Ex Parte MacCarter et al

Patent Trial and Appeal Board

Jun 13, 2016

11639476 (P.T.A.B. Jun. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/639,476 12/15/2006
26813 7590 06/13/2016
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
FIRST NAMED INVENTOR
Dean J. Maccarter
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
365.00050120 6615
EXAMINER
LAU, JONATHAN S
ART UNIT PAPER NUMBER
1673
MAILDATE DELIVERY MODE
06/13/2016 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 DEAN J. MACCARTER
and JOHN A. ST. CYR
Appeal2014-006422
Application 11/639,476
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW, Administrative Patent Judges.
PERCURIAM
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to a method
for treating a pulmonary dysfunction. The Examiner rejected the claims as
obvious and obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Bioenergy, Inc., also
known as RiboCor, Inc. (see App. Br. 1 ).
Appeal2014-006422
Application 11/639,476
Statement of the Case
Background
Appellants' invention relates to "the use of pharmaceutical or
nutritional supplements to improve the function of the cardiac-pulmonary
axis in those patients in which the function of the cardiac-pulmonary axis is
suboptimal" (Spec. 2: 10-12).
The Claims
Claims 6 and 8-14 are on appeal. Independent claim 6 is
representative and reads as follows (emphasis added):
6. A method of treating a pulmonary dysfunction that is
chronic obstructive pulmonary disease in a subject who is not
suffering from cardiac complications comprising the chronic
administration of three to five grams of D-ribose two to four
times daily to the subject, with the proviso that the D-ribose is
not administered with folic acid and/or folate, and with the
proviso that the method does not comprise oxygen therapy.
The Issues
A. The Examiner rejected claims 6, 9-11, 13, and 14 under 35 U.S.C.
§ 103(a) as obvious over St. Cyr2 and Gosker3 (Ans. 3-5).
B. The Examiner rejected claims 8 and 12 under 35 U.S.C. § 103(a) as
obvious over St. Cyr, Gosker, and Murray4 (Ans. 6-7).
2 St. Cyr et al., US 6,218,366 Bl, issued Apr. 17, 2001.
3 Harry R. Gosker et al., Skeletal muscle dysfunction in chronic obstructive
pulmonary disease and chronic heart failure: underlying mechanisms and
therapy perspectives, 71 THE AMERICAN JOURNAL OF CLINICAL NUTRITION
1033-1047 (2000).
4 TEXTBOOK OF RESPIRATORY MEDICINE 1340-1342 (John F. Murray et al.
eds., 2nd ed., Volume 2, 1994) (hereinafter "Murray").
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Application 11/639,476
C. The Examiner rejected claims 6, 9, and 10 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1 and 10 of St. Cyr and Gosker (Ans. 7-9).
D. The Examiner rejected claims 6 and 8-10 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1 and 10 of St. Cyr, Gosker, and Murray (Ans. 9-10).
A. 35 USC§ 103(a) over St. Cyr and Gosker
The Examiner finds that St. Cyr teaches
a method of treating pulmonary dysfunction by increasing
tolerance to hypoxia (column 15, claim 1, column 16, claim 10,
and column 4, lines 15-30). St. Cyr et al. discloses [that] hypoxia
means any state in which the tissue oxygen saturation is reduced
to a less than optimal level and hypoxia may be chronic as in
congestive heart failure or pulmonary dysfunction (column 3,
lines 10-20). . . . St. Cyr et al. discloses the treatment of patients
having cardiac complications (column 4, lines 40-65) as well of
persons free of disease in transient situations of hypoxia ... St.
Cyr et al. discloses the embodiment wherein D-ribose is
administered in three doses daily (column 12, line 65 and column
13, lines 1-5). St. Cyr et al. discloses the embodiment of the
method wherein 3-10 g of ribose are administered daily (column
15, lines 1-5). St. Cyr et al. discloses the treatment includes
administration of preferred compositions that include D-ribose
alone (column 2, line 25).
(Ans. 3--4.) The Examiner concludes that it would have been obvious to
combine St. Cyr et al. in view of Gosker et al. in order to select
the patient having chronic pulmonary dysfunction to be a patient
having chronic obstructive pulmonary disease who is not
suffering from cardiac complications. . . . One of ordinary skill
in the art would have had a reasonable expectation of success to
combine St. Cyr et al. in view of Gosker et al. because St. Cyr et
al. teaches treatment of conditions that are the systemic
consequences common to both chronic obstructive pulmonary
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Application 11/639,476
disease (COPD) and chronic heart failure (CHF) taught by
Gosker et al.
(Id. at 5.)
The issue with respect to this rejection is: Does the evidence of
record support the Examiner's conclusion that St. Cyr and Gosker render the
claims prima facie obvious?
Findings of Fact
1. St. Cyr teaches that:
The administration of ribose raises the hypoxic threshold of
mammals experiencing a hypoxic condition. The presence of an
effective amount of ribose in the tissue of a mammal increases
the tolerance to hypoxia and decreases the symptoms of hypoxia
in mammals experiencing chronic hypoxia due to cardiovascular
disease or peripheral vascular disease.
(St. Cyr Abstract; see also Ans. 3--4.)
2. St. Cyr teaches that "[t ]he preferrred [sic] compositions include
D-Ribose alone or, optionally, in combination with vasodilators and/or
inotropic agents in pharmaceutically acceptable carriers" (St. Cyr 2:24--27;
see also Ans. 3--4 ).
3. St. Cyr teaches that "[h]ypoxia may be chronic as in congestive
heart failure, coronary artery disease, peripheral vascular disease or
pulmonary dysfunction" (St. Cyr 3:16-18; see also Ans. 3--4).
4. St. Cyr teaches that
administration of ribose can also increase the tolerance of tissue
to low oxygen availability, that is, to hypoxia. Energy and
oxygen availability can each independently influence tissue
integrity and function. Although ribose has been shown to
enhance energy levels under conditions of normal oxygen
availability, the present invention surprisingly shows that when
ribose is present, tissue can endure low oxygen availability while
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Application 11/639,476
still maintaining normal function, without being subjected to the
deleterious effects due to low oxygen.
(St. Cyr 4: 17-25; see also Ans. 3--4.)
5. St. Cyr teaches that
Even persons free of disease occasionally experience
transient situations of hypoxia. Such situations include exposure
to high altitudes, anaesthesia, tachycardia, surgical procedures
that temporarily interrupt blood flow .... Such persons would
benefit by the raising of the hypoxic threshold.
The present method comprises the administration of an
effective amount of D-Ribose for an adequate period of time to
raise the hypoxic threshold in mammals.
(St. Cyr 4:65-5:8; see also Ans. 3--4.)
6. St. Cyr teaches that "[t]he group was selected to be
homogeneous regarding fitness level, gender and mean age with no known
metabolic, neuronal, endocrine or cardiopulmonary disorders" (St. Cyr 8:33-
36; see also Ans. 3--4).
7. St. Cyr teaches that"[ o ]ver a six-month period, the patient
received intermittent doses of 5-10 grams per day ofD-ribose" (St. Cyr
12:41--43; see also Ans. 3--4).
8. St. Cyr teaches a patient "received orally administered D-ribose
( 40 gm in three divided doses daily) for three days" (St. Cyr 12:65-13: 1; see
also Ans. 3--4).
9. Gosker teaches
Low exercise tolerance has a large influence on health
status in chronic obstructive pulmonary disease and chronic heart
failure. . . . There are striking similarities between both disorders
with respect to the muscular alterations underlying the
impairment. . . . In both diseases, muscular impairment is
multifactorially determined; hypoxia ... may contribute to the
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Application 11/639,476
observed muscle abnormalities and each factor has its own
potential for innovative treatment approaches.
(Gosker Abstract; see also Ans. 4.)
10. Gosker teaches that "[a]lthough the primary impairments in
chronic obstructive pulmonary disease (COPD) and chronic heart failure
(CHF) clearly differ, there is a striking resemblance in the systemic
consequences of these diseases" (Gosker 1033, pt col.; see also Ans. 4).
11. Gosker teaches that "[i]n COPD and CHF, oxygen delivery to
peripheral and respiratory muscles may be insufficient as a result of
hypoxemia, reduced blood supply, or both. In both cases, muscle tissue may
become hypoxic and this could lead to the adaptive changes in skeletal
muscle described above" (Gosker 1036, 2nd col.; see also Ans. 4).
Principles of Law
The Supreme Court explains that "the [obviousness] analysis need not
seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ." KSR Int 'l v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
"The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results."
Id. at 416. "If a person of ordinary skill can implement a predictable
variation,§ 103 likely bars its patentability." Id. at 417.
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2-13; FF 1-11) and agree that the
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Application 11/639,476
claims are obvious over St. Cyr and Gosker. We address Appellants'
arguments below.
Appellants contend that
Gosker et al. is postulating that hypoxia, among a number of
other conditions including oxidative stress, disuse, medication,
nutritional depletion, and systemic inflammation, may be a
possible cause of impaired muscle function resulting from
COPD and CHF. Further, the Examiner has provided neither
evidence nor a basis in fact and/or technical reasoning to
reasonably support the determination that the hypoxia is an
inherent characteristic that necessarily flows from COPD.
(App. Br. 5---6; citing Gosker 1033, 2nd col.) Appellants argue that "Gosker
et al. does not teach that hypoxia is an inherent result of COPD" (id. at 6; see
also Reply Br. 2--4).
We are not persuaded. St. Cyr teaches that "[t]he presence of an
effective amount of ribose in the tissue of a mammal increases the tolerance
to hypoxia" (FF 1; see also FF 2), "[h ]ypoxia may be chronic as in
congestive heart failure, coronary artery disease, peripheral vascular disease
or pulmonary dysfunction" (FF 3; see also FF 5, 6). As the Examiner points
out, "Gosker et al. teaches in both COPD and CHF, oxygen delivery to
peripheral and respiratory muscles may be insufficient as a result of
hypoxemia, reduced blood supply, or both, and in both cases, muscle tissue
may become hypoxic and this could lead to the adaptive changes in skeletal
muscle" (Ans. 11 (citing Gosker 1036, 2nd col.); see also FF 11). Gosker
also teaches that "[ t ]here are striking similarities between both disorders
with respect to the muscular alterations underlying the impairment. . . . In
both diseases, muscular impairment is multifactorially determined; hypoxia
... may contribute to the observed muscle abnormalities and each factor has
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its own potential for innovative treatment approaches" (FF 9; see also FF
10).
Accordingly, the combined teachings of St. Cyr and Gosker regarding
treating patients with COPD would yield predictable results of decreasing
the symptoms of hypoxia with an effective amount of ribose as the Examiner
explains that
one of ordinary skill in the art would have relied on the guidance
of the prior art as motivation to combine the prior art in order to
select the patient population treated in the method of treating
pulmonary dysfunction by increasing tolerance to hypoxia taught
by St. Cyr et al. to be the subgenus of those patients having the
pulmonary dysfunction chronic obstructive pulmonary disease
(COPD) that exhibits hypoxia, which is a primary impairment
that clearly differs from cardiac complications such as chronic
heart failure (CHF), as taught by Gosker et al.
(Ans. 12-13.)
Conclusion of Law
The evidence of record supports the Examiner;s conclusion that St.
Cyr and Gosker render claims 9 and 11 prima facie obvious. Appellants do
not argue separately the claims for this obviousness rejection. Therefore,
claims 9 and 10 fall with claim 6, and claims 13 and 14 fall with claim 11.
B. 35 USC§ 103(a) over St. Cyr, Gosker, and Murray
Appellants contend that "[ t ]he deficiencies of St. Cyr et al. in view of
Gosker et al. as applied to claim 6 have been discussed herein above.
Further, Appellants respectfully submit that Murray et al. fail to correct the
deficiencies of St. Cyr et al. in view of Gosker et al." (App. Br. 6.) Having
affirmed the obviousness rejection of claims 6 and 11, over St. Cyr and
Gosker for the reasons given above, we therefore affirm the rejection of
claims 8 and 12.
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Application 11/639,476
C. Obviousness-type double patenting over claims 1 and 10 of St. Cyr
and Gosker
The Examiner determines that "[c]laims 1 and 10 of U.S. Patent No.
6,218,366 do not specifically teach treating chronic obstructive pulmonary
disease in a subject who is not suffering from cardiac complications
comprising chronic administration of D-ribose (instant claim 6)" (Ans. 9).
The Examiner finds that "Gosker et al. teaches as above" and
concludes that "[i]t would have been obvious to one of ordinary skill in the
art to combine claims 1 and 10 of U.S. Patent No. 6,218,366 (St. Cyr et al.)
in view of Gosker et al. for the same reasons as recited above" (id.).
Appellants similarly contend that "Gosker et al. does not teach that
hypoxia is an inherent result of COPD" (App. Br. 10). Accordingly, we are
not persuaded for the reasons discussed above.
Therefore, we affirm the rejection of claim 6 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1 and 10 of St. Cyr and Gosker. Appellants do not argue
separately the claims for this obviousness-type double patenting rejection.
Therefore, claims 9 and 10 fall with claim 6.
D. Obviousness-type double patenting over claims 1 and 10 of St. Cyr,
Gosker, and Murray
The Examiner determines that
Claims 1 and 10 of U.S. Patent No. 6,218,366 do not
specifically teach treating chronic obstructive pulmonary disease
in a subject who is not suffering from cardiac complications
comprising chronic administration of D-ribose (instant claim 6).
Claims 1and10 of U.S. Patent No. 6,218,366 do not specifically
teach the pulmonary dysfunction in a subject is caused by
exposure to industrial or environmental organic solvent or toxins
or tobacco smoke (instant claim 8).
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(Ans. 9--10.)
The Examiner finds that "Gosker et al. teaches as above" and "Murray
et al. teaches as above" (Ans. 10).
The Examiner concludes that "[i]t would have been obvious to one of
ordinary skill in the art to combine claims 1 and 10 of U.S. Patent No.
6,218,366 (St. Cyr et al.) in view of Gosker et al. and Murray et al. for the
same reasons as recited above" (id.).
Appellants contend that
The deficiencies of Claims 1 and 10 of St. Cyr et al. in view of
Gosker et al. as applied to claim 6 have been discussed herein
above. Further, Appellants respectfully submit that Murray et al.
fail to correct the deficiencies of St. Cyr et al. in view of Gosker
et al.
(App. Br. 10-11.) Accordingly, we are not persuaded for the reasons
discussed above.
Therefore, we affirm the rejection of claim 6 under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over claims 1 and 10 of St. Cyr, Gosker, and Murray. Appellants do not
argue separately the claims for this obviousness-type double patenting
rejection. Therefore, claims 8-10 fall with claim 6.
SUMMARY
In summary, we affirm the rejection of claims 6 and 11 under
35 U.S.C. § 103(a) as obvious over St. Cyr and Gosker. Claims 9-10 fall
with claim 6 and claims 13 and 14 fall with claim 11.
We affirm the rejection of claims 8 and 12 under 35 U.S.C. § 103(a)
as obvious over St. Cyr, Gosker, and Murray.
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Application 11/639,476
We affirm the rejection of claim 6 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1 and 10 of St. Cyr and Gosker. Claims 9 and 10 fall with claim 6.
We affirm the rejection of claim 6 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1 and 10 of St. Cyr, Gosker, and Murray. Claims 8-10 fall with
claim 6.
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
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