Ex Parte Thanoo et al

Patent Trials and Appeals Board

Apr 10, 2019

12328136 - (D) (P.T.A.B. Apr. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/328, 136 12/04/2008 Bagavathikanun Chithambara Thanoo
21130 7590 04/12/2019
BENESCH, FRIEDLANDER, COPLAN & ARONOFF LLP
ATTN: IP DEPARTMENT DOCKET CLERK
200 PUBLIC SQUARE
SUITE 2300
CLEVELAND, OH 44114-2378
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.
29362.19 6429
EXAMINER
ORWIG, KEVIN S
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
04/12/2019 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):
patent@beneschlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BAGA VATHIKANUN CHITHAMBARA THANOO,
GONTO JOHNS III, and BYUNG HO W00 1
Appeal 2018-00263 8
Application 12/328, 136
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FRED MAN, and
ERICA A. FRANKLIN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of making sustained release microparticles, which have been rejected for
indefiniteness, obviousness, and obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as Oakwood Laboratories,
LLC. Appeal Br. 4.
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Application 12/328, 136
STATEMENT OF THE CASE
The Specification discloses "methods for optimizing the release
profiles of biologically active agents encapsulated in sustained release
microparticles." Spec. ,r 17. "Also disclosed are methods for changing the
release rate of the biologically active agent from the microparticles by
treating the post-formation microparticles with an added dilution
composition as part of a continuous, aseptic process." Id. Specifically, "[a]
predetermined solvent exposure level, correlating to a predetermined amount
of dilution composition [] to be added, is calculated for a desired release
rate. The specific release rate is then obtained through the addition of the
dilution composition." Id. ,r 45.
Claims 1, 2, 4--9, and 12-15 are on appeal. Claims 1 and 2 are
illustrative and read as follows:
1. A method for forming sustained release microparticles
comprising the steps of:
preparing a dispersed phase comprising an active agent
and a polymer dissolved in solvents;
preparing a continuous phase;
feeding a portion of the dispersed phase and a portion of
the continuous phase into a mixer to form a microparticle
dispersion comprising microparticles that are sufficiently solid
as to be filterable;
continuously transferring the microparticle dispersion to
a vessel as the remaining portions of the dispersed and the
continuous phase are continuously fed into the mixer,
as the filterable microparticle dispersion is transferred to
the vessel, adding a third phase comprising a dilution
composition to the vessel, wherein the third phase is added to
the vessel in an amount ranging from 50% to 300% of the
volume of the continuous phase to reach a combined volume of
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liquid until the solid microparticle formation process is
complete,
maintaining the combined volume of liquid in the vessel
constant level by:
(a) removing a first portion of the combined
volume of the liquid from the vessel at a rate equivalent
to the rate at which the microparticle dispersion and the
third phase are continuously added to the vessel, and
(b) retaining the solid microparticles and a second
portion of liquid in the vessel; and
subjecting the solid microparticles to repeated washing
with water or air-sweep or hot water or any combinations
thereof.
2. The method of claim 1, wherein the combined volume of
liquid in the vessel is maintained constant by processing the
liquid through any method of separation of liquid from
particulates, such as a hollow fiber system.
Claims 5 and 13 are the other independent claims and are directed to
methods similar to that of claim 1, except that: (a) claim 5 recites adding a
third phase in an amount of 100% to 300% of the volume of the continuous
phase; and (b) claim 13 is limited to leuprolide as the active agent.
The claims stand rejected as follows:
Claims 1, 2, 4--9, and 12-15 under 35 U.S.C. § 112, second paragraph,
as indefinite (Ans. 3);
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Claims 1, 2, 4--7, 9, and 12-15 under 35 U.S.C. § I03(a) as obvious
based on Thanoo '126, 2 Jeyanthi, 3 Yang, 4 and Thanoo '802 5 (Ans. 5);
Claim 1, 2, 4--9, and 12-15 under 35 U.S.C. § I03(a) as obvious based
on Thanoo '126, Jeyanthi, Yang, Thanoo '802, and Thanoo '294 6 (Ans. 17);
Claims 1, 2, 4--9, and 12-15 for obviousness-type double patenting
based on the claims ofThanoo '126, in view of Jeyanthi, Thanoo '802, and
optionally Thanoo '294 (Ans. 19);
Claims 1, 2, 4--9, and 12-15 for obviousness-type double patenting
based on the claims ofThanoo '802, in view ofThanoo '126, Jeyanthi, and
optionally Thanoo '294 (Ans. 20).
I
The Examiner has rejected all of the claims on appeal as indefinite, on
two bases. The Examiner rejects all of the claims because each of the
independent claims recites "washing with ... hot water." The Examiner
reasons that "[t]he term 'hot' is a relative term which renders the claims
indefinite" and therefore "the metes and bounds of the[] claims are
indefinite." Ans. 3--4.
2 Thanoo et al., US 5,945,126, issued Aug. 31, 1999.
3 R. Jeyanthi et al., Effect of Solvent Removal Technique on the Matrix
Characteristics of Polylactide/Glycolide Microspheres for Peptide Delivery,
38 Journal of Controlled Release 235-244 (1996).
4 Yi-Yan Yang et al., Effect of Preparation Conditions on Morphology and
Release Profiles of Biodegradable Polymeric Microspheres Containing
Protein Fabricated by Double-Emulsion Method, 55 Chemical Engineering
Science 2223-2236 (2000).
5 Thanoo et al., US 6,270,802 Bl, issued Aug. 7, 2001.
6 Thanoo et al., US 2005/0042294 Al, published Feb. 24, 2005.
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The Examiner also rejects claims 2 and 15 because they "recite the
limitation 'such as a hollow fiber system' and it is not clear whether the
phrase 'such as' is a limitation or whether it is merely listing disclosed
examples and/or embodiments." Id. at 4.
Appellants argue that "the 'hot water' wash is one of the three
methods for washing the resultant solid microparticles - 'water or air-sweep
or hot water or any combinations thereof."' Appeal Br. 12. Appellants also
argue that "the term 'such as' clearly suggests that any filtration methods
including the hollow fiber filter can be used." Id.
We reverse the rejection under 35 U.S.C. § 112, second paragraph.
"[A] patent is invalid for indefiniteness if its claims, read in light of the
specification delineating the patent, and the prosecution history, fail to
inform, with reasonable certainty, those skilled in the art about the scope of
the invention." Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 901
(2014) ( emphasis added).
We conclude that neither of the disputed limitations-"hot water" and
"such as a hollow fiber system"-results in any uncertainty in claim scope.
Each of the independent claims recites a "hot water" washing step; however,
they also encompass carrying out the washing step using "water" of any
temperature. The recitation of "hot water" therefore does not affect the scope
of the claims. Similarly, the recitation of "a hollow fiber system" in claims 2
and 15 does not affect the scope of those claims, because they encompass
processing liquid "through any method of separating liquid from
particulates."
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In summary, we conclude that the claim language identified by the
Examiner does not make the scope of the claims uncertain. We therefore
reverse the rejection under 35 U.S.C. § 112, second paragraph.
II
The Examiner has rejected claims 1, 2, 4--7, 9, and 12-15 as obvious
based on Thanoo '126, Jeyanthi, Yang, and Thanoo '802. The Examiner
finds that Thanoo '126 discloses a process meeting most of the limitations of
claim 1, and teaches that "a variety of solvent removal steps may be
employed, including dilution of the mixture with more CP [ continuous
phase], including infinite dilution." Ans. 7. The Examiner concludes that
"Thanoo [' 126] is therefore considered to render obvious, on its own, the
step of adding a third phase ( dilution composition) to the microparticle
mixture for the purpose of removing residual solvent." Id.
Nevertheless, the Examiner cites Jeyanthi and Yang "to further
illustrate the obviousness of this [dilution] step." Id. The Examiner finds that
"Jeyanthi reports on the effect of solvent removal techniques on the matrix
characteristics of micro spheres for peptide delivery." Id. "J eyanthi studies
two techniques for solvent removal, one of which, the 'Dilution (Dil)
technique', involves dilution of the CP (i.e. addition of a dilution
composition)" with "dilutions of 1.5 and 2.5 times the initial volume of the
CP (i.e. the dilution composition is 150-250% the volume of the CP)." Id. at
8. "Jeyanthi teaches that the Dilution technique ... resulted in microspheres
with a uniform, honeycomb-like pore structure" and "the volume of the
dilution composition affected the pore size." Id. The Examiner cites Yang as
evidence that pore size affects the release rate of microparticles. Id. at 9.
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As to maintaining a constant volume of liquid in the dilution vessel,
the Examiner finds that Thanoo "'802 teaches that it is important, where the
advantages of a generally continuous process are to be obtained, to
coordinate and control flow of material into and out of the formulating
vessel" in order to "keep[] the volume in the vessel approximately constant."
Id. at 10.
The Examiner concludes that it would have been obvious "to use a
dilution phase as suggested by Thanoo [' 126] and taught by Jeyanthi in the
process of Thanoo [' 126]" in order to "1) enhanc[ e] the solvent removal and
adjust[] the pore structure of the microparticles and 2) increas[ e] the speed
of microparticle formation." Id. The Examiner also concludes that it would
have been obvious "to maintain a constant volume in the vessel to which the
dilution phase is added ... since [Thanoo] '802 teaches that it is important,
where the advantages of a generally continuous process are to be obtained,
to coordinate and control flow of material into and out of such vessels." Id.
at 10-11. The Examiner also concludes that the washing step of claim 1
would have been obvious, because "Thanoo [' 126] teaches an air sweep
after forming the microparticles" and Thanoo "'802 teaches washing with
wash water, which can be done multiple times." Id. at 12.
We agree with the Examiner that the method of claim 1 would have
been obvious to a person of ordinary skill in the art based on the cited
references. Thanoo '126 discloses "a continuous process for producing
active agent containing polymer bodies, and more particularly
microspheres." Thanoo '126, 2:20-22. "Preferably, the method comprises
emulsifying [] dispersed and continuous phases in a manner adapted to cause
solidification of said dispersed phase polymer within about 10 seconds. Still
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more preferably solidification occurs within about 5 seconds." Id. at 3: 16-
20.
"In order to incorporate the active agent into the dispersed phase it is
usually necessary to dissolve the active agent in a solvent." Id. at 4:49--51.
Thanoo '126 teaches that the polymer used in its process can vary and
"[ s ]olvents for the polymer will also vary depending upon a number of
factors." Id. at 4:62, 6:38-39. "The polymer, active agent and solvent or
solvents are combined to form the dispersed phase." Id. at 6:60-61. "Any
suitable medium in which the dispersed phase will form droplets or
inclusions may be used as a continuous phase." Id. at 7:24--26.
"[T]he disperse phase should be introduced into a highly intense
mixing zone ... to cause a high rate of solvent removal from the dispersed
phase to the continuous phase and, preferably, corresponding to a high rate
of polymer solidification." Id. at 11 :42--47. "Once the emulsion of dispersed
phase and continuous phase is formed, the emulsion is continuously
transferred from the reaction vessel 10 to a solvent removal tank 22." Id. at
12:50-52.
Thanoo '126 exemplifies making microspheres (id. at 14:5-8) by
preparing a dispersed phase comprising a polymer (poly(lactide-co-
glycolide ), or PLGA), an active agent (leuprolide acetate), and solvents
(dichloromethane and methanol) (id. at 14:9--18); preparing a continuous
phase (0.35% polyvinyl alcohol in water) (id. at 14:26-29); feeding the two
phases into a reactor simultaneously (id. at 14:35-39); transferring
microspheres to a vessel (solvent evaporation tank; id. at 14:45--46);
removing solvent by constantly replacing the air in the head space of the
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tank (id. at 14:47-53); and filtering and washing with water for injection
(WFI; id. at 14:55-58).
Example 1 of Thanoo '126 does not include adding a third phase
comprising a dilution composition. However, Thanoo '126 states that
[ o ]ther solvent removal steps ... would be apparent to those of
ordinary skill in the art in view of the instant disclosure. Thus,
increased or infinite dilution with continuous phase, or
replacing solvent saturated continuous phase with fresh
continuous phase, the use of an air sweep and/ or vacuum and
the like can be used to extract additional solvent in the solvent
removal tank after formation of the microspheres.
Id. at 13:20-28.
Jeyanthi discloses that PLGA microspheres prepared by emulsification
using dilution of the continuous phase (CP) had a uniform, honeycomb-like
pore structure without a hollow core, with the pore size depending on the
volume of dilution composition used. Jeyanthi 235, abstract. That is,
"[fJollowing initial extraction of solvents ... during droplet formation,
subsequent solvent removal was achieved by dilution of the CP ... to
predetermined volumes." Id. at 236, bridging paragraph. "The internal pore
structure of biodegradable polymeric delivery systems plays an important
role in the release characteristics of the entrapped agents." Id. at 235, left col.
"At higher dilution, pores were larger since removal of CH2Cb [solvent] was
faster and polymer precipitation more rapid." Id. at 241-242. Yang states that
"[p ]orous micro spheres have a large surface area and hence have a high
initial burst. ... [T]he dilution/extraction technique resulted in uniform and
porous microspheres." Yang 2224, left col., citing Jeyanthi.
Thanoo '802 discloses "a method and apparatus for processing and
formulating active agent containing polymer bodies, and more particularly
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microspheres and microcapsules." Thanoo '802, 1 :53-56. "The method and
apparatus ... are most preferably employed to formulate microspheres
produced in accordance with the process disclosed in ... U.S. Pat. No.
5,945,126." Id. at 2:6-10. "It is important in the practice of the preferred
embodiment, where the advantages of a generally continuous process are to
be obtained, to coordinate and control flow of material into and out of the
formulating vessel 16[,] ... keeping the volume in the formulating vessel 16
approximately constant." Id. at 6: 1-10.
We conclude that a process meeting all of the limitations of claim 1
would have been obvious based on the above disclosures. Thanoo '126
discloses a process that includes most of the claimed steps, including
preparing dispersed and continuous phases; feeding a portion of the two
phases into a mixer under conditions that rapidly form microparticles (i.e.,
preferably within 5-10 seconds); transferring the microparticles to another
vessel for solvent removal; and washing the microparticles with water.
Thanoo '126 exemplifies a process in which residual solvent is
removed from the microparticles by evaporation, rather than by adding a
dilution composition as claimed. However, Thanoo '126 expressly suggests
"increased or infinite dilution with continuous phase, or replacing solvent
saturated continuous phase with fresh continuous phase" as "[ o ]ther solvent
removal steps ... [that] would be apparent to those of ordinary skill in the
art." Id. at 13:20-25. Thus, it would have been obvious to modify the
method of Example 1 in Thanoo '126 by substituting increased dilution with
continuous phase in place of the exemplified method of solvent evaporation.
In addition, Jeyanthi discloses that solvent removal by dilution results
in microparticles with a uniform honeycomb-like pore structure in which
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pore size varies based on the amount of dilution composition used, and Yang
discloses that the porosity of microspheres affects the rate of drug release
from them. Thus, it would have been obvious to vary the amount of
continuous phase used as dilution composition in order to achieve a desired
release rate for a given drug. See In re Boesch, 617 F.2d 272, 276 (CCPA
1980) ("[D]iscovery of an optimum value of a result effective variable in a
known process is ordinarily within the skill of the art."); In re Aller, 220
F.2d 454, 456 (CCPA 1955) ("[W]here the general conditions of a claim are
disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.").
Finally, Thanoo '802 discloses that achieving the advantages of a
continuous microparticle-formation process requires coordinating the flow
of materials into and out of a vessel, such as the solvent removal vessel of
Thanoo '126, to keep the volume of liquid in the vessel approximately
constant. In addition, as the Examiner pointed out (Ans. 11 ), common sense
dictates that liquids are added to and removed from a vessel at the same rate
in a continuous process, so that the vessel does not overflow or run dry
during the process.
In summary, the cited references disclose all of the limitations of
claim 1 and provide reasons for combining them. The claimed process
therefore would have been obvious to a person of ordinary skill in the art
based on the cited prior art.
Appellants argue that "Thanoo [' 126] 's suggestion of 'diluting the
mixture with more CP' is a part of the 'solvent removal step,' that occurs
after the completion of the microparticle formation process. By stark
contrast, the claimed method requires addition of measured amounts of
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dilution composition until the microparticle formation is complete." Appeal
Br. 15.
This argument is not persuasive, because it is contradicted by the
Thanoo Declaration.7 Dr. Thanoo states that, "[i]n contrast to Jeyanthi, the
process described in the Subject application is used to prevent the loss of
drug load, from microspheres that have already been formed." Thanoo Deel.
,r 8. "I developed the process of immediate formation of microspheres
(hardened particles) by subjecting a stream of dispersed phase ... and a
stream of continuous phase into a very high shear force." Id. Claim 1
requires that the dispersed phase and continuous phase are fed into a mixer
under conditions that form "microparticles that are sufficiently solid as to be
filterable."
Consistent with the claim language and Dr. Thanoo's description,
Appellants' Specification states that, "[ o ]nee the dispersed phase 12 and
continuous phase 14 are combined, the freshly formed microparticles ... are
generally sufficiently solid and filterable, such that they are suitable for the
continuous processing of microparticles using hollow fiber filter." Spec. ,r 3 8.
Dr. Thanoo states that the process disclosed by Thanoo '126 similarly
"causes the rapid solidification of dispersed phase polymer within about 10
seconds. These rapidly formed microspheres are both solid and filterable."
Thanoo Deel. ,r 9 ( citation omitted). "[T]hey could be concentrated by use of
a dialysis type (i.e. hollow fiber filter) filtration system and further processed
... because they were fully formed, hardened microspheres." Id.
7 Declaration under 37 C.F.R. § 1.132 of B.C. Thanoo, filed Feb. 13, 2005.
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Thus, as described in the Specification and in the Thanoo Declaration,
the claimed process and the process disclosed by Thanoo '126 both cause
rapid solidification of the dispersed phase to form hardened microparticles.
The Specification states that the disclosed process includes "adding a
measured amount of a dilution composition to the microparticle dispersion
after the microparticles have been formed; wherein the amount of the
dilution composition is sufficient to alter the release rate for the active
agent." Spec. ,r 3. Thus, read in light of the Specification, the recitation of
"adding a third phase comprising a dilution composition ... to reach a
combined volume of liquid until the solid microparticle formation process is
complete" ( claim 1) would reasonably be interpreted to mean that the
dilution composition is added, over time, until a sufficient amount has been
added to achieve the desired release rate for the active agent in the
microparticles.
Appellants distinguish the claimed process from the microparticle
formation process of Jeyanthi, on the basis that "Jeyanthi only adds a
dilution phase to sufficiently harden the soft microspheres" whereas "[ t ]he
dispersion as claimed ... consists of fully formed, solid and processable
microparticles." Appeal Br. 16-17.
The Examiner, however, cites Jeyanthi for its disclosures that dilution
results in specific morphology of the microparticles and that the amount of
added dilution composition affects pore size. The rejection, therefore, is not
based on following Jeyanthi's microparticle-formation process, but on
modifying the process of Thanoo '126 based on J eyanthi' s teachings.
Appellants also argue that "it would not have been obvious for a
person to experiment with the amount of dilution needed because the
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problem of drug loss was not encountered at the time of Thanoo' s
invention." Appeal Br. 16. Dr. Thanoo explains that "[i]n scaling up the
process of immediately formed microspheres, ... we noticed that the
microspheres were losing drug load ... due to residual solvent extracted
from the microspheres into the continuous phase." Thanoo Deel. ,r 10.
Dr. Thanoo states that "[ t ]he surprising result was that the addition of more
aqueous solution to the system (dilution) prevented the [] drug loss of the
micro spheres. The dilution process of the Subject Application was not to
form microspheres but to prevent the loss of drug and the change in drug
release profiles." Id.
Appellants argue that,
[l]ike the Thanoo '126 patent, the inventors of the '802 patent
did not encounter the problem of drug loss from formed
microspheres until the batch size of the microparticles was
increased. Hence, there was no motivation for the inventors at
the time of filing the '802 patent, or J eyanthi' s invention, or
Thanoo 's invention to add a dilution composition as required by
the independent claims 1, 5 and 13 to mitigate the effects of
increasing the batch size.
Appeal Br. 18.
These arguments are not persuasive. "In determining whether the
subject matter of a patent claim is obvious, neither the particular motivation
nor the avowed purpose of the patentee controls." KSR Int'! Co. v. Teleflex
Inc., 550 U.S. 398,419 (2007). "[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." Id. at 420.
Here, the references would have made it obvious to modify the
process of Thanoo '126 to include adding a dilution composition, in certain
amounts, in order to produce microparticles with uniform pores of specific
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sizes, in order to achieve a desired rate of release of an active agent, as
evidenced by J eyanthi and Yang.
To the extent that Appellants intend to rely on the "surprising result"
alleged in the Thanoo Declaration, we note that Appellants have not pointed
to evidence of record showing such results, nor have they provided any
comparison to a prior art process. "[I]t is well settled that unexpected results
must be established by factual evidence." In re Geisler, 116 F.3d 1465, 1470
(Fed. Cir. 1997). "[T]he results must be shown to be unexpected compared
with the closest prior art." In re Baxter Travenol Labs., 952 F.2d 388, 392
(Fed. Cir. 1991). Appellants' reliance, if any, on unexpected results as
evidence of nonobviousness is therefore unpersuasive.
We affirm the rejection of claim 1 under 35 U.S.C. § 103(a) based on
Thanoo '126, Jeyanthi, Yang, and Thanoo '802. Claims 2, 4--7, 9, and 12-15
were not argued separately and therefore fall with claim 1. 3 7 C.F .R.
§ 4I.37(c)(l)(iv).
The Examiner has also rejected all of the claims as obvious based on
Thanoo '126, Jeyanthi, Yang, Thanoo '802, and Thanoo '294. For the
reasons discussed above, we agree that claim 1 would have been obvious
based on Thanoo '126, Jeyanthi, Yang, and Thanoo '802. The Examiner's
additional reliance here on Thanoo '294 here does not change that
conclusion. We affirm the rejection of claim 1 under 35 U.S.C. § 103(a)
based on Thanoo '126, Jeyanthi, Yang, Thanoo '802, and Thanoo '294.
Claims 2, 4--9, and 12-15 were not argued separately and therefore fall with
claim 1. 37 C.F.R. § 4I.37(c)(l)(iv).
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III
The Examiner has rejected all of the claims on appeal for
obviousness-type double patenting based on the claims of either
Thanoo '126 or Thanoo '802, each in view of the other and in view of
Jeyanthi and optionally Thanoo '294. The Examiner concludes that the
instant claims are not patentably distinct from the claims of Thanoo '126 or
Thanoo '802 because the differences between the claims would have been
obvious based on the other Thanoo patent(s) and Jeyanthi. Ans. 19--20. We
find no error in the Examiner's reasoning or conclusion.
Appellants argue that the double patenting rejections should be
reversed for the same reasons presented in regard to the obviousness
rejections. Appeal Br. 20-21. Appellants' argument is unpersuasive for the
reasons discussed above. We therefore affirm both of the double patenting
rejections.
SUMMARY
We reverse the rejection of claims 1, 2, 4--9, and 12-15 under
35 U.S.C. § 112, second paragraph.
We affirm the rejection of claims 1, 2, 4--7, 9, and 12-15 under
35 U.S.C. § 103(a) based on Thanoo '126, Jeyanthi, Yang, and Thanoo '802.
We affirm the rejection of claims 1, 2, 4--9, and 12-15 under 35 U.S.C.
§ 103(a) based on Thanoo '126, Jeyanthi, Yang, Thanoo '802, and Thanoo
'294.
We affirm the rejection of claims 1, 2, 4--9, and 12-15 for
obviousness-type double patenting based on the claims of either
Thanoo '126 or Thanoo '802, each in view of the other and in view of
Jeyanthi and optionally Thanoo '294.
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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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