Lance GOOBERMAN

Patent Trials and Appeals Board

May 27, 2021

2020003073 (P.T.A.B. May. 27, 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.
15/283,751 10/03/2016 Lance L. GOOBERMAN CU-71282 JPL 7700
26530 7590 05/27/2021
LADAS & PARRY LLP
224 SOUTH MICHIGAN AVENUE
SUITE 1600
CHICAGO, IL 60604
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
05/27/2021 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):
ChicagoUSPTO@ladas.net
uspto@dockettrak.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD

Ex parte LANCE L. GOOBERMAN

Appeal 2020-003073
Application 15/283,751
Technology Center 1600

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
TAWEN CHANG, Administrative Patent Judges.

PRATS, 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 22–33. 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 Lance L.
Gooberman. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
The claims are directed to methods for blocking and/or reversing the
physiological effects of one or more opioids. Claim 22 is representative and
reads as follows:
22. A method to block and/or reverse physiological effects of
one or more opioids selected from 3-Methylbutyrfentanyl (3-
MBF), 3-Methylfentanyl (3-MF), 4-Chloroisobutyrfentanyl (4-
CliBF, a.k.a. p-CliBF), 4-Fluorobutyrfentanyl (4-FBF, a.k.a.
pFBF), 4-Fluoroisobutyrfentanyl (4-FiBF, a.k.a. p-FiBF), 4-
Methoxybutyrfentanyl (4-MeOBF, a.k.a. p-MeO-BF),
4-Fluorofentanyl (4-FF, a.k.a. p-FF), Acetylfentanyl (AF),
Acrylfentanyl, AD-1211, AH-7921, α-Methylfentanyl (“China
White”), Butyrfentanyl (BF), Desmethylprodine (MPPP),
Furanylfentanyl (Fu-F), 4'-Nitromethopholine, Nortilidine,
O-Desmethyltramadol, Valerylfentanyl
comprising administrating a pharmaceutical formulation
in the form of liquid solution for spray administration by the
nasal and/or buccal route containing naltrexone in a
pharmaceutically efficacious amount as the active ingredient.

Appeal Br. 14.
REFERENCE(S)
The prior art relied upon by the Examiner is:
Name Reference Date
Fintan Keegan
(“Keegan”)
US 2017/0071851 A1 Mar. 16, 2017
David Davies et al.
(“Davies”)
WO 00/62757 A1 Oct. 26, 2000
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REJECTION(S)
The following rejections are before us for review:
(1) Claims 22–33, under 35 U.S.C. § 112(b) as being indefinite (Ans.
3–4);
(2) Claims 22, 24, 26, 27, 28, 30, 32, and 33, under 35 U.S.C.
§ 102(a)(2) as being anticipated by Keegan (Ans. 4–5); and
(3) Claims 22–33, under 35 U.S.C. § 103 as being unpatentable over
Keegan and Davies (Ans. 5–7).
INDEFINITENESS
As an initial matter, we note that while the Examiner restated the
rejection for indefiniteness in the Examiner’s Answer, Appellant did not
present argument traversing the rejection for indefiniteness in its Appeal
Brief. See Appeal Br. 7 (list of appealed rejections does not include rejection
for indefiniteness).
We note, however, that after the appealed Final Office Action (entered
February 26, 2019), the Examiner stated that “[t]he rejection of claims 22-33
under 35 USC 112-2 has been withdrawn after careful consideration.”
Advisory Act. 2 (entered April 25, 2019). Accordingly, we find that
Appellant’s traversal of the indefiniteness rejection in the Reply Brief is
sufficiently timely.
Turning to the merits of the indefiniteness rejection, the Examiner
determines that “[c]laim 22 recites the limitation ‘efficacious amount’ which
is a relative term.” Ans. 3. The Examiner determines, however, that the
“efficacious amount would differ from case by case, whether patient is at the
chronic stage, weight, age, tolerance capability etc.” Id. at 3–4.
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Therefore, the Examiner concludes, “[t]he scope of an efficacious
amount is unclear and confusing. Thus, any amount would be encompassed
by the unclear scope of the claim.” Ans. 4.
We agree with Appellant that the term “efficacious amount” does not
render Appellant’s claims indefinite. See Reply Br. 2.
A claim does not comply with 35 U.S.C. § 112, second paragraph,
“when it contains words or phrases whose meaning is unclear.” In re
Packard, 751 F.3d 1310, 1314 (Fed. Cir. 2014) (approving, for pre-issuance
claims, the standard from MPEP § 2173.05(e)); see also Ex parte McAward,
Appeal 2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017)
(precedential) (adopting the approach for assessing indefiniteness approved
by the Federal Circuit in Packard).
That is, “claims are required to be cast in clear—as opposed to
ambiguous, vague, indefinite—terms.” Packard, 751 F.3d at 1313; see also
Nautilus, Inc. v. Biosig, Insts., Inc., 572 U.S. 898, 908–10 (2014) (“[A]
patent’s claims, viewed in light of the specification and prosecution history,
[must] inform those skilled in the art about the scope of the invention with
reasonable certainty. The definiteness requirement, so understood, mandates
clarity, while recognizing that absolute precision is unattainable.”).
In the present case, Appellant’s independent claim 22 recites “[a]
method to block and/or reverse physiological effects of one or more opioids
selected from” a list of opioids recited in the claim. Appeal Br. 14.
Appellant’s claim 28, the other independent claim on appeal, also recites
“[a] method to block and/or reverse physiological effects of one or more
opioids selected from” a list of opioids recited in the claim. Appeal Br. 15.
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Thus, although the appealed independent claims both recite
administering the active ingredients in pharmaceutically efficacious
amounts, claims 22 and 28 both expressly recite the effect that must result
from administering the active agents—blocking and/or reversing the
physiological effects of the one or more opioids listed in the claims. We are
not persuaded, therefore, that in reciting administration of efficacious
amounts, claims 22 and 28 are ambiguous, vague, or unclear.
Moreover, the fact that the effect of administering the active agent
might vary from case to case does not persuade us that a skilled artisan
would be unable to determine, with reasonable certainty, whether a
particular administration exhibited an effect encompassed by the claims.
Further, while claims 22 and 28 encompass administering any amount of the
active agents that block and/or reverse any physiological effects of the listed
opioids to any degree, it is well settled that “breadth is not to be equated
with indefiniteness.” In re Miller, 441 F.2d 689, 693 (CCPA 1971).
In sum, we are not persuaded, for the reasons discussed, that
Appellant’s claims are indefinite. We therefore reverse the Examiner’s
rejection of claims 22–33 under 35 U.S.C. § 112(b).
ANTICIPATION
We select Appellant’s claim 22 as representative of the claims rejected
by the Examiner as being anticipated by Keegan. See 37 C.F.R.
§ 41.37(c)(1)(iv) (2018).
In rejecting Appellant’s claim 22 as anticipated by Keegan, the
Examiner finds that Keegan describes nasally administering naltrexone in
amounts encompassed by claim 22 to opioid overdose patients, or suspected
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opioid overdose patients, wherein the opioid is one or more of those listed in
claim 22. See Ans. 4.
Appellant contends, for a number of reasons, that the Examiner erred
in finding that Keegan anticipates Appellant’s representative claim 22. See
Appeal Br. 10–13; see also Reply Br. 3 (“It is in fact impossible for Keegan
to anticipate the claimed inventions.”).
Having carefully considered all of the evidence and arguments
submitted by Appellant and the Examiner, Appellant does not persuade us
that the Examiner erred in determining that Keegan anticipates Appellant’s
representative claim 22.
Our reviewing court has explained that a reference “need not always
include an express discussion of the actual combination [of claimed
elements] to anticipate. Instead, a reference may still anticipate if that
reference teaches that the disclosed components or functionalities may be
combined and one of skill in the art would be able to implement the
combination.” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1344
(Fed. Cir. 2016) (citation omitted); see also In re Gleave, 560 F.3d 1331,
1334 (Fed. Cir. 2009) (“As long as the reference discloses all of the claim
limitations and enables the subject matter that falls within the scope of the
claims at issue, the reference anticipates—no actual creation or reduction to
practice is required.”) (internal quotations omitted); Net MoneyIN, Inc. v.
VeriSign, Inc., 545 F.3d 1359, 1369 n.5 (Fed. Cir. 2008) (The inquiry is “not
constrained to proceed example-by-example when reviewing an allegedly
anticipating prior art reference. Rather, the [reviewer] must, while looking
at the reference as a whole, conclude whether or not that reference discloses
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all elements of the claimed invention arranged as in the claim.”) (emphasis
added).
In the present case, Keegan discloses “drug products adapted for nasal
delivery of an opioid receptor antagonist. Opioid receptor antagonists are a
well recognized class of chemical agents. They have been described in
detail in the scientific and patent literature.” Keegan ¶ 69. Keegan explains
that “[p]ure opioid antagonists, such as naloxone, are agents which
specifically reverse the effects of opioid agonists but have no opioid agonist
activity.” Id.
Keegan discloses that opioid antagonists useful in its nasal
formulations are not limited to naloxone, but also include naltrexone, as
recited in Appellant’s claim 22:
While many of the embodiments of the pharmaceutical
compositions described herein will be described and
exemplified with naloxone, other opioid antagonists can be
adapted for nasal delivery based on the teachings of the
specification. In fact, it should be readily apparent to one of
ordinary skill in the art from the teachings herein that the
devices and pharmaceutical compositions described herein may
be suitable for other opioid antagonists. The opioid receptor
antagonists described herein include μ-opioid antagonists and δ-
opioid receptor antagonists. Examples of useful opioid
receptor antagonists include naloxone, naltrexone,
methylnaltrexone, and nalmefene. Other useful opioid receptor
antagonists are known (see, e.g., Kreek et al., U.S. Pat. No.
4,987,136).
Keegan ¶ 73 (emphasis added).
Keegan discloses that naltrexone, the active ingredient recited in
Appellant’s claim 22, is useful by itself in nasal formulations:
Also provided are devices adapted for nasal delivery of a
pharmaceutical composition to a patient, comprising a
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therapeutically effective amount of an opioid antagonist,
wherein the device is pre-primed, and wherein the
therapeutically effective amount is about 4 mg to about 12 mg.
In some embodiments, the therapeutically effective amount is
equivalent to about 3.4 mg of naloxone hydrochloride. In some
embodiments, the therapeutically effective amount is equivalent
to about 4 mg of naloxone hydrochloride. In some
embodiments, the opioid antagonist is selected from
naltrexone, methylnaltrexone, and nalmefene, and
pharmaceutically acceptable salts thereof. In some
embodiments, the opioid antagonist is naltrexone
hydrochloride. In some embodiments, the opioid antagonist is
methylnaltrexone bromide. In some embodiments, the opioid
antagonist is nalmefene hydrochloride. In some embodiments,
the opioid antagonist is the only pharmaceutically active
compound in pharmaceutical composition.
Keegan ¶ 74 (emphasis added).
As recited in Appellant’s claim 22, Keegan discloses that its nasal
formulations are in liquid form. Keegan ¶ 76.
As the Examiner notes (see Ans. 8), Keegan discloses nasally
administering naltrexone to treat opioid overdose patients, as recited in
Appellant’s claim 22:
Also provided are devices, kits, and pharmaceutical
formulations for, and methods of, treating opioid overdose or a
symptom thereof, reversing the psychotomimetic and dysphoric
effects of agonist-antagonists such as pentazocine, diagnosing
suspected acute opioid overdosage, treating opioid addiction, or
treating septic shock, comprising nasally administering to a
patient in need thereof a therapeutically effective amount of
an opioid antagonist, wherein the therapeutically effective
amount is about 2 mg to about 12 mg. In some embodiments,
the therapeutically effective amount is equivalent to about 4.4
mg of naloxone hydrochloride dihydrate. In some
embodiments, the therapeutically effective amount is equivalent
to about 4 mg of naloxone hydrochloride. In some
embodiments, the patient is an opioid overdose patient. In
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some embodiments, the patient is not breathing. In some
embodiments, the opioid antagonist is the only
pharmaceutically active compound in said pharmaceutical
composition. In some embodiments, the opioid antagonist is
selected from naltrexone, methylnaltrexone, and nalmefene,
and pharmaceutically acceptable salts thereof. In some
embodiments, the opioid antagonist is naltrexone
hydrochloride.
Keegan ¶ 469 (emphasis added).
Keegan discloses that opioid compounds that cause overdose treatable
by its methods include compounds recited in Appellant’s claim 22, such as
3-Methylbutyrfentanyl and 3-Methylfentanyl. Keegan 8 (Table A).
Given the above teachings, Appellant does not persuade us that the
Examiner erred in determining that, when viewed as a whole, Keegan
describes nasally administering a liquid naltrexone formulation to treat
overdose caused by 3-Methylbutyrfentanyl and/or 3-Methylfentanyl.
Appellant does not persuade us, therefore, that the Examiner erred in
determining that Keegan, when viewed as a whole, describes a process
having all of the elements of Appellant’s representative claim 22, arranged
as in the claim.
Indeed, because Keegan must be viewed as a whole, disregarding or
ignoring the teachings in paragraphs 73 and 74 of Keegan, as posited by
Appellant (see Appeal Br. 11–12), would be erroneous. See Net MoneyIN,
545 F.3d at 1369 n.5 (The inquiry is “not constrained to proceed example-
by-example when reviewing an allegedly anticipating prior art reference.
Rather, the [reviewer] must, while looking at the reference as a whole,
conclude whether or not that reference discloses all elements of the claimed
invention arranged as in the claim.”) (emphasis added).
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Similarly, because the reference must be viewed as a whole, the fact
that Keegan’s working examples might only use naloxone (see Appeal Br.
12) does not demonstrate that Keegan fails to anticipate claim 22. See Net
MoneyIN, 545 F.3d at 1369 n.5 (noting that the inquiry is “not constrained to
proceed example-by-example”). Indeed, Appellant points to nothing in this
Board’s non-precedential decision in Ex parte Zerbe suggesting that it would
be proper to ignore the express teachings in Keegan, reproduced above,
when evaluating the Examiner’s finding of anticipation. See Appeal Br. 11–
12.
Appellant contends that “[t]he courts have long held that a computer
generated list of chemical entities without specific teaching of use is not a
proper basis for rejection. In re Donohue (II) 766 F.2d 531, 226 USPQ 619
(Fed. Cir. 1985).” Appeal Br. 11.
Appellant, however, points to no discussion in Donohue that mentions
anything about computer generated lists. See Appeal Br. 11. To the
contrary, Donohue expressly states that, for the purposes of anticipation,
“[i]t is not . . . necessary that an invention disclosed in a publication shall
have actually been made in order to satisfy the enablement requirement.”
Donohue, 766 F.2d at 533; accord, Gleave, 560 F.3d at 1334 (“As long as
the reference discloses all of the claim limitations and enables the subject
matter that falls within the scope of the claims at issue, the reference
anticipates—no actual creation or reduction to practice is required.”)
(internal quotations omitted).
Thus, absent some evidence that the teachings discussed above in
Keegan are not enabling, the fact that Keegan’s working examples might not
include naltrexone, and the fact that Keegan does not include experimental
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evidence of naltrexone’s efficacy, are insufficient to show that Keegan fails
to anticipate claim 22. See Appeal Br. 13; Reply Br. 3; see also Gleave, 560
F.3d at 1335 (“[I]n the context of a claimed method for treating a disease, a
prior art reference need not disclose proof of efficacy to anticipate the
claim.”) (internal quotations omitted).
We are not persuaded that Appellant has advanced persuasive
evidence suggesting that the disclosures in Keegan describing the nasal
administration of naltrexone to treat opioid overdose, reproduced above, are
non-enabling. In that regard, we acknowledge Appellant’s citation of
Exhibits A2 and B3 to the Appeal Brief. See Appeal Br. 12 (citing Exhibit
B); Appeal Br. 13 (citing Exhibit A).
Appellant, however, does not point to, nor do we discern, any
discussion in either of the exhibits to the Appeal Brief that specifically
mentions anything about naltrexone. See Appeal Br. 11–12 (citing Exhibit
B); Appeal Br. 13 (citing Exhibit A). Appellant, moreover, does not point to
any persuasive evidence suggesting that the alleged difficulties of using
naloxone to treat fentanyl overdose, supposedly shown by Exhibits A and B,
demonstrates that Keegan’s disclosures regarding naltrexone, an entirely
different chemical compound, are non-enabling.
We note, in addition, that the articles in Exhibits A and B both have
publication dates after the October 3, 2016, filing date of the present
application, and Appellant points to no evidence suggesting that the

2 Jessica Firger, Fentanyl Found in Georgia Resists Life-Saving Naloxone
Antidote, NEWSWEEK 1–9 (2017).
3 Ronald B. Moss & Dennis J. Carlo, Higher doses of naloxone are needed
in the synthetic opioid era, 14 SUBSTANCE ABUSE TREATMENT, PREVENTION,
AND POLICY 1–6 (2019) (https://doi.org/10.1186/s13011-019-0195-4).
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information disclosed in those articles would have been known or available
to skilled artisans at the time the present application was filed. See Exhibit
A (2017 publication date); Exhibit B (2019 publication date). Further, while
Appellant contends that “many references” have been provided to show that
treatment of overdose from fentanyl and/or its analogs is “highly
unpredictable” (Reply Br. 3), Appellant does not cite any specific references
or evidence other than Exhibits A and B noted above, to support the asserted
unpredictability, or inferred lack of enablement, in relation to the disclosures
in Keegan.
Accordingly, for the reasons discussed, we are not persuaded that
Appellant has advanced evidence sufficient to show that the disclosures in
Keegan describing the nasal administration of naltrexone to treat opioid
overdose, including overdose caused by 3-Methylbutyrfentanyl and/or 3-
Methylfentanyl, are non-enabling. Appellant’s arguments alleging teaching
away by Keegan are also unpersuasive of non-anticipation by the reference.
See Celeritas Techs. Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354, 1361 (Fed.
Cir. 1998) (“[T]he question whether a reference ‘teaches away’ from the
invention is inapplicable to an anticipation analysis.”) (citation omitted).
Appellant argues, in view of OSI Pharmaceuticals, LLC v. Apotex
Inc., 939 F.3d 1375, 1383 (Fed. Cir. 2019), that Keegan “does not provide or
disclose any data or other information about naltrexone’s ‘efficacy’ in
treating fentanyl and fentanyl analog exposure – there is no clinical human
data nor even in vitro data.” Reply Br. 3. We are not persuaded.
As an initial matter, we are not persuaded that we should consider
Appellant’s arguments regarding OSI, because we are not persuaded that
those arguments are properly presented for the first time in the Reply Brief.
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See 37 C.F.R. § 41.41(b)(2) (“Any argument raised in the reply brief which
was not raised in the appeal brief, or is not responsive to an argument raised
in the examiner’s answer, including any designated new ground of rejection,
will not be considered by the Board for purposes of the present appeal,
unless good cause is shown.”); Ex parte Borden, 93 USPQ2d 1473, 1477
(BPAI 2010) (The reply brief is not “an opportunity to make arguments that
could have been made in the principal brief on appeal to rebut the
Examiner’s rejections, but were not.”) (“Informative”).
In any event, the ground of unpatentability involved in OSI was for
obviousness, not for anticipation. See OSI, 939 F.3d at 1379. Appellant
points to no discussion in OSI suggesting that a reference asserted as being
anticipatory must present evidence of efficacy. Directly to the contrary, as
noted above, our reviewing court has expressly stated that “in the context of
a claimed method for treating a disease, a prior art reference need not
disclose proof of efficacy to anticipate the claim.” Gleave, 560 F.3d at 1335
(internal quotations omitted).
In sum, for the reasons discussed, Appellant does not persuade us of
reversible error in the Examiner’s finding that, when viewed as a whole,
Keegan describes nasally administering a liquid naltrexone formulation to
treat overdose caused by 3-Methylbutyrfentanyl and/or 3-Methylfentanyl.
Appellant does not persuade us, therefore, that the Examiner erred in
determining that Keegan, when viewed as a whole, describes a process
having all of the elements of Appellant’s representative claim 22, arranged
as in the claim.
We therefore affirm the Examiner’s rejection of claim 22 as
anticipated by Keegan. Because they were not argued separately, claims 24,
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26, 27, 28, 30, 32, and 33 fall with claim 22. See 37 C.F.R.
§ 41.37(c)(1)(iv).
OBVIOUSNESS
In rejecting claims 22–33 for obviousness over Keegan and Davies,
the Examiner relied on the disclosures discussed above in Keegan describing
treatment of fentanyl derivative overdoses with naltrexone, and cited Davies
as evidence that additional features recited in Appellant’s dependent claims,
including dosage amounts and formulation ingredients, would have been
obvious variations of the process described in Keegan. See Ans. 5–7.
Appellant does not contend that the Examiner erred in determining
that a skilled artisan would have combined the cited teachings in Keegan and
Davies in the manner posited in the rejection. Rather, Appellant contends
that “with the failure of setting out anticipation rejection, therefore, the
Examiner has also failed to provide a prima facie case of obviousness
against the present U.S. application serial no. 15/283,751.” Appeal Br. 13.
We select claim 22 as representative of the claims subject to this
ground of rejection. See 37 C.F.R. § 41.37(c)(1)(iv).
As discussed above, Appellant does not persuade us that the Examiner
erred in determining that Keegan, when viewed as a whole, describes a
process having all of the elements of Appellant’s representative claim 22,
arranged as in the claim. Accordingly, Appellant does not persuade us that
the Examiner erred in determining that the process recited in Appellant’s
claim 22 would have been obvious to a skilled artisan, in view of the
teachings in Keegan, when combined with Davies. See In re McDaniel, 293
F.3d 1379, 1385 (Fed. Cir. 2002) (“It is well settled that ‘anticipation is the
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epitome of obviousness.’”) (quoting Connell v. Sears, Roebuck & Co., 722
F.2d 1542, 1548 (Fed. Cir. 1983)).
We therefore affirm the Examiner’s rejection of claim 22 for
obviousness over Keegan and Davies. Because they were not argued
separately, claims 23–33 fall with claim 22. See 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
22–33 112(b) Indefiniteness 22–33
22, 24, 26,
27, 28, 30,
32, 33
102(a)(2) Keegan 22, 24, 26,
27, 28, 30,
32, 33

22–33 103 Keegan, Davies 22–33
Overall
Outcome
22–33

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