CTC BIO, INC.

Patent Trials and Appeals Board

Sep 24, 2021

2021000406 (P.T.A.B. Sep. 24, 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.
15/738,194 12/20/2017 Hong Ryeol JEON 16477-000029-US-NP 1070
28997 7590 09/24/2021
Harness Dickey (St. Louis)
7700 Bonhomme, Suite 400
St. Louis, MO 63105
EXAMINER
GREENE, IVAN A
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
09/24/2021 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):
bkamer@hdp.com
stldocket@hdp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HONG RYEOL JEON, BONG-SANG LEE, HYUN-IL KIM, and
HAN-SEUNG LEE
Appeal 2021-000406
Application 15/738,194
Technology Center 1600
Before JOHN E. SCHNEIDER, DEBRA L. DENNETT, and
RACHEL H. TOWNSEND Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 1, 3, 5–11, and 13. We have jurisdiction
under 35 U.S.C. § 6(b).
We Affirm.

1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R.
§ 1.42(a). Appellant identifies the real party in interest as CTC Bio, Inc.
Appeal Br. 3.
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Application 15/738,194
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CLAIMED SUBJECT MATTER
The claims are directed to “a purgative composition for cleansing an
intestinal tract with high quality of bowel cleansing and high drug
compliance, and a method for cleansing an intestinal tract using the same.”
Spec. ¶ 1. Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A purgative composition comprising polyethylene glycol,
sorbitol and sodium picosulfate, wherein the composition
comprises 40 to 60g of polyethylene glycol, 10 to 28g of sorbitol,
and 1 to 10mg of sodium picosulfate per 100ml of the com
position in a liquid dosage form.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Aronson US 2006/0029570 A1 Feb. 9, 2006
Thomas2 WO 2009/036906 A1 Mar. 26, 2009
Skoog et al., Effects of osmotically active agent on colon transit, 18
Neurogastroenterol. Motil. 300 (2006)
Haringsma and Mulder, Colon cleansing, in Procedures in
Hepatogastroenterology, 2d ed. (Tygat and Mulder, eds., 1997)

REJECTION
The Examiner has rejected the pending claims under 35 U.S.C. § 103
as unpatentable over Aronson in view of Skoog, Thomas, and Haringsma.

2 The Examiner and Appellant both refer to this reference as Thomas. The
first named inventor is Petersen-Brann. For consistency we shall also refer to
this reference as Thomas. Citations are to the English machine translation of
record.
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OPINION
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that the subject matter of
claims 1, 3, 5–11, and 13 would have been obvious to one of ordinary skill
in the art at the time the invention was made over Aronson combined with
Skoog, Thomas, and Haringsma.
The Examiner finds Aronson teaches a therapeutic polyethylene
glycol (“PEG”) solution concentrate for the treatment of constipation or
gastrointestinal lavage. Final Act. 6. The Examiner finds Aronson teaches
that the solution may comprise from about 0.1 to 0.8 g PEG per mL of
solution which the Examiner finds equals 10 to 80 g PEG per 100 mL of
solution. Id. The Examiner finds that Aronson teaches that the solution may
comprise a stimulant laxative such as bisacodyl and a sweetener. Id. The
Examiner finds that Aronson does not teach the use of sorbitol as a
sweetener nor does it teach the use of sodium picosulfate. Id. at 7.
The Examiner finds Skoog teaches that sorbitol can be used as a
sweetener and as an osmotic laxative. Id. The Examiner finds Skoog teaches
using sorbitol in amounts of 10 and 27 g results in accelerated colon transit.
Id. at 7–8.
The Examiner finds Thomas teaches compositions which combine
osmotic laxatives such as PEG and sorbitol with stimulant laxatives such as
bisacodyl and sodium picosulfate. Id. at 9. The Examiner finds Thomas
teaches using from 1 to 20 mg or preferably 5 to 10 mg of the stimulant
laxatives. Id.
The Examiner finds Haringsma teaches colon cleansing using PEG
containing compositions where part of the PEG is replaced with sorbitol to
improve the taste of the composition. Id. at 9–10.
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The Examiner concludes
It would have been prima facie obvious to one of ordinary
skill in the art before the effective filing date of the claimed
invention to produce a purgative liquid dosage form including
from about 0.1 g to about 0.8 g PEG per mL of solution (i.e. 10-
80 g per 100 mL of solution), the PEG having an average
molecular weight of 3350, and further including a sweetener and
a stimulant laxative such as bisacodyl, as taught by ARONSON,
and the sweetener/osmotic purgative being sorbitol at 10–27 g,
as the sorbitol would have improved the palatability of the
compositions without undesirable concomitant side effects (i.e.
no significant effects on abdominal pain, nausea and bloating),
as taught by SKOOG, and further to include the stimulant
laxative bisacodyl or sodium picosulfate in a preferable amount
of 1 to 20 mg, or a more preferable amount [of] 5 to 10 mg, as
taught by THOMAS.

Id. at 12–13.
Appellant contends “None of the cited art teaches or suggests
inclusion of PEG, sorbitol and sodium picosulfate or PEG, sorbitol and
bisacodyl in the recited concentrations in a single formulation.” Appeal Br.
7. Appellant contends that the Examiner has not shown why one skilled in
the art would combine the teachings of the references. Id. Appellant
contends that one skilled in the art would not combine the teachings of the
references as Aronson relates to overnight relief of constipation whereas
Aronson and Skoog are for accelerated colonic cleansing. Id. at 7–8.
Appellant also contends that the art teaches away from the present invention
as it teaches that the use of sorbitol can have serious side effects. Id. at 9–10.
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. We find the Examiner has established a
prima facie showing that the subject matter of the claims would have been
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obvious over Aronson combined with Skoog, Thomas, and Haringsma to a
person of ordinary skill in the art at the time the invention was made.
Appellant has not produced evidence showing, or persuasively argued, that
the Examiner’s determinations on obviousness are incorrect. Only those
arguments made by Appellant in the Briefs have been considered in this
Decision. Arguments not presented in the Briefs are waived. See 37 C.F.R.
§ 41.37(c)(1)(iv) (2015). We have identified claim 1 as representative;
therefore, all claims fall with claim 1. We address Appellant’s arguments
below.
Appellant argues that none of the references teach the use of the
different ingredients recited in the claims in a single composition. Appeal
Br. 7. Appellant argues that there is no guidance in the references to
combine the references as suggested by the Examiner. Id.
We are not persuaded by Appellant’s argument. Aronson teaches a
PEG containing laxative composition having a PEG concentration
overlapping with the concentrations recited in claim 1. Aronson ¶ 14.
Aronson also teaches that that composition may contain a sweetener.
Aronson ¶ 15. Finally, Aronson teaches that the composition may include a
stimulant laxative such as bisacodyl. Id. 19. Thus Aronson teaches a laxative
composition that comprises PEG, a sweetener and a stimulant laxative such
as bisacodyl.
Skoog teaches that sorbitol is a sweetener that can be used in a
laxative compositions. Skoog, 300. Thomas and Haringsma both teach that
sorbitol can be used as a laxative. Thomas, 1; Haringsma, 280. Given the
teachings of the references, we find that one skilled in the art would have
been guided to use sorbitol as the sweetener in the composition of Aronson.
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Thomas teaches that both bisacodyl and sodium picosulfate are
stimulant laxatives and that they can be used in amounts that overlap with
the ranges recited in claim 1. Thomas, 2. We find that it would have been
obvious to one skilled in the art to substitute sodium picosulfate for
bisacodyl taught in Aronson. It is obvious to those skilled in the art to
substitute one known equivalent for another. See In re Omeprazole Patent
Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) (“[T]his court finds no . . .
error in [the] conclusion that it would have been obvious to one skilled in the
art to substitute one ARC [alkaline reactive compound] for another.”).
Thus we agree with the Examiner that the guidance to combine the
teachings of the references lies within the references themselves, particularly
within Aronson. Ans. 6–7.
Appellant contends that one skilled in the art would not have been
motivated to combine the references as the compositions disclosed are
intended for different applications. Appeal Br. 7. Appellant contends that
Aronson is directed to overnight relief of constipation, whereas Skoog and
Haringsma are directed to accelerated colonic treatment or for cleansing
prior to a colonoscopy or surgery. Id.
We have considered this argument and the teachings of the references
and we are unpersuaded that the rejection is in error. While Aronson
suggests that the disclosed composition may be used for overnight relief of
constipation, Aronson also teaches “[t]he polyethylene glycol solution of the
present invention may be used in much larger doses as a preparation for
cleansing the bowel for diagnostic or operative purposes (e.g., as a
gastrointestinal lavage preparation with or without supplemental
electrolytes).” Aronson ¶ 39. Aronson also teaches PEG may be combined
with bisacodyl to form a gastrointestinal preparation. Id. We agree with the
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Examiner that the references are not inconsistent and that it would have been
obvious to modify Aronson to include the laxative agents taught by the other
references. Ans. 4–6.
Appellant contends that the art teaches away from the use of sorbitol
in a laxative composition. Appeal Br. 9–10. Appellant cites to Shaver3 and
Skoog for support of this proposition. Id. Appellant points to the discussion
in Skoog concerning various adverse effects caused by sorbitol. Id. at 9.
Appellant also points to the passage in Shaver that mentions that sorbitol led
to serious side effects including death. Id.
We have considered Appellant’s arguments and the references of
record and are not persuaded that the art, as a whole, teaches away from the
use of sorbitol. “A reference that teaches away is a significant factor to be
considered in determining unobviousness, the nature of the teaching is
highly relevant, and must be weighed in substance. A known or obvious
composition does not become patentable simply because it has been
described as somewhat inferior to some other product for the same use.” In
re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
While Shaver discusses certain serious side effects that may result
from the use of certain sugar alcohols and the consensus not to use such
compounds in laxatives, the study referenced in Shaver was conducted in
1979. Shaver ¶ 11. Skoog, Thomas, and Haringsma, reporting work done
almost twenty years later, and all teach the use of sorbitol in laxative
compositions. Thus, at the time the present invention was made the art
supported the use of sorbitol.

3 Shaver, WO2012/102799 A2, published Aug. 2, 2012. (“Shaver”)
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With respect to Skoog, while Skoog noted that the absence of
significant side effects may have been due to a type II error, Skoog
unequivocally states “a single dose of sorbitol (27 g) markedly accelerated
colonic transit and increased flatulence, but not other gastrointestinal
symptoms in healthy subjects.” Skoog, 305. Skoog also reports an earlier
study that 10 g of sorbitol taken with a meal was well tolerated. Id. at 300.
Based on the foregoing, we agree with the Examiner that the art, when
viewed as a whole, does not teach away from the use of sorbitol in a laxative
composition.
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that the subject matter of claims 1, 3, 5–11, and 13
would have been obvious to one of ordinary skill in the art at the time the
invention was made over Aronson combined with Skoog, Thomas, and
Haringsma.
CONCLUSION
The Examiner’s rejection is affirmed.
More specifically, the rejection of claims 1, 3, 5–11, and 13 under 35
U.S.C. § 103 as unpatentable over Aronson in view of Skoog, Thomas, and
Haringsma is affirmed
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3, 5–11,
13
103 Aronson, Skoog,
Thomas,
Haringsma
1, 3, 5–11,
13

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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED