDocketing@wbd-us.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EDOUARD S.P. BOUVIER, KEVIN D. WYNDHAM,
THOMAS H. WALTER, and LYNDA NEUE
Appeal 2019-006868
Application 13/512,751
Technology Center 1700
Before KAREN M. HASTINGS, JAMES C. HOUSEL, and
DEBRA L. DENNETT, Administrative Patent Judges.
HASTINGS, 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, 3, 10, 13, 17–20, 24, 38, and 39. See
Final Act. 1. Claims 2, 4–9, 11, 12, 14–16, 21–23, 25–37, and 40–55 have
been cancelled. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37 C.F.R.
§ 1.42. The real party in interest is “WATERS TECHNOLOGIES
CORPORATION” by virtue of being the assignee of 100% of the interest in
the present application. Appeal Br. 4.
Appeal 2019-006868
Application 13/512,751

2
CLAIMED SUBJECT MATTER
The claims are directed to a device for performing size exclusion
chromatography. Claim 1 is reproduced below (the key disputed limitations
are emphasized).
1. A device for performing size exclusion
chromatography comprising:
a housing having at least one wall defining a chamber
having an entrance opening and an exit opening;
a first connection fitting at or about the entrance opening
and a second connection fitting at or about the exit opening, the
first connection fitting further comprising a fitting nut held to the
at least one wall by cooperating threads or interlocking grooves,
and the second connection fitting further comprising a second
fitting nut held to the at least one wall by cooperating threads or
interlocking grooves;
a stationary phase material comprising a core composition
and a surface composition held in said chamber;
wherein said stationary phase material comprises particles
represented by Formula 1:

wherein:
X represents the core composition wherein said core
composition comprises a silica core material, a metal oxide core
material, an organic-inorganic hybrid core material, or a group of
block polymers thereof;
W is hydrogen or hydroxyl; and
Q is represented by Formula 2:
Appeal 2019-006868
Application 13/512,751

3

wherein
n1 an integer from 0-18;
n2 an integer from 0-18;
each occurrence of R1, R2, R3 and R4 independently represents
hydrogen, fluoro, lower alkyl, a protected alcohol, a deprotected alcohol, a
zwiterion, or a group Z, wherein Q is attached to [X] through Z;
Z is represented by Formula 3

wherein x is an integer from 1-3,
y is an integer from 0-2,
z is an integer from 0-2,
and x+y+z = 3
each occurrence of R5 and R6 independently represents methyl, ethyl,
n-butyl, iso-butyl, tert-butyl, iso-propyl, thexyl, substituted aryl,
unsubstituted aryl, cyclic alkyl, branched alkyl, lower alkyl, a
protected alcohol, a deprotected alcohol, or a zwiterion group;
B1 represents -OR7, -NR7' R7'' , -OSO2CF3, or-Cl; where each of R7, R7'
and R7" represents hydrogen, methyl, ethyl, n-butyl, iso-butyl,
tert-butyl, iso-propyl, thexyl, phenyl, branched alkyl, or lower alkyl;

Y represents a heteroatom linkage; an ester linkage; an ether linkage; a
thioether linkage; an amine linkage; an amide linkage; an imide linkage; a
urea linkage; a thiourea linkage; a carbonate linkage; a carbamate linkage; a
heterocycle linkage; a triazole linkage; a urethane linkage; a dial linkage; or
a polyol linkage; and

A represents
i.) a hydrophilic terminal group and said hydrophilic terminal group is
an alcohol, diol, glycidyl ether, epoxy, trial, polyol, pentaerythritol,
Appeal 2019-006868
Application 13/512,751

4
pentaerythritol ethoxylate, 1,3-dioxane-5,5-dimethanol, ethylene
glycol, propylene glycol, poly(ethylene glycol), or
poly(propyleneglycol), wherein said hydrophilic terminal group is in a
protected form or a deprotected form;
ii.) hydrogen, fluoro, methyl, ethyl, n-butyl, t-butyl, i-propyl, or
lower alkyl;

and wherein the particles of the stationary phase material
have diameters with a mean size distribution of 0.4-2.0 microns;
and
a sample injector in fluid communication with the housing
that delivers a sample at a rate of 0.1mL/min to 0.8 mL/min to
the stationary phase to elute compounds of the sample from the
chamber by size with largest sized compounds eluting before
smaller sized compounds.

Appeal Br. Claims Appendix 25–28.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Legendre US 2004/0035793 A1 Feb. 26, 2004
Granger US 2006/0144770 A1 July 6, 2006

REJECTION
Claims 1, 3, 10, 13, 17–20, 24, 38 and 39 are rejected under pre-AIA
35 U.S.C. § 103(a) as being unpatentable over U.S. Patent Publication No.
2006/0144770 by Granger et al. (Granger) in view of U.S. Patent Publication
No. 2004/0035793 by Legendre Jr. et al. (Legendre). Final Act. 2.

Appeal 2019-006868
Application 13/512,751

5
OPINION
Upon consideration of the evidence of record and each of Appellant’s
contentions as set forth in the Appeal Brief, as well as the Reply Brief, we
determine that Appellant has not demonstrated reversible error in the
Examiner’s rejection (e.g., see generally Ans.). In re Jung, 637 F.3d 1356,
1365–66 (Fed. Cir. 2011) (explaining the Board’s long-held practice of
requiring Appellant(s) to identify the alleged error in the Examiner’s
rejection). We sustain the rejections generally for the reasons expressed by
the Examiner in the Final Office Action and the Answer.
We add the following primarily for emphasis.
It has been established that the predictable use of known prior art
elements performing the same functions they have been known to perform is
normally obvious, and the combination of familiar elements is likely to be
obvious when it does no more than yield predictable results. KSR Int’l Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007); see also id. (“the [obviousness]
analysis need not seek out precise teachings directed to the specific subject
matter of the challenged claim, for a court can take account of the inferences
and creative steps that a person of ordinary skill in the art would employ.”);
In re Fritch, 972 F.2d 1260, 1264–65 (Fed. Cir. 1992) (a reference stands for
all of the specific teachings thereof as well as the inferences one of ordinary
skill in the art would have reasonably been expected to draw therefrom).
Appellant’s main contention is that the Examiner impermissibly
“cherry-picked” portions from different chromatography systems in Granger
and thus there is a lack of a reason to use the claimed flow rate taught and
associated with an analytical column in Granger with the nanocolumn and its
column material of Granger (Appeal Br. 12–14; Reply Br. 2–4). Appellant
Appeal 2019-006868
Application 13/512,751

6
also argues that the Examiner has not established that either of the applied
references teach or suggest “size exclusion chromatography” (SEC) as
recited in the preamble and body of the claim (Appeal Br. 15–17; Reply Br.
5, 6). Appellant further contends that the Examiner did not properly
consider the evidence relied upon, that is, Specification Example 9, as
evidence of unexpected results for the use of sub-two micron particles in
SEC (Appeal Br. 20–23; Reply Br. 6–10). Appellant’s arguments are not
persuasive of reversible error for reasons presented by the Examiner (Ans.
7–20).
There is no dispute that, as found by the Examiner, Granger teaches or
suggests a column material encompassed by the claimed material particles
that is known for use in chromatography separations and that Legendre
exemplifies that a connection fitting as claimed is known for use in
chromatography separations (Final Act. 1–5), such that its use as first and
second connection fittings in Granger’s column would have been obvious
(Final Act. 5). Again, Appellant does not dispute that Granger teaches or
suggests the claimed particle material for use in chromatography
separations. Granger also establishes its materials may withstand pressures
from 1000 psi to as high as 20,000 psi (Granger ¶ 89). As pointed out by the
Examiner, Granger and Legendre are both directed to chromatographic
separation and each teach a range of particles sizes that encompass the
claimed range (e.g., Ans. 4, 5, 15; Granger ¶42, Legendre ¶77 (Legendre
teaches its most preferred particle size is 1–3 microns)). Notably,
Appellant’s Specification discusses in the Background section that size
exclusion chromatography (SEC) processes using a packed bed of particles
(the stationary phase) through which the mobile phase flows is known in the
Appeal 2019-006868
Application 13/512,751

7
prior art (Spec. 1, l. 30–col. 2, l. 10).2 Appellant’s invention is directed to
the use of a column/stationary phase material “which can operate at
pressures greater than 5000 psi and fast flow rates” (Spec. 2:19–20).
Even assuming that Appellants are correct that Granger may teach the
use of packing particles in a nanocolumn that may operate at lower flow
rates than recited in claim 1, one of ordinary skill in the art would have
inferred and readily appreciated that a known or obvious material for use in
a chromatography separation, such as that in Granger, may also predictably
be used in the known SEC (size exclusion chromatography) process
admitted to be prior art. In any event, as pointed out by the Examiner, the
use of the column for SEC is an intended use, and Appellants’ arguments
regarding flow rates focus on a process parameter in an apparatus claim
(Ans. 9, 10). It is well established that when there is a reason to conclude
that the structure of the prior art is capable of performing the claimed
function/process, the burden shifts to the applicant to show that the claimed
function patentably distinguishes the claimed structure from the prior art
structure. See, e.g., In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997).

2 An applicant cannot defeat an obviousness rejection by asserting that the
cited references fail to teach or suggest elements which the applicant has
acknowledged are taught by the prior art. Constant v. Advanced Micro-
Devices, Inc., 848 F. 2d 1560, 1570 (Fed. Cir. 1988) (“A statement in a
patent that something is in the prior art is binding on the applicant and
patentee for determinations of anticipation and obviousness.”) and In re
Nomiya, 509 F.2d 566, 571n.5 (CCPA 1975) (A statement by an applicant
that certain matter is prior art is an admission that the matter is prior art for
all purposes).

Appeal 2019-006868
Application 13/512,751

8
Appellant has not provided any evidence that the Granger/Legendre
column would not have been capable of use for a size exclusion
chromatography process. Attorney’s arguments in a brief cannot take the
place of evidence. In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
Likewise, Appellant has not provided any persuasive reasoning or credible
evidence to refute the Examiner’s determination that the Granger/Legendre
column would have been capable of processing flow rates in the recited
range.
Likewise, Appellant’s arguments regarding the lack of motivation to
combine the, at best differing, chromotography embodiments discussed in
Granger are also unpersuasive for the reasons given above. That is, the
arguments fail to account for “the inferences and creative steps that a person
of ordinary skill in the art would employ.” See KSR, 550 U.S. at 418. Cf.,
In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) (“[T]he law does not
require that the references be combined for the reasons contemplated by the
inventors.”); see also In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006).
It has been established that obviousness does not require absolute
predictability of success; all that is required is a reasonable expectation of
success. In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009). Furthermore,
inasmuch as the packing material as recited was obvious and/or known in
the art as suitable for a chromatographic separation process, it is incumbent
upon Appellant to establish that the present inventors had to resort to more
than routine experimentation to determine if it would have been effective in
a known SEC chromatographic separation, e.g., of the type admitted to be
prior art. However, no such evidence is of record.
Appeal 2019-006868
Application 13/512,751

9
Thus, Appellant has not shown reversible error in the Examiner’s
position that it would have been obvious for one of ordinary skill to have
used known/obvious chromatography column material particles as
exemplified in Granger for the chromatography Granger/Legendre column
for admittedly known SEC processes. See KSR, 550 U.S. at 417 (the
predictable use of known prior art elements or steps performing the same
functions they have been known to perform is normally obvious; the
combination of familiar elements/steps is likely to be obvious when it does
no more than yield predictable results); see also In re Merck & Co., Inc., 800
F.2d 1091, 1097 (Fed. Cir. 1986) (“Non-obviousness cannot be established
by attacking references individually where the rejection is based upon the
teachings of a combination of references.”) and In re Sneed, 710 F.2d 1544,
1550 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the
references be physically combinable to render obvious the invention under
review.”).
Next, with respect to Appellant’s proffered evidence of unexpected
results due to the claimed range of 0.1 to 2 micron for the particle sizes of
the column material, it is well established that a prima facie case of
obviousness exists where the prior art and claimed ranges overlap. See In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003); Titanium Metals Corp. v.
Banner, 778 F.2d 775, 783 (Fed. Cir. 1985). In fact, when, as here, the
claimed ranges are almost completely encompassed by the prior art, the
conclusion of obviousness is even more compelling than in cases of mere
overlap. The normal desire of scientists or artisans to improve upon what is
already generally known provides motivation to determine where in a
disclosed set of ranges is the optimum combination. Indeed, the law is
Appeal 2019-006868
Application 13/512,751

10
replete with cases in which the difference between the claimed invention and
the prior art is the claimed range or other variable within the claims. These
cases have consistently held that the Appellant must show that the particular
range is critical, generally by showing that the claimed range achieves
unexpected results relative to the prior art range. In re Woodruff, 919 F.2d
1575, 1578 (Fed. Cir. 1990).
Appellant’s discussion in the Specification and Briefs that a prior art
literature, Held, establishes that one would not have expected sizes lower
than 2.0 microns to work in an SEC separation process are likewise not
persuasive. First of all, the Specification states that for the sub 2 micron
particles “similar benefits” have not been demonstrated for SEC process as
in an traditional HPLC process (Spec. 4:5–8). A lack of similar benefits
from one process compared to another process falls short of establishing
non-obviousness of the device claimed here. Cf. In re Boe, 355 F.2d 961,
965, (CCPA 1966)(court affirmed rejections based on art which rendered the
claimed invention obvious to those of ordinary skill in the art despite the fact
that the art teachings relied upon were phrased in terms of a non-preferred
embodiment or as being unsatisfactory for the intended purpose).
In any event, Appellant has not provided the required side-by-side
comparison of the claimed invention with the closest prior art which is
commensurate in scope with the claims, and has not adequately explained
why the results would have been unexpected by one of ordinary skill in the
art. See In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991); In
re Klosak, 455 F.2d 1077, 1080 (CCPA 1972). The evidence must show
that the unexpected results extend throughout the claimed subject matter but
do not extend into the prior art teachings that fall outside of the claimed
Appeal 2019-006868
Application 13/512,751

11
subject matter, i.e., that the claimed ranges are critical for obtaining the
unexpected result. See, e.g., In re Harris, 409 F.3d 1339, 1344 (Fed. Cir.
2005) (“Even assuming that the results were unexpected, Harris needed to
show results covering the scope of the claimed range. Alternatively Harris
needed to narrow the claims.”); In re Greenfield, 571 F.2d 1185, 1189
(CCPA 1978) (“Establishing that one (or a small number of) species gives
unexpected results is inadequate proof, for ‘it is the view of this court that
objective evidence of non-obviousness must be commensurate in scope with
the claims which the evidence is offered to support.”’) (quoting In re Tiffin,
448 F.2d 791, 792 (CCPA 1971)); and In re Hill, 284 F.2d 955, 958–59
(CCPA 1960) (To establish unexpected results over a claimed range, an
applicant should compare a sufficient number of tests both inside and
outside the claimed range to show the criticality of the claimed range.).
Appellant mainly discusses that Example 9 shows that 1.6 micron
particles worked better than 2.6 micron particles for a particular SEC
separation process (Appeal Br. 23). Thus, even assuming arguendo that the
improved performance for 1.7 micron particles compared to 2.6 micron
particles discussed by Appellant rose to the level of unexpected results, this
evidence falls short of establishing that the entire claimed range of “0.4 to
2.0 microns” exhibits unexpected results (see also, Ans. 18–20).
Accordingly, a preponderance of the evidence supports the
Examiner’s obviousness determination and Appellant has not shown error in
the Examiner’s obviousness determination of the claimed ranges of particle
sizes over the applied prior art.
Moreover, it is well settled that it would have been obvious for an
artisan with ordinary skill to develop workable or even optimum ranges for
Appeal 2019-006868
Application 13/512,751

12
result-effective parameters. In re Woodruff, 919 F.2d at 1577; In re Boesch,
617 F.2d 272, 276 (CCPA 1980); In re Aller, 220 F.2d 454, 456 (CCPA
1955).
“A recognition in the prior art that a property is affected by the
variable is sufficient to find the variable result-effective.” In re Applied
Materials, Inc., 692 F.3d 1289, 1297 (Fed. Cir. 2012). The applied prior art
reasonably indicates that particle size is a result effective variable in
chromatography separation processes. Accordingly, substantial evidence
supports the Examiner’s obviousness determination of the particle sizes
recited in the device of claim 1.
Accordingly, we sustain the Examiner’s rejection of independent
claim 1, as well as all claims dependent thereon since none are argued
separately (see generally Appeal Br.).
CONCLUSION
The Examiner’s rejection is AFFIRMED.
Appeal 2019-006868
Application 13/512,751

13
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 10, 13,
17–20, 24,
38, 39
103(a) Granger, Legendre 1, 3, 10, 13,
17–20, 24,
38, 39

Overall
Outcome
1, 3, 10, 13,
17–20, 24,
38, 39

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