AL-MELH, MANAL MANSOUR ABU.

Patent Trials and Appeals Board

May 28, 2020

15680113 - (D) (P.T.A.B. May. 28, 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.
15/680,113 08/17/2017 MANAL MANSOUR ABU AL-MELH 32898.00 1475
37833 7590 05/28/2020
Richard C. Litman
Nath, Goldberg & Meyer
112 S. West Street
Alexandria, VA 22314
EXAMINER
COHEN, MICHAEL P
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
05/28/2020 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):
mbashah@nathlaw.com
uspto@4patent.com
uspto@nathlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte MANAL MANSOUR ABU AL-MELH
__________

Appeal 2019-005387
Application1 15/680,113
Technology Center 1600
__________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

TOWNSEND, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to an
anesthetic chewing gum, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
“Various techniques currently exist for controlling or managing the
pain associated with dental procedures,” including use of topical anesthetics
and medicated wax, which assist in relieving mucosal discomfort. (Spec.

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 the inventor.
(Appeal Br. 3.)
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¶ 3.) According to Appellant’s Specification “[t]hese techniques generally
do not provide pain relief for prolonged periods of time.” (Id.)
Appellant’s invention of an anesthetic chewing gum, seeks to solve
“the aforementioned problems.” (See id. ¶¶ 4, 8.)
Claims 1–11 are on appeal.2 Claim 1 is representative and reads as
follows:
1. An anesthetic chewing gum, comprising a combination of an
analgesic component and a chewing gum base component:
the analgesic component consists of 2 mg lidocaine HCL
and 2 mg prilocaine HCL; and
the chewing gum base component comprises a chewing
gum base.
(Supplemental Appeal Br. 4.)

2 Claims 12–20 remain pending but are withdrawn from consideration.
(Appeal Br. 6.)
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The prior art relied upon by the Examiner is:

Name Reference Date
Faust et al. US 4,822,597 Apr. 18, 1989
Cherukuri et al. US 4,753,805 June 28, 1988
D. Donaldson et al., A Comparison of the Effects of EMIA ® Cream and
Topical 5% Lidocaine on Discomfort During Gingival Probing, 42
Anesth. Prog. 7–10 (1995)
B. Hyrup et al., The MediChew technology platform, 2(5) Expert Opin.
Drug. Deliv. 927–33 (2005)
S.A. Chaudhary and A. F. Shahiwala, Medicated chewing gum – a
potential drug delivery system, 7(7) Expert Opin. Drug. Deliv. 871–85
(2005)
M. Paradkar et al., Formulation development and evaluation of medicated
chewing gum of anti-emetic drug, 24 Saud Pharm. J. 153–64 (2016)

The following grounds of rejection by the Examiner are before us on
review:
Claim 1 under 35 U.S.C. § 103(a) as unpatentable over Faust and
Donaldson.
Claim 2 under 35 U.S.C. § 103(a) as unpatentable over Faust,
Donaldson, and Hyrup.
Claims 3, 4, 6–9, and 11 under 35 U.S.C. § 103(a) as unpatentable
over Faust, Donaldson, Hyrup, and Chaudhary.
Claim 5 under 35 U.S.C. § 103(a) as unpatentable over Faust,
Donaldson, Hyrup, Chaudhary, and Paradkar.
Claim 10 under 35 U.S.C. § 103(a) as unpatentable over Faust,
Donaldson, Hyrup, Chaudhary, and Cherukuri.3

3 The Examiner’s rejection indicates this grouping of references is directed
at claim 11. We determine that this is an inadvertent error because claim 10
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DISCUSSION
The Examiner finds that Faust teaches an anesthetic chewing gum
where the anesthetic may be “selected from the group generally known as
local or topical anesthetics such as lidocaine.” (Non-Final Action 4.) The
Examiner further explains that Faust teaches that the selected anesthetic is
included in the composition in an amount from about 1.5 mg to 5 mg, which
overlaps with the claimed range. (Id.)
The Examiner finds that Donaldson teaches “oral treatment with a 1:1
mixture of prilocaine and lidocaine known as EMLA (Eutectic Mixture of
Local Anesthetics) is somewhat more effective than lidocaine alone in
reducing the pain caused by probing the gingival tissue with a metal probe.”
(Id. at 5.)
The Examiner concludes from the foregoing that it would have been
obvious to one of ordinary skill in the art to substitute EMLA for lidocaine
in Faust with a reasonable expectation of success. (Id.)
We agree with the Examiner’s conclusion of obviousness. In
particular, Faust teaches that the chewing gum composition includes a local
anesthetic in a manner that the anesthetic is readily released and available to
anesthetize (provide a numbing effect) the throat and mouth areas, and
thereby providing relief to irritated areas. (Faust abstract; 1:12–15.) Thus,
we disagree with Appellant that Faust is only directed “to be an effective
sore throat remedy” (Appeal Br. 8 (citing Faust 1:41–52)). “It is well settled

concerns peppermint oil, not claim 11, and the Examiner relies on Cherukuri
to address the obviousness of including peppermint oil in a chewing gum
formulation. (Non-Final Action dated July 25, 2018 at 11–12.)
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that a prior art reference is relevant for all that it teaches to those of ordinary
skill in the art.” In re Fritch, 972 F.2d 1260, 1265 (Fed. Cir. 1992).
Furthermore, although Faust only exemplifies a chewing gum that
includes hexylresourcinol (Faust 5–6 (table); Appeal Br. 8) as the anesthetic,
it teaches that lidocaine is among the 10 preferred anesthetics for use (Faust
1:66–2:3). “[A]ll disclosures of the prior art, including unpreferred
embodiments, must be considered.” In re Lamberti, 545 F.2d 747, 750
(CCPA 1976). For this reason, we also disagree with Appellant that the
Examiner erred by “arbitrarily” selecting lidocaine from among the 10
anesthetics (Appeal Br. 11). Faust reasonably suggests that each of the 10
ingredients would be expected to achieve a chewing gum that achieves
numbing of the mouth and throat and in the amounts identified as being the
useful range.4 Faust teaches that range to be in between 1.5 to about 5.0 mg.
(Faust 2:7–8.)

4 Appellant belatedly argues in the Reply Brief that Faust teaches away
from the use of lidocaine. (Reply Br. 5–6.) First, “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.” Ex parte
Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative). As stated in Ex
parte Borden, consideration by the Board of new arguments presented for
the first time in the Reply Brief that could have been presented earlier would
“vitiate the force of the requirement in Board Rule 37(c)(1)(vii) that ‘[a]ny
arguments or authorities not included in the brief . . . will be refused
consideration by the Board, unless good cause is shown.”’ Id. We do not
find any substantial differences in the Examiner’s initial findings and the
Examiner’s findings stated in the Answer that would warrant the new
arguments presented in the Reply Brief for the first time. (Compare Non-
Final Action 4 (“Faust teaches useful anesthetics may be selected from the
group generally known as local or topical anesthetics such as lidocaine.”),
with Ans. 5 (“Faust teaches lidocaine as a preferred anesthetic (column 1,
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Donaldson provides a comparative study of the intraoral use of
EMLA5 compared to lidocaine for anesthetizing the gingiva. (Donaldson 7.)
That EMLA is not registered for intraoral use (Appeal Br. 9, 12) does not
negate the evidence of effectiveness provided in Donaldson. Indeed,
“[c]onclusive proof of efficacy is not necessary to show obviousness.”
Hoffmann–La Roche Inc. v. Apotex Inc., 748 F.3d 1326, 1331 (Fed. Cir.
2014).
The EMLA anesthetic in Donaldson was applied by being placed on a
splint that was put in position in the first premolar region. (Donaldson 8.)
EMLA was determined to be “significantly more effective than 5%
lidocaine.” (Id. at 9.) Donaldson further notes that it was reported that
EMLA was more effective than lidocaine in anesthetizing palatal mucosa.
(Id. at 8.) Donaldson also notes that it was reported that EMLA was
effective in anesthetizing the mucobuccal fold. Thus, not only does
Donaldson teach EMLA is better than lidocaine in anesthetizing gingiva, it
was also known that EMLA was effective at anesthetizing other mucosa of
the mouth. Thus, we agree with the Examiner that Donaldson provides a
motivation for one of ordinary skill in the art to use a eutectic mixture of
lidocaine and prilocaine rather than lidocaine alone in an anesthetic chewing
gum.

lines 65-96)”).). Second, we do not find any disclosure in Faust that would
indicate that lidocaine is not likely to be useable in an anesthetic chewing
gum and result in numbing of the mouth and throat areas.
5 It is undisputed that EMLA in Donaldson is the brand name of a 1:1
mixture of lidocaine and prilocaine.
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Although Faust is concerned with anesthetizing throat and mouth
areas generally, there can be no doubt that the gingiva is in the mouth.
Moreover, Donaldson teaches that it was also known that EMLA was
effective in anesthetizing other mucosa. Thus, we agree with the Examiner
that one of ordinary skill in the art would have had a reasonable expectation
of success in substituting prilocaine and lidocaine for lidocaine in the
chewing gum of Faust with an expectation of at least achieving numbing of
mucosa and gingiva.
Chewing gum is masticated with teeth over a significant number of
minutes and the anesthetic would be expected to deposit at least in part in
the gingiva near the masticating teeth. Although Donaldson’s use on the
gingiva is through a more direct and constant application to the gingiva than
would result from use of prilocaine and lidocaine in chewing gum, we agree
with the Examiner that one of ordinary skill in the art would expect
reasonable success using prilocaine and lidocaine in gum rather than
lidocaine as taught for use in Faust. That is particularly so given that
Donaldson notes that EMLA applied to the gingiva with a toothbrush “was
effective in producing anesthesia of gingival tissue when applied over a 4-
min period.” (Id.) For these reasons, we are not persuaded by Appellant’s
argument, unsupported by evidence, that “there is no expectation of success”
and no reason to expect “the substitution would yield a predictable result”
(Appeal Br. 12). “Attorney’s argument in a brief cannot take the place of
evidence.” In re Pearson, 494 F.2d 1399, 1405 (CCPA 1974).
Finally, that Donaldson teaches EMLA in a cream form (Reply Br. 7;
Appeal Br. 11–12) does not persuade us of nonobviousness of using a 1:1
mixture of prilocaine and lidocaine in a chewing gum formulation. That is
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because the numbing effect is achieved by the anesthetic and not by any
ingredients in the vehicle containing the anesthetics. KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007) (“[T]he analysis need not seek out
precise teachings directed to the specific subject matter of the challenged
claim, for a court can take account of the inferences and creative steps that a
person of ordinary skill in the art would employ.”). It would have been well
within the ordinary skill in the art to determine in what vehicle to include a
1:1 mixture of the anesthetics lidocaine and prilocaine for use in a chewing
gum formulation.
Furthermore, “[t]he combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results.” Id. at 416. As discussed above, the teachings in
Donaldson provide strong evidence of predictable results of the use of a 1:1
mixture of the anesthetics lidocaine and prilocaine for achieving a numbing
effect in the mouth on the gingiva and other soft tissues.
Thus, for the foregoing reasons we affirm the Examiner’s rejection of
claim 1 as being obvious over Faust and Donaldson.
Appellant has not argued the remaining rejections, which are all
directed to dependent claims, for any other reason except the urged failure of
Faust and Donaldson to render obvious claim 1. (See Appeal Br. 6.) Thus,
Appellant has waived any argument directed to the dependent claims. Hyatt
v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the appellant fails to
contest a ground of rejection to the Board, . . . the Board may treat any
argument with respect to that ground of rejection as waived.”). We affirm
the Examiner’s rejections of the remaining claims because, as we explained,
we conclude that claim 1 is obvious from Faust and Donaldson.
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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1 103(a) Faust, Donaldson 1
2 103(a) Faust, Donaldson,
Hyrup
2
3, 4, 6–9, 11 103(a) Faust, Donaldson,
Hyrup, Chaudhary
3, 4, 6–9, 11
5 103(a) Faust, Donaldson,
Hyrup, Chaudhary,
Paradkar
5
10 103(a) Faust, Donaldson,
Hyrup, Chaudhary,
Cherukuri
10
Overall
Outcome
1–11

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