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 the Claims
Claims 2, 4-8, 22, and 25 have been cancelled previously. Claims 1, 3, and 9-21 are pending. Claims 9-20 stand withdrawn with traverse.
Claims 1, 3, and 21 are under current examination.
Withdrawn Rejections
All rejections not reiterated have been withdrawn.
Specifically with regard to the rejection under 35 USC §103 over Alakhov, Palepu, Kim, Buehler, and Kirincic has been withdrawn in view of the amendment to the claims to clarify that the claimed composition is a concentrate suitable for storage rather than a “ready-to-use” composition as had been recited in the claims filed 10/29/2025 and argued to patentably define over the cited art in the remarks filed on the same date.
A terminal disclaimer for US 17/262,608 is on file.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, and 21 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, lines 16 and 17 recites “…a maximum solubility…”. This language renders the claim indefinite because it suggests that there could be greater than one solubility of cabazitaxel in the composition. Amending the claim to recite "the solubility" would obviate the rejection. This will not raise concerns over antecedent basis because the solubility of a substance is an inherent property of the substance for a particular composition.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Response to Arguments
Applicant's arguments filed 03/13/2026 have been fully considered but they are not persuasive. Applicant’s comment on page 7 that claim 1 has been amended to address the indefiniteness rejection over the phrase “a maximum solubility” and “a solubility” is noted. The claim stands rejected because only one of the two incidences of “a maximum” was amended as stated.
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (WO2016/149162; publication date: 09/22/2016; cited in the IDS filed 11/23/2022).
With regard to claims 1, 3, and 21, Zhao discloses a composition for parenteral administration (i.e. an injection composition) comprising taxane compounds complexed with cyclodextrins and polyethylene glycol (abstract). Claim 1, as amended, requires the composition to be a concentrated aqueous solution suitable for storage. Zhao discloses that the invention is a concentrated composition that is diluted to the appropriate dose in a pharmaceutically acceptable aqueous medium and delivered parenterally to the patient that avoids potential exposure of medical personnel when using a lyophilized composition and also eliminates problems associated with incomplete dissolution, precipitation after dissolution, and frothing during dissolution (0036). Zhao teaches solutions of taxane that are designed to be stable for extended storage (0007, 0045 - 0051). In an embodiment, compositions contain a taxane, a b-cyclodextrin derivative, PEG, povidone (i.e. polyvinylpyrrolidone) and Zhao suggests weight ratios such as 1:50:30:5, 1:40:30:5, 1:60:20:5, 1:40:20:5, or 1:30:30:5 (0011). The composition further comprises water (claim 1, examples) and a weak acid such as citric acid in an amount sufficient to adjust the pH to between 3 and 8 (0030). The taxane may be cabazitaxel (0010), the cyclodextrin derivative may be sulfobutylether-b-cyclodextrin (0010), the PEG may be inter alia PEG300 or PEG400 (0010), and the povidone may be PVP K12 (0034).
Instant claim 1 requires that the composition be free of polysorbate and ethanol. Zhao’s intent is to formulate taxanes without using toxic additives such as polysorbates. Zhao discloses further that the composition can contain an alcohol suitable for parenteral administration (0011). While example composition contain ethanol (see e.g. table 3, para 0050), Zhao teaches any alcohol that is compatible with parenteral administration is suitable and teaches e.g. benzyl alcohol in addition to ethanol (0028). It would have been prima facie obvious to use any other parenterally acceptable alcohol in place of the ethanol in Zhao’s examples because such was within the broader scope of the invention.
With regard to the relative amounts of each substance recited in instant claims 1, 3, and 21, the examiner does not consider these limitations to patentably define over Zhao because the exemplary ratios taught by Zhao and listed supra are close to or fall within the claimed proportions. Moreover, Zhao directs the artisan of ordinary skill to seek compositions in which the taxane is solubilized and stable. It would have been merely routine to optimize the quantity of each enhancer of aqueous solubility (the specific cyclodextrin derivative, PEG and PVP) in order to reach optimal solubility for a particular taxane and cyclodextrin derivative. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). See MPEP 2141.03 and 2144.05(II)(A). In the instant case, Zhao suggests formulating cabazitaxel, suggests using sulfobutylether-b-cyclodextrin to increase solubility and also teaches that PEG300 or PEG400 in combination with polyvinylpyrrolidone can further enhance the solubility of the taxane-cyclodextrin derivative complex. Arriving at optimal amounts is not considered inventive within the meaning of 35 USC §103.
Similarly, the examiner does not consider the functional language recited in claim 1, “in the composition, a maximum solubility of cabazitaxel is ≥ 40 mg/ml and the solubility of cabazitaxel after dilution with a diluent is 0.1-0.26 mg/ml, and a crystal precipitation time in the diluent is about 6 hours to about 8 hours. Zhao directs the artisan of ordinary skill to formulate taxanes, including cabazitaxel, as concentrated solutions using the claimed solubilizing agents to increase aqueous solubility of the taxane. Examples contain a taxane, docetaxel at 10 mg/mL (0045) indicating tens of mg per mL solubility was achievable. Zhao teaches further that the composition can be diluted into saline or dextrose for intravenous administration and that one of ordinary skill can determine the requisite degree of dilution for cancer treatment (0036 and 0037). As the claimed solubilizing agents were known to be combined to serve the purpose of solubilizing cabazitaxel, the examiner considers it merely routine to optimize the ratios of each solubilizing agent to cabazitaxel to achieve a desired concentration for the concentrate or for the diluted solution. See above regarding the obviousness of routine experimentation.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3, and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
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 KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/ Primary Examiner, Art Unit 1617
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