Ex Parte Rossmanith et al

Patent Trial and Appeal Board

Mar 19, 2018

14058772 (P.T.A.B. Mar. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/058,772 10/21/2013 Peter ROSSMANITH
23599 7590 03/21/2018
MILLEN, WHITE, ZELANO & BRANIGAN, P.C.
2200 CLARENDON BL VD.
SUITE 1400
ARLINGTON, VA 22201
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
MERCK-3906-COl 9406
EXAMINER
BROWN, MINDY G
ART UNIT PAPER NUMBER
1636
NOTIFICATION DATE DELIVERY MODE
03/21/2018 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):
docketing@mwzb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PETER ROSSMANITH, PATRICK JULIAN MESTER, and
MARTIN WAGNER
Appeal2017-002495
Application 14/05 8, 772 1
Technology Center 1600
Before FRANCISCO C. PRATS, JENNIFER MEYER CHAGNON, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a method of
isolating cells from a complex sample. The Examiner entered one rejection
for anticipation and seven rejections for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We affirm the anticipation rejection, and also affirm three obviousness
rejections that are related to the anticipation rejection.
Of the four remaining obviousness rejections, we affirm one and
reverse three.
1 Appellants states that the "real party in interest herein is Merck Patent
GmbH." Appeal Br. 1.
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Application 14/05 8, 772
STATEMENT OF THE CASE
The following rejections are before us for review: 2
(1) Claims 1, 3, 5, 6, 10, and 16, under 35 U.S.C. § 102(b) as
anticipated by Johnson3 (Ans. 2-3);
(2) Claims 1-3, 5-10, and 14-16, under 35 U.S.C. § 103(a) as being
obvious over Johnson and Rossmanith4 (Ans. 4-7);
(3) Claim 4, under 35 U.S.C. § 103(a) as being obvious over Johnson,
Jourdan,5 and Liu6 (Ans. 7-9);
(4) Claim 13, under 35 U.S.C. § 103(a) as being obvious over
Johnson, Wang,7 Carda-Broch,8 and Matsumoto9 (Ans. 9-12);
2 The Examiner also entered a provisional obviousness-type double
patenting rejection over claims in Application No. 13/390,528. Ans. 18-20.
Our review of the electronic file indicates that application was abandoned on
December 12, 2017. The Examiner's double patenting rejection is therefore
moot.
3 Jennifer L. Johnson, Isolation & Identification of Pathogenic Yersinia
Enterocoliticafrom Meat and Poultry Products, Chapter 9 in USDA/PSIS
Microbiology Laboratory Guidebook (3rd ed., 1998).
4 WO 2008/017097 Al (published Feb. 14, 2008).
5 Alissa D. Jourdan et al., Development of a Fluorogenic 5' Nuclease PCR
Assay for Detection of the ail Gene of Pathogenic Yersinia enterocolitica, 66
Appl. Environ. Microbiol. 3750-3755 (2000).
6 Dongyou Liu, Preparation of Listeria Monocytogenes Specimens for
Molecular Detection and Identification, 122 Int'l. J. Food Microbiol. 229-
242 (2008).
7 Jian-Hua Wang et al., Direct Extraction of Double-Stranded DNA Into
Ionic Liquid l-Butyl-3-methylimidazolium Hexajluorophosphate and Its
Quantification, 79 Anal. Chem. 620-625 (2007).
8 S. Carda-Broch et al., Solvent Properties of the l-Butyl-3-
Methylimidazolium Hexajluorophosphate Ionic Liquid, 375 Anal. Bioanal.
Chem. 191-199 (2003).
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(5) Claim 17, under 35 U.S.C. § 103(a) as being obvious over Johnson
and Chomczynski10 (Ans. 12);
(6) Claims 1-3, 5, 7-10, and 14-16, under 35 U.S.C. § 103(a) as
being obvious over Rossmanith and Lahiri 11 (Ans. 13-15);
(7) Claim 13, under 35 U.S.C. § 103(a) as being obvious over
Rossmanith, Lahiri, Wang, Carda-Broch, and Matsumoto (Ans. 15-17); and
(8) Claim 17, under 35 U.S.C. § 103(a) as being obvious over
Rossmanith, Lahiri, and Chomczynski (Ans. 17-18).
Claims 1 and 16 are the independent claims on appeal, and read as
follows:
1. A method for isolating cells from a complex sample
comprising the steps of:
a ) providing a complex sample,
b ) incubating said sample with an extraction solution
that comprises at least MgCb and/or an ionic liquid
having a melting point below 100°C, the incubating of
the sample resulting in a mixture,
c ) isolating said cells from the mixture of step b ),
including making a quantitative determination of the
cells.
16. A method for isolating cells from a complex sample
comprising incubating said complex sample with an extraction
solution that comprises at least MgCb and/or an ionic liquid
9 Michiaki Matsumoto et al., Toxicity of Ionic Liquids and Organic Solvents
to Lactic Acid-Producing Bacteria, 98 J. Biosci. Bioengineer. 344-347
(2004).
10 US 5,346,994 (issued Sep. 13, 1994).
11 Debomoy K. Lahiri and Bill Schnabel, DNA Isolation by a Rapid Method
from Human Blood Samples: Effects of MgCh, EDTA, Storage Time, and
Temperature on DNA Yield and Quality, 31 Biochemical Genetics 321-328
(1993).
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having a melting point below 100°C, the incubating of the
sample resulting in a mixture; and isolating said cells from the
mixture, including making a quantitative determination of the
cells.
Appeal Br. 16-17.
ANTICIPATION
The Examiner's Prima Facie Case
In rejecting claims 1, 3, 5, 6, 10, and 16 as anticipated by Johnson, the
Examiner cited page 9-5 of the reference as describing the claimed step of
providing a complex sample, and pages 9-6 and 9-26 as describing the
claimed step of incubating the sample in a solution (ITC broth) containing
MgCb. Ans. 2.
As to the claimed step of isolating the incubated cells from the
cell/broth mixture, the Examiner cited page 9-18, left column, as "describing
the isolation procedure after incubation with ITC broth." Id.
As to the requirement in the claims for the isolating step to include
making a quantitative determination of the cells, the Examiner noted that
"Johnson teaches that the cells are analyzed by cell counting (see pg. 9-8,
section 9.41, describing that the colonies are counted and then subjected to
further testing in section 9.42)." Id. at 3.
Lastly, the Examiner noted that "[r]egarding 'an ionic liquid having a
melting point below 100 °C to generate a mixture', the limitation is recited
in the alternative and is not required by claims 1 and 16." Id.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
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After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
We select claim 1 as representative of the claims subject to this
rejection. 37 C.F.R. § 41.37(c)(l)(iv). In the present appeal, Appellants do
not persuade us that the Examiner failed to show, by a preponderance of the
evidence, that Johnson describes a process having all of the steps required by
claim 1.
Appellants do not dispute, nor do we discern error in, the Examiner's
finding that Johnson describes claim l's steps of (a) providing a complex
sample, and (b) incubating the sample with a solution that contains MgCb.
In that regard, we note, as the Examiner found, that Johnson's process is
directed to determining whether meat and poultry products contain the
pathogenic bacterium Yersinia enterocolitica (Johnson 9-1 ), and includes an
initial step of providing homogenized meat or poultry samples (id. at 9-5),
which are then transferred into ITC broth (id. at 9-6), which contains MgCb
(id. at 9-26).
As to claim 1 's step ( c) of isolating the cells from the mixture of step
(b ), the Examiner cites page 9-18 (Johnson's Figure 1 ), as noted above. The
protocol shown in Johnson's Figure 1 is also described on page 9-6 of the
reference, which explains that, after incubation in the ITC broth for two
days, the cells are then plated onto two types of agar, "SSDC and CIN agars,
[which] are recommended for the isolation of pathogenic Y. enterocolitica."
Id. at 9-6 (emphasis added).
The full protocol for producing isolated colonies of Y. enterocolitica
on SSDC and CIN agar plates reads as follows:
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Id.
ITC broth: Transfer 2 ml of sample homogenate supernatant
into 100 ml ITC broth contained in an Erlenmeyer flask.
Incubate at 25°C for 2 days. Spreadplate 0.1 ml onto SSDC
agar and incubate the plates at 30°C for 24 h. Spreadplate 0.1
ml onto CIN agar, and incubate the plates at 32°C for 18 h.
Also, remove 0.5 ml of the ITC enrichment, treat it with KOH,
then streak onto CIN. Reincubate the ITC enrichment at 25°C
for another 24 h. After the plate incubation is complete,
examine the plates as described below. If colonies having
typical Y. enterocolitica morphology are not visible on the
plates, the ITC culture should be plated out as before.
Johnson discloses that Y. enterocolitica colonies may be identified on
the SSDC and CIN agar plates using certain visual criteria. Id. at 9-7.
Colonies suspected of being Y. enterocolitica are removed from the
SSDC and CIN plates and grown on three additional types of agar to confirm
the identity of the pathogen:
Select a colony on CIN or SSDC having morphology typical of
Y. enterocolitica and emulsify colony in about l ml of sterile
saline (0.85%). Use this to first inoculate a slant of Simmon's
Citrate Agar, then inoculate Kligler' s Iron Agar, and a tube of
urea agar. Repeat until 5 colonies having morphology typical
of Y. enterocolitica have been selected from each plate of
selective agar.
Id. at 9-8.
Because Johnson's process includes the steps of removing an aliquot
of the ITC-treated cells and producing isolated colonies of the cells on the
SSDC and CIN agar plates, we agree with the Examiner that Johnson's
process includes claim l's step of "isolating [the] cells from the mixture of
step b )."
Appellants do not persuade us to the contrary. Appellants contend
that Johnson does not isolate cells as required by claim 1 because "[t]he
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colonies in Johnson are always present in the plates, which means they are in
a matrix in the plates, in all steps." Appeal Br. 5; see also id. at 6 ("[T]he
matrix containing the cells is present in all steps of Johnson and the cells are
never released from the matrix."); Reply Br. 2 ("Isolating, in the context of
the specification, clearly means isolating of individual cells .... ").
We first note that Appellants are incorrect in asserting that Johnson
never releases its cells from the colony-containing plates. As noted above,
after producing isolated colonies of the cells on the SSDC and CIN agar
plates, colonies suspected of being Y. enterocolitica are removed from the
plates, emulsified in sterile saline, and grown on three additional types of
agar to confirm the identity of the pathogen. Johnson 9-8.
Moreover, and contrary to Appellants' arguments, claim 1 does not
recite isolating the cells from any and/or all cell-containing media. Rather,
claim 1 recites only "isolating [the] cells from the mixture of step b ). "
Appeal Br. 16. Because Johnson's process produces colonies of cells that
have been isolated from the ITC broth, Appellants do not persuade us that
claim 1 fails to encompass Johnson's process in this regard.
It might be true, as Appellants argue, that the Specification describes a
process which separates the cells from the cell-containing matrix. See
Appeal Br. 5 (citing Spec. 35-36). It is well settled, however, that preferred
embodiments are not to be read into the claims from the Specification. See
In re Trans Texas Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007)
("[W]hile 'the specification [should be used] to interpret the meaning of a
claim,' courts must not 'import[ ] limitations from the specification into the
claim.' ... [I]t is improper to 'confin[ e] the claims to th[ e] embodiments'
found in the specification .... ") (quoting Phillips v. AWH Corp., 415 F.3d
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1303, 1323 (Fed. Cir. 2005) (citations omitted, bracketed text in internal
quotes in original).
Accordingly, for the reasons discussed, Appellants do not persuade us
that the Examiner erred in finding that Johnson's process includes claim l's
step of isolating the cells from the mixture of step (b ). Appellants also do
not persuade us that the Examiner erred in finding that Johnson's isolating
step includes "making a quantitative determination of the cells" as claim 1
also requires.
As noted above, after producing isolated colonies of the cells on the
SSDC and CIN agar plates, colonies suspected of being Y. enterocolitica are
removed from the plates, emulsified in sterile saline, and grown on three
additional types of agar to confirm the identity of the pathogen. Johnson 9-
8. As to this identity-confirming procedure, Johnson directs the practitioner
to "[r ]epeat until 5 colonies having morphology typical of Y. enterocolitica
have been selected from each plate of selective agar." Id.
Because Johnson's process, thus, requires counting five of the isolated
cell-containing colonies, we agree with the Examiner that Johnson describes
"making a quantitative determination of the cells" as claim 1 requires.
Appellants do not persuade us to the contrary. Appellants contend
that counting the number of colonies, as taught in Johnson, "is not a
'quantitative determination of the cells.'" Appeal Br. 5.
In particular, Appellants contend that they "provided on the record an
excerpt from 'Microbiological Examination of Water and Wastewater,'
Csuros et al., regarding plate counting procedures such as generally referred
to in Johnson." Id. at 6. Appellants contend that "Csuros confirms that such
a method regards the counting of colonies, that there can be problems with
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mixing of different colonies and that it is 'only an indirect, qualitative
estimation of the bacterial population."' Id.
Appellants contend, moreover, that a number of disclosures in their
Specification make it "clear that the quantitative determination of the cells
means that the claimed method is distinct from methods for quantitative
determination of colonies which contain cells." Id. (citing Spec. 11, 12, 37-
44).
We first note that Appellants do not explain where in the record the
Csuros reference appears, nor do Appellants provide a citation or a copy of
the reference so that we may independently evaluate the accuracy of
Appellants' characterization of it. In any event, Appellants do not persuade
us that claim l's step of "making a quantitative determination of the cells"
excludes counting cell colonies as described in Johnson.
It is well settled that during examination the PTO must interpret terms
in a claim using "the broadest reasonable meaning of the words in their
ordinary usage as they would be understood by one of ordinary skill in the
art, taking into account whatever enlightenment by way of definitions or
otherwise that may be afforded by the written description contained in the
applicant's specification." In re Morris, 127 F.3d 1048, 1054 (Fed. Cir.
1997).
As explained in In re Zletz, 893 F.2d 319, 322 (Fed. Cir. 1989), the
reason for this rule of claim interpretation is that "during patent prosecution
when claims can be amended, ambiguities should be recognized, scope and
breadth of language explored, and clarification imposed." (Citations
omitted.).
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In the present case, Appellants' arguments imply that claim 1 should
be interpreted as requiring an actual counting of the individual cells to
determine the number of discrete cells isolated from the mixture of step (b ).
Claim 1, however, does not recite a step of counting individual cells.
Rather, claim 1 requires only "making a quantitative determination of the
cells." Appeal Br. 16. It is undisputed that the colonies counted in Johnson
contain cells.
Moreover, although Appellants' Specification discloses that cell
counting is one example of how a quantitative determination of cells can be
made, the Specification discloses the determination can be made in a number
of other ways:
The cells isolated with the method according to the present
invention may be used for quantitatively or qualitatively
determining the cells in the sample. This can be achieved, for
instance, by cell counting, by PCR methods, in particular by
real time PCR, by using lectins or by methods involving
antibodies, viral binding proteins, aptamers or antimicrobial
peptides (AMP) directed to surface structures of said cells
(e.g.[,] cell specific ELISA or RIA).
Spec. 11 (emphasis added); see also id. at 12 ("The amount of the cells in
the sample can be determined by any method known in the art, in particular
by microbiological methods (e.g.[,] dilution series), cell count, FACS
analysis, real time PCR etc.").
In addition, contrary to Appellants' contention that the plate count
method is inadequate to provide a quantitative determination of the cells as
required by claim 1, Appellants' Specification expressly describes the plate
count method as providing "[ v ]iable cell quantification." Spec. 3 7; see id.
("Viable cell quantification from the remaining bacterial pellet following
matrix lysis is performed using the plate count method (PCM) .... "); see
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also id. at 40 ("Artificially contaminated foodstuffs, containing a 4-step
decimal dilution series of either L monocytogenes or S. Typhimurium, are
subjected to plate count quantification after matrix lysis."); id. at 41 (also
describing "plate count quantification"). Thus, Appellants do not persuade
us that the Examiner erred in determining that, when viewed in light of the
Specification, claim 1 's step of "making a quantitative determination of the
cells" encompasses the quantification methods described in Johnson.
In sum, Appellants do not persuade us, for the reasons discussed, that
the Examiner failed to show, by a preponderance of the evidence, that
Johnson describes a process having all of the steps and features required by
claim 1. Accordingly, we affirm the Examiner's rejection of claim 1 as
anticipated by Johnson. Because they were not argued separately, claims 3,
5, 6, 10, and 16 fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
OBVIOUSNESS-
JOHNSON AND ROSSMANITH
The Examiner's Prima Facie Case
In rejecting claims 1-3, 5-10, and 14-16 for obviousness over
Johnson and Rossmanith, the Examiner relied on the teachings in Johnson,
discussed above, as to claims 1, 3, 5, 6, 10 and 16. See Ans. 4-5.
The Examiner found, however, that Johnson differs from Appellants'
claims 2, 7-9, and 15, in that "Johnson does not teach that the sample is
spiked with a defined amount of control cells prior to incubation with an
extraction solution." Id. at 5.
The Examiner also found that Johnson differs from Appellants' claims
in that Johnson "does not teach that the sample is pre-incubated with a
compound exhibiting osmotic stress-protective properties to the cells or that
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the sample is further incubated with at least one biopolymer degrading
enzyme or the isolation methods recited in claim 15." Id.
The Examiner cited Rossmanith as evidence that it would have been
obvious to include the missing elements recited in the dependent claims in
Johnson's process. Id. at 5-7.
Analysis
Appellants do not present separate argument as to any of the claims
subject to this ground of rejection. See Appeal. Br. 7-8.
We select claim 1 as representative of the claims subject to this
rejection. 37 C.F.R. § 41.37(c)(l)(iv).
For the reasons discussed above, Appellants do not persuade us that
the Examiner erred in finding that Johnson teaches or suggests a process
having all of the steps and features required by claim 1. We, therefore,
affirm the Examiner's rejection of claim 1 for obviousness over Johnson and
Rossmanith. Because they were not argued separately, claims 3, 5, 6, 10,
and 16 fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
We acknowledge Appellants' contention that "Rossmanith was cited
in this ground of rejection for alleged pertinence to preferred features of the
dependent claims 7-9 and 15 regarding specifics of the incubating step"
(Appeal Br. 7), as well as Appellants' contention that an ordinary artisan
would not have combined Rossmanith with Johnson (id. at 7-8).
Appellants, however, fail to present separate argument regarding
claims in compliance with our rules: "[ u ]nder each heading identifying the
ground of rejection being contested, any claim(s) argued separately or as a
subgroup shall be argued under a separate subheading that identifies the
claim(s) by number." 37 C.F.R. § 41.37(c)(l)(iv).
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Appellants have not presented argument as to claims 7-9 and 15 by
providing a separate subheading as required by rule. Nonetheless, even
selecting claim 7 as representative of claims 7-9 and 15, Appellants do not
persuade us that the Examiner erred in concluding that the claimed invention
would have been obvious.
As the Examiner found, Rossmanith discloses that spiking the sample
with a defined amount of control cells, as recited in Appellants' claim 7
"allows to determine the efficiency of the method of the present [cell
isolation] invention and may also indicate the amount of the cells to be
isolated and determined present in the initial sample." Rossmanith 11.
We acknowledge, as Appellants contend (Appeal Br. 8), that
Rossmanith's cell isolation process uses different reagents than Johnson.
See, e.g., Rossmanith 11.
Appellants do not explain specifically, however, how that fact
demonstrates that the Examiner erred in determining that it would be
desirable, and therefore obvious, to spike Johnson's initial sample with a
defined amount of control cells, as taught by Rossmanith, as a way to
determine the efficiency of Johnson's method, as also taught by Rossmanith.
Appellants, therefore, do not persuade us that the Examiner erred in
concluding that the process recited in claim 7 would have been obvious over
Johnson and Rossmanith.
Accordingly, we affirm the Examiner's rejection of claim 7 over those
references. Claims 8, 9, and 15 were argued in the same claim grouping and
therefore fall with claim 7. 37 C.F.R. § 41.37( c )(1 )(iv).
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OBVIOUSNESS-
JOHNSON, JOURDAN, AND LIU
In rejecting claim 4 over Johnson, Jourdan, and Liu, the Examiner
relied on the teachings in Johnson, discussed above, as to claim 1, and cited
Jourdan and Liu as evidence that it would have been obvious to use the
concentration of MgCb recited in claim 4 in Johnson's process. Ans. 7-9.
Appellants argue only that Jourdan and Liu fail to remedy the
deficiencies, discussed above, of Johnson as to claim 1, from which claim 4
depends. Appeal Br. 8. As discussed above, however, Appellants do not
persuade us that the Examiner erred in determining that Johnson describes,
teaches, and/or suggests, a process having all of the steps and features
required by claim 1. Because Appellants, therefore, do not identify, nor do
we discern, error in the Examiner's obviousness rejection of claim 4 over
Johnson, Jourdan, and Liu, we affirm the Examiner's rejection of that claim
over those references.
OBVIOUSNESS-
JOHNSON, WANG, CARDA-BROCH, AND MATSUMOTO
In rejecting claim 13 over Johnson, Wang, Carda-Broch, and
Matsumoto, the Examiner relied on the teachings in Johnson, discussed
above, as to claim 1, and cited Wang, Carda-Broch, and Matsumoto as
evidence that it would have been obvious to use the ionic liquids recited in
claim 13 in Johnson's process. Ans. 9-11.
Appellants argue only that Wang, Carda-Broch, and Matsumoto fail to
remedy the deficiencies, discussed above, of Johnson as to claim 1, from
which claim 13 depends. Appeal Br. 9. As discussed above, however,
Appellants do not persuade us that the Examiner erred in determining that
Johnson describes, teaches, and suggests, a process having all of the steps
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and features required by claim 1. Because Appellants, therefore, do not
identify, nor do we discern, error in the Examiner's obviousness rejection of
claim 13 over Johnson, Wang, Carda-Broch, and Matsumoto, we affirm the
Examiner's rejection of that claim over those references.
OBVIOUSNESS-
JOHNSON AND CHOMCZYNSKI
The Examiner's Prima Facie Case
In rejecting claim 1 7 over Johnson and Chomczynski, the Examiner
relied on the teachings in Johnson, discussed above, as to claim 1, and cited
Chomczynski as evidence that it would have been obvious to use an ionic
liquid encompassed by claim 17 in Johnson's process. Ans. 12.
Analysis
In this instance, Appellants persuade us that the preponderance of the
evidence does not support the Examiner's conclusion of obviousness.
Specifically, we find persuasive Appellants' contention that an
ordinary artisan would not have used Chomczynski's DNA-isolating buffer
in Johnson's process of isolating live cells because "[Chomczynski] is lysing
and destroying the cells" in order to obtain DNA and/or RNA and/or
proteins. Appeal Br. 10.
We acknowledge, as the Examiner found, that Chomczynski's
extraction solvent may include ammonium thiocyanate, encompassed by
Appellants' claim 1 7. See Chomczynski 7: 11-1 7.
Consistent with Appellants' contention that Chomczynski's solvent
lyses and destroys cells, however, Chomczynski uses the solvent to extract
intact DNA, RNA, and protein from homogenized tissue into distinct
aqueous, organic, and interphases. See id. at 5:5-61 (Examples 1 and 2).
Accordingly, we agree with Appellants that a skilled artisan seeking to
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obtain intact cells, as taught in Johnson, would not have been prompted by
either Chomczynski or Johnson to use Chomczynski's solvent in Johnson's
process.
The Examiner contends that "there is nothing in the claims that
precludes one from lysing the cells and performing additional tests on the
cells and the sample. There is nothing in the claims to indicate that the cells
remain intact." Ans. 29.
We are not persuaded. Claim 1, from which claim 1 7 depends, recites
"[a] method for isolating cells from a complex sample." Appeal Br. 16.
Claim 1 recites, in step b ), incubating a cell-containing sample with an
extraction solution, and then, in step c) "isolating said cells from the mixture
of step b)." Id. (emphasis added).
Contrary to the Examiner's contention, therefore, claim 17, through its
dependency on claim 1, requires isolating intact cells in step c ). Because
Chomczynski's extraction solvent undisputedly lyses and destroys cells,
using Chomczynski's solvent in step b) would not result in the isolation of
cells, as claim 17 requires. The Examiner does not persuade us, therefore,
that the combination of Johnson and Chomczynski teaches or suggests a
process having all of the steps and features required by claim 1 7.
Accordingly, we reverse the Examiner's rejection of claim 17 over those
references.
OBVIOUSNESS-
ROSSMANITH AND LAHIRI
The Examiner's Prima Facie Case
In rejecting claims 1-3, 5, 7-10, and 14-16 over Rossmanith and
Lahiri, the Examiner cited Rossmanith as describing a cell isolation process
having substantially all of the steps and features required by the rejected
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claims, but differing from the claims in that Rossmanith "does not expressly
teach that the extraction solution contains MgCb." Ans. 14.
As evidence that it would have been obvious to include MgCb in
Rossmanith' s cell extraction buffer, the Examiner cited Lahiri as teaching
that "when isolating DNA from cells, magnesium chloride is both commonly
and advantageously used in the extraction buffer (see Abstract and pg. 323,
1st and 2nd full paragraphs)." Id.
The Examiner reasoned, therefore, that a skilled artisan would have
considered it obvious to include MgCb in Rossmanith's extraction buffer
"because Lahiri et al. taught that buffer conditions for isolation of DNA for
complex samples, such as blood, optimally contained magnesium ions in the
form ofMgCb." Id.
Analysis
In this instance, Appellants again persuade us that the preponderance
of the evidence does not support the Examiner's conclusion of obviousness.
Specifically, we find persuasive Appellants' contention that Lahiri's
disclosure, that "a particular amount of MgCb was advantageous for
isolating DNA from blood[,] does not provide any teaching or suggestion
that MgCb would be advantageous for isolating cells from a sample."
Appeal Br. 11.
As the Examiner found, Rossmanith describes a method "for isolating
cells from a complex sample comprising the steps of: a) providing a
complex sample, b) incubating said sample with: at least one chaotrope, a
buffer and at least one detergent, c) isolating said cells from the resulting
mixture by centrifugation or filtration." Rossmanith, Abstract.
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Rossmanith explains, in particular, that its method involves isolating
intact viable cells. Id. at 7 ("The method of the present invention allows the
isolation of cells having or comprising a cell wall. Due to the presence of a
cell wall as the outer barrier the cells can be subjected to substances like
chaotropes [for example urea] without affecting their viability.").
In contrast to isolating intact cells, Lahiri's process involves using its
MgCb-containing buffer to isolate DNA from lysed cells obtained from
blood, as Appellants contend. See Lahiri 322 ("One milliliter of blood was
treated with an equal volume of low-salt buffer containing 10 mMTris-HCl,
pH 7.6, 10 mMKCl, 2 mMEDTA (TKE) containing 4 mMMgCb (TKM).
Twenty five microliters ofNP-40 was added and the cells were lysed by
inverting several times.") (emphasis added).
Thus, although Lahiri discloses that an optimal MgCb concentration is
"critical to obtaining intact, high molecular weight (HMW) DNA" from
lysed cells (Lahiri, Abstract), we are not persuaded that the Examiner has
explained adequately why that teaching would have prompted a skilled
artisan to include MgCb in a buffer used for isolating intact viable cells, as
taught in Rossmanith. Because the Examiner, therefore, has not explained
adequately why the combination of Rossmanith and Lahiri teaches or
suggests a process having all of the steps and features required by claims 1-
3, 5, 7-10, and 14-16, we reverse the Examiner's rejection of those claims
over those references.
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OBVIOUSNESS-
ROSSMANITH, LAHIRI,
WANG, CARDA-BROCH, AND MATSUMOTO
The Examiner's Prima Facie Case
In rejecting claim 13 over Rossmanith, Lahiri, Wang, Carda-Broch,
and Matsumoto, the Examiner relied on the combination of Rossmanith and
Lahiri, discussed above, as to claim 1, and cited Wang, Carda-Broch, and
Matsumoto as evidence that it would have been obvious to use an
imidazolium ionic liquid encompassed by claim 13, in Rossmanith's
process. Ans. 15-17.
As to motivation for the posited combination, the Examiner noted,
among other disclosures, Wang's teaching that imidazolium ionic liquids
encompassed by claim 13 "afforded the clear advantages of being green."
Id. at 17. In that regard, the Examiner also noted Matsumoto's teaching that
imidazolium ionic liquids were "advantageous in chemical processes as
replacements for volatile, conventional organic solvents due to their having
effectively no vapor pressure, the improvement they yield in selectivity and
yield in enzymatic reactions, and their limited toxicity to microbes." Id. at
17.
The Examiner cited Carda-Broch as evidence that one of the ionic
liquids used in Wang, l-butyl-3-methylimidazolium hexafluorophosphate,
has a melting point of -8 °C, thus satisfying the limitation of an "ionic liquid
having a melting point below 100°C" as required by claim 13 (and claim 1,
from which claim 13 depends). Id. at 16.
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Analysis
In this instance, Appellants do not persuade us that the Examiner
failed to show, by a preponderance of the evidence, that the process recited
in claim 13 would have been obvious to a skilled artisan.
Appellants incorporate by reference their arguments, discussed above,
as to the combination of Rossmanith and Lahiri, and also argue that Wang,
Carda-Broch, and Matsumoto fail to remedy the deficiencies, discussed
above, of the combination of Rossmanith and Lahiri as to claim 1, from
which claim 13 depends. Appeal Br. 13.
We agree with Appellants, for the reasons discussed above, that the
combination of Rossmanith and Lahiri does not suggest the process recited
in claim 1, to the extent that claim 1 requires using MgCh in the claimed
process.
Claim 1, however, alternatively encompasses incubating the cell-
containing complex sample in an extraction solution that comprises an ionic
liquid having a melting point below 100°C, instead of an MgCb-containing
solution. See Appeal Br. 16. And claim 13, which depends from claim 1,
limits that ionic liquid to compounds that Appellants do not dispute are
described by Wang and Matsumoto.
Thus, Appellants' argument, that the combination of Rossmanith and
Lahiri does not suggest using an MgCb-containing solution in Rossmanith' s
process, does not address (or demonstrate error in) the Examiner's
conclusion that it would have been obvious to use an ionic liquid having a
melting point below 100°C, as recited in Appellants' claim 13.
In that regard, we note, as the Examiner found, that Wang teaches that
"[ c ]onventional [biological] extraction procedures with organic solvents
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pose a series of problems attributed to their toxicity. In this respect, ionic
liquid as a green solvent provides a promising alternative." Wang 620. We
note also Matsumoto's disclosure that bacteria can grow in the presence of
imidazolium-based ionic liquids. Matsumoto 344 ("We found that
Lactobacillus delbruekii subsp. lactis NRIC 1683 could grow in the
presence of a second phase of imidazolium-based ionic liquids as well as
in the absence of the ionic liquids.") (Abstract).
Appellants do not explain specifically how or why the Examiner erred
in determining that it would have been desirable to use imidazolium-based
ionic liquids encompassed by claim 13 in Rossmanith's process, particularly
when viewing Rossmanith in light of Wang's disclosure of the advantages of
such ionic liquids, and Matsumoto's disclosure that bacterial cells grow in
such liquids. Similarly, that Rossmanith' s guanidine thiocyanate might not
be an ionic liquid with melting point below 100°C (see Appeal Br. 10-11 ),
does not explain why the Examiner erred in concluding that it would have
been obvious to use the ionic liquids described in Wang and/or Matsumoto
in Rossmanith' s process.
Moreover, although Appellants aver that the Rossmanith/Lahiri
combination does not teach or suggest isolating and quantitating cells (see
Appeal Br. 13), Rossmanith discloses that its process includes both of those
steps. See Rossmanith, Abstract (describing its process as a method "for
isolating cells from a complex sample comprising the step[] of ... isolating
said cells from the resulting mixture by centrifugation or filtration"); id. at
11 ("According to a preferred embodiment of the present invention the
amount of the cells in the sample is determined.").
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In sum, for the reasons discussed, we are not persuaded that
Appellants have explained adequately how or why the Examiner erred in
determining that the process recited in claim 13 would have been obvious in
view ofRossmanith, Lahiri, Wang, Carda-Broch, and Matsumoto. We,
therefore, affirm the Examiner's rejection of that claim over those
references.
OBVIOUSNESS-
ROSSMANITH, LAHIRI, AND CHOMCZYNSKI
The Examiner's Prima Facie Case
In rejecting claim 17 over Rossmanith, Lahiri, and Chomczynski, the
Examiner relied on the teachings in Rossmanith and Lahiri, discussed above,
as to claim 1, and cited Chomczynski as evidence that it would have been
obvious to use an ionic liquid encompassed by claim 17 in Johnson's
process. Ans. 17-18.
Analysis
In this instance, for reasons similar to the Examiner's rejection of
claim 1 7 over Johnson and Chomczynski discussed above, Appellants
persuade us that the preponderance of the evidence does not support the
Examiner's conclusion of obviousness.
As noted above, consistent with Appellants' contention that
Chomczynski's solvent lyses and destroys cells, Chomczynski uses its
solvent to extract DNA, RNA, and protein from homogenized tissue into
distinct aqueous, organic, and interphases. See 5:5-61 (Examples 1 and 2).
Accordingly, we agree with Appellants that a skilled artisan seeking to
obtain intact cells, as taught in Rossmanith, would not have been prompted
to use Chomczynski's solvent in Rossmanith's process. We, therefore,
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reverse the Examiner's rejection of claim 17 over Rossmanith, Lahiri, and
Chomczynski.
SUMMARY
For the reasons discussed, we affirm the Examiner's rejection of
claims 1, 3, 5, 6, 10, and 16 under 35 U.S.C. § 102(b) as anticipated by
Johnson.
For the reasons discussed, we affirm the Examiner's rejection of
claims 1-3, 5-10, and 14-16 under 35 U.S.C. § 103(a) as being obvious
over Johnson and Rossmanith.
For the reasons discussed, we affirm the Examiner's rejection of claim
4 under 35 U.S.C. § 103(a) as being obvious over Johnson, Jourdan, and
Liu.
For the reasons discussed, we affirm the Examiner's rejection of claim
13 under 35 U.S.C. § 103(a) as being obvious over Johnson, Wang, Carda-
Broch, and Matsumoto.
For the reasons discussed, however, we reverse the Examiner's
rejection of claim 17 under 35 U.S.C. § 103(a) as being obvious over
Johnson and Chomczynski.
For the reasons discussed, we reverse the Examiner's rejection of
claims 1-3, 5, 7-10, and 14-16, under 35 U.S.C. § 103(a) as being obvious
over Rossmanith and Lahiri.
For the reasons discussed, however, we affirm the Examiner's
rejection of claim 13 under 35 U.S.C. § 103(a) as being obvious over
Rossmanith, Lahiri, Wang, Carda-Broch, and Matsumoto.
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For the reasons discussed, we reverse the Examiner's rejection of
claim 17 under 35 U.S.C. § 103(a) as being obvious over Rossmanith,
Lahiri, and Chomczynski.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 3 7 C.F .R. § 1.13 6( a).
AFFIRMED-IN-PART
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