Ex Parte Charan et al

Patent Trial and Appeal Board

Dec 7, 2012

11529128 (P.T.A.B. Dec. 7, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte CHATAN CHARAN and SARVAJNA DWIVEDI
__________

Appeal 2011-010319
Application 11/529,128
Technology Center 1600
__________

Before ERIC GRIMES, LORA M. GREEN, and JEFFREY N. FREDMAN,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134 from the
Examiner‟s rejection of claims 1-24, 35-37, and 67-71. We have jurisdiction
under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
Claims 1, 18, 35, and 67 are the independent claims on appeal, and are
drawn to aqueous compositions of anti-gram-negative antibiotic (claims 1,
18, and 35), and a method of administration (claim 67). Claims 1 and 18 are
representative, and read as follows:
1. A unit dose container containing an aqueous composition for
aerosolization comprising:
anti-gram-negative antibiotic or salt thereof being present in the unit dose
container at an amount from about 400 mg to about 750 mg and a
concentration from about 40 mg/ml to about 200 mg/ml.

18. An aqueous composition, consisting essentially of:
an anti-gram-negative antibiotic or salt thereof;
a bronchodilator; and
water.

The following grounds of rejection are before us for review:
I. Claims 17, 22, 35, and 69 stand rejected under 35 U.S.C. § 112,
second paragraph, as being indefinite (Ans. 5).
II. Claims 1-3, 7-11, 35, 36, and 67-69 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Osbakken
1
(Ans. 6).
III. Claims 1-5, 7, 8, 14, and 35 stand rejected under 35 U.S.C.
§ 102(b) as being anticipated by Malvolti
2
(Ans. 6).

1
Osbakken et al., US 6,576,224 B1, issued Jun. 10, 2003.
2
Malvolti et al., US 6,987,094 B2, issued Jan. 17, 2006. The Examiner also
refers to Malvolti et al., WO 03/004005 A1, published January 16, 2003, but
cites to the US Patent in the body of the rejection.
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IV. Claims 6, 9-12, 15-17, 36, 37, and 67-71 stand rejected under 35
U.S.C. §103(a) as being rendered obvious by the combination of
Malvolti (US Patent 6,987,094) and Osbakken (Ans. 8).
V. Claims 1-5, 14, 15, 18-22, 35, 36, and 67-71 stand rejected under
35 U.S.C. §103(a) as being rendered obvious by Lintz
3
(Ans. 11).
VI. Claims 12, 13, 16, 17, 23, and 24 stand rejected under 35 U.S.C.
§103(a) as being rendered obvious by Lintz as further combined
with Gooch
4
or Johnson
5
(Ans. 15).
VII. Claims 1-24, 35-37, and 67-71 stand rejected under 35 U.S.C.
§103(a) as being rendered obvious by the combination of Smith
6

and Jauernig
7
(Ans. 17).
VIII. Claims 1-24, 35-37, and 67-71 stand provisionally rejected on the
ground of nonstatutory obviousness-type double-patenting as being
unpatentable over claims 1-21 and 35-42 of copending USSN
12/341,780 (Ans. 20).
IX. Claims 1-24, 35-37, and 67-71 stand provisionally rejected on the
ground of nonstatutory obviousness-type double-patenting as being

3
Lintz et al., US 2007/0071686 A1, issued Mar. 29, 2007. The Examiner
also refers to Lintz et al., WO 2005/037256 A2, published April 28, 2005,
but cites to the US Published Application in the body of the rejection.
4
Gooch, Stability of albuterol and tobramycin when mixed for aerosol
administration, 36 RESPIRATORY CARE 1387-90 (1991) (EMBASE®
Abstract only).
5
Johnson, Keith A., WO 92/00107, published January 9, 1992.
6
Smith et al., US 5,508,269, issued Apr. 16, 1996.
7
Jauernig et al., US 2005/0244339 A1, published Nov. 3, 2005.
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unpatentable over claims 35, 39, 40, and 67-74 of copending
USSN 11/992,347 (Ans. 21).

We affirm.

ISSUE (Rejection I-Indefiniteness)
Has the Examiner established by a preponderance of the evidence of
record that the skilled artisan would not understand the metes and bounds of
claims 22 and 69 on the basis that they use the term “about”?

FINDINGS OF FACT
FF1. The Examiner rejects claims 17, 22, 35, and 69 as indefinite (Ans. 5).
FF2. According to the Examiner:
Claims 22 and 69 are considered vague and indefinite
because they contain the term “at least about. ...” and “less than
about” respectively. These terms are indefinite because “at
least” and “less than” are static limitations while “about” is a
dynamic limitation. Thus employing both a static and a
dynamic term together renders the scope indefinite.

(Id.)

ANALYSIS
Appellants argue that the term “at least about” is not indefinite (App.
Br. 5). Specifically, Appellants assert that the range encompassed by
“about” would be clear to the skilled artisan from the context of the claim
(id. at 5-6).
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We agree with Appellants that the Examiner has not established that
the ordinary artisan would not understand the metes and bounds of the
limitations “at least about” and “less than about” within the context of the
claims. We thus reverse the rejection.

ISSUE (Rejection II-Anticipation over Osbakken)
Does the preponderance of the evidence support the Examiner‟s
finding that Osbakken teaches anti-gram negative compositions being
present in a unit dose, wherein the antibiotic is present in an amount of from
about 400mg to 750mg and a concentration of 40 mg/ml to about 200
mg/ml?

FINDINGS OF FACT
FF3. The Examiner rejected claims 1-3, 7-11, 35, 36, and 67-69 as being
anticipated by Osbakken (Ans. 6).
FF4. The Examiner finds that Osbakken teaches a unit dose for aerosol
administration for the treatment of chronic sinusitis (Ans. 6 (citing
Osbakken, Abstract and Summary)).
FF5. The Examiner finds that in Example 1, Osbakken teaches a
formulation of an anti-gram negative antibiotic at a concentration of 114
mg/ml (id.).
FF6. The Examiner cites Table 1 of Osbakken, finding that the Table “lists
various active agents and their dosages that can be administered according to
the teachings of Osbakken et al. Amikacin, which has a preferable dose
range of 50-500 mg” (id. at 6-7).
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FF7. The Examiner further finds that “Osbakken teaches that „to prepare a
unit dose, the ingredients of such formulations generally will be dissolved in
a solvent such as water or saline solution, in a volume between 0.5 and 6.0
mls, more preferably between about 2 and 4 mls and most preferably
between about 2.5 and 3.5 mls” (id. at 23 (citing Osbakken, col. 9, ll. 17-
22)).
FF8. The Examiner thus finds
to prepare a unit dose of amikacin an amount of up to 500 mg
amikacin is dissolved in a unit dose vial comprising 3.5 ml
water. This unit dose comprises 500 mg of amikacin in a
concentration of 142.85 mg/ml. The said unit dose anticipates
the claimed invention.

(Id. at 24.)
FF9. Specifically, Osbakken teaches that appropriate medications used for
formulating the pharmaceutical compositions may be found in Table 1, and
that the compositions will ideally be formulated as unit dose or multi-dose
vials (Osbakken, col. 7, ll. 46-55).
FF10. For example, as found by the Examiner, amikacin may be present in a
range of 50—500 mg (id. at col. 15, Table 1).
FF11. Osbakken also teaches that “[t]o prepare a unit dose, the ingredients of
such formulations generally will be dissolved in a solvent such as water or
saline solution, in a volume between about 0.5 and 6.0 mls, . . . most
preferably between about 2.5 and 3.5 mls” (id. at col. 9, ll. 17-22).
ANALYSIS
As to independent claim 1, Appellants argue that Osbakken “does not
disclose a unit dose container containing an anti-gram negative antibiotic or
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salt thereof being present at an amount and concentration as claimed” (App.
Br. 5). Appellants further assert that the “amikacin in Table 1 is [not?] at a
concentration of „from about 40 mg/ml to about 200 mg/ml.‟ as required by
claim 1” (Reply Br. 5-6). According to Appellants, “the Examiner is trying
to meet the concentration limitation from one example and the dose
limitation from a second example (which is also directed to a different active
agent, no less)” (id. at 6).
We do not find Appellants‟ arguments convincing. We acknowledge
that in an anticipation rejection, “it is not enough that the prior art reference .
. . includes multiple, distinct teachings that [an ordinary] artisan might
somehow combine to achieve the claimed invention.” Net MoneyIN, Inc. v.
VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Instead, the reference
“must clearly and unequivocally disclose the claimed [invention] or direct
those skilled in the art to the [invention] without any need for picking,
choosing, and combining various disclosures not directly related to each
other by the teachings of the cited reference.” Id. (quoting In re Arkley, 455
F.2d 586, 587 (CCPA 1972)).
The Federal Circuit has also explained, however, that the inquiry is
“not constrained to proceed example-by-example when reviewing an
allegedly anticipating prior art reference. Rather, the [reviewer] must, while
looking at the reference as a whole, conclude whether or not that reference
discloses all elements of the claimed invention arranged as in the claim.” Id.
at 1369 n. 5 (emphasis added).
Here, Osbakken teaches that appropriate medications may be found in
Table 1, and they may be formulated as a solution in a unit dose vial (FF9).
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Osbakken then goes on to teach that the volume may be from 0.5 to 6.0 mls,
with a preferred range between 2.5 to 3.5 mls (FF8). Thus, as found by the
Examiner, when 500 mg of amikacin (which is encompassed by the unit
dose amount of about 400 mg to about 750 mg of claim 1) is dissolved in 3.5
mls, a concentration of 142.85 mg/ml is obtained (FF8). That finding of the
Examiner is not a picking and choosing of distinct teachings, but follows
directly from the teachings of Osbakken. We thus affirm the rejection as to
claim 1, and claims 2, 3, and 7-11 fall with claim 1 (see App. Br. 8).
As to independent claims 35 and 67, Appellants essentially reiterate
the arguments made with respect to claim 1 (id. at 8-9). Those arguments
are not found to be convincing for the reasons set forth with respect to claim
1. Claims 36, 68, and 69 fall with those claims (see id.).

ISSUE (Rejection III-Anticipation over Malvolti)
Does the preponderance of the evidence support the Examiner‟s
finding that Malvolti teaches anti-gram negative compositions being present
in a unit dose, wherein the antibiotic is present in an amount of from about
400mg to 750mg and a concentration of 40 mg/ml to about 200 mg/ml?

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FINDINGS OF FACT
FF12. The Examiner rejects claims 1-5, 7, 8, 14, and 35 as being anticipated
by Malvolti (Ans. 7)
FF13. The Examiner finds that Malvolti teaches “preparations of 7.5%
tobramycin solution at pH 5.2 in a unit dose vial of 2 ml, comprising
tobramycin at 150 mg, sodium chloride at 9 mg, sufficient sulphuric acid
and sodium hydroxide to adjust the pH and water up to 2 ml in (see Example
1, col. 6)” (id.).
FF14. According to the Examiner, “[s]ince [the] claims do not recite a total
volume of the unit dose, the said concentration range at a 6 ml would
provide a formulation comprising 450 mg of tobramycin, which meets the
claimed limitations” (id. at 25).
FF15. Example 1 of Malvolti teaches a unit dose vial (2 ml) having the
following composition:

(Malvolti, col. 6, Example 1.)

ANALYSIS
As to independent claim 1, Appellants argue that Malvolti does not
teach the claimed amount and concentration, but discloses “a unit dose vial
with 150 mg Tobramycin” (App. Br. 9). Appellants make similar arguments
as to independent claim 35 (id. at 9-10).
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We reverse this rejection. While we agree with the Examiner that if
Malvolti taught a unit dose of 6 ml that would anticipate the composition of
claim 1, what is required by claim 1 is a unit dose containing anti-gram-
negative antibiotic at an amount from about 400 mg to about 750 mg. The
Examiner‟s reasoning is more appropriate in an obviousness rejection, while
this is a rejection under anticipation.

ISSUE (Rejection IV-obviousness over Malvolti and Osbakken)
Does the preponderance of the evidence of record support the
Examiner‟s conclusion that the combination of Malvolti and Osbakken
renders obvious claims 6, 9-12, 15-17, 36, 37, and 67-71?

FINDINGS OF FACT
FF16. The Examiner rejects claims 6, 9-12, 15-17, 36, 37, and 67-71 as
being rendered obvious by the combination of Malvolti and Osbakken (Ans.
8).
FF17. The teachings of Malvolti and Osbakken are set forth above (see, e.g.,
FFs 3-15).
FF18. The Examiner notes that Malvolti does not specifically teach a
formulation containing a gram-negative anti-infective in a concentration of
100 to 200 mg/ml (Ans. 9).
FF19. The Examiner concludes, however, that it would have been obvious to
the ordinary artisan to provide higher concentrations of medicament as that
would allow for smaller volumes (id. at 10).
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ANALYSIS
As to claims 9-12, 15, and 17, Appellants argue that neither Malvolti
nor Osbakken teach or suggest the amount and concentrations required by
claim 1 (App. Br. 10). Appellants further assert that the modification
proposed by the Examiner is not one that would have been within the grasp
of the ordinary artisan, and there is no evidence that the ordinary artisan
would have combined the references as suggested by the Examiner (id.).
Appellants further assert that they have “unexpectedly found advantages as
discussed throughout the specification” (id. at 11).
We affirm the rejection as to these claims. As discussed as to the
anticipation rejection over Osbakken, Osbakken does teach aqueous
composition of anti-gram negative antibiotics in the claimed amounts and
composition. While Appellants assert that the combination is beyond the
grasp of the ordinary artisan, they provide no evidence or scientific
reasoning to support that argument. Nor do Appellants point to any errors in
the Examiner‟s analysis.
As to Appellants‟ assertion that they have “unexpectedly found
advantages,” as noted by the Examiner (Ans. 26), Appellants fail to
specifically point to any such advantages, but only make the conclusory
statement that such advantages are “discussed throughout the specification”
(App. Br. 11). “It is well settled that unexpected results must be established
by factual evidence. Mere argument or conclusory statements in the
specification does not suffice.” In re DeBlauwe, 736 F.2d 699, 705 (Fed.
Cir. 1984).
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As to claims 36 and 37, as well as independent claim 67, Appellants
essentially reiterate the arguments made with respect to claims 9-12, 15, and
17 (see App. Br. 11-13). We thus affirm the rejection of those claims for the
reasons set forth with respect to claims 9-12, 15, and 17.

ISSUE (Rejections V and VI-obviousness over Lintz)
Has the Examiner established by a preponderance of the evidence of
record that Lintz renders obvious anti-gram negative antibiotic compositions
being present in a unit dose, wherein the antibiotic is present in an amount of
from about 400mg to 750mg and a concentration of 40 mg/ml to about 200
mg/ml?

FINDINGS OF FACT
FF20. The Examiner rejects claims 1-5, 14, 15, 18-22, 35, 36, and 67-71 as
being rendered obvious by Lintz.
FF21. The Examiner finds that Lintz teaches “a liquid preparation in the
form of an aqueous solution for inhalation containing about 80 to 120 mg of
tobramycin per ml (see [0016])” (Ans. 27; see also id. at 12).
FF22. The Examiner also finds that Lintz teaches “that the formulations may
be in a single or multiple dose containers (see [0037]).” (id.)
FF23. The Examiner notes that Lintz does not specifically disclose “a unit
dose container comprising from about 400 mg to about 750 mg of the
antibiotic” (id.).
FF24. The Examiner concludes that such doses are rendered obvious by
Lintz as Lintz discloses unit and multiple doses, as well as the claimed
concentration ranges, and that the ordinary artisan “would have been able to
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determine the amount of medicament based on the concentration range”
(id.).
FF25. The Examiner notes that the claimed unit dose container is not limited
to any particular volume (id.). Thus, according to the Examiner, “[f]or
example a unit dose container with a volume of 3.5 ml would contain more
than 400 mg of tobramycin at a concentration of 120 mg/ml” (id.).

ANALYSIS
As to claim 1, Appellants argue that Lintz “does not teach or suggest a
unit dose container containing an amount and concentration as claimed,” and
that the Examiner does not provide a reason to modify Lintz to arrive at the
claimed invention (App. Br. 13).
We do not find Appellants‟ arguments convincing. As found by the
Examiner (FFs 21 and 22), Lintz teaches an aqueous solution of tobramycin
that has the claimed concentration, and its packaging in single dose or
multiple dose containers. The only thing not taught is the amount being
from about 400 mg to about 750 mg, but we agree with the Examiner that it
would have been well within the level of skill of the ordinary artisan to
determine the appropriate dosage, and thus, the appropriate amount of
tobramycin to package into a single container. See In re Boesch, 617 F.2d
272, 276 (CCPA 1980) (noting that determining the optimum values of
result effective variables is ordinarily within the skill of the art). We thus
affirm the rejection as to claim 1. Claims 2-5, 14, and 15 fall with that claim
(see App. Br. 14).
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As to claim 18, Appellants argue that that claim recites “consisting
essentially of,” and that Lintz discloses formulations that include “other
essential ingredients” (App. Br. 14). For example, Appellants assert that
Lintz teaches the desirability of an acidic adjuvant (id.).
Appellants‟ arguments are not convincing. The “phrase „consisting
essentially of‟ limits the scope of a claim to the specified ingredients and
those that do not materially affect the basic and novel characteristic(s) of a
composition.” In re Herz, 537 F.2d 549, 551-52 (CCPA 1976) (emphasis
added); see also PPG Indus., Inc. v. Guardian Indus. Corp., 156 F.3d 1351,
1354 (Fed. Cir 1998). Appellants bear the burden of establishing that the
basic and novel characteristics of the claimed invention would be materially
affected by, or at least reasonably expected to be materially affected by, any
component or step of an applied reference that is argued to be excluded by a
“consisting essentially of” transitional phrase used in the claims. See In re
De Lajarte, 337 F.2d 870, 873-74 (CCPA 1964); Ex parte Hoffman, 12
USPQ2d 1061, 1063-64 (BPAI 1989).
Here, Appellants do not point to, nor can we find, anything in the
Specification that defines the basic and novel characteristics of the
composition of claim 18. We conclude that the basic characteristics are the
pharmaceutical properties of being an anti-gram-negative antibiotic and a
bronchodilator. Appellants have not established that the presence of an
acidic adjuvant would affect those properties of the composition taught by
Lintz. We thus affirm the rejection as to claim 18. Claims 19-22 fall with
that claim (see App. Br. 14).
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As to claims 35 and 67, Appellants essentially reiterate the arguments
made with respect to claim 1 (see App. Br. 14-15). We thus affirm the
rejection as to those claims for the reasons set forth with respect to claim 1.
Claims 36 and 68-71 fall with those claims (see id.).
As to the rejection of claims 12, 13, 16, 17, 23, and 24 over Lintz as
combined with Gooch or Johnson, Appellants reiterate the arguments made
with respect to claims 1 and 18. We thus affirm that rejection as well.

ISSUE (Rejection VII-obviousness over Smith and Jauernig)
Has the Examiner established by a preponderance of the evidence of
record that the combination of Smith and Jauernig renders obvious anti-gram
negative antibiotic compositions being present in a unit dose, wherein the
antibiotic is present in an amount of from about 400mg to 750mg and a
concentration of 40 mg/ml to about 200 mg/ml?

FINDINGS OF FACT
FF26. The Examiner rejects claims 1-24, 35-37, and 67-71, all of the claims
on appeal, as being rendered obvious by the combination of Smith and
Jauernig (Ans. 17).
FF27. The Examiner finds that Smith teaches a formulation for the delivery
of aminoglycosides by aerosolization, wherein the aminoglycosides may be,
for example, gentamicin, amikacin, and tobramycin (id. at 18).
FF28. The Examiner also finds that the “formulations contain from 200-500
mg of aminoglycosides in 5 ml of the quarter normal saline,” which
“corresponds to 40-100 mg/ml (see col. 6, lines 9-19)” (id.).
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FF29. The Examiner finds that Smith teaches that the “formulations are
typically stored in a five ml low-density vials (see col. 8, lines 65-67)” (id. at
28).
FF30. Thus, the Examiner finds that Smith teaches “a unit dose vial
containing from about 200 to 500 mg of an antibiotic at a concentration
range of up to 100 mg/ml” (id.).
FF31. According to the Examiner, Smith “lacks disclosure on adding other
active agents and osmolality” (Ans. 18).
FF32. The Examiner relies on Jauernig to remedy those deficiencies (id. at
18-19).

ANALYSIS
As to claim 1, Appellants argue that both Smith and Jauernig fail to
teach or suggest “a unit dose container containing an amount and
concentration of an aqueous composition as claimed” (App. Br. 16).
Appellants further assert that the modification proposed by the Examiner is
not one that would have been within the grasp of the ordinary artisan, and
there is no evidence that the ordinary artisan would have combined the
references as suggested by the Examiner (id.). Appellants further assert that
they have “unexpectedly found advantages as discussed throughout the
specification” (id.).
Again Appellants‟ arguments are not convincing. As found by the
Examiner, Smith teaches a unit dose vial containing from about 200 to 500
mg of an antibiotic at a concentration range of up to 100 mg/ml, which
meets the limitation of claim 1 of “anti-gram-negative antibiotic or salt
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thereof being present in the unit dose container at an amount from about
400 mg to about 750 mg and a concentration from about 40 mg/ml to about
200 mg/ml.” In that regard, we note that “[i]n cases involving overlapping
ranges . . . even a slight overlap in range establishes a prima facie case of
obviousness.” In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). In
addition, as noted by the Peterson, “[t]he normal desire of scientists or
artisans to improve upon what is already generally known provides the
motivation to determine where in a disclosed set of percentage ranges is the
optimum combination of percentages.” Id. at 1330. Moreover, while
Appellants assert there are “unexpected . . . advantages,” they do not point to
any data or evidence supporting that assertion. Thus, as Appellants have not
pointed out how the Examiner‟s findings are in error, we affirm the rejection
as to claim 1. Claims 2-17 fall with claim 1 (see App. Br. 16).
As to claim 18, Appellants argue that Smith discloses formulations
that include other essential ingredients, and does not teach or suggest a
composition that consists essentially of the claimed ingredients (App. Br.
17). Appellants assert that Jauernig does not remedy those deficiencies (id.).
Appellants‟ arguments are not convincing, as Appellants have not
demonstrated how the addition of the other ingredients disclosed by Smith
affects the basic and novel properties of the composition of claim 18. We
note that the Examiner relied on Jauernig for the inclusion of other active
agents, such as albuterol (a bronchodilator) (Ans. 28). We thus affirm the
rejection as to claim 18. Claims 19-34 fall with claim 18 (see App. Br. 17).
As to independent claims 35 and 67, Appellants essentially reiterate
the arguments made with respect to claim 1 (App. Br. 18-19). We thus
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affirm the rejection of those claims for the reasons set forth with respect to
claim 1. Claims 36, 37, and 68-71 fall with those claims (see id.).

ISSUE (Rejections VIII and IX-Obviousness Double Patenting)
Appellants do not argue the merits of these rejections (see App. Br.
20). We thus summarily affirm them.

SUMMARY
We reverse Rejections I and III, but affirm rejections II and IV-IX.

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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