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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/09/2026 has been entered.
Applicants' arguments, filed 04/09/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1, 2, 5, 6, 21-23, and 34 are pending and under examination.
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 1, 2, 5, 6, 21-23, and 34, stand rejected under 35 U.S.C. 103 as being unpatentable over Sun (US 20180289818 A1) in view of Machado et al (US 20090221688 A1), as evidenced by Robinson (Merck Manual, 2023).
Sun teaches compositions comprising docetaxel and human serum albumin comprising a mixture of an organic solution of docetaxel and polar organic solvent (i.e., the first liquid composition) and a first aqueous solution of water and human serum albumin (i.e., the second aqueous composition) (abs, ¶¶ 53-56, 290). As evidenced by Robinson water is a parenterally acceptable vehicle (Parenteral Route of Administration and Dosage Forms). The polar organic solvents include ethanol (¶¶ 285, 288). In some embodiments, the aqueous formulation can be free of surfactants including polysorbate 80 (¶ 17). Polysorbate 80 was known to be attributed to side-effects including the occurrence of unpredictable hypersensitivity reactions and cumulative fluid retention (¶ 4). Formulations of docetaxel and polysorbate 80 needed to be administered within 4 hours due to limited stability (¶ 4). In some embodiments, the formulation is a clear aqueous solution (transparent and free of visible particles or precipitation of undissolved docetaxel, ¶ 162) for at least 2 hours, at least 4 hours, at least 6 hours, at least 8 hours, at least 24 hours, at least 48 hours, or at least 72 hours (¶¶ 118, 198). The compositions can be administered to patients (¶ 40) via various routes, such as parenterally, including intravenous, etc. (¶ 187). The compositions are suitable for sterile formulations, including sterile injection solutions, suspensions, etc. (¶ 155). The compositions may further include a pharmaceutically acceptable carrier (¶ 169), such as saline (¶ 171). Docetaxel in free base and in salt form are suitable (¶ 142). Organic acids can be included in the formulations (¶ 142). The amount of first aqueous solvent in the first aqueous solution is from about 0.01 mL to about 10 mL per 1 mg of human serum albumin (¶ 293), resulting in 0.01-10% (w/v). The volume ratio of water to the amount of polar organic solvent ranges from about 1:1 to about 1000:1 (¶ 298). In a particular embodiment, 10 mg docetaxel was dissolved in 10 mL polar organic solvent with the aqueous phase having 20 mL of water (ex. 1), thereby resulting in about 0.33 mg/mL of docetaxel in the mixed composition. Sun teaches the appropriate doses of docetaxel will vary depending on condition to be treated, severity of the disease, etc., as recognized by those skilled in the art (¶ 217).
Sun does not teach an embodiment as instant claimed comprising ethanol, the intended use limitations of claims 2 and 21, an embodiment as instantly claimed comprising an organic acid, an embodiment as instantly claimed comprising human serum albumin in the ratio of claim 6, an embodiment as instantly claimed wherein the first liquid composition is a sterile solution, nor an embodiment as instantly claimed wherein the resulting concentration of docetaxel are those of claim 23.
Machado et al teach highly stable pharmaceutical compositions containing docetaxel where it was known to further include an organic acid with a pKa between 2.5-4.5 as a degradation inhibitor for docetaxel (abs). The addition of the organic acid inhibits the epimerization of docetaxel to 7-epi-docetaxel, which has prejudicial effects (¶ 27). It was discovered that the addition of a degradation inhibitor can increase the shelf-life of the dosage forms when stored at room temperature, and therefore increases the stability of the pharmaceutical preparations while avoiding the formation of undesirable degradation products (¶ 28). The degradation inhibitors that may be employed, include, but are not limited to, citric, tartaric, and ascorbic acids, or other organic acids with a pKa between 2.5 and 4.5 (¶ 29).
Regarding the ethanol of claim 1, it would have been obvious to formulate the first liquid composition of Sun by selecting from polar organic solvents taught to be suitable, such as ethanol.
Regarding the organic acid of claim 1, it would have been obvious to further include an organic acid, where organic acids were known to act as degradation inhibitors for docetaxel, in order to inhibit the degradation of docetaxel into 7-epi-docetaxel, and improve docetaxel stability and the shelf-life of the formulations, as taught by Machado et al.
Regarding the parenterally acceptable vehicle of claim 1, where the second aqueous composition of Sun comprises human serum albumin and water, a parenterally acceptable vehicle as evidenced above, the limitation is met.
Even if water would not be a suitable parenterally acceptable vehicle according to the instant invention, it would have been obvious to formulate the second aqueous composition with other known parenterally acceptable vehicles, including saline, as taught by Sun, where Sun teaches the formulations are suitable for parenteral formulations that can be administered intravenously, etc.
Regarding the polysorbate 80 of claim 1, it would have been obvious to formulate the first and second compositions free of polysorbate 80, where polysorbate 80 was known to have negative side effects and compositions of docetaxel and polysorbate 80 have limited stability, as taught by Sun.
Regarding mixing in less than 24 hours prior to administration of claim 1, this limitation is intended use where the instant claim appears to be directed to a first and second composition to be mixed at a later time (i.e., less than 24 hours prior to administration). Therefore, where the first and second compositions of Sun are formulated separately, and are taught to be mixed, it appears the first and second compositions are capable of being mixed at any time, including less than 24 hours prior to administration to a patient, thereby meeting the intended use limitation. Further, a skilled artisan would recognize that the compositions of Sun would not be stable indefinitely, where it is taught that the aqueous formulations are clear (i.e., stable) for at least 2 hours, at least 72 hours, etc., and would therefore have motivation to mix the components at a reasonably short time prior to administration, such as less than 24 hours.
Regarding claims 2 and 21, where the instant claims are directed to a pharmaceutical formulation comprising a first and second composition that are mixed at a later time, as discussed above, it appears that first and second compositions of Sun would be capable of being mixed in a variety of containers known to the skilled artisan, including infusion bags or bottles, thereby meeting the intended use limitation.
Further, regarding the injecting limitation of claim 21, it appears the first liquid composition of Sun would be capable of being injected into an infusion bag or bottle containing the second aqueous composition, where the claim is simply directed to the intended use of combining two liquids in an infusion bag or bottle and where Sun teaches the first and second compositions are mixed together.
Regarding claim 5, where the second aqueous composition of Sun comprises human serum albumin and water, a parenterally acceptable vehicle as evidenced above, the product by process limitations are met.
Even if water would not be a suitable parenterally acceptable vehicle according to the instant invention, it would have been obvious to formulate the second aqueous composition with other known parenterally acceptable vehicles, including saline, as taught by Sun, where Sun teaches the formulations are suitable for parenteral formulations that can be administered intravenously, etc.
Regarding claim 6, it would have been obvious to formulate the second aqueous composition of Sun with a concentration of human serum albumin from about 0.01-10% (w/v), as taught by Sun (from the calculations above), thereby overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 22, while Sun does not specifically disclose that the first liquid composition is a sterile solution, Sun does teach the formulations are suitable for various sterile formulations. Therefore, it would be expected that the first liquid composition would be a sterile solution. Even if not, when formulating a pharmaceutical composition, a skilled artisan would recognize that the pharmaceutical formulation would need to be sterile in order to avoid infection, etc., prior to its administration to a patient.
Regarding claim 23, it would have been obvious to formulate the first and second compositions of Sun that would result in a docetaxel concentration upon mixing, in known amounts from the working embodiments of Sun, such as about 0.33 mg/mL, falling within the claimed range. Further, as taught by Sun, the docetaxel concentration can vary and a skilled artisan can adjust the amounts accordingly, depending on the desired treatments, severity of the disease, etc., in order to optimize the therapeutic properties of the resulting pharmaceutical formulations. 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. Where 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. See MPEP 2144.05(II)(A).
Regarding claim 34, where the inclusion of an organic acid is made obvious above, it would have been obvious to select from suitable organic acids known to inhibit degradation of docetaxel and improve the stability of docetaxel formulations, such as citric acid, tartaric acid, ascorbic acid, etc., as taught by Machado et al.
Response to Arguments
First, Applicant asserts that Sun makes clear that docetaxel has very poor water solubility and that, consequently, the clinical intravenous administration of commercially available docetaxel is formulated in a highly concentrated solution containing docetaxel and polysorbate 80. Applicants assert the reasonable expectation of stability with excluding polysorbate 80 appears to be based on a period of at most 3 days in Sun. Applicants assert for comparison, the Machado formulations, all of which contain polysorbate 80, stability is measured for a period of 6 to 30 months. Applicants assert the skilled artisan would look to the relevant time periods for guidance.
Second, Applicants assert that Machado’s compositions are distinct from the instantly claimed formulation in that they contain polysorbate 80, whereas the present claims exclude polysorbate 80. Applicants assert it would not have been obvious to remove such a feature in Machado to obtain a formulation that does not contain polysorbate 80, where applicants assert polysorbate 80 is an advantageous feature that provides stability and solubility to docetaxel.
Third, Applicants assert that Machado teaches that the stabilizing effect of organic acids on docetaxel is neither uniform nor predictable, where not all of the acids examined were adequate to obtain superior stability. Applicants assert that this demonstrates that, in order to obtain additional stability it is necessary to add one or more acid with unique characteristics. Applicants assert this is a result of the complex interaction between the components of the compositions and involves various factors. Applicants note that the strongest acid used by Machado, maleic acid with a first pK of 1.94, does not provide the greatest stability. Applicants assert that these results suggest that it is not the organic acid, but the combination of organic acid and polysorbate 80 that determines the stability of docetaxel to epimerization.
First, respectfully, this argument is not persuasive. Sun appears to be discussing a known commercial formulation of docetaxel in the prior art, of which the reference is trying to improve upon. While Sun teaches docetaxel has poor water solubility, the reference also teaches, in the same paragraph, that docetaxel administration is associated with the occurrence of unpredictable hypersensitivity reactions and cumulative fluid retention, which is attributed, in part, to the presence of polysorbate 80, and Sun aims to formulate a stable and non-toxic formulation of docetaxel. From this, and where Sun teaches polysorbate 80 can be excluded, it would have been reasonably expected that a stable formulation, which is one of the goals of Sun, can be achieved without the use of polysorbate 80.
Regarding the stability argument, the examiner notes that the claims are directed to a first and second liquid that can be mixed at a later time, such as immediately prior to administration, similar to what is taught by Sun. Applicants assert that without polysorbate 80, the reasonable expectation of stability would be at most 3 days, however, Sun teaches that the mixed compositions are clear for at least 3 days, not at most 3 days, and are taught as being stable (see ¶¶ 25, 134). Accordingly, the skilled artisan would recognize that the stability of at least 3 days of Sun after mixing would be suitable for administration within 24 hours after mixing, as required by the claims. Purely arguendo, even if there would be some expectation of less stability when excluding polysorbate 80, the resulting mixtures would be expected to be stable for at least long enough to meet the intended use of being mixed less than 24 hours prior to administration, were the reference teaches stable formulations where polysorbate 80 can be excluded. The skilled artisan would have motivation to formulate the composition of Sun without polysorbate 80, in order to avoid the negative side effects, while having the reasonable expectation that the compositions would be capable of being mixed less than 24 hours prior to administration, as recited in the instant claim.
Second, respectfully, this argument is not persuasive. Machado was simply relied upon for teaching organic acids, including citric acid, etc., were known to serve as a degradation inhibitors for docetaxel, inhibiting the epimerization of docetaxel to 7-epi-docetaxel, which has prejudicial effects; and increases the shelf-life and stability of the dosage forms. The reference was not relied upon for motivation to formulate a docetaxel formulation without polysorbate 80, as motivation for doing so was provided by Sun.
Third, respectfully, this argument is not persuasive. The reference teaches organic acids with a pKa between 2.5-4.5 were known to act as degradation inhibitors of docetaxel. Machado recognizes the harmful and toxic effects of docetaxel degradation, and aims to prevent its degradation. Machado generally teaches that it is advantageous to add at least one weak organic acid and/or antioxidant, in the preparation of pharmaceutical solutions of docetaxel, where this addition inhibits the epimerization to 7-epi-docetaxel whose prejudicial effects have been previously exposed. While there may be some variation in the results presented in tables 1 and 2 of Machado, all of the suitable organic acids taught by Machado as degradation inhibitors of docetaxel appear to be improved over compositions without the organic acids. Additionally, Machado appears to suggest that the biocompatible vehicle, preferably polysorbate 80, will also act to epimerize docetaxel without the inclusion of the organic acids. Accordingly, it appears that the agent responsible for inhibiting degradation of docetaxel is the organic acid, and not necessarily the combination of polysorbate 80 and organic acid, where polysorbate 80 acts to degrade docetaxel. Obviousness requires only a reasonable expectation of success, not absolute expectation of success; at least some degree of predictability is all that is required. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See MPEP 2143.02. Following these teachings, the skilled artisan would reasonably expect that the addition of the organic acids taught by Machado would function to help prevent or limit the degradation of docetaxel in the compositions made obvious above by Sun, which is taught to be desirable by Sun and Machado.
Claims 1, 2, 5, 6, 21-23, and 34, are rejected under 35 U.S.C. 103 as being unpatentable over Sun (US 20180289818 A1) in view of Machado et al (US 20090221688 A1), and De et al (US 20070082838 A1, hereinafter “De”, cited on IDS dated 01/12/2026), as evidenced by Robinson (Merck Manual, 2023).
Sun and Machado et al are discussed above, and additional motivation for including organic acids to the composition made obvious above is provided by De.
De teaches stable pharmaceutical compositions of poorly water soluble pharmaceutical agents and stabilizing agents which function to increase stability of the compositions (abs). The use of stabilizing agents provide extended stability of formulations of poorly water soluble pharmaceutical agents such as docetaxel under certain conditions, for example upon dilution for administration (abs). Stabilizing agents include citric acid, etc., wherein the stability of the composition is enhanced as compared to that of a composition without the stabilizing agent (¶¶ 19, 39, 71, 72).
It would have been obvious to further include an organic acid, where organic acids were known to act as degradation inhibitors for docetaxel, in order to inhibit the degradation of docetaxel into 7-epi-docetaxel, and improve docetaxel stability and the shelf-life of the formulations, as taught by Machado et al. Additionally, where De teaches stabilizing agents including citric acid, etc., were known to improve the stability of docetaxel formulations, it would have been obvious to further include citric acid, in order to enhance docetaxel stability compared to that of a composition without the stabilizing agent.
The additional limitations of claims 1, 2, 5, 6, 21-23, and 34, are rejected for the same reasons discussed above as applied to each and every claimed limitation.
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 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 5, 6, 21-23, and 34, stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/325,311, hereinafter ‘311. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘311 disclose a method for preparing a pharmaceutical formulation comprising docetaxel, or a pharmaceutically acceptable salt thereof, and human serum albumin, comprising a first liquid composition comprising docetaxel and ethanol in an infusion bag and a second aqueous composition comprising human serum albumin and a parenterally acceptable vehicle, wherein the formulation does not contain polysorbate 80, and wherein the first liquid composition and the second liquid composition are mixed in less than 24 hours prior to being infused or administered to patients (claim 1). The formulation further comprises an organic acid (claim 2). The limitations of instant claims 2, 5, 6, 21, 22, and 23 are the same limitations recited in claims 2-7 of ‘311.
The claims of ‘311 do not disclose wherein the organic acid is those of claim 34.
Machado et al are discussed above.
It would have been obvious to include known organic acids known to improve the stability of docetaxel, such as citric, tartaric, and ascorbic acids, as taught by Machado et al.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants assert the ‘311 application is a later-filed child of the present application. Applicants assert the present application was filed earlier than the ‘311 application and is therefore the first, and thus, Applicants assert the ‘311 reference is not a proper ODP reference that can be used to invalidate any claims of the present application.
Respectfully, this argument is not persuasive. According to MPEP 804(I)(B)(1)(b)(i), if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent. Thus, where the provisional double patenting rejection over the claims of the ‘311 application is not the only rejection remaining in the application having the earlier patent term filing date, the rejection is maintained.
Claims 1, 2, 5, 6, 21-23, and 34, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/839,035 (newly published, reference application), hereinafter ‘035, in view Machado et al (US 20090221688 A1) and De et al (US 20070082838 A1, hereinafter “De”, cited on IDS dated 01/12/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘035 disclose a pharmaceutical composition prepared by injecting a first liquid composition comprising docetaxel and ethanol into an infusion bag or bottle containing a second aqueous composition comprising human serum albumin in a parenterally acceptable vehicle (claim 1). The composition does not include polysorbate 80 (claim 1). The composition is prepared within 24 hours prior to being infused to a patient (claim 1). The concentration of human serum albumin is from about 0.01% to about 20% (w/v) (claim 4). The concentration of docetaxel in the formulation is from about 0.05 mg/ml to about 0.5 mg/ml (claim 3).
The claims of ‘035 do not disclose the addition of an organic acid, or the specifically wherein the first liquid composition is sterile.
It would have been obvious to include an organic acid, such as citric, tartaric, and ascorbic acids, for the same reasons discussed above by Machado et al. Additional motivation is provided by De, where stabilizers, including citric acid, were known to improve the stability of docetaxel formulations compared to those without, for the same reasons discussed above.
It would have been obvious to formulate the human serum albumin solution of ‘035 with a concentration of human serum albumin from about 0.01-10% (w/v), as taught by Sun, thereby overlapping the claimed range, where both are drawn to pharmaceutical formulations comprising docetaxel and human serum albumin.
Regarding the sterile first liquid, where the composition of ‘035 is a pharmaceutical composition for infusion to a patient, it would have been obvious to formulate the first liquid composition as a sterile solution, where the skilled artisan would recognize is desirable for pharmaceutical formulations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants assert present claim 1 recites an organic acid, which is absent from the claims of the ‘035 application. Applicants assert Machado does not cure the above defect of the ‘035 claims for the same reasons discussed above.
Respectfully, this argument is not persuasive. It would have been obvious to modify the claims of the ‘035 application to further include an organic acid, for the same reasons discussed above and of record.
Claims 1, 2, 5, 6, 21-23, and 34, are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12090134, hereinafter referred to as ‘134, in view of Sun (US 20180289818 A1), Machado et al (US 20090221688 A1), and De et al (US 20070082838 A1, hereinafter “De”, cited on IDS dated 01/12/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘134 disclose a pharmaceutical composition comprising docetaxel and human serum albumin, wherein the composition is a clear aqueous solution, wherein the composition is prepared by: obtaining an organic solution of docetaxel in a polar-miscible organic solvent; obtaining a first aqueous solution comprising human serum albumin; and mixing the organic solution of docetaxel and the first aqueous solution of human serum albumin to obtain a second aqueous solution comprising the composition comprising Docetaxel and human serum albumin. The water-miscible organic solvent is ethanol. The mixing comprises adding the organic solution comprising docetaxel to the first aqueous solution comprising human serum albumin.
The claims of ‘134 do not disclose the addition of an organic acid, the concentration of human serum albumin of claim 6, wherein the first liquid composition is sterile, the intended use limitations of being mixed less than 24 hours prior to administration, or mixed or injected into an infusion bag or bottle, nor the docetaxel concentration of claim 23.
Sun, Machado et al, and De, are discussed above.
It would have been obvious to include an organic acid, such as citric, tartaric, and ascorbic acids, where organic acids were known to act as degradation inhibitors for docetaxel, in order to inhibit the degradation of docetaxel into 7-epi-docetaxel, and improve docetaxel stability and the shelf-life of the formulations, as taught by Machado et al. Additional motivation is provided by De, where stabilizers, including citric acid, were known to improve the stability of docetaxel formulations compared to those without, for the same reasons discussed above.
It would have been obvious to formulate the human serum albumin solution of ‘134 with a concentration of human serum albumin from about 0.01-10% (w/v), as taught by Sun, thereby overlapping the claimed range, where both are drawn to pharmaceutical formulations comprising docetaxel and human serum albumin.
Regarding the intended use limitations, where the solutions of ‘134 are formulated separately, and are mixed, it appears the solutions are capable of being mixed at any time, including less than 24 hours prior to administration to a patient, thereby meeting the intended use limitation. Further, it appears where the claims of ‘134 disclose the mixing is adding the organic solution to the first aqueous solution, that the organic solution would be capable of being injected into an infusion bag or bottle containing the first aqueous solution, thereby meeting the intended use limitation.
It appears that the solutions compositions of ‘134 would be capable of being mixed in a variety of containers known to the skilled artisan, such as infusion bags or bottles, thereby meeting the intended use limitation, and for the same reasons discussed above.
Regarding the amount of docetaxel, it would have been obvious to formulate the compositions of ‘134 that would result in a docetaxel concentration upon mixing, in known amounts from the working embodiments of Sun, such as about 0.33 mg/mL, falling within the claimed range. Further, as taught by Sun, the docetaxel concentration can vary and a skilled artisan can adjust the amounts accordingly, depending on the desired treatments, severity of the disease, etc., in order to optimize the therapeutic properties of the resulting pharmaceutical formulations.
The claims of the following are also rejected in view of Sun (US 20180289818 A1), Machado et al (US 20090221688 A1), and De et al (US 20070082838 A1, hereinafter “De”, cited on IDS dated 01/12/2026), for the same reasons discussed above:
U.S. Patent No. 12090135, hereinafter referred to as ‘135, drawn to a pharmaceutical composition of docetaxel and human serum albumin comprising: an organic solution of docetaxel and a first aqueous solution of human serum albumin. The organic solvent is ethanol.
The claims of ‘135 do not disclose the addition of an organic acid, wherein the first liquid composition is sterile, the intended use limitations of being mixed less than 24 hours prior to administration, or mixed or injected into an infusion bag or bottle, nor the specific docetaxel concentration of claim 23.
It would have been obvious to modify the claims of ‘135 to include the organic acid, such as citric, tartaric, and ascorbic acids, formulating the first liquid composition as a sterile solution, and the docetaxel concentration taught by Sun, Machado et al, and De, for the same reasons discussed above.
Regarding the intended use limitations, the limitations appear to be met where the components of the composition appear to be capable of being mixed at less than 24 hours, or mixed or injected into an infusion bag or bottle, for the same reasons discussed above.
U.S. Patent No. 10780172, hereinafter referred to as ‘172, drawn to a method of preparing a pharmaceutical composition comprising docetaxel and human serum albumin comprising: an organic solution of docetaxel and a first aqueous solution of human serum albumin. The organic solvent is ethanol.
The claims of ‘172 do not disclose the addition of an organic acid, the concentration of human serum albumin of claim 6, wherein the first liquid composition is sterile, the intended use limitations of being mixed less than 24 hours prior to administration, or mixed or injected into an infusion bag or bottle, nor the specific docetaxel concentration of claim 23.
It would have been obvious to modify the claims of ‘172 to include the organic acid, such as citric, tartaric, and ascorbic acids, the concentration of human serum albumin of claim 6, formulating the first liquid composition as a sterile solution, and the docetaxel concentration taught by Sun, Machado et al, and De, for the same reasons discussed above.
Regarding the intended use limitations, the limitations appear to be met where the components of the composition appear to be capable of being mixed at less than 24 hours, or mixed or injected into an infusion bag or bottle, for the same reasons discussed above.
U.S. Patent No. 11419842, hereinafter referred to as ‘842, drawn to a pharmaceutical composition of docetaxel and human serum albumin, where the docetaxel is mixed with polar water-miscible organic solvent and a first aqueous solution containing human serum albumin, wherein the solution is clear.
The claims of ‘842 do not disclose wherein the organic solvent is ethanol, the addition of an organic acid, the concentration of human serum albumin of claim 6, wherein the first liquid composition is sterile, the intended use limitations of being mixed less than 24 hours prior to administration, or mixed or injected into an infusion bag or bottle, nor the specific docetaxel concentration of claim 23.
It would have been obvious to modify the claims of ‘842 to include ethanol as the organic solvent, an organic acid such as citric, tartaric, and ascorbic acids, the concentration of human serum albumin of claim 6, formulating the first liquid composition as a sterile solution, and the docetaxel concentration taught by Sun, Machado et al, and De for the same reasons discussed above.
Regarding the intended use limitations, the limitations appear to be met where the components of the composition appear to be capable of being mixed at less than 24 hours, or mixed or injected into an infusion bag or bottle, for the same reasons discussed above.
Response to Arguments
Applicants assert present claim 1 recites an organic acid, which is absent from the claims of ‘134. Applicants assert Machado does not cure the above defect of the ‘134 claims for the same reasons discussed above.
Respectfully, this argument is not persuasive. It would have been obvious to modify the claims of the ‘134 application to further include an organic acid, for the same reasons discussed above and of record.
The examiner notes that Applicants do not appear to have addressed the double patenting rejections over the claims of ‘135, ‘172, and ‘842. Accordingly, the claims stand for the same reasons above and of record.
Claims 1, 2, 5, 6, 21-23, and 34, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/899,360 (reference application), hereinafter referred to as ‘360, in view of Sun (US 20180289818 A1), Machado et al (US 20090221688 A1), and De et al (US 20070082838 A1, hereinafter “De”, cited on IDS dated 01/12/2026). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘360 disclose a pharmaceutical composition comprising docetaxel and human serum albumin comprising: an organic solution of docetaxel in polar water-miscible organic solvent, a first aqueous solution comprising human serum albumin; and mixing the two to obtain a second aqueous solution comprising docetaxel and human serum albumin. The polar water-immiscible organic solvent is ethanol.
The claims of ’360 do not disclose the addition of an organic acid, the concentration of human serum albumin of claim 6, wherein the first liquid composition is sterile, the intended use limitations of being mixed less than 24 hours prior to administration, or mixed or injected into an infusion bag or bottle, nor the docetaxel concentration of claim 23.
Sun, Machado et al, and De are discussed above.
It would have been obvious to include an organic acid, such as citric, tartaric, and ascorbic acids, where organic acids were known to act as degradation inhibitors for docetaxel, in order to inhibit the degradation of docetaxel into 7-epi-docetaxel, and improve docetaxel stability and the shelf-life of the formulations, as taught by Machado et al. Additional motivation is provided by De, where stabilizers, including citric acid, were known to improve the stability of docetaxel formulations compared to those without, for the same reasons discussed above.
It would have been obvious to formulate the human serum albumin solution of ‘360 with a concentration of human serum albumin from about 0.01-10% (w/v), as taught by Sun, thereby overlapping the claimed range, where both are drawn to pharmaceutical formulations comprising docetaxel and human serum albumin.
Regarding the intended use limitations, where the solutions of ‘360 are formulated separately, and are mixed, it appears the solutions are capable of being mixed at any time, including less than 24 hours prior to administration to a patient, thereby meeting the intended use limitation.
It appears that the solutions compositions of ‘360 would be capable of being mixed in a variety of containers known to the skilled artisan, such as infusion bags or bottles, thereby meeting the intended use limitation, and for the same reasons discussed above.
Regarding the amount of docetaxel, it would have been obvious to formulate the compositions of ‘360 that would result in a docetaxel concentration upon mixing, in known amounts from the working embodiments of Sun, such as about 0.33 mg/mL, falling within the claimed range. Further, as taught by Sun, the docetaxel concentration can vary and a skilled artisan can adjust the amounts accordingly, depending on the desired treatments, severity of the disease, etc., in order to optimize the therapeutic properties of the resulting pharmaceutical formulations.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants assert present claim 1 recites an organic acid, which is absent from the claims of ‘360. Applicants assert Machado does not cure the above defect of the ‘360 claims for the same reasons discussed above.
Respectfully, this argument is not persuasive. It would have been obvious to modify the claims of the ‘360 application to further include an organic acid, for the same reasons discussed above and of record.
Conclusion
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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