Ex Parte St. Cyr et al

Patent Trial and Appeal Board

Oct 26, 2015

10585961 (P.T.A.B. Oct. 26, 2015)

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.
10/585,961 09/29/2008 John A. St. Cyr 365.0006 0101 6292
26813 7590 10/27/2015
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
EXAMINER
BLAND, LAYLA D
ART UNIT PAPER NUMBER
1673
MAIL DATE DELIVERY MODE
10/27/2015 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JOHN A. ST. CYR
and DAVID J. PERKOWSKI
__________

Appeal 2013-003223
Application 10/585,961
Technology Center 1600
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.

PER CURIAM

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134 involving claims to a method
for treating sepsis. The Examiner rejected the claims on the grounds of
failing to comply with the written description requirement, obviousness, and
obviousness-type double-patenting. We have jurisdiction under 35 U.S.C.
§ 6(b). We affirm the obviousness rejection, but reverse the other rejections.

1 Appellants identify the Real Party in Interest as Bioenergy, Inc. (see App.
Br. 1).
Appeal 2013-003223
Application 10/585,961

2
Statement of the Case
Background
Appellants’ invention relates to administering “D-Ribose . . . as a
single agent or more preferably in combination with D-Glucose to a patient
scheduled for a procedure requiring general anaesthesia” (Spec. 3: 3–5).
The Claims
Claims 29–38 are on appeal. Independent claim 29 is representative
and reads as follows (emphasis added):
29. A method for treating sepsis in a mammal in and/or
released from an intensive care unit (ICU) comprising:
administering an antibiotic to the mammal; and
administering D-Ribose to the mammal.
The Issues
A. The Examiner rejected claims 29–38 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement
(Ans. 3–4).
B. The Examiner rejected claims 29–38 under 35 U.S.C. § 103(a) as
obvious over St. Cyr ’942,2 St. Cyr ’366,3 Taylor,4 and Cunha5 (Ans. 4–6).
C. The Examiner rejected claims 29–38 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over

2 St. Cyr et al., US 6,159,942, issued Dec. 12, 2000.
3 St. Cyr et al., US 6,218,366 B1, issued Apr. 17, 2001.
4 David E. Taylor et al., Mitochondrial Respiration After Sepsis and
Prolonged Hypoxia, 275 AM. J. PHYSIOL. LUNG CELL MOL. PHYSIOL. L139–
L144 (1998).
5 BA Cunha, Antibiotic Treatment of Sepsis, 79 MED. CLIN. NORTH AM. 3:
551–558 (abstract only) (1995).
Appeal 2013-003223
Application 10/585,961

3
claims 1–10 of U.S. Patent No. 6,218,366 (St. Cyr ’366), Taylor, and Cunha
(Ans. 6–8).
A. 35 U.S.C. § 112, First Paragraph, New Matter
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that the phrase “for treating sepsis”
represents new matter?
Findings of Fact
1. The Specification teaches that:
Patients are admitted to intensive care units (ICU)
whenever their medical condition requires constant monitoring.
. . . Additionally, a common condition requiring ICU
admittance is sepsis. Sepsis can be defined as a fulminant
infection which has become disseminated throughout the body.
. . . If the infection is not controllable by antibiotic therapy and
the bodily functions are not maintained by supportive therapy,
the patient may go into shock . . . . A study will be designed to
determine whether patients in the ICU with low ATP levels are
able to benefit from ribose administration as an adjunct to the
usual therapies for sepsis.
(Spec. 24: 11–29)
Principles of Law
[I]t is the specification itself that must demonstrate possession
[of the invention]. And while the description requirement does
not demand any particular form of disclosure . . . or that the
specification recite the claimed invention in haec verba, a
description that merely renders the invention obvious does not
satisfy the requirement.
Ariad Pharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed.
Cir. 2010).
Appeal 2013-003223
Application 10/585,961

4
Analysis
The Examiner finds that:
Page 24 of the specification states that ribose administration can
be used as an adjunct to usual therapies for sepsis, but page 24
provides no details about dosage, etc. for treatment of sepsis.
The detailed information with respect to dosage and timing of
administration of ribose as recited in the new claims is given in
the specification specifically for recovery after general
anaesthesia, as mentioned on pages 1-23 of the specification.
Page 24 of the specification mentions sepsis independently of
general anaesthesia, and recites the use of ribose in cases where
antibiotic therapy has failed, but does not recite concurrent
treatment with antibiotic and ribose.
(Ans. 4.)
Appellants contend that because “[t]he specification clearly discloses
the commonly known antibiotic therapy for the treatment of sepsis” (citing
Spec. 24: 15) and “the [] specification further discloses ribose administration
as an adjunct to the usual therapies for sepsis,” (citing Spec. 24: 22–23),
“concurrent treatment with antibiotic (i.e., a usual therapy for sepsis) and the
adjunct ribose is adequately supported by the specification” (App. Br. 3–4;
see also Reply Br. 2–3; emphasis omitted).
The Examiner responds that “[t]here is no disclosure of using ribose
to treat sepsis itself” and that “[t]he specification discloses ‘if infection is not
controllable by antibiotic therapy,’ but does not disclose that antibiotics are
the ‘usual therapies’ which might benefit from addition of ribose” (Ans. 8).
We find that Appellants have the better position. The Specification
clearly recites the administration of ribose “as an adjunct to the usual
therapies for sepsis,” antibiotic therapy to control infection, and “a common
condition requiring ICU admittance is sepsis” (FF 1; see also Ans. 4 (“Page
Appeal 2013-003223
Application 10/585,961

5
24 of the specification mentions . . . antibiotic therapy”)). Further, claims 29
and 34 do not require administering an antibiotic concurrently with
administering D-Ribose, only that both therapies are administered to a single
patient with sepsis, and the therapies may therefore be administered
sequentially.
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the phrase “for treating sepsis” represents new matter.
B. 35 U.S.C. § 103(a) over St. Cyr ’942, St. Cyr ’366, Taylor, and Cunha
The Examiner finds that “St. Cyr ‘942 teaches oral administration of
ribose [column 3, line 16] to a subject suffering from sepsis [column 3, lines
43-46]” and that St. Cyr ’942 also teaches that “[r]ibose was also given to a
patient who had been in the intensive care unit as a result of an extensive
bacterial infection [column 9, Example 6]” (Ans. 5). The Examiner finds
that “St. Cyr ‘366 teaches administration of ribose to subjects experiencing a
hypoxic condition [see abstract]” (id.). The Examiner finds that “Taylor
teaches that tissue hypoxia is likely to occur during sepsis [page L139,
second column, second paragraph]” (id.). The Examiner finds that “Cunha
teaches that antibiotic therapy is critical to treatment of the septicemic
patient” (id. at 6).
The Examiner concludes that:
[i]t would have been obvious to one of ordinary skill in
the art at the time the invention was made to treat sepsis in a
patient in and/or released from an ICU using ribose and an
antibiotic. St. Cyr ‘942 and ‘366 teach administration of ribose
to treat sepsis and hypoxic conditions, including to ICU
patients. Hypoxia is likely to occur during sepsis, as taught by
Taylor. Thus, the skilled artisan would use ribose to treat sepsis
Appeal 2013-003223
Application 10/585,961

6
and hypoxia which would likely occur with the sepsis.
Antibiotics are commonly used to treat sepsis. The skilled
artisan would treat sepsis using antibiotics and ribose because
both are known for treating sepsis. The use of ribose would
have the added benefit of treating hypoxia, a complication of
sepsis.
(Id.)
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that St. Cyr ’942, St. Cyr ’366, Taylor,
and Cunha render the claims obvious?
Findings of Fact
2. St. Cyr ’942 teaches that “D-ribose is given orally . . . to
enhance the energy of the mammal” and that “the group of subjects
benefitting from the method of the invention are mammals having a chronic
low energy level due to . . . sepsis” (St. Cyr ’942, col. 3, ll. 16–18 and 43–
46; see Ans. 5).
3. St. Cyr ’942 teaches that a subject “sustaining a systemic
bacterial infection, which required admission to the intensive care unit” was
administered D-ribose (St. Cyr ’942, col. 9, ll. 55–60 and col. 10, l. 4; see
Ans. 5).
4. St. Cyr ’366 teaches that “[t]he presence of an effective amount
of ribose in the tissue of a mammal increases the tolerance to hypoxia and
decreases the symptoms of hypoxia” (St. Cyr ’366, Abstract; see Ans. 5).
5. Taylor teaches that “local hypoperfusion and tissue hypoxia are
likely to occur during sepsis” (Taylor, L139, second column, second full
paragraph; see Ans. 5).
6. Cunha teaches “antibiotic therapy is critical to the treatment of
the septicemic patient” (Cunha, Abstract; Ans. 6).
Appeal 2013-003223
Application 10/585,961

7
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). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417.
Analysis
The Examiner finds that “St. Cyr ‘942 and ‘366 teach administration
of ribose to treat sepsis . . . conditions, including to ICU patients” (Ans. 5–6;
FF 2–4). The Examiner finds that “[a]ntibiotics are commonly used to treat
sepsis” (Ans. 6; FF 6).
We agree with the Examiner that “[i]t would have been obvious to one
of ordinary skill in the art at the time the invention was made to treat sepsis
in a patient in and/or released from an ICU using ribose and an antibiotic”
because “both [antibiotics and ribose] are known for treating sepsis” (Ans. 6;
FF 2–3, 6).
Appellants contend that “St. Cyr ‘942 envisions administering a
pentose to increase the energy available to ‘mammals having a chronic low
energy level due to . . . sepsis’” (citing St. Cyr ’942, col. 3, ll. 43–47) but
“there is no teaching or suggestion in St. Cyr ‘942 of actually treating any of
the listed conditions” (App. Br. 4).
We are not persuaded. St. Cyr ’942 teaches that “D-ribose is given
orally” to “mammals having a chronic low energy level due to . . . sepsis”
(FF 2; emphasis added). The Examiner therefore correctly finds that St. Cyr
‘942 specifically suggests treatment of sepsis with D-ribose (Ans. 5).
Appeal 2013-003223
Application 10/585,961

8
Appellants contend that “Cunha actually teaches away from the
administration of other agents with the [antibiotic] to treat sepsis” because
“Cunha cautions that combining other agents (i.e., corticosteroids and
mediator therapy) with antibiotics has no place in the treatment of the septic
patient (‘corticosteroids and mediator therapy have no place in the treatment
of the septic patient;’ lines 11-12 of Cunha abstract)” (App. Br. 5–6;
emphasis omitted).
We do not find this argument persuasive. First D-ribose is not a
corticosteroid or a mediator therapy, but rather is given to “enhance the
energy of the mammal” (FF 2). Second, as noted above, the claims do not
require concurrent therapy with both D-ribose and antibiotics, but
encompass sequential therapies where either antibiotics or D-ribose are
administered followed by the other therapy. Cunha does not criticize or
otherwise discredit treatment with D-ribose for patients with sepsis, nor does
Cunha teach away from sequential therapies including D-ribose. Like our
appellate reviewing court, “[w]e will not read into a reference a teaching
away from a process where no such language exists.” DyStar Textilfarben
GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1364
(Fed. Cir. 2006).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that St.
Cyr ’942, St. Cyr ’366, Taylor, and Cunha render the claims obvious.
C. Obviousness-type double patenting over claims 1–10 of U.S. Patent
No. 6,218,366, Taylor, and Cunha
The Examiner finds that “the ‘366 patent claims administration of
ribose to increase tolerance to hypoxia in a subject, but does not claim
Appeal 2013-003223
Application 10/585,961

9
administration to a patient suffering from sepsis” (Ans. 7; see also FF 4).
The Examiner finds that “Taylor teaches that tissue hypoxia is likely to
occur during sepsis [page L139, second column, second paragraph]” (Ans. 7;
see also FF 5). The Examiner concludes that “it would have been obvious to
treat patients undergoing hypoxia due to sepsis” because “Cunha teaches
that antibiotic therapy is critical to treatment of the septicemic patient.”
(Ans. 7.)
We are not persuaded by the Examiner’s reasoning. While tissue
hypoxia may occur during sepsis, the Examiner has not provided evidence
that hypoxia and sepsis are necessarily related. In other words, not all
tissues that have hypoxia are in patients with sepsis. “Inherency . . . may not
be established by probabilities or possibilities. The mere fact that a certain
thing may result from a given set of circumstances is not sufficient.”
MEHL/Biophile Int’l. Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir.
1999).

SUMMARY
In summary, we reverse the rejection of claims 29–38 under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement.
We affirm the rejection of claims 29–38 under 35 U.S.C. § 103(a) as
obvious over St. Cyr ’942, St. Cyr ’366, Taylor, and Cunha.
We reverse the rejection of claims 29–38 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1–10 of U.S. Patent No. 6,218,366, Taylor, and Cunha.

Appeal 2013-003223
Application 10/585,961

10
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

bar