Ex Parte Sanders

Patent Trials and Appeals Board

Apr 11, 2019

14448493 - (D) (P.T.A.B. Apr. 11, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/448,493 07/31/2014 Mark Sanders
11951 7590 04/15/2019
Pepper Hamilton LLP (Rochester)
70 Linden Oaks
Suite 210
Rochester, NY 14625
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
29522.1053 3326
EXAMINER
HAGHIGHATIAN, MINA
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
04/15/2019 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):
USPTOinboxroc@pepperlaw.com
BadumK@pepperlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK SANDERS
Appeal2017-009899
Application 14/448,493
Technology Center 1600
Before DEBORAH KATZ, JOHN G. NEW, and JOHN E. SCHNEIDER,
Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2017-009899
Application 14/448,493
Appellant 1 seeks our review under 35 U.S.C. § 134(a), of the
Examiner's decision to reject claims 21-30. (Appeal Brief filed
March 6, 2017 ("App. Br.") 1.) We have jurisdiction under 35 U.S.C.
§ 6(b). We AFFIRM.
The Examiner rejected claims 21-30 under 35 U.S.C. § 103(a) over
Radhakrishnan, 2 Green, 3 Clarke, 4 Newman, 5 and Brand. 6 (Final Office
Action issued July 6, 2016 ("Final Act.") 3-10.)
Appellant's Specification is directed to a combination of active
ingredients with different particle sizes. (See Specification ("Spec.") 2:3-8.)
Appellant reports that the combination of a first active ingredient in a
"coarse fraction" and a second active ingredient in a "fine fraction," wherein
the coarse fraction has a greater mass median aerodynamic diameter
(MMAD) than the fine fraction and the combination is "especially useful in
the treatment of respiratory disorders." (Id. at 2:8-13.)
Appellant's claim 21, with indentations and spacing added, recites:
A dry powder, bimodal pharmaceutical composition
comprising a bronchodilator and a corticosteroid,
wherein the bronchodilator possesses a greater mass
median aerodynamic diameter (MMAD) than the corticosteroid,
and
1 Appellant reports that Innovata Biomed Limited is the real party in interest.
(App. Br. 1.)
2 US Patent No. 5,192,528, issued March 9, 1993.
3 US Patent No. 5,955,439, issued September 21, 1999.
4 PCT Publication WO 00/48587, published August 24, 2000.
5 Newman, "Aerosol Deposition Considerations in Inhalation Therapy," 88
CHEST 152S-160S (1985).
6 Brand et al., Intrapulmonary Distribution of Deposited Particles, 12
JOURNAL OF AEROSOL MEDICINE 275-284 (1999).
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Application 14/448,493
wherein the MMAD of the bronchodilator is from 4 to 12
µm and the MMAD of the corticosteroid is from 1 to 4 µm.
(App. Br. 17, Claims App'x.) Thus, Appellant's claimed dry powder
composition has three requirements: (1) that the MMAD of the
bronchodilator be greater than the MMAD of the corticosteroid; (2) that the
MMAD of the bronchodilator be from 4 to 12 µm; and (3) that the MMAD
of the corticosteroid be from 1 to 4 µm.
Appellant does not argue for the separate patentability of any of the
rejected claims. We focus on claim 21 in our review. See 37 C.F.R.
§ 4I.37(c)(l)(iv).
Finding of Facts
1. Radhakrishnan teaches delivery of liposomes containing
corticosteroids to the lungs. (See Radhakrishnan abstract.)
2. Radhakrishnan teaches liposomes having sizes of greater than
about 2-3 µm are deposited predominantly in the upper regions of the
respiratory tract, and that particle sizes less than about 2 µm favor deposition
in the lower pulmonary regions (such as deep lung or parenchymal lung
sites). (See Radhakrishnan 1:69-2:1-5; see Final Act. 3--4.)
3. Radhakrishnan teaches that liposomes having sizes greater than
3 µm can be used for treating bronchoconstriction by favoring deposition in
the upper respiratory tract. (See Radhakrishnan 3:37--41; see Final Act. 4.)
4. Radhakrishnan teaches that liposomes having sizes less than
about 2 µm can be used to treat interstitial lung diseases by favoring
deposition in lower pulmonary regions. (See Radhakrishnan 3:37--41; see
Final Act. 4.)
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5. Green teaches that preferred medicaments for treatment by
inhalation of respiratory ailments, such as asthma, include bronchodilators
(e.g., salmeterol xinafoate) and anti-inflammatory steroids ( e.g., fluticasone
propionate). (See Green 2:31-3:3; see Final Act. 5.)
6. Green teaches that at least 95% by weight of the particles of
medicament disclosed will have a diameter of less than 15 µm, preferably in
the range of 1-10 µm, for example in the range of 1-5 µm. (See Final Act.
5, citing Green 1:54---61.)
7. Clarke teaches an inhalable pharmaceutical composition
combining a bronchodilator (formoterol), and an anti-inflammatory
corticosteroid (fluticasone propionate) for the treatment of inflammatory or
obstructive airways diseases. (See Clarke 1 and abstract.)
8. Clarke teaches that the bronchodilator and corticosteroid can be
present in a dry powder for inhalation. (See Clarke 3.)
9. Newman teaches that "[p]article or droplet size is potentially
the most important factor determining the site of aerosol deposition."
(Newman 153S.)
10. Newman teaches that small particles of less than 2 µm and
peaking at approximately 3 µmare deposited mostly in the alveoli. (See
Newman 153S; see Final Act. 7.)
11. Newman teaches that larger particles are deposited in the
tracheobronchial and other larger pathways, with particles of 5-10 µm being
deposited mostly in large conducting pathways. (Newman 153S; see Final
Act. 7.)
12. Brand teaches that distribution in the lung is strongly dependent
on particle size and that "it should be possible to determine and influence the
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Application 14/448,493
preferential site of drug deposition to develop efficient inhalation therapy
strategies." (Brand abstract; see Final Act. 8.)
Analysis
The prior art teaches a dry powder composition comprising a
bronchodilator and a corticosteroid. (See Clarke 8 (Example 3); see
Examiner's Answer issued May 15, 2017 ("Ans.") 5.) The prior art also
teaches that different sites in the respiratory system can be targeted using
particles of different sizes. (See Radhakrishnan abstract, 1 :69-2:6 and 3:37-
41; see also Newman 153S; see Ans. 3--4.) Brand teaches that by choosing
different particle sizes one can determine and influence drug deposition to
develop efficient inhalation therapy strategies. (Brand abstract.)
The issue raised by Appellant is whether there is any basis in the prior
art for a dry powder composition comprising a bronchodilator and a
corticosteroid having the size limitations claimed. (See App. Br. 9.) We
agree with the Examiner that there is and that Appellant's claimed
compositions would have been obvious.
The Examiner determined that even though the references do not
expressly recite a composition having the recited particle size ranges, one of
ordinary skill in the art would have considered it obvious to select different
particle size ranges because the art teaches that particles of different sizes
deposit in different areas of the respiratory system and can be used to treat
different conditions. (Ans. 3--4.) The prior art supports this determination.
For example, Radhakrishnan teaches that particles greater than 2-3 µm favor
deposition in the upper respiratory tract and can be used to treat
bronchoconstriction. (Radhakrishnan 3:36--41; see Ans. 3--4.)
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Radhakrishnan also teaches that particles less than about 2 µm favor
deposition in the lower pulmonary regions and can be used, for example, to
treat interstitial lung disease. (See id.)
Similarly, Newman teaches that dry powder particles of different sizes
deposit in different pathways of the lung, wherein particles of 1-5 µm have
peak deposition in the small conducting airways and alveoli and that
particles of 5-10 µm have peak deposition in large conducting airways. (See
Newman 152s and Table 1; see Ans. 4.) Newman states that "[p]article or
droplet size is potentially the most important factor determining the site of
aerosol deposition." (Ans. 4, quoting Newman 153s.)
The Examiner concludes that these teachings would indicate to those
of ordinary skill in the art that different active agents, such as the
bronchodilators and corticosteroids taught in Green and Clarke, could have
different MMAD in order to deposit in different sites and treat different
specific conditions. (See Ans. 5.)
According to Appellant, the Examiner erred because the only
references that teach dry powder formulations are Green and Clarke.
Appellant argues that Green teaches particle sizes of medicaments to be
inhaled into the lungs as having a diameter of less than 15 µm, preferably 1
to 10 µm, and exemplified as 1 to 5 µm. (See App. Br. 9, citing Green 1:54--
61.) Appellant argues further that Clarke teaches a combination of
bronchodilator and corticosteroid that are dry powders of mean particle
diameter up to 10 µm, for example 0.1 to 5 µm and preferably 1 to 5 µm.
(See App. Br. 9, citing Clarke 4 and 8.) Appellant argues that even though
Clarke teaches both components of the claimed composition (bronchodilator
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and corticosteroid), there is no teaching that compares the size of the
particles of these different drugs. (See App. Br. 9 and 12.)
This argument is unpersuasive because the rejection is not based on
the teachings of Green and Clarke alone, but also Radhakrishnan, Newman,
and Brand, which demonstrate knowledge in the art of the uses of
differential sizing of drug particles. (See Ans. 3--4.) Similarly, Appellant's
arguments that Newman teaches only about deposition sites for aerosolized
drugs and that Radhakrishnan teaches only about aqueous suspension of
liposomes are unpersuasive because the Examiner cites Green and Clarke,
which demonstrate the knowledge in the art of dry powder compositions of a
bronchodilator and a corticosteroid. (See Ans. 5; see App. Br. 10 and 12.)
Appellant argues that the aqueous liposomal suspension taught in
Radhakrishnan is not germane to the claimed dry powder composition
claimed. (See App. Br. 10.) According to Appellant, Radhakrishnan "draws
clear distinctions in the ability of drug particles to be deposited and active in
the respiratory tract based on how the particles are formulated." (App. Br.
11, citing Radhakrishnan 1 :51-2:30; see also App. Br. 13.)
Radhakrishnan teaches that "[a] propellant-solvent aerosol, although
capable of dissolving the drug at relatively high concentration, is generally
unable to reach the deep lung, in part because of rapid evaporation of the
solvent and concomitant change in aerosol particle size." (Radhakrishnan
2: 14--19.) But, Radhakrishnan also teaches that "mist particle sizes of
greater than about 2-3 microns are deposited predominantly in the upper
regions of the respiratory tract, whereas particle sizes less than about 2
microns favor deposition in the lower pulmonary regions, including deep-
lung or parenchymal lung sites .... " (Radhakrishnan 1:68-2:6 (citations
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omitted).) Thus, even if producing particles as claimed may present some
difficulties, we are not persuaded that those of ordinary skill in the art would
have read Radhakrishnan to teach that only liposomes of the claimed size
could be produced. We are not persuaded that those of ordinary skill in the
art would have understood Radhakrishnan to teach that only liposomes of
certain sizes will deposit in particular locations in the respiratory system.
Appellant does not argue or direct us to evidence showing that those
of ordinary skill in the art would not have been able to make dry powder
compositions with the MMADs taught in Radhakrishnan and Newman and
recited in Appellant's claims. In contrast, Green teaches that the particles of
bronchodilator and corticosteroid are preferably in the range of 1-10 µm
(see Green 1:54---61) and the declaration evidence Appellant submits
( discussed below) indicates that dry powders of corticosteroid with an
MMAD size range of less than 3 micron were well known and commonly
practiced in the art (see Declaration of Iain Davidson, PhD under 37 C.F.R.
§ 1.132 ("Davidson Deel.") ,r,r 7-8). (See Ans. 7.) In view of that evidence
and the teachings in Newman and Brand about differential sizes of dry
particles and deposition in specific areas of the respiratory system, the
preponderance of the evidence does not support Appellant's argument that
the effects of particle size are relevant only to liposomes.
Appellant argues further that Dr. Davidson's declaration is evidence
that the claimed compositions would not have been obvious. (See App. Br.
14--16.) Dr. Davidson testifies that although there are a number of
combination products comprising bronchodilator and corticosteroid on the
market, none have an active ingredient with an MMAD greater than 4 µm.
(See Davidson Deel. ,r,r 6-9.) Dr. Davidson testifies that many of the
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Application 14/448,493
marketed products have MMAD figures in the range of 1.0-3 .5 µm and that
in some marketed products the bronchodilator is the larger component and in
other products the corticosteroid is the larger component. (See id. ,r 9.)
Appellant argues that the "scientific and commercial success of the
compositions that preceded the present application would have directed a
person of ordinary skill in the art away from the composition claimed in the
present application." (App. Br. 15.) We are not persuaded by this argument.
Prior art "teaches away" from a claimed product "when it suggests that the
developments flowing from its disclosures are unlikely to produce the
objective of the applicant's invention." Syntex LLC v. Apotex, Inc., 407 F.3d
1371, 1380 (Fed. Cir. 2005)). Dr. Davidson does not testify what the
information he reports would have suggested to one of ordinary skill in the
art, or how the teachings of the prior art would have expressly discouraged
or diverted a person of ordinary skill from Appellant's invention. (See In re
Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).) Dr. Davidson merely presents
two tables with MMAD data. Appellant does not direct us to any other
evidence showing that existing products would have suggested to those of
ordinary skill in the art that that the claimed composition would have been
unlikely to produce the objective of the claimed compositions or to explain
why. For example, we do not know from Dr. Davidson's declaration
whether business decisions controlled the marketing of the products
reviewed. Accordingly, Dr. Davidson's declaration does not persuade us
that the claimed compositions are not obvious.
Appellant has not persuaded us that the Examiner erred in rejecting
claims 21-30 as being obvious over the prior art under 35 U.S.C. § 103(a).
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Conclusion
Upon consideration of the record and for the reasons given, we sustain
the Examiner's rejection of claims 21-30 under 35 U.S.C. § 103(a) over
Radhakrishnan, Green, Clarke, and Newman as evidenced by Brand.
Therefore, we affirm the decision of the Examiner.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.
AFFIRMED
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