Johnson & Johnson Consumer Inc.

Patent Trials and Appeals Board

May 3, 2021

2020004358 (P.T.A.B. May. 3, 2021)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/832,394 03/15/2013 Der-Yang Lee MCP5229USNP 7533
27777 7590 05/03/2021
JOSEPH F. SHIRTZ
JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK, NJ 08933-7003
EXAMINER
GOTFREDSON, GAREN
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
05/03/2021 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
jnjuspatent@corus.jnj.com
lhowd@its.jnj.com
pair_jnj@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DER-YANG LEE and SHUN POR LI
Appeal 2020-004358
Application 13/832,394
Technology Center 1600
Before RACHEL H. TOWNSEND, DEVON ZASTROW NEWMAN, and
MICHAEL A. VALEK, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims to a pharmaceutical formulation as
failing to comply with the written description requirement, as being obvious,
and for non-statutory double patenting. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.

1 We use the term “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Johnson &
Johnson Consumer Inc. (Appeal Br. 2.)
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STATEMENT OF THE CASE
Phenylephrine is an over-the-counter oral nasal decongestant and is
widely used for the temporary relief of nasal congestion. (Spec. 1.) It is
available in immediate release formulation as 10 mg tablets, and the dosing
regimen is one tablet every four hours, not to exceed 60 mg in 24 hours. (Id.
at 1–2.)
According to Appellant’s Specification, “[l]ess frequent
administration [of a medication] results in improved patient compliance.”
(Id. at 4.) Appellant’s Specification also notes that “constant therapeutic
plasma levels of active components can be more effective and even
efficacious compared to the fluctuations seen when multiple doses of a
conventional immediate release formulation are given.” (Id.) Appellant’s
invention is directed at a sustained release formulation of phenylephrine.
Claims 1–3, 8, and 18–27 are on appeal. Claim 1, reproduced below,
is illustrative of the claimed subject matter:
1. A pharmaceutical formulation, wherein said pharmaceutical
formulation comprises two or more extended release particles,
wherein said two or more extended release particles each
comprise phenylephrine and a cation polystyrene sulfonate
complex,
wherein at least 90% of said cation polystyrene sulfonate
comprises particle sizes of about 74 μm to about 177 μm prior
to being combined with the phenylephrine,
wherein said phenylephrine and cation polystyrene
sulfonate complex is coated with a coating,
wherein said two or more phenylephrine and cation
polystyrene sulfonate complexes are not variably coated at
different levels of coating and thus achieve a coating level,
wherein the amount of the coating level as compared to
the coated drug-resin complex is from 30% to 45% by weight,
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wherein the coating consists of cellulose acetate and
hydroxypropylcellulose,
wherein the coating consists of from 67% to 83% by
weight cellulose acetate,
wherein said extended release particles exhibit
bioavailability for at least about 8 hours upon administration,
wherein serum concentration of the extended release
particles exhibit intersubject variability within the range depicted
in Figure 2 upon administration to two or more subjects, and
wherein the serum concentration of the extended release
particles exhibit a second peak at about 12 hours after
administration in said subjects.
(Appeal Br. 16 (paragraphing added).)
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Challapalli US 2005/0112198 A1 May 26, 2005
Hall US 2007/0148239 A1 June 28, 2007
Pilgaonkar US 2013/0230587 A1 Sept. 5, 2013

REJECTIONS
The following rejections made by the Examiner are before us on
appeal:2
Claims 1–3, 8, and 18–27 are rejected under 35 U.S.C. § 112 (pre-
AIA), first paragraph, as failing to comply with the written description
requirement.

2 The Examiner’s rejection of the claims under 35 U.S.C. § 112, second
paragraph made in the Final Action was withdrawn in the Answer. (Ans. 3.)
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Claims 1–3, 8, 18–21, and 23–27 are rejected under pre-AIA 35
U.S.C. § 103(a) as unpatentable over Pilgaonkar and Challapalli.
Claim 22 is rejected under pre-AIA 35 U.S.C. § 103(a) as
unpatentable over Pilgaonkar, Challapalli, and Hall.
Claims 1–3, 8, and 18–27 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over the claims of copending
Application No. 13/832,694 and Pilgaonkar.
Claims 1–3, 8, and 18–27 on the ground of non-statutory obviousness-
type double patenting as being unpatentable over the claims of copending
Application No. 14/966,079 and Pilgaonkar or Hall.

DISCUSSION
I. Written Description
The Examiner finds that the following negative limitation of claim 1,
which was added during prosecution, “said two or more phenylephrine and
cation polystyrene sulfonate complexes are not variably coated at different
levels of coating,” is not supported by the Specification. (Final Action 3;
Ans. 3.) We disagree with the Examiner’s finding.
As Appellant points out (Appeal Br. 8), the Specification states that
the coating applied to the resinate particles “can be layered” and “added in
succession until the desired coating level is achieved.” (Spec. 16.) In other
words, Appellant describes a manner by which multiple resinate particles
can be coated to achieve a specific coating level.
Moreover, the Specification describes coated resinate particles having
a 35% coating level and a 40% coating level that underwent dissolution
analysis. (Spec. 33–35 (Example 4 (Tables 10A and Table 10B)); Appeal
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Br. 7–8.) The Examiner agrees that the 35% coating level and a 40%
coating level are “embodiments show[ing] phenylephrine resinate particles
that have been coated to a coated level as described at paragraph 70.” (Ans.
4.) We agree that the Specification sufficiently describes resinate particles
that are coated with the same level of coating at either 35% coating level or
40% coating level. We note that another way to state “are not variably
coated at different levels of coating” is that the resinate complexes are
coated to the same level of coating. And, the Specification describes two
batches of particles each of which are not variably coated at different levels.
Thus, contrary to the Examiner’s suggestion (Final Action 3), we are
not presented with a Specification that is missing a “positive” disclosure
upon which an exclusionary recitation cannot be based. The Examiner’s
position that Appellant’s claim can be interpreted to encompass formulations
where the only resin particles present have the same level of coating or
where some of the particles are coated to one level, e.g. 35%, while others
are coated to another level, e.g., 40% (Ans. 4) notwithstanding, we find that
the “negative” limitation, which can be interpreted as the “two or more
phenylephrine and cation polystyrene sulfonate complexes” being coated to
the same level of coating, has a basis in the original disclosure.
Consequently we reverse the Examiner’s rejection of claims 1–3, 8,
and 18–27 under 35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to
comply with the written description requirement.

II. Obviousness
To address this dispute, we must first consider claim construction.
The Examiner finds that that claim 1’s requirement that the formulation
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“comprises two or more extended release particles” where the “two or more
extended release particles each comprise phenylephrine and a cation
polystyrene sulfonate complex” and the “two or more phenylephrine and
cation polystyrene sulfonate complexes are not variably coated at different
levels of coating” is met by a composition that includes one set of
phenylephrine and cation polystyrene sulfonate complexes that have the
same level of coating even if that composition also comprises other
phenylephrine and cation polystyrene sulfonate complexes that have a
different level of coating from the first set. (Ans. 5.) Appellant does not
dispute the foregoing claim interpretation and we agree with the Examiner
that the claim language allows for such formulation. That is because
“‘[c]omprising’ is a term of art used in claim language which means that the
named elements are essential, but other elements may be added and still
form a construct within the scope of the claim.” Genentech, Inc. v. Chiron
Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). As the Examiner recognized, so
long as the formulation includes a first set of two or more extended release
particles that have the same level of coating of cellulose acetate and
hydroxypropylcellulose, the claim does not exclude a second set of release
particles having a level of coating that differs from the first set.
Given the foregoing construction, we agree with the Examiner that
Pilgaonkar’s teaching that the drug-resin complexes are variably coated at
different levels of barrier coating does not preclude the reference from
teaching or suggesting a composition that meets the limitations of claim 1.
As the Examiner explains, and Appellant does not dispute, “Pilgaonkar
expressly teaches that the composition comprises ‘at least two variably
coated populations’ of drug-resin complexes, wherein the first population is
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variably coated from the second population (paragraph 42).” (Ans. 5.) In
other words, Appellant does not dispute that Pilgaonkar teaches a first set of
coated drug-resin complexes having one level of coating, which level varies
from the second population, but the particles of the first set do not have a
varying coating level from each other. Consequently, we do not find
Appellant’s arguments regarding Pilgaonkar teaching away from the claimed
composition because it teaches formulations having more than one set of
drug-resin complexes that are variably coated at different levels of barrier
coating of release modifier (Appeal Br. 11–12) persuasive of non-
obviousness.
As the Examiner also found (Final Action 5), Pilgaonkar teaches that
the drug of the drug-resin complex can be phenylephrine (Pilgaonkar ¶ 15)
and that the resin can be Amberlite® IRP693 (Id. ¶ 24), the latter of which is
disclosed in Appellant’s Specification as being a resin that “may be used in
accordance with the invention” (Spec. 14). The Examiner further finds that
Pilgaonkar teaches the drug-resin complex may be coated with release
modifiers that may comprise those recited in claim 1 (Final Action 54; Ans.

3 The Examiner relies on Challapalli for its express disclosure that
Amberlite® IRP69 possesses particle sizes of 47–149 microns, (Final Action
7), which includes particles within the claimed range of about 74 to about
177 microns.
4 The Examiner identifies cellulose acetate and
hydroxypropylmethylcellulose (Final Action 5 (citing Pilgaonkar ¶¶ 36 and
38)) rather than cellulose acetate and hydroxypropylcellulose in the Final
Action, as recited in claim 1. However, we find this to be an inadvertent
error, recognized by Appellant (Appeal Br. 13 (“Pilgaonkar, which only
includes (1) phenylephrine, (2) cellulose acetate and
(3) hydroxypropylcellulose in laundry lists”).) Indeed, Pilgaonkar
recognizes cellulose acetate as a “[s]uitable polymeric water-insoluble
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6–7). (See Pilgaonkar ¶ 36 (listing water insoluble release modifiers
including cellulose acetate), id. ¶ 38 (listing water soluble release modifiers
including hydroxypropylcellulose).) Moreover, as the Examiner finds (Final
Action 7) Pilgaonkar teaches that a combination of more than one release
modifier may be used in combination. (Pilgaonkar ¶ 35.) In addition, as the
Examiner finds, Pilgaonkar teaches “[t]he coated drug-resin complex may
comprise 1–75% by weight of the coating (paragraph 42).” (Final Action 5.)
And, as the Examiner finds, “Pilgaonkar expressly discloses coating the drug
resin complexes with the release modifier at varying levels, and selecting
particular proportions of the variably coated complexes in order to obtain a
desired bioavailability (see paragraph 10).” (Id.; see also Pilgaonkar ¶ 42
(“Optimum coat weight and coat thickness may be determined”).)
Appellant does not dispute that the claimed active agent and release
modifiers are disclosed by Pilgaonkar. (Appeal Br. 13.) Appellant,
however, contends that because Pilgaonkar includes a laundry list of release
modifiers that can be used as coatings, as well as a laundry list of active
agents, and does not disclose an example in which phenylephrine is
administered, that it “does not provide any guidance that would lead one
skilled in the art to the claimed invention.” (Id.) Moreover, Appellant
argues that Pilgaonkar “recognized” that sustained release was difficult to
achieve (Id. (citing Pilgaonkar ¶ 5).)

release modifier” (Pilgaonkar ¶36) and hydroxypropylmethylcellulose and
hydroxypropylcellulose as “[s]uitable water soluble release modifiers” (Id. ¶
38). And the Examiner noted in the Answer that Pilgaonkar teaches
cellulose acetate and hydroxypropylcellulose as examples of release
modifiers that may be used as coatings. (Ans. 6–7.)
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We do not find these arguments persuasive. First, as the Examiner
explained, Pilgaonkar’s recognition of the difficulty of achieving sustained
release was not a conclusion with respect to the coated compositions it
describes as achieving better sustained release properties, but rather with
regard to “uncoated drug-resin complexes.” (Ans. 5.) Furthermore, the
guidance of Pilgaonkar is that a number of active agents may be complexed
with a cation exchange resin that is coated with at least one release modifier
to provide sustained release compositions for up to 12 or 24 hour release5 for
treatment or management of cold and/or flu like symptoms. (See, e.g.,
Pilgaonkar ¶ 54–55.) Phenylephrine is a well-known active agent for
treatment of congestion (Id. ¶ 15) and congestion is a well-known symptom
associated with cold and/or flu. Consequently, we disagree that Pilgaonkar
does not guide one of ordinary skill in the art to select phenylephrine as the
active agent.

5 We do not find Appellant’s argument that Pilgaonkar “only shows
dissolution for dextromethorphan within T=0 to 6 hours” (Appeal Br. 11
(citing Pilgaonkar ¶¶ 65–66)) persuasive of non-obvious of the claimed
composition. Even as to dextromethorphan, Pilgaonkar does not teach that
drug release was complete at 6 hours. Notably, in none of the compositions
tested was 100% of the drug released by 6 hours. The experiment simply
evaluated various compositions over a six hour period to determine whether
a formulation released the active from the complex satisfactorily over six
hours, as compared to excessively retaining the active agent in the complex
or releasing the agent too quickly in a six hour period. (Pilgaonkar ¶¶ 65–66
(concluding that composition C release “is neither too retarded nor too
fast.”).) Thus, the experiment does not even demonstrate that dissolution
only occurs up to 6 hours. And Pilgaonkar, in fact, teaches that it is
desirable to provide sustained release of an anti-tussive, which
dextromethorphan is (Pilgaonkar ¶ 15), for about 6 to about 24 hours (Id. ¶
55).
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Moreover, regarding the choice of release modifiers, “[r]eading a list
and selecting a known compound to meet known requirements is no more
ingenious than selecting the last piece to put into the last opening in a jig-
saw puzzle. It is not invention.” Sinclair & Carroll Co. v. Interchemical
Corp., 325 U.S. 327, 335 (1945); see also Merck & Co. Inc. v. Biocraft
Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989). Furthermore, as a
general rule, “discovery of an optimum value of a result effective variable in
a known process is ordinarily within the skill of the art [and obvious.]” In re
Boesch, 617 F.2d 272, 276 (CCPA 1980). Accordingly, “where the general
conditions of a claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine experimentation.” In re
Applied Materials, Inc., 692 F.3d 1289, 1295–96 (Fed. Cir. 2012) quoting In
re Aller, 220 F.2d 454, 456 (CCPA 1955). The motivation to optimize
comes from the natural desire of those skilled in the art to experiment with,
and improve upon, known conditions taught in the prior art. In re Peterson,
315 F.3d 1325, 1330 (Fed. Cir. 2003).
Here, Pilgaonkar recognizes that the selection of resins to use with an
active agent is a result effective variable dependent on the active agent and
the desired drug release characteristics, as is the coat weight and coating
level to use. As the Examiner found (Ans. 7), Pilgaonkar teaches that the
level of the coating (e.g., coat thickness) as well as the coat weight can be
optimized “for each drug-resin complex” in order to obtain a desired release
profile of the drug “and generally depends on the drug release characteristics
of the resin for that particular active ingredient.” (Pilgaonkar ¶ 42.) Thus,
we agree with the Examiner that the selection of the specific modifiers from
the list of water insoluble and water soluble release modifiers taught by
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Pilgaonkar would have been obvious to one having ordinary skill in the art,
as would the barrier layer thickness (i.e., the claimed amount of coating level
%).
The fact that Pilgaonkar “do[es] not provide biological data to
demonstrate that its formulas (even the formulas it has exemplified) meet the
challenges provided when administered in human subjects,” whereas the
claimed invention “has been tested in humans” (Appeal Br. 13) also does not
establish error in the Examiner’s rejection of the claims for obviousness.
Scientific experimentation to confirm a prior art disclosure “does not give
rise to a patentable invention.” PharmaStem Therapeutics, Inc. v. ViaCell,
Inc., 491 F.3d 1342, 1363–64 (Fed. Cir. 2007); cf. Pfizer, Inc. v. Apotex,
Inc., 480 F.3d 1348, 1364, 1367–69 (Fed. Cir. 2007) (simply because the
formation and properties of a new compound must be verified through
testing does not mean that the compound satisfies the test for patentability
“since the expectation of success need only be reasonable, not absolute”); In
re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986) (“Obviousness does
not require absolute predictability.”).
For these reasons, we determine that the Examiner has met its burden
to articulate a sufficient prima facie showing of obviousness based on the
cited references and are not persuaded by Appellant’s arguments to the
contrary.
Appellant’s unexpected results arguments are likewise unpersuasive.
In particular, we agree with the Examiner (Ans. 9–10) that Appellant has not
compared the claimed invention to the closest prior art. “Although it is well
settled that comparative test data showing an unexpected result will rebut a
prima facie case of obviousness, the comparative testing must be between
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the claimed invention and the closest prior art.” In re Fenn, 639 F.2d 762,
765 (CCPA 1981) (emphasis added).
According to Appellant, the Specification shows that the claimed
formulation upon administration did not have much intersubject variability
in plasma concentration profiles, and had a secondary peak for all subjects at
about 12 hours, neither of which was achieved with prior art compositions.
(Appeal Br. 12 (referring to Figure 2 and Spec 10).) The prior art references
to which Appellant refers are Ptacek6 and Montieth.7 (Appeal Br. 12.) As
the Examiner explained, and Appellant does not dispute, the comparison
Appellant makes is to “an immediate release stock solution of phenylephrine
that is not coated with any release modifiers” and “an immediate release
phenylephrine formulation whose structural composition and configuration
is not disclosed by the reference” and a controlled release phenylephrine
formulation for delivery within a desired location in the GI tract whose
structural composition and configuration also is not disclosed by the
reference. (Ans. 10.) Appellant has not established that the immediate
release formulations of Ptacek and Montieth include a resinate-active agent
complex as taught by Pilgaonkar. Nor has Appellant established that the
controlled release formulation of Montieth includes a resinate-active agent
complex as taught by Pilgaonkar.
Appellant bears the burden of providing factual evidence of non-
obviousness to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d

6 Ptacek et al., Development and validation of a liquid chromatography-
tandem mass spectrometry method for determination of phenylephrine in
human plasma and its application to a pharmacokinetic study, 858J.
Chromatography B, 263–268, (2007). (Id.)
7 Montieth et al., US 2008/0020055 A1, published Jan. 24, 2008. (Id.)
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688, 692 (Fed. Cir. 1990). Appellant has not met that burden here because
Appellant has not established that formulations of Ptacek or Montieth are
closer prior art than the resinate-active agent complex as taught by
Pilgaonkar. Thus, Appellant has not established that it has presented
comparative evidence to the closest prior art.
Thus, for the foregoing reasons, we affirm the Examiner’s rejection of
claim 1 as being obvious from Pilgaonkar and Challapalli. Claims 2, 3, 8,
18–21, and 23–27 have not been argued separately and stand or fall with
claim 1. 37 C.F.R. § 41.37(c)(1)(iv).
Appellant’s position that the Examiner’s obviousness rejection of
claim 22 is in error relies on the arguments discussed above with respect to
Pilgaonkar (Appeal Br. 13–14), which we do not find persuasive. Thus, we
also affirm the Examiner’s rejection of claim 22 as being obvious from
Pilgaonkar, Challapalli, and Hall.
III. Non-Statutory obviousness-type double patenting
Appellant does not contest the Examiner’s rejection of the claims for
obviousness-type double patenting. (Appeal Br. 14.) Nor has Appellant
indicated that a terminal disclaimer has been filed. Consequently, we
summarily affirm the Examiner’s rejections of claims 1–3, 8, and 18–27 on
the ground of non-statutory obviousness-type double patenting as being
unpatentable over the claims of copending Application No. 13/832,694 or
14/966,079 and Pilgaonkar or Hall. Hyatt v. Dudas, 551 F.3d 1307, 1314
(Fed. Cir. 2008) (“When the appellant fails to contest a ground of rejection
to the Board, . . . the Board may treat any argument with respect to that
ground of rejection as waived.”).

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DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–3, 8, 18–
27
112, first
paragraph
Written
Description
1–3, 8, 18–
27
1–3, 8, 18–
21, 23–27
103(a) Pilgaonkar,
Challapalli
1–3, 8, 18–
21, 23–27

22 103(a) Pilgaonkar,
Challapalli, Hall
22
1–3, 8, 18–
27
Provisional
Obviousness-type
Double Patenting
1–3, 8, 18–
27

1–3, 8, 18–
27
Provisional
Obviousness-type
Double Patenting
1–3, 8, 18–
27

Overall
Outcome
1–3, 8, 18–
27

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED