PEOPLEBIO, INC.

Patent Trials and Appeals Board

Oct 15, 2021

2020005796 (P.T.A.B. Oct. 15, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
15/532,185 06/01/2017 Byoung Sub LEE 6680L-000147-US-NP 4040
28997 7590 10/15/2021
Harness Dickey (St. Louis)
7700 Bonhomme, Suite 400
St. Louis, MO 63105
EXAMINER
EMCH, GREGORY S
ART UNIT PAPER NUMBER
1699
NOTIFICATION DATE DELIVERY MODE
10/15/2021 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):
bkamer@hdp.com
stldocket@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BYOUNG SUB LEE, KWAN SOO LEE, SHIN WON KIM,
KUN TAEK LIM, GWANG JE KIM, and JI SUN YU
Appeal 2020-005796
Application 15/532,185
Technology Center 1600
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and
RACHEL H. TOWNSEND Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–3 and 6–21. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.CLAIMED SUBJECT MATTER

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as Peoplebio,
Inc. Appeal Br. 3.
Appeal 2020-005796
Application 15/532,185
2
Certain diseases are associated with abnormal aggregation or
misfolding of proteins including Alzheimer's disease, Creutzfeldt-Jakob
disease, spongiform encephalopathies, Parkinson's disease, Huntington's
disease, and amyotrophic lateral sclerosis. Spec. 1. Determination of the
presence or progress of such diseases is difficult because of the relatively
small amount of the aggregate-forming proteins in a given sample. Id. at 2.
The present invention is directed to an improved method for detecting
aggregate forms of aggregate-forming proteins.
Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A method for detecting an aggregate form of an
isolated aggregate-forming polypeptide in a biosample, the
method comprising the steps of:
(a) spiking a biosample from a subject having or
suspected as having a disease or condition involving the
multimeric form of the aggregate-forming polypeptide with (i) a
monomeric or multimeric form of the aggregate-forming
polypeptide, (ii) a hydrophobic deleted derivative of the
aggregate-forming polypeptide, or (iii) a monomeric or
multimeric form of the aggregate-forming polypeptide and a
hydrophobic deleted derivative of the aggregate-forming
polypeptide;
(b) additionally forming an aggregate form of the
aggregate-forming polypeptide by incubating a product of step
(a);
(c) contacting, with a product of step (b ), a binder-label
in which a signal generation label is conjugated to a binder
binding to the aggregate form of the aggregate-forming
polypeptide; and
(d) detecting a signal generated from the binder-label
bound to the aggregate form of the aggregate-forming
polypeptide,
wherein the incubating in step (b) is carried out for a
sufficient incubation time for multimerization of the spiked (i),
(ii), or (iii) by the biosample.
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REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
An (“An ’070”) US 8,026,070 B2 Sept. 27, 2011
An (“An ’026”) US 8,008,026 B2 Aug. 30, 2011
Staffler EP 2 579 042 A1 Apr. 10, 2013
Castilla, et al., Detection of prions in blood,11 Nature Medicine 983
(2005)
Amersham ECL Western Blotting Detection Kit - GE Healthcare Life
Sciences, https://www.gelifesciences.com/en/us/shop/protein-
analysis/blotting-and-detection/blotting (last visited Apr. 8, 2019)

REJECTIONS
The Examiner has rejected the pending claims as follows:
Claims 1–3 and 6–21 have been rejected under 35 U.S.C. § 112(a) for
failure to comply with the written description requirement.
Claims 1, 6, 12, and 14–16 have been rejected under 35 U.S.C.
§ 102(a)(1) as anticipated by Castilla.
Claims 1–3, 6–8, 12–15, and 17–21 have been rejected under 35
U.S.C. § 103 as unpatentable over An ’070 in view of Castilla.
Claims 1–3 and 6–21 have been rejected under 35 U.S.C. § 103 as
unpatentable over An ’070 in view of Castilla and Staffler.
Claims 1–3, 6–8, 12–15, and 17–21 have been rejected on the ground
of non-statutory obviousness-type double patenting over An ’070 in view of
Castilla.
Claims 1–3 and 6–21 have been rejected on the ground of non-
statutory obviousness-type double patenting over An ’070 in view of Castilla
and Staffler.
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Claims 1, 6–8, 12–14, and 17–21 have been rejected on the ground of
non-statutory obviousness-type double patenting over An ’026 in view of
Castilla.
Claims 1–3 and 6–21 have been rejected on the ground of non-
statutory obviousness-type double patenting over An ’026 in view of Castilla
and Staffler.
OPINION
Written Description
The issue before us with respect to this rejection is whether the
Examiner properly conclude that the Specification fails to reasonably convey
to those skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.
The Examiner finds that the Specification fails to provide adequate
written disclosure to support the broad genus of “binder-labels” i.e., a signal
generation label conjugated to a binder which binds to the aggregate form of
the aggregate-forming polypeptide recited in the claims because it fails to
provide sufficient distinguishing identifying characteristics of the genus.
Final Act. 6. The Examiner finds that while the Specification contains a
broad description of types of binders that may be used e.g., peptide aptamer,
antibody, the Specification only provides two working examples of an
antibody “binder-label”. Id. at 3. The Examiner finds that the Specification
gives a functional description of the binder-labels, i.e., binding to the
aggregate form of the polypeptide, but that functional description is
inadequate to describe the structure of the binder-labels that are required to
bind to the aggregate. Id. at 5. The Examiner concludes:
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Consequently, in the absence of sufficient recitation of
distinguishing identifying characteristics, the specification does
not provide adequate written description of the claimed genus
of binders nor guidance as to which of the myriad of molecules
encompassed by the claimed antibodies would meet the
limitations of the claims. Further, given the well-known high
level of polymorphism of immunoglobulins and antibodies, the
skilled artisan would not have recognized that applicant was in
possession of the vast repertoire of antibodies encompassed by
the claimed invention.
Vas-Gath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir.
1991), clearly states that "applicant must convey with
reasonable clarity to those skilled in the art that, as of the filing
date sought, he or she was in possession of the invention. The
invention is, for purposes of the 'written description' inquiry,
whatever is now claimed." (See page 1117). The specification
does not "clearly allow persons of ordinary skill in the art to
recognize that [he or she] invented what is claimed." (See Vas-
Gath at page 1116).
The skilled artisan cannot envision the detailed chemical
structure of the genus of binders used in the instant method, and
therefore conception is not achieved until reduction to practice
has occurred, regardless of the complexity or simplicity of the
method of identification. Adequate written description requires
more than a mere statement that it is part of the invention and
reference to a potential method of isolating it. The compound
itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606
(CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co.
Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991 ). Therefore, the instant
claims does not meet the written description provision of 35
U.S.C. §112 (a).
Id. at 6–7.
Appellant contends that the Examiner is improperly focusing on an
individual element of the claims and not the invention as a whole. Appeal
Br. 6. Appellant contends that the invention is directed to a method for
detecting an aggregate form of an isolated aggregate-forming polypeptide in
a biosample, where said method includes spiking a biosample from a
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subject, incubating the spiked sample to form an aggregate form of a
polypeptide, contacting the aggregate form with a binder-label, and detecting
a signal generated from the binder-label. Id. at 7. Appellant argues that while
the method includes a binder-label, “the claimed invention is much more
than the binder itself.” Id. at 8.
Appellant contends that even if the binder-label was an essential part
of the invention. The Specification gives an adequate description of the
binder-labels. Id. at 9. Appellant points out that the Specification discloses
two antibodies that will work in the claimed method and Appellant has
identified sixteen more. Id. Appellant contends that other binders are well
known in the art. Id.
Appellant concludes:
Appellants respectfully submits that one of ordinary skill
in the art would understand that the particular identity of the
binder is not essential to the claim so long as it binds to the
aggregate form of the aggregate-forming polypeptide. It is the
concept of this binding that the disclosure as filed describes,
thus reasonably conveying to the artisan that Appellant was in
possession of the invention at the time the application was filed.
The specification describes and exemplifies both binders and
the aggregate-forming polypeptide that the binders bind to.
(Specification, p. 4, 1. 20 through p. 5, 1. 7; p. 13, 1. 3-10.).
Since the invention is directed to a method for detecting an
aggregate from of an aggregate-forming polypeptide, and not to
the binder or binder-label per se, a full sequence disclosure of
all possible antibodies, as suggested by the Examiner, is not
required.
Id. at 11–12.
We have considered the arguments presented by the parties and the
evidence of record and find that Examiner has the better argument.
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While we agree with Appellant that the use of the binder-label is just
one part of the claimed method, it is an essential part of the method in that it
allows one practicing the method to ascertain whether the aggregates are
present. Thus, the issue is whether Appellant has described the binder-label
in such terms as to convey to one skilled in the art that the inventors had in
their possession the broad genus of binder-labels recited in the claims at the
time the application was filed. We agree with the Examiner that the answer
is no.
A “sufficient description of a genus instead requires the disclosure of
either a representative number of species falling within the scope of the
genus or structural features common to the members of the genus so that one
of skill in the art can ‘visualize or recognize’ the members of the genus.”
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010).
The present Specification teaches that the term “binder” embraces a
wide variety of species including an antibody, a peptide aptamer, an
AdNectin, an affibody, an avimer, or a Kunitz domain. Spec. 13. The
Specification gives only two examples of binders that function as claimed,
both of which are antibodies. Spec. 21. Appellant has cited to other
examples of binders which are also antibodies. Appeal Br. 9. However,
Appellant has not cited any examples of other binders of the types cited in
the Specification such as a peptide aptamer, an AdNectin, an affibody, an
avimer, or a Kunitz domain. In addition, Appellant has not pointed to any
disclosure of any structural features common to members of the genus in
regard to being able to function to bind the aggregate. Therefore, Appellant
has not provided a sufficient description of the genus such that one skilled in
the art can visualize or recognize the members of the genus.
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Based on the foregoing we affirm the rejection under 35 U.S.C.
§ 112(a).

Anticipation
The Examiner finds that Castilla discloses each of the limitations of
claims 1, 6, 12, and 14–16. With respect to claim 1, the Examiner finds
Castilla teaches a method for detecting an aggregate form
of an isolated aggregate-forming polypeptide (prion) in a blood
sample, the method comprising the steps of: (a) spiking a blood
sample from a subject having or suspected as having a disease
or condition involving the multimeric form of the aggregate-
forming polypeptide (hamsters with clinical signs of scrapie
disease) with, (i) a monomeric or multimeric form of the
aggregate-forming polypeptide ("normal hamster brain
homogenate" provides a source of prion, i.e. monomeric PrPC;
(b) additionally forming an aggregate form of the aggregate-
forming polypeptide, i.e. aggregates of PrP8c, by incubating a
product of step (a); (c) contacting, with a product of step (b), a
binder-label in which a signal generation label is conjugated to
a binder (3F4 antibody) binding to the aggregate form of the
aggregate-forming polypeptide; and (d) detecting a signal
generated from the binder-label bound to the aggregate form of
the aggregate forming polypeptide (through Enhanced
Chemiluminescence assay - kit provided by Amersham,
wherein the "binder-label" is horse radish peroxidase (HRP)
conjugated to the "binder"; see attached Amersham Western
Blotting Detection Kit description page), wherein the
incubating in step (b) is carried out for a sufficient incubation
time for multimerization of the spiked (i) by the blood sample
(see p.984, first 2 full paragraphs, Fig.2 and p.985), thus
meeting the limitations of claims 1 and 6.
Final Act. 10.
Appellant contends that Castilla does not disclose all of the limitations
of the claims. Appeal Br. 14. Specifically, Appellant argues that Castilla
does not disclose the step of spiking the biosample nor does Castilla disclose
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the step of incubation as those steps are defined in the Specification. Id. at
14–15.
The issue before us is whether a preponderance of the evidence
supports the Examiner’s conclusion that claims 1, 6, 12, and 14–16 are
anticipated by Castilla.
“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
“[N]ot unlike a determination of infringement, a determination of
anticipation, as well as obviousness, involves two steps. First is construing
the claim, . . . followed by, in the case of anticipation or obviousness, a
comparison of the construed claim to the prior art.” Key Pharms. v. Hercon
Labs. Corp., 161 F.3d 709, 714 (Fed. Cir. 1998).
[A]s an initial matter, the PTO applies to the verbiage of the
proposed claims 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).
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Office Action
and Answer regarding this rejection. We find the Examiner has established
that the claims are anticipated by Castilla. Appellant has not produced
evidence showing, or persuasively argued, that the Examiner’s
determinations on anticipation are incorrect. Only those arguments made by
Appellant in the Briefs have been considered in this Decision. Arguments
not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv)
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(2015). We have identified claim 1 as representative; therefore, all claims
fall with claim 1. We address Appellant’s arguments below.
Appellant contends that Castilla does not disclose “spiking a
biosample” as that term is used in the Specification. Appeal Br. 12–13.
Appellant contends that Castilla discloses mixing two aliquots from a
normal brain and a scrapie brain together and that does not constitute
“spiking.” Id. Appellant contends that “spiking” as used in the Specification
refers to adding a form of an aggregate-forming peptide to a biosample. Id.
at 13. Appellant contends that Castilla teaches mixing two biosamples which
may or may not have an aggregate-forming peptide. Id. Appellant also points
to the examples in the present Specification which use a purified aggregate
forming peptide. Id.
We have considered the arguments presented by Appellant and the
evidence of record and are not persuaded that Castilla does not disclose
“spiking” as the term is used in the claim. While we agree with Appellant
that the claims call for adding an aggregate-forming peptide to a biosample,
we do not construe the claim to require that a purified or isolated peptide be
added. The Specification defines “spiking” as “a procedure of adding to or
adding to and then mixing with a biosample to be analyzed, a monomeric
form (or multimeric form) of an aggregate-forming polypeptide and/or a
hydrophobic deleted derivative of an aggregate-forming polypeptide.” Spec.
7. We discern nothing in this definition that requires the peptide added to the
biosample to be free of other components. That the examples used purified
peptides does not lead us to interpret the claims as requiring isolated
peptides. “[W]hile it is true that claims are to be interpreted in light of the
specification . . . , it does not follow that limitations from the specification
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may be read into the claims. . . . [T]he claims define the invention.” Sjolund
v. Musland, 847 F.2d 1573, 1581–82 (Fed. Cir. 1988).
Appellant contends that Castilla does not disclose “spiking” a
biosample because Castilla discloses mixing aliquots of a normal brain and a
scrapie brain homogenate and that this is not spiking a biosample to
determine if the biosample contains an aggregate-forming peptide. Appeal
Br. 12–13. While Castilla discloses preparing a mixture of a normal brain
homogenate with a scrapie brain homogenate, Castilla also discloses mixing
blood believed to contain an aggregate-forming peptide with a homogenate
from a scrapie brain resulting in detection of prions in the blood sample. See
Castilla 984 (left column). Thus, we agree with the Examiner that Castilla
discloses the spiking step recited in the present claims. Ans. 7–8.
Appellant contends that Castilla does not disclose the step of
incubating the spiked biosample. Appeal Br. 13. Appellant contends that, as
the term is defined in the Specification, incubating calls for letting the
sample “stand undisturbed or subjected to mild shaking.” Id. Appellant
contends that Castilla calls for sonication of the sample which is not the
same as mild shaking. Id.
We are again unpersuaded by Appellant’s argument. While we agree
with Appellant that Castilla discloses sonication of the spiked biosample,
Castilla discloses that aggregates are formed first and then the aggregates are
sonicated to form smaller pieces. Castilla 982 (right column). Claim 1 does
not preclude the presence of an additional step following the aggregation
step.
We also agree with the Examiner that the term incubation does not
preclude the use of sonication. The Specification defines incubation as
“standing or shaking a biosample to be analyzed at a predetermined
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temperature for a predetermined period of time, and such shaking is,
preferably, mild shaking.” Spec. 12 (emphasis added). Appellant’s argument
that incubation is limited to mild or no shaking is inconsistent with the broad
definition found in the Specification. See Ans. 8.
Appellant contends that the sonication step in Castilla is done for the
purpose of breaking up the aggregated prions. Appeal Br. 14. Appellant
contends that this is in contrast with the present invention which promotes
aggregation by avoiding agitation. Id.
We have considered Appellant’s argument and remain unpersuaded
that the rejection is in error. As discussed above, Castilla teaches that the
aggregation step is performed first followed by sonication. As presently
drafted, the claims do not preclude a sonication step after the aggregates are
formed.
Based on the foregoing we conclude that a preponderance of the
evidence supports the Examiner’s finding that claims 1, 6, 12, and 14–16 are
anticipated by Castilla.
Obviousness Based on An ’070 Combined with Castilla
The Examiner finds An ’070 teaches as method for
differentially detecting a multimeric form from a monomeric
form of a multimer-forming polypeptide in a biosample,
comprising: (a) contacting the biosample to a capturing
antibody recognizing an epitope on the multimer-forming
polypeptide to capture the monomeric form, multimeric form or
monomeric and multimeric forms; (b) contacting the
monomeric form, multimeric form or monomeric and
multimeric forms captured by the capturing antibody to a
detecting antibody recognizing an epitope which is overlapped
with, but not identical to the epitope of (a); wherein said
detecting antibody is linked to a label generating a detectable
signal; and said epitope recognized by the capturing antibody or
detecting antibody is not repeated in the monomeric form of a
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multimer-forming polypeptide; and (c) detecting the formation
of a multimeric form-detection antibody complex by measuring
a signal generated from the label linked to the detecting
antibody (see the patent claims). The '070 patent teaches that
the biosample is blood (see col. 7, line 11) and that the blood
sample is spiked and subsequently incubated to form aggregates
for a sufficient time for multimerization (see e.g. Example
XIII), as in claims 1, 17 and 20.
Final Act. 13.
The Examiner finds An ’070 does not teach “spiking a sample from a
subject having or suspected of having a disease as claimed” but the Castilla
teaches this limitation. Id. at 14.
The Examiner concludes:
It would have been prima facie obvious to the person of
ordinary skill in the art to arrive at the claimed invention from
the '070 patent and Castilla et al. The person of ordinary skill in
the art would have been motivated to make and use the claimed
invention since both the '070 patent and Castilla teach the same
or very similar methods of measuring aggregate-forming
polypeptides to diagnose diseases associated with said
polypeptides and because Castilla teaches that spiking a blood
sample from a subject with such a disease provides superior
amplification of the polypeptide signal such that disease can be
diagnosed. The person of ordinary skill in the art would have
had a reasonable expectation of success based on the
cumulative disclosures of these prior art references.
Id. at 14–15.
Appellant contends that the references fail to teach all of the elements
of the claims. Appeal Br. 15. Appellant contends that An ’070 fails to teach
the spiking step and fails to teach that the biosample if from a subject having
or suspected as having a disease or condition involving the multimeric form
of the aggregate-forming polypeptide. Id.
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Appellant contends that Castilla also does not teach spiking for the
reasons set forth by Appellant in response to the anticipation rejection. Id. at
16.
Appellant also contends that the method used by An ’070 to detect
aggregate forming peptides is significantly different that the method used in
the claimed invention. Id. at 16–18.
The issue before us is whether a preponderance of the evidence
supports the Examiner’s conclusion that the subject matter of claims 1–3, 6–
8, 12–15, and 17–21 would have been obvious to one of ordinary skill in the
art at the time the invention was made over An ’070 combined with Castilla.
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Office Action
and Answer regarding this rejection. We find the Examiner has established a
prima facie showing that the subject matter of the claims would have been
obvious over An ’070 combined with Castilla to a person of ordinary skill in
the art at the time the invention was made. Appellant has not produced
evidence showing, or persuasively argued, that the Examiner’s
determinations on obviousness are incorrect. Only those arguments made by
Appellant in the Briefs have been considered in this Decision. Arguments
not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv)
(2015). We have identified claim 1 as representative; therefore, all claims
fall with claim 1. We address Appellant’s arguments below.
Appellant contends that An does not teach the claim limitation calling
for spiking a biosample from a subject having or suspected as having a
disease or condition involving the multimeric form of the aggregate-forming
polypeptide. Appeal Br. 15. Appellant contends that An ’070 does not teach
spiking the sample and that the blood evaluated was from healthy
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individuals. Id.at 15–16. Appellant contends that Castilla does not cure the
deficiency of An ’070 in that Castilla does not disclose spiking. Id.
Appellant does not persuade us that the rejection is in error. While An
’070 may not teach the limitation calling for spiking a biosample from a
subject having or suspected of having a disease or condition associated with
a multimeric form of an aggregate forming peptide, we agree with the
Examiner that this is taught by Castilla. Final Act. 14. As discussed above,
Castilla discloses adding scrapie brain homogenate to blood of hamsters
with clinical signs of scrapie. Castilla 984 (left column). We find that this
teaches the limitation of spiking a biosample from a subject suspected of
having a disease or condition associated with a multimeric form of an
aggregate forming peptide.
Appellant contends that the method of detecting the aggregate
forming peptide used in An ’070 is different than the method used in the
present invention as the method in An can only detect aggregate multimers
and not unaggregated monomers. Appeal Br. 17.
We are not persuaded by Appellant’s argument. Claim 1 only requires
“detecting a signal generated from the binder-label bound to the aggregate
form of the aggregate-forming polypeptide.” Appeal Br. 24 (Claims App.)
Thus the detection of unaggregated monomers is irrelevant to the issue of
whether claim 1 is taught or suggested by An ’070.
Based on the foregoing we conclude that a preponderance of the
evidence supports the Examiner’s conclusion that the subject matter of claim
1 would have been obvious to one of ordinary skilled in the art at the time
the invasion was made over An ’070 combined with Castilla.
Obviousness Based on An ’070 Combined with Castilla and Staffler
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The Examiner reiterates his findings with respect to the teachings of
An ’070 and Castilla. Final Act. 15. The Examiner finds that neither An ’070
nor Castilla teaches the use of Aβ peptides. Id. The Examiner finds that this
teaching is supplied by Staffler. Id. Specifically, the Examiner finds
Staffler teaches incubating Aβ peptides, including Aβ 3-
42, for a time sufficient to form aggregates, e.g. for 1 day (see
[0017]), as in the instant claims 9-11 and 16. Staffler teaches
incubating at 37°C (see [0044]), as in claim 15. Staffler teaches
allowing the peptides to incubate prior to spiking blood rather
than after spiking.
Id.
The Examiner concludes
It would have been prima facie obvious to the person of
ordinary skill in the art to arrive at the claimed invention from
the [An]'070 patent, Castilla et al. and Staffler et al. The person
of ordinary skill in the art would have been motivated to make
and use the claimed invention since the [An]'070 patent teaches
the incubation of Aβ peptides, in general, in order to result in
aggregation of the peptides for diagnosis of disease, while
Staffler teaches Aβ 3-42 as a specific Aβ peptide for incubation
to result in aggregation. As in stated in MPEP §2144.06,
substituting one equivalent element for another known for the
same purpose renders an invention obvious and an "express
suggestion to substitute one equivalent component or process
for another is not necessary to render such substitution obvious.
In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)." The
person of ordinary skill in the art would have had a reasonable
expectation of success based on the cumulative disclosures of
these prior art references.
Id. at 15–16.
Appellant contends that Staffler is not relevant to the claimed method.
Appeal Br. 18. Appellant contends that Staffler is directed to detecting Aβ
antibodies with Aβ particles whereas An’070 is directed to using antibodies
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to detect aggregate forming peptides. Id. Appellant contends that one skilled
in the art would not be motivated to combine An ’070 with Staffler. Id.
The issue before us is whether a preponderance of the evidence
supports the Examiner’s conclusion that the subject matter of claims 1–3 and
6–21 would have been obvious to one of ordinary skill in the art at the time
the invention was made over An combined with Castilla and Staffler.
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Office Action
and Answer regarding this rejection. We find the Examiner has established
a prima facie showing that the subject matter of the claims would have been
obvious over An ’070 combined with Castilla and Staffler to a person of
ordinary skill in the art at the time the invention was made. Appellant has
not produced evidence showing, or persuasively argued, that the Examiner’s
determinations on obviousness are incorrect. Only those arguments made by
Appellant in the Briefs have been considered in this Decision. Arguments
not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(1)(iv)
(2015). We have identified claim 1 as representative; therefore, all claims
fall with claim 1. We address Appellant’s arguments below.
Appellant contends that Staffler is not relevant to the present
invention, as Staffler uses a different approach to determine aggregate-
forming peptides are present in a sample. Appeal Br. 18. Appellant contends
that Staffler used aggregate-forming peptides to detect the presence of
antibodies whereas the present invention and An ’070 use the opposite
approach. Id.
We have considered Appellant’s arguments and the evidence of
record and are not convinced that the rejection is in error. We agree with the
Examiner that the teachings of Staffler are relevant to the present invention
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as they both address diagnosing diseases associated with aggregate-forming
peptides. Ans. 10. With respect to the different methodology used in Staffler,
we do not agree that this would deter one skilled in the art from combining
the teachings of An ’070 and Castilla with Staffler. Staffler is cited primarily
for teaching the specific Aβ peptides recited in claims 9–11 and 16 are
peptides of interest with respect to the aggregate-forming peptides associated
with Alzheimer’s disease. See Staffler ¶ 3.
Based on the foregoing, we conclude that a preponderance of the
evidence supports the Examiner’s conclusion that the subject matter of
claims 1–3 and 6–21 would have been obvious to one of ordinary skill in the
art at the time the invention was made over An ’070 combined with Castilla
and Staffler.
Obviousness-Type Double Patenting based on An ’070
The Examiner finds that the present claims are not patentably distinct
from claims 1–17 of An ’070 in view of Castilla alone or Castilla combined
with Staffler. Final Act. 19–22.
The Examiner finds that the claims of An ’070 encompass all of the
elements of the present claims with the exception of the spiking requirement
and, for claims 9–11 and 16, the use of specific peptides. Id. The Examiner
finds that Castilla teaches the spiking limitation and that Staffler teaches the
specific peptides. Id.
Appellant contends that neither An ’070 nor Castilla teach the spiking
limitation recited in the claims. Appeal Br. 18–19. Appellant contends that
Staffler does not compensate for the deficiencies of An ’070 and Castilla. Id.
We have considered the arguments presented by the Examiner and
Appellant and find the Examiner has the better position. As discussed above,
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while An ’070 may not teach the spiking step recited in the present claims,
we find that Castilla teaches that step.
We conclude that the evidence of record supports the Examiner’s
rejections for obviousness-type double patenting based on An ’070.
Obviousness-Type Double Patenting Based on An ’026
The Examiner has rejected the pending claims for obvious-type
double patenting over An ’026 combined with either Castilla or Castilla and
Staffler. Final Act. 23–26. The Examiner’s findings mirror those made with
respect to An ’070 above. See id.
Appellant contends that the references do not teach or suggest the
spiking step recited in the claims. Appeal Br. 21. Appellant also argues that
the claims of An ’026 call for the presence of a solid phase carrier whereas
the present claims do not. Id.
We have considered the arguments presented by the Examiner and
Appellant and based on the evidence of record and we find that the
Examiner has the better positon.
As disused above, Castilla teaches the spiking step recited in the
present claims. We also agree with the Examiner that An ’026 claims a
method that recited in the claims of An ’026 encompasses the same steps are
recited in the instant claims other than the step of spiking the sample. Final
Act. 23–25.
We conclude that the evidence of record supports the Examiner’s
rejections for obviousness-type double patenting based on An ’026.
CONCLUSION
The Examiner’s rejections are affirmed.
More specifically,
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The rejection of claims 1–3 and 6–21 under 35 U.S.C. § 112(a) for
failure to comply with the written description requirement is affirmed.
The rejection of claims 1, 6, 12, and 14–16 under 35 U.S.C. § 102 as
anticipated by Castilla is affirmed.
The rejection of claims 1–3, 6–8, 12–15, and 17–21 under 35 U.S.C.
§ 103 as unpatentable over An ’070 in view of Castilla is affirmed.
The rejection of claims 1–3 and 6–21 under 35 U.S.C. § 103 as
unpatentable over An ’070 in view of Castilla and Staffler is affirmed.
The rejection of claims 1–3, 6–8, 12–15, and 17–21 on the ground of
non-statutory obviousness-type double patenting over An ’070 in view of
Castilla is affirmed.
The rejection of claims 1–3 and 6–2 on the ground of non-statutory
obviousness-type double patenting over An ’070 in view of Castilla and
Staffler is affirmed.
The rejection of claims 1, 6–8, 12–14, and 17–21 on the ground of
non-statutory obviousness-type double patenting over An ’026 in view of
Castilla is affirmed.
The rejection of claims 1–3 and 6–21 on the ground of non-statutory
obviousness-type double patenting over An ’026 in view of Castilla and
Staffler is affirmed.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–3, 6–21 112(a) Written
Description
1–3, 6–21
1, 6, 12, 14–
16
102(a)(1) Castilla 1, 6, 12, 14–
16

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1–3, 6–8,
12–15, 17–
21
103 An ’070, Castilla 1–3, 6–8,
12–15, 17–
21

1–3, 6–21 103 An ’070, Castilla,
Staffler
1–3, 6–21
1–3, 6–8,
12–15, 17–
21
Obviousness-type
Double Patenting,
An ’070, Castilla
1–3, 6–8,
12–15, 17–
21

1–3, 6–21 Obviousness-type
Double Patenting,
An ’070, Castilla,
Staffler
1–3, 6–21
1, 6–8, 12–
14, 17–21
Obviousness-type
Double Patenting,
An ’026, Castilla
1, 6–8, 12–
14, 17–21

1–3, 6–21 Obviousness-type
Double Patenting,
An ’026, Castilla,
Staffler
1–3, 6–21
Overall
Outcome
1–3, 6–21

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED