Alex Garvin

Patent Trials and Appeals Board

Jan 21, 2020

12008385 - (D) (P.T.A.B. Jan. 21, 2020)

APPLICATION NO. FILING DATE
12/008,385 01/11/2008
34725 7590 01/21/2020
CHALKER FLORES, LLP
14951 North Dallas Parkway, Suite 400
DALLAS, TX 75254
FIRST NAMED INVENTOR
Alex Garvin
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONERFORPATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
ATTORNEY DOCKET NO.
PTC:1000
CONFIRMATION NO.
9083
EXAMINER
POHNERT, STEVEN C
ART UNIT PAPER NUMBER
1634
MAIL DATE DELNERYMODE
01/21/2020 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
____________

Ex parte ALEX GARVIN
____________

Appeal 2019-001241
Application 12/008,385
Technology Center 1600
____________

ERRATUM
The Decision on Appeal for the above-identified application mailed
January 21, 2020 contains errors.
Page 3 of the Decision reads: “We REVERSE.” This should read:
“We AFFIRM.”
Page 4 of the Decision should read:

ISSUES AND ANALYSES

We agree with, and adopt, the Examiner’s findings,
reasoning, and conclusion that the claims on appeal lack written
descriptive support. We do not agree with, nor do we adopt the
Examiner’s findings, reasoning, and conclusion that the claims
are obvious over the combined cited prior art.

On page 9, the Decision reads: “We consequently reverse the
Examiner’s rejection of claims 40 and 45 upon this ground.” Because we
affirm the Examiner’s rejection with respect to Section A, Issue 1, the
Appeal 2011-007347
Application 10/961,784

2
sentence should read: “We consequently affirm the Examiner’s rejection of
claims 40 and 45 upon this ground.”
Similarly, the CONCLUSION of the Decision on page 21 of the
Decision should read, in relevant part: “The Examiner’s rejection of claims
40 and 45 under 35 U.S.C. § 112, first paragraph, is affirmed.” Page 22 of
the Decision should therefore read:

AFFIRMED

Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
40, 45 112, first
paragraph
Lack of written
descriptive support
40, 45
40, 45 103(a) Gill, Greenspoon,
Eshleman, Winkler,
Bianchi, Atkinson,
Nakanishi, Kwon,
Latham, van Santen,
Sanyal
  40, 45
Overall
Outcome
40, 45

All other portions of the Decision on Appeal remain unchanged. The
time period(s) established by the original Decision on Appeal mailed
January 21, 2020 are reset to the mailing date of this erratum. Any
confusion caused regarding this matter is regretted.

If there any questions pertaining to this Erratum, please contact the
Patent Trial and Appeal Board at 571-272-9797.

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALEX GARVIN1
Appeal2019-001241
Application 12/008,385
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
JAMIE T. WISZ, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 We use the word "Appellant" to refer to the "applicant" as defined in
37 C.F.R. § 1.142. Appellant identifies Alex M. Garvin as the real party-
in-interest. App. Br. 2.
Appeal2019-001241
Application 12/008,385
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner's Non-Final Rejection of claims 40 and 45 as unpatentable under
35 U.S.C. § 112, first paragraph, as lacking written descriptive support.
Claims 40 and 45 also stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of P. Gill et al., Forensic
Application of DNA "Fingerprints," 318 NATURE 577-79 (1985) ("Gill"), J.
Eshleman et al., Use of DNase to Eliminate Contamination in Ancient DNA
Analysis, 22 ELECTROPHORESIS 4316-19 (2001) ("Eshleman"), A. Winkler
et al., Gene Expression and Activity of Specific Opioid-Degrading Enzymes
in Different Brain Regions of the AA and ANA Lines of Rats, 1406 BIOCHEM.
BIOPHYS. ACTA, 219-27 (1998) ("Winkler"); P.G. Bianchi et al., Effect of
Deoxyribonucleic Acid Protamination on Fluorochrome Staining and In Situ
Nick-Translation of Murine and Human Mature Spermatozoa, 49 BIOL.
REPRO. 1083-88 (1993) ("Bianchi"), P.W. Atkinson et al., Association of
Exogenous DNA with Cattle and Insect Spermatozoa in Vitro, 29 MOL.
REPRO. DEV. 1-5 (1991) ("Atkinson"), S.A. Greenspoon et al., Application
of the BioMek® 2000 Laboratory Automation Workstation and the DNA IQ™
System to the Extraction of Forensic Casework Samples, 49(1) J. FORENSIC
SCI. 1-11 (2004) ("Greenspoon"), A. Nakanishi et al., Gene Transfer in the
Chicken by Sperm-Mediated Methods, 36 MOL. REPRO. DEV. 258-61 (1993)
("Nakanishi"), Kwon (US 2004/0038213 Al, February 26, 2004) ("Kwon"),
Latham et al. (WO 2004/090114 A2, October 21, 2004) ("Latham"), V.L.
van Santen, Characterization of the Bovine Herpesvirus 4 Major Immediate-
Early Transcript, 65(10) VIROL. 5211 (1991) ("van Santen"), and A. Sanyal
et al., An Effective Method of Completely Removing Contaminating Genomic
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Application 12/008,385
DNAfrom an RNA Sample to be Used for PCR, 8 MOL. BIOTECH. 135-37
( 1997) ("Sanyal"). 2
We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
NATURE OF THE CLAIMED INVENTION
Appellant's claimed invention is directed to a method for the isolation
of sperm DNA from swabs taken from rape victims without having to
perform a change in buffers. Spec. Abstr.
REPRESENTATIVE CLAIM
Independent claim 40 is the only independent claim on appeal
and representative. Claim 40 recites:
40. A method of separating human sperm DNA from human
non-sperm DNA in sexual assault samples comprising:
contacting a sample containing human sperm cells and
human non-sperm cells with proteinase-K in an extraction buffer
solution comprising t-octylphenoxypolyethoxyethanol,
2 Appellant also appeals the Examiner's conclusion that Appellant has not
complied with one or more conditions for receiving the benefit of an earlier
filing date for the patent application under 35 U.S.C. § l 19(e). App. Br. 10
(citing Non-Final Act. 2-5). However, the Examiner's finding in this
respect is not itself a ground for rejection of the claims, nor does it form
the basis of another rejection from which Appellant appeals, nor does
Appellant rely on the earlier filing date to antedate a reference.
Consequently, we do not reach this issue. See 37 C.F.R. § 41.3l(a)(l)
("Every applicant, any of whose claims has been twice rejected, may
appeal from the decision of the examiner to the Board").
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wherein the extraction buffer solution does not contain
sodium dodecyl sulfate;
digesting the human non-sperm cells with the proteinase-
K·
'
adding a DNAse I to the same extraction buffer solution in
which the non-sperm cells were digested without a centrifugation
step or a filtration step with respect to the addition of the DNAse
I;
selectively degrading non-sperm DNA from the non-
sperm cells with the DNAse I;
inactivating the DNAse I and lysing the sperm by adding
ethylenediaminetetraacetic (EDTA) and dithiothreitol (DTT) for
at least 5 minutes at 56°C; and
separating sperm DNA from the human sperm for further
analysis of the sperm DNA
App. Br. 45.
ISSUES AND ANALYSES
We do not agree with, nor do we adopt, the Examiner's findings,
reasoning, and conclusion that the claims on appeal lack written description
or are obvious over the combined cited prior art. We address the arguments
raised by Appellant below.
A. Rejection of the claims under 25 U.S.C. §112, first paragraph
Issue 1
Appellant argues that the Examiner erred in concluding that the
limitation of claim 40 reciting "inactivating the DNAse I and lysing the
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sperm by adding ethylenediaminetetraacetic (EDTA) and dithiothreitol
(DTT) for at least 5 minutes at 56°C" lacks written descriptive support in the
Specification. App. Br. 13.
Analysis
The Examiner acknowledges that Appellant's Specification discloses
that: "The next step is to inactivate the nuclease, and to lyse the sperm. This
is done by adding: 25 mM EDT A ( ethylenediaminetetraac[ etic] acid), and 50
mM DTT( dithiothreitol). Incubation is for 5 minutes at 56 degrees." Non-
Final Act. 6 ( quoting Spec. 7). However, the Examiner finds, the recitation
of 5 minutes does not provide written descriptive support for incubation
times of more than 5 minutes, which is within the scope of the amended
claim. Id. The Examiner therefore concludes that incubation times of
greater than 5 minutes is new matter that is not supported by the
Specification. Id.
Appellant argues that the Specification's disclosure of an incubation
time of 5 minutes at 56°C provides support for the incubation to be for a
duration of "at least 5 minutes," as recited in the claim. App. Br. 13.
According to Appellant, the disclosure of a 5 minute incubation time is a
statement of the best mode of practicing the invention. Id. Appellant
contends that a disclosure of the best mode does not limit the general
disclosure that the solution is to be incubated. Id. Appellant asserts that a
skilled artisan who understands that the best mode incubation time is 5
minutes will know that an acceptable incubation time may be more than 5
minutes, but that the incubation time must be at least 5 minutes, without
requiring undue experimentation. Id. at 13-14. Appellant argues that the
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claimed method is not limited to the specific example that is set forth in the
disclosure of the best mode. Id. at 14.
We are not persuaded by Appellant's argument. The standard for
satisfying the written description requirement is whether the disclosure
"allow[ s] one skilled in the art to visualize or recognize the identity of the
subject matter purportedly described." Alcon Research Ltd. v. Barr Labs.,
Inc., 745 F.3d 1180, 1190 (Fed. Cir. 2014) (quoting Enzo Biochem, Inc. v.
Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002). "[T]he critical inquiry
is whether the patentee has provided a description that 'in a definite way
identifies the claimed invention' in sufficient detail that a person of ordinary
skill would understand that the inventor was in possession of it at the time of
filing." Alcon, 7 45 F .3d 1190-91 ( quoting Ariad Pharm., Inc. v. Eli Lilly &
Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010)). However, "a description that
merely renders the invention obvious does not satisfy the requirement."
Ariad, 598 F.3d at 1352.
Appellant's Specification expressly discloses that: "Incubation is for 5
minutes at 56 degrees." Spec. 7. However, the claim 40 recites "at least 5
minutes," thus including within its scope intervals much longer than the
claimed interval.
Our reviewing court has held that: "[T]he PTO has the initial burden
of presenting evidence or reasons why persons skilled in the art would not
recognize in the disclosure a description of the invention defined by the
claims." In re Wertheim, 541 F.2d 257, 263-264 (C.C.P.A. 1976). "By
pointing to the fact that claim 1 reads on embodiments outside the scope of
the description, the PTO has satisfied its burden." Id. The burden therefore
falls upon Appellant to show that a person of ordinary skill in the art would
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Application 12/008,385
be able to recognize that the identity of the subject matter described includes
intervals longer than, indeed potentially much longer than, the 5 minutes
disclosed by the Specification. Id.; Alcon, 745 F.3d at 1190. Appellant has
failed to meet this burden by offering objective evidence of record, and we
consequently are not persuaded by Appellant's arguments in this regard.
Issue 2
Appellant argues that the Examiner erred in finding that Appellant's
Specification fails to provide written descriptive support for the limitation of
claim 40 reciting: "adding a DNAse I to the same extraction buffer solution
in which the non-sperm cells were digested without a centrifugation step or a
filtration step with respect to the addition of the DNAse I." App. Br. 14.
Analysis
The Examiner acknowledges that Appellant's Specification discloses
general support for excluding centrifuging and filtration. Non-Final Act. 6.
However, the Examiner finds, the Specification does not reveal support for
excluding centrifuging and filtration from the step adding DNAse I. Id. at
6-7. The Examiner reasons that this step is a new embodiment which is not
specifically described by the original Specification and therefore introduces
new matter. Id. at 7.
Appellant argues that, because the Specification generally excludes
centrifugation and filtration, that general exclusion applies to any and all
specific instances of excluding centrifugation and filtration in the claimed
method. App. Br. 15. According to Appellant, excluding centrifugation and
filtration from the step of adding DNAse I to the same extraction buffer
solution in which the non-sperm cells were digested is not a new
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embodiment and is therefore not new matter. Id. Appellant contends that
the Specification, as originally filed, discloses that the DNase I is added to
the solution without centrifugation or filtration at any step of the claimed
method, and that the limitation is therefore fully supported by the disclosures
of the Specification. Id.
We agree with Appellant. Appellant's Specification does not disclose
the use of centrifugation or filtration in any step of the claimed method,
either in its general description or in the Examples provided. Because the
claims recite "without a centrifugation step or a filtration step," this negative
limitation requires that the Specification disclose a reason why such steps
are excluded. See Santarus, Inc. v. Par Pharm. Inc., 694 F.3d 1344, 1351
(Fed Cir. 2012) (holding that "[n]egative claim limitations are adequately
supported when the specification describes a reason to exclude the relevant
limitation"). Nevertheless, the Specification discloses that "Unfortunately,
the processes of centrifugation and careful removal of supernatant are
difficult to automate, labor intensive, and result in the loss of some sperm."
Spec. 4. Furthermore, the Specification discloses that, with respect to
filtration, the prior art discloses filtration methods, but:
Unfortunately the pores of these filters will expand under
pressure requiring that only gravity be used as the driving force
to minimize the unwanted passage of epithelial cells. In the
absence of a strong driving force, capillary action on the filter
surface competes with gravity flow through the filter and results
in a large retention volume and difficulties with sample handling
(present applicant's observation). Furthermore, DNA from
epithelial cells lysed by the harsh detergent required for efficient
cell re-suspension will pass through the filter with intact sperm.
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Spec. 5. The Specification also discloses that, with respect to the teachings
of the prior art: "Although this [ filtration-based] method avoids
centrifugation, it still requires a separation step, and the sperm DNA must be
eluted from the filter, a process that can result in sperm DNA loss." Id. at 7.
When considered in view of the Specification's disclosure that its:
"preferred method is fast, suitable for automation, and provides reliable
results even when the amount of sperm present in a test sample is much
smaller than the amount of non-sperm cells" (Spec. 6), we conclude that the
Specification has disclosed sufficient reason to exclude centrifugation and
filtration generally from the claimed method. Furthermore, the exclusion of
centrifugation and filtration generally from the method also supports the
exclusion of centrifugation and filtration from all of the steps of the claimed
method, including the recited step.
We consequently reverse the Examiner's rejection of claims 40 and 45
upon this ground.
B. Rejection of the claims under 35 U.S.C. 103(a)
Issue
Appellant argues that the Examiner erred because: ( 1) the combined
cited prior art does not meet all the claim limitations; and (2) the Examiner
has not provided proper analysis supporting rationale why a person skilled in
the art would have combined the applied art to arrive at the claimed
invention. App. Br. 16.
Analysis
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The Examiner finds that Gill teaches that "sperm nuclei can be
separated from vaginal cellular debris, obtained from semen contaminated
vaginal swabs, enabling positive identification of the male donor/suspect. It
is envisaged that DNA fingerprinting will revolutionize forensic biology
particularly with regard to the identification of rape suspects." Non-Final
Act. 8 ( quoting Gill 577). The Examiner finds that Gill further teaches that:
Because preliminary experiments showed that semen-
contaminated vaginal swabs contained large amounts of DNA
from the female, tending to obscure many of the bands from the
sperm, female cells were preferentially lysed by preliminary
incubation in an SDS/proteinase K mixture. Sperm nuclei are
impervious to this treatment because they are ramified with
cross-linked thiol-rich proteinsl4 and can therefore be separated
from the female component by centrifugation.
Id. ( quoting Gill 578).
The Examiner also finds that Gill teaches lysis of sperm nucleic with
SDS/proteinase Kand DTT mixture. Non-Final Act. 8 (citing Gill 578).
Therefore, the Examiner finds, Gill recognizes the issues of contaminating
DNA from the female (non-sperm DNA), and demonstrates that methods of
isolating sperm DNA contaminated with vaginal epithelial cells and vaginal
epithelial cells by using a protease and a detergent were known in the prior
art. Id. However, the Examiner acknowledges, Gill neither teaches nor
suggests the use of a nuclease to remove contaminating epithelial cell DNA
without centrifugation or filtration. Id. at 9.
The Examiner finds that Greenspoon teaches the use of the DNA IQ
system (Promega Corp.) for isolation of DNA for analysis of forensic
samples including sexual assault samples. Non-Final Act. 9. The Examiner
finds that Greenspoon teaches that an advantage of this system is that it does
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not use centrifugation or filtration, allowing for hands-off automation. Id.
( citing Greenspoon 1 ).
The Examiner finds that Eshleman teaches the use of DNAse I to
eliminate contaminating DNA. Non-Final Act. 9 (citing Eshleman 4316).
The Examiner finds that Winkler teaches the use of DNase I to
degrade contaminating DNA in samples prior to PCR analysis. Non-Final
Act. 9 ( citing Winkler 221 ).
The Examiner finds that Bianchi teaches that mature sperm cells are
resistant to DNase 1. Non-Final Act. 9 (citing Bianchi 1087).
The Examiner finds that Atkinson teaches a study in which
extracellular DNA is degraded from sperm samples of Bos taurus, Lucilia
cuprina and Apis melifera, but chromosomal DNA was left intact. Non-
Final Act. 9 ( citing Atkinson 4).
The Examiner finds that Nakanishi teaches that: "some of the DNA
associated with the sperm was DNase I resistant, suggesting inten1alization
of exogenous DNA." Non-Final Act. 9 ( citing Nakanishi 259).
The Examiner therefore concludes that it would have been prima facie
obvious to one of ordinary skill in the art to improve the method of Gill to
include the use of DNase I. Non-Final Act. 9. The Examiner reasons that a
skilled artisan would have been motivated to degrade contaminating DNA
and protein are degraded such that they do not interfere with the assay of
DNA from sperm. Id. at 9-10. The Examiner further reasons that a skilled
artisan would have been motivated to exclude centrifugation and exclude
filtration from the DNAse I addition step, because it would have allowed for
hands-free automation. Id. at 10.
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The Examiner finds that Gill, Eshleman, Bianchi, Atkinson,
Nakanishi, and Greenspoon do not teach or suggest the use ofDNase I in a
buffer that has not been changed. Non-Final Act. 10. The Examiner finds
that Kwon teaches a method of genotyping animals via lysing samples with
proteinase Kin a solution comprising a buffer agent, triton X-100, and other
salts. Id. ( citing Kwon ,i 106).
The Examiner finds that Latham teaches DNase I digestion of DNA
using DNase I with triton-X-100 and a salt solution with an ionic strength of
greater than 25 mM. Non-Final Act. 10 ( citing Latham ,i 21 ). The
Examiner finds that Latham teaches triton X-100 enhances DNase I activity,
and that that EDTA quenches DNAse I activity. Id. (citing Latham Exs. 19,
14, iJ 116).
The Examiner finds that Van Santen teaches that "[t]o inactivate
DNase and liberate viral DNA, sodium dodecyl sulfate (SDS) was added."
Non-Final Act. 11. The Examiner therefore finds that the prior art teaches
that the presence of SDS inhibits DNAse I. Id.
Finally, the Examiner finds that Sanyal teaches that:
We have found that heating alone [ ( at 65°C)] is not enough to
inactivate DNase I. Inclusion of ethylenediamine tetraacetic acid
(EDTA) before heat inactivation of the enzyme is virtually
obligatory to completely destroy the DNase I. If DNase I is not
completely inactivated, then the cDNA will not be stable and will
be refractory to PCR. Here we present a method using DNase I
for the preparation of cDNA devoid of contaminating genomic
DNA.
Non-Final Act. 12 (quoting Sanyal 135). The Examiner finds that Sanyal
teaches inactivation of DNAse I using 25 mM EDT A for 10 minutes. Id.
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The Examiner therefore concludes that it would have been prima facie
obvious to one of ordinary skill in the art to exclude the use of SDS from the
protease digestion and that DNase I can be used with triton-XI 00. Non-
Final Act. 11. The Examiner reasons that a skilled artisan would have been
motivated to eliminate the need to change buffers to minimize SDS and
inactivation of DNAse I. Id.
Appellant argues that the cited references neither teach nor suggest all
of the limitations of the claims on appeal. App. Br. 18. Appellant also
disputes the Examiner's citation to eleven separate references which,
Appellant alleges, have only been put together using Appellant's
Specification as a blueprint. Id. at 16-17. Appellant points to, inter alia, the
Board's prior decision in Ex parte Haymond, 41 USPQ2d 1217 (B.P.A.I.
1996), which stated that "we note that it is impermissible to use the claimed
invention as an instruction manual or 'template' to piece together isolated
disclosures and teachings of the prior art so that the claimed invention may
be rendered obvious." Id. at 17 (quoting Haymond, 41 USPQ2d at 1220).
Appellant argues all of the prior art methods use a buffer change,
filtration, or centrifugation, and the present invention does not. App. Br. 18.
Appellant contends that a desire to eliminate the "time and handling required
for centrifugation or filtering," as cited by the Examiner is irrelevant and
inoperative if the prior art method requires a buff er change, centrifugation,
or filtration. Id. According to Appellant, the concept of adding a nuclease
to the same extraction buffer in which the non-sperm cells were digested
comes from the disclosures of Appellant's Specification, and not from the
prior art. Id. Similarly, Appellant argues, the concept of adding a nuclease
to the same extraction buffer in which the non-sperm cells were digested,
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without a centrifugation or filtration step, with respect to the addition of the
nuclease also comes from the disclosures of the Specification, and not from
the prior art. Id. at 18-19.
With respect to the Gill reference, Appellant argues that Gill teaches
that, when subjected to treatment with a mixture of SDS and Proteinase K,
"female cells [i.e., non-sperm cells] were preferentially lysed by preliminary
incubation in an SDS/proteinase K mixture." App. Br. 19 (quoting Gill
578). Appellant contends that Gill teaches that "Sperm nuclei are
impervious to this treatment because they are ramified with cross-linked
thiol-rich proteins and can therefore be separated from the female
component by centrifugation. Sperm nuclei were subsequently lysed by
treatment with an SDS/proteinase K/DTT mixture." Id. at 20. However,
argues Appellant, Gill teaches lysing the non-sperm cells with a mixture of
SDS and proteinase K, whereas Appellant's claimed method does not use
SDS.
Appellant further asserts that Gill also teaches using SDS in the
mixture that lyses the sperm nuclei after the sperm nuclei have been
separated by centrifugation. App. Br. 20. Appellant notes that, whereas Gill
teaches the required use of centrifugation to separate the sperm nuclei from
"the female component," Appellant's claimed method does not separate the
sperm pellet from the buffer in which the non-sperm cells are digested with
the protease. Id.
Turning to the Greenspoon reference, Appellant contends that
Greenspoon teaches a robotic system (the DNA IQ™ System) that is used to
automate the extraction of evidentiary DNA from forensic casework
samples. App. Br. 21. According to Appellant, the Greenspoon system
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"employs a silica coated paramagnetic resin that binds DNA with high
affinity in the presence of chaotropic agents such as guanidinium. Because
no centrifugation or filtration steps are needed with this system, it readily
lends itself to the application of 'hands off automated extraction." Id.
( quoting Greenspoon 1 ). Appellant also notes that Greenspoon teaches that
"Moreover, the DNA remains tightly coupled to the silica coated
paramagnetic resin for the entire process until the elution step." Id. ( quoting
Greenspoon, Abstr.).
Appellant asserts that Greenspoon' s system operates on a principle
that is totally different when compared to the principle of operation of
Appellant's claimed invention. App. Br. 22. Appellant contends that
Greenspoon requires, inter alia, the use of a paramagnetic resin and a
magnet, and further teaches that: "The most notable features added by the
Promega scientists are a magnetic plate on the deck (MagnaBot), a shaking
platform attached as a right side module (DPC, Los Angeles, CA) and a
thermal exchange unit which sits atop the shaking platform, attached to a
water bath by tubing." Id. ( quoting Greenspoon 1 ).
Appellant asserts that Greenspoon's teaching that "no centrifugation
or filtration steps are needed with this system" applies only to that portion of
the Greenspoon system during which the DNA remains tightly coupled to
the silica coated paramagnetic resin." App. Br. 22. Specifically, Appellant
argues that the differential extraction procedure of Greenspoon "relies on
previously published techniques (10), until the point at which a sperm pellet
was generated and washed three times." App. Br. 23 ( quoting Greenspoon
3). Appellant points out that footnote (10) of Greenspoon, referred to in the
quoted passage, refers to the Gill reference, and that Greenspoon thus
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teaches the use of the centrifugation technique of Gill to generate a sperm
pellet. Id.
Appellant also argues that Greenspoon teaches that: "Initial
experience with mixed stains, consisting of sperm and non-sperm cells,
demonstrated that the BioMek® 2000/DNA IQ™ System could complete
the DNA extraction once the sperm cells were separated from the non-sperm
cells (data not shown)." App. Br. 24. Appellant therefore argues that
Greenspoon teaches that an intact sperm pellet must be separated from the
non-sperm cells before the robot extraction can complete the DNA
extraction using the Greenspoon system. Id.
Appellant argues that, even if it were, arguendo, proper to combine
the teachings of Greenspoon with the teachings of Gill and with the
teachings of the other cited references, the combined Greenspoon-Gill
method would still require ( 1) the use of SDS and (2) the use of
centrifugation for separating the sperm nuclei. App. Br. 27. Appellant
argues that the Examiner's proposed combination of Greenspoon with
Gill, Eshleman, Winkler, Bianchi, Atkinson, Nakanishi, Kwon, Latham, van
Santen, and Sanyal would still not disclose or suggest the method of the
present invention. Id.
Specifically, Appellant contends that Eshleman teaches the use of
DNAse to eliminate contaminating DNA in tubes and reaction mixes that are
used in the Eshleman process before introducing the DNA sample to be
analyzed. App. Br. 27. Appellant argues that Eshleman teaches that: "The
addition of a DNAse to tubes and reaction mixes prior to the introduction of
the ancient DNA template can eliminate contaminant DNA produce unless
the template itself is contaminated." Id. ( quoting Eshleman 4316).
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Appellant asserts that the process taught by Eshleman is not able to
eliminate contaminating DNA when the template itself contains the
contaminating DNA. Id.
Appellant argues that Winkler teaches the use of DNAse to degrade
contaminating DNA in a sample of RNA before a PCR process, in the
absence ofRNase. App. Br. 30 (citing Winkler 221). Appellant contends
that Winkler neither teaches nor suggests combining the use of a DNAse
with a protease. Id.
Appellant next disputes the Examiner's conclusion that, although
Bianchi, Atkinson and Nakanishi teach that DNA of intact sperm is not
sensitive to DNAse, that it would have been obvious for a person who is
skilled in the art "to improve the method of Gill to include the use of DN ase
I." App. Br. 31 (quoting Non-Final Act. 9). Appellant contends that the
motivation reasoned by the Examiner for combining the references with the
Gill method (minimizing contamination by non-sperm DNA) does not exist
because the Gill method requires the use of centrifugation to separate the
sperm nuclei, prior to lysis of the sperm cells. Id. Appellant argues that the
motivation proposed by the Examiner for combining the references is legally
insufficient because there would have been no need to add DNAse to the
Gill method, which has separated the sperm cells by centrifugation. Id.
Appellant also disputes the Examiner's finding that the combination
of Kwon and Latham and van San ten teach or suggest the limitation of claim
40 requiring the use ofDNase I in a buffer that has not been changed. App.
Br. 34. Appellant disputes the Examiner's finding that Kwon teaches lysis
of samples by proteinase K and that Latham teaches DNAse I digestion of
DNA. Id. at 35 (citing Non-Final Act. 10). According to Appellant, the
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Examiner's conclusion that motivation would have existed for a person of
ordinary skill in the art to combine the references with Gill is deficient
because there is no need to add DNAse to the Gill method, which separates
the sperm cells by centrifugation. Id. Furthermore, Appellant argues, the
Gill method still requires (1) the use of SDS and (2) the use of centrifugation
for separating the sperm nuclei, both of which are excluded by the claimed
method, and which the combination of Gill with Eshleman, Winkler,
Bianchi, Atkinson, Greenspoon, Nakanishi, Kwon and Latham neither
teaches nor suggests. Id. at 36.
Appellant argues further that van Santen teaches that, to isolate viral
DNA from host DNA one must add DN ase I to destroy the host DNA. App.
Br. 38 (citing van Santen 5212). Appellant contends that the van Santen
method employs multiple centrifugations and multiple buffers, requiring a
first centrifugation (low speed) to remove cell debris and a second
centrifugation (25,000 rpm) to pellet the virions. Id. Moreover, argues
Appellant, van Santen also teaches the use of 2% SDS to deactivate DNAse,
which is not present in the claims. Id. at 39.
Finally, Appellant argues that Sanyal teaches removing genomic DNA
from an RNA sample. App. Br. 40. Appellant asserts that Sanyal is silent
concerning the selective removal of a first type DNA from a DNA sample
that contains two types of DNA. Id. Appellant also points out that Sanyal
teaches a two-step method requiring: (1) adding the EDTA to the RNA
sample at room temperature (approximately 22°C); and then (2) applying a
heat inactivation process at 65°C for ten minutes. Id. Appellant argues that,
in contrast, Appellant's claimed method uses: (1) both EDTA and DTT for
inactivating the DNAse I; and (2) performs the inactivation step at a
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temperature of 56°C ( equal to 133°F) for at least five minutes. Id.
Appellant argues that the claimed method requires only one temperature, and
does not require an additional heating step at an increased temperature level.
Id.
We are not persuaded that the Examiner has established motivation to
combine the references sufficient to support a prima facie conclusion of
obviousness. As an initial matter, we do not find persuasive many of
Appellant's arguments with respect to why the references could not have
been combined. We remind Appellant that:
The test for obviousness is not whether the features of a
secondary reference may be bodily incorporated into the
structure of the primary reference; nor is it that the claimed
invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the
art.
In re Keller, 642 F.2d 413,425 (C.C.P.A. 1981). Furthermore, all elements
of each prior art reference need not read on the claimed invention, rather, the
proper test for obviousness is what the combined teachings would have
suggested to a person of ordinary skill in the art. In re Kotzab, 217 F.3d
1365, 1370 (Fed. Cir. 2000). Appellant's arguments that, e.g., many of the
cited references could not be used to modify Gill, because Gill requires
certain other steps, is not persuasive when those steps could be obviated by
the substitution of steps taught in the other references. Rather, the essence
of obviousness is what the combined teachings of the references would have
suggested to a person of ordinary skill in the art. Keller, 642 F.2d at 425.
Nevertheless, a prim a facie conclusion of obviousness requires "a
reason that would have prompted a person of ordinary skill in the relevant
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field to combine the elements in the way the claimed new invention does."
KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007). In the appeal
before us, the references, from significantly disparate fields of endeavor,
cited against the relatively simple, independent claim on appeal militates
against a prim a facie conclusion of obviousness, and strongly suggests, as
Appellant argues, the employment of hindsight analysis.
In analyzing whether hindsight was employed in assembling the
rejection, the proper analysis in this context is whether "an artisan of
ordinary skill in the art at the time of the invention, confronted by the same
problems as the inventor and with no knowledge of the claimed invention,
... [ would] have selected the various elements from the prior art and
combined them in the manner claimed." Princeton Biochemicals, Inc. v.
Beckman Coulter, Inc., 411 F.3d 1332, 1337 (Fed. Cir. 2005).
In the Examiner's rejection, the author cites references directed to,
inter alia: (1) the use of a silica coated paramagnetic resin to bind sample
DNA in an automated system (Greenspoon); (2) use of DNase to eliminate
contamination in ancient DNA analysis (Eshleman); (3) investigating the
activity and gene expression of neutral endopeptidase and angiotensin
converting enzyme in different brain regions of alcohol-preferring and
alcohol-avoiding lines of rats via HPLC analysis (Winkler); (4) examining
the efficacy of gene transfer by sperm-mediated methods (Nakanishi,
Atkinson); (5) maturation of human and murine spermatozoa (Bianchi);
compositions and methods for making and using a synthetic bovine DNase I
(Latham); ( 6) characterizing the bovine herpesvirus 4 major
immediate-early transcript (van Santen); (7) genotyping by in situ PCR
amplification of a polynucleotide in a tissue biopsy; and (8) a method for
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removing contaminating genomic DNA from an RNA sample to be used for
PCR (Sanyal). The Examiner's findings and conclusions provide no clues as
to why a person of ordinary skill in this particular art would have had reason
to combine these references differing in subject matter, and which are
largely irrelevant to the claimed subject matter.
Furthermore, the Examiner's reasoning that it would have been
obvious to combine the references to arrive at the claims, because the
references teach various steps recited in the claims, borders dangerously on
the tautological. The Examiner concludes that a skilled artisan would have
looked to the cited references as teaching the various steps recited in the
claims, because the references teach elements of the individual limitations,
without explaining why a person of ordinary skill would have looked to
combine those particular references.
In our review of this appeal, the initial burden falls upon the Examiner
to establish a prima facie case of obviousness. Because we conclude that the
Examiner has failed to "articulate[] reasoning with some rational
underpinning to support the legal conclusion of obviousness" and,
specifically, "a reason that would have prompted a person of ordinary skill
in the relevant field to combine the elements in the way the claimed new
invention does," we reverse the Examiner's rejection of claims 40 and 45
upon this ground. See KSR, 550 U.S. at 418.
CONCLUSION
The Examiner's rejection of claims 40 and 45 under 35 U.S.C.
§ 112, first paragraph, is reversed.
The Examiner's rejection of claims 40 and 45 under 35 U.S.C.
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§ 103(a) is reversed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv).
1111ms.J
•••••11•··•11111•••••• 40,45
40,45
Overall
Outcome
112, first
para raph
103(a)
REVERSED
Lack of written
descriptive support
Gill, Greenspoon,
Eshleman, Winkler,
Bianchi, Atkinson,
Nakanishi, Kwon,
Latham, van Santen,
San al
22
40,45
40,45
40,45