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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/3/2026 has been entered.
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
Examined Herein: 32-46
Priority
Acknowledgment is made of applicant's claim for priority under based upon an application filed in PRO 63/078,067 filed on 9/14/2020, PRO 63/227,180 filed on 7/29/2021, PRO 63/241,999 filed on 9/8/2021, and PCT/US2021/050091 filed on 9/13/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/27/2023, 12/3/2024, 10/28/2025, and 3/23/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings received on 3/7/2023 are accepted.
Withdrawn Rejections
The rejection of claims 32, 34, 35, and 38-46 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Sun is hereby withdrawn in view of Applicant’s amendments to claim 1 and persuasive remarks that Sun does not teach the claim limitations as amended. [Remarks 3/7/2023, Page 5-6]
The rejection of claims 32, 34, 35, 38, and 46 under 35 U.S.C. 102(a)(1) and 102(a)(2) over Malhotra is hereby withdrawn in view of Applicant’s amendments to claim 1 and persuasive remarks that Malhotra does not teach the claim limitations as amended. [Remarks 3/7/2023, Page 5-6]
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 nonobviousness.
Claims 32-46 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (US 2019/0083448 A1, Published 3/21/2019).
With respect to claim 32, Sun discloses a composition (Example 1) comprising cabazitaxel, methanol, human serum albumin (HSA), and a parenterally acceptable vehicle, water. [Sun, 0425-0426]
With respect to claim 33, Sun discloses the composition comprises 4 mg cabazitaxel, 10 mL methanol, and 1.2 g HSA. [Sun, 0425-0426]
With respect to claim 39, Sun discloses the composition is a clear, or transparent, solution free of visible particles or precipitates. [Sun, 0077, 0425-0426]
With respect to claim 40, Sun discloses the composition stays a clear, or transparent, solution free of visible particles or precipitates for about 24 hours. [Sun, 0426]
With respect to claim 44 and 45, Sun discloses the composition was filtered by a 0.22 µm aqueous phase filter. [Sun, 0425] Therefore, the composition does not comprise particles greater than 0.22 µm in size. [Sun, 0103]
Also, with respect to claim 32, Sun discloses a composition (Example 16) comprising cabazitaxel, methanol, human serum albumin (HSA), and a parenterally acceptable vehicle, water. [Sun, 0475]
With respect to claim 39, Sun discloses the composition is a clear, or transparent, solution free of visible particles or precipitates. [Sun, 0077, 0475]
With respect to claim 41, Sun discloses the concentration of cabazitaxel in the composition is about 0.16 mg/mL. [Sun, 0475] (This value was obtained by the following calculation: Concentration of cabazitaxel (mg/mL) = 15 mg cabazitaxel ÷ (28.3 mL methanol + 66 mL water) = ~0.159 mg/mL).
With respect to claim 42, Sun discloses the concentration of HSA in the composition is about 0.1 % w/v. [Sun, 0475] (This value was obtained by the following calculation: Concentration of HSA = (mass of solute (g) ÷ volume of solution mL) × 100% = 4.95 g HSA ÷ (28.3 mL methanol + 66 mL water) × 100% = 0.05 % w/v).
With respect to claim 43, Sun discloses the pH value of the composition is about 6.8. [Sun, 0477-0481]
Claim 32 recites the limitation “wherein the infusion composition is prepared by injecting a liquid composition comprising cabazitaxel, ethanol and citric an organic acid into an infusion bag or bottle containing an aqueous composition comprising human serum albumin in a parenterally acceptable vehicle, wherein mixing of the liquid composition and the aqueous composition is
done in an infusion bag/bottle” which is a product by process limitation. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." MPEP 2113(I) In the instant case, the claimed product is obvious from the product disclosed by Sun. Therefore, the claim is unpatentable even if the product disclosed by Sun was made by a different process. Furthermore, while the limitation “contained in an infusion bag/bottle” does not itself recite a process, the limitation is drawn to the preparation process rather than the product. The product is placed in an infusion/bottle bag as a part of the preparation process. Thus, for the same reasons described above, this limitation is also unpatentable.
Claim 34, 35, 38, and 46 recite limitations that merely narrows the product by process limitation defined above. For the same reasons described above, the claim is unpatentable even if the product disclosed by Sun was made by a different process. Accordingly, since the patentable limitations of claim 32 are obvious over Sun, the limitations of claim 34, 35, 38, and 46 have also obvious over Sun.
Sun does not disclose either composition comprises citric acid or ethanol. (Claim 32) Sun does not disclose the composition (Example 1) comprises ethanol. (Claim 33) Sun does not disclose either composition is at least 10% or 30% cabazitaxel in the composition is free (unbound in solution) cabazitaxel. (Claim 36 & 37)
However, with respect to claim 32 and 33, Sun discloses methanol and/or ethanol may function as the polar water miscible organic solvent in the composition. [Sun, 0106,0304, 0406]
Also, with respect to claim 32, Sun discloses citric acid is a buffer that may be added to the aqueous solution (water). [Sun, 0081]
With respect to claim 36 and 37, Sun discloses that, in some embodiments, the amount of cabazitaxel that is bound to the HSA in the aqueous solution is at least 40-100%. [Sun, 0102] This teaching implies that about 0-60% of cabazitaxel in the composition is free (unbound in solution).
Modifying the compositions disclosed by Sun by substituting methanol for ethanol and adding citric acid to the aqueous solvent results in the composition of claim 32 and 33.
Modifying the composition disclosed by Sun so that 0-60% of cabazitaxel in the composition is free (unbound in solution), results in the composition of claim 36 and 37.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Sun by substituting methanol for ethanol and have a reasonable expectation of success. Sun discloses a composition comprising a water miscible organic solvent, methanol. Sun further discloses ethanol is also a water miscible organic solvent and may function as such in the composition. In view of this express teaching by Sun, it is reasonable to expect the composition may be modified by substituting methanol for ethanol. One would have been motivated to do so because it is prima facie obvious to substitute functional equivalents known for the same purpose, when the equivalency is recognized in the prior art. MPEP 2144.06 In the instant case, Sun discloses methanol and ethanol are both water miscible organic solvents suitable for use in the composition, thereby recognizing them as functional equivalents. Therefore, one of ordinary skill in the art would be motivated to substitute a water miscible organic solvent for another known water miscible organic solvent.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Sun by adding citric acid to the aqueous solution (water) and have a reasonable expectation of success. Sun discloses a composition comprising an aqueous solution. Sun further discloses a buffer like citric acid may be added to the aqueous solution. In view of this express teaching by Sun, it is reasonable to expect the composition may be modified by adding citric acid to the aqueous solution (water). One would have been motivated to do so because it is prima facie obvious to modify a prior art reference when some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to do so. MPEP 2144(I) In the instant case, Sun discloses buffers like citric acid may be used to render the formulation suitable for parenteral administration and compatible with the blood of the intended recipient. Therefore, one would have been motivated by the expectation that the aforementioned modification could confer compatibility between the composition disclosed by Sun and the blood of the intended recipient, particularly in the context of parenteral administration.
It would be obvious to one of ordinary skill in the art to modify the composition disclosed by Sun so that 40-60% of cabazitaxel in the composition is free (unbound in solution) and have a reasonable expectation of success. Sun discloses an aqueous solution comprising cabazitaxel and HSA. Sun further discloses that, in some embodiments, the amount of cabazitaxel that is bound to the HSA is at least 40-100%, which implies 0-60% of cabazitaxel in the composition is free. In view of this implicit teaching, it is reasonable to expect the composition disclosed by Sun may be modified so that 0-60% of cabazitaxel in the composition is free. One would have been motivated to do so because it is prima facie obvious to modify a prior art reference when some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to do so. MPEP 2144(I) In the instant case, Sun implicitly discloses that in one embodiment, 0-60% of cabazitaxel in the composition is unbound in solution. Therefore, one of ordinary skill in the art would have been motivated to modify the composition so that fraction of free cabazitaxel falls within the range suggested by the prior art.
Response to Arguments
Applicant’s arguments, filed 3/7/2023, with respect to the rejections under 35 U.S.C. 102(a)(1) and 102(a)(2) over Sun and Malhotra have been fully considered and are persuasive. Applicant’s arguments essentially state that Sun and Malhotra do not teach the claimed composition, as amended. Therefore, the rejection has been withdrawn. [Remarks 3/7/2023, Page 5-6]
However, Applicant is reminded that the instant claims are drawn to a composition not a method of preparing a composition. Any limitation (with rare exceptions) drawn to preparing the composition constitutes a product-by-process limitation and does not patentably distinguish the claimed composition from the prior art.
Applicant's arguments with respect to the rejection under 35 U.S.C 103 over Sun have been fully considered but they are not persuasive.
Applicant asserts “Further, as shown, for example, in Example 13 of the present application, a composition comprising citric acid provides a surprising improvement in the stability of cabazitaxel in organic solvents. This result would not have been expected by a POSITA based on Sun, which says nothing about citric acid improving the stability of cabazitaxel compositions.” [Remarks 3/7/2023, Page 7, Paragraph 2]
Applicant’s arguments are not persuasive because Sun identifies citric acid as a buffer. It is well established that buffers stabilize compositions by maintaining a consistent pH. Therefore, it is not surprising that a buffer, such as citric acid, stabilizes cabazitaxel in organic solvents.
Moreover, allegations of unexpected results should be made in accordance with MPEP 716.02. Namely, to establish that the claimed invention unexpectedly differs from the prior art, Applicant must (1) provide evidence demonstrating that the claimed invention in fact achieves unexpected results, (2) the results are unobvious and of both statistical and practical significance, (3) the evidence is commensurate in scope with the claims, and (4) the claimed invention is compared with the closest prior art. Applicant has not provided such evidence and the mere assertion of surprising improvement in stability is insufficient to overcome the rejection of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAILA A CRAIG whose telephone number is (703)756-4540. The examiner can normally be reached Monday-Friday 0800-1600.
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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