Elanco US Inc.

Patent Trials and Appeals Board

Mar 6, 2020

15513735 - (D) (P.T.A.B. Mar. 6, 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.
15/513,735 03/23/2017 Thomas Alan Marsteller X20298 9286
159715 7590 03/06/2020
Elanco US Inc.
Patent Division
2500 Innovation Way
Greenfield, IN 46140
EXAMINER
DECK, JASON A
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/06/2020 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):
patents@elanco.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte THOMAS ALAN MARSTELLER, MATTHEW JOHN RITTER,
THOMAS EDMUND WEBER, JANE GRANVILLE OWENS,
CHRISTOPHER LEIGH PULS, and KELLY SHERN ROSENKRANS

Appeal 2019-006728
Application 15/513,735
Technology Center 1600
Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
JAMIE T. WISZ, Administrative Patent Judges.

WISZ, Administrative Patent Judge.

DECISION ON APPEAL

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Application 15/513,735

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STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1–4 and 11. We have jurisdiction under
35 U.S.C. § 6(b).
We AFFIRM.
CLAIMED SUBJECT MATTER
The Specification describes “compositions containing narasin and
methods of using narasin to treat a nursery pig for porcine epidemic diarrhea
virus infection.” Spec. 1. Claim 1, the only independent claim, is
illustrative of the claimed subject matter and is reproduced below:
1. A method of treating porcine epidemic diarrhea virus
(PEDV) infection comprising administering to a nursery pig
narasin with an orally-acceptable carrier;
wherein said nursery pig is at least 7 days old and less than
about 10 weeks old.
Appeal Br. 9 (Claims App.).
REJECTIONS
The Examiner rejected claims 1–4 and 11 under 35 U.S.C. § 103 as
obvious over Gale,2 in view of Wuethrich,3 and as evidenced by the
Wikipedia page for PEDV.4

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 Elanco US
Inc. Appeal Br. 2.
2 Gale et al., US 3,995,027, issued Nov. 30, 1976 (“Gale”).
3 Wuethrich et al., The effect of narasin on apparent nitrogen digestibility
and large intestine volatile fatty acid concentrations in finishing swine, J
ANIM SCI, 76:1056–1063 (1998) (“Wuethrich”).
4 https://en.wikipedia.org/wiki/Porcine_epidemic_diarrhea_ virus (accessed
April 17, 2018) (“Wikipedia”).
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ISSUES AND ANALYSIS
According to the Examiner, Gale discloses that the antibiotic A-
28086A (i.e., narasin) is useful against viral infections, such as coronavirus
in pigs. Final Act. 4 (citing Gale, Abstract, 23:37–57, 27:64–68, Table 2).
The Examiner also finds that Gale discloses that narasin is effective in
treating viral infection in baby pigs and that the disclosed antibiotics should
be administered in feed at a rate of about 2.5–10 g per 100 pounds of feed in
sows (i.e., adult pigs), which the Examiner calculates to be about 55–220
mg/kg of feed. Id. (citing Gale 27:64–68, 28:1–4, Table 2).
The Examiner concedes that Gale does not specifically disclose the
treatment of PEDV infection in nursery pigs with narasin, as claimed, but
finds that Wuethrich “discloses that the administration of narasin resulted in
beneficial improved apparent nitrogen digestibility, decreased fecal nitrogen,
and increased relative concentrations of propionic acid in the large intestine
of pig.” Id. (citing Wuethrich, Abstract). The Examiner also cites to
Wikipedia as evidence that PEDV is a coronavirus. Id.
The Examiner finds that one of ordinary skill in the art at the time of
the invention would have been motivated to treat a nursery pig by
administering narasin because Gale teaches that narasin was useful in
treating similar coronavirus-based infections in pigs in general, and also
exemplified treatment of pigs that were younger and older than the claimed
nursery pigs. Id. at 4–5. According to the Examiner, based on the teachings
in the prior art, one of ordinary skill in the art would have had reason to treat
pigs of all ages, including the claimed nursery pigs and would have done so
with a reasonable expectation of success in making an improved treatment of
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viral infection in pigs. Id. at 5. The Examiner also finds that, “[a]bsent
criticality, the treatment of any age of pig would have been obvious.” Id.
According to the Examiner, “[o]ne would have been motivated to treat
PEDV because those of skill knew that PEDV was a coronavirus, and those
of skill further understood that narasin had beneficial adjunctive properties
in pigs.” Id. The Examiner further finds that one of skill in the art would
have been motivated to use narasin in an amount of 60 mg/kg in feed
because Gale “teaches a preferred amount which encompasses the instantly
claimed amount, and those of skill know that dosing is a result-effect
variable that needs adjustment to optimize the outcome.” Id.
Appellant argues that Gale does not disclose narasin treatment of
“nursery pigs” (between 7 days and 10 weeks old) as claimed, but, rather,
only shows treatment of sows (older pigs) and 2–4 day baby piglets. Appeal
Br. 6–7 (citing Gale 27:14–32). Similarly, according to Appellant,
Wuethrich does not disclose administration of narasin to nursery pigs. Id. at
7. Appellant also argues that administration of narasin to nursery pigs is
contraindicated based on Carpenter,5 which discloses that “when
administered with feed, narasin has been reported to be toxic to nursery pigs
when supplied at a concentration of about 83 mg/kg feed, at least in the
presence of tiamulin.” Id. (citing Spec. 1:22–24; Carpenter, Abstract).
The Examiner responds that the amount of narasin cited by Carpenter,
83 mg/kg, “is well-above the instantly claimed range and is noted by
Carpenter to have been due to a feed-mixing error.” Ans. 7 (citing Carpenter
333). The Examiner also finds that “Carpenter states that it was known that

5 Carpenter et al., Tiamulin and narasin toxicosis in nursery pigs, SWINE
HEALTH PROD. 6:333–336 (2005) (“Carpenter”).
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tiamulin precipitated adverse reactions with other compounds, and
specifically precipitated adverse reactions with narasin, potentially due to
the accumulation of the narasin, resulting from inhibition of its oxidative
biotransformation by tiamulin;” therefore, the toxicity disclosed by
Carpenter is not related to the use of narasin without tiamulin. Id. at 8
(citing Carpenter 335).
Appellant responds that “treatments applied to nursing (or new-born)
piglets, finishing pigs, and breeding sows cannot automatically be applied to
nursery pigs, a very sensitive stage of development.” Reply Br. 3.
Appellant also argues that Gale discloses a broad range of antibiotic
concentrations but does not specify the particular amount of narasin
administered and that only three of the six narasin-treated piglets survived
challenge with the TGE virus, but there is no indication of whether (or how
many) piglets died from narasin treatment alone. Id. at 3–4 (citing Gale
26:38–28:31).
Appellant also cites to Rovira6 as “further evidence that a person of
ordinary skill would be reluctant to use narasin to treat viral infections in
nursery pigs.” Id. at 4. Appellant argues that Rovira discloses that the
effects of narasin intoxication may not be immediately detected; therefore,
“[q]uite likely the surviving piglets treated in Gale would have suffered from
a failure to thrive later in development, and thus a skilled artisan would not
have had a reasonable expectation of success in using narasin to treat viral
infections in nursery pigs nor any motivation for doing so.” Id.

6 Rovira et al., Diagnosis of ionophore intoxications in pigs, NATIONAL HOG
FARMER (2016) (“Rovira”).
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Having considered Appellant’s arguments in support of claim 1, we
are not persuaded of any reversible error in the Examiner’s rejection of
claim 1. Gale discloses that narasin is useful against viral infections, such as
coronavirus, in pigs. Gale, Abstract, 23:37–57, 27:64–68, Table 2.
Although, as Appellant argues, Gale does not specifically disclose treatment
of nursery pigs, it discloses treatment of pigs generally as well as treatment
of baby pigs and adult pigs (sows). Id. Appellant has not pointed to any
unexpected results in the treatment of nursery pigs.
The law is replete with cases in which the difference between
the claimed invention and the prior art is some range or other
variable within the claims. These cases have consistently held
that in such a situation, the applicant must show that the
particular range is critical, generally by showing that the
claimed range achieves unexpected results relative to the prior
art range.
In re Woodruff, 919 F. 2d 1575, 1578 (Fed. Cir. 1990). Based on the
disclosure in Gale, one of skill in the art would have been motivated to
administer narasin to nursery pigs with a reasonable expectation of success
of treating a coronavirus such as PEDV.
Appellant also argues that treatment of nursery pigs with narasin
would have been contraindicated based on the disclosure in Carpenter.
Appeal Br. 7–8. However, we agree with the Examiner that Carpenter does
not teach away from the claimed invention because it discloses that toxicity
was observed when there was a high amount of narasin (83.1 mg/kg) in the
feed and the narasin was administered with tiamulin, which is known to
precipitate adverse reactions with tiamulin. Carpenter 333, 335. Therefore,
one of skill in the art would not necessarily have been dissuaded from
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administering narasin to nursery pigs in a dose smaller than 83.1 mg/kg and
without tiamulin.
With regard to Appellant’s argument that Gale discloses a wide range
of antibiotics, we agree with the Examiner that the range recited in Gale
(55–220 mg/kg of feed) overlaps with the claimed range of about 60 mg/kg.
“In cases involving overlapping ranges, we and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
2003). Furthermore, we agree with the Examiner that one of skill in the art
would have been motivated to optimize the amount of narasin to achieve the
most beneficial effects in combating PEDV. See In re Aller, 220 F.2d 454,
456 (CCPA 1955) (“[W]here 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.”).
As stated above, Appellant also cites to Rovira in their Reply Brief.
Reply Br. 4. First, we find that citation to this reference is improper under
37 C.F.R. § 41.41 as introducing new evidence in the Reply Brief. Second,
this reference appears to have been published in 2016, after the priority date
of the instant application; therefore, Appellant has not established that one of
ordinary skill in the art would have had knowledge of the Rovira disclosure
at the time of the invention. Furthermore, we are not persuaded by
Appellant’s argument that only three of six-narasin treated piglets survived
challenge with the TGE virus, because this 50% survival rate is an
improvement over the 0% survival rate shown for the control group. Reply
Br. 3–4; Gale 27:54–62. Lastly, with regard to Appellant’s argument that the
piglets disclosed in Gale would have suffered from a failure to thrive later in
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development, there is no evidence that this is the case. “Attorneys’ argument
is no substitute for evidence.” Johnston v. IVAC Corp., 885 F.2d 1574, 1581
(Fed. Cir. 1989).
For the reasons described herein and those already of record, we
sustain the Examiner’s rejection of independent claim 1 under 35 U.S.C.
§ 103 as being obvious over Gale in view of Wuethrich, as evidenced by
Wikipedia. Other than the arguments regarding dosage amounts, discussed
above, claims 2–4 and 11 are not argued separately, and, therefore, fall with
claim 1. See 37 C.F.R. § 41.37(c)(1)(iv).
CONCLUSION
For the reasons described herein and those already of record, we
affirm the Examiner’s rejection of claims 1–4 and 11.
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–4, 11 103 Gale, Wuethrich,
Wikipedia
1–4, 11

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