Ex Parte Chattopadhyay et al

Patent Trial and Appeal Board

Mar 17, 2016

12017414 (P.T.A.B. Mar. 17, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/017,414 01122/2008
7609 7590 03/18/2016
RANKIN, HILL & CLARK LLP
23755 Lorain Road - Suite 200
North Olmsted, OH 44070-2224
FIRST NAMED INVENTOR
Pratibhash Chattopadhyay
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.
FER-16886.001 6345
EXAMINER
KASSA, TIGABU
ART UNIT PAPER NUMBER
1619
MAILDATE DELIVERY MODE
03/18/2016 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PRATIBHASH CHATTOPADHYA Y, BORIS Y. SHEKUNOV,
and K. ADAM GIBSON 1
Appeal2013-003005
Application 12/01 7 ,414
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
for producing an aqueous suspension of particles. We have jurisdiction
under 35 U.S.C. § 6(b ).
We affirm-in-part.
1 According to Appellants, the real party in interest is Ferro Corporation.
(Appeal Br. 2.)
Appeal2013-003005
Application 12/01 7 ,414
STATEMENT OF THE CASE
Background
"The present invention relates to the production of polymeric micro
and nanoparticles via the supercritical fluid extraction of emulsions." (Spec.
iT 2.)
Claims on Appeal
Claims 1-3 and 7-13 are on appeal. 2 (Appeal Br. 26-28.) Claim 1 is
illustrative and reads as follows:
1. A method for producing an aqueous suspension of particles comprising:
preparing an aqueous solution;
preparing an organic solution comprising a polymer and a drug dissolved
in an organic solvent that is not miscible in the aqueous solution;
simultaneously flowing the organic solution and the aqueous solution into
an in-line homogenization device to form an emulsion having a
continuous phase comprising the aqueous solution and a
discontinuous phase comprising the organic solution, wherein the
emulsion exits from the in-line homogenization device as an
emulsion effluent stream;
contacting the emulsion effluent stream exiting from the in-line
homogenization device with a stream of a supercritical extraction
fluid to form a mixture;
injecting the mixture into an extraction vessel maintained at a temperature
and a pressure sufficient to maintain the supercritical fluid in a
supercritical state whereby the supercritical extraction fluid extracts
the organic solvent from the discontinuous phase of the emulsion and
into the supercritical extraction fluid and thereby precipitates
particles comprising the drug and the polymer into the continuous
aqueous phase to form the aqueous suspension of particles; and
2 Claims 4---6 are withdrawn from further consideration as being drawn to a
non-elected species. (Appeal Br. 4.)
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Appeal2013-003005
Application 12/01 7 ,414
separating the aqueous suspension of particles and the supercritical
extraction fluid containing the extracted organic solvent from each
other.
Appellants describe their claimed method with reference to the
following Figure 1 from the Specification:
Supercritical Extraction
Fluid Source ----.-;
Supercrttical Extraction
Fluid Pump
Aquecus Solution High Pressure
(Waler + Optional Liquid Pump
Surfactant)
- - ''.1------+-i * ---
Organic Solution
(Organic Solvent +
Drug + Polymer)
High Pressure
Liquid Pump
FIG. 1
Separation
Vassel
Extraction
Vessel
Supercritical Extraction Fluid
+ Organic Solvent
~->'<>-----~J
Sack-pressure
Regulator
L* Colle~:;;-1
\hllv~- l
b=d
Prcduct (Aqueous
Suspension of Particles
Containing Drug and
Polymer)
(Appeal Br. 16, depicting schematic of method.)
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Application 12/01 7 ,414
Examiner's Rejections
1. Claims 1-3 and 7-13 stand rejected under 35 U.S.C. § 103(a) as
obvious over Chattopadhyay '9903 and Chattopadhyay '319.4 (Ans. 3.)
2. Claims 1-3 and 9-13 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1-51 of Chattopadhyay '990
(Id.)
3. Claims 1, 2, 9, and 10 stand rejected on the ground ofnonstatutory
obviousness-type double patenting over claims 1-5 and 12-19 of U.S. Patent
No. 6,998,051.5 (Id. at 4.)
4. Claims 1, 2, 5, and 9 stand rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1-3, 5, 8, and 9 of U.S.
Patent No. 7,279,181. 6 (Id.)
5. Claims 1, 2, and 5 stand provisionally rejected on the ground of
nonstatutory obviousness-type double patenting over claims 1, 8, 9, 11, 14
and 15 of copending Application No. 10/534,665.7 (Id.)
3 Chattopadhyay et al., US 6,966,990 B2, issued Nov. 22, 2005
("Chattopadhyay '990").
4 Chattopadhyay et al., US 2004/0026319 Al, published Feb. 12, 2004
("Chattopadhyay '319").
5 Chattopadhyay et al., US 6,998,051 B2, issued Feb. 14, 2006 ("the '051
patent").
6 Chattopadhyay et al., US 7,279,181 B2, issued Oct. 9, 2007 ("the '181
patent"). The reference to claim 5 is an error because claim 5 has been
withdrawn.
7 Chattopadhyay et al., US 2006/0153921, published July 13, 2006. This
application issued as the '181 patent. See Rejection 4.
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Application 12/01 7 ,414
6. Claim 1 stands provisionally rejected on the ground of nonstatutory
obviousness-type double patenting over claims 1, 9, and 13 of copending
Application No. 11/687,266.8
As to the obviousness rejection, Appellants present arguments for the
patentability of claims 1, 2, and 9-12 as a group, and we limit our discussion
to claim 1 as representative of those claims. Appellants separately argue
claims 3, 7 and 8, and 13.
As to the double patenting rejections, Appellants present arguments
for the patentability of the respective claims in each rejection as a group.
Because all three of the respective double patenting rejections include claim
1, we limit our discussion to claim 1 as representative of the respective
claims.
FINDINGS OF FACT
FF 1. The Examiner finds that Chattopadhyay '990 teaches "a method for
producing composite particles using a supercritical fluid extraction
technique on an emulsion." (Ans. 5.)
FF 2. Chattopadhyay '990 teaches methods in which the emulsion can be
contacted with the supercritical fluid. In one method, the emulsion is placed
in an extraction chamber and supercritical fluid is supplied into the
extraction chamber. In another method, the supercritical fluid is placed into
an extraction chamber and the emulsion is directed from an emulsion source
through a nozzle into the extraction chamber. (Chattopadhyay '990, col. 4, 1.
60-col. 5, 1. 49; col. 10, 11. 36---67; Appeal Br. 11-12.)
8 Patent Office records indicate that Application No. 11/687,266 is
abandoned, and no continuing applications are pending. This provisional
rejection is therefore moot.
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Application 12/01 7 ,414
FF 3. Chattopadhyay '990 teaches that emulsification is accomplished by an
emulsification device that can be a static mixer. (Chattopadhyay '990, col.
6, 11. 55---60.)
FF 4. Chattopadhyay '319 teaches methods for producing aqueous
suspensions of particles by extracting solvents from emulsions using a
supercritical fluid. In one method, the supercritical fluid is introduced into
an extraction chamber containing the emulsion. (Spec. i-f 4; Appeal Br. 13-
14.)
FF 5. Chattopadhyay '319 teaches that "[t]he rate of solvent extraction can
affect the size of the particle formed," and that generally, "the faster the
extraction rate, the smaller the particles are that are formed."
(Chattopadhyay '319, ,-r 47.)
FF 6. The Examiner finds that the faster the solvent extraction rate, as
taught by Chattopadhyay '319, means the faster the flow rate of supercritical
fluid. (Ans. 10.)
FF 7. The Examiner agrees that both Chattopadhyay '990 and
Chattopadhyay '319 teach that "the emulsion mixture meets the supercritical
fluid in the extraction chamber." (Ans. 4--5.)
ISSUES
Whether a preponderance of evidence of record supports the
Examiner's conclusion of (1) obviousness under 35 U.S.C. § 103(a), and (2)
obviousness-type double patenting.
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DISCUSSION
Obviousness Under 35 U.S.C. § 103(a)
Principles of Law
The Examiner bears the initial burden of establishing a prima facie
case of obviousness. In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Analysis
Claim 1
The Examiner rejected claim 1 based on the teachings of
Chattopadhyay '990. (Final Act. 3-5.)9 While the Examiner found that the
prior art teaches that the emulsion mixture meets the supercritical fluid in the
extraction chamber, the Examiner also found that "where the emulsion
mixture meets the supercritical fluid does not really matter." (Id. at 4.)
Appellants argue that
In both methods described in Chattopadhyay et al. '990,
initial contact between the supercritical fluid and the emulsion
occurs in an extraction chamber. ii~nd, in neither method
disclosed in Chattopadhyay et al. '990 is there any suggestion
that an emulsion effluent stream exiting from an in-line
homogenization device can or should be contacted with a stream
of a supercritical extraction fluid to form a mixture, which
mixture is then injected into an extraction vessel.
(Appeal Br. 13.)
We find that the difference between the cited prior art and claim 1 is
where the emulsion makes initial contact with the supercritical fluid. In the
cited prior art, initial contact occurs in the extraction vessel. In claim 1,
initial contact occurs prior to injection into the extraction vessel.
9 Office Action dated Feb. 2, 2012.
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On the record before us, we find that the Examiner has the better
position. A person of ordinary skill in the art "is also a person of ordinary
creativity, not an automaton." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,
421 (2007). Here, a person of ordinary skill would have been faced with
finite choices for the initial contact of the emulsion and supercritical fluid -
either within the extraction vessel or prior to introduction into the extraction
vessel. Both choices achieve the goal of having the emulsion and
supercritical fluid in contact within the extraction vessel. The ordinary
artisan's selection of mixing the emulsion and supercritical fluid prior to
entry into the extraction chamber might well have been the result of "a
design need or market pressure," such as the desirability of having only one
inlet into the extraction chamber rather than two. See id. Moreover, picking
one of a finite number of known solutions to a known problem is obvious.
See id. Accordingly, the Examiner has established a prima facie case of
obviousness as to claim 1 and, as discussed below, Appellants have not
overcome that prima facie case.
Appellants argue that claim 1 is nonobvious because the contacting
step (prior to injection) is not shown in the prior art. (Appeal Br. 13.) We
are not persuaded. The court in Perfect Web Techs., Inc. v Info USA, Inc.,
587 F.3d 1324 (Fed. Cir. 2009), affirmed the obviousness of method
claims even though one of four steps in the independent claim did not
appear in the prior art. Id. at 1327-30. In its decision, the court
acknowledged that obviousness "may include recourse to logic,
judgment, and common sense available to the person of ordinary skill
that do not necessarily require explication in any reference or expert
opinion." Id. at 1329. As discussed above, we find a similar rationale
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Application 12/01 7 ,414
applicable here.
Appellants also argue that the step at which the emulsion meets
the supercritical fluid "does matter," including for the reasons set forth
in paragraphs 35 and 36 of the Specification. (Appeal Br. 18.) We are
not persuaded. Paragraph 35 is equivocal, beginning with "[i]n many
cases." (Spec. i-f 35.) Moreover, paragraphs 35 and 36 focus on the time
between formation of the emulsion and contact with the supercritical fluid
rather than the mixing of those components prior to injection into the
extraction vessel. (See id. at i-fi-135, 36.)
Appellants' argue further that the claimed contacting step (prior to
injection) includes the use of an "in-line homogenization device," which
they assert is not disclosed in Chattopadhyay '990 or Chattopadhyay '319.
(Appeal Br. 18.) As recited in claim 1, the in-line homogenization device
forms the emulsion. (Appeal Br. 26.) However, Chattopadhyay '990
teaches a method that includes the formation of an emulsion, and that
the emulsion is formed by an emulsification device. (FF 3.)
Chattopadhyay '990 also teaches the use of an emulsion source that
directs emulsion into contact with the supercritical fluid. (FF 2.)
Accordingly, we are not persuaded by Appellants' argument that the use
of an in-line homogenization device is not disclosed by Chattopadhyay
'990.
Finally, we agree with Appellants' argument that they have "no
burden whatsoever to provide any objective data demonstrating that
final products produced by the claimed method ... are different than
final products made by the processes cited in the prior art." (Reply Br.
3.) We note, however, that once the Examiner establishes a prima facie
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case of obviousness, the burden of producing contrary evidence or
arguments shifts to Appellants. See In re Best, 562 F.2d 1252, 1254--55
(CCPA 1977); In re Oetiker, 977 F.2d 1443, 1445--46 (Fed. Cir. 1992). In
this case, Appellants' arguments do not overcome the prima facie case
of obviousness as to claim 1.
Claim 3
Claim 3 recites "[t]he method according to claim 1 wherein the in-line
homogenization device is a static mixer." Appellants contend that neither
Chattopadhyay '990 nor Chattopadhyay '319 "disclose the use of a
static mixer in this manner." (Appeal Br. 19.) We are not persuaded.
Chattopadhyay '990 teaches the use of an emulsion device that can be a
static mixer. (FF 3.) Given this teaching, and the fact that claim 1 is not
patentable over Chattopadhyay '990, we agree with the Examiner that
dependent claim 3 is also unpatentable as obvious.
Claims 7 and 8
Claims 7 and 8 both depend from claim 1, and recite the time it takes
for the emulsion effluent stream from the in-line homogenization device to
contact the stream of the supercritical extraction fluid. (Appeal Br. 27.)
The Examiner's rejection of claims 7 and 8 was included with a
citation to Chattopadhyay '319 and a discussion of the flow rate of the
supercritical fluid. (Non-Final at 8.) 10 However, claims 7 and 8 are
directed to the flow rate of the emulsion from the in-line
homogenization device, not the flow rate of the supercritical fluid.
10 Office Action dated June 22, 2011.
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Application 12/01 7 ,414
Accordingly, we find that the Examiner has not satisfied the burden of
establishing a prima facie case of obviousness.
Claim 13
Claim 13 recites, in pertinent part, "[t]he method according to claim 1
wherein a mean particle size of the particles ... is selected by adjusting a
flow rate of the stream of the supercritical extraction fluid relative to a flow
rate of the emulsion effluent stream." (Appeal Br. 28.) The Examiner found
that Chattopadhyay '319 teaches the relationship between the size of the
particle formed and the flow rate of the supercritical fluid (FF 5, 6), and
concluded that claim 13 was obvious based on the combination of
Chattopadhyay '990 and Chattopadhyay '319. Appellants argue that this
method is not taught or suggested by either of those references. (Appeal Br.
21-22.) We conclude that the Examiner has established a prima facie case
of obviousness as to claim 13, and that Appellants' arguments do not
overcome that prima facie case.
Conclusion of Law
A preponderance of evidence of record supports the Examiner's
conclusion that claims 1, 3, and 13 are obvious under 35 U.S.C. § 103(a).
Claims 2 and 9-12 were not argued separately and fall with claim 1.
A preponderance of evidence of record fails to support the Examiner's
conclusion that claims 7 and 8 are obvious under 35 U.S.C. § 103(a).
Obviousness-Type Double Patenting
Principles of Law
Obviousness-type double patenting prohibits the issuance of claims in
a second patent that are "not patentably distinct from the claims of the first
patent." In re Langi, 759 F.2d 887, 892 (Fed. Cir. 1985) (citations omitted).
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Application 12/01 7 ,414
"A later patent claim is not patentably distinct from an earlier patent claim if
the later claim is obvious over, or anticipated by, the earlier claim." Eli Lilly
& Co. v. Barr Labs., Inc., 251F.3d955, 968 (Fed. Cir. 2001) (citations
omitted).
Analysis
Rejection 2
The Examiner concluded that claim 1 was not patentably distinct from
claims 1-51 of Chattopadhyay '990. (Final Act. 6.) Appellants argue that
the claims of the present application are not co-extensive in scope with
claims 1-51 of Chattopadhyay '990 because the present claims require the
specific steps of "e.g., in-line homogenization of the emulsion, contact
between the emulsion and the supercritical fluid outside of the extraction
chamber to form a mixture, which is then injected into the extraction
chamber." (Appeal Br. 22.)
Claim 1 of Chattopadhyay '990 includes the steps of contacting an
emulsion with a supercritical fluid, and extracting an organic solvent from
emulsion droplets using the supercritical fluid. (Chattopadhyay '990, cols.
14--15.) Claim 7 of Chattopadhyay '990 recites the step of forming the
emulsion. (Id. at col. 15.) Accordingly, for the reasons set forth above in
connection with the obviousness rejection, we agree with the Examiner that
claim 1 is not patentably distinct from the cited claims of Chattopadhyay
'990.
Rejection 3
The Examiner concluded that claim 1 was not patentably distinct from
claims 1-5 and 12-19 of the '051 patent. (Final Act. 7.) Appellants make
the same argument as set forth in Rejection 2 above. (Appeal Br. 23.)
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Application 12/01 7 ,414
Claim 1 of the '051 patent includes the steps of contacting an
emulsion with a supercritical fluid, and extracting an organic solvent from
the discontinuous nonaqueous phase of the emulsion. ('051 patent, col. 17.)
Accordingly, for the reasons set forth above in connection with the
obviousness rejection, we agree with the Examiner that claim 1 is not
patentably distinct from the cited claims of the '051 patent.
Rejection 4
The Examiner concluded that claims 1, 2, and 9 were not patentably
distinct from claims 1-3, 5, 8, and 9 of the '181 patent. (Final Act. 7.)
Appellants contest the rejection. (Appeal Br. 23-24.) We note that the
claims of the '181 patent include, for example, the formation of frozen
particles and freeze-drying those particles. (' 181 patent, cols. 9, 10.)
Accordingly, based on our review of the record, we conclude that the
Examiner has failed to establish a prima facie case of obviousness-type
double patenting as to claims 1, 2, and 9 over claims 1-3, 5, 8, and 9 of the
' 181 patent.
Conclusion of Law
A preponderance of evidence of record supports the Examiner's
conclusion that claim 1 is unpatentable on the ground of nonstatutory
obviousness-type double patenting over claims 1-51 of Chattopadhyay '990.
Claims 2, 3, and 9-13 were not argued separately and fall with claim 1.
A preponderance of evidence of record supports the Examiner's
conclusion that claim 1 is unpatentable on the ground of nonstatutory
obviousness-type double patenting over claims 1-5 and 12-19 of the '051
patent. Claims 2, 9, and 10 were not argued separately and fall with claim 1.
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A preponderance of evidence of record fails to support the Examiner's
conclusion that claims 1, 2, and 9 are unpatentable on the ground of
nonstatutory obviousness-type double patenting over claims 1-3, 5, 8, and 9
of the ' 181 patent.
SUMMARY
The rejection of claims 1-3 and 9-13 under 35 U.S.C. § 103(a) is
affirmed.
The rejection of claims 7 and 8 under 35 U.S.C. § 103(a) is reversed.
The rejection of claims 1-3 and 9-13 on the ground of nonstatutory
obviousness-type double patenting over claims 1-51 of Chattopadhyay '990
is affirmed.
The rejection of claims 1, 2, 9, and 10 on the ground of nonstatutory
obviousness-type double patenting over claims 1-5 and 12-19 of the '051
patent is affirmed.
The rejection of claims 1, 2, and 9 on the ground of nonstatutory
obviousness-type double patenting over claims 1-3, 5, 8, and 9 of the '181
patent is reversed.
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-IN-PART
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