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 .
Response to Amendment
The amendment filed 4/6/2026 has been entered. Any previous rejection not reiterated herein has been withdrawn.
New Grounds of Rejection
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of 35 U.S.C. 103 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.
Claim(s) 20, 21 and 24-35 are rejected under 35 U.S.C. 103 as being unpatentable over Schltz WO 2015/058173 (Abbvie Inc., on IDS filed 10/10/2024) in view of Shenoy et al., (US 2009/0093617 A1, April 09, 2009).
Regarding claims 20-21 and 27, Schltz teaches formulations for stabilizing antibody (Ab) compositions, including for freeze/spray-drying, see pages 4-6. The formulations include polymers, such as HPMC and HPMCAS-LF (as the preferred polymer), see page 10 and 55. The Ab may be in a concentration of 20 mg/ml which is directly within the instantly claimed range, see for example, page 15. The formulations include acidic (HCl) compositions with histidine buffers at a pH of about 5.0-6.5, which is directly within the claimed range, see pages 32-33. Schltz teaches optimizing all of the conditions and amounts of components, which significantly overlap with the claimed ranges, see pages 37+.
Regarding claims 24-26, the Ab includes, monoclonals, humanized, fragments, etc. pages 26+.
Regarding claims 28-33, the formulations provide stabile forms that are stable for 12 months under various conditions, see pages 41+. Also it is noted that same compositions must have the same properties.
Regarding claim 34 and 35, Schltz teaches the formulations may be in various solid forms, and may be encapsulated with an enteric coating, including PLGA, which when spray-dried would be consider to be within the scope of a rod as claimed. Same components and same processes, must have the same result. Otherwise, such rods would an obvious design choice.
While Schltz clearly suggests the that the histidine buffer is histidine-HCl by stating that the compositions are acidic and buffered with histidine, Schltz fails to specifically recite histidine-HCl as the buffer.
However, histidine-HCl is a known histidine buffer as shown by Shenoy. Example 31 discloses the use of 0.495 mg/ml L-histidine HCI and 1.8 mg polysorbate 20 ([0275]).
As a whole it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the formulations disclosed by Schltz to arrive at the instantly claimed formulations since Schltz teaches the use of the same components in the formulations in overlapping ranges that may be optimized to provide for highly stable antibody formulations. It also would have been obvious to use histidine-HCl as the histidine buffer in Schltz since histidine-HCl is a known histidine buffer as shown by Shenoy.
Claim(s) 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over unpatentable over Schltz WO 2015/058173 in view of Shenoy et al., (US 2009/0093617 A1, April 09, 2009) as applied to claims 20, 21 and 24-35 above, and further in view of Bristol et al., (Impact of Hydroxypropyl Methylcellulose Acetate Succinate Critical Aggregation Concentration on Celecoxib Supersaturation, Nov. 05, 2021).
Schltz and Shenoy are discussed hereinabove.
Regarding claims 22 and 23, while Schltz broadly teaches the use of HPMCAS as a preferred polymer and teaches HPMCAS-LF, there is no specific teaching of HPMCAS-HF as claimed.
However, Bristol teaches that polymers play an important role in amorphous solid dispersions (ASDs), enhancing stability in the solid state and maintaining supersaturation in aqueous solutions of intrinsically low-water-soluble drug candidates. Bristol teaches the equivalency of all three grades of HPMCAS (HF/MF/LF), see for example, (Conclusions, page 4307).
It would have as a whole been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to substitute and/or use any of the HPMCAS grades in the invention of Schltz, including HPMCAS-HF, because Schltz teaches that HPMCAS, in general, is a preferred polymer and Bristol teaches the equivalency of all three grades of HPMCAS (HF/MF/LF).
Conclusion
No claims are allowed at this time.
To expedite and potential allowance in a subsequent action, it is suggested that, at least, claim 49 is canceled since this claim is withdrawn and it not subject to any potential rejoinder since it has not been kept within the same scope of the elected composition claim throughout prosecution.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael G Hartley whose telephone number is (571)272-0616. The examiner can normally be reached 10-6:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at 5712721424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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