Leonore Herzenberg et al.

Patent Trials and Appeals Board

Oct 8, 2021

2021003066 (P.T.A.B. Oct. 8, 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.
12/837,341 07/15/2010 Leonore A. Herzenberg 128587-00502 4007
86738 7590 10/08/2021
MCCARTER & ENGLISH, LLP BOSTON
265 Franklin Street
Boston, MA 02110
EXAMINER
LOVE, TREVOR M
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
10/08/2021 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):
docket@mccarter.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte LEONORE A HERZEBERG and JAMES ANDRUS
__________

Appeal 2021-003066
Application 12/837,341
Technology Center 1600
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for treating pain by administering a combination formulation containing
acetaminophen and N-acetylcysteine. The Examiner rejected the claims 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. Appellant identifies the Real Party in Interest as The Board
of Trustees of the Leland Stanford Junior University (see Appeal Br. 1). We
have considered the Specification filed July 15, 2010 (“Spec.”); Non-Final
Rejection of Apr. 17, 2020 (“Non-Final Act.”); Appeal Brief filed Jan. 19,
2021 (“Appeal Br.”); Examiner’s Answer filed Feb. 2, 2021 (“Ans.”); and
Reply Brief filed Apr. 5, 2021 (“Reply Br.”).
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Statement of the Case
Background
“[A]cetaminophen, in its various formulations, has become the largest
selling over the counter (OTC) drug throughout the world. It presently
constitutes 35% of the analgesic market in North America” (Spec. ¶ 3).
“Acetaminophen initially was not thought to present toxicity risks when
used at recommended doses. However, more recent studies demonstrate
significant toxicity at recommended doses, both in healthy individuals and in
persons with diseases or other conditions that result in glutathione (GSH)
depletion” (id. ¶ 4). “Acetaminophen toxicity is treated by rapid
administration of N-acetylcysteine (NAC), a cysteine prodrug that supplies
the cysteine necessary for the synthesis of glutathione (GSH),” (id. ¶ 12).
The Specification teaches “compositions that improve the therapeutic
efficacy or a given dose of acetaminophen comprising acetaminophen and
N-acetylcysteine” (Spec. ¶ 25).
The Claims
Claims 10, 16–19, 24–27, 32, and 33 are on appeal. Claim 10 is an
independent claim, is representative and reads as follows:
10. A method for treating pain, comprising:
(a) identifying a human subject in need of analgesic
relief; and
(b) administering to the subject a combination
formulation containing acetaminophen and N-acetylcysteine,
wherein a dose of the combination formulation is determined by
a molar ratio of acetaminophen to N-acetylcysteine of 1:1,
1:0.5, 1:0.25, or 1:0.125; wherein the N-acetylcysteine
supplements the analgesic activity of the acetaminophen in the
formulation such that a lower maximum daily dose of
acetaminophen can be used to achieve the same therapeutic
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effect as would be achieved with a maximum daily dose of
unsupplemented acetaminophen, wherein the lower maximum
daily dose of acetaminophen in the combination formulation
based on age and weight of the subject is less than the standard
maximum daily dose of acetaminophen alone; and wherein the
standard maximum daily dose of acetaminophen based on age
and weight of the subject is defined as: 200 mg for a subject 0-3
months of age; 6-11 pounds body weight; 400 mg for a subject
4-11 months of age; 12-17 pounds body weight; 600 mg for a
subject 12-23 months of age; 18-23 pounds body weight; 800
mg for a subject 2-3 years of age; 24-35 pounds body weight;
1200 mg for a subject 4-5 years of age; 36-47 pounds body
weight; 1600 mg for a subject 6-8 years of age; 48-59 pounds
body weight; 2000 mg for a subject 9-10 years of age; 60-71
pounds body weight; 2400 mg for a subject 11 years of age; 72-
95 pounds body weight; 3200 mg for a subject 12 years of age;
96 pounds body weight; and 4000 mg for a subject greater than
12 years of age.

The Rejection
The Examiner rejected claims 10, 16–19, 24–27, 32, and 33 under 35
U.S.C. § 103(a) as obvious over Fluimucil2 and Witzel3 (Final Act. 3–7).
The Examiner finds Fluimucil teaches
(a) identifying a human subject in need of analgesic or
antipyretic relief (see entire document, for instance, sec. 4.1 );
and (b) administering an oral formulation of a pharmaceutical
composition to the human subject, the pharmaceutical
composition comprising: (i) a unit dose of acetaminophen; and
(ii) a therapeutic efficacy-enhancing amount of N-
acetylcysteine; wherein the total of all unit doses administered
per day is an amount less than a standard maximum daily dose

2 Fluimucil Complex Monograph Translation (2007). We number the
unnumbered pages in sequential order from 1–11 (“Fluimucil”).
3 Witzel et al., US 4,127,645, issued Nov. 28, 1978 (“Witzel”).
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of acetaminophen (i.e., not more than 1500 mg per day for
subjects over 12 years of age (see entire document, for instance,
sec. 2 and 4.2), wherein the pharmaceutical composition is
characterized by a molar ratio of acetaminophen to N-
acetylcysteine of about 1 :0.37, which falls between the claimed
ratios of 1:0.5 and 1:0.25
(Non-Final Act. 4). The Examiner acknowledges that “FLUIMUCIL does
not directly teach the tablet is coated,” as required by dependent claims 17
and 26 (id. at 5).
The Examiner finds Witzel teaches “coatings for effervescent tablets
to protect the effervescent couple from moisture absorption” (Non-Final Act.
5). The Examiner finds Witzel teaches “coating the compressed tablet
resulted in improved taste and improved shelf-life relative to uncoated
cores” (id.). The Examiner finds it obvious to “improve the shelf life and
palatability of the effervescent tablets taught in FLUIMUCIL by coating the
tablets as taught in Witzel. . . . because Witzel teaches the coating is
especially effective for improving the properties of effervescent tablets using
bicarbonate and citric acid as the effervescent couple”(id.).
The issues with respect to this rejection are:
(i) Does a preponderance of the evidence of record support the
Examiner’s conclusion that the combination of Fluimucil and Witzel render
the rejected claims obvious?
(ii) If so, has Appellant provided evidence of unexpected results that,
when balanced with the prima facie case, supports a finding of non-
obviousness?
Findings of Fact
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1. Fluimucil teaches “FLUIMUCIL COMPLEX 500 mg/200 mg
effervescent tablets” where each effervescent tablet is composed of
Paracetamol (DOE) 500 mg and Acetylcysteine (DOE) 200 mg as well as
excipients (Fluimucil 1). Fluimucil teaches: “Acetylcysteine is the N-acetyl
derivative of the amino acid cysteine” (Fluimucil 8).
2. Fluimucil teaches the therapeutic indications for the
composition are “[s]ymptomatic relief of cold and influenza, which may or
may not include fever, mild to moderate pain and thick mucus” (Fluimucil
1).
3. Fluimucil teaches recommended doses where “[f]or subjects
over 12 years: one effervescent tablet every 8-12 hours (two or three times
per day). Do not exceed the 600-mg dose/day (3 effervescent tablets) of
acetylcysteine” (Fluimucil 1).
4. Fluimucil teaches that a “specific antidote exists for
paracetamol-induced toxicity: N-acetylcysteine. 300 mg/kg of IV
administered N-acetylcysteine (equivalent to 1.5 mL/kg of 20% aqueous
solution; pH: 6.5) is recommended for a period of 20 hours and 15 minutes”
(Fluimucil 7).
5. Fluimucil teaches ranges for the use of acetylcysteine,
specifically teaching “[a]cetylcysteine is absorbed via the intestinal mucosa
when administered orally. The maximum concentration is reached after 30
minutes to one hour at doses of 200 mg to 600 mg. Some studies indicate
that its pharmacokinetics is dose-dependent” (Fluimucil 9).
6. The Examiner finds the “pharmaceutical composition is
characterized by a molar ratio of acetaminophen to N-acetylcysteine of
about 1:0.37, which falls between the claimed ratios of 1:0.5 and 1:0.25”
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(Non-Final Act. 4).
7. Witzel teaches “a method for improving shelf life of a tablet
containing an effervescent couple by coating the effervescent couple with a
sugar or sugar alcohol” (Witzel 1:12–14).
8. Witzel teaches an “off-taste or salty taste of the core portion is
effectively masked by the two flavors present in such tablets. The tablets of
the invention are also found to be highly effective in inhibiting or reducing
formation of dental plaque” (Witzel 4:15–19).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Final Act. 3–7, FF 1–8) and agree that the combination of Fluimucil and
Witzel renders the claims obvious. We address Appellant’s arguments
below.
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The phrases at
issue in claim 10 are the listed “standard maximum daily dose of
acetaminophen based on age and weight” as it relates to the statement that
“N-acetylcysteine supplements the analgesic activity of the acetaminophen
in the formulation such that a lower maximum daily dose of acetaminophen
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can be used to achieve the same therapeutic effect as would be achieved with
a maximum daily dose” (Claim 10).
We recognize that claim 10 teaches that the combination of N-
acetylcysteine and acetaminophen permit a lower maximum daily dosage,
but claim 10 does not recite this dosage. Thus, claim 10 is reasonably
understood to encompass any dosage less than the standard maximum daily
acetaminophen dose when combined with a dose of N-acetylcysteine in the
recited ratios of 1:1, 1:0.5, 1:02.5, or 1:0.125.
Appellant contends that “an important distinction between the claimed
invention and the prior art is that according to the claimed invention, an
amount of acetaminophen in the formulation that is decreased from the
standard maximum daily dose is specified for administration to the patient”
(Appeal Br. 11). Appellant contends “[t]hese standard maximum allowable
doses that are provided as the standard to be used to define a lower amount
of acetaminophen when used in combination with NAC are the same
standard maximum allowable doses” (id. at 14).
We find this argument unpersuasive because claim 10 only defines a
maximum dose, as discussed above and as argued by Appellant. Claim 10
does not define a minimum dose. In this case, Fluimucil teaches a
recommended dose below the maximum dose (FF 1, 3). Specifically,
Fluimucil teaches a recommended dose for subjects over 12 years that limits
treatment to three tablets in a 24 hour period, or 1500 mg acetaminophen
combined with 600 mg of N-acetylcysteine (FF 1, 3). Thus, following the
recommendations of Fluimucil necessarily results in administration of a dose
that is decreased from the standard maximum dose for adults and therefore
falls within the dosage limits set by claim 10. These facts are similar to
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Montgomery where the drug ramipril was administered to patients in need of
stroke prevention and the Court found that “efficacy is inherent in carrying
out the claim steps.” In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir.
2012). Here too, efficacy in analgesic relief with the maximum
recommended dose suggested by Fluimucil is inherent in administration to
patients for “[s]ymptomatic relief of . . . mild to moderate pain” (FF 2).
Appellant contends “the claims are directed to particular molar ratios
of acetaminophen to N-acetylcysteine of 1:1, 1:0.5, 1:0.25, or 1:0.125, not a
range, and the monograph does not teach the claimed molar ratios with
sufficient specificity” (Appeal Br. 15).
The Examiner finds, and Appellant does not dispute, that Fluimucil
teaches a dose of 500 mg acetaminophen to 200 mg N-acetylcysteine (FF 1)
which results in a molar ratio of 1:0.37 that falls between the claimed ratios
of 1:0.5 and 1:0.25 (FF 6). Instead, Appellant asserts that because claim 10
does not recite a range, but rather recites specific ratio values of the two
drugs between Fluimucil’s ratio value falls, that fails to disclose “that the
combination has to be therapeutically effective” (Appeal Br. 16).
We analogize these facts to Brandt, where the claim recited a specific
density value range and the prior art was adjacent to, but did not abut, the
recited range. In re Brandt, 886, F.3d 1171, 1174 (Fed. Cir. 2018). Brandt
rejected the requirement that “an examiner can only find a prima facie case
of obviousness if there is an overlap between the claimed range and prior art
range.” Id. at 1177. Instead, Brandt found that “because the claimed range
and the prior art range abut one another, and Appellants conceded as fact
that there is no meaningful distinction between the two ranges, substantial
evidence supports the Board's finding.” Id. at 1177–78.
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We therefore are not persuaded by Appellant’s argument here because
Brandt and routine optimization situations apply here. Indeed, the instant
facts are superior to Brandt for the Examiner because the ratio value in
Fluimucil does not merely abut one end of a range, but rather is extremely
close to, and falls between, two of the ratio values recited in claim 10. Thus,
whether the amount of N-acetylcysteine in the Fluimucil composition was
slightly raised or was slightly lowered, the final ratio value of
acetaminophen to N-acetylcysteine would move closer to one of the values
recited in claim 10. And this represents nothing more than “routine
optimization of drug dosage to maximize therapeutic effect.” Ariosa
Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282 (Fed. Cir. 2015).
Appellant contends that:
It would not have been obvious to the ordinary skilled artisan to
use N-acetylcysteine for supplementing the therapeutic activity
of acetaminophen, much less using acetaminophen and N-
acetylcysteine in a molar ratio of acetaminophen to N-
acetylcysteine of 1:1, 1:0.5, 1:0.25, or 1:0.125, such that the
amount of acetaminophen in the formulation is decreased from
the standard maximum daily dose without any loss of
therapeutic effect, as claimed, based on the combined teachings
of the monograph and Witzel. Appellant underscores that the
combination has to be therapeutically effective, which the
combination of the monograph and Witzel is not.
(Appeal Br. 16).
We find this argument unpersuasive because Fluimucil teaches a
commercially available composition for pain (FF 2) that is necessarily
therapeutically effective and necessarily shares the inherent ability to
achieve the same therapeutic activity as would be achieved with a maximum
dose because Fluimucil recognized that the N-acetylcysteine component can
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function as an antidote for acetaminophen induced toxicity (FF 4).
However, even if we discount this express disclosure in Fluimucil, this
advantage is inherent in administration of the Fluimucil composition itself.
“Inherency is not necessarily coterminous with the knowledge of
those of ordinary skill in the art. Artisans of ordinary skill may not
recognize the inherent characteristics or functioning of the prior art.”
MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365
(Fed.Cir.1999). Just as the ordinary artisan producing sprouts may have
been unaware that the sprout growing process resulted in sprouts rich in
glucosinolates in Cruciferous Sprout, so too, even if Fluimucil had been
unaware that N-acetylcysteine was protective against overdoses of
acetaminophen, because Fluimucil’s caplet contained both drugs, “[i]t
matters not that those of ordinary skill heretofore may not have recognized
these inherent characteristics.” In re Cruciferous Sprout Litigation, 301 F.3d
1343, 1350 (Fed. Cir. 2002). Therefore, it would indeed have been both
expressly and inherently obvious to administer Fluimucil to patients in pain
in order relieve their symptoms.
Appellant contends that Fluimucil
teaches that this tablet is to be administered no more than 3
times per day, delivering a maximum daily dose of 1500 mg
acetaminophen and 600 mg N-acetylcysteine to an adult patient.
This would not be effective to provide analgesic or antipyretic
relief for an adult equivalent to a 4000 mg daily dose of
acetaminophen alone, because the total amount of the combined
composition administered to the patient is simply insufficient.
Witzel, which merely discloses an effervescent tablet that
includes a core portion containing an effervescent couple and
an outer portion containing a sugar or sugar alcohol, wherein
the tablet is useful in reducing or inhibiting formation of dental
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plaque, does not cure the defects of the monograph. The
Examiner has provided no plausible reason for one skilled in
the art to choose elements of the monograph, directed to an
effervescent tablet delivering a maximum daily dose of 1500
mg acetaminophen and 600 mg N-acetylcysteine with the
effervescent tablet of Witzel, containing a core portion and an
outer portion, used for reducing or inhibiting dental plaque, to
arrive at the claimed invention.
(Appeal Br. 17–18).
We find this argument unpersuasive. As to the main argument
regarding efficacy, we note that claim 10 does not require administration of
any particular dosage. In particular, claim 10 does not require
administration of an amount of acetaminophen and N-acetylcysteine
equivalent to the 4000 mg maximum daily dose of acetaminophen
recommended for adults. “[A]ppellant’s arguments fail from the outset
because . . . they are not based on limitations appearing in the claims.” In re
Self, 671 F.2d 1344, 1348 (CCPA 1982)).
As to the argument that there is no reason to combine the disclosures
of Fluimucil and Witzel, the Examiner reasonably finds it obvious to use the
coatings of Witzel on the tablets of Fluimucil “to improve the shelf life and
palatability of the effervescent tablets taught in FLUIMUCIL by coating the
tablets as taught in Witzel” (Non-Final Act. 6). This combination appears
focused on claims 17 and 26, not claim 10, but the Examiner provides a
persuasive reason, not persuasively rebutted by Appellant, to include
Witzel’s coatings on the Fluimucil tablet.
Appellant contends the reasonable expectation of success “standard
has not been met” and that “the state of the art at the time of filing pointed to
equal concerns over the potential risks associated with decreasing the
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maximum daily approved dose of acetaminophen” (Appeal Br. 19).
Appellant similarly argues that neither Fluimucil nor Witzel, “taken alone or
in combination, provide any indication of which parameters are critical to
arrive at an NAC/acetaminophen formulation” (Appeal Br. 24).
We find this argument unpersuasive because as we already noted,
claim 10 does not require the use of the maximum dose, but encompasses
the use of any effective dose. Therefore, in the context of claim 10, there is
virtually an absolute expectation of success in administering the composition
of Fluimucil to patients in order to relieve pain (FF 1–3). Indeed, Appellant
does not identify any evidence that the composition of Fluimucil would not
function to treat pain. And “[o]bviousness does not require absolute
predictability of success . . . all that is required is a reasonable expectation of
success.” In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009). Administering
the analgesic compound of Fluimucil to treat pain certainly has a reasonable
expectation of success. There is no requirement in the claims to administer
an overdose of the drug as mentioned by Appellant (see Appeal Br. 19) and
if there were, Fluimucil suggests administration of extra N-acetylcysteine as
the treatment (FF 4).
Appellant contends:
The present specification therefore points to an ongoing
tension between the impetus to reduce dosage levels of
acetaminophen in order to address toxicity concerns, and the
need to ensure that patients suffering from pain and fever can
continue to receive adequate therapeutic relief. The claimed
invention provides a formulation which satisfies this unmet
need.
(Appeal Br. 21).
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We are not persuaded. To establish a long-felt need, three elements
must be proven: First, the need must have been a persistent one that was
recognized by ordinarily skilled artisans. In re Gershon, 372 F.2d 535, 538
(CCPA 1967). Second, the long-felt need must not have been satisfied by
another before Appellant’s invention. See Newell Companies, Inc. v.
Kenney Mfg. Co., 864 F.2d 757, 768 (Fed. Cir. 1988) (“[O]nce another
supplied the key element, there was no long-felt need or, indeed, a problem
to be solved . . . .”). Third, the invention must, in fact, satisfy the long-felt
need. In re Cavanagh, 436 F.2d 491, 496 (CCPA 1971).
As to the first and third elements, Appellant states that acetaminophen
toxicity “has led the FDA to suggest a reduction in the maximum daily
dosage of acetaminophen to 3000-3250 mg/day” (Appeal Br. 20). As this
maximum dosage is identical to that recited in claim 10, the argued long-felt
need does not permit the use of a dose higher than that already permitted by
FDA. Thus, Appellant does not demonstrate either that there is a need for a
higher dose or that the invention satisfies the need for a dose higher than
3250 mg/day.
Equally importantly, Fluimucil is a composition that falls within the
reasonably understood teachings of claim 10 and would satisfy the need.
“That which infringes if later anticipates if earlier.” Polaroid Corp. v.
Eastman Kodak Co., 789 F.2d 1556, 1573 (Fed. Cir. 1986). While
Fluimucil may not literally infringe or anticipate claim 10 because the ratio
falls between two claimed ratios and is not identical to them, Fluimucil
would have been reasonably understood as satisfying the need for a
composition composed of acetaminophen and N-acetylcysteine in an amount
sufficient to limit acetaminophen toxicity (FF 4). Consequently, Appellant
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has not persuasively demonstrated that any need for safer acetaminophen
was unmet.
Appellant cites the Herzenberg Declaration4 for the contention that:
Herzenberg teaches that supplying NAC at the same time as
acetaminophen ingestion, (e.g., by formulating NAC with
acetaminophen) increases the level of acetaminophen that can
be tolerated. Acetaminophen has two activities: (1) a GSH-
depleting toxicity, and (2) a positive analgesic effect that is
independent of the toxicity effect. Herzenberg discloses that
NAC prevents the toxicity effects of acetaminophen on GSH,
allowing the nontoxic analgesic effect to be useful at higher
acetaminophen levels. In other words, NAC combined with
acetaminophen allows physicians to increase the level of
acetaminophen that can be tolerated to an amount above the
standard dosage level, thereby providing them with more
effective treatment options.
(Appeal Br. 23).
We find this argument unpersuasive because even if Appellant
discovered a new benefit of the combination of acetaminophen and N-
acetylcysteine, “[n]ewly 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 Laboratories, Inc., 246 F.3d 1368,
1376 (Fed. Cir. 2001). That is, the administration of the Fluimucil tablets to
patients would inherently and necessarily result in the benefits of GSH-
depleting toxicity and improved analgesic effect and would necessarily
permit physicians to administer higher doses of acetaminophen with reduced
toxicity. And while Fluimucil appears to actually suggest this itself (FF 4),
even if Fluimucil were entirely silent on the protective effect of N-

4 Declaration of Dr. Leonore A. Herzenberg, dated Apr. 17, 2018.
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acetylcysteine on acetaminophen toxicity, claim 10 does not require
administration of any dose higher than that recommended by Fluimucil and
therefore that maximum dosage (FF 3) falls within the scope of claim 10 and
would inherently share in the same properties as those discovered by Dr.
Herzenberg and recited by claim 10. In the absence of any claim limitation
requiring administration of any particular dosage, we need not determine
whether it would have been obvious to exceed the recommended dosage of
Fluimucil in this case.
Conclusions of Law
(i) A preponderance of the evidence of record supports the
Examiner’s conclusion that the combination of Fluimucil and Witzel render
the rejected claims obvious.
(ii) Appellant has not provided evidence of unexpected results that,
when balanced with the prima facie case, supports a finding of non-
obviousness.
DECISION SUMMARY
In summary:
Claims
Rejected
35
U.S.C. §
Reference(s)/Basis Affirmed Reversed
10, 16–19,
24–27, 32, 33
103 Fluimucil, Witzel 10, 16–19,
24–27, 32, 33

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED