ELIAZ THERAPEUTICS, INC.

Patent Trials and Appeals Board

Dec 7, 2020

2020003593 (P.T.A.B. Dec. 7, 2020)

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.
15/296,267 10/18/2016 ISAAC ELIAZ ECON-0102-CIP 7627
80308 7590 12/07/2020
The Kelber Law Group
6701 Democracy Blvd
Suite 300
Bethesda, MD 20817
EXAMINER
DEAK, LESLIE R
ART UNIT PAPER NUMBER
3799
NOTIFICATION DATE DELIVERY MODE
12/07/2020 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):
steve@kelberlawgroup.com
susan@kelberlawgroup.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ISAAC ELIAZ
____________

Appeal 2020-003593
Application 15/296,2671
Technology Center 3700
____________

Before NINA L. MEDLOCK, CYNTHIA L. MURPHY, and
BRUCE T. WIEDER, Administrative Patent Judges.

WIEDER, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner’s rejection of claims 1–12. We have jurisdiction under
35 U.S.C. § 6(b). An oral hearing was held November 19, 2020.
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies the real party in interest as Eliaz
Therapeutics, Inc. (Appeal Br. 2.)
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CLAIMED SUBJECT MATTER
Appellant’s “invention relates to apparatus and methods employed to
selectively treat agents in a mammal’s blood outside of its body.” (Spec.
¶ 4.)
Claim 1 is the sole independent claim on appeal. It recites:
1. A method for treating a mammal exhibiting kidney
disease, comprising:
Identifying a mammal with kidney disease with elevated
galectin-3 (“Gal-3”) levels wherein said mammal would benefit
from a reduction in fibrosis formation,
withdrawing an amount of blood from said mammal and
introducing it into an ex vivo treatment system, wherein said
treatment system selectively removes Gal-3 from said withdrawn
blood by passing said blood through a module provided with a
moiety which selectively binds Gal-3,
wherein said withdrawn blood, after passing said module,
exhibits a Gal-3 level lower than that in said withdrawn blood
prior to passing through said module; and
thereafter returning said withdrawn blood, to said patient.

REJECTIONS
Claims 1–12 are rejected under 35 U.S.C. § 103 as unpatentable in
view of Duffin (US 2012/0164628 A1, pub. June 28, 2012) and Rolke
(WO 2015/138438 A1, pub. Sept. 17, 2015).
Claims 1–9 and 12 are rejected on the ground of nonstatutory double
patenting as unpatentable over claims 1 and 3–5 of Eliaz (US 8,764,695 B2,
iss. July 1, 2014).

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ANALYSIS
Obviousness is a legal conclusion involving a determination of
underlying facts.
Under § 103, the scope and content of the prior art are to be
determined; differences between the prior art and the claims at
issue are to be ascertained; and the level of ordinary skill in the
pertinent art resolved. Against this background, the obviousness
or nonobviousness of the subject matter is determined. Such
secondary considerations as commercial success, long felt but
unsolved needs, failure of others, etc., might be utilized to give
light to the circumstances surrounding the origin of the subject
matter sought to be patented.

KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting Graham v.
John Deere Co. of Kansas City, 383 U.S. 1, 17–18 (1966)).
Appellant argues that the references do not teach the identification
step of claim 1. Specifically, Appellant argues that “Rolke does not suggest
identification of a patient with kidney disease, or somehow suggest
addressing fibrosis.” (Appeal Br. 14.) Appellant argues that “such an
identification step would be taught away from the claimed subject matter,
because Rolke specifically teaches the administration of a therapeutic agent
to the selected patent . . . NOT apheresis of any type.” (Id. at 15.)
The Examiner answers that “Rolke clearly states that the ability to
downregulate galectin-3 may alleviate renal injury (via fibrosis) and increase
renal function (see Rolke p2, ln 5-21). As such, Rolke teaches the selection
of patients with kidney disorders that may benefit from a reduction in
galectin-3.” (Answer 5.) The Examiner also answers that “the Rolke
reference does not specifically ‘criticize, discredit, or otherwise discourage
the solution claimed…’ to constitute a teaching away. In re Fulton,
391 F.3d 1195, 1201, (Fed. Cir. 2004).” (Id.)
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Rolke teaches “methods for the treatment of kidney disorder, such as
chronic kidney disease . . . , using a galectine-3 [sic] inhibitor.” (Rolke,
Abstract.) Specifically, Rolke teaches that “studies have shown that
increases in circulating levels of galectin-3 are associated with worse
outcomes in patients with end-stage renal disease (ESRD)” and that other
studies “have demonstrated a direct, causal role of galectin-3 expression and
secretion by macrophages in the formation of tissue fibrosis leading to
kidney failure.” (Id. at 2, ll. 5–10.) Rolke further teaches:
These findings collectively underscore the potential of
indirectly or directly targeting galectin-3 in the treatment of
kidney disorders. Because the ability to downregulate galectin-
3 may alleviate renal injury and increase renal function, there is
a great need in the art to identify compounds that target galectin-
3, or galectin-3 mediated signaling pathways, in order to
appropriately determine an efficacious and cost-effective course
of therapeutic treatment.

(Id. at 2, ll. 16–21.) In other words, Rolke teaches that lowering the level of
galectin-3 in patients identified with kidney disorders may alleviate renal
injury and increase renal function, and that there may be a relation between
galectin-3 expression and secretion by macrophages in the formation of
tissue fibrosis leading to kidney failure.
In view of these teachings in Rolke, we do not find persuasive
Appellant’s argument that Rolke does not teach identifying a patient with
kidney disease. Nor do we find persuasive Appellant’s argument that Rolke
does not address fibrosis.
With regard to Appellant’s teaching away argument, we note as an
initial matter that “[a] reference may be said to teach away when a person of
ordinary skill, upon reading the reference, would be discouraged from
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following the path set out in the reference, or would be led in a direction
divergent from the path that was taken by the applicant.” In re Gurley,
27 F.3d 551, 553 (Fed. Cir. 1994). “Under the proper legal standard, a
reference will teach away when it suggests that the developments flowing
from its disclosures are unlikely to produce the objective of the applicant’s
invention.” Syntex (U.S.A.) LLC v. Apotex, Inc., 407 F.3d 1371, 1380 (Fed.
Cir. 2005).
As discussed above, Rolke teaches “that increases in circulating levels
of galectin-3 are associated with worse outcomes in patients with end-stage
renal disease” (Rolke 2, ll. 5–6), and that “the ability to downregulate
galectin-3 may alleviate renal injury and increase renal function” (id. at 2,
ll. 17–18). Rolke teaches the use of galectin-3 inhibitors to downregulate
the level of galectin-3 in the blood. (Id. at 2, ll. 23–24.)
Appellant directs us to no language in Rolke suggesting that other
methods for reducing circulating levels of galectin-3 are unlikely to produce
the objective of the claimed invention, i.e., lowering the level of galectin-3
in the blood. Therefore, we are not persuaded that Rolke teaches away from
apheresis for downregulating the level of galectin-3 in the blood. Nor are
we persuaded that the Examiner erred in determining that “[s]ince Rolke’s
method reduces the amount of galectin-3 within a patient, it would have
been obvious . . . to use Duffin’s extracorporeal treatment to reduce the
galectin-3 level within a patient with kidney failure.” (Answer 3–4; see also
Final Action 4.)2

2 Duffin teaches “[m]ethods, devices and systems for capturing biomarkers,”
and, in particular, “methods, compositions, and systems that utilize affinity
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Appellant argues that the prior art does not teach returning the blood
to the patient. Specifically, Appellant argues that Ambrus “explains the
blood is withdrawn, even separated, and tested, but never returned to the
body. See Co[l]. 7, ll. 1-2.” (Reply Br. 9.) Appellant further argues that
Ambrus “neither describes nor discloses a port, apparatus or means to return
the blood to the patent” and that “it would not make any sense to provide for
return of treated blood to the patient in [Ambrus].” (Id. at 10.)3 Ambrus
teaches a “device includ[ing] an inlet port 32 for the blood and an outlet
port 34 for the effluent” (Ambrus, col. 7, ll. 1–2), and Appellant argues that
Ambrus’s use of the term “effluent” “refer[s] to liquid waste” and does not
return blood to the patient. (Reply Br. 10, citing “Dictionary.com, Miriam
[sic] Webster.com.”)

capture devices comprising a processing chamber, affinity capture agent and
porous membrane.” (Duffin ¶ 2.) Duffin teaches that the biomarker can be
a “tumor biomarker that can include . . . galectin-3.” (Id. ¶ 10.) Duffin
states that it incorporates by reference Ambrus (US 6,528,057 B1, iss.
Mar. 4, 2003) in its entirety. (Id. ¶ 53.) Duffin teaches that in devices such
as those disclosed in Ambrus, “a biological medium, can be passed through
the lumen of a hollow fiber membrane, wherein an affinity capture agent is
located . . . , which forms a means to accept and immobilize biomarkers.
Thus, the device retains biomarkers bound by the affinity capture agent
while allowing other biological media components to pass through the
lumen.” (Id.)
3 In arguing that the prior art does not enable the withdrawal, treatment, and
return of the treated blood to the mammal, Appellant asserts that the
Examiner relied on Tullis (WO 2010/033514 A1, pub. Mar. 25, 2010) to
teach returning blood, after treatment, to the mammal. (Appeal Br. 17–18.)
The Examiner answered that reliance for this teaching was on Ambrus, not
Tullis. (Answer 6–7.)
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As an initial matter, we note that Dictionary.com provides four
definitions for the noun “effluent.” Specifically, “2 something that flows out
or forth; outflow; effluence. 3 a stream flowing out of a lake, reservoir, etc.
4 sewage that has been treated in a septic tank or sewage treatment plant.
5 sewage or other liquid waste that is discharged into a body of water, etc.”
(dictionary.com/browse/effluent?s=t (last visited Nov. 12, 2020).) In view
of these definitions, we are not persuaded that Ambrus used the term
“effluent” to refer to liquid waste as opposed to, e.g., something that flows
out or forth.
Moreover, Ambrus teaches a method that “comprises the steps of
obtaining a patient’s blood, contacting the blood with immobilized affinity
molecules specific for the virus, and returning the unbound blood to the
individual.” (Ambrus, col. 4, ll. 40–43 (emphasis added); see also id.
at col. 5, ll. 34–40.) Therefore, we disagree with Appellant that Ambrus
does not teach returning the blood to the patient and that “it would not make
any sense to provide for return of treated blood.” (See Reply Br. 10.) It
follows that we are also not persuaded that Ambrus fails to teach an outlet
port for the blood.
To the extent Appellant maintains that Ambrus does not enable the
step of returning blood to the mammal (see Appeal Br. 17–21), the Federal
Circuit has held that
[w]hile a reference must enable someone to practice the
invention in order to anticipate under § 102(b), a non-enabling
reference may qualify as prior art for the purpose of determining
obviousness under § 103. Reading & Bates Constr. Co. v. Baker
Energy Resources Corp., 748 F.2d 645, 652, 223 USPQ 1168,
1173 (Fed.Cir.1984) (reference that lacks enabling disclosure is
not anticipating, but “itself may qualify as a prior
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art reference under § 103, but only for what is disclosed in it”
(emphasis in original)).

Symbol Techs., Inc. v. Opticon, Inc., 935 F.2d 1569, 1578 (Fed. Cir. 1991).4
Therefore, we do not find persuasive Appellant’s non-enablement argument
with regard to this § 103 rejection.
In view of the above, we are not persuaded that the Examiner erred in
rejecting claim 1 under §103. Claims 2–12 fall with claim 1. See Reply
Br. 16, 17.

The nonstatutory obviousness-type double patenting rejection5
The Examiner finds that “Eliaz claims the removal of galectin-3 in an
extracorporeal treatment comprising the steps of identifying a patient,
removing blood from the patient, contacting the blood with a galectin-3
affinity molecule, and returning the treated blood to the patient . . . .” (Final
Action 6.)
Appellant argues that “[n]othing in the prior art of record, including
the claims of [Eliaz], would suggest selecting an individual in need of gal-3
modification to address fibrosis.” (Appeal Br. 22.) Appellant also argues,

4 With regard to claims rejected as anticipated, the Federal Circuit has “held
that publications used as prior art by the PTO are presumed enabling.” In re
Morsa, 713 F.3d 104, 110 (Fed. Cir. 2013) (citing In re Antor Media Corp.,
689 F.3d 1282, 1288 (Fed. Cir. 2012)).
5 We note that on November 2, 2020, a terminal disclaimer was filed
attempting to disclaim “the terminal part of the statutory term of any patent
granted on the instant application which would extend beyond the expiration
date of the full statutory term of [Eliaz].” On November 3, 2020, the
terminal Disclaimer was disapproved because “[t]he person who signed the
terminal disclaimer is not the applicant, patentee or an attorney or agent of
record.”
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for the first time in the Reply Brief, that “[n]othing in Claims 1, 3-5, 15
and 16, taken in isolation or taken together, suggests or discloses that a
module with a moiety which selectively binds galectin-3 should be used in
the process claimed.” (Reply Br. 17.)
Claim 1 of Eliaz recites “selecting a mammal in need of reduction of
circulating levels of galectin-3.” Claim 15 of Eliaz recites “said mammal is
selected because it is in need of inhibition of development or extension of
fibroses mediated by gal-3.”
Claim 1 of Eliaz further recites “conducting plasmapheresis on the
blood of said mammal to reduce circulating levels of active gal-3, wherein
said plasmapheresis is conducted so as to selectively remove galectin-3 (gal-
3).” Plasmapheresis includes the step of “contacting said separated plasma
with moieties that bind gal-3.” (Eliaz, col. 14, ll. 29–30 (claim 7).)
In view of the above, we do not find Appellant’s argument persuasive
of error.

CONCLUSION
The Examiner’s rejection of claims 1–12 under 35 U.S.C. § 103 is
affirmed.
The Examiner’s rejection of claims 1–9 and 12 on the ground of
nonstatutory double patenting is affirmed.

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Specifically:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–12 103 Duffin, Rolke 1–12
1–9, 12 Nonstatutory Double
Patenting
1–9, 12
Overall
Outcome
1–12

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