Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Priority and Status of the Claims
1. This application is a 371 PCT/US2022/071462 03/31/2022, which claims benefit of the provisional application: 63168817 03/31/2021.
2. Claims 1-5, 7, 9-10, 12-13, 18-20 and 24-26 are pending in the application.
3. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
4. The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-5,7, 9-10, 12, 19-20 and 25-26 are rejected under 35 U.S.C. 103(a) as
being obvious over Stevens et al. US 2017/0114005 A1.
Applicants claim a pharmaceutical composition comprising consisting of about
100mg to about 125 mg of micronized solabegron or a pharmaceutically
acceptable salt er a derivative thereof, and a pharmaceutically acceptable excipient,
wherein at least 90% of the micronized solabegron has a particle size of about 0.1
micron to 30 microns and wherein the pharmaceutical composition is an immediate
release composition, see claim 1. Dependent claims 1-5 further limit the scope of
compositions, i.e., specific excipients including mannitol or sucrose or magnesium.
Applicants claim a method of treating overactive bladder or one or more
symptoms thereof, in a subject in need thereof, comprising orally administering to the
subject a pharmaceutical composition comprising consisting of a therapeutically effective
amount of about 100 mg to about 125 mg of micronized solabegron or a
pharmaceutically acceptable salt or a derivative thereof, and a pharmaceutically
acceptable excipient, wherein at least 90% of solabegron particles have a particle size
of about 0.1 micron to 30 microns and wherein the pharmaceutical composition is an
immediate release composition, see claim 9. Dependent claims 12, 19-20 and 25-26
further limit the scope of methods, i.e., specific sympotoms including frequency of
urinary urgency, dose and administration strategy.
Determination of the scope and content of the prior art (MPEP §2141.01)
Stevens et al. ‘005 discloses a pharmaceutical composition comprising: a
therapeutically effective amount of a solid compound according to Formula II:
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(i.e., solabegron) or a pharmaceutically acceptable salt,
stereoisomer, solvate or polymorph thereof; and at least one pharmaceutically
acceptable carrier or excipient, wherein the excipient, is selected from microcrystalline
cellulose, dicalcium phosphate, starch, magnesium stearate and/or lactose, see claim 20
in columns 18 and section [0058] in column 7. The administration dose of solabegron is
from 100 mg to 600 mg, see section [0058] in column 7. Stevens et al. ‘005 composition
cane formula as tablets, capusules, granules or powder, see section [0054] in column 7.
Stevens et al. ‘005 compositions are used for treating overactive bladder disorder
including urinary urgency, frequent urination, nocturia, urinating unintentionally and urge
incontinence, see section [0040] in column 5 and claim 22 in column 19.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Stevens et al. ‘005 is that the instant claims are embraced within the scope of Stevens et al. ‘005. Stevens et al. ‘005 compositions and methods of use read on the instant compositions and methods of use in claims1-5,7, 9-10, 12, 19-20 and 25-26.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-5,7, 9-10, 12, 19-20 and 25-26 prima facie obvious because one would be motivated to employ the compositions and methods of use of Stevens et al. ‘005 to obtain instant invention.
Moreover, the concentration of solabegron of Stevens et al. ‘005 is from 100 mg to about 600 mg, see section [0058] in column 7. The instant solabegron ranges from 100 mg to 125, see claims 1 and 9. The amount of a specific amount of ingredient solabegron of the instant composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, optimization of parameters (dose, administration strategy) from known compositions and methods of use of Stevens et al. ‘005 is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results based on factors such as the severity of the condition being treated for treating depression, see MPEP 2144.05. Therefore Stevens et al. ‘005 renders obviousness over the instant invention.
The motivation to make the claimed methods of use derived from the known compositions and methods of use of Stevens et al. ‘005 would possess similar activity to that which is claimed in the reference.
Double Patenting
5. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1 and 9 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Stevens et al. US 10,751,311, and over claim 2 of Stevens et al. US 11,691,944, over claim 2 of Stevens et al. US 12,435,026, over claim 32 of Stevens et al. US 10,065,922, over claim 11 of Stevens et al. US 10,844,004, and over claim 2 of Stevens et al. US 12,435,026 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a pharmaceutical composition comprising consisting of about
100mg to about 125 mg of micronized solabegron or a pharmaceutically
acceptable salt er a derivative thereof, and a pharmaceutically acceptable excipient,
wherein at least 90% of the micronized solabegron has a particle size of about 0.1
micron to 30 microns and wherein the pharmaceutical composition is an immediate
release composition, see claim 1.
Applicants claim a method of treating overactive bladder or one or more
symptoms thereof, in a subject in need thereof, comprising orally administering to the
subject a pharmaceutical composition comprising consisting of a therapeutically effective
amount of about 100 mg to about 125 mg of micronized solabegron or a
pharmaceutically acceptable salt or a derivative thereof, and a pharmaceutically
acceptable excipient, wherein at least 90% of solabegron particles have a particle size
of about 0.1 micron to 30 microns and wherein the pharmaceutical composition is an
immediate release composition, see claim 9.
Stevens et al. ‘311 claims a pharmaceutical composition comprising: an
immediate release composition comprising about 75 mg of solabegron and at least one
pharmaceutically acceptable carrier, and a delayed release composition comprising
about 200 mg of solabegron and at least one pharmaceutically acceptable carrier, and
wherein the pharmaceutical composition achieves a first plasma Cmax of about 0.5
μg/ml to about 4 μg/ml in about 0.75 hours to about 4 hours after administration, a
second plasma Cmax of about 0.5 μg/ml to about 4 μg/ml in about 6 hours to about
16 hours after administration, a first plasma Cmin of about 0.25 mg/ml to about 1.5
mg/ml between the first plasma Cmax and the second plasma Cmax in about 4
hours to about 8 hours after administration, a second plasma Cmin of about 0.01
mg/ml to about 1 mg/ml before about 24 hours after administration, and wherein the
second plasma Cmin is achieved after the second plasma Cmax, and wherein
the pharmaceutical composition reduces desensitization of a beta-3 adrenoceptor when
compared to an immediate release pharmaceutical composition comprising an equivalent
amount of solabegron administered twice daily, and wherein the pharmaceutical
composition is a solid, see claim 1 in column 30-31. Stevens et al. ‘311 compositions are
used for treating overactive bladder disorder including urinary urgency, frequent
urination, nocturia, urinating unintentionally and urge incontinence.
Stevens et al. ‘944 claims a pharmaceutical composition comprising: a
therapeutically effective amount of a solid compound according to Formula II:
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(i.e., solabegron) or a pharmaceutically acceptable salt, or
stereoisomer, thereof, wherein the solid compound is an anhydrous crystalline solid or
hydrated isopropanol solvate; and at least one pharmaceutically acceptable carrier or
excipient, see column 34. Stevens et al. ‘944 compositions are used for treating
overactive bladder disorder including urinary urgency, frequent urination, nocturia,
urinating unintentionally and urge incontinence.
Stevens et al. ‘026 claims a pharmaceutical composition comprising: a
therapeutically effective amount of a solid compound according to Formula II:
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(i.e., solabegron), wherein the compound is characterized by: an
x-ray powder diffraction pattern having peaks expressed in degrees 2θ at 17.6, 18.7, 19.6, 20.1, 20.5, 23.7, and 25.8; and a differential scanning calorimetry (DSC) thermograph exhibiting a very broad peak at about 67° C., a broad peak at about 131° C., and a narrow peak at about 180° C.; and at least one pharmaceutically acceptable carrier or excipient, see column 34. Stevens et al. ‘026 compositions are used for treating overactive bladder disorder including urinary urgency, frequent urination, nocturia, urinating unintentionally and urge incontinence.
Stevens et al. ‘922 claims a pharmaceutical composition comprising: a
therapeutically effective amount of a solid compound according to Formula II:
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(i.e., solabegron), and at least one pharmaceutically acceptable carrier or excipient, see column 38. Stevens et al. ‘922 compositions are used for treating overactive bladder disorder including urinary urgency, frequent urination, nocturia, urinating unintentionally and urge incontinence.
Stevens et al. ‘004 claims a pharmaceutical composition comprising: a
therapeutically effective amount of a solid compound according to Formula II:
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(i.e., solabegron), or a pharmaceutically acceptable salt or stereoisomer, in the form of a hydrate of isopropanol solvate; and at least one pharmaceutically acceptable carrier or excipient, see columns 34-35. Stevens et al. ‘004 compositions are used for treating overactive bladder disorder including urinary urgency, frequent urination, nocturia, urinating unintentionally and urge incontinence.
The difference between instant claims and Stevens et al. ’311, ‘944, ‘922, ‘004, and ‘026 is that the instant claims are embraced within the scope of Stevens et al. ’311, ‘944, ‘922, ‘004, and ‘026, and they read on the instant composition and methods of use in claims 1 and 9.
One having ordinary skill in the art would find the claims 1 and 9 prima facie obvious because one would be motivated to employ the compositions and methods of use of Stevens et al. ’311, ‘944, ‘922, ‘004, and ‘026 to obtain instant invention.
Moreover, the concentration of instant solabegron in the compositions ranges from 100 mg to 125, see claims 1 and 9, for example while Stevens et al. ‘922 represent a range from 100 mg to 600 mg, see column 15. The amount of a specific amount of ingredient solabegron of the instant composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, optimization of parameters (dose, administration strategy) from known compositions and methods of use of Stevens et al. ’311, ‘944, ‘922, ‘004, and ‘026 is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results based on factors such as the severity of the condition being treated for treating depression, see MPEP 2144.05. Therefore Stevens et al. ’311, ‘944, ‘922, ‘004, and ‘026 render obviousness over the instant invention.
The motivation to make the claimed compositions and methods of use derived from the known compositions and methods of use of Stevens et al. ’311, ‘944, ‘922, ‘004, and ‘026 would possess similar activity to that which is claimed in the reference.
Claim Objections
Claims 13, 18 and 24 are objected to as being dependent on rejected claims 1
and 9.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
December 30, 2025