Sergei Zenovich et al.

Patent Trials and Appeals Board

Jul 27, 2020

2019007024 (P.T.A.B. Jul. 27, 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.
11/322,156 12/29/2005 Sergei Mikhailovich Zenovich U016087-6 8674
140 7590 07/27/2020
LADAS & PARRY LLP
1040 Avenue of the Americas
NEW YORK, NY 10018-3738
EXAMINER
PIHONAK, SARAH
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
07/27/2020 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):
nymail@ladas.com
nyuspatactions@ladas.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte SERGEI MIKHAILOVICH ZENOVICH and
BORIS KHAIMOVICH STRELETS
__________

Appeal 2019-007024
Application111/322,156
Technology Center 1600
__________

Before FRANCSICO C. PRATS, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of orally administering repeated doses of at least one vicinal
dithioglycol which results in blocking the development and/or reducing the
rate of development of pathological processes associated with formation of
tetrahydroisoquinolines, which have been rejected as obvious, for
obviousness-type double patenting, and/or as indefinite. 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. Appellant identifies itself as the real party in interest.
(Appeal Br. 1.)
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STATEMENT OF THE CASE
Appellant’s Specification states that “[i]t is known that treating
patients with the syndrome of alcoholic or narcotic dependence has a
restricted effect, because a remission lasting for more than one year after the
treatment in a medical hospital is registered [in] only a few percent of
patients.” (Spec. 1) Appellant’s invention is directed at a method of
administration of a compound to prevent alcoholic and narcotic dependence
or block pathological processes induced by use of alcoholic beverages or
other substances having addictive potential. (Id. at 2.)
Claims 9–11, 14, 17, 18, and 22–44 are on appeal. Claim 22 is
representative and reads as follows:
22. A method which comprises a course of prophylactic oral
administration to a subject being at risk of suffering from
development of pathological processes caused by using alcohol-
containing beverages and/or substances having an addictive
potential with repeated doses a composition comprising as at
least one vicinal dithioglycols of general formula (1)
R1CH(SH)CH(SH)R2 (1)
where R1 is selected from the groups: (-H) or (-COOH);
R2 is selected from the groups: (-COOH), or (-CH2-
SO3H);
or derivative salts thereof, obtained on the basis of salt forming
groups (-COOH) or (-SO3H); thereby blocking the development
and/or for reducing the rate of development of pathological
processes associated with formation of tetrahydroisoquinolines
(THIQs) caused by using alcohol-containing beverages and/or
substances having an addictive potential.
(Appeal Br. 15–16.)

The prior art relied upon by the Examiner is:
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Name Reference Date
Zenovich I WO 2001/0491332 July 12, 2001
Zenovich II US 2003/0018063 A1 Jan. 23, 2003
R.D. Myers and C.L. Melchior, Alcohol Drinking: Abnormal Intake
Caused by Tetrahydropapaveroline in Brain,196 Science 554–556(1977)

The following grounds of rejection by the Examiner are before us on
review:
Claims 9–11, 14, 17, 18, and 22–44 under 35 U.S.C. § 103(a) as
unpatentable over Zenovich I, Myers, and Zenovich II.
Claims 9–11, 14, 17, 18, and 22–44 obviousness-type double
patenting over the claims of U.S. Patent Nos. 7,229,637 or 7,820,196 or
7,824,705 in combination with Myers and Zenovich II.
Claims 30, 31, 36, and 40 under 35 U.S.C. § 112, second paragraph,
as being indefinite.
DISCUSSION
Obviousness
The Examiner finds that Zenovich I teaches the use of the claimed
vicinal dithioglycol as a food or beverage additive “for reducing the severity
of alcoholic hangover syndrome and the unfavorable consequences which
occur immediately during the first 24 hours of alcohol consumption (p. 6, 3rd
full para).” (Non-Final Action3 13.) The Examiner further finds that
Zenovich I teaches “these agents are known in the art for treating chronic
alcoholism.” (Ans. 24.) In addition, the Examiner finds that Zenovich I
“teaches the vicinyl dithioglycols to be reactive with ketonic or carbonyl

2 We rely on the certified translation submitted by Appellant.
3 We refer to the Non-Final Action dated October 30, 2018.
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compounds, particularly aldehydes and ketones in ethanol products (p. 6,3rd
full para; pp. 10-11, bridging para).” (Non-Final Action 14.)
The Examiner recognizes that “Zenovich [I] does not explicitly teach
prophylaxis of the origination or development of dependence disease or
dependence formation, or reducing the rate of development of pathological
processes associated with formation of tetrahydroisoquinolines (THIQs).”
(Id.) However, the Examiner determines that these all would have been
obvious from the teachings of Myers and Zenovich II.
In particular, the Examiner finds that “Myers teaches
tetrahydroisoquinolines (THIQs), such as THP, as products of ethanol
metabolism, and that THP induces alcohol consumption in increasingly
excessive amounts in animal models, even in animals that normally reject
alcohol (see Abstract of Meyers).” (Id. at 15.) In addition, the Examiner
finds that Myers teaches “THIQs are thought to be generated from
acetaldehyde, the first ethanol metabolite.” (Id.)
The Examiner further finds that “Zenovich II affirms” Zenovich I’s
teaching that “vicinal dithioglycols such as unithiol irreversibly bind
aldehydes present in alcoholic beverages.” (Ans. 27; Non-Final Act. 15.)
According to the Examiner,
one of ordinary skill in the art, in reviewing the teachings of
Zenovich I, Myers, and Zenovich II would have been motivated
to have orally administered unithiol to a subject for
prophylactic or therapeutic treatment of a subject at risk of
developing pathological processes caused by alcohol
consumption, with the reasonable expectation that oral
administration of unithiol would have resulted in binding of
unithiol to acetaldehyde irreversibly, which would prevent
acetaldehyde from reacting with catecholamines thereby
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suppressing the formation of THIQs, which are implicated in
the addictiveness of alcohol consumption.
(Ans. 24–25.)
We agree with the Examiner’s conclusion of obviousness but rely on
fewer references. In affirming a multiple reference rejection under 35
U.S.C. § 103, the Board may rely on fewer than all of the references relied
on by the Examiner in an obviousness rationale without designating it as a
new ground of rejection. In re Bush, 296 F.2d 491, 496 (CCPA 1961).
The method of claim 22 requires “prophylactic oral administration” of
“repeated doses” of a vicinal dithioglycol of general formula 1 to a subject,
inter alia, “at risk of suffering from development of pathological processes
caused by using alcohol-containing beverages.” The result of such
administration is to “thereby block[] the development and/or for reduc[e] the
rate of development of pathological processes associated with formation of
tetrahydroisoquinolines (THIQs).” Thus, the method targets patients who
drink alcohol. We conclude that the “thereby” clause is not stating a
condition under which the positively recited method step must occur, see,
e.g., Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329–30 (Fed. Cir. 2005),
but rather simply expresses the intended result of the process step of the
repeated oral administration of the claimed compound. Consequently, we
determine that the “thereby” clause is not given any weight. See, e.g.,
Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed.
Cir. 2003) (a “whereby clause in a method claim is not given weight when it
simply expresses the intended result of a process step positively recited.”).
There is no explicit definition of what is meant by a pathological
process in Appellant’s Specification. Appellant’s Specification indicates
that pathological processes “originate as a consequence of using ethanol-
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containing beverages and/or substances having an addictive potential.”
(Spec. 4.) The Specification also indicates that the claimed compounds
bring about “effects which manifest themselves first of all in connection
with drinking household-grade ethanol or indulging in alcohol-containing
beverages, and also in connection with using psychoactive substances.” (Id.
at 4.) A list of effects is provided and includes dependence formation,
withdrawal syndrome formation, somatovegetative symptoms of withdrawal
syndrome, the formation of morbid attraction to alcohol, the formation of
quantitative control loss, tolerance development, organ pathologies
(particularly of the brain, liver, myocardium), and alcoholism amnesia. (Id.)
This list appears to be exemplary of pathological processes, but does not
appear to be exhaustive of such processes. We conclude that the claimed
pathological process is simply an effect on the body originating as a
consequence of using ethanol-containing beverages.
Appellant’s Specification does not identify a particular patient
population that is at risk of suffering from development of pathological
processes caused by using alcohol-containing beverages. However, as
discussed above Appellant’s Specification does state that the processes
“originate as a consequence of using ethanol-containing beverages.” (Spec.
4.) Consequently, we determine that an individual who has imbibed an
alcoholic beverage is a target patient of the claimed invention.
We agree with Appellant that the Examiner’s rejection fails to
establish a reasonable expectation that the oral administration of a vicinyl
dithioglycols, such as unithiol, (a) would prevent acetaldehyde from reacting
with catecholamines, (b) which would in turn suppress the formation of the
THIQ, THP, or condensation products of biogenic amine metabolism formed
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in the presence of ethyl alcohol generally (c) which would in turn inhibit the
development of pathological processes caused by using alcohol-containing
beverages and/or substances having an addictive potential in the subject.
(Reply Br. 3.) The fact that Myers teaches THIQs derived from
catecholamines may be induced by acetaldehyde, which is a first metabolite
of ethanol (Myers 554), does not provide evidence that unithiol, which
undisputedly can irreversibly react with aldehydes, when ingested would
reasonably be expected to prevent the formation of the THIQ known as
THP, or any other condensation products of biogenic amine metabolism, not
identified particularly in Myers, but which Myers indicates have been
implicated in the addictive liability of alcoholic beverages. At best, the prior
art relied on by the Examiner provides an invitation to explore whether
unithiol might prevent the formation of THP or other condensation products
of biogenic amine metabolism. This invitation to experiment does not
equate to prima facie obviousness under § 103. See In re Kubin, 561 F.3d
1351, 1359 (Fed. Cir. 2009).
However, that Myers does not establish a reasonable expectation that
unithiol would suppress the formation of the THIQs and the claimed
“pathological processes” does not preclude affirming the Examiner’s
rejection for obviousness. That is because we conclude such an effect of
administering the claimed compound is a result that is necessarily achieved
by the administration of unithiol that is taught by Zenovich.
“[M]erely discovering and claiming a new benefit of an old process
cannot render the process again patentable.” King Pharmaceuticals, Inc. v.
Eon Labs, Inc., 616 F.3d 1267, 1275–76 (Fed. Cir. 2010) (citations
omitted)). This is precisely the description of the claimed invention set forth
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in Appellant’s Specification: “We have revealed novel properties of said
substances, owing to which their effect for a new purpose manifests itself.”
(Spec. 5.)
As the Examiner found, Zenovich I indicates that vicinyl dithioglycol
has been used “for treating chronic alcoholism and relieving delirium
tremens paroxysms (‘the horrors’),” as well as teaching adding such a
compound to food or drink to alleviate the severity of a hangover from
alcohol “which set in immediately during the first 24 hours after alcohol
consumption. (Zenovich I 5, 6.) In other words, Zenovich I teaches
administering the claimed compounds to a person who has imbibed alcohol
at least once, as well as to one who has drank enough alcohol to be
considered to be suffering from alcoholism. We conclude that such a person
is at risk for the development of pathological processes caused by drinking
the alcohol which is a beverage that has addictive potential. As discussed
above a pathological process is a process that “originate[s] as a consequence
of using ethanol-containing beverages and/or substances having an addictive
potential.” (Spec. 4.)
Appellant’s Specification explains that administering the claimed
compounds “leads to blocking or inhibiting the process of formation of
THIQs.” (Spec. 8.) This is a property that is simply a result of
administration of the compound, it is inherent in the administration of the
compound.
Furthermore, Appellant’s Specification additionally states that the
blocking or inhibiting of forming THIQs after administration affects “the
process of formation of withdrawal syndrome and dependence syndrome.”
(Id.) Consequently, this effect on a pathological process is also an inherent
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property resulting from the administration of the claim compound, which
administration is taught by Zenovich I. Such is consistent with Appellant’s
Specification indicating that “we have discovered novel properties of general
formula (1).” (Id. at 5.)
Consequently, we conclude that the oral administration of the
compounds described in Zenovich I to the patient population in Zenovich I,
which we have explained meet the “at risk” requirement of the claimed
method, would necessarily block or reduce the development of at least one
pathological process associated with THIQs. Inherency can be used in
establishing prima facie obviousness. See, e.g., Alcon Research, Ltd. v.
Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2012) (finding the method
limitation “stabilizing conjunctival mast cells” to be met inherently by a
prior art teaching of administering a concentration of the claimed compound
in an amount that overlapped with amounts recited in the claim). It is not
necessary for Zenovich I to recognize the effect of the administration of the
claimed compound would block or reduce the development of at least one
pathological process associated with THIQs for such a conclusion to render
obvious the claimed invention. See In re Kubin, 561 F.3d 1351, 1357 (Fed.
Cir. 2009) (stating “[e]ven if no prior art of record explicitly discusses the
[limitation], [applicant’s] application itself instructs that [the limitation] is
not an additional requirement imposed by the claims on the [claimed
invention], but rather a property necessarily present in [the claimed
invention]”); In re Kao, 639 F.3d 1057, 1070 (Fed. Cir. 2011) (“Substantial
evidence supports the Board’s finding, based upon the specification, which
confirms that the claimed ‘food effect’ is an inherent property of
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oxymorphone itself, present both in controlled release and immediate release
formulations of that drug”).
The only limitation not specifically discussed in Zenovich I is the
repeated doses. However, we find that such administration would have been
obvious in light of Zenovich I’s teaching that the claimed compounds have
been used to treat chronic alcoholism and relieving delirium tremens
paroxysms. (Zenovich I 5.) That is, one who has chronic alcoholism or
“horrors” would likely need to receive a dose of the claimed compound on
more than one occasion.
Appellant’s arguments concerning the impossibility of predicting the
effect of administration of the claimed compound (Appeal Br. 5–7; Reply
Br. 4–5) is not persuasive as the effect is the inherent result of administering
the compound orally, which is the method taught by Zenovich I.
Appellant’s argument that there is evidence that the administration of the
claimed compound could have had the opposite of a prophylactic effect
(Appeal Br. 7) is also unavailing. The evidence does not establish that the
claimed effect is not inherent. Rather, the evidence is simply an in vitro
study on reaction kinetics and a conclusion that one of skill in the art might
have drawn based thereon as to the rate of THIQ formation if unithiol were
administered to a patient. (See Zenovich Declaration dated May 11, 2018
¶ 8; Ans. 22–23.)
For the foregoing reasons, we affirm the Examiner’s rejection of
claims 9–11, 14, 17, 18, and 22–44 as being obvious from Zenovich I,
Myers, and Zenovich II.

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Obviousness-Type Double Patenting
The Examiner cites Myers and Zenovich II for the reasons discussed
above. (See, e.g., Non-Final Action 19.) The Examiner finds that the claims
of US Patent 7,229,637 are directed to treating a subject suffering from acute
alcohol intoxication through oral or transdermal administration of a vicinal
dithioglycol. (Non-Final Action 18.) The Examiner further finds that those
“suffering from acute alcohol intoxication, are included within subjects at
risk of developing pathological processes caused by alcohol beverage
consumption.” (Id. at 20.) The Examiner concludes that it would have been
obvious
that by administering unithiol to a subject suffering from a
consequence of consumption of alcoholic beverages, such as
alcoholism, ethanol withdrawal syndrome, or delirium tremens,
unit[h]iol would have irreversibly bound to acetaldehyde
generated from ethanol metabolism, thereby preventing or
inhibiting the formation of THIQs, which are associated with
the addictive property of ethanol beverages
and would have prevented the development of pathological processes along
with development of alcohol dependence. (Id.)
The Examiner’s rejection that relies on the claims of the ’196 and
’705 patents is similar. (See Non-Final Action 21–27; Ans. 29–30.) The
claims of those patents are directed to treating a subject to remove or
alleviate the effects of alcohol consumption after oral intake of alcohol; and
treating a subject to remove or alleviate the effects of alcohol consumption
after intake of alcohol, respectively. (Non-Final Action 21, 25; Ans. 29.)
The Examiner states that as in the obviousness rejection,
[o]ne of ordinary skill in the art would have had a reasonable
expectation of success in applying the steps of the US patents
for prophylactic oral administration to a subject at risk of
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developing pathological processes caused by consumption of
alcoholic beverages with the understanding that oral
administration of a vicinal dithioglycol would have resulted in
irreversible binding of unithiol to acetaldehyde derived from
ethanol consumption, which would have prevented
acetaldehyde from reacting with a catecholamine, thereby
preventing formation of THIQs.
(Ans. 30.)
However, the fact that Myers teaches THIQs derived from
catecholamines such as THP may be induced by acetaldehyde and that
condensation products of biogenic amine metabolism formed in the presence
of ethyl alcohol have been implicated in the addictive liability of alcoholic
beverages does not provide evidence that unithiol or any other vicinyl
dithioglycol that can irreversibly react with aldehydes, would reasonably be
expected to (a) prevent the formation of THP from catecholamine after
alcohol consumption, or (b) prevent another condensation product of
biogenic amine metabolism implicated in addictive liability of alcoholic
beverages. Rather, at best Myers provides an invitation to investigate
whether vicinyl dithioglycols administered orally to a subject who drinks
alcohol and is subject to becoming addicted to it (a) could prevent aldehyde
produced from ethanol consumption from interacting with catecholamine
such that THP would be prevented from forming or (b) could prevent some
other known but unnamed condensation product from a biogenic amine
known to be formed in the presence of ethanol and known to be implicated
in the addictive liability of alcoholic beverages from forming.
Nevertheless, we conclude that the claimed invention would have
been obvious over the patented claims for the same reasons discussed above
in the obviousness rejection regarding Zenovich I. While the patented
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claims are directed at methods for treating acute alcohol intoxication, or
alleviating the effects of alcohol consumption after its intake orally, the
result recited in the claims on appeal is an inherent property of the oral
administration of the compounds recited in the patented methods.
Appellant’s arguments against these rejections are the same unpredictability,
no reasonable expectation of success arguments that we addressed above.
(Appeal Br. 11–12.) We do not find them persuasive for the same
reasoning. That is, regardless of whether one of ordinary skill in the art
would have appreciated that the administration of the claimed compounds
recited in the patented claims would have achieved the effect recited in the
claims on appeal, the result nevertheless is due to an inherent property of the
compound that manifests upon administration of the drug. “[T]he new
realization alone does not render the old invention patentable.” Perricone v.
Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005).
Consequently, we affirm the Examiner’s rejection of claims 9–11, 14,
17, 18, and 22–44 obviousness-type double patenting over the claims of U.S.
Patent Nos. 7,229,637 or 7,820,196 or 7,824,705 in combination with Myers
and Zenovich II.

Indefiniteness
The Examiner finds that claims 30, 31, 36, and 40 do not clearly set
forth the metes and bounds of protection desired because they each recite a
broad effect to the body but also a narrow effect by referring to the broad
effect “particularly” applying to certain body parts. (Non-Final Action 28.)
We agree with the Examiner’s conclusion that the claims are indefinite
because it is not clear whether the claim scope is limited to the broad effect
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to the body or only the effect in the particular body parts. We find contrary
to Appellant’s argument (Appeal Br. 12), that the Examiner analyzed the
claim scope appropriately and did not apply a per se rule.
Appellant’s argument that the issue was not raised previously “in the
long prosecution of this case” is not persuasive of error.
Thus, we affirm the Examiner’s rejection of claims 30, 31, 36, and 40
as being indefinite.

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
9–11, 14,
17, 18, 22–
44
103 Zenovich I, Myers,
Zenovich II
9–11, 14,
17, 18, 22–
44

9–11, 14,
17, 18, 22–
44
Nonstatutory
Double Patenting:
7,229,637, Myers,
Zenovich II
9–11, 14,
17, 18, 22–
44

9–11, 14,
17, 18, 22–
44
Nonstatutory
Double Patenting:
7,820,196, Myers,
Zenovich II
9–11, 14,
17, 18, 22–
44

9–11, 14,
17, 18, 22–
44
Nonstatutory
Double Patenting:
7,824,705, Myers,
Zenovich II
9–11, 14,
17, 18, 22–
44

30, 31, 36,
40
112 Indefiniteness 30, 31, 36,
40

Overall
Outcome
9–11, 14,
17, 18, 22–
44

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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