Ex Parte Yun et al

Patent Trial and Appeal Board

Aug 30, 2018

12761297 (P.T.A.B. Aug. 30, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/761,297 04/15/2010
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 Joonkyoo 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.
P AL0-003CIP 1855
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 JOONKYOO YUN and
PATRICK YUARN-BOR LEE
Appeal2017-006039
Application 12/7 61,297
Technology Center 1600
Before ULRIKE W. JENKS, RY AN 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 12/761,297
STATEMENT OF THE CASE
According to the Specification, "[t]here are a variety of disease
conditions that are known to increase in severity and/or occurrence during
certain times of the day." Spec. ,r 2. Similarly, the Specification explains,
"[t]here are also multiple disease conditions which have been shown to vary
in occurrence or severity depending on the particular season of the year." Id.
The Specification describes "[ m ]ulti-dose active agent packages and
methods for using the same for treating a subject for a condition." Spec. ,r 4.
"The subject invention ... includes multi-dose active agent packages for use
in methods for treating a subject for a condition that has seasonal variations
by modulating at least a portion of the autonomic nervous system during at
least one predetermined season of the year." Id. ,r 138. According to the
Specification, the "multi-dose active agent package of the subject invention
can be a seasonal package that includes daily discrete or continuous unit
doses" and further "[ t ]he seasonal package may be a two or more stage
pharmaceutical pack, e.g., containing at least about 90 daily unit doses in
two stages." Id. ,r,r 142, 143; see also id. at Figs. 1-3 (showing various
seasonal and yearly multi-dose packages).
The Specification explains that the multi-dose package may include
first and second active agents. Id. ,r 145. Further, "[t]he first and second
active agents may differ in one or more respects, e.g., they may be different
active agents ( different types), they may be the same active agent but may
differ in dose of active agent, etc." Id. According to the Specification,
"[ m ]ultiple dosage units of one or more pharmacological agents may be
packaged in a single container, e.g., a single blister pack, tube, bottle," etc.,
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or the dosage units "may be individually packaged and/or individually
labeled such that certain packages may have more than one container of a
pharmacological agent or of different pharmacological agents." Id. ,r 147. 2
The "multi-dose active agent package can have any suitable shape, e.g., a
rectangular or square box, a cylindrical tube, a rectangle, square, or circular
blister package, etc." Id. ,r 148.
Claims 1-3, 6-11, 13, 14, and 27-33 are on appeal. Claim 1 is
illustrative and is reproduced below:
1. A multi-dose active agent package comprising:
a plurality of unit dosage forms of a same active agent,
wherein each of the plurality of unit dosage forms comprises the
same active agent and a pharmaceutically acceptable carrier, and
wherein the active agent comprises an angiotensin converting
enzyme inhibitor and modulates at least a portion of the
autonomic nervous system to alter the parasympathetic
activity/sympathetic activity ratio of a subject in a manner
effective to treat the subject for a condition, and wherein the
plurality of unit dosage forms comprises two different dosages
of the same active agent; and
a package, wherein the package holds each of the two
different dosages in a separate section, and
wherein the multi-dose active agent package is tailored for
a particular subject and the pharmaceutically acceptable carrier
of each of the two different dosages is the same.
App. Br. 22 (Claims App.).
2 The Specification lists numerous "[r ]epresentative pharmacological agents
... that may be used" including, inter alia, beta-blockers, angiotensin
converting enzyme (ACE) inhibitors, statins, antihistamines, calcium
channel blockers, and anti-coagulants. Spec. ,r 69. 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 67.
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The claims stand rejected as follows:
I. Claims 1-3, 6-11, 13, 14, and 27-33 under 35 U.S.C. § 101 for
claiming patent ineligible subject matter ("Rejection I").
II. Claims 1-3, 6, 10, 11, 13, 14, and 27-33 under 35 U.S.C.
§ I03(a) as obvious over Chen3 and Wertheimer4
("Rejection II").
III. Claims 1, 2, 9-11, 13, 14, and 27-33 under 35 U.S.C. § I03(a)
as obvious over Chen, DePadova, 5 and Wikander6
("Rejection III").
IV. Claims 1, 2, 7, 8, 10, 11, and 27-29 under U.S.C. § I03(a) as
obvious over Chen and D' Angelo 7 ("Rejection IV").
V. Claims 1-3, 6-11, 13, 14, and 27-33 under U.S.C. § I03(a) as
obvious over Hermelin8 ("Rejection V").
Appellants identify the following related and co-pending appeals:
Appeal No. 2017-005964 (US Appl. No. 12/888,172); and Appeal No.
2017-005980 (US Appl. No. 13/169,897). App. Br. 3. Like the claims in
the present appeal, the Examiner entered rejections for lack of patent-eligible
3 Chen, US 2002/0045184 Al, published Apr. 18, 2002.
4 Albert I. Wertheimer et al., The Economics of Mail Service Pharmacy, 7
PHARMACOECONOMICS 111-18 (1995).
5 DePadova, WO 93/02679 Al, published Feb. 18, 1993.
6 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).
7 D' Angelo et al., US 5,756,117, issued May 26, 1998.
8 Hermelin et al., US 6,375,956 Bl, issued Apr. 23, 2002.
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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. 4--7, 22-30; see also Final Act. (dated
Feb. 25, 2016) 2-5; Funk Brothers Seed Co. v. Kala Inoculant Co., 333 U.S.
127, 130-31 (1948) (holding claims to a composition of different bacterial
strains was directed to "the work of nature" and, thus, patent ineligible).
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More specifically, according to the Examiner, claim 1 is "directed to an
ACE inhibitor ... that encompasses natural products." Ans. 4--5 (citing
FitzGerald9 as evidence that naturally-occurring peptides have ACE
inhibitory activity). As for the required pharmaceutically acceptable carrier,
the Examiner finds the carrier may simply be water; so, even with the ACE
inhibitor, the Examiner finds the claims "encompass a mixture of naturally
occurring products" with no change in structure or function of the active
agent. Id. at 5---6 ( citing Spec. ,r,r 4 7, 65). And, although the Examiner
acknowledges claim 1 's recitation of a "package," the Examiner states that
"[ t ]he package does not impart a physical or functional difference in the
products contained therein." Id. at 5.
Appellants argue "the claims are not directed to a product of nature."
Reply Br. 2. To the contrary, Appellants contend, claim 1 is "directed to a
package with two different dosages of an ACE inhibitor 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 that hold different dosage
units of an active agent and a structural element of the system for
structurally distinguishing between the different dosage units." App. Br. 7.
At step one of the Alice/ Mayo analysis, we ask whether claim 1 is
directed to patent ineligible subject matter. Because all inventions, at some
level, embody or apply laws of nature, abstract ideas, etc., "we tread
9 Richard J. FitzGerald et al., The Emerging Role of Dairy Proteins and
Bioactive Peptides in Nutrition and Health, 134 J. NUTR. 980S-988S (2004).
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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 1 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
1. Ans. 3-7. Appellants emphasize the claimed package with separate
sections for holding different doses of the active agent. On this record,
Appellants have the better position. True, claim 1 requires an ACE
inhibitor. And, as the Examiner has shown, some naturally occurring
compounds may have ACE-inhibitory activity. Ans. 5. 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 4, 13 8--49; see also id. at Figs. 1-3 ( depicting packages) and ,r,r 214--17
(Examples). The package is described as providing an alleged improvement
in dosing of the active agent to account for temporal (e.g., seasonal)
variations of a condition - it keeps separate a plurality of different unit
dosages of the same active agent, so that more or less of the agent can be
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taken depending on the condition's severity, such as with package-included
cues like color-coding or identification of the day, week, month, etc. when
particular dosages should be taken. Id. 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 (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, menstrual related disorders, pain, bacterial
infections, and so on). Spec. ,r 69. Tellingly, yet unsurprisingly, the active
agents (known categories of drugs, like ACE inhibitors, beta blockers, and
antihistamines) are not described as being the invention.
We thus conclude that claim 1 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 an ACE inhibitor. To be sure, the features of the package are in
many ways broadly recited. Whether the package and those 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 1 is merely
directed to nature's handiwork. It is not.
The answer to the first question of the Alice/Mayo analysis is "no" -
we are unpersuaded claim 1 is directed to a product of nature. 10 Because the
answer at step one is "no," the inquiry is over and moving to step two is
10 Whether claim 1 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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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 1 ( and its
dependent claims) under§ 101 is reversed. The rejection of claim 13, the
other independent claim on appeal, as well as the claims that depend from
claim 13, is also reversed for substantially the same reasons.
II. OBVIOUSNESS
a. Chen and Wertheimer (Rejection II)
The Examiner rejected claims 1-3, 6, 10, 11, 13, 14, and 27-33 as
obvious over Chen and Wertheimer. Final Act. 8-13; Ans. 7-10, 30-46.
The bases of the rejection are described further below.
Appellants do not argue the rejected claims separately. We, thus,
choose claim 1 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., claims 1 and 2 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:
In other embodiments, the invention is directed to a drug
packaging system as disclosed herein comprising packaging
material comprising therein combined prescription drug therapy
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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. 31-37. 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. In the
pharmaceutical arts, a drug's strength is understood to mean the dosage."
Ans. 32; see also Final Act. 11 ("the phrase 'different strengths' teaches and
suggests two different dosages, not two separate drugs"); see also Ans. 36
( 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. Moreover, the Examiner finds, "since any prescription
medication is by definition prescribed (i.e., tailored) to an individual patient,
this limitation flows from the prior art of Chen." Ans. 8.
The Examiner finds that Chen teaches or suggests all the limitations
of claim 1, except that Chen does not expressly "disclose that the same
pharmaceutically acceptable carrier of each of the two different dosages is
the same." Ans. 9. Nevertheless, the Examiner reasons that it would have
been obvious to the skilled person "to formulate drugs in the same carrier
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since he or she would merely be using a known solvent (technique) as a
carrier for the same drug." Id. at 9--10.
Although not specifically a limitation of claim 1, the Examiner further
finds that Chen does not disclose that the multi-dose package is a seasonal
package (e.g., a package having a 90-day supply). Ans. 10 (finding Chen
teaches "a drug packaging system comprising drugs for up to 28 days"); see,
e.g., Chen ( claims 16-17, 20). The Examiner finds, however, that
Wertheimer evidences standard prescription durations and corresponding
shipment of drugs to fill the prescription over that duration. Ans. 10 ("it was
standard in the art to prescribe maintenance medications for between 1-3
months. . . . Wertheimer, which provides evidence that prescription drugs
were available for 72, 90 or 180 day supplies"). The Examiner reasons the
skilled artisan "would be motivated to formulate the package of Chen to
accommodate a longer [seasonal] prescription duration." Id. ("choosing
from a finite list of possible time-periods for which a prescription is
written").
We agree with and adopt the Examiner's findings concerning the
scope and content of Chen and Wertheimer, the Examiner's reasoning on the
motivation to combine the prior art, and the Examiner's conclusion of
obviousness as to claim 1. Final Act. 8-13; Ans. 7-10, 30-46. 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 ACE inhibitors 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
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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
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 an ACE inhibitor, are reasonable on this
record. See, e.g., Final Act. 11 ("the phrase 'different strengths' teaches and
suggests two different dosages, not two separate drugs"); Ans. 36 ("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)").
Appellants argue Chen fails to teach a package that comprises "two
different dosages of the same active agent, as recited in the claimed
invention." App. Br. 9. Rather, Appellants contend, "Chen is directed to
drug packaging systems for use in combination therapy wherein two
different drugs (i.e., NSAID and a proton pump inhibitor) are placed in the
same package for ease of administration to a subject." Id. at 10. According
to Appellants, "although each of the first and second different drugs may be
the same 1J!J2.i;_ of drug, there is neither any teaching nor can it be inferred that
the first and second drugs in the package would contain different amounts of
the same active agent." Id. ("Chen discloses that it is meant that the two
drugs can be selected from the same general type of drug, and having 'the
same strength or different strengths'" such as "that the first and second drugs
can both be NSAIDs"); 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
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that the drugs may be the same drug in different strengths. Id. Chen's
teachings are clearly not limited to packages that include NSAIDs and
proton pump inhibitors. 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
NSAID and the second drug is a proton pump inhibitor). 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 forms of an ACE
inhibitor combined with multiple dosage forms of a calcium channel
blocker, or other drugs. Chen ,r 1 O; 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
means "the same general type 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 category. See, e.g., Ans. 35 ("The strength
of a given drug typically refers to the amount of 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. Appellants
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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."' App. Br. 11.
We remain unpersuaded. The prior art is not limited to its working
examples when the rejection is based on obviousness. Merck & Co. v.
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. Ans. 31-3 7, 40-41.
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.
Appellants contend the Examiner wrongly "equates a same type of
drug with a same type o(active agent," yet these terms are "[not]
interchangeable." App. Br. 11-12. We disagree. As already explained, by
referring to use of the same drug in the same or different "strengths," Chen
appears, on balance, to reference the strength/ dosage of the active agent, not
a generic category of different types of drugs. Ans. 35-36, 38-39.
Appellants contend "Chen provides no factual evidence to suggest
providing different dosage amounts of a single type of active agent." App.
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Br. 12. Rather, Appellants argue, "Chen is replete with disclosing various
examples of administering a physician-recommended single dosage amount
o(a single drug to a patient over an extended treatment period." Id.
Here again, the prior art in an obviousness inquiry is not limited to its
preferred embodiments or working examples. As the Examiner points out,
"although Chen exemplifies NSAIDs, it is clear that Chen teaches and
suggests more than one unit dosage of the same active agent." Ans. 40-42
(Appellants cited paragraphs "represent particular embodiments of Chen, but
are not the only embodiments disclosed by Chen"). Indeed, Chen also
suggests different "starting and maintenance doses of various agents." 11
Ans. 40. Even if exemplified with drugs other than ACE inhibitors in Chen,
a package with such starting and maintenance doses would otherwise be
encompassed by the breadth of claim 1. Ans. 42, 45--46.
Appellants argue that "Wertheimer does not make up for Chen's
deficiency" and that "it is not seen where the motivation is to provide an
ACE inhibitor in a seasonal package." App. Br. 13. We are, however,
unpersuaded that Chen is deficient in the manner suggested by Appellants.
The Examiner has provided persuasive reasoning on this record for
combining Chen and Wertheimer ( e.g., accommodating a longer prescription
duration by providing a 90-day supply). Ans. 10. And, in any event, claim
1, which is the only claim separately argued by Appellants, does not
specifically require a "seasonal package." App. Br. 22.
11 See, e.g., Chen ,r,r 92, 94, 105, 106.
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Finally, Appellants refer to an interview with the Examiner during
which the Examiner purportedly indicated that claim 1 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
prescribe starting/loading doses followed by different maintenance doses as
evidenced by at least Chen. See, e.g., Ans. 33 (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 1 would have been
obvious over Chen and Wertheimer. Claims 2, 3, 6, 10, 11, 13, 14, and 27-
33 have not been argued separately and therefore fall with claim 1.
b. Chen, DePadova, Wikander (Rejection III)
The Examiner rejected claims 1, 2, 9-11, 13, 14, and 27-33 as
obvious over Chen, DePadova, and Wikander. Final Act. 8-13; Ans. 11-15,
30-47. We agree with and adopt the Examiner's findings concerning the
scope and content of Chen, DePadova, and Wikander, 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 DePadova and Wikander "fail to make up for the deficiency in
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Chen" as described above. App. Br. 14. We are unpersuaded that Chen is
deficient as explained above regarding Rejection II. Accordingly, the
rejection over Chen, DePadova, and Wikander is affirmed.
c. Chen and D' Angelo (Rejection IV)
The Examiner rejected claims 1, 2, 7, 8, 10, 11, and 27-29 as obvious
over Chen and D' Angelo. Final Act. 8-13; Ans. 15-17, 30-48. We agree
with and adopt the Examiner's findings concerning the scope and content of
Chen 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 IV, arguing
only that D 'Angelo "fails to make up for the deficiency in Chen" as
described above. App. Br. 14. We are unpersuaded that Chen is deficient as
explained above regarding Rejection II. Accordingly, the rejection over
Chen and D 'Angelo is affirmed.
d. Hermelin (Rejection V)
The Examiner rejected claims 1-3, 6-11, 13, 14, and 27-33 as
obvious over Hermelin. Final Act. 13-14; Ans. 17-21, 49-68. The bases of
the rejection are described further below.
Except as provided below, Appellants do not argue the rejected claims
separately. Claim 1 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
extended period of time." Ans. 1 7-18 ( citing Hermelin Fig. 3 ( depicting a
container for long-term storage of multiple blister packs (like depicted in
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Fig. 2)). The Examiner finds that Hermelin teaches, "the drug packages may
contain angiotensin converting enzyme inhibitors and calcium channel
blockers (see column 17, lines 29-51; particularly quinapril at line 50 and
nifedepine at line 31 ). " Ans. 18. Further, the Examiner finds, Hermelin
"contemplate[ s] an embodiment in which 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 3 5 (same). The Examiner
finds that Hermelin does not disclose that the pharmaceutically acceptable
carrier of the two different dosages is the same, but the Examiner reasons
that use of a common carrier would have been obvious. Ans. 19-20
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("merely ... using a known solvent (technique) as a carrier for the same
drug").
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 1. Final Act. 13-14; Ans. 17-21, 49-
68. 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 ACE inhibitor "quinapril." Id. at 17:29-51 (disclosing,
inter alia, nifedepine (a calcium channel blocker), quinapril (an ACE
inhibitor), and "combinations thereof'). The reason for providing quinapril
( 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 an angiotensin converting enzyme inhibitor." App. Br. 15.
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Further, according to Appellants, quinapril 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 g_
single embodiment of the packaging system providing different dosage units
o(the same prescription substance (i.e .• quinapril)"); 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 ACE inhibitor ( quinapril), as would be necessary if anticipation
was the issue. In re Arkley, 455 F.2d 586, 587 (CCPA 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 and as explained
above (Rejection II), when obviousness is the issue, the teachings of the
prior art are not limited to the art's working examples or preferred
embodiments. Ans. 53, 57; 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, quinapril. 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. ( citing
Hermelin 10:37-38). This argument is unpersuasive for at least two reasons.
First, Hermelin' s full definition of biologically-active substances is:
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"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
1) active agents. Id. This definition broadly encompasses both non-
prescription and prescription substances, including the ACE inhibitor
quinapril 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 ACE inhibitor quinapril. 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
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the dosage units and biologically-active substances, which Hermelin
discloses may be provided in uneven doses on a package, include the
prescription substance and ACE inhibitor, quinapril. See, e.g., Ans. 50.
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. 17-18. Appellants
contend this "lends further support" to Appellants' interpretation and that
"Hermelin did not intend to interchangeably group a prescription substance
as equating with 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. 59 ("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 1.
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
effective combination therapy with "no indication" that "prescription
substances should be administered in a varied dosage amount." Id. And,
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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 amounts of a single prescription
substance." Id.
Appellants' arguments remain unpersuasive. As explained above,
Hermelin teaches expressly 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 quinapril.
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. 63. But the Examiner is not
proposing 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. at
63---68. 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. 65---66.
For the reasons above, the preponderance of the evidence on this
record supports the Examiner's conclusion that claim 1 would have been
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obvious over Hermelin. Claims 2, 3, 6, 9--11, 13, 14, and 27-33 have not
been argued separately and therefore fall with claim 1.
In Appellants' Reply Brief, Appellants contend the Examiner erred by
including claims 7 and 8 in the rejection based on Hermelin for the first time
in the Examiner's Answer. Reply Br. 6. Claims 7 and 8 depend from claim
1, and require the agent be in transdermal or parenteral form. App. Br. 22.
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 7 and 8 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. 3.
The Examiner, nevertheless, explains that inclusion of these dependent
claims does not constitute a new grounds of rejection. Id.
If Appellants believed the Examiner's inclusion of claims 7 and 8 in
the Answer improperly raised new grounds of rejection, the Appellants
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. 12 We, thus, also
affirm the rejection of claims 7 and 8 for the reasons provided above.
12 Although the Examiner could have provided more explicit findings as to
claims 7 and 8 in the Answer, we observe that in the related and co-pending
appeal (2017-005964) involving similar claims to those at issue here, the
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SUMMARY
We reverse the rejection for patent-ineligible subject matter, but
affirm the rejections for obviousness on appeal.
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
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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