Ex Parte MacCarter et al

Patent Trial and Appeal Board

Oct 21, 2016

11118613 (P.T.A.B. Oct. 21, 2016)

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.
11/118,613 04/29/2005 Dean J. MacCarter 365.0005 0101 6641
26813 7590 10/24/2016
MUETING, RAASCH & GEBHARDT, P.A.
P.O. BOX 581336
MINNEAPOLIS, MN 55458-1336
EXAMINER
LAU, JONATHAN S
ART UNIT PAPER NUMBER
1673
MAIL DATE DELIVERY MODE
10/24/2016 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
__________

Appeal 2015-002641
Application 11/118,613
Technology Center 1600
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TIMOTHY G. MAJORS, Administrative Patent Judges.

PER CURIAM

DECISION ON APPEAL1
This is Appeal under 35 U.S.C. § 134 involves claims 28–43 (Br. 3).
Examiner entered rejections under 35 U.S.C. § 103(a) 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.)” (Br. 1).
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STATEMENT OF THE CASE
Appellants’ “invention relates to a method for supplementing the diet
of subjects having reduced ventilatory efficiency so as to improve the
subject’s VE” in which a “pentose is administered to a patient” (Spec. 4:9–
10, 12).
Claims 28–43 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of St. Cyr,2 Doyle,3 Frank,4 Skues,5 and
Macnaughton.6
Claims 28–43 stand rejected on the ground of nonstatutory
obviousness-type double patenting as being unpatentable over claims 1–10
of St. Cyr, Doyle, Frank, Skues, and Macnaughton.

Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?

2 St. Cyr et al., US 6,218,366 B1, issued Apr. 17, 2001.
3 Doyle et al., Prevalence of Pulmonary Disorders in Patients with Newly
Diagnosed Rheumatoid Arthritis, 19 Clin. Rheumatol. 217–221 (2000).
4 Frank et al., Pulmonary Dysfunction in Rheumatoid Disease, 63 Chest
1:27–34 (1973).
5 Skues and Welchew, Anaesthesia and rheumatoid arthritis, 48 Anaesthesia
989–997 (1993).
6 Macnaughton et al., Measurement of carbon monoxide transfer and lung
volume in ventilated subjects, 6 Eur. Respir. J. 231–236 (1993).
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FACTUAL FINDINGS (FF)
We adopt Examiner’s findings concerning the scope and content of
the prior art (Ans. 2–13), and repeat the following findings for emphasis.
FF 1. St. Cyr teaches that
[t]he 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.)
FF 2. St. Cyr teaches that “[t]he preferred 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. 6).
FF 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).
FF 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
still maintaining normal function, without being subjected to the
deleterious effects due to low oxygen.
(St. Cyr 4:17–25; see also Ans. 3.)
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FF 5. Doyle teaches that “[t]he finding of unexplained airway obstruction in
patients with rheumatoid arthritis (RA) has been widely reported,” that
“[b]ecause RA is a systemic inflammatory disease the inflammatory process
might also involve the patient’s airways . . . and might therefore cause
AHR,” and that “[t]he correlations between airway histamine levels,
eosinophil counts and neutrophil counts and the extent of pulmonary
involvement in RA . . . also point to the significance of airway inflammation
in this disease” (Doyle 217, col. 2; see also Ans. 4).
FF 6. Doyle teaches
The most striking finding in this study is the high
prevalence of pulmonary abnormalities revealed in a group of
patients with newly diagnosed RA: nine of 17 patients (53%)
were found to have at least one abnormality on pulmonary
evaluation. Although no specific pattern of abnormality, such as
AHR, was found, the range of abnormalities in early RA patients
is intriguing. Hypoxia (12%), radiographic interstitial disease
(12%), airflow obstruction (12%), lung restriction (18%) and
AHR (24%) were discovered. Interestingly, seven of the nine
patients with newly diagnosed RA and at least one pulmonary
abnormality were smokers (78%), whereas only one of the eight
nonsmokers had a pulmonary abnormality (12%).
(Doyle 219, col. 2; see also Ans. 4.)
FF 7. Frank teaches
During an investigation of pulmonary dysfunction in 41
consecutive patients with classical or definite rheumatoid
arthritis, it was found that 41.4 percent had abnormalities of
pulmonary diffusion. Generally the physiologic profile was one
of decreased vital capacity, decreased total lung capacity, and
arterial hypoxemia; these abnormalities were supported by the
pathologic findings of percutaneous lung biopsy. . . . It is
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concluded that pulmonary fibrosis is common in rheumatoid
disease and should be regarded as an expected manifestation,
rather than an unusual complication, of the systemic process
connoted by the term rheumatoid disease.
(Frank 27, Abstract; see also Ans. 4.)
FF 8. Skues teaches
Pulmonary manifestations of rheumatoid arthritis are more
common in men than in women, with pleural disease affecting
between 3% and 12.5% of patients. . . .
However, studies examining chest wall compliance of patients
with rheumatoid arthritis in the absence of pulmonary disease
. . . suggest that rib cage “stiffness” may contribute to reduced
lung volume and ventilatory efficiency. . . .
Airflow obstruction has also been reported with increasing
frequency in patients with rheumatoid disease.
(Skues 992, col. 1; see also Ans. 4.)
FF 9. Macnaughton teaches that
[t]he technique of assessing Dm and Vc by measuring TLCO at
different values of FIO2 was first described by ROUGHTON and
FORESTER . . . . It has been shown to be both accurate and
reproducible, and has been used to access change in Vc [(volume
of pulmonary capillary blood)] in a variety of pathological states
including emphysema . . ., rheumatoid arthritis . . ., and
pulmonary embolism . . . .
(Macnaughton 235, col. 1; see also Ans. 4–5.)

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ANALYSIS
Each of Appellants’ independent claims 28, 34, 42, and 43 requires,
inter alia, “[a] method for improving the ventilator efficiency” and “the
ingestion of an effective amount of D-ribose by the subject” (see Appellants’
claims 28, 34, 42, and 43). Claim 28 further requires “a subject in need of
improving the ventilator efficiency and suffering from an autoimmune
disease resulting in poor pulmonary function” (see Appellants’ claim 28).
Claims 34 and 43 further require “a subject in need of improving the
ventilator efficiency and suffering from rheumatoid lung” (see Appellants’
claims 34 and 43). Claim 42 further requires “a subject in need of
improving the ventilator efficiency and suffering from an autoimmune
disease resulting in poor pulmonary function” (see Appellants’ claim 42).
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. teaches many
conditions produce hypoxia (column 2, line 5). St. Cyr et al.
teaches the hypoxia may be chronic as in congestive heart failure,
coronary artery disease, peripheral vascular disease or
pulmonary dysfunction, or transient (column 3, lines 15–20). St.
Cyr et al. teaches administration of D-ribose to patients subject
to acute or chronic hypoxia in adequate amounts for a period of
time to raise the hypoxic threshold (column 5, lines 5–15).
(Ans. 3.) Examiner concludes that it would have been obvious to
combine the teaching of St. Cyr et al. in view of Doyle et al.,
Frank et al., Skues et al. and Macnaughton et al. in order to select
the treatment of a patient with rheumatoid lung and in need [of]
improv[ed] ventilator efficiency with the method of St. Cyr et al.
. . . It would have been obvious to use a known technique of
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assessing respiratory function in a patient to improve a similar
method of treating respiratory function in patient in the same
way, such as improving the identification and monitoring of the
patients to be treated. One of ordinary skill in the therapeutic arts
would have been motivated to select treatment of a patient
experiencing hypoxia due to the pulmonary dysfunction
[associated with] rheumatoid lung with a known method for
treatment of pulmonary dysfunction by increasing tolerance to
hypoxia, and Frank et al. teaches pulmonary dysfunction in
rheumatoid arthritis is common.
(Id. at 5–6.)
We adopt Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Ans. 2–13; FF 1–9) and agree that the
claims are obvious over St. Cyr, Doyle, Frank, Skues, and Macnaughton.
We address Appellants’ arguments below.
Appellants contend that
one of skill in the art would not have a reason to believe that the
method taught by St. Cyr et al. in view of Doyle et al., Frank et
al., and Skues et al. would necessarily and inevitably result in
improving the ventilator efficiency of the subject in need of
improving the ventilator efficiency. For example, as discussed
herein above, systolic or diastolic heart failure will almost
certainly impact ventilator efficiency; however, there is no
indication that the group of subjects recited in the present claims
have any cardiac condition, much less systolic or diastolic heart
failure.
(Br. 6.)
We do not find this argument persuasive. The ordinary artisan,
informed by (i) Doyle that airway obstruction is associated with pulmonary
involvement, and prevalent in rheumatoid arthritis and hypoxic patients (FF
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5–6), by (ii) Frank that “pulmonary fibrosis is common in rheumatoid
disease” (FF 7), by (iii) Skues that “[p]ulmonary manifestations of
rheumatoid arthritis are more common” and that “rib cage ‘stiffness’ may
contribute to reduced lung volume and ventilatory efficiency” in patients
with rheumatoid arthritis (FF 8), and by (iv) Macnaughton that there is a
change in volume of pulmonary capillary blood in rheumatoid arthritis
patients (FF 9), would have predictably administered known pulmonary,
hypoxia, or rheumatoid arthritis treatments to these patients including the
ribose treatment of St. Cyr and done so with a reasonable expectation of
success (FF 1–4).
Appellants argue that “a pulmonary dysfunction such as chronic
obstructive pulmonary disease in the absence of lung congestion, for
example, may not even impact ventilator efficiency” (Br. 6).
This argument is unpersuasive. We find Appellants’ argument,
lacking supporting evidence, insufficient to rebut the express teachings of
Doyle, Frank, Skues, and Macnaughton. See In re Geisler, 116 F.3d 1465,
1470 (Fed. Cir. 1997) (“[A]ttorney argument [is] not the kind of factual
evidence that is required to rebut a prima facie case of obviousness”).
Appellants contend that “[t]he Examiner further relied on Skues et al.
for allegedly disclosing ‘that a subject having pulmonary dysfunction due to
rheumatoid arthritis is predicted to have reduced lung volume and ventilator
efficiency’ . . . . Appellants respectfully disagree” (Br. 6).
As Examiner explains,
the rejection of record is not predicated on knowledge that the
mechanism of the treatment of St. Cyr et al. is specifically to
improve the ventilator efficiency of the subject. . . . [T]he
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method taught by the combination of St. Cyr et al. in view of
Doyle et al., Frank et al., Skues et al. and Macnaughton et al. is
not predicated on an inherent result of improving the ventilator
efficiency of the subject. However, the mechanism of action by
which the treatment of St. Cyr et al. functions in treating
pulmonary dysfunction by increasing tolerance to hypoxia would
have been the necessary and inevitable result of administering
the same compound to the same patient population to treat the
same disease as taught by St. Cyr et al. in view of Doyle et al.,
Frank et al., Skues et al. and Macnaughton et al.
(Ans. 10–11.)
Moreover, even if some unpredictability remained because the exact
biophysiological mechanism underlying the association was not well
understood, that would not mean the claims are nonobvious because the
prior art provides reasons to administer D-ribose to the patient population at
issue as discussed above. Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364
(Fed. Cir. 2007) (“[O]bviousness cannot be avoided simply by a showing of
some degree of unpredictability in the art . . . , the expectation of success
need only be reasonable, not absolute.”)
Appellants contend that “Skues et al. recite that pleural disease affects
between 3% and 12.5% of patients having rheumatoid arthritis, and that rib
cage ‘stiffness’ may contribute to reduced lung volume and ventilator
efficiency,” and that “Skues et al. does not report original results, but is a
review article” (Br. 7).
We do not find this argument persuasive and agree with Examiner that
[Appellants appear] to interpret the teachings of Skues et al. as
limited to the cited reference 34 to Begin et al. Skues et al. as a
review article establishes the knowledge that would have
understood by one of ordinary skill in the art. For example,
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Skues et al. provides no citation to literally support that
knowledge of one of ordinary skill in the art that pleural disease
affects only 3–12.5% of patients having rheumatoid arthritis.
Therefore that Begin et al. does not expressly state measurements
of reduced lung volume and ventilator efficiency in rheumatoid
arthritis patients having pulmonary manifestations does not
negate teachings in Skues et al. regarding what of [sic] one of
ordinary skill in the art would have understood.
(Ans. 12.)
Appellants contend that, in regard to Macnaughton, that
it is not clear how the description of a method to assess change
in capillary blood volume (Vc) in a pathological state such as
rheumatoid arthritis provides that which is missing from St. Cyr
et al. in view of Doyle et al., Frank et al., and Skues et al.
(Br. 8.)
As Examiner explains,
Macnaughton et al. teaches assessment of respiratory function in
a rheumatoid arthritis patient that has pulmonary dysfunction of
hypoxia as taught by Skues et al. in terms of ventilator efficiency
would have been obvious. Therefore it would have been obvious
to one of ordinary skill in the art at the time of the invention that
selection of the rheumatoid arthritis patient that has pulmonary
dysfunction of hypoxia as taught by Doyle et al., Frank et al. and
Skues et al. would also be in need of improving ventilator
efficiency because Macnaughton et al. teaches assessment of
respiratory function.
(Ans. 13.)
Obviousness-type double patenting over claims 1–10 of St. Cyr, Doyle,
Frank, Skues, and Macnaughton:
Appellants contend that “Appellants respectfully traverse [this]
rejection for at least the same reasons discussed herein above” (Br. 10). We
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thus affirm the obviousness-type double patenting rejection for the reasons
discussed above.
CONCLUSION OF LAW
We affirm the rejection of claims 28, 34, and 42 under 35 U.S.C.
§ 103(a) as obvious over St. Cyr, Doyle, Frank, Skues, and Macnaughton.
Claims 29–33 and 40 fall with claim 28, and claims 35–39 and 41 fall with
claim 34.
We affirm the rejection of claims 28–43 under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
claims 1–10 of St. Cyr, Doyle, Frank, Skues, and Macnaughton.

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).

AFFIRMED