Ex Parte Gold

Board of Patent Appeals and Interferences

Jan 19, 2011

10755038 (B.P.A.I. Jan. 19, 2011)

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.
10/755,038 01/09/2004 Avram Reuben Gold 2111-040037 7887
28289 7590 01/19/2011
THE WEBB LAW FIRM, P.C.
700 KOPPERS BUILDING
436 SEVENTH AVENUE
PITTSBURGH, PA 15219
EXAMINER
DIXON, ANNETTE FREDRICKA
ART UNIT PAPER NUMBER
3771
MAIL DATE DELIVERY MODE
01/19/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte AVRAM REUBEN GOLD
__________

Appeal 2009-015120
Application 10/755,038
Technology Center 3700
__________

Before TONI R. SCHEINER, ERIC GRIMES, and
FRANCISCO C. PRATS, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134 involves claims to methods of
treating functional somatic syndromes. The Examiner rejected the claims as
obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
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STATEMENT OF THE CASE
Claims 1, 5, 6, 8-12, 16, 17, 19, and 20 are pending and on appeal
(App. Br. 5).2 Claims 1 and 12, the independent claims, are representative
and read as follows:

1. A method of treating functional somatic
syndromes comprising the steps of:
determining whether a patient suffers from inspiratory
airflow limitation during sleep;
identifying such a patient as having a functional somatic
syndrome; and
treating such a patient with an upper airway stabilization
technique;
wherein treating such a patient with an upper airway
stabilization technique comprises stabilizing the airway with
positive airway pressure therapy.

12. A method of treating functional somatic
syndromes comprising the steps of:
determining whether a patient suffers from inspiratory
airflow limitation during sleep;
identifying such a patient as having one or more
symptoms of a functional somatic syndrome; and
treating such a patient with an upper airway stabilization
technique;
wherein treating such a patient with an upper airway
stabilization technique comprises stabilizing the airway with
positive airway pressure therapy.

2 Appeal Brief filed May 7, 2008.
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The following rejections3 are before us for review:
(1) Claims 1, 5, 6, 11, 12, 16, and 17, rejected under 35 U.S.C. §
103(a) as obvious over Thornton4 and Goor5 et al. (Ans. 5-10);
(2) Claims 8, 9, 19, and 20, rejected under 35 U.S.C. § 103(a) as
obvious over Thornton, Goor, and Kowallik6 et al. (Ans. 10-11); and
(3) Claim 10, rejected under 35 U.S.C. § 103(a) as obvious over
Thornton, Goor, and Bennett7 (Ans. 12).
OBVIOUSNESS
ISSUE
The Examiner cites Thornton as disclosing a device “for treating
breathing disorders, i.e. patient suffering from obstructive sleep apnea and
snoring” (Ans. 5). The Examiner also finds that “it is known in the art that
symptoms are identified by medical personnel to arrive at a treatment plan to
alleviate the patient’s medical condition, in order to identify a diagnosis
compatible with the symptoms and treatments” (id. at 5-6).
Thus, the Examiner reasons, “upon a physician identifying symptoms
associated with a patient suffering from inspiratory airflow limitation during
sleep, the physician would treat a patient with the Thornton device, and
would utilize the information and knowledge from the symptoms and

3 The Examiner entered each of the current rejections as a new ground of
rejection (see Ans. 3-4). Appellant acknowledged the new grounds, and
explicitly “requests that the appeal be maintained and submits this Reply
Brief addressing each of the new grounds of rejection” (Reply Br. 1).
4 U.S. Patent No. 5,954,048 (filed April 16, 1997).
5 U.S. Patent No. 6,322,515 B1 (filed June 2, 1999).
6 U.S. Patent No. 6,752,766 B2 (filed January 28, 2002).
7 U.S. Patent No. 5,378,686 (filed September 21, 1992).
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treatment to arrive at a diagnose [sic] of functional somatic syndrome” (id. at
6).
The Examiner finds that Thornton “does not expressly disclose an
explicit correlation between the symptoms of functional somatic syndrome
and sleep apnea. However, at the time the invention was made, the
correlation between the symptoms of functional somatic syndrome and sleep
apnea were known,” as evidenced by Goor (id.). Based on Goor’s teachings,
the Examiner finds that an ordinary artisan would understand that sleep
apnea “presents a patient having airflow limitation during sleep and would
present a person with un-refreshed and fragmented sleep from the repetitive
instances of arousal during the sleep cycle” (id.).
Therefore, the Examiner concludes, an ordinary artisan would have
considered it obvious to “use the device of Thornton with a method of
treating the functional somatic syndrome as taught by Goor in order to treat
the symptoms [of] functional somatic syndrome, such as air flow limitation
during sleep” (id. at 7).
Appellant contends that the method of claim 1 stems from the
“pioneering recognition and discovery that inspiratory airflow limitation
during sleep demonstrably plays a primary role in development of the
functional somatic syndromes” (Reply Br. 6). Based on this discovery,
Appellant discloses and claims “treatment of inspiratory airflow limitation
via an upper airway stabilization technique, like positive airway pressure
therapy as one provided example, [which] ‘improves the symptoms/signs
associated with the functional somatic syndromes’” (id. (quoting Spec.
[0066])). Accordingly, Appellant urges, “Appellant alone identifies a causal
connection between inspiratory airflow limitation during sleep and the
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functional somatic syndromes and further teaches the corrective regimen of
upper airway stabilization” (id.).
Appellant also argues that functional somatic syndromes have specific
medically recognized definitions and sets of identifying characteristics, and
are “a unique class of disorders for which current medical science has been
unable to identify a unifying underlying cause” (id. at 7). In contrast,
Appellant argues, neither Thornton nor Goor mentions anything about
functional somatic syndromes, nor do those references describe any type of
causal connection between sleep apnea, its remedies and diagnostic methods,
and functional somatic syndromes (id. at 7-11, 13-14).
Appellant further argues that the Examiner incorrectly identified sleep
disorders, such as sleep apnea, as falling within the rubric of functional
somatic syndromes (id. at 12). Thus, Appellant urges:
[T]he very foundation of the reasoning present in the
Examiner’s Answer in support of the rejection of claim 1 is
fundamentally flawed and based on an incorrect reading of
Appellant’s disclosure relating to a method of diagnosing sleep
disorders which may stem concurrently from Appellant’s work
in the field of functional somatic syndromes.

(Id.)
Appellant concludes:
[T]he Examiner’s Answer appears to assume that a physician
would not only treat a patient identified as suffering from
inspiratory airflow limitations during sleep with the Thornton
device, but would also utilize this information to arrive at a
diagnosis of a functional somatic syndrome. Fundamentally,
the Examiner’s Answer makes a leap in logic that a recognized
expert in the field of Sleep Medicine declares is not present.
Only Appellant’s disclosure provides the relationship between
inspiratory airflow limitations during sleep and the functional
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somatic syndromes. This relationship is not present in either
Thornton or Goor.

(Id. at 14; see also App. Br. 25 (Evidence Appendix (citing Declaration of
Dr. Mark H. Sanders under 37 C.F.R. § 1.132 (executed May 16, 2007))).)
Appellant reiterates the above arguments in traversing the Examiner’s
obviousness rejection of claim 12 (see Reply Br. 15-18).
In view of the positions advanced by Appellant and the Examiner, the
issue is whether the evidence of record supports the Examiner’s conclusion
that a person of ordinary skill in the art would have considered the methods
recited in claims 1 and 12 obvious in view of Thornton and Goor.
FINDINGS OF FACT (“FF”)
1. In the section entitled “Description of the Related Art,” the
Specification states:
Functional somatic syndromes (FSS) may be defined as
physical syndromes without an organic disease explanation,
demonstrable structural changes, or established biochemical
abnormalities. Thus, patients suffering from functional somatic
syndromes are characterized more by symptoms, suffering, and
disability than by consistently demonstrable tissue
abnormalities. Functional somatic syndromes are thought to be
multiaxial syndromes in which psychological factors
(depression), neurological factors (increased pain sensitivity),
hormonal factors (orthostatic hypotension and alterations in the
hypothalamic-pituitary adrenal axis), and sleep-related factors
(frequent arousal and alpha frequency intrusion into sleep)
interact to produce a complex clinical presentation.

(Spec. [0005].)
2. The Specification also states:
The functional somatic syndromes generally include: chronic
fatigue syndrome, fibromyalgia, irritable bowel syndrome,
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migraine/tension headaches, and temporomandibular joint
syndrome. Other examples of functional somatic syndromes are
thought to include: premenstrual syndrome, multiple chemical
sensitivity, sick building syndrome, repetition stress injury, side
effects of silicone breast implants, Gulf War syndrome, chronic
whiplash, restless leg/periodic limb movement syndrome, and
like ailments.

(Id.)
3. The Specification further states, in the section entitled “Description of
the Related Art”:
In addition to a common symptom of excessive
sleepiness/fatigue, functional somatic syndromes feature other
symptoms/signs such as: chronic fatigue, irritable bowel,
migraine/tension headaches, temporomandibular joint pain,
premenstrual pain, sleep-onset insomnia, sleep maintenance
insomnia, unrefreshing sleep, EEG evidence of sleep
fragmentation, bruxism, muscle pain, muscle tenderness,
gastroesophageal reflux (i.e., heartburn), abdominal pain,
abdominal urgency, diarrhea, depression, orthostatic syncope,
and alpha-delta sleep.

(Id. at [0007].)
4. The May 16, 2007 Declaration of Mark H. Sanders (“Declaration”)
states that paragraph [0005] of the Specification “correctly identifies a
medical literature-identified listing of functional somatic syndromes”
including the syndromes listed in FF 2, above (Declaration 2, ¶ 5).
5. In addition to describing treatments for functional somatic syndromes,
Appellant’s Specification discloses methods for diagnosing sleep disorders:
In another embodiment, the present invention is a method
of diagnosing a sleep disorder. The diagnosing method
generally includes determining whether a patient suffers from
one or more symptoms of a functional somatic syndrome, and
diagnosing such a patient as having sleep-disordered breathing.
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The diagnosed patient may be treated with an airway
stabilization technique in accordance with the present invention.
(Spec. [0014].)
6. The Specification then states that the “patient may be diagnosed as
having obstructive sleep apnea/hypopnea (OSA/H) or upper airway
resistance syndrome (UARS) based on whether alpha-delta sleep is present
in the patient's sleep cycle . . . and may then be treated with an airway
stabilization technique” (id. at [0015]).
7. The Specification then states that the “airway stabilization technique
may include stabilizing the patient's airway with a mechanical stabilization”
(id. at [0016]).
8. The Specification then states:
The diagnosing step of the method may be based on one
or more symptoms of a functional somatic syndrome, such as
chronic fatigue, irritable bowel, migraine headaches, tension
headaches, temporomandibular joint pain, premenstrual pain,
sleep-onset insomnia, sleep maintenance insomnia,
unrefreshing sleep, EEG evidence of sleep fragmentation,
bruxism, muscle pain, muscle tenderness, heartburn, abdominal
pain, abdominal urgency, diarrhea, depression, orthostatic
syncope, and alpha-delta sleep.

(Id. at [0017].)
9. As background to its invention, Thornton discloses:
Many people experience breathing problems, which may
result in difficulty sleeping, in snoring, or in other more serious
conditions such as obstructive sleep apnea. One treatment for
such breathing disorders involves the use of devices inserted
into a user’s mouth for extending the user's lower jaw forward.
These devices open the breathing passageway more fully to
allow easier breathing through the nose and mouth.

(Thornton, col. 2, ll. 14-21.)
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10. Thornton discloses that the “device and method of the present
invention reduce or eliminate disadvantages and problems associated with
devices and methods for improving breathing” (id. at col. 2, ll. 42-44).
11. Thornton discloses that its invention “increases the opening of the
user’s breathing passageway to increase effectiveness of treatments for
breathing disorders such as obstructive sleep apnea, while remaining more
comfortable for the user” (id. at col. 2, l. 65 through col. 3, l. 2).
12. Thornton discloses that “another important technical advantage of the
present invention includes providing a removable connector for coupling the
device to a face mask that may be used in cooperation with the device and a
gas supply system for treatment of snoring, obstructive sleep apnea, or other
breathing disorders” (id. at col. 3, ll. 5-10).
13. In particular, Thornton discloses that its device “may be adapted for
use in connection with a face mask . . . and a continuous positive air pressure
(CPAP) system . . . for supplying a gas to [the] face mask” (id. at col. 4, ll.
44-46).
14. Goor discloses a method of “monitoring changes in the peripheral
arterial vasoconstriction in reaction to such state or condition, particularly
those related to cardiopulmonary distress and blood pressure in order to
detect or monitor the physiological state or medical condition of the patient”
(Goor, col. 1, ll. 25-29).
15. Goor discloses that while its invention “relates to detecting and
monitoring numerous physiological states and medical conditions, four
particular examples generally related to cardiopulmonary distress and blood
pressure are provided herein; namely, myocardial ischemia, sleep staging,
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sleep apnea syndrome, and continuous blood pressure monitoring” (id. at
col. 1, ll. 36-41).
16. Goor discloses:
Sleep apnea syndrome is one of the most common and
serious sleep disorders. It is characterized by repetitive
episodes of upper airway collapse during sleep resulting in
interruption of airflow despite persistent respiratory effort.
Obstructive apneas are typically associated with progressively
increasing asphyxia until termination by a brief arousal from
sleep and restoration of upper airway patency.

(Id. at col. 6, ll. 51-57.)
17. Goor discloses:
To diagnose sleep apnea syndrome, usually simultaneous
recordings are made on a multi-channel recorder consisting of
an electroencephalogram (EEG), electro-oculogram (EOG),
submental electromyogram (EMG), oro-nasal airflow (by
thermistors or thermocouples) and thoraco-abdominal
movements (by respiratory belt), snoring intensity (by dB
meter), pulse oximetry and leg movements.

(Id. at col. 6, l. 63, through col. 7, l. 3.)
18. Goor discloses that, “[i]in addition to the obstructive sleep apnea
syndrome which results in frank cessations of breathing, there are additional
obstructive sleep disordered breathing conditions recognized in the medical
literature. These conditions are called hypopnea and upper airway resistance
syndrome (UARS), respectively” (id. at col. 7, ll. 18-23).
PRINCIPLES OF LAW
As the Supreme Court pointed out in KSR Int'l Co. v. Teleflex
Inc., 550 U.S. 398 (2007), when determining whether the prior art supplied a
reason for practicing the claimed subject matter, the analysis “need not seek
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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.” Id. at 418; see also id. at
421 (“A person of ordinary skill is . . . a person of ordinary creativity, not an
automaton.”).
As to claim interpretation, “[u]nless the steps of a method actually
recite an order, the steps are not ordinarily construed to require one.”
Interactive Gift Express, Inc. v. CompuServe Inc., 231 F.3d 859, 875 (Fed.
Cir. 2000).
ANALYSIS
We have carefully considered all of Appellant’s arguments, but are
not persuaded that the evidence of record fails to support the Examiner’s
prima facie case of obviousness.
Claim 1 recites a method of treating functional somatic syndromes.
To perform the method, the practitioner must determine whether a patient
suffers from inspiratory airflow limitation during sleep. The practitioner
must also identify the patient as having a functional somatic syndrome. The
practitioner must also treat the patient with an upper airway stabilization
technique that includes positive airway pressure therapy.
Goor discloses a method for diagnosing sleep apnea, which is one of
the most common and serious sleep disorders (FF 14-18). Thornton
discloses a method for treating sleep apnea through the use of a CPAP
(continuous positive air pressure) device, which allows easier breathing (FF
9-13). Given these disclosures, we agree with the Examiner that Goor and
Thornton teach claim 1’s steps of determining whether a patient suffers from
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inspiratory airflow limitation during sleep, and treating the patient with
positive airway pressure therapy.
We agree with Appellant, however, that neither Thornton nor Goor
identifies sleep apnea syndrome as a functional somatic syndrome, nor do
those references explicitly identify any particular airway obstructive disorder
as a functional somatic syndrome. We also agree with Appellant that, when
viewed in context, the sections of the Specification describing Appellant’s
sleep disorder-treating embodiment do not show that an ordinary artisan
would have considered obstructive airway sleep disorders like sleep apnea to
necessarily be functional somatic syndromes (FF 5-8).
Nonetheless, as Appellant concedes, it was recognized in the art that
chronic fatigue syndrome was a known functional somatic syndrome, and
that symptoms of functional somatic syndromes included chronic fatigue as
well as sleep-related problems such as sleep maintenance insomnia and
unrefreshing sleep (FF 1-4). Thus, we agree with the Examiner that an
ordinary artisan, aware of the fatigue- and sleep-related characteristics of
functional somatic syndromes, would reasonably have inferred that at least
some of the individuals suffering from sleep patterns disrupted by the
inspiratory airflow limitations described in Thornton and Goor would also
be identified as having a fatigue-related functional somatic syndrome, such
as chronic fatigue syndrome, and the treatment of those individuals would
meet the limitations of the claims on appeal.
Moreover, as noted above, unless they specifically require the steps to
be performed in a particular order, process claims encompass any method
that includes all the claimed steps. See Interactive Gift Express v.
CompuServe, 231 F.3d at 875. In the instant case, claim 1 encompasses first
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performing the step of identifying a patient as having a functional somatic
syndrome, such as chronic fatigue syndrome, then determining whether the
patient suffers from inspiratory airflow limitation during sleep, and then
treating that patient with positive airway pressure therapy.
As discussed above, chronic fatigue syndrome is a disorder
recognized in the art as a functional somatic syndrome, and art-recognized
symptoms of functional somatic syndromes include chronic fatigue and
sleep-related problems such as sleep maintenance insomnia and unrefreshing
sleep (FF 1-4). Thus, we conclude that an ordinary artisan, having identified
a patient as having chronic fatigue syndrome, or another functional somatic
syndrome with symptoms such as chronic fatigue, sleep maintenance
insomnia, and/or unrefreshing sleep, would have considered it obvious to
determine whether that patient suffered from a sleep-disrupting inspiratory
airflow limitation like the sleep apnea described in Thornton and Goor, and
if appropriate, would have treated that patient with positive airway pressure,
as recited in claim 1.
Accordingly, we agree with the Examiner that the evidence of record
supports a conclusion that an ordinary artisan viewing Thornton and Goor
would have considered a process with all of the steps recited in claim 1,
including the step of identifying a patient as having a functional somatic
syndrome, prima facie obvious.
We therefore affirm the Examiner’s obviousness rejection of claim 1
over Thornton and Goor, as well as its dependent claims 5, 6, and 11, which
were not argued separately. See 37 C.F.R. § 41.37(c)(1)(vii).
Claim 12 recites a process with the same steps as claim 1, except that
rather than identifying a patient as having a functional somatic syndrome,
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claim 12 only requires the practitioner to identify “one or more symptoms of
a functional somatic syndrome.” As noted above, it was known in the art
that such symptoms included chronic fatigue as well as sleep-related
problems such as sleep maintenance insomnia and unrefreshing sleep (FF 1-
3).
Given that Goor and Thornton would have advised an ordinary artisan
that sleep apnea sufferers also suffered from disrupted sleep, we agree with
the Examiner that an ordinary artisan prompted by Goor and Thornton to
diagnose and treat sleep apnea would also have considered it obvious to
identify at least one fatigue- or sleep-related symptom of a functional
somatic syndrome in such patients, as required by claim 12. Accordingly,
we also affirm the Examiner’s obviousness rejection of claim 12 over
Thornton and Goor, as well as its dependent claims 16 and 17, which were
not argued separately. See 37 C.F.R. § 41.37(c)(1)(vii).
The Examiner rejected claims 8, 9, 19, and 20, all of which depend
either from claim 1 or claim 12, as obvious over Thornton, Goor, and
Kowallik (Ans. 10-11). The Examiner concluded that, while the claimed
steps of categorizing a patient as having upper airway resistance syndrome
(UARS) or obstructive sleep apnea/hypopnea (OSA/H) were not described
in Thornton or Goor, those steps would nonetheless have been obvious to an
ordinary artisan in view of Kowallik’s teachings of applying those criteria to
categorize patients suffering from respiratory disorders (id.).
Appellant directs no specific argument to this rejection. Accordingly,
as Appellant points to no deficiency in the Examiner’s prima facie case, and
we detect none, we affirm the Examiner’s obviousness rejection of claims 8,
9, 19, and 20 over Thornton, Goor, and Kowallik.
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The Examiner also rejected claim 10 as obvious over Thornton, Goor,
and Bennett (Ans. 12). The Examiner concluded that, while the claimed step
of observing alpha-delta sleep of a patient was not described in Thornton or
Goor, that step would nonetheless have been obvious to an ordinary artisan
in view of Bennett’s teaching of applying that diagnostic method in
diagnosis of functional somatic syndromes (id.).
Appellant directs no specific argument to this rejection. Accordingly,
as Appellant points to no deficiency in the Examiner’s prima facie case, and
we detect none, we affirm the Examiner’s obviousness rejection of claim 10
over Thornton, Goor, and Bennett.

SUMMARY
We affirm the Examiner’s rejection of claims 1, 5, 6, 11, 12, 16, and
17 under 35 U.S.C. § 103(a) as obvious over Thornton and Goor.
We also affirm the Examiner’s obviousness rejection of claims 8, 9,
19, and 20 over Thornton, Goor, and Kowallik.
We also affirm the Examiner’s obviousness rejection of claim 10 over
Thornton, Goor, and Bennett.

TIME PERIOD
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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cdc

THE WEBB LAW FIRM, P.C.
700 KOPPERS BUILDING
436 SEVENTH AVENUE
PITTSBURGH, PA 15219