BAYER HEALTHCARE LLC

Patent Trials and Appeals Board

Sep 10, 2020

2020001513 (P.T.A.B. Sep. 10, 2020)

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.
15/730,565 10/11/2017 Roland H. Johnson 2920951-121001 1492
84331 7590 09/10/2020
McBee Moore & Vanik, IP, LLC
7900 Westpark Drive, Suite A100
McLean, VA 22102
EXAMINER
IVANOVA, SVETLANA M
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
09/10/2020 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):
docketing@mmviplaw.com
eofficeaction@appcoll.com
smcbee@mmviplaw.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ROLAND H. JOHNSON, DOUGLAS I. HEPLER,
KATHLEEN G. PALMA, and WILLIAM R. CAMPBELL
____________

Appeal 2020-001513
Application 15/730,565
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134(a) involving claims to a
chewable solid dosage form containing imidacloprid. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse and enter a new ground of rejection.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Bayer
Healthcare LLC, (see Appeal Br. 1).
2 We have considered and herein refer to the Specification of Oct. 11, 2017
(“Spec.”); Non-Final Office Action of Mar. 11, 2019 (“Non-Final Act.”);
Appeal Brief of July 10, 2019 (“Appeal Br.”); Examiner’s Answer of Oct.
22, 2019 (“Ans.”); and Reply Brief of Dec. 20, 2019 (“Reply Br.”).
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Statement of the Case
Background
“[T]he market for ectoparasite control in mammals has long been
dominated by compositions for topical administration” (Spec. ¶ 3). Known
topical compositions for use on dogs and cats include imidacloprid for
treating fleas and fipronil for treating fleas, ticks, and scabies (id.).
However, topical compositions have various disadvantages, including
toxicity to humans and environmental contamination (id. ¶ 4). “It is
therefore desirable to provide an orally deliverable compound for control of
targeted parasites. It is especially desirable to provide such a compound in a
readily consumable dosage form” (id. ¶ 5).
The Claims
Claims 1–6, 8–15, 19, 21–24, and 26–28 are on appeal.3 Independent
claim 1 is representative and reads as follows:
1. A chewable solid dosage form comprising an
ectoparasiticidally effective amount of imidacloprid, wherein
the chewable solid dosage form comprises from about 1.75 mg
to about 108 mg of imidacloprid.

(Appeal Br. 30).

3 Claims 7, 16–18, 20, and 25 are cancelled. Claim 9 appears to depend on
cancelled claim 7. Should prosecution be re-opened, we encourage
Appellant to address the dependency of claim 9.
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The Rejection
The Examiner rejected claims 1–6, 8–15, 19, 21–24, and 26–28 as
unpatentable under 35 U.S.C. § 103(a) as obvious over Hershberger,4
Mencke,5 Dryden,6 and Solecki.7
The Examiner finds Hershberger teaches a liquid composition that
“can be admixed, topped, or otherwise added to solid pet food, which can
thus be prepared as a . . . chewable soft treat” for pets that may contain
imidacloprid, for treating flea or tick infestations (Ans. 6–7; emphasis
omitted). The Examiner relies on Mencke, Solecki, and Dryden to teach
safe amounts of imidacloprid (id. at 11–12).
Appellant asserts “no combination of prior art suggests the claimed
chewable solid dosage form comprising an ectoparasiti[ci]dally effective
amount of imidacloprid” (Appeal Br. 12). Specifically, Appellant contends
“Hershberger’s oral dosage form is indisputably a liquid” (id.). Appellant
contends that “Hershberger discloses pouring the liquid over solid food for
immediate consumption by the pet, not for further processing into
tablets/soft treats” (id. at 14). Appellant further contends that “[t]he ordinary
meaning of solid does not include a liquid as in Hershberger” (id. at 15).
The Examiner responds “in Hershberger the composition itself is
liquid, but Hershberger provides that it can be admixed, topped, or otherwise

4 Hershberger, US 2005/0158367 A1, published July 21, 2005.
5 Mencke et al., US 5,712,295, issued Jan. 27, 1998.
6 Dryden et al., Comparative Speed of Kill of Selamectin, Imidacloprid, and
Fipronil-(S)-Methoprene Spot-On Formulations against Fleas on Cats, 6
Veterinary Therapeutics *1–5 (2005).
7 Solecki, Pesticide residues in food, the International Programme on
Chemical Safety, Toxicological Evaluations, IMIDACLOPRID, Joint
Meeting on Pesticide Residues 1-28 (2001).
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added to solid pet food, which can thus be prepared as a tablet, capsule,
chewable soft treat” (Ans. 6).
We begin with claim interpretation, since before a claim is properly
interpreted, its scope cannot be compared to the prior art. The term in
dispute is “chewable dosage form” as recited in claim 1. We first turn to the
Specification which is, “[i]n most cases, the best source for discerning the
proper context of claim terms.” Metabolite Labs., Inc. v. Lab. Corp. of Am.
Holdings, 370 F.3d 1354, 1360 (Fed. Cir. 2004).
The Specification discloses:
The parasiticidal compositions of the invention can be provided
in any therapeutically acceptable pharmaceutical form. For
example, the compositions can be formulated for oral
administration as drug powders . . . beads, microbeads, pellets,
pills, microtablets, compressed tablets or tablet triturates,
molded tablets or tablet triturates, and in capsules, which are
either hard or soft and contain the composition as a powder,
particle, bead, solution or suspension. The parasiticidal
compositions can also be formulated for oral administration as a
solution or suspension in an aqueous liquid, as a liquid
incorporated into a gel capsule.
(Spec. ¶ 30). The Specification discloses “[o]ne especially useful delivery
format for animals is the soft (mildly friable under pressure) chewable treat
for edible consumption” (Spec. ¶ 40). The Specification discloses a process
for manufacturing a chewable dosage vehicle wherein:
dry ingredients of the chew mixture are blended first, then an
oil suspension of the active blended therein, followed by
admixture with the liquid ingredients (e.g., humectants and
softening agents) to form a thoroughly blended mixture. After
blending, the chew mixture is discharged without compression
from a port through the blender into a suitable container for
processing into individual dosage units with a forming machine.
(Spec. ¶ 66).
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Therefore, in light of the Specification, we interpret the phrase
“chewable dosage form” in claim 1 as a pharmaceutical form that is distinct
from liquid or gel capsule forms, and that is provided in a solid and
chewable formulation for administration to animals.
We find the Examiner’s arguments to the contrary unpersuasive. The
Examiner finds the “term ‘solid’ does not exclude the presence of liquids
ingredients” (Ans. 4). Although we agree with the Examiner the claimed
chewable solid dosage form may contain liquid ingredients, the resulting
dosage form is unambiguously solid in its final composition. Moreover, the
Specification itself distinguishes between a chewable solid dosage form and
a gelatin capsule which may contain the medicament in a liquid solution or
suspension. Accordingly, to the extent that the Examiner is reading “solid
dosage form” out of the claims, that interpretation is not reasonable.
The Examiner also finds “in Hershberger the composition itself is
liquid, but Hershberger provides that it can be admixed, topped, or otherwise
added to solid pet food, which can thus be prepared as a tablet, capsule,
chewable soft treat” (Ans. 6; emphasis omitted).
We also find this interpretation unpersuasive. When Hershberger
teaches “a liquid composition that can be admixed, topped, or otherwise
added to a pet food” (Hershberger 7), we appreciate that the pet might then
chew the resultant treated pet food. But that interpretation also reads the
concept of “solid dosage form” out of the claim, relying solely on the word
“chewable” because any medicament, liquid, gel, or solid, could be added to
food and thereby be transmuted to a “chewable solid dosage form.”
However, “the broadest reasonable interpretation must be reasonable in light
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of the claims and specification.” PPC Broadband, Inc. v. Corning Optical
Commc’ns RF, LLC, 815 F.3d 747, 755 (Fed. Cir. 2016).
Because Hershberger does not teach a “chewable solid dosage form”
and that missing element is not supplied by Mencke, Dryden, or Solecki, the
references do not render the claims obvious.
Conclusion of Law
The evidence of record does not support the Examiner’s finding that
Hershberger, Mencke, Dryden, and Solecki render the claims obvious.

New Ground of Rejection
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new ground of rejection. Claims 1–6, 8–15, 19, 21–24, and 26–28 are
rejected under 35 U.S.C. § 103 as obvious over Cleverly8 and CN’620.9
Findings of Fact
1. Cleverly teaches a solid chewable veterinary formulation
containing an effective amount of at least one pharmaceutical agent; at least
one filler; at least one disintegrant; at least one non-animal product
containing flavor; at least one binder; at least one humectant; and at least one
granulating solvent (Cleverly 17, claim 1).
2. Cleverly teaches the pharmaceutical agent may be imidacloprid
(Cleverly 18–19, claims 12, 25).

8 Cleverly et al., US 2004/0037869 A1, published Feb. 26, 2004 (of record
Oct. 11, 2017). We note that Cleverly was previously applied against the
significantly-narrower “single dose” method claims of the parent application
No. 12/471,129.
9 CN 1386420 A, published Dec. 25, 2002 (of record Oct. 11, 2017).
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3. Cleverly teaches administering insecticides, including
substituted pyridylmethyl derivatives such as imidacloprid for treating
blood-sucking pests including fleas (Cleverly ¶¶ 87–88).
4. CN’620 teaches an antiparasitic composition for pets that
contains imidacloprid and is highly effective on fleas (CN’620, 1).
5. CN’620 teaches a solid oral preparation of imidacloprid for a
cat or dog, providing a daily dose of 0.2–7 mg/kg (CN’620, 1).
6. CN’620 teaches preparing an oral tablet having a weight of 1 g
containing 0.12% (w/w) imidacloprid (CN’620, 4 (Example 5)).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “[W]hen the
question is whether a patent claiming the combination of elements of prior
art is obvious,” the answer depends on “whether the improvement is more
than the predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. at 417.
Analysis
Cleverly teaches a chewable solid dosage form containing
imidacloprid effective for treating fleas (FF 1–3). Cleverly does not teach an
amount of imidacloprid. CN’620 teaches solid oral dosage forms for
treating fleas in cats and dogs, containing 0.2–7 mg/kg imidacloprid (FF 4–
5). CN’620 teaches a specific tablet composition containing 1.2 mg
imidacloprid (1 g x 0.12%) (FF 6). A person of ordinary skill in the art
would have been motivated to use the dose amounts taught by CN’620 with
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Cleverly’s chewable solid dosage form as both references teach imidacloprid
solid oral dosage forms for treating fleas in pets (FF 3, 6).
The resulting combination teaches a chewable solid dosage form
containing 0.2–7 mg/kg imidacloprid, i.e., an ectoparasiticidally effective
amount. Applying the Examiner’s uncontested finding that the average size
of a domestic house cat is 5 kg (Ans. 10), a person of ordinary skill in the art
would have had a reasonable expectation of success in preparing a chewable
solid dosage form containing about 1–35 mg of imidacloprid. Accordingly,
the prior art teaches the chewable solid dosage form of claim 1, including a
dose amount that overlaps the claimed dose amount. “[T]he existence of
overlapping or encompassing ranges shifts the burden to the applicant to
show that [the] invention would not have been obvious.” In re Peterson,
315 F.3d 1325, 1330 (Fed. Cir. 2003).
With regard to claims 2, 3, 8, 19, 21–24, and 26, CN’620 teaches solid
oral dosage forms for treating fleas in cats and dogs, containing 0.2–7 mg/kg
imidacloprid, a range that overlaps the claimed range (FF 3–6).
With regard to claim 4, Cleverly teaches a chewable solid dosage
form containing imidacloprid effective for treating fleas (FF 1–3).
With regard to claims 5 and 910, Cleverly teaches treatment of fleas
(FF 1). As to the packaging and label, these simply represent printed matter
that does not patentably distinguish the invention from claim 1. See In re
Ngai, 367 F.3d 1336, 1339 (Fed. Cir. 2004) (“All that the printed matter
does is teach a new use for an existing product. . . . He is not, however,
entitled to patent a known product by simply attaching a set of instructions
to that product.”)

10 We note that claim 9 depends from cancelled claim 7.
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With regard to claims 6 and 10–14, CN’620 teaches overlapping solid
oral dosage forms for treating cats and dogs, containing 0.2–7 mg/kg
imidacloprid, a range that overlaps the claimed range (FF 5) and therefore
necessarily comprise doses effective to kill fleas, flea larvae or eggs, ticks,
helminthes, and scabies. “Products of identical chemical composition can
not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 708
(Fed. Cir. 1990).
With regard to claim 15, Cleverly teaches including “product
containing flavor or flavor derived from a non-animal source” (Cleverly
¶ 14).
With regard to claim 27, claim 12 of Cleverly suggests a formulation
with a single pharmaceutical agent that may be imidacloprid as does CN’620
(FF 2, 6).
With regard to claim 28, Cleverly teaches dosage form components
including pregelatinized starch (Cleverly ¶ 230), glycerin (Cleverly, Claim
2), croscarmellose sodium (Cleverly ¶ 242), corn oil and polyethylene glycol
(Cleverly ¶ 189). “It is prima facie obvious to combine two compositions
each of which is taught by the prior art to be useful for the same purpose, in
order to form a third composition which is to be used for the very same
purpose. . . . [T]he idea of combining them flows logically from their
having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d
846, 850 (C.C.P.A. 1980).
We note that Appellant argues that the Specification provides
evidence of unexpected results (Appeal Br. 23–26). Appellant’s evidence of
unexpected results relies on compositions containing 5 mg and 3 mg of
imidacloprid (See id. at 24–25). Appellant’s evidence does not provide a
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reasonable basis for concluding that embodiments within the entire range of
the claimed amount (about 1.75 mg to about 108 mg) would behave in the
same manner as the tested embodiments. Accordingly, Appellant’s evidence
of alleged unexpected results is not commensurate with the scope of the
claims. See In re Lindner, 457 F.2d 506, 508 (CCPA 1972).
Appellant also argues that the present invention solves a long-felt
need (Appeal Br. 27). However, Appellant’s argument does not include any
evidence of either a long-felt need, or that the claimed composition meets
that need. “Attorneys’ argument is no substitute for evidence.” Johnston v.
IVAC Corp., 885 F.2d 1574, 1581 (Fed. Cir. 1989).
Considering the prior art and Appellant’s evidence of unexpected
results, we conclude that the claims would have been obvious over Cleverly
and CN’620.

CONCLUSION
In summary:

Claims
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed New
Ground
1–6, 8–15,
19, 21–24,
26–28
103 Hershberger,
Mencke, Dryden,
Solecki
1–6, 8–15,
19, 21–24,
26–28

1–6, 8–15,
19, 21–24,
26–28
103 Cleverly, CN’620 1–6, 8–15,
19, 21–24,
26–28
Overall
Outcome
1–6, 8–15,
19, 21–24,
26–28
1–6, 8–15,
19, 21–24,
26–28

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This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the
appellant, within two months from the date of the decision, must
exercise one of the following two options with respect to the new
ground of rejection to avoid termination of the appeal as to the
rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the
opinion of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.

Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.

REVERSED, 37 C.F.R. § 41.50(b)