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 of PCT/US2022/014750 02/01/2022, which claims benefit of 63/144,059 with a filing date 02/01/2021.
2. Claims 1-34 are pending in the application.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1 and 4 recites the limitation “amorphous form” without X-ray diffraction pattern data, is ambiguous and indefinite, i.e., see line 1 in claim 1 and 4. It is noted that a fully X-ray diffraction pattern data is the fingerprint characteristics of amorphous form compound. Incorporation of an X-ray diffraction pattern data into claims 1 and 4 respectively (i.e., claim 8) would obviate the rejection.
4. 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
5. 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 and 4 are rejected under 35 U.S.C. 103(a) as being obvious
Over Baker et al. US 6,087,358, and Frank et al. Molecular Pharmaceutics, 2019,16:
682-688.
Applicants claim an amorphous form of pretomanid, see claim 1. Dependent claims 2-3 further limit the scope of compound, i.e., the form in a solid dispersion.
Applicants claim an amorphous solid dispersion comprising pretomanid or a pharmaceutically acceptable salt thereof, see claim 4.
Determination of the scope and content of the prior art (MPEP §2141.01)
Baker et al. ‘358 discloses a compound 3S 4-(Trifluromethoxy)benzyloxy-6-nitro-2H-3,4-dihydro-[2-1b]imidazopyran (i.e., pretomanid) in a crystallized form (e.g. amorphous form), see Example 41 in column 45. Baker et al. ‘358 pretomanid ca be formulated with excipients or carrier solid dosage form including as oral, parenteral, or liquid form as inhalation form and for treating mycobacterial infection, see columns 19-20.
Frank et al. disclose that polymers are used for amorphous solid dispersions stabilization, which can decrease recrystallization of amorphous form of a pharmaceutical compound.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Baker et al. ‘358 and Frank et al. is that the instant claims are embraced within the scope of Baker et al. ‘358 and Frank et al. Baker et al. ‘358 and Frank et al. compound read on the instant claims 1 and 4.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1 and 4 prima facie obvious because one would be motivated to employ the composition and methods of use of Baker et al. ‘358 and Frank et al. to obtain instant invention.
It is prima facie obvious to combine teachings from Baker et al. ‘358 and Frank et
al. which provide compositions of pretomanid and methods of use comprising
compound/composition from Baker et al. ‘358 and Frank et al., each of which is taught
by the prior art to be useful for the same purpose, i.e., for treating mycobacterial
infection, to be used for the very same purpose. Therefore idea of combining them
flows logically from theirs having been individually taught in the prior art." In re
Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), see MPEP
2144.06.
The motivation to make the claimed complex or compositions and methods of use derived from the known composition and methods of use of Baker et al. ‘358 and Frank et al. would possess similar activity to that which is claimed in the reference.
Double Patenting
6. 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 1,4 and 10 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Taneja et al. co-pending application No. 17/628,263. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim an amorphous form of pretomanid, see claim 1.
Applicants claim a amorphous solid dispersion comprising pretomanid or a pharmaceutically acceptable salt thereof, and comprising one or more pharmaceutically acceptable excipients, see claims 4 and 10.
Taneja et al. ‘263 claims an oral pharmaceutical composition comprising a granulate comprising a pharmaceutically effective amount of pretomanid or a pharmaceutically acceptable solvate thereof, wherein the granulate has a bulk density in a range of about 0.3 to 0.8 g/mL, wherein the granulate has a particle size distribution such that no more than about 30 wt.% of the granulate is retained on an ASTM #60 (250pm) sieve, and wherein at least 40 wt.% of the pretomanid is dissolved within 20 minutes as measured in a USP-II Apparatus at 37 ±2°C in 0.5% hexadecyltrimethylammonium bromide (HDTMA) in 0.1N HCl, see claim 1.
The difference between instant claims and Taneja et al. ‘263 is that the instant claims are embraced within on the scope of Taneja et al. ‘263.
One having ordinary skill in the art would find the claim 1 prima facie obvious because one would be motivated to employ the compositions of Taneja et al. ‘263 to obtain instant invention.
The motivation to make the claimed compositions from the known compositions of Taneja et al. ‘263 would possess similar activity to that which is claimed in the reference.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim Objections
7. Claim 34 is objected to as being the following informalities: claim 34 shall
depend on claim 32.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
December 01, 2025