Ex Parte Fine et al

Patent Trial and Appeal Board

Feb 12, 2018

13310359 (P.T.A.B. Feb. 12, 2018)

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.
13/310,359 12/02/2011 David H. FINE 16250.0027 3894
27890 7590 02/14/2018
STEPTOE & JOHNSON LLP
1330 CONNECTICUT AVENUE, N.W.
WASHINGTON, DC 20036
EXAMINER
BLANCHARD, DAVID J
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
02/14/2018 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):
hfox @ steptoe. com
ipdocketing @ steptoe.com
lfielding @ steptoe.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID H. FINE, ROBERT F. ROSCIGNO, GREGORY
VASQUEZ, BRYAN JOHNSON, and RUAN DENTON.1
Appeal 2018-000174
Application 13/310,359
Technology Center 1600
Before FRANCISCO C. PRATS, JOHN E. SCHNEIDER, and
DAVID COTTA, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method for treating a patient with nitric oxide which have been rejected
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
The use of low concentrations of inhaled nitric oxide
(NO) can prevent, reverse, or limit the progression of disorders
which can include, but are not limited to, acute pulmonary
vasoconstriction, traumatic injury, aspiration or inhalation
1 Appellants identify the Real Party in Interest as GeNO LLC. Br. 3.
Appeal 2018-000174
Application 13/310,359
injury, fat embolism in the lung, acidosis, inflammation of the
lung, adult respiratory distress syndrome, acute pulmonary
edema, acute mountain sickness, post cardiac surgery acute
pulmonary hypertension, persistent pulmonary hypertension of
a newborn, perinatal aspiration syndrome, haline membrane
disease, acute pulmonary thromboembolism, heparin-protamine
reactions, sepsis, asthma and status asthmaticus or hypoxia.
Spec. ^ 4. The Specification describes a NO delivery system which
can be used to treat a variety of conditions. Spec. ^ 6.
Claims 1-5, 7, 9, 12-16, 40^16, and 49-55 are on appeal. Claim 1 is
representative and reads as follows:
1. A method of treating a patient after cardiopulmonary
resuscitation has been performed on the patient comprising:
passing nitrogen dioxide through a system configured to
convert the nitrogen dioxide into a pure nitric oxide gas; and
delivering the pure nitric oxide gas to the patient after
cardiopulmonary resuscitation via inhalation between about 15
minutes and about 3 hours after cardiopulmonary resuscitation
has been performed on the patient, wherein nitric oxide is
delivered intermittently to the patient for at least 24 hours,
wherein the intermittently includes not with every inhalation or
on for a predetermined period and off for a predetermined
period.
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Appeal 2018-000174
Application 13/310,359
The claims stand rejected under 35 U.S.C. § 103(a) as unpatentable
over Rounbehler2 combined with Minamishima,3 Heinonen,4 and Stenzler.5
DISCUSSION
Issue
The issue on appeal is whether a preponderance of the evidence
supports the Examiner’s conclusion that claims 1-5, 7, 9, 12-16, 40 46, and
49-55 would have been obvious over Rounbehler combined with
Minamishima, Heinonen, and Stenzler.
The Examiner finds that Rounbehler discloses a NO delivery system
which uses a surface active material such as silica gel coated with an
aqueous solution of an antioxidant to convert nitrogen dioxide to NO. Final
Act. 3. The Examiner finds that Minamishima discloses that the
administration of NO following CPR improves the patient outcome. Id. The
Examiner finds that Heinonen discloses intermittent administration of NO
delivers a therapeutic effect similar to constant NO administration and that
intermittent administration allows for more effective use of NO and reduced
environmental emissions. Id. The Examiner finds that Stenzler discloses a
method of supplying a therapeutic amount of NO by alternating the delivery
2 Rounbehler et al., US 2006/0180147 Al, published Aug. 17, 2006
(“Rounbehler”).
3 Minamishima et al., Inhaled Nitric Oxide Improves Outcomes After
Successful Cardiopulmonary Resuscitation in Mice, 124 Circulation 1645
(2011) (“Minamishima”).
4 Heinonen et al., Theoretical and experimental comparison of constant
inspired concentration and pulsed delivery in NO therapy, 26 Intensive Care
Med. 1116 (2000) (“Heinonen”).
5 Stenzler et al., US 2007/0144515 Al, published June 28, 2007
(“Stenzler”).
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Appeal 2018-000174
Application 13/310,359
of one or more breaths of NO with one or more breaths of oxygen. Final
Act. 4. The Examiner concludes
All the claimed elements herein are known in the prior
art and one skilled in the art could have combined the elements
as claimed by known methods with no change in their
respective functions, and the combination would have yielded
predictable results to one of ordinary skill in the art at the time
of the invention.
In light of the foregoing discussion, the claimed subject
matter would have been obvious within the meaning of 35 US C
103(a). From the teachings of the references, it is apparent that
one of ordinary skill would have had a reasonable expectation
of success in producing the claimed invention. Therefore, in the
absence of evidence to the contrary, the invention as a whole
would have been prima facie obvious to one of skill in the art at
the time the claimed invention was made, as evidenced by the
references.
Final Act. 6.
Appellants contend that the Examiner has failed to provide any
motivation to combine the references in the manner suggested by the
Examiner. Br. 6-7. Appellants also contend that only by using hindsight
could the Examiner combine the references. Id.
Principles of Law
[T]he examiner bears the initial burden, on review of the prior
art or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
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Appeal 2018-000174
Application 13/310,359
“In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
patentee controls. . . . [A]ny need or problem known in the field of endeavor
at the time of invention and addressed by the patent can provide a reason for
combining the elements in the manner claimed.” KSR Int’l Co. v. Teleflex
Inc., 550 U.S. 398, 419-20 (2007) (citation omitted).
“Any judgment on obviousness is in a sense necessarily a
reconstruction based upon hindsight reasoning, but so long as it
takes into account only knowledge which was within the level
of ordinary skill at the time the claimed invention was made
and does not include knowledge gleaned only from applicant’s
disclosure, such a reconstruction is proper.”
In re McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
Analysis
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. We find the Examiner has established that
the subject matter of the claims would have been obvious to one of ordinary
skill in the art at the time the invention was made over Rounbehler combined
with Minamishima, Heinonen, and Stenzler. Appellants have not produced
evidence showing, or persuasively argued, that the Examiner’s
determinations on obviousness are incorrect. Only those arguments made by
Appellants in the Briefs have been considered in this Decision. Arguments
not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv)
(2015). We have identified claim 1 as representative; therefore, all claims
fall with claim 1. We address Appellants’ arguments below.
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Appeal 2018-000174
Application 13/310,359
Appellants contend that the Examiner has not stated a motivation to
combine the references. Br. 6-8. Appellants contend that there is no
motivation to use the intermittent flow systems of Heinonen and Stenzler
with the NO delivery systems of Rounbehler. Id.
We have considered Appellants’ arguments and find them
unpersuasive. As he Examiner points out, motivation to use the intermittent
systems of Heinonen and Stenzler can be found in the references themselves.
Ans. 6-7. For example, Heinonen teaches that pulsed NO delivery is as
effective as constant NO delivery with respect to pulmonary vasodilatation
and “provides more effective NO usage and reduced environmental
exhausts, thereby eliminating the need for scavenging.” Heinonen 1122.
Stenzler teaches that pulsed administration of NO reduces the risk of toxicity
of nitric oxide gas. Stenzler Abstract.
Appellants also contend that the Examiner improperly used hindsight
in combining the references. Br. 7. Again, we are unpersuaded. As
discussed above, the motivation to combine the references can be found in
both Heinonen and Stenzler.
Conclusion
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 would have been obvious over
Rounbehler combined with Minamishima, Heinonen, and Stenzler.
Claims 2-5, 7, 9, 12-16, 40 46, and 49-55 have not been argued
separately and therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
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Application 13/310,359
SUMMARY
We affirm the rejection under 35 U.S.C. § 103(a).
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
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