DETAILED ACTION
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 .
Status of Claims
A new claim set was filed on 3/2/26 with the following:
Amended claims
59, 62, 110
Newly canceled claims
Newly added claims
Previously canceled claims
1-55, 66-108, 111-138
Previously withdrawn claims
Claims under instant examination
56-65, 109-110
Withdrawn Claim Objections/Rejections
The objections to claim 59 for minor informalities are hereby withdrawn in view of the claim amendments filed on 3/2/26.
The rejections of claims 62 and 110 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention are hereby withdrawn in view of the claim amendments filed on 3/2/26.
The rejections of claims 56-65 and 109-110 under 35 U.S.C. 103 as being unpatentable over Brough et al. (US 2009/0053315; published: Feb. 26, 2009; in IDS dated 11/24/23), in view of Paetz et al. (US 2013/0142871; published: Jun. 6, 2013; in IDS dated 11/24/23) are hereby withdrawn in view of the are hereby withdrawn in response to the Applicants arguments filed on 3/2/26.
Oath/Declaration
The 1.132 Declaration filed on 3/2/26 was considered and persuasive to overcome the previous claim rejections under 35 U.S.C 103(a). The declaration states that it was known in the art that DFX is poorly water soluble, has a very high melting point (264-265 ˚C), and demands a high drug load due to its high therapeutic dose (Declaration: p. 5, [11]). Declarant states that Paetz et al. (i.e., the secondary reference relied upon for the deficiencies of Brough et al.) describes its method of “melt processing” DFX, a binder and a disintegrant as resulting in DFX being “embedding in the excipients” such that the DFX preferably remains in crystalline form (directing attention to [0074]) and therefore, one of ordinary skill in the art would not understand Paetz as motivating one of skill in the art to convert DFX from a crystalline to amorphous form (Declaration: p. 6, [13]).
New Claim Rejections - 35 USC § 112(a) - New Matter
Applicant' s claim amendments have necessitated the following new grounds of rejection.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 62 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
37 CFR 1.118 (a) states that “No amendment shall introduce new matter into the disclosure of an application after the filing date of the application”. Specifically, the limitation of claim 62 that includes the phrase “by weight” is considered new matter.
It is noted that Applicants direct attention to [0029, 0035, 0042, 0050, 0065, 0078] of the originally filed specification for support for all claim amendments filed on 3/2/26. The Examiner first notes that there are no paragraph numbers recited in the originally filed specification, so the Examiner is assuming that such is the numbering in the US PGPub. After review of such paragraphs, the specification is silent with regards to measurement of the % of DFX in the composition. The specification does not indicate if the percent range is based on, for example, weight, volume or moles.
MPEP §2163.06 notes "If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981)." MPEP §2163.02 teaches that "Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP §2163.06 further notes "When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not "new matter" is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure".
Maintained Double Patenting
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. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
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 56-65 and 109-110 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10 of now U.S. Patent No. 11,439,650 in view of Brough et al. (US 2009/0053315; of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same pharmaceutical composition produced by thermokinetic compounding APIs with one or more pharmaceutically acceptable excipients (e.g., overlapping species of polymers) until melt blended into an amorphous composite. The difference is that the instant application requires the API to be deferasirox. However, Brough et al. teach the claimed method steps can be used to form an amorphous product of a poorly soluble API and excipients. Therefore, it would have been obvious to one of ordinary skill in the art to substitute any poorly soluble API into the method of Brough et al. Thus, the instant claims and the application claims are obvious variants.
Claims 56-65 and 109-110 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of now U.S. Patent No. 12,023,343 in view of Brough et al. (US 2009/0053315; of record). Although the conflicting claims are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same pharmaceutical composition made by a process or process of making the same pharmaceutical composition, wherein the process comprises thermokinetic compounding APIs with one or more pharmaceutically acceptable excipients (e.g., overlapping species of polymers) until melt blended into an amorphous composite. The difference is that the instant application requires the API to be deferasirox. However, Brough et al. teach the claimed method steps can be used to form an amorphous product of a poorly soluble API and excipients. Therefore, it would have been obvious to one of ordinary skill in the art to substitute any poorly soluble API into the method of Brough et al. It is also noted that the ‘343 method represents a species (with regards to additional ingredients, formulated as immediate, delayed or modified release, API particle size and additional processing method steps such as hot melt extrusion, melt granulation, compression molding, tablet compression, capsule filling, film-coating, or injection molding) within the scope of the instantly claimed genus. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cor. 1993). Thus, the instant claims and the application claims are obvious variants.
Claims 56-65 and 109-110 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 11,878,005. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to the same composition comprising the same compound (crystalline DFX), a second API, one or more pharmaceutically acceptable excipients (e.g., poly(vinyl acetate)-co-poly(vinylpyrrolidone) and a surfactant, wherein the thermokinetic compounding produces a melt blended pharmaceutical composite (an amorphous solid dispersion) comprising about 30-60% DFX (about 95% purity) and remains amorphous per x-ray diffraction analysis following storage in an open container at about 40 °C, relative humidity of about 75%, at five weeks and wherein the composite has a single glass transition temperature. The ‘005 claims are directed to the method of making the abovementioned composition, whereas the instant claims are directed to the composition. The difference is that the ‘005 method is directed to providing the abovementioned crystalline DFX and one or more pharmaceutically acceptable excipients and compounding the materials of the first step in a thermokinetic mixer at about 100-200 °C for 5-300 seconds to form the abovementioned composition. However, one of ordinary skill in the art would recognize that if he/she knew how to make the instantly claimed composition (method of ‘005), then it is obvious that the instant composition was known at the time of filing. Thus, the instant claims and the application claims are obvious variants.
Response to Arguments
Applicants’ arguments were directed to instantly withdrawn rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617