WISCONSIN ALUMNI RESEARCH FOUNDATION

Patent Trials and Appeals Board

Oct 6, 2020

2020001355 (P.T.A.B. Oct. 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.
15/146,020 05/04/2016 William E. Fahl 09820695-P120378US04 4897
60961 7590 10/06/2020
Intellectual Property Dept./DeWitt LLP
Wisconsin Alumni Research Foundation
2 East Mifflin Street,
Suite #600
Madison, WI 53703-2865
EXAMINER
RODRIGUEZ, RAYNA B
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
10/06/2020 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):
IP-DOCKET@dewittllp.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte WILLIAM E. FAHL
____________

Appeal 2020-001355
Application 15/146,020
Technology Center 1600
____________

Before ULRIKE W. JENKS, AMEE A. SHAH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

SHAH, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Pursuant to 35 U.S.C. § 134(a), the Appellant1 appeals from the
Examiner’s decision to reject claims 1, 4–15, 17, 18, and 20–23, which are
all of the pending claims. 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. The Appellant identifies the real party in interest as the
Wisconsin Alumni Research Foundation. Appeal Br. 2.
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CLAIMED SUBJECT MATTER
According to the Specification, “[r]adiotherapy-induced dermatitis is a
common side effect seen in up to 85% of patients who receive a course of
radiotherapy as part of their cancer therapy regimen.” Spec. 1. “A topically
administered radioprotector that could be applied prior to radiotherapy on
each of the 30 irradiation days would reduce pain and long term scarring and
would improve patient compliance in receiving all days of treatment.” Id.
“There is also a need for new systemically administered radioprotectors that
lack the side effects of nausea/vomiting and hypotension/fainting that have
hampered the use of current generation aminothiol radioprotectors, most
notably the five carbon aminothiophosphonate, amifostine.” Id. The
Specification
disclose[s] a process in which: (i) the number of alkylamine
segments in the aminothiol backbone is systematically increased
to increase drug-DNA affinity and ionic interaction, resulting in
increased growth inhibition that is associated with this enhanced
drug-DNA interaction, and (ii) the placement or ‘display’ of a
free thiol reactive oxygen species (ROS) scavenger at the end of
a short alkyl side chain that displaces or ‘displays’ the scavenger
moiety away from the DNA backbone to theoretically enable
ROS scavenging before ROS attack on dG bases within cellular
DNA. This work has resulted in a small family of new
aminothiol molecules, the prototype of which, PrC-210,
. . . described in initial detail here.
Id. at 2.
Claims 1, 15, and 18 are the independent claims. Claim 1 is
illustrative of the subject matter on appeal and is reproduced below (with
added paragraphing and bracketing for reference):
1. A method for protecting a subject from ionizing
radiation, the method comprising:
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[a)] administering systemically to the subject a
radioprotector compound comprising a free thiol and a
positively-charged backbone,
wherein the radioprotector compound comprises a
structure according to:

wherein R and R' are independently selected from H and
CH3,
[b)] wherein systemic administration of the radioprotector
compound to the subject protects the subject from ionizing
radiation.

REJECTION(S)
Claims 1, 4–15, 17, 18, and 20–23 stand rejected under pre-AIA
35 U.S.C. §§ 102(b)/103(a) as anticipated by, or in the alternate, as obvious
over Fahl et al. (US 7,314,959 B2, iss. Jan. 1, 2008) (“Fahl”).

OPINION
The Appellant contends that the Examiner’s rejection of independent
claim 1 is in error because Fahl does not disclose or render obvious
“systemically administering certain radioprotector compounds,” as recited in
limitation a) of claim 1 and similarly recited in limitation a) of independent
claim 15 and limitation b) of independent claim 18. Appeal Br. 4.
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Conversely, the Examiner finds that Fahl’s oral administration meets the
claimed systemic administration. See Non-Final Act. 6; Ans. 12. After
careful review of the record before us, we are not persuaded of Examiner
error.
The Appellant contends that the plain and ordinary meaning of
“systemic administration” is “a route of administration into the circulatory
system so that the entire body is affected. The definition contrasts this with
topical administration, in which the effect is generally local.” Appeal
Br. 15–16. The Examiner does not disagree. See id. (quoting Advisory
Action 5 (mailed Aug. 15, 2018) (“The Examiner acknowledges that
Wikipedia teaches systemic administration is a route of administration into
the circulatory system so that the entire body is affected and contrasts this
with topical administration, in which the effect is generally local.”)). Rather,
the issue is whether Fahl’s disclosure of oral administration is a systemic
administration as claimed. See Appeal Br. 7–18; Ans. 15–18, 20–21, 24–25,
29–30, 32, 35–37.
The Examiner finds that Fahl discloses an embodiment whereby “the
compositions are formulated for oral administration to reduce or prevent
gastrointestinal distress that results from cancer therapy.” Non-Final Act. 6
(citing Fahl, col. 10, ll. 25–27); see also id. at 11; Ans. 5, 15–16.
Specifically, the Examiner finds that Fahl discloses oral administration of
the composition and “teaches the patient would be instructed to consume a
‘shake’ containing the chemoprotective amine in an orally acceptable
solution or liposome emulsion before breakfast in the morning, in the 1-5
days preceding chemotherapy.” Ans. 11 (citing Fahl, col. 10, ll. 25–31,
col. 53, ll. 9–15); Non-Final Act. 11. The Examiner notes that “[i]t [is] well
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understood in the art that oral administration is a type of systemic
administration” (Non-Final Act. 6), and cites to Verma et al. (Int. J
Pharmaceutical Studies and Research, 2010; 1(1):54-59) (id. at 17) as
supporting evidence. The Examiner also notes that the Appellant’s
Specification includes oral administration such that “it appears clear that
what [the Appellant] means by ‘systemically’ includes oral administration.”
Non-Final Act. at 6. The Examiner further finds that “Fahl teaches 1%-15%
of a drug in most topical formulations is systemically bioavailable.” Ans. 12
(citing Spec. “Example 3, page 2”; Fahl, col 45, ll. 37–40); Non-Final
Act. 11.
The Examiner’s findings are supported. Although Fahl is certainly
focused on topical or local administration, Fahl discloses oral administration
of a compound “for reducing or preventing toxic side effects of radiotherapy
or chemotherapeutic agents” in the gastrointestinal tract. See Fahl, col. 1,
ll. 20–22, col. 10, ll. 24–28. The pharmaceutical preparation of such a
compound is preferably “formulated as a liquid for coating the surface of the
gastrointestinal tract.” Id. at col. 7, ll. 18–23. Delivery vehicles suitable for
this compound include, for example, oils encapsulated into standard gel
tablets and emulsions (id. at col. 49, ll. 34–42) that are delivered by mouth
such as by instructing the patient “to consume a ‘shake’ containing the
chemo-protective amine in an orally acceptable solution or liposome
emulsion before breakfast in the morning, in the 1–5 days preceding
chemotherapy” (id. at col. 53, ll. 6–16). Although Fahl states that “[t]he
goal of such delivery systems is to contact these internal surfaces topically
with the chemoprotective amine” and “[t]opical delivery is not an efficient
means for systemic drug delivery,” Fahl acknowledges that “between
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1%-15% of a drug in most topical formulations is systemically
bioavailable.” Id. at col. 45, ll. 29–40. And although Fahl intends to
minimize such biovailability by aiming for “less than 10%, preferably less
than 5% and most preferably less than 1% of the chemoprotective amine,
provided topically e.g., dermal, intradermal, mucosal or GI epithelial
delivery, move to reach the dermis and/or other underlying tissues,” it is not
altogether avoided. Id. at col. 45, ll. 40–45.
We are not persuaded of error by the Appellant’s arguments that Fahl
“teaches against administering the aminothiols systematically [sic].” Appeal
Br. 4; see also id. at 5–7. We do not disagree that Fahl discusses the serious
side effects as a reason to avoid systemic administration of polyamine
analogs (see Fahl, col. 1, ll. 51–53, col. 45, ll. 4–9), and teaches that topical
administration is the focus of Fahl.
However, Fahl acknowledges that the serious side effects would not
occur with low enough systemic delivery (see id. at col. 1, ll. 53–60), and
Fahl also specifically teaches oral administration (Fahl, col. 53, ll. 5–18).
Fahl recognizes that with the oral administration, there is some systemic
bioavailability of its formulations (see id. at col. 45, ll. 29–45). See also
Ans. 11. The Appellant does not direct attention to, and we do not see,
where Fahl discusses how systemic administration is altogether avoided with
the oral intake of a shake or tablet, despite the fact that “[t]he goal of such
delivery systems is to contact these internal surfaces[, such as mucosal cells
of the gastrointestinal tract], topically with the chemoprotective amine”
(Fahl, col. 45, ll. 29–31).
We note that the claims do not require a specific therapeutic amount
or a minimum threshold amount that must be systemically administered, just
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that radioprotection is provided. The Appellant’s Specification discusses
topical administration, states a need for systemic administration, and
discusses a study regarding topical administration of PrC-210 aminothiol on
rats. See Spec. 1, ll. 17–27; 4, ll. 17–29. There are no further details on
what amount of compound must be systemically bioavailable to be
considered systemic administration and provide radioprotection.
Fahl teaches that the oral administration, such as by drinking a shake
1–5 days prior to chemotherapy, which administration would provide for
systemic absorption of the drug through the gastrointestinal tract, “would
allow the chemoprotective amine to be present when the chemotherapy
drugs or radiotherapy act on the GI mucosal epithelium.” Fahl, col. 53,
ll. 12–18. Thus, we conclude that Fahl teaches the required radioprotection
by systemic administration.
We are also not persuaded of error by the Appellant’s arguments that
Fahl’s oral administration is not a form of systemic administration. See
Appeal Br. 8–17. The Examiner provides evidence that “it is well
understood in the art that oral administration wherein a drug is placed in the
mouth and swallowed is a known systemic route of administration.” Ans.,
e.g., 16. And, as discussed above, Fahl specifically acknowledges there
would be some systemic administration as some of the compound would be
absorbed systemically. The Appellant does not provide adequate support or
reasoning to explain how Fahl’s ingested shake would be processed in the
gastrointestinal system in an unconventional manner so as not to be absorbed
through the gastrointestinal tract into the circulatory system to some
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extent.”2 As also discussed above, the claims do not require a certain
amount of “systemic efficacy” (Appeal Br. 16), nor is any such amount
discussed in the Specification.
Thus, we are not persuaded of error in the Examiner’s rejection under
35 U.S.C. § 102(b) of independents claims 1, 15, and 18. Therefore, we
sustain the Examiner’s rejection of independent claims 1, 15, and 18 and
dependent claims 4–14, 17, and 20–23 under 35 U.S.C. § 102(b) as
anticipated by Fahl. Because we sustain this rejection, we do not reach the
alternate rejection of the claims under 35 U.S.C. § 103(a).

CONCLUSION
The Examiner’s decision to reject claims 1, 4–15, 17, 18, and 20–23
under 35 U.S.C. §§ 102(b)/103(a) is sustained.

In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/
Basis
Affirmed Reversed
1, 4–15, 17,
18, 20–23
102(b)/103(a) Fahl 1, 4–15, 17,
18, 20–23

2 Although the Declarations referred to by the Appellant “confirm that the
oral administration in Fahl et al is taught as a form of local or topical
administration rather than a form of systemic administration” (Appeal Br. 9),
none explains how the drug would be completely prevented from being
absorbed through the gastrointestinal tract into the circulatory system.
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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)(l)(iv).
AFFIRMED