Ex Parte O

Patent Trial and Appeal Board

Dec 6, 2017

13696922 (P.T.A.B. Dec. 6, 2017)

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.
13/696,922 01/04/2013 Nathan Francis O'Connor 2010P00372WOUS 4803
24737 7590 12/08/2017
PTTTT TPS TNTFT T FfTTTAT PROPFRTY fr STANDARDS
EXAMINER
465 Columbus Avenue JANG, CHRISTIAN YONGKYUN
Suite 340
Valhalla, NY 10595 ART UNIT PAPER NUMBER
3735
NOTIFICATION DATE DELIVERY MODE
12/08/2017 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):
patti. demichele @ Philips, com
marianne. fox @ philips, com
katelyn.mulroy @philips .com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte NATHAN FRANCIS O’CONNOR1
Appeal 2017-001213
Application 13/696,922
Technology Center 3700
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
ELIZABETH A. LaVIER, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
appellant states that the real party-in-interest is Koninklijke Philips
Electronics N.V. App. Br. 1.
Appeal 2017-001213
Application 13/696,922
SUMMARY
Appellant files this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 1-5, 7, 10-13 and 15. Specifically,
claims 1,3,4, and 7 stand rejected as unpatentable under 35 U.S.C. § 103(a)
as being obvious over the combination of Richards et al., Lung and Chest
Wall Compliance of Apneic Paralyzed Infants, 40(2) J. Clin. Invest. 273-
78 (1961) (“Richards”) and Morch et al. (US 2,969,789, March 23, 1956)
(“Morch”).
Claim 2 stands rejected as being unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Richards, Morch, and
Euliano et al. (US 7,425,201 B2, September 16, 2008) (“Euliano”).
Claim 5 stands rejected as unpatentable under 35 U.S.C. § 103(a) as
being over the combination of Richards, Morch, and Blomberg et al. (US
2004/0097821 Al, May 20, 2004) (“Blomberg”).
Claims 10-13 and 15 stand rejected as unpatentable under 35 U.S.C.
§ 103(a) as being obvious over the combination of Richards, Morch, and
Blomberg.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellant’s invention is directed to a method of estimating upper
airway resistance or lung compliance of a patient that includes inducing a
central apnea in the patient and providing a known pressure stimulus
comprising a flow of breathing gas having a known pressure level to the
patient while the patient is experiencing central apnea. Abstract.
2
Appeal 2017-001213
Application 13/696,922
REPRESENTATIVE CLAIM
Appellant argues all of the claims together. App. Br. 8. Claim 1 is
representative of the claims on appeal and recites:
1. A method of estimating upper airway resistance or lung
compliance of a patient, comprising:
inducing a central apnea in the patient by providing
a central apnea inducing stimulus that comprises
increasing a tidal volume of gas delivered to the patient to
a point that causes the patient’s level of partial pressure of
CO2 in the patient's blood to fall below an apneic
threshold;
providing a known pressure stimulus comprising a
flow of breathing gas having a known pressure level to the
patient while the patient is experiencing the central apnea;
determining a patient flow-related parameter
associated with the known pressure stimulus; and
estimating the upper airway resistance or the lung
compliance of the patient using the patient flow-related
parameter.
App. Br. 9.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner’s findings of fact and
conclusions that the appealed claims are obvious over the cited prior art. We
address the arguments raised by Appellant below.
3
Appeal 2017-001213
Application 13/696,922
Issue
Appellant argues the Examiner erred in concluding it would have been
obvious to one of ordinary skill in the art to modify the procedure taught by
Richards with the teachings of Morch. App. Br. 5.
Analysis
The Examiner finds Richards teaches a method of estimating the lung
compliance of a patient, comprising inducing a central apnea in the patient
Final Act. 3 (citing Richards 274). The Examiner finds that, although
central sleep apnea is a common term in the art, the phenomenon of central
apnea is not common and occurs when there is a cessation of airflow as a
result of a lack of central nervous system-mediated respiratory drive. Id.
(citing Spec. ^ 33). The Examiner finds that Richards teaches providing a
known pressure stimulus comprising a flow of breathing gas having a known
pressure level to the patient while the patient is experiencing the central
apnea and determining a patient flow-related parameter (i.e., upper airway
resistance or lung compliance) associated with the known pressure stimulus.
Id. (citing Richards 274, 275).
The Examiner finds that Richards is silent with respect to the
limitation requiring providing a central apnea-inducing stimulus that
comprises increasing a tidal volume of gas delivered to the patient to a point
that causes the partial pressure of CO2 (“pCCh”) in the patient’s blood to fall
below an apneic threshold. Final Act. 4. The Examiner finds that Morch
teaches providing a central apnea-inducing hyperventilatory stimulus,
comprising increasing respiration volume and increasing respiration rate,
that causes breathing to stop (i.e., a central apnea). Id. (citing Morch col. 6,
4
Appeal 2017-001213
Application 13/696,922
11. 70-72). The Examiner thus finds the method of Morch comprises
increasing a tidal volume of gas delivered to the patient to a point that causes
the pC02 in the patient’s blood to fall below an apneic threshold. Id. (citing
Morch col. 6,11. 62, 65-70).
The Examiner therefore concludes that it would have been obvious to
a person of ordinary skill in the art to modify the apnea-inducing stimulus of
Richards by applying the method taught by comprising hyperventilating the
patient by increasing the volume of gas (and increasing the respiration rate)
to a point that causes the patient’s blood pC02 to fall below an apneic
threshold. Final Act. 4-5. The Examiner finds the method of Morch is
preferable because it decreases the blood pC02 and increases p02, which the
Examiner finds is important for ensuring the patient’s lungs are entirely still
for the longest possible time, so as to facilitate the measurement of lung
compliance. Id. at 5 (citing Morch 6,11. 62-70).
Appellant argues that Richards teaches a method by which pulmonary
compliance was measured in newborn infants by administering
succinylcholine chloride intravenously to induce central apnea and making
lung compliance measurements in the intubated subjects by providing flow
to the lungs. App. Br. 4. Appellant contends that the Examiner erroneously
proposes a modification of the teachings of Richards with those of Morch,
which teach increasing the tidal volume of gas being delivered to a newborn
infant to the point at which the partial pressure of pC02 in the blood falls
below the apneic threshold. Id. at 6.
Appellant contends that it was well known in the art that such an
increase in tidal volume can cause the newborn infant to experience
hypocapnia (reduced carbon dioxide in the blood) as a result of such
5
Appeal 2017-001213
Application 13/696,922
hyperventilation. App. Br. 6. Appellant points to their Exhibits A and B
(filed October 20, 2015) as evidence that hypocapnia has been shown to: (1)
potentiate lung injury through increased capillary permeability and
decreased lung compliance, and (2) induce seizures in children. Id.
Consequently, Appellant asserts, a person of ordinary skill in the art would
have found the modification proposed by the Examiner be medically
unacceptable due to the risk posed to the subject infant’s respiratory system.
Id.
Appellant points to the Examiner’s finding that, although Appellant’s
Exhibit A demonstrates negative results of hypocapnia, it also shows that
hypocapnia can be used to treat patients with cerebral edema or brain
injuries and, therefore, that there are positive effects of inducing hypocapnia.
App. Br. 6 (citing Final Act. 6). Appellant asserts that the infant subjects
taught by Richards are not patients with cerebral edema or other brain
injuries and, consequently, one of ordinary skill in the art would not consider
the brain injury related “positive effects” of inducing hypocapnia, and would
have therefore had no reason to modify the procedure described in the
Richards paper. Id. at 6-7.
Appellant takes further exception to the Examiner’s finding that it was
also known in the art that febrile seizures, such as might be induced to
hypocapnia, are not dangerous to children. App. Br. 7 (citing Final Act. 12-
13). Appellant contends that, although this may be true, the occurrence of
febrile seizures during the procedures taught by Richards would disrupt the
measurements that are being performed in those procedures. Id. Therefore,
Appellant argues, a person of ordinary skill in the art would not have wanted
to risk causing such febrile seizures, and instead would have used the central
6
Appeal 2017-001213
Application 13/696,922
apnea-inducing technique taught by Richards, i.e., intravenous
administration of succinylcholine chloride. Id. According to Appellant,
whereas the Examiner states that Exhibit B “does not provide enough
evidence about the presence of hypocapnia before the onset of febrile
seizures,” Appellant argues that Exhibit B does at least show a correlation
between febrile seizures and low CO2 in the blood. Id.
Appellant further disputes the Examiner’s finding that, because
Exhibit A teaches potentially positive effects of hypocapnia, such as
reducing luxury perfusion in brain injury to prevent worsening of cerebral
edema or for treatment of chronic diseases such as persistent pulmonary
hypertension and perinatal aspiration syndrome, these benefits would be
applicable because the infant subjects of Richards did not have any of the
conditions that the Examiner states would benefit from hypocapnia. App.
Br. 7 (citing Final Act. 13). Appellant contends that, even if the risk caused
by the proposed modification of Richards with Morch would not have been
deemed medically unacceptable, one of ordinary skill in the art would
nevertheless not have wanted to introduce any unnecessary risk that could
have been avoided by simply adhering to the method taught by Richards. Id.
Finally, Appellant disputes the Examiner’s finding that, by claiming
the method of the present invention, Appellant is admitting that the risks
associated with the claimed method are acceptable in the determination of
lung compliance. App. Br. 7-8. Appellant argues that the method of the
present invention was developed, not by one of merely ordinary skill in the
art, but instead by experts in the field that have the experience and skill to
assess the acceptability of such risks. Id. at 8. Appellant argues that one of
merely ordinary skill in the art would not have had the skill or expertise to
7
Appeal 2017-001213
Application 13/696,922
make such a determination and, instead, based on the teachings of the prior
art (Exhibits A and B) would have been led in a different direction. Id.
The Examiner acknowledges that Richards teaches that its
methodology is applied to infants from 5 to 76 days of age. Ans. 4.
However, the Examiner finds that the purpose of the method taught by
Richards is to show measurements of total lung and chest wall compliance in
anesthetized, paralyzed infants as the authors of the reference state that they
were unable to find any previous reports for this population. Id. The
Examiner finds that Richards does not teach that any part of the method
used, as it reads on the claims, are specific to the infant population, but
rather that it teaches merely the use of a known method for determining
compliance and applying it to the measurement of a specific population. Id.
The Examiner further finds that one skilled in the art would have
known to perform the same study on different populations for the purpose of
retrieving data on lung compliance. Ans. 4. As such, the Examiner states,
the proposed modification does not require its use specifically or exclusively
upon infants, but could be readily applied to the general population. Id. The
Examiner finds that, since the combination of the references does not require
one of ordinary skill in the art to apply the method only to an infant
population, and because such a limitation is not recited within the claims, the
arguments regarding whether Appellant has the skill and expertise to make a
determination with regards to the medical acceptability versus one of
ordinary skill in the art of its recited invention is moot. Id.
We are not persuaded by Appellant’s arguments. Appellant’s
arguments are all based upon the contention that the methods taught by
Richards are understood to be applicable strictly to infants and that the
8
Appeal 2017-001213
Application 13/696,922
combination of the methods of Richards and Morch would have posed
unacceptable medical risks to such infants, thus discouraging a person of
ordinary skill in the art from combining the references. We acknowledge
that the methods set forth in Richards were applied only to infants in that
reference, and that Richards is generally directed to the issue of the
measurement of infantile lung compliance. See, e.g., Richards 273.
However, Richards also teaches that measurement of lung compliance
was also practiced in adults, including apneic adults. Id. (“The [respiratory
compliance] values observed in unconscious subjects, therefore, more
closely approximate those of ... unanesthetized, apneic polio patients being
ventilated by a mechanical respirator” (internal references omitted)).
Moreover, Richards is expressly directed to a method of measuring infant
lung compliance as a means of comparison to what was known about adult
lung compliance, in addition to providing insight into the respiratory
functions of infants. Id. (“However, since lung compliance relates closely to
the functional residual capacity, a comparison of infant and adult lungs on
this basis suggests that they are similar in compliance” (internal references
omitted)). Appellant points to no teaching of Richards, nor can we discern
any, that teaches or suggests that the measurement methods disclosed by
Richards are incapable of being practiced on adults. Moreover, Appellant’s
claims are not directed to, either expressly or inherently, measurement of
upper airway resistance or lung compliance exclusively in infants.
Furthermore, Richards taught that central apnea was induced by
succinylcholine chloride, which is well-known in the art as a paralytic agent
used to facilitate tracheal intubation. See, e.g., Succinylcholine, available
at\ https://www.drugbank.ca/drugs/DB00202 (last visited December 1,
9
Appeal 2017-001213
Application 13/696,922
2017). Richards teaches, moreover, that: “[i]n order to eliminate muscular
effort, large doses of a neuromuscular blocking agent [i.e., succinylcholine
chloride] were employed.” Richards 276.
Morch teaches an alternative, non-drug-induced method of inducing
central apnea:
The extreme example is hyperventilation-apnea. Assume the
surgeon wants the patient’s lungs to be entirely still for a brief
period. In the human system, this would be tantamount to holding
one's breath. To effect the stated object, it is desirable to
hyperventilate, i.e., to clear the blood of carbon dioxide and build
up the supply of oxygen therein, to the extent possible in the
period immediately prior to apnea, so that breathing may be
stopped for the longest possible period.
Morch col. 6,11. 62-70. We agree with the Examiner that a person of
ordinary skill in the art would have understood that this method of inducing
central apnea in a patient would have been applicable to measurements of
upper airway resistance or lung compliance in a patient. Appellant’s
arguments generally, and specifically their exhibits A and B, are directed to
the potential harmful effects of the application of the methods of Morch to
infants, however, the scope of the claims on appeal are not limited to infants,
and Appellant adduces no evidence that such methods could not be applied
to patients generally, as recited in the claims.
Furthermore, although it is understood that hypocapnia can have
harmful side effects in critically ill patients (see, e.g., Exhibit A Abstr.) and
in infants (Exhibit B Abstr.), Appellant adduces no evidence that a person of
ordinary skill in the art would understand that the risks of inducing
hypocapnia outweigh the benefit of measuring upper airway resistance or
lung compliance in patients generally.
10
Appeal 2017-001213
Application 13/696,922
Finally, we are not persuaded by Appellant’s attempt to draw a
distinction between a person of ordinary skill in the art and “experts in the
field that have the experience and skill to assess the acceptability of such
risks.” See App. Br. 8. On the contrary, a person of ordinary skill would be
a person capable of understanding the art in their field of endeavor and
would therefore understand the commensurate risks involved, particularly as
set forth in Appellant’s Exhibits A and B. See Custom Accessories, Inc. v.
Jeffrey-Allan Industries, Inc., 807 F.2d 955, 963 (Fed. Cir. 1986) (“The
person of ordinary skill is a hypothetical person who is presumed to be
aware of all the pertinent prior art”). Appellant adduces no evidence to
show that their hypothetical experts in the field necessarily possess a level of
expertness greater than that of a person of ordinary skill in the field of
pulmonary research that would permit them to make such a calculation.
We consequently adopt the Examiner’s findings and conclusions and
we affirm the Examiner’s rejection of the claims.
DECISION
The Examiner’s rejection of claims 1-5, 7, 10-13 and 15 as
unpatentable under 35 U.S.C. § 103(a) is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
11