KATAIRO GmbH et al.

Patent Trials and Appeals Board

Sep 1, 2021

2021001596 (P.T.A.B. Sep. 1, 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.
15/095,702 04/11/2016 Ulrich Schraermeyer SCHRAERMEYER-3 4648
28157 7590 09/01/2021
URSULA B. DAY, ESQ.
35 WEST 35TH STREET
SUITE 900
NEW YORK, NY 10001
EXAMINER
MCMILLIAN, KARA RENITA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
09/01/2021 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):
patentlaw@ursuladay.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ULRICH SCHRAERMEYER, JÖRG SENN-BILFINGER, and
ERNST STURM
Appeal 2021-001596
Application 15/095,702
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
JOHN G. NEW, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision2 to reject claims directed to a method of treating an eye disorder as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

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 Katairo GmbH and
Takeda GmbH. Appeal Br. 2. Oral argument was heard on August 17, 2021,
and a transcript of the hearing is part of the record.
2 We have considered, and herein refer to, the Specification of April 11,
2016 (“Spec.”); Final Office Action of January 22, 2020 (“Final Act.”);
Appeal Brief of August 18, 2020 (“Appeal Br.”); Examiner’s Answer of
Appeal 2021-001596
Application 15/095,702
2
CLAIMED SUBJECT MATTER
The claims are directed to a method of treating eye disease in a patient
with a compound that interacts with lipofuscin. Claim 1, reproduced below,
is illustrative of the claimed subject matter:
1. A method of treatment of a patient suffering from an eye
disease caused by lipofuscin accumulated in retinal pigment
endothelium cells, comprising:

administering to the subject in need of such treatment a
medication comprising a compound according to the following
formula I as active ingredient in suitable amount,

in which
R1 is methyl or hydroxymethyl, one of the substituents R2a and
R2b is hydrogen and the other is hydroxy, methoxy, ethoxy,
isopropoxy, methoxyethoxy or ethoxypropoxy, one of the
substituents R3a and R3b is hydrogen and the other is hydroxy,
methoxy, ethoxy, isopropoxy, methoxyethoxy or
methoxypropoxy, where R2a or R2b on the one hand and R3a or
R3b on the other hand are not simultaneously hydroxy, and its
salts, wherein the administered medication interacts with the
lipofuscin accumulated in the retinal pigment endothelial cells
causing removal.

November 2, 2020 (“Answer”); Reply Brief of December 30, 2020 (“Reply
Br.”), and Transcript of August 17, 2021 hearing (“Tr.”).

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Application 15/095,702
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REJECTION(S)
Appellant requests review of Examiner rejection of claims 1–17 under
35 U.S.C. § 103(a) over Price3 in view of Simon4 and Senn-Bilfinger.5
OPINION
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
Findings of Fact
We agree with and adopt Examiner’s findings of fact and reasoning
regarding the scope and content of the prior art set out in the Final Office
Action and Answer. For emphasis only we highlight the following:
FF1. Price teaches that angiogenesis requires copper, and that
reducing in vivo amounts of copper with “copper chelators, (e.g.,
tetrathiomolybdate) [and low copper diets] may be effective in
treating diseases (e.g., solid tumor growth), which require
angiogenesis.” Price ¶ 4 (emphasis omitted).
FF2. Price teaches disease conditions that are characterized by
aberrant vascularization include diabetic retinopathy, age related
macular degeneration, neovascular glaucoma, pterygium, ocular
neovascularization, and macular degeneration among others. Price
¶¶ 26, 148; Ans. 4. Price teaches that the methods are applied “[m]ore
preferably, [to] diseases characterized by aberrant vascularization

3 Price et al., WO 2007/142626 A1, published Dec. 13, 2007.
4 W.A. Simon et al., Soraprazan: Setting New Standards in Inhibition of
Gastric Acid Secretion, 321 J. PHARMACOL. EXP. THER. 866–74 (2007).
5 Senn-Bilfinger, WO 00/17200, published March 30, 2000.
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[that] include cancer, macular degeneration and rheumatoid arthritis.”
Price ¶ 148; Ans. 4.
FF3. Price teaches that thiomolybdate or thiotungstate compounds
treat aberrant vascularization. Price ¶ 147; Ans. 4. Price teaches that
thiomolybdates are acid labile drugs that degrade under acidic
conditions. Price ¶ 6.
FF4. Price teaches a method for administering thiomolybdate or
thiotungstate compound in combination with a proton pump inhibitor.
Price ¶ 103; Ans. 5. “Proton pump inhibitors are compounds that
inhibit or suppress gastric acid secretion by inhibition of the H+-K+
ATPase enzyme system at the secretory surface of gastric parietal
cells.” Price ¶ 103. Price teaches that the particularly preferred proton
pump inhibitors include omeprazole, lansoprazole, rabeprazole,
pantoprazole, and esomeprazole. Id. ¶ 106; Ans. 5.
FF5. Simon teaches that soraprazan is a reversible, and fast-acting
inhibitor of gastric H,K-ATPase that is superior over esomeprazole.
Simon, Abstract, 871–872; Ans. 5. Soraprazan is also known as
BYK61359 or (7R,8R,9R)-2,3-dimethyl-8-hydroxy-7(2-
methoxyethoxy )-9-phenyl- 7,8,9,10-tetrahydro-imidazo-[1,2-h][1,7]-
naphthyridine]. Simon, 867.
Soraprazan shows immediate inhibition of acid secretion
in various in vitro models and in vivo and was found to
be more than 2000-fold selective for H,K-ATPase over
Na,K- and Ca-ATPases. Soraprazan is superior to
esomeprazole in terms of onset of action and the extent
and duration of pH elevation in vivo in the dog.
Id. at Abstract.
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FF6. The Specification teaches that “[m]acular degeneration in both
forms [wet and dry] is associated with an accumulation of lipofuscin
and melano-lipofuscin.” Spec. ¶ 11.
Principles of Law
“[E]xaminer bears the initial burden, on review of the prior art or on
any other ground, of presenting a prima facie case of unpatentability.” In re
Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
“Whether the rejection is based on ‘inherency’ under 35 U.S.C. § 102,
on ‘prima facie obviousness’ under 35 U.S.C. § 103, jointly or alternatively,
the burden of proof is the same, and its fairness is evidenced by the PTO’s
inability to manufacture products or to obtain and compare prior art
products.” In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (footnote omitted).
“Newly discovered results of known processes directed to the same purpose
are not patentable because such results are inherent.” Bristol-Myers Squibb
Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001).
Analysis
Appellant does not present arguments for the separate patentability of
the claims, accordingly, we select claim 1 to be representative of the claims
on appeal. 37 C.F.R. § 41.37(c)(1)(iv).
Claim Construction
We begin with claim interpretation because before a claim is properly
interpreted, its scope cannot be compared to the prior art. We note that the
claim 1 recites “comprising” twice.
In the first iteration, “comprising” references the administration of a
medication to a patient population. “The transition ‘comprising’ in a method
claim indicates that the claim is open-ended and allows for additional steps.”
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Invitrogen Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1368 (Fed. Cir.
2003) (citations omitted). Accordingly, we determine the claim to
encompass additional method steps beyond the recited administration step.
In the second iteration, “comprising” references a medicament. In
composition claims, “‘[c]omprising’ is a term of art used in claim language
which means that the named elements are essential, but other elements may
be added and still form a construct within the scope of the claim.”
Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). Here,
claim 1 recites a medicament comprising formula (I).6 Accordingly, we
determine that the medicament can include additional elements, including
other actives.
We, therefore, interpret claim 1 to be directed to a method of treating
a patient suffering from an eye disease caused by lipofuscin accumulation in
retinal pigment endothelium cells, where the active method step includes
administering a compound of formula (I), such as for example soraprazan.
Because claim 1 recites the transitional claim language comprising, the
claim encompass additional active agents and method steps.
Examiner’s Prima Facie Case
Examiner finds that Price teaches treating aberrant vascularization,
such as that associated with macular degeneration, by administering a
combination of “a thiomolybdate or thiotungstate compound and
administering an effective amount of a proton pump inhibitor, H2 antagonist
or active metabolite thereof, or antacid.” Ans. 4; FF1–FF4. Examiner
acknowledges that Price does not teach the compound soraprazan. Ans. 5.

6 Examiner finds that the compound soraprazan encompasses formula I, I*,
or I** as recited in claim 1. See Ans. 3.
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Examiner looks to Simon to teach the H,K-ATPase inhibitor soraprazan.
Ans. 5; FF5. Examiner finds that “soraprazan is a highly potent inhibitor of
gastric H,K-ATPase that is superior over esomeprazole in terms of onset of
action and the extent and duration of pH elevation.” Ans. 5; FF5. Examiner
finds that there was motivation to use soraprazan as a proton pump inhibitor
because of its “improved properties as compared to the proton pump
inhibitor[], i.e. esomeprazole” and concludes that “it would have been
obvious and within the purview of an artisan practicing the invention to
substitute soraprazan for the proton pump inhibitors listed in Price et al. with
a reasonable expectation success.” Ans. 6.
After considering the record and the arguments in the Appeal Brief
and Reply Brief, we adopt Examiner’s findings of fact and reasoning
regarding the scope and content of the prior art (Final Act. 7–11; Ans. 3–7;
FF1–FF6) and agree that the treatment recited in claim 1 would have been
obvious over Price, Simon, and Senn-Bilfinger. We address Appellant’s
arguments below.
Argument 1
Appellant contends that claim 1 “refers to the removal through
interaction of lipofuscin with the medication containing the compound” in
the preamble and that this is an intent of purpose. Appeal Br. 11 (citing
Jansen v. Rexall Sundown, Inc., 342 F.3d 1329 (Fed. Cir. 2003)).
Specifically, Appellant contends that none of the references cited by
Examiner mention “lipofuscin.” Id.
We are not persuaded by Appellant’s contention. Examiner has
provided a sufficiently articulated rationale for treating patients having
macular degeneration with a composition containing thiomolybdate or
thiotungstate compound in combination with the proton pump inhibitor
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soraprazan, the latter which falls within the scope of the formula I
compound. See Ans. 3–7. As Examiner explains, the claims do not “not
exclude the eye conditions of Price that are characterized by aberrant
vascularization, namely macular degeneration, since the wet form of macular
degeneration is an eye condition characterized by aberrant vascularization
and caused by lipofuscin accumulated in retinal pigment endothelium.”
Ans. 9; FF6.
It is not necessary that the prior art suggests or the same advantage or
result discovered by applicant when the steps of the claim are the same as
those described or suggested by the prior art. See, e.g., In re Kahn, 441 F.3d
977, 987 (Fed. Cir. 2006) (motivation question arises in the context of the
general problem confronting the inventor rather than the specific problem
solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor
Danek, Inc., 424 F.3d 1293, 1323 (Fed. Cir. 2005) (“One of ordinary skill in
the art need not see the identical problem addressed in a prior art reference
to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013
(CCPA 1972); In re Dillon, 919 F.2d 688 (Fed. Cir. 1990), cert. denied, 500
U.S. 904 (1991). Here, Price teaches a combination pharmaceutical
treatment comprising a proton pump inhibitor, as claimed, to improve
bioavailability of the active agent to suppress vascularization in patients
suffering from macular degeneration. See FF1–FF4. The patient population
in Price overlaps with the patient population recited in claim 1. Compare
FF2 with FF6. Because there is a reason to treat the same patient population
using a combination treatment containing thiomolybdate or thiotungstate and
the proton pump inhibitor soraprazan, the interaction between lipofuscin and
soraprazan would be a necessary result of its administration. The mere
recognition of latent properties in the prior art does not render nonobvious
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an otherwise known invention. In re Prindle, 297 F.2d 251, 254 (CCPA
1962). Here, the latent property identified by Appellant is the interaction of
soraprazan with lipofuscin.
Argument 2
Appellant contends that Examiner erroneously relies on inherency.
Appeal Br. 12 (citing In re Rijckaert, 9 F.3d 1531, 1534 (Fed. Cir. 1993)).
We are not persuaded by Appellant’s contention. Here, Examiner has
directed us to evidence in the record that describes administering a
thiomolybdate or thiotungstate compound in conjunction with a proton pump
inhibitor for the purpose of treating aberrant vascularization, a problem
associated with macular degeneration. See FF1–FF4. Examiner identified
motivation that further supports substituting one proton pump inhibitor for
another proton pump that works better. FF5. Specifically, Examiner
articulated that one of ordinary skill in the art would be motivated to make
this substitution because Simon teaches “that soraprazan is a highly potent
inhibitor of gastric H,K-ATPase that is superior over esomeprazole in terms
of onset of action and the extent and duration of pH elevation.” Ans. 5, see
also id. at 15; FF5. Claim 1 only recites that the medication interact with the
lipofuscin and thereby “causing removal” of the lipofuscin. Because of the
comprising language recited in the claim, the claimed treatment is not
limited to the interaction with lipofuscin “causing removal” as the sole
pathological treatment target. Here, administering a compound that prevents
vascularization in conjunction with soraprazan, as suggest by the
combination of references, would reasonably treat macular degeneration
even if the treatment treats additional physiological targets in the process.
During oral argument held on August 17, 2021, Appellant urged that
Price encompasses treatments, citing paragraphs 117, 118, and 144, that
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either do not require the use of a proton pump inhibitor or that suggests
using the proton pump inhibitor at suboptimal levels and, therefore, there is
no inherency based on a combination with Price. See Tr. 9:17–12:5. We note
that this is a new argument that is not found in the principal brief. Any new
arguments offered by Appellant’s representative at the Oral Hearing in
support of patentability, not in the record prior to oral hearing, have not been
considered because they are untimely. Accordingly, we do not consider any
new arguments raised during the Oral Hearing for purpose of deciding this
appeal. See 37 C.F.R. § 41.47(e) (new arguments may not be presented at
the Oral Hearing, except under circumstances not alleged to be present here).
See also Ex parte Borden, 93 USPQ2d 1473, 1476–77 (BPAI 2010)
(informative). Appellant has not shown a good cause that these arguments
could not have been made earlier. Accordingly, we will not consider this
new argument from the Oral Hearing.
Argument 3
Appellant contends that they obtained a patent on the treatment of dry
age-related macular degeneration (AMD) on the present disclosure. Appeal
Br. 13. According to Appellant, “[v]ascularization is not an issue [in dry
AMD] since it is the accumulation of lipofuscin as a major cause of the
AMD and the removal thereof that is claimed.” Id. Appellant contends that
Examiner has failed to establish a nexus between the claimed combination
and the references. Appeal Br. 13; Reply Br. 3.7
We are not persuaded by Appellant’s contention. Soraprazan is a
superior proton pump inhibitor. FF5. Here, Examiner’s articulated rationale

7 The Reply Brief is not paginated. Therefore, all references to page numbers
of the Reply Brief refer to page numbers as if the Reply Brief was numbered
consecutively beginning with the first page.
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recognizes the superior performance of the inhibitor soraprazan and cites
this as a reason to substitute it for a proton pump inhibitor in Price. See Ans.
5 (“soraprazan is a highly potent inhibitor of gastric H,K-ATPase that is
superior over esomeprazole in terms of onset of action and the extent and
duration of pH elevation.”), id. at 12.
While a new and nonobvious method of using an existing (or
obvious) composition may itself be patentable, see Perricone v.
Medicis Pharm. Corp., 432 F.3d 1368, 1378 (Fed.Cir.2005), a
newly-discovered result or property of an existing (or obvious)
method of use is not patentable. See Abbott Labs. v. Baxter
Pharm. Prods., 471 F.3d 1363, 1368–69 (Fed.Cir.2006);
Brassica Prot. Prods. LLC v. Sunrise Farms (In re Cruciferous
Sprout Litig.), 301 F.3d 1343, 1350–51 & n. 4 (Fed.Cir. 2002);
Bristol-Myers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368,
1376 (Fed.Cir. 2001).
Allergan, Inc. v. Sandoz Inc., 726 F.3d 1286, 1295–96 (Fed. Cir. 2013)
(emphasis omitted).
The new property identified by Appellant is the interaction of
soraprazan with lipofuscin. “From the standpoint of patent law, a compound
and all of its properties are inseparable; they are one and the same thing.” In
re Papesch, 315 F.2d 381, 391 (CCPA 1963). Examiner has directed us to
sufficient evidence in the record from which to conclude that there is a
reason to treat the same patient population with a combination treatment that
includes the proton pump inhibitor soraprazan. Based on that combination
Examiner concluded that Appellant’s method is obvious over the cited prior
art and, therefore, the burden of proof shifts to Appellant to demonstrate that
the claimed properties would not have been present in the method derived
from the combined cited prior art. See In re Best, 562 F.2d at 1254–55; In re
Oetiker, 977 F.2d at 1445–46. Appellant has not met this burden, and we are
therefore not persuaded by Appellant’s argument.
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CONCLUSION
We conclude, considering the totality of the cited evidence and
arguments, that the preponderance of the evidence supports Examiner’s
conclusion of obviousness with respect to claim 1, and Appellant has not
provided sufficient rebuttal evidence or evidence of secondary
considerations that outweighs the evidence supporting Examiner’s
conclusion. As Appellant does not argue the claims separately, claims 2–17
fall with claim 1. 37 C.F.R. § 41.37 (c)(1)(iv).
DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–17 103 Price, Simon,
Senn-Bilfinger
1–17

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