Ex Parte Green et al

Patent Trial and Appeal Board

Apr 27, 2017

13888636 (P.T.A.B. Apr. 27, 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.
13/888,636 05/07/2013 Francis H. Y. GREEN 68106-9 8272
23971 7590 05/01/2017
BENNETT JONES LLP
C/O MS ROSEANN CALDWELL
4500 BANKERS HALL EAST
855 - 2ND STREET, SW
CALGARY, AB T2P 4K7
CANADA
EXAMINER
HAGHIGHATIAN, MINA
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
05/01/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte FRANCIS H. Y. GREEN, TAMER Y. EL MAYS, and
SAMUEL SCHURCH1
Appeal 2015-007059
Application 13/888,636
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
DAVID COTTA, Administrative Patent Judges.
JENKS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims directed
to composition and a method of dilating constricted airways using
perfluorocarbon. The Examiner rejects the claims as anticipated and
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 According to Appellants, the Real Party in Interest is Solaeromed Inc.
Br. 2.
Appeal 2015-007059
Application 13/888,636
STATEMENT OF THE CASE
Claims 1—16 are on appeal, and can be found in the Claims Appendix
of the Appeal Brief. Claims 1 and 11 are representative of the claims on
appeal, and read as follows:
I. A pharmaceutical composition having therapeutic synergy for
treating a mammal suffering from a respiratory disease
characterized by intermittent or chronic obstruction of the
airways of the lungs by dilating the airways, comprising a
perfluorocarbon and CO2.
II. A method for dilating a constricted airway of the lungs of a
mammal comprising introducing into the lungs a therapeutically
effective amount of a perfluorocarbon.
The following grounds of rejection are before us for review:
I. claims 11—15 under 35 U.S.C. § 102(b) as being anticipated by
Faithfull;2
II. claims 1—7 and 9-16 under 35 U.S.C. § 103(a) as unpatentable
over Rosenberg3 in view of Garrett;4
III claim 8 under 35 U.S.C. § 103(a) as unpatentable over
Rosenberg in view of Garrett and further in view of Zapol;5
IV. claims 1—10 and 16 under 35 U.S.C. § 103(a) as unpatentable
over Faithfull in view of Garrett ’332;6 and
2 Faithfull et al, US 5,490,498, issued Feb. 13, 1996 (“Faithful”).
3 Rosenberg, US 5,531,219, issued July 2, 1996.
4 Garrett, EP 0727219 Bl, published June 16, 2004.
5 Zapol et al., US 5,873,359, Feb. 23, 1999 (“Zapol”).
6 Garrett, US 6,001,332, issued Dec. 14, 1999 (“Garrett ’332”).
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Application 13/888,636
V. claims 1—16 under 35 U.S.C. § 103(a) as unpatentable over
Albrecht7 in view of Fisher.8
I. Anticipation by Faithfull
The issue is: Does the evidence of record support the Examiner’s
finding that the reference anticipates a method of administering
perfluorocarbon to the lung for the purpose of dilating a constricted airway?
Findings of Fact
FF1. Faithfull teaches “the step of introducing into the lung of the patient
an effective therapeutic amount of a fluorocarbon liquid” such as “a
brominated fluorocarbon and a still more [preferable] fluorocarbon is
perfluorooctylbromide.” Id. at 4:46—63.
FF2. Faithfull teaches that the lavage technique with a fluorocarbon is
useful for treating asthma. Faithfull 14:5—7. Additionally, Faithfull
teaches that “[t]he fluorocarbon could be administered together with a
bronchodilator including but not limited to Albuterol, Isoetharines,
perbuteral or an anti-allergenic agent.” Id. at 14:39-42.
Principle of Law
Discovery of a property inherent to a prior art process does not render
that process patentable, even if the prior art did not appreciate the property.
Verdegaal Bros. Inc. v. Union Oil Co., 814 F.2d 628, 633 (Fed. Cir. 1987).
7 Albrecht, US 6,432,384 B2, issued Aug. 13, 2002.
8 H. Kenneth Fisher and Thomas A. Hansen, Site of Action of Inhaled 6 Per
Cent Carbon Dioxide in the Lungs of Asthmatic Subjects before and after
Exercise, 114 Am. Rev. Resp. Dis. 861—870 (1976) (“Fisher”).
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Application 13/888,636
Analysis
Appellants contend that Faithfull “does not teach use of a
perfluorocarbon (PFC) as an airway dilator (e.g., bronchodilator). There is
nothing in Faithfull [] to suggest that airways in the lung, i.e., bronchi and
bronchioles, which are constricted . . . can be relaxed or dilated by the
administration of a perfluorocarbon.” Br. 7 (emphasis removed).
Appellants contend that “[pjerfluorocarbon as a bronchodilator is an
unknown property.” Id. (emphasis removed). Appellants cite In re Hack,
245 F.2d 246, 248 (CCPA 1957) to support their position that the discovery
of a new use for an old structure based on unknown properties of the
structure might be patentable to the discoverer as a process of using.
We have reviewed Appellants’ contentions that the Examiner erred in
rejecting claims 11—15 as anticipated by Faithfull. Br. 6—9. We disagree
with Appellants’ contentions and adopt the findings concerning the scope
and content of the prior art set forth in the Examiner’s Answer and the Final
Rejection dated May 28, 2014. The Examiner has identified that Faithfull
discloses methods of treating subjects using perfluorocarbon. FF1 and FF2.
The Examiner identified that Faithfull teaches administering the
perfluorocarbon to the same patient population as the instantly claimed
population, i.e. patients that have a constricted airway such as patients
having asthma. FF2. Because Faithfull teaches the same method steps
applied to the same patient population, the method would inherently achieve
the same result, that of “dilating a constricted airway.” See Ans. 5; see also
id. at 21 (“the same active compound (perfluorocarbon), administered to the
same target site (the lungs) of the patient via the same method.”). The
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Application 13/888,636
dilation of the airways is a natural result of applying the product to the lungs
of an asthmatic patient.
In some cases, [an] inherent property corresponds to a claimed
new benefit or characteristic of an invention otherwise in the
prior art. In those cases, the new realization alone does not
render the old invention patentable. . . . Thus, when considering
a prior art method, the anticipation doctrine examines the natural
and inherent results in that method without regard to the full
recognition of those benefits or characteristics within the art field
at the time of the prior art disclosure.
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1378 (Fed. Cir. 2005).
We acknowledge Appellant’s reliance on Hack, but do not agree with
Appellants contention that Hack applies to the present facts. Hack explains
that “the discovery or invention of a new use of a known . . . composition of
matter or material may be patentable” if it is presented as a method or
process claim and not product a claim. In re Hack, 245 F2.d at 248. There
is no question that claim 11 is directed to a method claim. The Examiner
has identified that Faithfull administers perfluorocarbon to same patient
group, i.e. to asthmatics, into the same area, i.e. the lungs, in the recited
effective amounts. Ans. 4; FF2. The problem with Appellant’s reliance on
Hack is that the method of “introducing into the lungs a therapeutically
effective amount of a perfluorocarbon” is already disclosed in Faithfull and
therefore the present claims are not directed to a new use of an old
composition.
Claim 11 additionally recites that the method is “for dilating a
constricted airway of the lungs.” This limitation merely describes the
desired result from carrying out the claimed active method step of
administering the compound to on the same patient population. When the
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Application 13/888,636
“use” of the old composition is claimed so that it directed to a result or
property of that composition, then the claim is anticipated. In
re May, 574 F.2d 1082, 1090 (CCPA 1978).
Accordingly, we affirm the rejection of claim 11 under 35 U.S.C.
§ 102(b) over Faithfull. Claims 12—15 were not separately argued and fall
with claim 11. 37 C.F.R. § 41.37(c)(l)(iv).
II. & III Obviousness over Rosenberg and Garrett
The Examiner rejects claims 1—7 and 9—16 under 35 U.S.C. § 103(a)
over Rosenberg and Garrett, and claim 8 over the combination of Rosenberg,
Garrett, and Zapol. Since both of these rejections rely upon the teaching of
Rosenberg and Garrett regarding the application perfluorocarbon and CO2
for the purpose of dilating patient airways, the same issue is dispositive for
both of these rejections, and we will consider the rejections together.
The issue is: Does the evidence of record support the Examiner’s
conclusion that the combination of references renders obvious a composition
containing a mixture of perfluorocarbon and CO2 and a method dilating a
constricted airway by administering perfluorocarbon to the lung?
Findings of Fact
FF3. Garrett teaches that “[ajcute asthma causes hypoxaemia and the
rational treatment of hypoxaemia is with oxygen.” Garrett 14.
“During an acute asthma attack, there is a marked exacerbation of the
underlying inflammation in the small and medium sized airways in the
lungs.” Id. at 12. Garrett teaches that “[a] helium-oxygen gas
mixture for use in obstructive airways disease is known.” Id. at | 6.
Garrett explains that there is “a need for a gas mixture which can be
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Application 13/888,636
made readily available to all patients for self administration.” Id. at
116.
FF4. Garrett teaches “that the use of air enriched to 6% by volume in
carbon dioxide assists the breathing of asthmatic patients.” Garrett
111. Garrett teaches a medical gas mixture that “contains from 3 to
7% carbon dioxide and most preferably does not exceed 5%.” Id. at 1
19.
FF5. Garrett teaches that “[cjarbon dioxide is also a bronchodilator.” Id. at
120.
FF6. Garrett teaches that “an advantageous gas mixture of the invention is
one containing 33 to 35% oxygen 3 to 5% carbon dioxide and the
balance helium.” Id. at 1122.
FF7. Rosenberg teaches administering perfluorocarbon in conjunction with
microparticulate medicaments to subjects.
Perfluorocarbons can serve as temporary lung surfactants
because they are biologically compatible, decrease the
surface tension sufficiently within the alveoli, cover the
lung surface easily and promote oxygen and carbon
dioxide exchange. When used in conjunction with
introduction of a powdered or other microparticulate
medicament, perfluorocarbon can facilitate delivery of the
medicament to the lungs where it is absorbed by lung
tissue
Rosenberg 9: 20-27.
FF8. Rosenberg teachers that the “perfluorocarbon liquid is introduced into
the pulmonary air passages by injecting the liquid into and through an
endotracheal tube between breaths of air supplied by continued
positive pressure ventilation.” Id. at 11:37-40. “[T]he volume of
introduced perfluorocarbon liquid, [in Rosenberg] is equivalent to
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Application 13/888,636
0.01% to 100% of the pulmonary functional residual capacity of the
host.” Id. at 5:11—13, see id. at 11:42-43. The perfluorocarbon
chemicals taught include: Cl OF 18 (“F-decalin”, “perftuorodecalin” or
“FDC”), and F-2-butyhetrahydrofuran (“FC-75” or “RM101”),
brominated perfluorocarbons, as well as FC-77. See Id. at 6:21 to
7:15.
FF9. Figure 2a of the Specification is reproduced below:
The effect of COZ 5% & FC-43 combined or alone on constricted airways
ao
D
JZc