Ex Parte 6270796 et al

Board of Patent Appeals and Interferences

Sep 22, 2010

90008111 (B.P.A.I. Sep. 22, 2010)

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.
90/008,111 07/07/2006 6270796 960014-2001.1 6321
20999 7590 09/22/2010
FROMMER LAWRENCE & HAUG
745 FIFTH AVENUE- 10TH FL.
NEW YORK, NY 10151
EXAMINER
TURNER, SHARON L
ART UNIT PAPER NUMBER
3991
MAIL DATE DELIVERY MODE
09/22/2010 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte J-MED PHARMACEUTICALS
Appellant & Patent Owner
____________

Appeal 2010-006150
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Technology Center 3900
____________

Before ROMULO H. DELMENDO, RICHARD M. LEBOVITZ, and
JEFFREY B. ROBERTSON, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL1

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
shown on the PTOL-90A cover letter attached to this decision.
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This is a decision on the appeal by the Patent Owner of U.S. Patent
No. 6,270,796 from the Patent Examiner’s rejections of claims 1-18 in an Ex
parte Reexamination proceeding. The Board’s jurisdiction in this appeal is
based under 35 U.S.C. §§ 6(b), 134, and 306. We affirm the Examiner.

STATEMENT OF THE CASE
U.S. Patent No. 6,270,796 (hereinafter “the ‘796 patent”) issued
August 7, 2001. The named inventor is Robert E. Weinstein. A Request for
Ex Parte Reexamination of claims 1-18 of the ‘796 patent was filed by
Third-Party Requester Steven J. Hultquist (“Requester”) on July 7, 2006,
pursuant to 35 U.S.C. §§ 302-307 and 37 C.F.R § 1.510 (“Req.”).
Reexamination was sought on the basis of more than thirty prior art
references (Req. 2-3).
Reexamination was granted by the Examiner in response to the
Request (Order Granting Request for Reexamination mailed Sept. 14, 2006).
In a Final Rejection dated February 13, 2008, patented claims 1-18 were
rejected.
The claims are identical to those in the ‘796 patent. No amendments
were made during the Reexamination proceeding. The final rejection was
appealed by the Patent Owner and a Supplemental Appeal Brief was filed
May 7, 2009 by the owner of the patent, J-Med Pharmaceuticals and the
licensee, Cornerstone BioPharma (App. Br. 1). Oral arguments were heard
on August 4, 2010. A written transcript of the oral arguments will be
entered into the electronic record in due course.
There are four grounds of rejection at issue in this appeal:
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1. Claims 1, 3, 6, 10, 12, and 15 under 35 U.S.C. § 102(b) as
anticipated by Middleton2 (Ans. 3).
2. Claims 1, 3, 6-10, 12, and 15-18 under 35 U.S.C. § 103(a) as
obvious in view of Knudsen3 and Howrie4 (id. at 4).
3. Claims 1-18 under 35 U.S.C. § 103(a) as obvious in view of
Knudsen and Meltzer5 (id. at 6).
4. Claims 2, 4, 5, 7-9, 11, 13, 14, and 16-18 under 35 U.S.C. § 103(a)
as obvious in view of Middleton, Knudsen, and Meltzer (id. at 8).
Claim 1 is representative and reads as follows:
1. A prepackaged therapeutic regimen comprising:
(a) a non-sedating first dosage unit, which includes a
nasal decongestant;
(b) a second dosage unit which does not include a nasal
decongestant and includes an antihistamine;
(c) indicia for distinguishing between said first and
second dosage units;
(d) administration instructions for the use of said dosage
units as a rhinitis regimen, such that said first dosage unit is
instructed for daytime administration and said second dosage
unit is instructed for nighttime administration; and
(e) a pharmaceutical dispensing container prefilled with
said dosage units and incorporating said indicia and
instructions.

2 R.S.W. Middleton, “Double Blind Trial in General Practice Comparing the
Efficacy of ‘Benylin Day and Night’ and Paracetamol in the Treatment of
the Common Cold”, 35 Brit. J. Clinical Practice 9, pp. 297-300 (1981).
3 Eric T. Knudsen, U.S. Pat. No. 4,295,567, Oct. 20, 1981.
4 Denise L. Howrie and Jerome H. Wolfson, “Phenylpropanolamine-induced
Hypertensive Seizures”, 102 J. Pediatrics 1, pp. 143-144 (1983).
5 Eli O. Meltzer, “Antihistamine- and Decongestant-induced Performance
Decrements”, 32 J. Occupational Med. 4, pp. 327-334 (1990).
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ANTICIPATION BY MIDDLETON
Claims 1, 3, 6, 10, 12, and 15 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Middleton.
Issue
The issue in this rejection is whether the Examiner established that
each and every limitation of the claims is found in Middleton.

Legal Principles
Under 35 U.S.C. § 102 a claim is anticipated “if each and every
limitation is found either expressly or inherently in a single prior art
reference.” Celeritas Techs. Ltd. v. Rockwell Int’l Corp., 150 F.3d 1354,
1361 (Fed. Cir. 1998).
“[W]hen the PTO shows sound basis for believing that the products of
the applicant and the prior art are the same, the applicant has the burden of
showing that they are not.” In re Spada, 911 F.2d 705, 708 (Fed. Cir. 1990).
“Inherency, however, may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from a given set of
circumstances is not sufficient.” In re Robertson, 169 F.3d 743, 745 (Fed.
Cir. 1999) (internal quotation marks omitted).

Factual Findings (“FF”)
Middleton
1. Middleton describes “Benylin Day and Night” for treating colds
and related upper respiratory tract infection (Middleton, p. 297, col. 1).
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2. The Benylin Day formulation contains paracetamol and the
decongestant phenylpropanolamine (PPA) for daytime relief without
antihistamine-induced drowsiness (id. at 297, col. 2).
3. The Benylin Night formulation contains paracetamol and the
antihistamine diphenhydramine hydrochloride (id.).
4. Middleton disclosed that the medication “was administered [to
patients] four times daily” in the form of three daytime tablets and one
nighttime tablet (id. at 298, col. 1).
5. Middleton concluded that “a significantly greater number of
patients felt that ‘Benylin Day and Night’ helped their cold symptoms more
than did paracetamol [alone] . . . and seemed to reduce the severity of
headache more than did paracetamol” (id. at 300, col. 1).
6. Middleton did not describe indicia on a container for distinguishing
between the Benylin Day and Benylin Night dosage units.
7. Middleton did not describe a pharmaceutical dispensing container
prefilled with the Benylin Day and Benylin Night dosage units.
8. Middleton taught that sedation was an added problem when using
antihistamines, limiting their daytime use (id. at 297, col. 2).

Analysis
Claim 1 is an independent claim drawn to a “prepackaged therapeutic
regimen” comprising five elements (a) through (e). The Examiner found
that Middleton’s Day and Night formulations, comprising a decongestant
and antihistamine, respectively, met the requirements of claimed elements
(a) and (b). As far as indicia (c) and dispensing container (e), the Examiner
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found “dosages are provided in tablet form with suitable packaging, [and as
for] indicia . . . see particularly p. 297 column 2 and p. 298, column 1.”
(Ans. 3.) The Examiner acknowledged that
the reference does not extensively describe the indicia for
distinguishing the tablets, the instructions or container, the
reference is noted to suitably provide these teachings as the
patients were provided with the aforementioned drugs for
administration under the guidelines stipulated for testing the
Benylin day and night formulations. Accordingly, the
preparation of the administered dosages were provided to the
patients with adequate indicia for distinguishing the tablets to
be taken at night vs. day . . . and dispensed to the patient in a
suitable container for providing the tablets to be taken within
the specified regime.
(Ans. 3-4.)
The Examiner did not meet the burden of establishing that Middleton
described all the limitations of the claimed prepackaged therapeutic regimen.
Middleton described daytime and nighttime medication formulations (FF1-
4) that meet the requirements of the claimed dosage units (a) and (b).
Middleton, however, did not describe the dosage units labeled with indicia
nor were the dosage units described as being prefilled in a “pharmaceutical
dispensing container,” as required by limitations (c) and (e) of claim 1 (FF6
& FF7). The Examiner acknowledged this deficiency, but apparently
concluded that indicia and a prefilled dispensing container must have been
provided in order for the patients to have followed Middleton’s specified day
and night regime (Ans. 4-5).
Anticipation is not established by a probability or a possibility that a
claimed feature is described within the four corners of a prior art reference.
In re Robertson, 169 F.3d at 745. The Examiner must have a sound basis for
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believing that such feature is actually present. In re Spada, 911 F.2d at 708.
In this case, there was no disclosure in Middleton about how the daytime
and nighttime formulas were labeled and packaged (FF6 & FF7). The
Examiner did not establish that indicia and a dispensing container prefilled
with both dosage units were the only ways in which the medications could
be supplied to the patients, while still complying with the specified day and
night regime. Consequently, we conclude that the Examiner did not meet
the burden of establishing that Middleton inherently met limitations (c) and
(e) of claim 1. The rejection is reversed.

OBVIOUSNESS OVER KNUDSEN AND HOWRIE
Claims 1, 3, 6-10, 12, and 15-18 stand rejected under 35 U.S.C.
§ 103(a) as obvious in view of Knudsen and Howrie.

Issues
Appellant contends that the Examiner erred in rejecting the claims
because:
• Knudsen taught a nighttime formulation in which the decongestant
was carefully balanced with the antihistamine to achieve controlled sedation,
and therefore there would have been no reason to eliminate the decongestant
from it. (App. Br. 13.)
• Howrie relates to an overdose of phenylpropanolamine used in a diet
aid and would not have motivated the skilled worker to eliminate it from
Knudsen’s nighttime formulation. (App. Br. 13.)

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Factual Findings (“FF”)
Knudsen
9. Knudsen describes a “pharmaceutical dispensing container which
holds two dosage units” for treatment of “respiratory tract disorders, the first
of these dosage units being indicated for day-time administration and being
non-sedative and the second of these dosage units being indicated for night-
time administration and being sedative.” (Knudsen, Abstract; see also col.
4, claims 7-9).
10. Knudson teaches that “as is often the case, a sedative action is
desired at night.” (Id. at col. 1, ll. 12-15.)
11. Figure 1, reproduced below, shows a dispensing container
described in Knudson:

Figure 1 shows a blister pack with one axis labeled “Day” and
“Night,” where dosage units 5 are for daytime administration (“Day”) and
dosage units 4 are for nighttime administration (“Night”). (Id. at col. 1, ll.
43-55.)
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12. Administration instructions are printed in the area labeled 6 of
Figure 1 (id. at col. 1, ll. 44-45), but may also be printed on a separate sheet
of paper (id. at col. 2, ll. 28-31).
13. To remove a dosage unit, a blister is pressed with the finger to
push the unit through the base 1 (id. at col. 2, ll. 20-23). The empty blister
“conveniently shows when the necessary dosage units have been taken.”
(Id. at col. 2, ll. 15-19.)
14. “A suitable non-sedative composition for use in the dosage units
comprises an antitussive and a decongestant.” (Id. at col. 3, ll. 21-23.)
15. “A suitable sedative composition for use in the dosage units
comprises an antitussive, a decongestant and an antihistamine.” (Id. at col. 3,
ll. 24-26.)
16. Knudsen teaches that phenylpropanolamine is a suitable
decongestant and that promethazine is a suitable histamine (id. at col. 3, ll.
32-35).

Howrie
17. Howrie teaches that phenylpropanolamine, “commonly included
in nonprescription products such as diet aids and cold preparations, has been
reported to cause headache, insomnia, nervousness, and elevation of blood
pressure.” (Howrie, p. 143, col. 2.)
18. Howrie reported on a 13-year old girl who experienced seizures
after ingesting a diet aid comprising phenylpropanolamine (id. at 143-144).

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‘796 Patent
19. The ‘796 Patent acknowledged that nasal decongestants are
“stimulatory” and “may produce nervousness, restlessness, and insomnia if
taken at night.” (’796 Patent, col. 1, ll. 36-42).
20. The ‘796 patent acknowledged that “[r]egimens have also been
commercialized which incorporate a decongestant for daytime and not for
nighttime.” (Id. at col. 3, ll. 29-30.)

The person of ordinary skill in the art
21. The ordinary skilled worker in the art is a person educated in
pharmacy and/or pharmacology, and knowledgeable about the
pharmacological activity of drugs.

Analysis
The Examiner found that Knudsen’s blister pack, with indices labeling
pharmaceutical compositions for day and night administration, met features
(a), (c), (d), and (e), as recited in independent claim 1. (Ans. 4-5.) The
Examiner found that the difference between the claimed subject matter and
Knudsen was that Knudsen did not describe “a second dosage unit which
does not include a nasal decongestant and includes an antihistamine,” as
recited in feature (b) of claim 1. (Ans. 5.) Rather, the Examiner found that
Knudsen’s antihistamine dosage unit also contained a decongestant (FF15).
However, the Examiner found that Howrie taught insomnia as a recognized
side effect of the decongestant phenylpropanolamine (“PPA”) described in
Knudsen (Ans. 5; FF17). The Examiner concluded that the ordinary skilled
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worker would have been “motivated by Howrie to omit
phenylpropanolamine from the night time preparation to eliminate the
contraindicated insomnia effects within the sedative night time dose.” (Ans.
6.)
Appellant contends that Knudsen taught a nighttime formulation in
which the decongestant was carefully balanced with the antihistamine to
achieve controlled sedation, and therefore there would have been no reason
to eliminate the decongestant from it (App. Br. 14-17).
Knudsen expressly discloses that it is “often” desirable to provide a
cold formulation with sedative activity at night (FF10). While Knudsen
achieves this effect with an antihistamine – which is undisputed to be
sedative – and a nasal decongestant (FF15), Appellant has not provided
evidence that Knudsen is limited to this combination for nighttime treatment
described as “suitable.” Thus, while Knudsen purportedly balanced the
stimulatory activity of PPA with the antihistamine promethazine, we do not
read Knudsen’s disclosure to be narrowly limited to this disclosed and albeit
“suitable” or preferred example in view of its more general description
nighttime dosage units “being sedative.” (FF9.) In fact, Knudsen says
nothing about it being necessary to balance a decongestant with an
antihistamine to achieve a sedative effect.
Appellant also contends that the ordinary skilled worker would not
have been prompted by Howrie to eliminate PPA from Knudsen’s nighttime
formulation because Howrie was a report about PPA-induced seizures
associated with diet aid ingestion (App. Br. 13).
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Howrie was relied upon by the Examiner for its teaching that the
decongestant PPA was known to cause insomnia (FF17). Appellant admits
in his own patent that decongestants were known to be “stimulatory” and to
be capable of producing “nervousness, restlessness, and insomnia if taken at
night.” (FF19). Thus, while Howrie was a report about seizures associated
with PPA administration, the disclosure that PPA also produced insomnia is
consistent with the admission in the ‘796 Patent that decongestants were
known to be associated with insomnia. Given these teachings, the Examiner
had sound reason for concluding that a person of ordinary skill in the art
would have been prompted to omit PPA from Knudsen’s nighttime
formulation in order to avoid its stimulatory effects.
In the Appeal Brief, it is stated that “Appellant was the first to
appreciate that the decongestant at night acts as a stimulant and has, for
certain patients, the negative side-effect of inadvertent insomnia” especially
when self-prescribed (App. Br. 17). This statement is not factually
supported. To the contrary, the ‘796 patent in its “Prior Art” section
expressly stated that decongestants “may produce . . . insomnia, if taken at
night” (FF19). This statement is merely consistent with Howrie’s teaching
that PPA can cause insomnia (FF 17).
While the ‘796 patent stated that the insomnia produced by nasal
decongestants “can be a source of confusion for individuals who mistakenly
attribute their inability to sleep” to the cold rather than to the “decongestant
medication” (‘796 patent, col. 1, ll. 41-45), this confusion does not negate
the fact that it was known that decongestants produce insomnia. Such fact,
as the Examiner concluded, would have prompted the ordinary skilled
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worker to have removed PPA from Knudsen’s nighttime formulation. In
this case, the ordinary skilled worker is a person educated in pharmacy
and/or pharmacology, knowledgeable in the pharmacology activity of drugs,
and thus would have recognized the stimulatory side-effects of PPA and
other nasal decongestants. (FF21.) This person is different from the
consumer of the drug product “who used the medication to treat his cold”
and “mistakenly attribute[d]” his inability to sleep to his illness, rather then
to the drug. Unlike the ordinary skilled worker, the cold product consumer
is not charged with drug knowledge and is not the person who would have
combined the prior art to have made the claimed invention.

Claims 3 and 12
Claims 3 and 12 depend on claim 1 and further require that the
antihistamine is sedating.
Appellant contends that the “claimed invention is directed to
particular regimens that do not forfeit daytime antihistaminic effect.” (App.
Br. 19). Appellant argues that the Examiner failed to recognize “that the
present invention specifically relates to the use of antihistamines such as
chlorpheniramine, that have a significantly longer half-life than the prior art
antihistamines, resulting in an antihistaminic effect throughout the day
following night-time administration” (id.).
The claims are not limited to sedating antihistamines which, when
administered at night, also have a daytime effect. Appellant has not directed
our attention to any disclosure in the ‘796 patent which would demand this
narrow interpretation of the term “sedating” antihistamine as recited in the
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claim. At column 4, line 66 to column 5, line 4 of the ‘796 patent, it is
stated:
It is a preferred object to provide a user with an [sic] therapeutic
combination of decongestant and antihistamine during the day,
either by single nighttime dosing of sedating antihistamine
which is suitable with respect to its half-life, duration of action,
and duration of side effect, or by utilization of non-sedating
antihistamine.
This statement does not restrict the sedating histamine to one that is
active during the day, as argued. Rather, it indicates that a dosage and
suitable properties of an antihistamine can be chosen to achieve this desired
daytime effect. Claims 3 and 12, however, are not limited to such a dosage
nor such an antihistamine. While a patent specification should be used to
interpret the meaning of a claim, it is not be used to import unnecessary
limitations into the claims. Playtex Prods., Inc. v. Procter & Gamble Co.,
400 F.3d 901, 908 (Fed. Cir. 2005).

OBVIOUSNESS OVER KNUDSEN AND MELTZER
Clams 1-18 stand rejected under 35 U.S.C. § 103(a) as obvious in
view of Knudsen and Meltzer.

Factual Findings (“FF”)
Meltzer
22. Meltzer discloses that in 1988 “sales of single-entity oral
antihistamines, oral decongestants, and combination oral antihistamine-
decongestant agents totaled more than $1.9 billion” (Meltzer, p. 328, col. 1).
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23. Meltzer teaches that chlorpheniramine suppresses the symptoms
of allergic rhinitis for thirty hours (id. at 328, col. 2)
24. Meltzer also describes non-sedating second generation
antihistamines (id. at 327, col. 1).
25. Meltzer discloses that decongestants, such as
phenylpropanolamine, “may cause CNS stimulation resulting in restlessness,
insomnia, apprehension, headache, and tremor in many persons.” (Id. at
332, col. 2.)

Analysis
The Examiner found that the prepackaged therapeutic regimen of
claim 1 would have been obvious over Knudsen and Meltzer for the same
reasons as for Knudsen and Howrie, but cited Meltzer (rather than Howrie)
for its teaching that PPA caused CNS stimulation, including insomnia (Ans.
6; FF25). Meltzer was also cited for its teaching of non-sedating
antihistamines as recited in claims 2 and 11.
Appellant contends that if “Meltzer were combined with Knudsen,
. . . the sedative promethazine would be replaced with a second-generation
non-sedative antihistamine, and inevitably result in insomnia when the
combination of a stimulatory decongestant and a non-sedative antihistamine
was administered at night.” (App. Br. 20).
This argument is not persuasive. The Examiner expressly cited
Meltzer for prompting a person of ordinary skill in the art to have omitted
the stimulatory PPA from Knudsen’s nighttime formation. Consequently,
insomnia would not have “inevitably” resulted upon nighttime
administration of a non-sedating antihistamine.
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As for Appellant’s arguments relating to Knudsen alone (App. Br. 20-
21), we refer to the discussion above on pages 10-11.
Claims 2-4 and 11-13
As to claims 3, 4, 12, and 13, Appellant reiterates its argument that
that the claimed invention is to particular administration regimes which do
not forfeit daytime antihistaminic effect (App. Br. 21). This argument is not
persuasive because the claims are not limited to antihistamines or dosages
that, when administered at night, maintain a daytime antihistaminic effect.
Appellant is arguing a limitation that does not appear in the claims.
With respect to claims 4 and 13, which recite that the antihistamine is
chlorpheniramine, Meltzer specifically discloses that chlorpheniramine is a
useful antihistamine effective for more than twenty-four hours (Meltzer, p.
328, col. 2; FF 24), giving a person of ordinary skill in the art reason to have
utilized it. Appellant contends that the Examiner had failed to recognize this
advantage of chlorpheniramine (App. Br. 21); however, Meltzer expressly
described it.
Claims 2 and 11 are drawn to a non-sedating antihistamine. Appellant
contends that
claims 2 and 11 of the ‘796 patent provide a method to
accomplish daytime antihistaminic as well as decongestant
effect without drowsiness, and is clearly distinct and allowable
over . . . Knudsen because Knudsen teaches no therapeutic
daytime antihistaminic benefit.
(App. Br. 22.)
Once again, Appellant is interpreting the claim too narrowly to require
that the non-sedating antihistamine have a daytime benefit.

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OBVIOUSNESS OVER MIDDLETON, KNUDSEN, AND MELTZER
Claims 2, 4, 5, 7-9, 11, 13, 14, and 16-18 stand rejected under 35
U.S.C. § 103(a) as obvious in view of Middleton, Knudsen, and Meltzer
(Ans. 8).
This rejection is based on the Middleton, Knudsen, and Meltzer prior
art references cited in the previous section 102 and 103 rejections. Because
the prior art is the same and the grounds of rejection are similar to the
rejections already addressed, we refer to pages 8-9 of the Answer for the
Examiner’s statement of the rejection.

Issue
Appellant contends there was “no reason to include Meltzer’s non-
sedative antihistamines in a nighttime formulation, when they could just as
easily be given during the day (because they do not cause sedation).” (App.
Br. 23.)

Analysis
At the time the patent involved in this reexamination proceeding was
filed, it was known to administer single-entity oral antihistamines and oral
decongestants (FF22). The idea of providing separate dosages units with an
oral antihistamine and an oral decongestant was not only well-established,
but was part of a billion-dollar market (id.) Assembling the separate
antihistamines and decongestants into a single dispensing container had also
been recognized in the prior art as evidenced by Knudsen, who also taught
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labeling the antihistamine for nighttime administration and the decongestant
for daytime administration (FF9 & FF11). While a reason for administering
the antihistamine at night was because of its sedation properties, the absence
of this side-effect would not have precluded or taught away from
administering it separately at a different time, for example, to monitor
whether the antihistamine dosage unit had been taken (FF13). As Knudsen
expressly taught segregating the antihistamine and decongestant in a single
dispensing container, following Knudsen’s direction is not inventive, but
following a path that had already been described in the prior art.
Moreover, we do not interpret claim 1 to require that the first and
second dosage units be administered at daytime and nighttime, respectively.
We interpret claim 1 to be a product claim with at least two separate dosage
units in a prefilled dispensing container. Administration instructions (d) are
included along with the dosage units, but these instructions do not transform
the product claim into a method claim. To the contrary, we treat the claimed
instructions feature as an intended use of the claimed product and not to
distinguish the product over the prior art.
Our interpretation is consistent with In re Gulack, 703 F.2d 1381,
1385 (Fed. Cir. 1983), which held that words or designs printed
(collectively, “printed matter”) on a substrate (e.g., paper) are not considered
patentable limitations unless the printed matter and substrate functionally
relate to each other. See also In re Ngai, 367 F.3d 1336, 1338 (Fed. Cir.
2004).
In Gulack, the numbers printed on a circular band permitted the user
to perform a mathematical activity with it. Gulack, 703 F.2d at 1386. Thus,
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to serve as a patentable limitation, the printed matter on the substrate must
interact with the substrate, enabling the user to perform a new and
nonobvious activity with the substrate. Here, the instructions do not
cooperate with the substrate upon which they are printed, but simply instruct
the user when to take the dosage units, an activity that under Gulack is
insufficient to confer patentability on an otherwise obvious combination.
Appellant argued that “[t]here is no reason to substitute Meltzer’s
non-sedative antihistamine for the promethazine in Knudsen, because there
would be nothing to counter the stimulant action of the decongestant in
Knudsen’s formulation.” (App. Br. 23.) This argument fails to address the
basis of the rejection. The Examiner expressly cited Meltzer for its teaching
that decongestants cause insomnia (FF25), prompting the ordinary skilled
worker to omit them from the nighttime formulation. Thus, it would not
have been necessary to counter PPA’s stimulatory activity because it would
have been absent.

Claims 2, 4, 11, and 13
Claims 2, 4, 11, and 13 have been argued separately (App. Br. 23).
These are the same arguments addressed in previous sections above.

BALANCING AMOUNTS OF THE
ANTIHISTAMINE AND DECONGESTANT
In the Appeal Brief and Reply Brief, Appellant argues that the
formulations of the prior art balanced amounts of the antihistamine and
decongestant for nighttime use and that the effectiveness of the formulations
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depended on both components (Reply Br. 6-7). Appellant contends that the
Examiner impermissibly broadened the disclosure of the cited prior art by
suggesting that the decongestant could be eliminated from the nighttime
formulations, rather than balancing it with an antihistamine (id. at 7-9).
Evidence from the ‘796 patent clearly establishes that commercial
formulations containing a decongestant and antihistamine were known prior
to the patent’s effective filing date (col. 2, l. 14 through col. 3, l. 47).
However, such combination products were not the only ones available in the
prior art. Firstly, Middleton expressly described a cold formulation with a
separate unit of the decongestant PPA for daytime relief and a separate unit
of the sedating antihistamine diphenhydramine hydrochloride for nighttime
use (FF1-FF4). The nighttime formulation lacked a decongestant (FF3).
Secondly, Meltzer taught that single-entity antihistamines and decongestants
were available commercially (FF22). Thus, the separate components were
available and had been used independently as taught by the Middleton
reference. Finally, Appellant’s own patent acknowledged that “[r]egimens
have also been commercialized which incorporate a decongestant for
daytime and not for nighttime.” (FF 20.) In sum, while a person of ordinary
skill in the art may have known to balance the effects of a stimulatory
decongestant with a sedating antihistamine when administered at the same
time, such a person’s knowledge was not confined to these dual
combinations.

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SECONDARY CONSIDERATIONS
In making an obviousness determination, we must consider (1) the
scope and content of the prior art; (2) the differences between the claimed
invention and the prior art; (3) the level of ordinary skill in the art; and (4)
any relevant secondary considerations, including commercial success, long-
felt but unsolved needs, and failure of others. Graham v. John Deere Co.,
383 U.S. 1, 17 (1966).
Commercial success
Issue
Did Appellant provide sufficient evidence of commercial success to
rebut the prima facie case of obviousness?

Legal Principles
To overcome a finding of obviousness by demonstrating commercial
success, there must be a nexus between commercial success and the claimed
features. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1312 (Fed. Cir.
2006). “[T]he asserted commercial success of the product must be due to
the merits of the claimed invention beyond what was readily available in the
prior art.” J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571
(Fed. Cir. 1997).
“[I]f the commercial success is due to an unclaimed feature of the
device, the commercial success is irrelevant. So too if the feature that
creates the commercial success was known in the prior art, the success is not
pertinent.” Ormco Corp., 463 F.3d at 1312 (footnotes omitted).
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Objective evidence of nonobviousness, including commercial success,
must be commensurate in scope with the claims. In re Tiffin, 448 F.2d 791,
792 (CCPA 1971) (evidence showing commercial success of thermoplastic
foam “cups” used in vending machines was not commensurate in scope with
claims directed to thermoplastic foam “containers” broadly).
“Denso argues that this [sales] evidence is insufficient because Tec
Air failed to provide market share data. Although sales figures coupled with
market data provide stronger evidence of commercial success, sales figures
alone are also evidence of commercial success.” Tec Air, Inc. v. Denso Mfg.
Mich., Inc., 192 F.3d 1353, 1360-61 (Fed. Cir. 1999).
In the present case, Huang has simply not provided
sufficient information upon which the PTO could determine
whether the grips were commercially successful. Although
Huang’s affidavit certainly indicates that many units have been
sold, it provides no indication of whether this represents a
substantial quantity in this market. This court has noted in the
past that evidence related solely to the number of units sold
provides a very weak showing of commercial success, if any.
In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996).
The ultimate determination of whether an invention is obvious is a
legal question based on the totality of the evidence. Richardson-Vicks, Inc.
v. The Upjohn Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997). Commercial
success and unexpected results, although supported by substantial evidence,
did not overcome a strong case of obviousness. Id. at 1484. See also Brown
& Williamson Tobacco Corp. v. Philip Morris, Inc., 229 F.3d 1120, 1131-32
(Fed. Cir. 2000).

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Factual Findings (“FF”)
26. According to Appellant, the “present invention is the subject of a
license to Cornerstone BioPharma, Inc. Under the license, Cornerstone
BioPharma, Inc. (as well as a previous licensee) has marketed and sold
AlleRx®, a product that meets all of the requirements of at least claim 1 of
the ‘796 patent” (App. Br. 26).
27. Appellant provided the following sales data for AlleRx® in the
Appeal Brief (App. Br. 26):
2001 $4.4 million
2002 $5.4 million
2003 $6.3 million
2004 $7.9 million
2005 $9.5 million
2006 “projected to increase to approximately $11 million”
28. Appellant stated that this sales growth represented “a year over
year growth from 2001 to 2006 exceeding 20%.” (Id.)
29. Appellant summarized the total prescriptions for AlleRx® as
follows (id. at 26-27):
2001 97,882
2002 118,462
2003 137,782
2004 170,872
2005 207,789
30. Appellant stated that these prescription numbers show “that total
prescription increases approached nearly 25% year over year” (id. at 27).
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Analysis
To establish commercial success, there must be a “nexus” between the
product from which the success arises and the claimed features of the
invention. Ormco Corp., 463 F.3d at 1312. That is, there must be a
connection between the commercial success and the merits of the claimed
invention.
In attempting to establish commercial success, Appellant relied on
sales and prescription data for AlleRx®, a product that was said to meet all
of the requirements of at least claim 1 (FF26). However, Appellant did not
disclose the composition of AlleRx®. Thus, while it may contain a
decongestant and antihistamine in separate dosage units, as required by
claim 1, the claim is open-ended and permits other ingredients to be
included, as well. Appellant has not established that the success of the
commercial product is due to the claimed features rather than to another
unclaimed feature, such as an additional pharmacological component in
AlleRx®. For this reason, we conclude that a nexus has not been established
between the claimed invention and AlleRx®.
In addition to this, independent claim 1 is unrestricted as to the type of
antihistamine (sedating, non-sedating) and decongestant. Dependent claims
further limit claim 1 as to the class of antihistamine (e.g., claims 2 and 3) as
well as to a specific antihistamine and decongestant (claims 4-6). Appellant
has not specified the specific antihistamine and decongestant present in
AlleRx® and whether the increased commercial sales would have been
reasonably expected with other antihistamines and decongestants, such as
those recited in claims 2-6, or that success would have been expected with
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all decongestants and antihistamines. Commercial success must be
commensurate in scope with the claims. Tiffin, 448 F.2d at 792.
In failing to establish a nexus between the commercial sales and
AlleRx®, Appellant has not provided evidence that it is the combination of
the features that is responsible for the increased sales. The concept of
providing oral antihistamines and decongestants in separate dosage units was
known in the art prior to the patent’s filing date (FF1-4 & 9). The concept of
a prefilled dispensing container with segregated dosage units was also found
in the prior art (FF9 & FF11). Thus, were the increased sales and
prescription numbers a consequence of the dispensing container, such
commercial success would have been a result of a feature that was readily
available in the prior art and not a basis upon which prima facie obviousness
could be rebutted. J.T. Eaton & Co., 106 F.3d at 1571; Ormco Corp., 463
F.3d at 1312.
In reaching the conclusion that the showing is insufficient evidence of
commercial success, we further observe that no market share data has been
presented, making the showing weak, at best. Tec Air, Inc., 192 F.3d at
1361; Huang, 100 F.3d at 140.

Long-felt Need
Appellant contends that “only after 14 years of failure . . . to address
and resolve the insomnia-related side effect that the Appellant made
the discovery on which the ‘796 patent is based. The fourteen-year gap
between the publication of Howrie and the filing of Appellant's U.S.
Provisional Patent Application 601063,710 (from which the '796 patent
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claims priority) evidences a long felt but previously unmet need.” (App. Br.
26).
This argument is not convincing. The “‘mere passage of time without
the claimed invention is not evidence of nonobviousness.’” In re Kahn, 441
F.3d 977, 990-91 (Fed. Cir. 2006) (citing Iron Grip Barbell Co. v. USA
Sports, Inc., 392 F.3d 1317, 1325 (Fed. Cir. 2004); In re Wright, 569 F.2d
1124, 1127 (CCPA 1977)).

Copying
Legal Principles
[C]opying by a competitor may be a relevant consideration in
the secondary factor analysis. Vandenberg, 740 F.2d at 1567.
Not every competing product that arguably falls within the
scope of a patent is evidence of copying. Otherwise every
infringement suit would automatically confirm the
nonobviousness of the patent. Rather, copying requires the
replication of a specific product.
Iron Grip Barbell Co., 392 F.3d at 1325.

Analysis
As evidence of copying, Appellant cited four separate legal actions
involving infringement of the ’796 patent. (App. Br. 27.) However, an
infringement action, alone, is insufficient evidence of copying. Iron Grip,
392 F.3d at 1325. Generally, replication of specific product is required. Id.
In addition, Appellant has not described the infringing product in any
of these actions. Consequently, we have insufficient evidence to determine
precisely what aspect of the claims and AlleRx® were copied. Without such
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description of the infringing products, we can not give this showing much
weight, if any.

SUMMARY
1. The rejection of claims 1, 3, 6, 10, 12, and 15 as anticipated under
35 U.S.C. § 102(b) by Middleton, is reversed.
2. The rejection of claims 1, 3, and 12 as obvious in view of Knudsen
and Howrie is affirmed. Claims 6-10 and 15-18 fall with claim 1 because
separate reasons for their patentability were not provided. 37 C.F.R.
§ 41.37(c)(1)(vii).
3. The rejection of claims 1-4 and 11-13 as obvious in view of
Knudsen and Meltzer is affirmed. Claims 5-10 and 14-18 fall with claim 1
because separate reasons for their patentability were not provided. 37 C.F.R.
§ 41.37(c)(1)(vii).
4. The rejection of claims 2, 4, 11, and 13 as obvious in view of
Middleton, Knudsen, and Meltzer is affirmed. Claims 5, 7-9, 14, and 16-18
fall with these claims because separate reasons for their patentability were
not provided. 37 C.F.R. § 41.37(c)(1)(vii).

AFFIRMED

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