Ex Parte Yun et al

Patent Trial and Appeal Board

Aug 30, 2018

13169897 (P.T.A.B. Aug. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/169,897 06/27/2011
93726 7590 09/04/2018
EPA - Bozicevic Field & Francis LLP
Bozicevic, Field & Francis
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
FIRST NAMED INVENTOR
Anthony Yun
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
PAL0-003CON2 2740
EXAMINER
BORGEEST, CHRISTINA M
ART UNIT PAPER NUMBER
1649
NOTIFICATION DATE DELIVERY MODE
09/04/2018 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@bozpat.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANTHONY YUN and
PATRICK YUARN-BORLEE
Appeal2017-005980
Application 13/169,897
Technology Center 1600
Before ULRIKE W. JENKS, RYAN H. FLAX, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 submit this appeal under 35 U.S.C. § 134 involving
claims to a multi-dose active agent package. The Examiner rejected the
claims for lack of patent-eligible subject matter and for obviousness. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Palo Alto Investors. App.
Br. 3.
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Application 13/169,897
STATEMENT OF THE CASE
According to the Specification, "[t]here are a variety of conditions
that can affect a female's health" and "[ c ]ertain conditions increase in
severity and/or occurrence during one or more phases of a female's
menstrual cycle." Spec. ,r 2. The Specification explains that "[m]ethods are
provided for treating a subject for a condition," and more specifically that
the "methods find use in the treatment of a variety of different conditions,
including various disease conditions, that increase in severity and/or
occurrence during one or more phases of the menstrual cycle." Id. ,r 204.
"Also provided [in the Specification] are systems and kits for use in
practicing the subject methods." Id. 2 ; see also id. ,r,r 192-200. According to
the Specification, "multiple dosage units of one or more pharmacological
agents may be present in a kit for multiple applications," which may be
individually packaged in single or multiple containers. Id. ,r 193. The
Specification describes such kits as including, for example, a "monthly pack
that includes daily discrete or continuous ... doses wherein the total number
of daily units present in ... [a] monthly pack ... may be equal to the total
number of days of a month or the days of the menstrual cycle." Id. ,r 194.
More specifically, the Specification discloses:
2 The Specification lists numerous "[r ]epresentative pharmacological agents
... that may be used" in the methods and kits/packages including, inter alia,
beta-blockers, angiotensin converting enzyme (ACE) inhibitors, statins,
antihistamines, calcium channel blockers, and anti-coagulants. Spec. ,r 67.
The Specification discloses that "[ d]osages for a given pharmacological
agent are readily determinable by those of skill in the art by a variety of
means." Id. ,r 65.
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Id.
[T]he monthly pack may include a number of pills to be
administered by a subject each day of the month or of the
menstrual cycle wherein the pack is configured to include certain
pills to be administered to a subject on certain days or during
certain menstrual cycle phases, where the type, dosage, etc. of
the pills of the pack may vary.
Claims 69--79, 91-94, 100, and 101 are on appeal. Claim 69, the only
independent appeal, is illustrative and is reproduced below:
69. A multi-dose active agent package comprising:
a first unit dosage of an active agent that is
formulated into a pharmaceutical composition that
comprises a pharmaceutically acceptable carrier, and a
second unit dosage of an active agent that is formulated
into a pharmaceutical composition that comprises a
pharmaceutically acceptable carrier;
wherein the active agent comprises a calcium
channel blocker,
wherein the amount of the active agent in the first
unit dosage differs from the amount of the active agent in
the second unit dosage; and
a package, wherein the package holds each of the
first unit dosage and the second unit dosage in a separate
section, and
wherein the first and second unit dosages of the
active agent are selected to treat a subject for a condition
that is increased in severity or occurrence during the luteal
phase of the menstrual cycle and the pharmaceutically
acceptable carrier of the first unit dosage is the same as the
pharmaceutically acceptable carrier of the second unit
dosage.
App. Br. 23 (Claims App.).
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The claims stand rejected as follows:
I. Claims 69--79, 91-94, 100, and 101 under 35 U.S.C. § 101 for
claiming patent ineligible subject matter ("Rejection I").
II. Claims 69--71, 74--79, 93, 94, 100, and 101 under 35 U.S.C.
§ I03(a) as obvious over Chen, 3 Price, 4 and DePadova5
("Rejection II").
III. Claim 72 under 35 U.S.C. § I03(a) as obvious over Chen,
Price, DePadova, and Hermelin6 ("Rejection III").
IV. Claim 73 under U.S.C. § I03(a) as obvious over Chen, Price,
DePadova, and Wikander7 ("Rejection IV").
V. Claims 69, 91, and 92 under 35 U.S.C. § I03(a) as obvious over
Chen, Price, and D' Angelo 8 ("Rejection V").
VI. Claims 69--79, 91-94, 100, and 101 under U.S.C. § I03(a) as
obvious over Hermelin ("Rejection VI").
Appellants identify the following related and co-pending appeals:
Appeal No. 2017-005964 (US Appl. No. 12/888,172); and Appeal No. 2017-
006039 (US Appl. No. 12/761,297). App. Br. 3. Like the claims in the
3 Chen, US 2002/0045184 Al, published Apr. 18, 2002.
4 William A. Price et al., Verapamil in the Treatment of Premenstrual
Syndrome: Case Report, 47 J. CLIN. PSYCHIATRY 213-14 (1986).
5 DePadova, WO 93/02679 Al, published Feb. 18, 1993.
6 Hermelin et al., US 6,375,956 Bl, issued Apr. 23, 2002.
7 Ida Wikander et al., Citalopram in Premenstrual Dysphoria: Is Intermittent
Treatment During Luteal Phases More Effective Than Continuous
Medication Throughout the Menstrual Cycle, 18 J. CLIN.
PSYCHOPHARMACOL. 390-98 (1998).
8 D' Angelo et al., US 5,756,117, issued May 26, 1998.
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present appeal, the Examiner entered rejections for lack of patent-eligible
subject matter and obviousness in these related appeals. Decisions in these
related appeals are being mailed concurrently with this Decision.
I. SUBJECT MATTER ELIGIBILITY
In analyzing patent eligibility under 35 U.S.C. § 101, the Supreme
Court has set forth a "framework for distinguishing patents that claim
[patent-ineligible] laws of nature, natural phenomena, and abstract ideas
from those that claim patent-eligible applications of those concepts." Alice
Corp. Pty. Ltd. v. CLS Bankint'l, 134 S. Ct. 2347, 2355 (2014) (internal
citation omitted). According to that framework, first "we determine whether
the claims at issue are directed to one of those patent-ineligible concepts."
Id. "If so, we then ask, ' [ w ]hat else is there in the claims before us?"' Id.
( quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66,
78 (2012)). To answer this second question,
we consider the elements of each claim both individually and as
an ordered combination to determine whether the additional
elements transform the nature of the claim into a patent-eligible
application .... [The Supreme Court has] described step two of
this analysis as a search for an inventive concept - i.e., an
element or combination of elements that is sufficient to ensure
that the patent in practice amounts to significantly more than a
patent upon the [ineligible concept] itself.
Id. (internal citations and quotation marks omitted).
The Examiner rejected all the pending claims under § 101 as being
directed to a product of nature. Ans. 3---6, 19-28; see also Final Act. ( dated
Feb. 26, 2016) 3-5; Funk Brothers Seed Co. v. Kala Inoculant Co., 333 U.S.
127, 130-31 (1948) (holding claims to a composition of different bacterial
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strains was directed to "the work of nature" and, thus, patent ineligible).
More specifically, according to the Examiner, claim 69 is "directed to active
agents that encompasses natural products" such as divalent cations like Ni2+
and Cd2+, or the element magnesium, which the Examiner finds are all
naturally-occurring calcium channel blockers. Ans. 4 ( citing Lacinova9 and
Moron 10). As for the required pharmaceutically acceptable carrier, the
Examiner finds the carrier may simply be water; so, even with the calcium
channel blocker, the Examiner finds the claims "encompass a mixture of
naturally occurring products" with no change in the agent's structure or
properties. Id. at 5. Although the Examiner acknowledges that claim 69
requires a "package," the Examiner states that the package "does not change
the structure or function of the recited active agents." Id. at 5.
Appellants argue "the claims are not directed to a product of nature."
Reply Br. 2. To the contrary, Appellants contend, claim 69 is "directed to a
package with two different dosages of a calcium channel blocker in different
locations of the package," which "package does not occur in nature, but is
instead man-made." Id.; App. Br. 6. Moreover, Appellants argue, "the
multi-dose package system of the claimed invention is not a generic
container" and instead requires "separate sections for separating two,
different dosage units of a same active agent." App. Br. 7.
9 L. Lacinova et al., Regulation of the calcium aJG subunit by divalent
cations and organic blockers, 39 NEUROPHARMACOLOGY 1254---66 (2000).
10 Antonio Fernandes Moron et al., Procedures for fetal neuroprotection:
use of magnesium sulfate, 35 REV. BRAS. GINECOL. OBSTET. 339-41 (2013).
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At step one of the Alice/ Mayo analysis, we ask whether claim 69 is
directed to patent-ineligible subject matter. Because all inventions, at some
level, embody or apply laws of nature, abstract ideas, etc., "we tread
carefully in construing this exclusionary principle lest it swallow all of
patent law." Alice, 134 S. Ct. at 2354. Hence, we must "ensure at step one
that we articulate what the claims are directed to with enough specificity to
ensure the step one inquiry is meaningful." Thales Visionix Inc. v. US., 850
F.3d 1343, 1347 (Fed. Cir. 2017).
We are unpersuaded that claim 69 is directed to a patent-ineligible
product of nature. The dispute between the Examiner and Appellants is
largely one of emphasis. The Examiner emphasizes the active agent in claim
69. Ans. 3-6. Appellants emphasize the claimed package with separate
sections for holding different doses of the active agent. App. Br. 6-9. On
this record, Appellants have the better position. True, claim 69 requires an
active agent that comprises a calcium channel blocker. And, as the
Examiner has shown, some naturally occurring substances are calcium
channel blockers. Ans. 4. But, as the Federal Circuit has confirmed, "[a]t
step one, ... it is not enough to merely identify a patent-ineligible concept
underlying the claim; [ the Board] must determine whether ... [the] patent-
ineligible concept is what the claim is 'directed to."' Rapid Litig. Mgmt.
Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1050 (Fed. Cir. 2016).
Reading the claims in light of the Specification, we find that the
claimed invention is, on balance, directed to the multi-dose package. Spec.
,r,r 192-200. The package is described as providing an alleged improvement
in dosing of the active agent to account for conditions that increase in
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severity or occurrence during portions of the menstrual cycle, to aid with
administering certain dosages to the subject on certain days, weeks, etc. See,
e.g., id. ,r 194. The active agent itself is, in material respects, secondary to
the multi-dose package as evidenced by the fact that the Specification
provides a roughly six-page laundry list of pharmacological agents
(numerous well-known agents that are generically and specifically
described) that can be used in combination with the package for treating a
likewise generic list of conditions ( e.g., cardiovascular conditions,
inflammatory conditions, gastrointestinal conditions, neurologic conditions,
pain, bacterial infections, and so on). Spec. ,r 67. We are not persuaded on
this record that the invention, and specifically claim 69, is directed to such
pharmacological agents, which the Examiner finds encompass naturally
occurring substances.
We thus conclude that claim 69 is directed to a multi-dose package
having separate sections that respectively hold a plurality of unit dosage
forms with different dosages of an active agent, which agent here happens to
comprise a calcium channel blocker. To be sure, the features of the package
are broadly recited. Whether the package and its features are new or
nonobvious is not the issue. The issue, for purposes of this rejection, is
whether a package with the structural features recited in claim 69 is merely
directed to nature's handiwork. It is not.
The answer to the first question of the Alice/Mayo analysis is "no"
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- we are unpersuaded claim 69 is directed to a product of nature. 11
Because the answer at step one is "no," the inquiry is over and moving to
step two is unnecessary. Thales, 850 F.3d at 1349 ("Because we find the
claims are not directed to an abstract idea, we need not proceed to step
two"). Accordingly, for the reasons above, the rejection of claim 69 (and its
dependent claims) under § 101 is reversed.
II. OBVIOUSNESS
a. Chen, Price, and DePadova (Rejection II)
The Examiner rejected claims 69--71, 74--79, 93, 94, 100, and 101 as
obvious over Chen, Price, and DePadova. Final Act. 7-13; Ans. 7-11, 28-
61. The bases of the rejection are described further below.
Appellants do not argue the rejected claims separately. We, thus,
choose claim 69 as representative. 37 C.F.R. § 4I.37(c)(l)(iv).
The Examiner finds that "[t]he claims in Chen (as well as paragraph
[001 OJ) disclose that the drug packaging system contain[ s] one or more unit
dosage forms of a first drug and one or more unit dosage forms of a second
drug." Final Act. 11; see also Ans. 8 (citing, e.g., claim 1 of Chen). Also,
the Examiner finds, " [ t ]he language of the claims and specification of Chen
make clear that one or more than one discrete measurable amounts of the
same active agent is contemplated," and further that "paragraph [0010] states
that the two drugs can be the same drug in either the same or different
strengths." Final Act. 11. Chen's paragraph 10 is reproduced below:
11 Whether claim 69 is patent ineligible under § 101 for other potential
reasons (e.g., abstract idea) is not an issue before us in this appeal.
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In other embodiments, the invention is directed to a drug
packaging system as disclosed herein comprising packaging
material comprising therein combined prescription drug therapy
comprising one or more unit dosage forms of a first drug and one
or more unit dosage forms of a second drug. Preferably, the first
and second drug are independently selected from the group
consisting of non-steroidal anti-inflammatory drugs, proton
pump inhibitors, calcium channel blockers, angiotensin
converting enzyme (ACE) inhibitors, anti-depressants, selective
serotonin reuptake inhibitors, antihistamines, decongestants,
biguanides, sulfonylureas, 3-hydroxy-3-methylglutaryl
coenzyme A (HMG CoA) reductase inhibitors, anti-epileptic,
and anti diabetics. It is meant that the two drugs can be the same
drug, e.g., the same strength or different strengths.
Chen ,r 10 ( emphases added); see also Ans. 28-32. According to the
Examiner, "Chen states in plain English that the two drugs may be the same
drug, for example in the same strength or different strengths." Ans. 29; see
also Ans. 33-34 ("It is the Examiner's reasoned belief that 'the same
strength or different strengths' refers to dosage, since 'strength' typically
refers to dosage in the pharmaceutical arts"); Final Act. 11 ("the phrase
'different strengths' teaches and suggests two different dosages, not two
separate drugs"); see also Ans. 31 ( explaining that Chen also teaches
providing starting (i.e., loading) and maintenance doses of a drug, which is
exemplified with NSAIDs ); Chen ,r,r 92, 94, 105, 106.
The Examiner finds that Chen does not expressly "teach that the first
and second unit dosages of the active agent are selected to treat a subject for
a condition that is increased in severity or occurrence during the luteal phase
of the menstrual cycle," the Examiner contends the claimed subject matter
is, nevertheless, obvious. Ans. 9-10. First, the Examiner finds this
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language is functional and does not structurally limit the claims, which are
"drawn to a product and not a method of treatment." Id. at 10. Second, the
Examiner finds that Price and DePadova teach treatment of premenstrual
syndrome (PMS) with, respectively, a calcium channel blocker (verapamil)
and an ACE inhibitor. Id. Thus, the Examiner finds, the secondary
references evidence that such agents are known to treat "a condition that
increases in severity during the luteal phase of the menstrual cycle" and
further provide a reason for selecting those agents from Chen's list of drugs
for inclusion in Chen's multi-dose packages. Id. at 10-11 (citing
Kerkhoven 12 for the proposition that it is prima facie obvious to combine two
compositions known to be useful for the same purpose to create a third
composition used for the same purpose).
We agree with and adopt the Examiner's findings concerning the
scope and content of Chen, Price, and DePadova, the Examiner's reasoning
on the motivation to combine the prior art, and the Examiner's conclusion of
obviousness as to claim 69. Final Act. 7-13; Ans. 7-11, 28--47. In short,
Chen teaches or suggests multi-dose drug packages, including one or more
dosage units/forms of the drugs. See, e.g., Chen ,r 10, claims 1-2; see also
id. at claim 19. Chen expressly identifies calcium channel blockers among a
short list of suitable drugs for selection for the first and/or second drugs in
the package. Chen ,r 10, claims 1-2. And Chen explicitly discloses that the
multiple "drugs [in the packaging system] can be the same drug, e.g., the
same strength or different strengths." Id. ,r 10 (emphases added). The
12 In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
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Examiner's interpretations of these teachings of Chen as teaching or
suggesting a package including multiple dosage units of different dosages of
the same active agent, comprising a calcium channel blocker, are reasonable
on this record. See, e.g., Ans. 31 ("The last sentence of paragraph [001 OJ of
Chen is consistent with the interpretation that the two drugs can be the same
drug in different strengths (dosages)."); see also Final Act. 11. Moreover, as
the Examiner determined, Price provides further motivation to have chosen a
calcium channel blocker (verapamil) from Chen's list and used to treat a
condition (PMS) that increases in severity during the luteal phase of the
menstrual cycle. Ans. 10-11; Price 214 ("results suggest that verapamil may
be useful in treating premenstrual tension syndrome").
Appellants argue "Chen is directed to drug packaging systems for use
in combination therapy wherein two different drugs are placed in the same
package for ease of administration to a subject." App. Br. 9. According to
Appellants, "each of the first and second different drugs [ of Chen] may be
the same tJ!I2..§_ of drug, [but] there is no teaching or suggestion in Chen that
the first and second drugs in the package can or would contain different
amounts of the same active agent." Id.; see also Reply Br. 3--4.
Appellants' argument is unpersuasive. As explained above, Chen
teaches that one or more dosage units of the multiple drugs may be included
in a package. Chen ,r 10, claims 1-2. And Chen further expressly teaches
that the drugs may be the same drug in different strengths. Id. Insofar as
Chen relates to "combination therapy," Chen suggests numerous
combinations that would satisfy that objective without demonstrating error
in the Examiner's interpretation of the reference, such as multiple dosage
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forms of a calcium channel blocker combined with multiple dosage forms of
an ACE inhibitor, NSAID, or other drugs. Chen ,r 10; see also Chen claim
18 ( depending from claim 1 and reciting that one or more dosage forms of a
third drug).
Nor are we persuaded that the cited language in Chen's paragraph 10
is limited to "the same tJ!Jl.£. of drug," as argued by Appellants. App. Br. 10.
That is not what the paragraph and relevant sentence says - indeed the
word "type" is never used in that paragraph or elsewhere in Chen. Chen
,r 10. Moreover, the Examiner persuasively rebuts Appellants on this point
by explaining that reference to "different strengths" in the relevant sentence
of Chen is more reasonably interpreted as referring to the dosage of a drug's
active agent, not a general drug type or category. See, e.g., Ans. 30 ("The
strength of a given drug typically refers to the amount of [the] drug in the
dosage form or a unit of the dosage form."). Appellants provide insufficient
persuasive evidence otherwise.
Appellants argue the Examiner's interpretation of the last sentence of
Chen's paragraph 10 is not consistent with Chen's teachings. App. Br. 10.
Appellants contend "none of Chen's examples describe a package with first
and second unit dosages that contain different amounts of the same active
agent" and, under the Examiner's interpretation, "a package could contain
two drugs that contain the same active agent (are the 'same drug') and have
the 'same strength,'" contradicting Chen's teachings related to combination
therapy. App. Br. 10-11.
We remain unpersuaded. The prior art is not limited to its working
examples when the rejection is based on obviousness. Merck & Co. v.
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Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Further,
Appellants' attorney argument cannot change what Chen expressly discloses
- that the multi-drug package can include one or more unit dosage forms of
the same drug in different strengths. Chen ,r 10. As explained above, the
Examiner has provided a reasoned explanation of how the skilled person
would interpret what is taught and suggested in Chen. See, e.g., Ans. 28-32.
And further, as explained above, Chen suggests that multiple drugs in
multiple dosage forms (in different or the same strengths) may be included
in Chen's multi-dose packages- it is not limited to only one or even two
drugs, thus, providing for various means of drug-combination therapy.
Moreover, as the Examiner points out, "[a]lthough Chen exemplifies
NSAIDs, ... it is clear that Chen teaches and suggests more than one unit
dosage of the same active agent." Ans. 30; see also id. at 29 (Appellants
cited paragraphs "represent[] a particular embodiment of Chen, but ... [are]
not the only embodiment[ s] disclosed in Chen"). Indeed, Chen also suggests
different "starting and maintenance doses of the same drug." 13 Id. at 31.
Even if exemplified with drugs other than calcium channel blockers in Chen,
a package with such starting and maintenance doses would otherwise be
encompassed by the breadth of claim 69. Ans. 30-31, 46-47.
Appellants argue Price and DePadova fail to make up for Chen's
deficiencies. App. Br. 11. Appellants contend the Examiner "failed to
provide any evidence or otherwise provide any motivation as to why one of
ordinary skill in the art would have had a reason to provide the ACE
13 See, e.g., Chen ,r,r 92, 94, 105, 106.
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inhibitor and a calcium channel blocker ... in different dosage amounts."
Id. Appellants further contend that "merely because Chen allegedly teaches
a multi-dose package including two different strengths of a protein pump
inhibitor and nonsteroidal anti-inflammatory drug [ (NS AID)] does not
provide any motivation to provide an ACE inhibitor and a calcium channel
blocker in different dosages." Id. at 12. According to Appellants, "Chen
and the secondary references cited by the Examiner are both directed
towards completely different types of drugs." Id. ("Chen is directed towards
administering proton pump inhibitors and nonsteroidal anti-inflammatory
drugs to treat patients for ulcers."). And, Appellants contend, Price and
DePadova teach administering a standard dose of the active agent, not
different dosage units as claimed. Id. at 12-13.
Appellants' arguments are unpersuasive. For reasons discussed
above, we disagree that Chen is deficient in the manner suggested by
Appellants. The Examiner also explained that the claim language regarding
treating a condition that is increased in severity during the luteal phase of the
menstrual cycle was functional, and not a structural requirement of claim 69.
Ans. 10. And, even to the extent required, at least Price provided a reason
for treating such a condition with a calcium channel blocker - one of the
drugs listed in Chen. Id. at 10-11, 41--45. Claim 69 does not require both
an ACE inhibitor and a calcium channel blocker, and Appellants did not
argue the claims separately. Id. at 35.
Also, contrary to Appellants' assertions, Chen's teachings are not
limited to combined administration of proton pump inhibitors and NSAIDs.
Quite the opposite, Chen expressly identifies suitable drugs as including
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calcium channel blockers and ACE inhibitors, among others, further
suggesting various drugs may be included in its multi-dose packages in the
same or different strengths. Ans. 36-37; see, e.g., Chen claims 1-2, 19,
,r 1 O; compare Chen claim 1 (listing NSAIDs, ACE inhibitors, calcium
channel blockers, and proton pump inhibitors as among the suitable drugs),
with dependent claim 4 ( reciting that the first drug is an NS AID and the
second drug is a proton pump inhibitor). Chen is not directed to "completely
different" drugs than Price and DePadova as Appellants argue. App. Br. 12.
Again, Chen expressly identifies calcium channel blockers and ACE
inhibitors as suitable agents to include in its packages. Chen ,r 10.
Appellants assert that Price administered the same, not different,
dosages of a calcium channel blocker. App. Br. 12-13. But the Examiner
did not rely on Price for teaching or suggesting the inclusion of different
dosages of a calcium channel blocker in a multi-dose package. Ans. 40-43.
That comes from Chen. See, e.g., Chen ,r 10. Appellants' argument does
not deal persuasively with the combined teachings in the art.
Finally, Appellants refer to an interview with the Examiner during
which the Examiner purportedly indicated that claim 69 is broad enough to
"read on situations where an initial loading dose is present with multiple
maintenance doses." App. Br. 13. Appellants do not assert, much less
explain, why this claim interpretation by the Examiner is incorrect. Instead,
according to Appellants, "no art has been cited by the Examiner showing
such a configuration." Id.
Appellants' contentions demonstrate no reversible error in the
Examiner's rejection. It is well known in the pharmaceutical arts to
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prescribe starting/loading doses followed by different maintenance doses as
evidenced by at least Chen. See, e.g., Ans. 30-31 (citing Chen ,r,r 92, 94,
105, 106). Appellants provide no persuasive evidence to the contrary.
For the reasons above, the preponderance of the evidence on this
record supports the Examiner's conclusion that claim 69 would have been
obvious over Chen, Price, and DePadova. Claims 70, 71, 74--79, 93, 94,
100, and 101 have not been argued separately and thus fall with claim 69.
b. Chen, Price, DePadova, and Hermelin (Rejection III)
The Examiner rejected claim 72 as obvious over Chen, Price,
DePadova, and Hermelin. Ans. 12-13, 2 8---61. We agree with and adopt the
Examiner's findings concerning the scope and content of Chen, Price,
DePadova, and Hermelin, the Examiner's reasoning on the motivation to
combine the prior art, and the Examiner's conclusion of obviousness.
Appellants provide no separate argument for Rejection III, arguing
only that Hermelin "fails to make up for the deficiency in Chen in view of
Price in view ofDePadova." App. Br. 14. We are unpersuaded of a
deficiency as explained above regarding Rejection II. Accordingly, the
rejection over Chen, Price, DePadova, and Hermelin is affirmed.
c. Chen, Price, DePadova, and Wikander (Rejection IV)
The Examiner rejected claim 73 as obvious over Chen, Price,
DePadova, and Wikander. Ans. 13-14, 28-61. We agree with and adopt the
Examiner's findings concerning the scope and content of Chen, Price,
DePadova, and Wikander, the Examiner's reasoning on the motivation to
combine the prior art, and the Examiner's conclusion of obviousness.
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Appellants provide no separate argument for Rejection IV, arguing
only that Wikander "fails to make up for the deficiency in Chen in view of
Price in view ofDePadova." App. Br. 14. We are unpersuaded of a
deficiency as explained above regarding Rejection II. Accordingly, the
rejection over Chen, Price, DePadova, and Wikander is affirmed.
d. Chen, Price, and D' Angelo (Rejection V)
The Examiner rejected claims 69, 91, and 92 as obvious over Chen,
Price, and D' Angelo. Ans. 14--16, 28---61. We agree with and adopt the
Examiner's findings concerning the scope and content of Chen, Price, and
D' Angelo, the Examiner's reasoning on the motivation to combine the prior
art, and the Examiner's conclusion of obviousness.
Appellants provide no separate argument for Rejection V, arguing
only that D' Angelo "fails to make up for the deficiency in Chen and Price."
App. Br. 15. We are unpersuaded of a deficiency as explained above
regarding Rejection II. Accordingly, the rejection over Chen, Price, and
D 'Angelo is affirmed.
e. Hermelin (Rejection VI)
The Examiner rejected claims 69--79, 91-94, 100, and 101 as obvious
over Hermelin. Ans. 17-19, 61-79. The bases of the rejection are described
further below.
Except as provided below, Appellants do not argue the rejected claims
separately. Claim 69 is representative. 37 C.F.R. § 4I.37(c)(l)(iv).
The Examiner finds, inter alia, that Hermelin teaches "a drug
dispensing apparatus that is configured to dispense tablets ... for an
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extended period of time." Ans. 1 7 ( citing Hermelin Fig. 3 ( depicting a
container for long-term storage of multiple blister packs (like depicted in
Fig. 2))). The Examiner finds that Hermelin teaches that "the drug packages
may contain calcium channel blockers and ACE inhibitors (see column 17,
lines 29-51; particularly nifedepine at line 31 and quinapril at line 50)."
Ans. 17. Further, the Examiner finds, Hermelin "contemplate[ s] that the
package may contain two dosage units of the same agent (see, for example,
claim 43)." Id. Claim 43 of Hermelin is reproduced below.
43. A method for providing optimal therapeutic support to an
animal by increasing compliance with a complex dosing regimen
and facilitating administration of uneven doses of at least one
biologically-active substance, which comprises:
providing the biologically-active substance in a blister
pack having a first row of a plurality of predetermined areas
and a second row of a plurality of predetermined areas; each
predetermined area of the first row defining a recess for
receiving a first dosage unit and each predetermined area of
the second row receiving a second dosage unit;
wherein the first row of predetermined areas corresponds
to a first time indicia and the second row of predetermined areas
corresponds to a second time indicia;
a second row of predetermined areas, each of the
predetermined areas defining a first recess adapted to receive a
second dosage unit, said second row of predetermined areas
having a second time indicia; and
wherein the first dosage unit and the second dosage unit
contain uneven amounts of the biologically-active substance.
Hermelin claim 43 ( emphases added); see also id. 8:29-44 ("wherein the
first dosage unit has a greater or lesser amount by weight of the biologically
active than the second dosage unit") and claim 35 (same). The Examiner
also finds that the claim language regarding selecting the agent to treat a
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subject for a condition does not provide a structural limitation that
distinguishes over the multi-dose package suggested in Hermelin. Ans. 18.
We agree with and adopt the Examiner's findings concerning the
scope and content ofHermelin, and the Examiner's reasoning and
conclusion of obviousness as to claim 69. Final Act. 13-15; Ans. 17-19,
61-79. Hermelin clearly discloses multi-dose packages with different
amounts ("uneven dosing") of the same biologically-active substance. See,
e.g., Hermelin claims 35 and 43; id. at 8:29-44, 10:56-65; see also id. at
Figs. 2-3 (showing multi-drug blister pack and extended care package
including such blister packs). Hermelin teaches that biologically-active
substances broadly include drugs, medicines, and the like. Id. at 10:38-50.
Hermelin further teaches that "dosage units may be prescription or non-
prescription substances, without limitation." Id. at 17:21-23. Hermelin,
thus, suggests that the "biologically-active substances" and "dosage units" as
disclosed include prescription substances - an "exemplary prescription
substance[]" in Hermelin is the calcium channel blocker "nifedepine." Id. at
17:29-51 (disclosing, inter alia, nifedepine (a calcium channel blocker),
quinapril (an ACE inhibitor), and "combinations thereof'). The reason for
providing nifedepine (with or without other drugs) in different
therapeutically effective dosage amounts ("uneven dosing") on a multi-dose
package ( e.g., blister pack) is reasonably suggested by Hermelin.
Appellants argue that "in the specific embodiment in which Hermelin
allegedly discloses a multi-dose package including uneven dosage units of a
biologically active substance that the biologically active substance does not
comprise a calcium channel blocker." App. Br. 15. Further, according to
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Appellants, nifedepine is described as a "prescription substance" and "is not
disclosed in Hermelin as an example of a biologically-active substance." Id.
at 16-17 ("Hermelin fails to disclose a single embodiment of the packaging
system providing different dosage units of the same prescription substance
(i.e .• nifedepine). "); Reply Br. 5-6.
Appellants' arguments are unpersuasive. This is a rejection for
obviousness, not anticipation. Hermelin need not describe a single or
particular embodiment of a multi-dose package with different/uneven dosage
units of the calcium channel blocker (nifedepine ), as would be necessary if
anticipation was the issue. In re Arkley, 455 F.2d 586, 587 (CCP A 1972)
("[P]icking and choosing may be entirely proper in the making of a 103,
obviousness rejection ... but it has no place in the making of a 102,
anticipation rejection"). Moreover, as the Examiner correctly notes, when
obviousness is the issue, the teachings of the prior art are not limited to the
art's working examples or preferred embodiments. Ans. 66; Merck, 874
F.2d at 807.
More fundamentally, however, we disagree with Appellants'
contention that Hermelin's biologically-active substances do not include
prescription substances and, in particular, nifedepine. Appellants argue that
"prescription substances" and "biologically-active substances" cannot be
used interchangeably. App. Br. 17-18. According to Appellants, "Hermelin
discloses that biologically-active substances refer to a 'hormone, steroid,
vitamin, fatty acid, amino acid, sugar, carbohydrate, or mineral."' Id. at 17
(citing Hermelin 10:37-38). This argument is not persuasive for at least two
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reasons. First, Hermelin'sfull definition of biologically-active substances is
reproduced below:
"Biologically-active substance[ s ]" refers to any substance or
substances comprising a drug, active therapeutic substance,
metabolite, medicament, hormone, steroid, vitamin, fatty acid,
amino acid, sugar, carbohydrate, polypeptide or mineral, any
substance used for treatment, prevention, diagnosis, cure or
mitigation of disease or illness, any substance which affects
anatomical structure or physiological function, or any substance
which alters the impact of external influences on an animal, or
metabolite thereof, and as used herein, encompasses the terms
"active substance", "therapeutic substance", "agent", "active
agent", "active therapeutic agent", "drug", "medication",
"medicine "[]"medicant" and the like, without limitation.
Hermelin 10:37-50 (emphases added). So, contrary to Appellants'
suggestion, biologically-active substances are not limited to vitamins,
minerals, etc. The definition expressly includes, without limitation, drugs,
medicine, medications, therapeutic substances, and (like Appellants' claim
69) active agents. Id. This definition broadly encompasses both non-
prescription and prescription substances, including the calcium channel
blocker nifedepine identified in Hermelin. Id. at 17:29-51.
Second, additional disclosures in Hermelin show why Appellants'
reading of the art is too narrow. Hermelin teaches that "[t]he dosage units of
the present inventive subject matter may comprise any biologically-active
substance, without limitation." Id. at 16:59---61. The very next paragraph of
Hermelin states that "[t]he dosage units may be prescription or non-
prescription substances, without limitation." Id. at 17:22-23. And, in the
paragraph following that, Hermelin identifies "[ n ]on-limiting exemplary
prescription substances," one of which is the calcium channel blocker
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nifedepine. Id. at 17:29-51. Read in context, we are persuaded that the
Examiner's interpretation of the art is correct, and that Hermelin teaches or
suggests that the dosage units and biologically-active substances, which
Hermelin discloses may be provided in uneven doses on a package, include
the prescription substance nifedepine. See, e.g., Ans. 62---63.
Appellants further contend that "it is common knowledge that even
prescribing a different unit dosage of the same type of prescribed substance
requires a separate doctor's prescription." App. Br. 18. Appellants contend
this "lends further support" to Appellants' interpretation and that "Hermelin
did not intend to interchangeably group a prescription substance as a
biologically-active substance." Id. at 18.
We reject Appellants' interpretation of Hermelin for reasons already
explained. Even assuming Appellants' attorney argument about the need for
separate prescriptions is accurate, this does not persuasively demonstrate
non-obviousness. See Ans. 71 ("there is no evidence of record suggesting
any 'procedural difficulty' with regard to obtaining different prescriptions
for different dosages ... "). Doctors can write multiple prescriptions (e.g.,
different dosages, different frequencies of administration, etc.) if that is what
a patient requires. Id. ("if a physician can write one prescription ... he or
she could write two"). In any event, on the record before us, Hermelin
teaches or suggests the multi-dose package recited in claim 69.
Appellants argue Hermelin describes a multi-dose package that
includes a single dosage unit of a prescription substance and a single dosage
unit of a non-prescription substance. App. Br. 19. Appellants contend
Hermelin "strongly suggests" encouraging patient compliance with more
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effective combination therapy with "no indication" that "prescription
substances should be administered in a varied dosage amount." Id. 14 And,
Appellants contend, there is "no motivation to modify Hermelin to remove
the single dosage unit of the non-prescription substance in favor of
incorporating multiple, different dosage units of a single prescription
substance." Id. at 20.
Appellants' arguments remain unpersuasive. As explained above,
Hermelin teaches that biologically active substances may be separately
included in a package in varied dosage amounts and, like the Examiner, we
find that biologically active substances are reasonably interpreted as
including prescription substances like the disclosed nifedepine. Hermelin
claims 35 and 43; id. at 8:29-44, 10:37-50, 10:56-65, 16:59-17:51; see,
e.g., Ans. 50. As pointed out by the Examiner, Appellants cite a single
embodiment (including a combination of prescription and non-prescription
substances) of Hermelin and take issue with an alleged lack of motivation to
alter this embodiment. Ans. 74--75. But the Examiner is not proposing
14 Appellants also assert that "there is strong support in the medical field to
not deviate from Hermelin's method of administering combination therapy"
because treating Alzheimer's patients with NSAIDs and vitamins provided
greater cognitive performance as allegedly evidenced by Fotuhi. App. Br.
19-21. We are not persuaded by Appellants' contentions because Hermelin
teaches that biologically active substances, which we find includes calcium
channel blockers as discussed, may be provided in a package in different
dosages. Hermelin claims 35 and 43; id. at 8:29-44, 10:37-50, 10:56-65,
16:59-17:51. Moreover, as the Examiner noted, Fotuhi is not of record.
Ans. 79 ("Fotuhi et al. is not of record and cannot be evaluated"). See 37
C.F.R. § 4I.33(d)(2) (evidence filed after the filing of the appeal will not be
admitted except under limited circumstances, which are not present here).
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modification of that embodiment and, instead, is relying on the broader
disclosure of Hermelin related to providing uneven dosing of a biologically
active substance, which includes prescription substances. Id. We reject
Appellants' contrary interpretation of the art as already explained. As for
Appellants' contentions related to combination therapy and patient
compliance, those relate to a description of the background prior art in
Hermelin (Hermelin 1 :41-55) and demonstrate no error in the Examiner's
rejection based on Hermelin's broader teachings. Ans. 76-77.
For the reasons above, the preponderance of the evidence on this
record supports the Examiner's conclusion that claim 69 would have been
obvious over Hermelin. Claims 70-79, 91-94, 100, and 101 have not been
argued separately and therefore fall with claim 69.
In Appellants' Reply Brief, Appellants contend the Examiner erred by
including claims 91 and 92 in the rejection based on Hermelin for the first
time in the Examiner's Answer. Reply Br. 6. Claims 91 and 92 depend
from claim 69, and require the agent be in transdermal or parenteral form.
App. Br. 24--25. Appellants contend "[i]t is not seen where these dosage
forms are taught or suggested in Hermelin." Reply Br. 6.
The Examiner indicated that, although claims 91 and 92 were rejected
elsewhere in the record based on§ 103(a), as an oversight, the Examiner
neglected to list those claims in the final rejection over Hermelin. Ans. 2-3.
The Examiner, nevertheless, explains that inclusion of these dependent
claims does not constitute a new ground of rejection. Id.
If Appellants believed the Examiner's inclusion of claims 91 and 92
in the Answer improperly raised new grounds of rejection, the Appellants
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could have requested that prosecution be reopened as provided by rule. 37
C.F.R. § 4I.39(b)(l). Appellants did not do so, but instead maintained the
appeal by filing their reply. 37 C.F.R. § 4I.39(b)(2). In any event,
Appellants' contentions are unpersuasive as Hermelin clearly discloses that
the dosage units may be provided in a variety of forms, including oral,
parenteral, and transdermal. See, e.g., Hermelin claim 23. 15 We, thus, also
affirm the rejection of claims 91 and 92 for the reasons provided above.
SUMMARY
We reverse the rejection for patent-ineligible subject matter, but
affirm the rejections for obviousness on appeal.
15 Although the Examiner could have provided more explicit findings as to
claims 91 and 92 in the Answer, we observe that in the related and co-
pending appeal (2017-005964) involving similar claims to those at issue
here, the Examiner indicated in an answer filed concurrent with the Answer
in the present case that "Hermelin contemplate many modes of
administration including transdermal and parenteral (see claim 23 of
Hermelin), thus meeting limitations set forth in [the] instant claims." See
Examiner's Answer (filed Dec. 27, 2016) in Appeal No. 2017-005964, at 15.
Appellants (represented by the same counsel as in the present appeal) did not
challenge the Examiner's findings related to Hermelin's teaching of
transdermal or parenteral dosages in either the appeal brief or reply brief in
this related appeal, which briefing was filed on the same respective days as
the Appeal Brief and Reply Brief in this case.
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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
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