Ex Parte Kurzweil

Patent Trial and Appeal Board

Mar 12, 2019

11424022 (P.T.A.B. Mar. 12, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/424,022 06/14/2006
26161 7590 03/14/2019
FISH & RICHARDSON P.C. (BO)
P.O. BOX 1022
MINNEAPOLIS, MN 55440-1022
FIRST NAMED INVENTOR
Raymond C. Kurzweil
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.
14202-037001 6832
EXAMINER
SIMS, JASON M
ART UNIT PAPER NUMBER
1631
NOTIFICATION DATE DELIVERY MODE
03/14/2019 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):
P ATDOCTC@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAYMOND C. KURZWEIL
Appeal2017-005096 1
Application 11/424,022
Technology Center 1600
Before DONALD E. ADAMS, ERIC B. GRIMES, and RYAN H. FLAX,
Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellant identifies "Kurzweil Technologies, Inc." as the real party in
interest (App. Br. 1 ).
Appeal2017-005096
Application 11/424,022
This Appeal2 under 35 U.S.C. § 134(a) involves claims 1, 2, 4--11,
13-20, 23-30, 32--45, and 59-71 (Final Act. 3 2). Examiner entered
rejections under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C.
§ 6(b ).
We AFFIRM.
2 On January 19, 2017, "Application 11/424,022 was ... assigned[, a first
Appeal Number,] Appeal No: 2017-003342," and Administratively
Remanded to Examiner to address the status of an "amendment under 3 7
C.F.R. § 41.33 ... filed on November 13, 2015," because Examiner's
"Advisory Action mailed December 2, 2015 does not indicate [by checking
box 3 and/or 7 of the Advisory Action,] whether or not this amendment
[ was] ... entered or denied entry" (see January 19, 2017 Patent Trial and
Appeal Board Docketing Notice and January 19, 2017 Order Remanding
Appeal to Examiner ("Administrative Remand")). Examiner did not
respond to the January 19, 2017 Administrative Remand. Thus, the status of
Appeal 2017-003342 was unclear on the record. To clarify this record, we
note that although boxes 3 and/or 7 of Examiner's December 2, 2015
Advisory Action were not checked, Examiner explained that the amended
claims "were [previously] entered and the amendment was acknowledged in
the Final Office Action at the second full paragraph" (see Examiner's
December 2, 2015 Advisory Action 2). Thus, the sole issue set forth in the
Administrative Remand of Appeal 2017-003342 is moot. Therefore, Appeal
2017-003342 is hereby DISMISSED. On February 23, 2017, a second
Appeal Number, Appeal No. 2017-005096, was assigned to Application
11/424,022 (see February 23, 2017 Patent Trial and Appeal Board
Docketing Notice). We address the merits of Appeal No. 2017-005096,
herein.
3 Examiner's September 8, 2015 Final Office Action.
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Application 11/424,022
STATEMENT OF THE CASE
Appellant's disclosure "relates to systems and methods for
synthesizing biological material" (Spec. 1:9). Claims 1, 17, 35, 39, and 59
are representative and reproduced below:
1. A system comprising:
a computer accessible database storing information
regarding cell phenotype, types of biological material to
synthesize, monomeric components of biological material, and
instructions for assembly of biological material;
a computer system in communication with the database,
the computer system comprising one or more processors and
memory;
an assembly unit electrically connected to the computer
system, the assembly unit being configured by the computer
system executing the instructions for assembly;
with the computer system configured to:
retrieve from the database the instructions for
assembly; and
retrieve from the database the information
regarding cell phenotype, types of biological material to
synthesize, and information regarding monomeric
components of biological material according to the
retrieved instructions for assembly; and
execute instructions, which instructions include the
instructions for assembly, to:
control the assembly unit according to the
instructions for assembly to synthesize the
biological material for a mis-functioning or
nonfunctioning polypeptide, and
retrieve from a repository unit storing the
monomer components of biological material
monomer components according to the instructions
for assembly; and
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Application 11/424,022
with the assembly unit synthesizing multimeric
molecules of biological material from the monomer
components for proper expression of a polypeptide by
executing the instructions for assembly to apply monomer
components retrieved from the repository unit based on the
execution of the instructions for assembly.
(App. Br. 28-29.)
17. A system comprising:
a database storing information regarding cell phenotype,
types of biological material to synthesize, information
regarding monomeric components of biological material, and a
plurality of sets of instructions for assembly of corresponding
types of biological material;
a computer in communication with the database, the
computer comprising one or more processors and memory, the
computer configured to:
retrieve a particular one of the sets of instructions
for assembly of a particular type of biological material
and corresponding information stored in the database for
the type of biological material;
execute the particular one of the instructions for
assembly for synthesizing the biological material, the
instructions for assembly to control an assembly unit for:
synthesis of biological material for a mis-
functioning or nonfunctioning polypeptide to
express a properly functioning polypeptide; or
synthesis of biological material that inhibits
the synthesis of a particular essential polypeptide
to express a properly functioning polypeptide;
a central unit responsive to execution of the instructions
for assembly to control an assembly unit; and
an assembly unit electrically connected to the central
unit, the assembly unit being configured to synthesize the
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Application 11/424,022
biological material based on execution of the instructions for
assembly executed by the computer.
(Id. at 31-32.)
35. A method comprising:
synthesizing a biological material by:
retrieving information stored in a database, the
information regarding cell phenotype, types of biological
material to synthesize, monomeric components of biological
material, and instructions for assembly;
executing instructions for assembly by a computer, the
computer configured by the instructions for assembly and
retrieved information to control an assembly unit for synthesis
of biological material;
applying monomers retrieved by the assembly unit from
a repository to apply the monomers in a manner directed by the
instructions for assembly, to synthesis biological material for a
mis-functioning or nonfunctioning polypeptide:
applying monomers retrieved by the assembly unit from
a repository to apply the monomers in a manner directed by the
instructions for assembly to synthesis biological material other
than a particular essential polypeptide, to express a properly
functioning polypeptide; and
introducing the synthesized biological material into a
cell.
(Id. at 34--35.)
39. A method of synthesizing a biological material, the method
compnsmg:
executing in a computer system, instructions for
assembly for synthesizing the biological material;
retrieving by the computer system from a database that
stores the instructions for assembly, information regarding cell
phenotype, types of biological material to synthesize, and
monomeric components of biological material;
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Application 11/424,022
controlling by execution of the instructions for assembly,
an assembly unit to synthesize the biological material for a mis-
functioning or nonfunctioning polypeptide or programmed not
to synthesize a particular essential polypeptide to express a
properly functioning polypeptide;
applying by the assembly unit, monomers from a
repository to synthesize the biological material according to the
instructions for assembly; and
introducing the synthesized biological material into a
cell.
(Id. at 35-36.)
59. A method of treating a human cell comprising:
executing, by a computer, instructions for assembly, for
controlling operation of an assembly unit;
synthesizing by the assembly unit, the biological material
based on the executed instructions for assembly, with the
executed instructions for assembly to configure the assembly
unit to apply monomers from a repository to synthesize the
biological material according to the instructions for assembly,
by:
synthesizing the biological material for a mis-
functioning or nonfunctioning polypeptide to express a
properly functioning polypeptide; or
inhibit synthesizing of a particular essential
polypeptide to express the properly functioning
polypeptide; and
administering the synthesized biological material to the
human cell.
(Id. at 37.)
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Grounds of rejection before this Panel for review:
I. Claims 1, 5-10, 13, 14, 17, 18, 20, 23-26, 32, 33, 59---62, and 64--66
stand rejected under 35 U.S.C. § I03(a) as unpatentable over the
combination of Anderson, 4 Zarling, 5 and O'Malley. 6
II. Claims 2, 4, 15, 16, 19, 27-29, 34, 63, and 67----69 stand rejected under
35 U.S.C. § I03(a) as unpatentable over the combination of Anderson,
Zarling, 0 'Malley, and Whitehouse. 7
III. Claims 11, 30, 35--45, 70, and 71 stand rejected under 35 U.S.C.
§ I03(a) as unpatentable over the combination of Anderson, Zarling,
O'Malley, Whitehouse, and Watson. 8
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Anderson "relates to methods for control of and display from devices
for biological and chemical processing" (Anderson 1: 10-12; see id. at
2:26-30 (Anderson's "invention may be applied in, but is not limited to, the
fields of chemical or biological synthesis such as the preparation of peptide,
oligomer, polymer, oligosaccharide, nucleic acid, ribonucleic acid,
porphyrin, and drug congeners"); see Ans. 9 4--5).
4 Anderson, US 6,456,942 B 1, issued Sept. 24, 2002.
5 Zarling et al., US 2003/0082551 Al, published May 1, 2003.
6 O'Malley et al., US 2004/0009495 Al, published Jan. 15, 2004.
7 Whitehouse et al., US 5,112,575, issued May 12, 1992.
8 Watson et al., US 2002/0081601 Al, published June 27, 2002.
9 Examiner's November 4, 2016 Answer.
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FF 2. Anderson discloses "a system for controlling and/or monitoring
equipment for synthesizing or processing biological or chemical materials
from a remote location" (Anderson 2: 1--4; id. at 11. 23-24 (Anderson's
system allows a user "to control or monitor more than one or a plurality of
pieces of equipment from ... a remote location"); Ans. 4--5).
FF 3. Anderson discloses that DNA synthesizers may be controlled
remotely, i.e., over a network (see Anderson 4:35--45; see also id. at 3: 1-10
(Anderson's method allows an operator to select various functions "from a
computer interface program"); 3: 13-26; 3:48-55; 5:7-17; see Ans. 4--5;
Ans. 5 ("the equipment and systems taught by Anderson require the
necessary repository units to synthesize the biological material and the
system being automated necessarily requires the instructions for performing
the method functions" and Anderson discloses "software and parameter files
and sequence files for performing the functions"); Ans. 8 (Anderson
"describes [a] ... system as being used with equipment such [as] a DNA
synthesizer")).
FF 4. Anderson's Figure 2 is reproduced below:
....... -/_.,.
I Hybdchwti~,n !
l Unit j
------------------··----------· ... --.. ,_
..............
Figure 2
\ LAN or i LI
-.,. ,,. - ! ~:~ttisis I
j Equipment i
:'""'"'"'"-··-···--··.i
Anderson's Figure 2, reproduced above, illustrates a remote workstation
linked via a network, i.e., internet, to a "server or intranet which is in tum
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Application 11/424,022
linked (preferably by the internet or an intranet) to chemical or biological
synthesis equipment" (Anderson 2:53-57).
FF 5. Examiner finds that Anderson "does not explicitly recite a database
storing ... information [ regarding cell phenotype, types of biological
material to synthesize, monomeric components of biological material,] and
assembly instructions" and relies on Zarling to make up for this deficiency
in Anderson (Ans. 5).
FF 6. Zarling "relates to the use of high-throughput methods for gene
targeting, recombination, phenotype screening and biovalidation of drug
targets utilizing enhanced homologous recombination (EHR) techniques"
utilizing "robotically driven single or multichannel pipetters to perform
liquid, particle, cell and organism handling, robotically controlled plate and
sample handling platforms, and thermally regulated plates or blocks for
temperature controlled reactions" (Zarling ,r 1; see generally Ans. 5).
FF 7. Zarling' s "methods ... utilize many robotic systems comprising ...
computer workstations programmed to manipulate devices" (Zarling ,r,r 22,
23, 358-360; see Ans. 5---6).
FF 8. Zarling's system preferably includes eight modules, including a
module "directed to automated design and synthesis of the targeting
polynucleotides" and a module "directed to database(s) used to store and
retrieve information" (Zarling ,r 175; see id. ,r 182 (Zarling's "software
program modules allow creation, modification, and running of methods");
,r 1 71 ("the entire or any part of the gene cloning reactions can occur in
solution, in cell extracts, in cells, in organisms, or on solid supports or in
arrays"); see Ans. 5---6, 20).
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FF 9. Zarling discloses:
[T]he use of a computer database greatly facilitates the storage,
manipulation and retrieval of the large amount of information
generated during the automated cloning procedure. During all
steps of this process, ... data concerning sequences, primers,
mi crop late barcodes, position of particular samples within a
microplate, and information about particular assays is entered
into the database. General information about the location of
reagents including, but not limited to, DNA libraries,
oligonucleotides, enzymes etc. is also stored in the database.
(Zarling ,r 356; see generally id. ,r 357; see Ans. 5---6.)
FF 10. Zarling's "methods compris[e] identifying a cell(s), embryo(s),
organism( s) having an altered phenotype induced by a biological activity of
... expressed target nucleic acid, wherein the identifying is done using a
robotic system" (Zarling ,r 24; see Ans. 5).
FF 11. Zarling' s "robotic systems compris[ e] means for[, inter alia,] ...
introducing ... target nucleic acid(s) into host cells[ and] ... expressing ...
target nucleic acid(s) in said cells" (Zarling ,r 25; see id. ,r 43 ("EHR can be
used to repair mutant genes, alter genes, or interrupt normal gene function");
see also Ans. 5, 17).
FF 12. Zarling discloses that "[r]ecombinase protein(s) (prokaryotic,
eukaryotic or endogenous to the target cell) may be exogenously induced or
administered to a target cell ... simultaneously or contemporaneously ...
with the targeting polynucleotide(s)" and that "[s]uch administration is
typically done by micro-injection, although electroporation, lipofection, and
other transfection methods known in the art may also be used" (Zarling
,r 159; see generally id. ,r,r 160-164; see Ans. 7 (Examiner finds that Zarling
discloses "an insertion unit ... for insertion [ of, inter alia, nucleic acid] into
a cell")).
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FF 13. Examiner finds that the combination of Anderson and Zarling does
"not explicitly teach a database storing ... cell phenotype data" and relies on
0 'Malley to make up for this deficiency in the combination of Anderson and
Zarling (Ans. 6).
FF 14. O'Malley "relates in some aspects to high throughput methods for
identifying properties of cells under a variety of cellular conditions"
(O'Malley ,r 3; see generally Ans. 6).
FF 15. O'Malley discloses "a database representing a library ofphenotypic
states of cells," wherein "the database [is] tangibly embodied on a computer-
readable medium" (O'Malley ,r 24; see also id. ,r 105 ("information about
expression levels of markers ( e.g., nucleic acid sequences or peptides), can
be included in a data structure ( e.g., as part of a database), on a computer-
readable medium, where the information may be correlated with other
information pertaining to the markers, for example, information about
phenotypic states"); ,r,r 106, 112-118; see Ans. 6).
FF 16. 0 'Malley discloses libraries of molecules, including "[ s ]mall
molecule combinatorial libraries," arrays comprising nucleic acids, probes
and the use of "a computer-controlled robot to apply probe to [a] ...
substrate" (O'Malley ,r,r 64---65, 81-84; see Ans. 6).
FF 1 7. Examiner finds that the combination of Anderson, Zarling, and
0 'Malley does "not explicitly recite limitations of claims such as a system
comprising input/output channels or a repository comprising biological
monomers such a[ s] nucleic acids" and relies on Whitehouse to make up for
this deficiency in the combination of Anderson, Zarling, and O'Malley (Ans.
8).
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FF 18. Whitehouse "relates to an improved apparatus and a method used to
synthesize polynucleotides or peptides, preferably in an automated manner"
(Whitehouse 1:8-10; see id. at 3:66-4:6 (Whitehouse discloses an
"apparatus for synthesizing any polynucleotide sequence, be it DNA or
RNA, and to the synthesis of peptides using amino acids," wherein, in
addition to a different set of reagents and reaction sequences, nucleotides are
used to synthesize a polynucleotide sequence and "some or all of the twenty
amino acids [are] used to synthesize peptides"); see Ans. 8 ( citing
Whitehouse, Abstract and 3-6) (Examiner finds that Whitehouse discloses
"a polynucleotide synthesizer which comprises channels and repositories of
biological monomers such a[ s] nucleic acids")).
FF 19. Examiner finds that the combination of Anderson, Zarling,
O'Malley, and Whitehouse does "not explicitly recite synthesizing
compositions, which use polymerases and that treat cancer and are
introduced into cells via electroporation and/or microinjection" and relies on
Watson to make up for this deficiency in the combination of Anderson,
Zarling, O'Malley, and Whitehouse (Ans. 9).
FF 20. Watson "relates to methods for treating and preventing cancer based
on ets2 that is overexpressed in various cancer tissues" (Watson ,r,r 2, 16).
FF 21. Watson discloses "[ a ]ntisense nucleic acid molecules may be
synthesized chemically or enzymatically, and delivered to cancer cells by
injection[s]" (Watson ,r 59; see also id. ,r 246 (Watson discloses that nucleic
acid molecules may be introduced into cancer cells by a number of means
including transfection, electroporation, and microinjection); see Ans. 9).
FF 22. Examiner finds that Watson discloses the use of "a polymerase, such
as in ... PCR for synthesizing biological materials" (see Ans. 9; see also
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Watson ,r 104 ("PCR can be carried out, e.g., by use of a thermal cycler and
Taq polymerase")).
ANALYSIS
REJECTION]:
The combination of Anderson, Zarling, and O 'Malley suggests a
system that comprises: (1) a computer system, i.e., workstation, that
comprises one or more processors and memory in communication, i.e.,
through a network, with (2) a computer accessible database that stores
information regarding cell phenotype, types of biological material to
synthesize, monomeric components of biological material, and instructions
for assembly of biological material, and (3) an assembly unit, i.e., a DNA
synthesizer, that is electrically connected to, and configured to execute
instructions provided by, the computer system (see FF 1-15). Therefore, we
find no error in Examiner's conclusion that, based on the combination of
Anderson, Zarling, and O'Malley, it would have been prima facie obvious,
at the time Appellant's invention was made,
to have used the databases for storing and retrieving
information taught by Zarling et al. and O 'Malley et al. for use
in the automated DNA synthesizers taught by Anderson. This
is because Anderson's method is also directed towards
automated synthesis and the modules taught by Zarling et al.
and O 'Malley et al. are easily customizable and adaptable to
other systems. Zarling et al. at paragraph [0182] describe the
hardware and software being customizable for adaptability and
multiple applications. 0 'Malley et al. explicitly describe at
paragraphs [0112]- [0118] whereby the database information is
accessible to users who may query the information and use it
for a variety of purposes such as generating biological material
(i.e. generating synthetic sequences or probes, etc.). Therefore
one of ordinary skill in the art would have been motivated to
have integrated the databases as taught by O 'Malley et al. and
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Zarling et al. for use in DNA automated synthesis being
performed in the method taught by Anderson and the results
would have been predictable to the skilled artisan.
Furthermore, the differences between the prior art and claimed
invention were encompassed in known variations or known in
principal [sic] in the prior art.
(Ans. 6-7 (alteration original); see FF 1-16.)
Claim 1:
Appellant's claim 1 is reproduced above (see supra Statement of the
Case; cf FF 1-16).
Anderson discloses a system for remotely controlling equipment, such
as, for example, a DNA synthesizer, over a network to produce a nucleic
acid of interest (FF 1--4; cf App. Br. 15 ("Anderson does not describe any
mechanism by which a computer sends instructions to an assembly unit to
synthesize any biological material according to such instructions for
assembly")). Zarling discloses introducing a nucleic acid of interest (e.g., a
nucleic acid that corrects a mis-functioning or nonfunctioning polypeptide)
into host cells (FF 12). Zarling and O'Malley both disclose databases and
identify the type of information that may be included in a database, which
includes "information regarding cell phenotype, types of biological material
to synthesize, monomeric components of biological material, and
instructions for assembly of biological material" (see FF 9, 14, 15; cf App.
Br. 28). In this regard, we note that Zarling discloses the use of a computer
database in biological procedures, wherein the database comprises
information concerning, inter alia, sequences, particular procedures, location
of reagents, etc. (FF 9). Zarling's database is used to store and retrieve
information and "software program modules allow creation, modification,
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and running of methods" (FF 8). In addition, O'Malley discloses a library of
phenotypic states of cells, information about expression levels of nucleic
acid and peptide markers, and information correlating information pertaining
to markers with, for example, information regarding phenotypic states, and
makes up for the foregoing deficiency in Anderson and Zarling (see FF 13,
15). Thus, we find no error in Examiner's conclusion that the combination
of Anderson, Zarling, and O'Malley would have made obvious Appellant's
claimed invention, including a database within the scope of Appellant's
claimed invention (see FF 1-15; see generally Ans. 12-15).
Therefore, we are not persuaded by Appellant's contention that
0 'Malley and Zarling relate to screening methods and, therefore,
"encumbers ... [E]xaminer's use of Zarling and O'Malley with Anderson to
teach [Appellant's] ... claimed features" (App. Br. 17; cf FF 1-15).
Further, because a DNA synthesizer operates only through the
execution of instructions resulting in the production of DNA, which may
encode a polypeptide, we are not persuaded by Appellant's contention that a
person of ordinary skill in this art would not have found that the combination
of Anderson, Zarling, and O 'Malley would have made prima facie obvious a
system that comprises a computer system configured to, inter alia, execute
instructions (see generally Ans. 11-12; cf Reply Br. 1-2).
For the foregoing reasons, we are not persuaded by Appellant's
contentions that:
[W]hat is missing from the combination of Anderson and
Zarling are the features of claim 1, such as, "a computer
accessible database storing information regarding cell
phenotype, types of biological material to synthesize,
monomeric components of biological material, and instructions
for assembly of biological material," or the feature that the
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system "execute[ s] instructions, which instructions include the
instructions for assembly to control the assembly unit according
to the instructions for assembly to synthesize the biological
material for a mis-functioning or nonfunctioning polypeptide"
and O'Malley does not "describe 'a computer accessible database storing
information regarding cell phenotype, types of biological material to
synthesize, monomeric components of biological material, and instructions
for assembly of biological material"' (App. Br. 17-18; see generally id. at
15-17; see Reply Br. 2-3).
Further, Zarling discloses a method for, inter alia, repairing a targeted
mutant gene by introducing a target nucleic acid into a cell and expressing
that target nucleic acid in the cell (see FF 11-12). Thus, we are not
persuaded by Appellant's contention that the combination of Anderson,
Zarling, and O'Malley fails to suggest controlling"' ... the assembly unit
according to the instructions to synthesize the biological material for a mis-
functioning or nonfunctioning polypeptide"' (App. Br. 15); see also id. at
11-13; id. at 15-16 (Appellant contends that its "set of instructions for the
assembly unit are determined by the computer, using for instance ' ...
information of a human's genetic code, altered to replace deleterious
information (e.g., deleterious mutations) with benign or beneficial
information"') (alteration and emphasis original, endnote omitted); see also
Reply Br. 3-9).
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Claim 810 :
Appellant's claim 8 requires that the repository unit of Appellant's
claimed system "comprises one or more different types of monomeric
biological components" (see App. Br. 30 (emphasis added); cf FF 1-16).
Appellant's claim 9 depends from and further limits the "monomeric
biological components" of Appellant's claim 8 as "includ[ing] one or more
of a nucleotide, amino acid, and tRNA" (id. ( emphasis added); see also id. at
19 ("Appellant describes monomeric components as ' [ t ]he monomeric
biological components can include one or more of a nucleotide, amino acid,
and tRNA"')). Thus, Appellant's claim 8 requires only one type of
monomeric biological component, e.g., either a nucleotide or an amino acid
(see id. at 19 and 30). In this regard, Appellant recognizes that "O'Malley
[discloses] nucleotide, amino acid, and mRNA (but not tRNA)" (id. at 19).
Therefore, Appellant recognizes that the combination of Anderson, Zarling,
and O'Malley would have rendered the subject matter of Appellant's claim 8
obvious (cf Reply Br. 9 ("No combination of Anderson, Zarling and
0 'Malley teaches the repository unit comprises one or more different types
of monomeric biological components") ( emphasis omitted)).
In addition, as Examiner explains, a DNA synthesizer, as disclosed by
the combination of Anderson, Zarling, and O 'Malley "necessarily must use a
repository comprising at least monomeric components comprising
nucleotides, which reads on the requisite one or more monomeric
10 Appellant's claim 8 depends from canceled claim 3. For the purposes of
this Appeal we consider claim 8 as if it depends from Appellant's claim 1
(see Reply Br. 9 n.29).
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components as claimed" (Ans. 15-16). We find no error in Examiner's
finding or conclusion.
Claims 17, 20, and 25:
Claim 1 7 is reproduced above and requires, inter alia, the claimed
system to comprise "a central unit responsive to execution of the instructions
for assembly to control an assembly unit" (App. Br. 31-32; see also id. at 20
("Claim 17 further distinguishes by requiring 'a central unit responsive to
execution of the instructions for assembly to control an assembly unit"'); cf
FF 1-16). Appellant's Specification discloses that a "central unit can
include one or more of a memory, a receiver, an engine, and an antenna"
(Spec. 3:4--5; see id. at 5:8-9 and 7:5-6; see also App. Br. 33 (Appellant's
claim 25 depends from and further limits claim 17 to require that "the central
unit comprises one or more of a memory, a receiver, an engine, and an
antenna"); cf FF 1-16). Appellant's claim 20 depends from and further
limits Appellant's claim 1 7 to require that "the computer is separate from the
central unit and the assembly unit" (see App. Br. 32; cf FF 1-16).
Appellant contends that Examiner "has not considered this feature in
the rejection on Appeal" (App. Br. 20; see id. at 21 ("In as much as ...
[E]xaminer has not addressed the central unit in the rejection on appeal it is
difficult for ... Appellant to formulate additional argument"); see also
Reply Br. 10-12). We are not persuaded.
As Examiner explains "the recited limitation [ regarding a central unit]
is broadly and reasonably interpreted as any ... component in the
communication path between the computer and assembly unit" (Ans. 17).
Thus, Examiner reasons that, in "a computer system that communicates with
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servers that communicate with the synthesizers, ... the servers read on the
broadly claimed central unit responsive to execution of the instructions for
assembly to control an assembly unit," set forth in Appellant's claim 17 (Id.
at 18 (emphasis added)). For the foregoing reasons, we are not persuaded by
Appellant's contention that "the issue is not the name given to the
component by Appellant, but that Appellant recognized an advantage(s) in
placing a central unit component in a communication path between the
computer and assembly unit, e.g., more specifically, placing the central unit
in a cell or outside a cell" (Reply Br. 10-11 ). In addition, Appellant failed
to persuade us that servers, as disclosed in the prior art combination, do not
comprise one or more of a memory, a receiver, an engine or an antenna,
therefore, we are not persuaded by Appellant's contention that Examiner
failed to establish that the combination of Anderson, Zarling, and O'Malley
fails to suggest "the specifics of one or more of a memory, a receiver, an
engine, and an antenna ofClaim 25" (Reply Br. 12).
Claim 18:
Appellant's claim 18 depends from and further limits the system of
Appellant's claim 17 to further comprise "a repository unit storing monomer
components of biological material for synthesizing ... the biological
material" (see App. Br. 32; cf FF 1-16).
For the reasons set forth above with respect to Appellant's claims 8
and 17, we are not persuaded by Appellant's contention that Appellant's
claim 18 "is allowable for analogous reasons given for claims 17 and 8" (see
App. Br. 20; Reply Br. 11 ).
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Claim 59:
Appellant's claim 59 is reproduced above (cf FF 1-16).
As discussed above, Zarling discloses a method for, inter alia,
repairing a targeted mutant gene by introducing a synthesized target nucleic
acid into a cell and expressing that target nucleic acid in the cell (see FF
11-12). Therefore, for the reasons discussed above, we are not persuaded by
Appellant's contention that the "combination of Anderson, O'Malley and
Zarling does not suggest administering the synthesized biological material
made by the method of [Appellant's] Claim 59 to a human cell" (App. Br.
21; see Reply Br. 12).
Claim 60:
Appellant's claim 60 depends from and further limits Appellant's
claim 59 to further comprise "using a central unit responsive to the
instructions for assembly to control the assembly unit and with the computer
residing inside the central unit" (see App. Br. 38 (emphasis added)).
Appellant contends that "[E]xaminer has not addressed the 'central
unit' feature in the rejection on appeal" (App. Br. 22). We are not
persuaded. As discussed above, with respect to Appellant's claim 17, the
prior art's disclosure of a server teaches and suggests Appellant's central
unit. Appellant failed to provide persuasive evidence or argument to support
a conclusion that a server does not comprise a computer, i.e., a processor,
and, thereby, read on a computer residing inside the central unit.
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Claim 61:
Appellant's claim 61 depends from and further limits Appellant's
claim 59 to further comprise "an insertion unit for insertion of synthesized
biological material into a cell; using a central unit responsive to the
instructions for assembly to control the assembly unit, and with the
computer residing outside the central unit and outside the cell" (see App. Br.
38; cf FF 1-16).
As Appellant recognizes, Examiner relied on Zarling to disclose an
insertion unit, wherein "Zarling teaches microinjection to deliver DNA to
cells" (App. Br. 22). For the reasons discussed above, we are not persuaded
by Appellant's contention that the combination of Anderson, Zarling, and
O'Malley fails to disclose Appellant's biological material or "a central unit
responsive to the instructions for assembly to control the assembly unit, and
with the computer residing outside the central unit and outside the cell" (see
App. Br. 22).
Claim 65 11 :
Appellant's claim 65 requires that "the central unit comprise[] one or
more of a memory, a receiver, an engine, and an antenna" (see App. Br. 38;
cf FF 1-16).
11 Appellant's claim 65 depends from Appellant's claim 59 (see App. Br.
37-38). Appellant's claim 59 does not require a central unit (see id. at 37).
Thus, the requirement in Appellant's claim 65 that "the central unit
comprises one or more of a memory, a receiver, an engine, and an antenna"
lacks antecedent basis to Appellant's claim 59 (see id. at 37-38). Therefore,
for the purposes of this Appeal, we interpret Appellant's claim 65 as: The
method of claim 59, further comprising a central unit comprising one or
more of a memory, a receiver, an engine, and an antenna (cf id. at 38).
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For the reasons set forth above with respect to Appellant's claims 25
and 59, we are not persuaded by Appellant's contention that Appellant's
claim 65 "is allowable for analogous reasons given for claims [ 5]9 and 25"
(see App. Br. 22; Reply Br. 12).
REJECTION 11:
Based on the combination of Anderson, Zarling, O'Malley, and
Whitehouse (see FF 1-17), Examiner concludes that, at the time Appellant's
invention was made, it would have been prima facie obvious
to have used the program to interface with a DNA synthesizer
as taught by Anderson, Zarling et al. and O 'Malley et al. in the
system of a polynucleotide synthesizer as taught by Whitehouse
et al. This is because Anderson at col. 2 and col. 4 describe[ s]
the program being interfaced with a DNA synthesizer.
Whitehouse et al. at col. 9, line 25 describes the invention being
used with a programmed computer. Therefore, one of ordinary
skill in the art would have recognized that applying the known
technique would have yielded predictable results and resulted in
an improved method. Furthermore, the differences between the
claimed invention and prior art were encompassed in known
variation or in a principal [sic] known in the prior art.
(Ans. 8; see FF 1-18.)
Claim 2:
Appellant's claim 2 depends from and further limits the system of
Appellant's claim 1 to:
further compris[ e] an insertion unit for insertion of synthesized
biological material into a cell the insertion unit coupled to the
repository unit and comprising:
a tip portion having an opening, which is configured to
pierce a membrane wall of the cell without permanently
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damaging the cell; and the insertion unit inserts the biological
material into the cell by flowing the biological material through
the opening in the tip.
(App. Br. 29; cf FF 1-18.)
Zarling discloses robotic systems comprising means for, inter alia,
introducing target nucleic acid(s) into host cells and expressing these target
nucleic acids( s) in the cells (see FF 11 ). In addition, Zarling discloses a
system comprised of linked modules, wherein the linked modules include,
inter alia, automated design and synthesis of polynucleotide modules, which
necessarily includes repository units; database modules; software program
modules that allow the creation, modification, and running of methods; and
device modules, such as devices to produce polynucleotides and insert
polynucleotides produced by the system into a cell (see FF 6-12). Thus, we
are not persuaded by Appellant's contention that a person of ordinary skill in
this art would not have considered the combination of Anderson, Zarling,
O'Malley, and Whitehouse to have suggested "an insertion unit for insertion
of synthesized biological material into a cell[, wherein] the insertion unit [is]
coupled to the repository unit" in the absence of impermissible hindsight
(see App. Br. 23; see also Reply Br. 12-13).
Claim 4:
Appellant's claim 4 depends from and further limits the system of
Appellant's claim 1 to require that
the assembly unit harvests biological nucleotides and amino
acids directly from cell cytoplasm and further comprises one or
more of an input channel to receive the harvested biological
nucleotides and amino acids and wherein synthesized biological
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material is released from the assembly unit and into the cell
through an output channel.
(See App. Br. 29 (emphasis added); cf FF 1-18.)
Appellant contends that the combination of Anderson, Zarling,
O'Malley, and "Whitehouse provides no teachings of the specifics of Claim
4, which requires that the assembly unit harvests biological nucleotides and
amino acids directly from cell cytoplasm ... and wherein synthesized
biological material is released from the assembly unit and into the cell
through an output channel" (App. Br. 24 (alteration original); see also Reply
Br. 13). We are not persuaded.
As Examiner explains, "an 'output channel' is broadly and reasonably
interpreted as reading on [Zarling's] microinjection assembly" and Zarling
describes methodology, wherein "gene cloning reactions can occur in
solution, in cell extracts, in cells, in organisms, or on solid supports," thus
reading on the requirement in Appellant's claim 4 "of harvesting biological
nucleotides and amino acids directly from cell cytoplasm" (Ans. 20; see FF
8, 11, 12).
Claim 19:
Appellant's claim 19 depends from and further limits the assembly
unit of Appellant's claim 17 to "further comprise[] one or more of an input
channel and an output channel" (see App. Br. 32; cf FF 1-18).
For the reasons set forth above with respect to Appellant's claim 17,
we are not persuaded by Appellant's contention that Appellant's "[c]laim 19
is allowable for reasons given for claim 17" (App. Br. 24; see Reply Br. 14).
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Claim 27:
Appellant's claim 27 depends from and further limits the system of
Appellant's claim 17 to "further comprise[] a repository unit, and the
repository unit comprises one or more different types of monomeric
biological components" (see App. Br. 33; cf FF 1-18).
Appellant contends that "no combination of Anderson, Zarling,
O'Malley[,] and Whitehouse teaches 'a repository unit ... comprises one or
more different types of monomeric biological components"' (App. Br. 24
(alteration original)). We are not persuaded for the same reasons discussed
above with respect to Appellant's claims 8 and 17.
Claim 63:
Appellant's claim 63 depends from and further limits the method of
Appellant's claim 59 to require that "the assembly unit comprises one or
more of an input channel and an output channel" (App. Br. 38; cf FF 1-18).
For the reasons set forth above with respect to Appellant's claims 19
and 59, we are not persuaded by Appellant's contention that "[c]laim 63 is
allowable for reasons given in claim 59 and analogous claim 19" (App. Br.
25; see Reply Br. 14).
REJECTION 111:
Based on the combination of Anderson, Zarling, O'Malley,
Whitehouse, and Watson (see FF 1-21), Examiner concludes that, at the
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time Appellant's invention was made, it would have been prima facie
obvious
to have used the electroporation and/or microinjection for
introducing sequences into cells as taught by Watson et al. in
the method for sequencing biological material taught by the
combination of Anderson, Zarling et al., O'Malley et al., and
Whitehouse et al. This is because one of ordinary skill in the
art would have recognized that applying the known technique
of electroporation and/or microinjection to a different method
used for synthesizing biological material, as taught by
Anderson and Whitehouse et al. would have yielded predictable
results. Furthermore, the differences between the prior art and
the claimed invention were encompassed in known variations
or in a principal [sic] known in the prior art.
(Ans. 9--10; see FF 1-22.)
Claim 11:
Appellant's claim 11 depends from and further limits the assembly
unit of the system of Appellant's claim 1 to comprise "one or more of a
polymerase or a ribosome" (App. Br. 30; cf FF 1-22).
According to Appellant, "what is not known from this combination of
references is to use either polymerase or a ribosome as the assembly unit for
a system in Claim 1 to synthesize multimeric molecules of biological
material from the monomer components for proper expression of a
polypeptide by executing the instructions for assembly to apply monomer
components ... based on the execution of the instructions for assembly."'
(see App. Br. 25-26). We are not persuaded. As Appellant recognizes,
polymerase is well-known and Watson discusses the known polymerase
chain reaction (PCR) process for synthesizing biological materials (see id.;
see also FF 22). Appellant's claim 11 does not require that the polymerase
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is the assembly unit (see App. Br. 30; see also Reply Br. 14--15). Therefore,
we are not persuaded by Appellant's contention that Watson's "discussion of
the polymerase chain reaction does not use the polymerase ... as the
assembly unit .... " (App. Br. 26).
Claim 35:
Appellant's claim 35 is reproduced above (see supra Statement of the
Case; cf FF 1-22).
For the reasons set forth above with respect to Appellant's claim 59,
we are not persuaded by Appellant's contention that Appellant's claim 35 is
"distinguish[ ed] over the cited art for analogous reasons as set out in claim
59" (App. Br. 26).
Appellant's review of the limitations set forth in Appellant's claim 35
fails to explain how Examiner's rationale for combining Anderson, Zarling,
O'Malley, Whitehouse, and Watson errs in determining the combination
suggested the subject matter of Appellant's claim 35 and is, therefore, not
persuasive (see id.). See In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011)
("[T]he Board [has] reasonably interpreted Rule 41.37 to require more
substantive arguments in an appeal brief than a mere recitation of the claim
elements and a naked assertion that the corresponding elements were not
found in the prior art.").
Claim 39:
Appellant's claim 39 is reproduced above (see supra Statement of the
Case; cf FF 1-22).
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For the reasons set forth above with respect to Appellant's claim 59,
we are not persuaded by Appellant's contention that Appellant's claim 39 is
"distinguish[ ed] over the cited art for analogous reasons as set out in claim
59" (App. Br. 26).
Appellant's review of the limitations set forth in Appellant's claim 39
fail to explain how Examiner's rationale for combining Anderson, Zarling,
O'Malley, Whitehouse, and Watson fails to suggest the subject matter of
Appellant's claim 39 and is, therefore, not persuasive (see id.). See Lovin,
652 F.3d at 1357.
Claim 70:
Appellant's claim 70 depends from and further limits the method of
Appellant's claim 59 to require that "the human has a cancer, a tissue
disorder, or a disorder of the nervous system" (see App. Br. 39). Appellant's
claim 59 does not, however, provide antecedent basis for a "human" (see id.
at 37). To the contrary, Appellant's claim 59 relates to "[a] method of
treating a human cell" (id. (emphasis added)). Thus, we interpret
Appellant's claim 70 to limit the method of treating a human cell of
Appellant's claim 59 to a method of treating, for example, a human cancer
cell (see FF 1-22).
For the reasons set forth above with respect to Appellant's claim 59,
we are not persuaded by Appellant's contention that "[ c ]laims 7 0-71 are
patentable for reasons discussed in conjunction with claim 59" (App. Br.
26).
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CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claims 1, 8, 17, 18, 20, 25, 59, 60, 61, and 65 under
35 U.S.C. § 103(a) as unpatentable over the combination of Anderson,
Zarling, and O'Malley is affirmed. Claims 5, 6, 7, 9, 10, 13, and 14 are not
separately argued and fall with claim 1. Claims 23, 24, 26, 32, and 33 are
not separately argued and fall with claim 17. Claims 62, 64, and 66 are not
separately argued and fall with claim 59.
The rejection of claims 2, 4, 19, 27, and 63 under 35 U.S.C. § 103(a)
as unpatentable over the combination of Anderson, Zarling, 0 'Malley, and
Whitehouse is affirmed. Claims 15 and 16 are not separately argued and fall
with claim 2. Claims 28, 29, and 34 are not separately argued and fall with
claim 27. Claims 67-69 are not separately argued and fall with claim 63.
The rejection of claims 11, 35, 39, and 70 under 35 U.S.C. § 103(a) as
unpatentable over the combination of Anderson, Zarling, O'Malley,
Whitehouse, and Watson is affirmed. Claims 30 is not separately argued
and falls with claim 11. Claims 36-38 are not separately argued and fall
with claim 35. Claims 40-45 are not separately argued and fall with claim
39. Claim 71 is not separately argued and falls with claim 70.
TIME PERIOD FOR RESPONSE
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
29