Christopher D. Breder

Patent Trials and Appeals Board

Oct 1, 2019

14795983 - (D) (P.T.A.B. Oct. 1, 2019)

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.
14/795,983 07/10/2015 Christopher D. Breder 063089-1004 3780
22428 7590 10/01/2019
FOLEY & LARDNER LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
EXAMINER
RAMACHANDRAN, UMAMAHESWARI
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
10/01/2019 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte CHRISTOPHER D. BREDER

Appeal 2018-006913
Application 14/795,983
Technology Center 1600
____________

Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject the claim for obviousness and on the ground of
non-statutory obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b). We AFFIRM.

1 Appellant identifies the real party in interest as Supernus Pharmaceuticals,
Inc. Appeal Br. 3.
We have considered, and herein refer to, the Specification of July 10, 2017
(“Spec.”); Non-Final Office Action of January 17, 2018 (“Non-Final Act.”);
Appeal Brief of April 16, 2018 (“Appeal Br.”); Examiner’s Answer of May
18, 2018 (“Ans.”); and Reply Brief of June 26, 2018 (“Reply Br.”).
Appeal 2018-006913
Application 14/795,983
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STATEMENT OF THE CASE
Claim 10 is on appeal, and reads as follows:
10. A method of treating attention deficit hyperactivity disorder
in a mammalian subject comprising orally administering to a
subject in need thereof a total dose of 0.1 mg to 0.5 mg of
mazindol per day as the sole active agent.
Appeal Br. 11 (Claims Appendix).
The claim stands rejected as follows:
Claim
Rejected
Basis
10 pre-AIA 35 U.S.C. § 103(a) over Kovacs ’5202 or
Kovacs ’1393
10 pre-AIA 35 U.S.C. § 103(a) over Konofal4 in view of
Kovacs ’520 or Kovacs ’139
10 pre-AIA 35 U.S.C. § 103(a) over Epstein5 and Kovacs ’139
10 provisional nonstatutory obviousness-type double patenting
over Application No. 14/841,898
Appellant does not provide substantive argument with respect to the
nonstatutory obviousness-type double patenting rejection, but instead
requests that this rejection6 be held in abeyance until allowable subject
matter is identified. See Appeal Br. 4. We, therefore, summarily affirm this
rejection over Application No. 14/841,898. See MPEP § 1205.02.

2 Kovacs et al., US 2009/0318520 A1, published Dec. 24, 2009.
3 Kovacs et al., WO 2009/155139 A1, published Dec. 23, 2009.
4 Konofal et al., US 2009/0136593 A1, published May 28, 2009.
5 Epstein et al., US 2002/0161002 A1, published Oct. 31, 2002.
6 Examiner additionally rejected claim 10 on the ground of nonstatutory
obviousness-type double patenting over Application No. 13/638,294 (see
Ans. 14). The notice of abandonment was mailed on Feb. 13, 2019, so this
rejection is moot.
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Obviousness
Since all three obviousness rejections rely on Kovacs ’520 or
Kovacs ’139 individually or in conjunction with either Konofal or Epstein,
we will discuss the rejections together. We note that Appellant does not
provide separate arguments with respect the obviousness combinations set
forth by Examiner but instead discusses the rejections together. See Appeal
Br. 4–10.
The issue is whether the preponderance of evidence of record supports
Examiner’s conclusion that treating attention deficit hyperactivity disorder
(ADHD) with 0.1 mg to 0.5 mg per day of mazindol as the sole active agent
is obvious?
A. Findings of Fact (FF)
FF1. Kovacs teaches isoindole derivatives encompassing mazindol.
Kovacs ’520 ¶ 13, 46; Kovacs ’139 ¶ 13, 45; see Ans. 5. Kovacs
teaches using mazindol to treat attention deficit hyperactivity disorder
(ADHD). Kovacs ’520 ¶¶ 13, 147; Kovacs ’139 ¶¶ 13, 123.
FF2. Kovacs teaches that “‘[t]herapeutically effective amount’ as used
herein, means the amount of a compound that, when administered to
an individual for treating a disease, is sufficient to effect such
treatment for the disease or to achieve the desired clinical response.”
Kovacs ’520 ¶ 44; Kovacs ’139 ¶ 43; see Ans. 5.
An effective amount means that amount necessary to
delay; the onset, inhibit the progression, halt altogether the
onset or progression of, or to reduce the clinical
manifestations or symptoms of the particular condition
being treated. In general, an effective amount for treating
a neurobehavioral disorder will be that amount necessary
to inhibit the symptoms of the particular neurobehavioral
disorder in-situ in a particular individual. When
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administered to an individual, effective amounts will
depend, of course, on the particular condition being
treated; the severity of the condition; individual patient
parameters including age, physical condition, size and
weight; concurrent treatment; frequency of treatment; and
the mode of administration. These factors are well known
to those of ordinary skill in the art and can be addressed
with no more than routine experimentation. It is preferred
generally that a minimum dose be used, that is, the lowest
safe dosage that provides appropriate relief of symptoms.
Kovacs ’520 ¶ 135 (emphasis added); Kovacs ’139 ¶ 111; see Ans. 6
(“It is preferred generally that a minimum dose be used, that is, the
lowest safe dosage that provides appropriate relief of symptoms.”).
FF3. Kovacs teaches dosage units containing “from about 0.001 to about
9000 mg of the active ingredient.” Kovacs ’520 ¶ 72; Kovacs ’139 ¶
53.
Dosage may be adjusted appropriately to achieve
desired drug levels, locally or systemically. Generally,
daily doses of active compounds will be from about 0.001
mg/kg per day to 200 mg/kg per day. However, it is
recognized that these are general ranges and the actual
dose used as contemplated in a given individual may [be]
less or greater than this dosage range. In the event that the
response in an individual subject is insufficient at such
doses, even higher doses (or effective higher doses by a
different, more localized delivery route) may be employed
to the extent that patient tolerance permits.
Kovacs ’520 ¶ 136; Kovacs ’139 ¶ 112.
FF4. Kovacs exemplifies treating a 14 year old patient having ADHD with
“[m]azindol at 2.5 mg/day as the sole agent.” Kovacs ’520 ¶ 147;
Kovacs ’139 ¶ 123. Kovacs teaches treating ADHD with an effective
amount of mazindol (Kovacs ’520 claims 11; Kovacs ’139 claims 21),
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and narrows the dose to between 1 and 2 mg per day (Kovacs ’520
claims 15; Kovacs ’139 claims 25).
FF5. Examiner finds that dosages of the isoindole derivatives contemplated
in Kovacs fall within the range claimed. “If for example, 0.01 mg of
mazindol is administered to ADHD patient (weighing 40 kg), the
amount administered will be 0.4 mg or 0.2 mg (20 kg subject) which
falls within the claimed range of 0.1–0.5 mg.” Ans. 20.
FF6. Konofal teaches using mazindol to treat ADHD. Konofal ¶ 1; Ans. 7.
The patient population in Konofal includes a newborn baby, a child,
an adolescent, or an adult; preferably “a child aged approximately 5 to
12 years.” See id. ¶ 38, claim 2; Ans. 8. The dosage of mazindol can
correspond to a daily dose of 1 to 2 mg. See id. claim 9 (“the dosage
corresponds to a daily dose of mazindol of between 1 and 2 mg.”).
FF7. Epstein teaches “treating ADHD (adult or child) by co-administering
(e.g., simultaneously or at different times) to the patient . . . an amount
of a catecholamine reuptake inhibitor sufficient to treat the attention
component of ADHD, and an amount of a dopamine reuptake
inhibitor sufficient to treat the movement disorder component.”
Epstein ¶ 196; see Ans. 9. Epstein teaches that mazindol is a
catecholamine reuptake inhibitor (Epstein ¶ 78), dopamine reuptake
inhibitor (id. ¶ 195), as well as a norepinephrine reuptake inhibitor (id.
¶ 8).
FF8. Epstein teaches starting low and gradually increasing the dose over
time.
A physician or veterinarian having ordinary skill in the art
can readily determine and prescribe the effective amount
of the pharmaceutical composition required. For example,
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the physician or veterinarian could start doses of the
compounds of the invention employed in the
pharmaceutical composition at levels lower than that
required in order to achieve the desired therapeutic effect
and gradually increase the dosage until the desired effect
is achieved.
Epstein ¶ 111. In addition, Epstein teaches that “[i]n general, a
suitable daily dose of a compound of the invention will be that amount
of the compound which is the lowest dose effective to produce a
therapeutic effect” and that a range of 0.0001 to 100 mg per kilogram
per day is generally sufficient. Id. ¶ 112; see Ans. 10.
B. Analysis
Examiner finds that Kovacs teaches treating ADHD with mazindol.
Ans. 5, FF1–FF4. Examiner finds that Kovacs teaches a daily dose between
1 and 2 mg and exemplifies a dosage of 2.5 mg per day. Ans. 5; FF4.
Examiner finds that Kovacs contemplates daily “dosage ranging from 0.001
mg/kg per day to 200 mg/kg/day.” Ans. 6; FF3. Examiner concludes that
“[i]t is obvious to vary and/or optimize the dosage amount of mazindol
provided in the composition, according to the guidance provided by Kovacs,
such as the desired concentrations of mazindol to effectively treat ADHD.”
Ans. 6; see FF3. Examiner recognizes that Konofal does not exemplify
dosages below 1 mg/day but finds that Kovacs teaches an overlapping range
and varying patient populations. Ans. 8 (“Though Konofal teach
administration of an effective amount of mazindol, the reference is not
explicit in teaching the total dose of mazindol as being 0.1 mg to 0.5 mg per
day); FF6 (“newborn baby, a child, an adolescent or an adult”); FF7 (“adult
or child”). Examiner finds that “[i]f for example the amount administered is
0.1 mg/kg and for a child weighing an average of 40 kg, an amount of 0.4
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mg will be administered which falls within the claimed amount.” Ans. 6;
FF5. In other words, Examiner concludes that the teachings of Kovacs,
either alone or in combination with and Epstein, suggests adjusting the
amount of active agent – mazindol – based on the per weight dosage. See
Ans. 5–6; see FF1–FF7. Equipped with this knowledge of adjusting the
mazindol dosage on a per weight basis in conjunction with appreciating the
difference in the size of the patients in the populations contemplated by the
references, one of ordinary skill in the art would have found it obvious to
treat ADHD with mazindol with the claimed dosage. See Ans. 5–6; see
FF1–FF7.
Appellant contends (1) there is no reason to drop the dose below that
shown to be effective in the prior art (Appeal Br. 4–5 (citing In re Sebek,
465 F.2d 904 (CCPA 1972) and In re Patel, 566 Fed. App’x 105 (2014));
(2) that the results at lower doses are unexpected (id. and 7–8 (citing the
Kidane Declaration7); and (3) that Examiner is improperly shifting the
burden (id. at 9–10); see Reply Br. 3.
We have reviewed Appellant’s contention but are not persuaded that
Examiner erred. We adopt the findings concerning the scope and content of
the prior art as well as conclusion as set forth in Examiner’s Answer and the
Non-Final Office Action. The findings of fact reproduced above are
referenced to highlight certain pertinent evidence. We address Appellant’s
arguments below.

7 Declaration under 37 C.F.R. § 1.132 by Dr. Argaw Kidane, signed July 28,
2017 (“Kidane Dec.”).
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1. Lowering Daily Dosage of Mazindol
Appellant contends that there is no reason to drop the dosage of
mazindol for the treatment of ADHD below the 1 to 2 mg disclosed in
Kovacs. Appeal Br. 4–5 (citing In re Sebek, 465 F.2d 904 (CCPA 1972) and
In re Patel, 566 Fed. App’x 105 (2014); Reply Br. 2–3.
We are not persuaded. Kovacs specifically discloses administering
the compounds having daily dosage range from 0.001 mg/kg per day to 200
mg/kg per day. FF3. Epstein similarly suggests a daily dosage range from
0.0001–100 mg/kg per day. FF8. Examiner finds that a child at 20 kg (44
lb.) or 40 kg (88 lb.) given a dosage of 0.01 mg/kg per day falls within the
claimed range. FF5. Of particular note is that the selected dosage picked by
Examiner is somewhere in the middle of the ranges disclosed in either
Kovacs or Epstein which suggests that if the endpoints were selected then
the claimed range squarely falls inside range disclosed in the prior art. That
overlap is sufficient to establish a prima facie case of obviousness. That
both Kovacs and Epstein specifically suggest dose optimization only serves
to emphasize this point. FF2, FF3, and FF8. See In re Peterson, 315 F.3d
1325, 1329 (Fed. Cir. 2003) (“[W]e and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness.”). Such a prima facie case may be rebutted “by
establishing that the claimed range is critical, generally by showing that the
claimed range achieves unexpected results relative to the prior art range.”
Id. at 1330 (citations omitted).
We do not agree with Appellant’s position that Examiner’s selection
of a child weight at 40 kg is somehow arbitrary. Appeal Br. 9. The average
weight of an adult human can be ascertained by consulting weight charts,
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therefore, Examiner’s selection of a child at 40 kg as being about half of the
average adult weight does not seem unreasonable (FF5), especially since
Kovacs, Konofal, and Epstein disclose that the patient population treatable
with mazindol includes newborns, children, adolescents, and adults. See
FF4, FF6, and FF7.
We agree with Examiner’s position that In re Sebek is not on point.
See Ans. 18. In Sebek the question was whether it was obvious to substitute
citrus molasses for the same concentration of citrus meal when there was no
indication that the two components worked similarly. Here, the question is
whether it would be obvious to adjust the dosage range of mazindol slightly
outside the numeric range claimed in Kovacs, but well within the range
contemplated in Kovacs as encompassing an effective amount of active
agent. As Examiner explains, the dosage optimization in this case is very
different than those considered in Sebek. Kovacs exemplifies a maintenance
dose of 2.5 mg/day for a 14 year old patient while claiming a range between
1–2 mg/day. Here, Kovacs’ claimed dose is already lower than the dose
specifically exemplified. FF4. Kovacs also explicitly teaches that you want
to give a therapeutically effective amount of mazindol when treating ADHD
and suggests that you would adjust the active agent depending on the
severity of the condition. Ans. 18; FF2–FF3. Kovacs, therefore, already
teaches that one of ordinary skill would adjust the amount of mazindol to the
lowest dose based on severity of symptoms and patient condition. See Ans.
18 (“Kovacs claim a method of treating ADHD comprising administering an
effective amount of mazindol.”); FF2 (“It is preferred generally that a
minimum dose be used, that is, the lowest safe dosage that provides
appropriate relief of symptoms.”).
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We also agree with Examiner that In re Patel is not on point because
Kovacs does teach an overlapping range with the claimed range. See Ans.
18–19; FF3. In addition, Examiner points out that Kovacs teaches that one
of ordinary skill in the art would be interested in applying the lowest
effective dosage that provides relief of symptoms. See Ans. 19; see FF2;
Kovacs ’520 claim 11 (“A method for the prevention and/or curative
treatment of attention deficit hyperactivity disorder, (ADHD) or at least one
of the symptoms associated with ADHD comprising administering to a
patient in need thereof an effective amount of mazindol.”). Examiner
explains that these teachings in Kovacs recognize that a therapeutically
effective amount will vary depending on compound, disease severity, age,
and weight. Ans. 19; see FF3 (“daily doses of active compounds will be
from 0.001 mg/kg per day to 200 mg/kg per day”).
Appellant also contends that the art already studied the full spectrum
of obvious doses and concluded that only those between 1–2 mg per day
appear to be effective, and therefore there is no reason to lower the dosage.
See Appeal. Br. 5–6. Appellant relies on the declaration of Dr. Kidane for
supporting the position “that once the effective range of a drug has been
established, ‘any further ‘optimization’ of the dose is typically carried out
within the range established during initial studies.’” Appeal Br. 6 (citing
Kidane Dec. ¶ 11). In other words, optimization would only occur within
the conventional dosage range already taught in the art. Id. at 7 (citing
Kidane Dec. ¶ 20).
We are not persuaded. As Examiner explains Kovacs recognizes that
a therapeutically effective amount will vary depending on compound,
disease severity, age, and weight. Ans. 19; see FF3 (“daily doses of active
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compounds will be from 0.001 mg/kg per day to 200 mg/kg per day”). The
Kidane Declaration provides a table from various clinical trials using
mazindol and finds that the lowest dose reported for ADHD treatment was
1 mg per day while the lowest oral dose for a different application was
0.5 mg per day. Kidane Dec. ¶ 13; see Appeal Br. 7. Thus, the Kidane
Declaration supports Examiner’s position that depending on the disease a
therapeutically effective amount of mazindol will differ.
Kovacs teaches that isoindole derivatives, such as mazindol, can be
administered in the range from 0.001–200 mg/kg per day. FF3. Kovacs
claims an effective dose mazindol to treat ADHD is in the range of 1–2
mg/day. FF4. Kovacs exemplifies administering 2.5 mg/day as a
maintenance dose of mazindol to a 14 year old patient. FF4. It is well
settled that “in a section 103 inquiry, ‘the fact that a specific [embodiment]
is taught to be preferred is not controlling, since all disclosures of the prior
art, including unpreferred embodiments, must be considered.’” Merck &
Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)
(quoting In re Lamberti, 545 F.2d 747, 750 (CCPA 1976)); see also In re
Mills, 470 F.2d 649, 651 (CCPA 1972) (“All the disclosures in a reference
must be evaluated, including nonpreferred embodiments, and a reference is
not limited to the disclosure of specific working examples.” (Citations
omitted).) Here, Kovacs teaches a general range of isoindole derivatives that
include mazindol (FF1), explains that an effective amount is the minimum
dose that provides the appropriate relief of symptom (FF2), and
contemplates adjusting the daily dose on a per kilogram basis (FF3). Based
on these combined disclosures in Kovacs, we agree with Examiner’s finding
that the claimed mazindol dose for the treatment of ADHD is obvious.
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2. Unexpected Results
Appellant contends that it was unexpected that mazindol exhibits
specific agonist activity at the μ-opioid receptor. Appeal Br. 7. “Those of
ordinary skill in the art, being unaware of this ‘additional’ activity, lacked
any basis to assume that a dose lower than those reported could be effective,
let alone one that is 50% lower.” Appeal Br. 8 (citing Kidane Dec. ¶ 17)
We are not persuaded. There has to be a nexus between the
unexpected property and the claimed invention. See In re Kao, 639 F.3d
1057, 1068 (Fed. Cir. 2011) (“Where the offered secondary consideration
actually results from something other than what is both claimed and novel in
the claim, there is no nexus to the merits of the claimed invention.”). In
addition, “when unexpected results are used as evidence of nonobviousness,
the results must be shown to be unexpected compared with the closest prior
art.” In re Baxter-Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
Examiner explains that Appellant has “not provided any evidence or
support identifying that the dosage amounts of 0.1–0.5 mg is critical to the
invention.” Ans. 21. Examiner points out that the Specification does not
provide any data that compares the presently claimed range of 0.1–0.5 mg
per day as providing any unexpected results over any other range
contemplated in the Specification. Id. Indeed, the Specification as
originally filed suggests that mazindol can be administered to treat central
nervous system disorders, including ADHD, at a range from 0.1–20 mg per
day. Spec. 9 (claims 1–8); see id. We agree with Examiner’s position that
there is insufficient “data or evidence in the specification demonstrating
some data points outside and inside of the [claimed] range[] . . . [from which
to extrapolate that one] is more effective or efficacious to support [a
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conclusion] that the claimed range, 0.1–0.5 mg has unexpected results.”
Ans. 7, id. at 21. The claims are directed to treating ADHD using mazindol
as a sole active agent at a daily dosage from 0.1–0.5 mg. The discovery that
the μ-opioid receptor is another target for mazindol and may also be a target
for ADHD is a valuable contribution but does not give rise to a patentable
invention because the art already recognizes that administration of mazindol
provides relief for ADHD. See FF1–FF7. Appellant’s declarant Dr. Kidane
attests that Appellant has discovered another receptor that is a target for
mazindol but the declaration has not established that there is a nexus
between the claimed dosage range and the μ-opioid receptor. See Kidane
Dec. ¶ 17. A showing in the Specification that μ-opioid receptor binds
mazindol tightly in an in vivo assay does not explain why the effect of
administering mazindol to patients at the claimed dosages is surprising,
especially when viewed in light of Kovacs’ teaching of administering an
overlapping range of active compound. As Examiner explains, “mazindol
being an agonist of μ-opioid receptor(s) is an inherent property of the
compound. . . . If additional activity is the reason for the dosage amount of
0.1–0.5 mg, there is no data in the specification as for administration of such
amounts has provided unexpected results (e.g. higher efficacy, or potency)
compared to 1 mg or 2 mg as argued by the Appellant[].” Ans. 22. Here,
Examiner acknowledged the alleged unexpected results but was just not
persuaded by the evidence. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
1372 (Fed. Cir. 2007) (“[W]e hold that even if Pfizer showed . . .
unexpectedly superior results, this secondary consideration does not
overcome the strong showing of obviousness in this case. Although
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secondary considerations must be taken into account, they do not necessarily
control the obviousness conclusion”).
We agree with Examiner that Appellant has not persuasively
demonstrated that the claimed dosage range is critical or that it otherwise
exhibits unexpected results over the dosages taught in Kovacs. Thus, when
weighing the record as a whole in light of Examiner’s comparatively strong
prima facie case, we determine that the preponderance of the evidence
supports Examiner’s rejections as to claim 10.
3. Burden
We agree that Examiner “‘bears the initial burden . . . of presenting a
prima facie case of unpatentability.’” In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). Appellant contends that Examiner is improperly shifting
the burden to Appellant to prove non-obviousness. Appeal Br. 9–10; see
Reply Br. 3. We are not persuaded. As discussed above, we find that
Examiner has identified sufficient evidence in the record from which to
conclude that administering mazindol for the purpose of treating ADHD was
known. FF1, FF6, FF7. Examiner has directed us to teachings in Kovacs
that suggest administering a dose of active ingredient ranging from 0.001
mg/kg per day to 200 mg/kg per day. FF3. Examiner also directs us to
teachings in Kovacs that suggest it is preferred that “the minimum dose be
used, that is, the lowest safe dosage that provides appropriate relief of
symptoms.” FF2; Ans. 6. Thus, Kovacs recognizes that “the actual dose
used as contemplated in a given individual may [be] less or greater than th[e]
dosage range” contemplated. FF3.
It is only in response to Appellant’s unexpected results argument that
Examiner asks that Appellant establish the criticality of the presently
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claimed range. Thus, there is nothing wrong with the timing of Examiner’s
request to provide more evidence or data because it was only made after
Examiner had already established a prima facie case and after Appellant
asserted unexpected results in rebuttal. As discussed above, we do not find
that the teaching in the Specification that mazindol exhibits specific agonist
activity at the μ-opioid receptor rises to the level of being unexpected. As
Examiner responds, the agonist activity of mazindol is an inherent property
associated with the compound. Ans. 22. Here, the art suggests treating the
same patient population (those suffering from ADHD) with the same
compound (mazindol) at overlapping concentration range (0.001–200 mg/kg
per day). FF1–FF8. The discovery that mazindol exhibits specific agonist
activity at the μ-opioid receptor is admittedly scientifically interesting but
this is not captured in the present claims. Scientific explanation how the
compound may work on the cellular level to treat a particular disease does
not take away from what is already taught in the art –– in this case treating a
patient with ADHD using mazindol at a daily dosage of 0.001 mg/kg–200
mg/kg. FF1–FF3.
Kovacs specifically discloses administering the compounds having
daily dosage from 0.001 mg/ kg per day to 200 mg/kg per day. FF3.
Epstein suggests a daily dosage range from 0.0001–100 mg/kg. FF8.
Examiner’s calculation that a child at 20 kg or 40 kg given a dosage is 0.01
mg/kg falls within the claimed range seems reasonable. FF5. Accordingly,
we find that Examiner has made a sufficient showing that the disclosures
relied upon provide a reasonable basis for the initial prima facie case.
Having determine that Examiner has presented sufficient evidence for a
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prima facie showing of obviousness, the burden then reasonably shifted to
Appellant provide a rebuttal.
We also do not agree with Appellant’s position that there is no dispute
that the prior art dosage range of mazindol does not overlap with the range
claimed. See Appeal Br. 8–9. Here, Appellant is limiting the dosage of
mazindol to those amounts exemplified in the references. A reference is not
limited to the specific embodiments. See Merck & Co. Inc. v. Biocraft
Laboratories Inc., 874 F.2d at 807. Thus, there is no reason to limit the
teachings of a reference to the exemplified embodiments while ignoring that
wider dosage ranges contemplated by the same reference.
We conclude that the evidence cited by the Examiner supports a prima
facie case of obviousness with respect to claim 10, and Appellant has not
provided sufficient rebuttal evidence or evidence of secondary
considerations when balanced with the evidence supporting the Examiner’s
conclusion of obviousness.
CONCLUSION
In summary:
Claims
Rejected
Basis Affirmed Reversed
10 pre-AIA 35 U.S.C. § 103(a) over
Kovacs ’520 or Kovacs ’139
10
10 pre-AIA 35 U.S.C. § 103(a) over
Konofal in view of Kovacs ’520 or
Kovacs ’139
10
10 pre-AIA 35 U.S.C. § 103(a) over
Epstein and Kovacs ’139
10
10 provisional nonstatutory
obviousness-type double patenting
over Application No 14/841,898
10
Outcome 10

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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).

AFFIRMED