Ex Parte Handyside

Patent Trial and Appeal Board

Dec 7, 2018

12093912 (P.T.A.B. Dec. 7, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/093,912 08/25/2008
143934 7590 12/11/2018
MRG/Illumina
c/o Mueting, Raasch & Gebhardt, P.A.
P.O. Box 581336
Minneapolis, MN 55458-1336
FIRST NAMED INVENTOR
Alan Handyside
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.
531.06550101 6863
EXAMINER
SISSON, BRADLEY L
ART UNIT PAPER NUMBER
1634
NOTIFICATION DATE DELIVERY MODE
12/11/2018 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):
ptodocketing@mrgs.com
illuminadocket@illumina.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ALAN HANDYSIDE
Appeal 2018-008186 1
Application 12/093,912
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to methods that
analyze the genomic DNA of pre-implantation human embryos produced by
in vitro fertilization. The Examiner rejected the claims for indefiniteness
and obviousness.
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse the Examiner's indefiniteness rejections, but affirm the
obviousness rejection.
1 Appellant states that the real party in interest "the assignee, BlueGnome
Limited, a wholly owned subsidiary of Illumina, Inc." Appeal Br. 3.
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Application 12/093,912
STATEMENT OF THE CASE
The following rejections are before us for review:
(1) Claims 20, 63, 67-72, 75, 76, and 79-83, rejected under 35 U.S.C.
§ 112, second paragraph, as being indefinite (Ans. 3-5); and
(2) Claims 20, 63, 67-72, 75, 76, and 79-83, rejected under 35 U.S.C.
§ 103 (a) as being unpatentable over Handyside, 2 Lareu, 3 admitted prior art,
Makarov, 4 Dhallan I, 5 and Dhallan II6 (Ans. 5-14).
Claims 63 and 79 are the independent claims on appeal, and read as
follows:
63. A method comprising:
(a) removing one to five cells from a pre-
implantation human embryo resulted from in vitro fertilization
(IVF);
(b) isolating genomic DNA from at least one
human target cell, wherein the at least one human target cell
consists of the one to five cells removed from the pre-
implantation human embryo resulted from IVF;
( c) detecting by oligonucleotide chip or
oligonucleotide microarray the genotype of at least 2,500
biallelic single nucleotide polymorphisms (SNPs) in the
genomic DNA isolated from the at least one human target cell,
wherein detecting by oligonucleotide chip or
2 A. H. Handyside et al., Pregnancies from biopsied human preimplantation
embryos sexed by Y-specific DNA amplification, 344 NATURE 768-70 (1990)
("Handyside").
3 M. Lareu et al., Typing Y-chromosome single nucleotide polymorphisms
with DNA microarray technology, 1239 lNT'L CONG. SERIES 21-25 (2003)
("Lareu").
4 US 2004/0197791 Al (published Oct. 7, 2004).
5 US 2006/0121452 Al (published June 8, 2006).
6 US 2004/0137470 Al (published July 15, 2004).
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oligonucleotide microarray the genotype of said at least 2,500
SNPs in the genomic DNA isolated from the at least one human
target cell is preceded by whole genome amplification;
( d) isolating maternal genomic DNA, wherein the
maternal genomic DNA is from the mother of the pre-
implantation human embryo resulted from IVF;
( e) detecting by oligonucleotide chip or
oligonucleotide microarray the genotype of said at least 2,500
biallelic SNPs in the maternal genomic DNA;
(f) isolating paternal genomic DNA, wherein the
paternal genomic DNA is from the father of the pre-
implantation human embryo resulted from IVF; and
(g) detecting by oligonucleotide chip or
oligonucleotide microarray the genotype of said at least 2,500
biallelic SNPs in the paternal genomic DNA;
wherein the said at least 2,500 biallelic SNPs are
distributed on at least 10 human chromosomes.
79. A method comprising:
(a) removing one to five cells from a pre-
implantation human embryo resulted from in vitro fertilization
(IVF);
(b) isolating genomic DNA from at least one
human target cell, wherein the at least one human target cell
consists of the one to five cells removed from the pre-
implantation human embryo resulted from IVF;
( c) detecting by oligonucleotide chip or
oligonucleotide microarray the genotype of at least 2,500
biallelic single nucleotide polymorphisms (SNPs) in the
genomic DNA isolated from the at least one human target cell,
each biallelic SNP having allele A or allele B,
wherein detecting by oligonucleotide chip or
oligonucleotide microarray the genotype of said at least 2,500
SNPs in the genomic DNA isolated from the at least one human
target cell is preceded by whole genome amplification;
( d) detecting whether the genotype is AA, AB, BB,
or absent for each of said at least 2,500 biallelic SNPs in the
genomic DNA isolated from the at least one human target cell;
( e) isolating maternal genomic DNA, wherein the
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Application 12/093,912
maternal genomic DNA is from the mother of the pre-
implantation human embryo resulted from IVF;
(f) detecting by oligonucleotide chip or
oligonucleotide microarray the genotype of said at least 2,500
biallelic SNPs in the maternal genomic DNA;
(g) detecting whether the genotype is AA, AB, or
BB for each of said at least 2,500 biallelic SNPs in the genomic
maternal DNA;
(h) isolating paternal genomic DNA, wherein the
paternal genomic DNA is from the father of the pre-
implantation human embryo resulted from IVF; and
(i) detecting by oligonucleotide chip or
oligonucleotide microarray the genotype of said at least 2,500
biallelic SNPs in the paternal genomic DNA;
(j) detecting whether the genotype is AA, AB, or
BB for each of said at least 2,500 biallelic SNPs in the paternal
genomic DNA;
wherein said at least 2,500 biallelic SNPs are
distributed on at least 10 human chromosomes.
Appeal Br., Claims App'x, 1--4.
INDEFINITENESS
The Examiner's Prima Facie Case
The Examiner concluded that independent claims 63 and 79 "are
indefinite with respect to what steps are encompassed by 'detecting by
oligonucleotide chip or oligonucleotide microarray the genotype' as a chip
and a microarray are not processes, but are seemingly are to be used in an
otherwise undefined method." Ans. 3.
The Examiner concluded that independent claims 63 and 79 are also
indefinite because the term "oligonucleotide" could be construed to have
multiple meanings, when consulting the Specification and the prior art. Id.
at 4--5.
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Analysis
As stated inJn re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he examiner bears the initial burden ... of presenting a
prima facie case of unpatentability ....
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.
Appellant persuades us that the preponderance of the evidence does
not support the Examiner's prima facie case of indefiniteness. Both claims
63 and 79 recite the step of "detecting by oligonucleotide chip or
oligonucleotide microarray the genotype of at least 2,500 biallelic single
nucleotide polymorphisms (SNPs) in the genomic DNA isolated from the at
least one human target cell." Appeal Br., Claims App'x 1 (claim 63); id. at 3
( claim 79).
As Appellant points out, and the Examiner does not dispute,
Appellant's Specification discloses a number of methods by which an
oligonucleotide chip or oligonucleotide array may be used to detect the
genotype of at least 2,500 biallelic single nucleotide polymorphisms (SNPs)
in the genomic DNA isolated from the at least one human target cell. See,
e.g., Spec. 13-14. Indeed, as discussed below, the Examiner relies on these
disclosures in asserting the obviousness of the processes recited in claims 63
and 79.
As we understand it, the Examiner's rejection is based on the fact that
the language "detecting by oligonucleotide chip or oligonucleotide
microarray" in claims 63 and 79 encompasses many different methods by
which an oligonucleotide chip or microarray may be used to detect the
claim-recited genotype. See Ans. 16-17 (arguing that it is unclear which
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species of process encompassed by the language at issue are encompassed
by claims 63 and 79). We are not persuaded.
A claim does not comply with 35 U.S.C. § 112, second paragraph,
"when it contains words or phrases whose meaning is unclear." In re
Packard, 751 F.3d at 1310, 1314 (Fed. Cir. 2014) (approving, for pre-
issuance claims, the standard from MPEP § 2173.05(e)); see also Ex parte
McAward, Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25,
2017) (precedential) (adopting the approach for assessing indefiniteness
approved by the Federal Circuit in Packard).
That is, "claims are required to be cast in clear-as opposed to
ambiguous, vague, indefinite-terms." Packard, 751 F.3d at 1313
It is well settled, however, that that "breadth is not to be equated with
indefiniteness." In re Miller, 441 F.2d 689, 693 (CCPA 1971). In the
present case, claims 63 and 79 encompass any process that uses an
oligonucleotide chip or oligonucleotide microarray to detect the genotype of
at least 2,500 biallelic single nucleotide polymorphisms (SNPs) in the
genomic DNA isolated from at least one human target cell.
Thus, although the language at issue might be broad, we are not
persuaded that the scope of the language at issue is unclear or ambiguous.
We, therefore, reverse the Examiner's rejection of claims 63 and 79, and
their dependent claims as being indefinite based on the language "detecting
by oligonucleotide chip or oligonucleotide microarray the genotype of at
least 2,500 biallelic single nucleotide polymorphisms (SNPs) in the genomic
DNA isolated from the at least one human target cell."
As noted above, the Examiner also concluded that independent claims
63 and 79 are indefinite because the term "oligonucleotide" can be construed
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to have multiple meanings, when consulting the Specification and the prior
art. Ans. 4--5. Again, we are not persuaded.
Both claims 63 and 79 recite using an "oligonucleotide chip or
oligonucleotide microarray" to detect the genotype of at least 2,500 biallelic
SNPs. Appeal Br., Claims App'x 1 (claim 63); id. at 3 (claim 79).
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).
Thus, although it might be true, as the Examiner contends, that the
prior art includes definitions of "oligonucleotide" that vary in breadth, the
proper legal scope of the term is the broadest reasonable interpretation
consistent with the Specification. Again, the fact that the claim language
might be broad does not persuade us that it is indefinite. See Miller, 441
F.2d at 693.
As noted above, moreover, Appellant's Specification provides a
number of examples of oligonucleotide chips and microarrays that may be
used in the claimed invention. See Spec. 14. In light of the multiple
examples in the prior art of products encompassed by the language at issue,
the Examiner does not persuade us that a skilled artisan would fail to
understand the scope of the terms "oligonucleotide chip" or "oligonucleotide
microarray." We, therefore, reverse the Examiner's rejection of the term
"oligonucleotide" as indefinite.
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OBVIOUSNESS
The Examiner's Prima Facie Case
In rejecting claims 20, 63, 67-72, 75, 76, and 79-83 for obviousness,
the Examiner cited Handyside as disclosing the claimed steps of removing
one to five cells from a pre-implantation !VF-produced embryo, isolating
genomic DNA from those cells, and subsequently amplifying and analyzing
the genomic DNA. See Ans. 8-9.
The Examiner conceded that Handyside' s process differed from the
claimed process in that Handyside did not describe screening thousands of
SNPs, nor did Handyside describe collecting or analyzing a DNA sample
from the father. Id. at 9. The Examiner cited Lareu as evidence that it was
known in the art to use microarray analysis to evaluate paternal genomic
DNA, for example in paternity testing. Id.
As evidence that an ordinary artisan would have been prompted to
screen for at least 2,500 SNPs when analyzing the genome of a pre-
implantation !VF-produced embryo, the Examiner cited Makarov as
disclosing that it was known in the art to detect thousands or even millions
of SNPs when analyzing a tissue sample. Id. at 11. The Examiner cited
admitted prior art disclosed in Appellant's Specification as evidence that
methods of analyzing genomic DNA for over 2,500 SNPs were conventional
in the art. Id. at 9-11.
The Examiner cited Dhallan I as evidence that, when using SNP
microarrays to detect fetal chromosomal abnormalities, it was desirable to
isolate maternal DNA, as recited in Appellant's claims, and also desirable to
examine all chromosomes when performing the microarray SNP analysis.
Id. at 11-12.
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The Examiner cited Dhallan II as evidence that, when using SNP
microarrays to detect fetal chromosomal abnormalities, it was desirable to
isolate both maternal DNA and paternal DNA, as recited in Appellant's
claims, when performing the microarray SNP analysis. Id.
Based on the references' combined teachings, the Examiner
concluded:
In view of the well-developed state of the art at the time
of filing and the commercial availability for not only kits to
isolate DNA from cells, but also the commercial availability of
microarrays and oligonucleotide chips, and the commercial
availability of software that would enable the assigning of
notional SNP haplotypes to an individual, it would have been
obvious to one of ordinary skill in the art at the time of filing to
have modified the method of Handyside et al., such that it was
expanded to test not only sex chromosomes, but to test up to all
human chromosomes for SNP in cells derived from the
maternal, paternal, and embryonic sources, and to detect any
desired number of SNPs, be it in the thousands or tens of
thousands, and wherein the SNPS occur in less than 500 bp
from one another, and as a result of having identified the
presence of SNPs, to then assign a notional SNP haplotype
based on the detected and inherited SNPs present.
Id. at 13-14.
The Examiner reasoned:
In view of the intense interest in early identification of
embryos that may be at risk of developing diseases and/or
syndromes, e.g., trisomy, said ordinary artisan would have been
amply motivated. And given the well-developed state of the art
and commercial availability of requisite reagents, said ordinary
artisan would have had a most reasonable expectation of
success.
Id. at 14.
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Analysis
Having carefully considered all of the evidence and arguments
presented by Appellant and the Examiner, Appellant does not persuade us
that the preponderance of the evidence fails to support the Examiner's
conclusion of obviousness.
Appellant contends that the Examiner did not "clearly articulate any
reason for a person having ordinary skill in the art to detect the genotype of
at least 2,500 biallelic SNPs on at least 10 chromosomes. (See, e.g.,
independent claims 63 and 79. )" Appeal Br. 18.
Appellant contends that the Examiner also did not "clearly articulate
any reason to detect 'by oligonucleotide chip or oligonucleotide microarray
the genotype' of the same 'at least 2,500 biallelic SNPs' in genomic DNA
isolated from a cell of a pre-implantation human embryo resulting from IVF,
maternal genomic DNA, and paternal genomic DNA." Id.; see also id. at
19--20 (reiterating same arguments).
The Examiner responds by reiterating that, given the interest in
analyzing the genetic material of a pre-implantation !VF-produced embryo
as taught in Handyside, an ordinary artisan would have been "motivated to
have used commercially-available means that would enable the detection of
10,000 SNPs on an oligonucleotide array, [and] SNPs that span some 22
chromosomes ... as such would require no further research and
development." Ans. 22; see also id. at 29 ("Given the intense interest in
detecting SNPs and well-developed state of the art, one of ordinary skill in
the art would be highly motivated to determine the genotype of an individual
via detection of thousands of SNPs across the genome of an individual.").
Appellant replies:
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[ A ]n articulation of a teaching or motivation to perform parts of
the claimed methods falls short of identifying any teaching or
motivation to detect at least 2,500 SNPs in genomic DNA
isolated from a cell of a pre-implantation human embryo
resulting from IVF, the same at least 2,500 SNPs in maternal
genomic DNA, and the same at least 2,500 SNPs in paternal
genomic DNA.
Reply Br. 4.
We find that the preponderance of the evidence supports the
Examiner's conclusion of obviousness. As the Supreme Court has
explained, in determining whether the prior art supplies a reason for
practicing the claimed subject matter, the 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." KSR Int 'l Co. v. Teleflex Inc., 550
U.S. 398,418 (2007); see also id. at 421 ("A person of ordinary skill is ... a
person of ordinary creativity, not an automaton.").
In the present case, as the Examiner found, and as required by
Appellant's claim 63, Handyside discloses a process in which a cell is
removed from a pre-implantation !VF-produced embryo, genomic DNA is
isolated therefrom, the genomic DNA is amplified, and the amplified DNA
is analyzed. Handyside 7 68 ("Two female embryos were transferred after in
vitro fertilization (IVF), biopsy of a single cell at the six- to eight-cell stage,
and sexing by DNA amplification of a Y chromosome-specific repeat
sequence. Both women are confirmed as carrying normal female twins.").
Handyside explains that the determination of the genomic sequences
of the embryo allows couples at risk of transmitting certain genetic diseases
to ensure that their !VF-produced offspring lack the genetic disorder:
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Id.
Diagnosis of genetic defects in preimplantation embryos would
allow those unaffected to be identified and transferred to the
uterus[]. ... Five couples at risk of transmitting recessive X-
linked diseases, including X-linked mental retardation,
adrenoieukodystrophy, Lesch-Nyhan syndrome and Duchenne
muscular dystrophy (DMD) were counselled about the
possibility of having preimplantation embryos sexed after IVF
and those identified as females replaced in the uterus.
Given Handyside' s disclosure of the desirability of determining the
presence of sequences of genomic DNA indicative of genetic disorders in
pre-implantation !VF-produced embryos, we agree with the Examiner that
Handyside suggests that it would have been desirable to ascertain the
presence of as many undesirable sequences as possible, when evaluating the
genomic DNA of pre-implantation !VF-produced embryos.
As the Examiner found, although Handyside does not disclose
performing microarray-based analysis of over 2,500 SNPs in at least 10
chromosomes as recited in Appellant's claim 63, Dhallan I discloses that,
when performing microarray-based SNP analysis of a fetal subject to
determine the presence of chromosomal abnormalities, it is useful to perform
an analysis of all of the subject's chromosomes, as well as maternal DNA.
See Dhallan I ,r 1244 ("Fetal chromosomal abnormalities are determined by
analyzing SNPs wherein the maternal template DNA is homozygous and the
template DNA obtained from the plasma is heterozygous. Plasma that is
isolated from blood of a pregnant female contains both maternal template
DNA and fetal template DNA."); id. ,r 1245 ("A DNA microarray can be
designed to contain SNPs located on the chromosome or chromosomes of
interest including but not limited to ... a DNA microarray containing SNPS
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located on each of the autosomal chromosomes and each of the sex
chromosomes .... ").
As the Examiner found, Makarov discloses that when performing a
microarray-based analysis of a subject's genomic DNA, it is useful to
evaluate multiple thousands of SNPs:
For purposes of detecting a large number of SNPs ( e.g.,
thousands, tens of thousands, hundreds of thousands, or
millions) from a single tissue sample, the original DNA sample
must be amplified many times to provide sufficient material for
analysis .... Locus-independent amplification of the entire
genomic library (amplification en masse) is an important step
in detection of genome polymorphisms, because it increases
the number of copies of the molecules which increases the
number of SNP assays that can be performed given a limited
amount of DNA collected from an individual human ....
Makarov ,r 391 (emphasis added).
Makarov explains:
Single nucleotide polymorphisms (SNPs) are important
markers for the identification of genomic regions associated
with complex diseases in humans. . . . There are likely over 10
million SNPs in the human genome, and analysis of even 1 % of
all human variations (100,000 SNPs) would result in a high-
resolution whole genome molecular fingerprint that can be used
to uniquely identify an individual.
Id. ,I 72.
As the Examiner found, moreover, Dhallan II discloses that when
using microarray-based techniques to determine the presence of genetic
disorders or chromosomal abnormalities in a fetal subject based on SNP
analysis, it is useful to also determine the corresponding sequences in both
maternal and paternal DNA:
In some embodiments, prior to determining the sequence of the
locus of interest on fetal DNA, the sequence of the locus of
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interest on maternal template DNA was determined. In some
embodiments, prior to determining the sequence of the locus of
interest on fetal DNA, the sequence of the locus of interest on
paternal template DNA was determined. In some
embodiments, the locus of interest is a single nucleotide
po 1 ymorp hism.
Dhallan II ,r 58.
Given that many thousands of SNPs associated with genetic disorders
and/or chromosomal abnormalities were known in the art (Dhallan I,
Makarov), and given that it was known to be useful to ascertain the maternal
and paternal genotypes when determining the presence of a genetic disorder
and/or chromosomal abnormality in a fetus (Dhallan II), we agree with the
Examiner that an ordinary artisan evaluating the genotype of a pre-
implantation !VF-produced embryo as taught in Handyside, being a person
of ordinary creativity, had a good reason for, and a reasonable expectation of
success in, evaluating as many SNPs as possible, including over 2,500, in
both the embryo and the parents, to ensure the absence of genetic disorders
and/or chromosomal abnormalities in the embryo, before implantation in the
uterus.
Given these teachings in the art identified by the Examiner, Appellant
does not persuade us that the Examiner failed to articulate a sufficient prior
art-based basis for performing a process having all of the steps and features
recited in Appellant's claim 63. Moreover, because the Examiner's prima
facie case relies on identified teachings in the prior art, Appellant does not
persuade us (see Appeal Br. 21-22; Reply 4--5) that the Examiner's prima
facie case of obviousness relies on improper hindsight gleaned from
Appellant's Specification.
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In sum, for the reasons discussed, Appellant does not persuade us that
the preponderance of the evidence fails to support the Examiner's prima
facie case of obviousness as to claim 63. We, therefore, affirm the
Examiner's obviousness rejection of claim 63, and its dependent claims,
which were not argued separately. See 37 C.F.R. § 4I.37(c)(l)(iv).
Appellant argues that the Examiner "provided no articulation why a
person having skill in the art at the time of the invention would have
detected whether the SNP genotype is AA, AB, or BB, or absent for each of
at least 2,500 biallelic SNPs." Appeal Br. 20-21. Accordingly, Appellant
contends, "[ fJor this additional reason, Appellant submits that the Examiner
failed to clearly articulate why each element of the method of claim 79 was
taught or was obvious in light of the cited prior art .... " Id. at 21.
The Examiner responds that, as evidenced by the cited prior art, "the
aspect of isolating genomic DNA, be it from the 'human target cell', the
mother, or the father was all well known in the art." Ans. 25. Additionally,
the Examiner contends, "the aspect of detecting SNPs in the genomic DNA,
as well as determining fetal chromosomal abnormalities was known in the
art. Such teachings speak directly to detecting/determining if the genotype
is AA, AB, BB, or absent (limitation of claim 79)." Id.
We find that a preponderance of the evidence supports the Examiner's
position. We first note that, under our rules, to present separate argument
regarding claims, "[ 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. § 4I.37(c)(l)(iv) (emphasis added). Appellant has not
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provided separate a subheading as required by rule and, therefore, has not
properly presented a separate argument as to claim 79.
In any event, as noted above, Dhallan II discloses that it was useful to
ascertain the maternal and paternal genotypes when determining the
presence of a genetic disorder and/or chromosomal abnormality in a fetus.
See Dhallan II ,r 58. Handyside, moreover, discloses the desirability of
knowing the genomic makeup of parents of a pre-implantation IVF-
produced embryo that is, knowing whether the parents are potential carriers
of a genetic disorder. See Handyside 7 68 ( describing counselling "[ f]ive
couples at risk of transmitting recessive X-linked diseases").
Given the teachings cited above as to the desirability of ascertaining
the presence in pre-implantation !VF-produced embryos of SNPs indicative
of genetic disorders and chromosomal abnormalities, we discern no error in
the Examiner's finding that an ordinary artisan, being a person of ordinary
creativity, had a good reason for determining whether the subject was
homozygous or heterozygous for a particular allele, that is, whether the
subject was AA, AB, BB, or lacked a particular genotype associated with a
particular disorder or abnormality. Similarly, given the interest in knowing
the corresponding genotype in the parents, as suggested by both Dhallan II
and Handyside, we discern no error in the Examiner's finding that an
ordinary artisan had a good reason for determining whether the parents of an
!VF-produced embryo undergoing genetic analysis were homozygous or
heterozygous for a particular allele, that is, whether the parents were AA,
AB, BB, or lacked a particular genotype associated with a particular disorder
or abnormality.
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Because Appellant does not persuade us, therefore, that the
combination of references cited by the Examiner fails to suggest a process
having all of the steps and features recited in Appellant's claim 79, we
affirm the Examiner's obviousness rejection of claim 79. Because they were
not argued separately, those claims depending from claim 79 fall with claim
79.
DECISION
For the reasons discussed, we reverse the Examiner's indefiniteness
rejections.
For the reasons discussed, we affirm the Examiner's obviousness
rejection.
TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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