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 .
Applicant’s arguments, filed 10/14/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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, 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), 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 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 up to at least 72 hours, 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.
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, Applicants assert that the negative proviso of not containing polysorbate 80 is not met where Sun recites that polysorbate was known to have negative side effects. Applicants assert that this statement appears to imply that it may be desirable to avoid polysorbate 80, however, the Office Action's statement merely identifies a possible problem; saying nothing on how to solve that problem, which is to provide a stable composition without using polysorbate 80. Applicants cite case law reciting that recognition of a need does not render obvious the achievement that meets that need. Applicants assert it would not have been obvious to obtain a formulation containing docetaxel without polysorbate 80. Second, Applicants assert the Office Action does not characterize Sun correctly regarding the addition of an acid. Applicants assert paragraph 142 of Sun provides a general disclosure regarding pharmaceutically acceptable salts, but without providing motivation to use organic acids in a liquid formulation. Applicants recite various arguments regarding the salts of docetaxel, stating that the salts of Sun may be preferred over the respective free base, which expresses a mere possibility and does not provide any expectation as to whether a salt would be predictably more stable than a free base; organic solvents do not necessarily facility stabilization of salts compared to the corresponding organic free bases; and that docetaxel lacks functional sites and cannot readily form salts with organic acids. Third, Applicants assert the inclusion of an organic acid provides improved chemical stability to the solution.
First, respectfully, this argument is not persuasive. Applicants assert Sun does not make obvious the negative proviso of not containing polysorbate 80, however, the reference is directed to stable formulations of docetaxel and explicitly teaches that polysorbate 80 was known to be attributed to side-effects including the occurrence of unpredictable hypersensitivity reactions and cumulative fluid retention and further teaches that polysorbate 80 can be excluded from the composition. As such, it would have been obvious for the skilled artisan to exclude polysorbate 80 in order to avoid the occurrence of unpredictable hypersensitivity reactions and cumulative fluid retention. The skilled artisan would have a reasonable expectation of excluding polysorbate 80 and maintaining an effective stable composition, where Sun is directed to stable formulations of docetaxel where polysorbate 80 can be excluded. Further, the working embodiments of Sun do not comprise polysorbate 80 and were taught to be stable (see for example, ex. 1, 2, etc.).
Second, respectfully, this argument is not persuasive. Applicants have amended independent claim 1 to now recite only docetaxel, which previously allowed for docetaxel in addition to salts thereof. The examiner notes that Applicants arguments with respect to the motivation to add an organic solvent in order to formulate docetaxel salts is moot, where the independent claims were amended to remove “or a pharmaceutically acceptable salt thereof,” now requiring docetaxel. In view of Applicants amendments, Machado et al is newly cited above to provide alternative motivation for the inclusion of an organic acid. As discussed above, Machado et al teach that organic acids were known to act as degradation inhibitors for docetaxel, improve docetaxel stability, and improve the shelf-life of docetaxel formulations. As such, it would have been obvious to further include an organic acid in order to inhibit the degradation of docetaxel into 7-epi-docetaxel, improve docetaxel stability, and improve the shelf-life of docetaxel formulations.
Third, respectfully, this argument is not persuasive. Applicants assert the inclusion of an organic acid provides improved chemical stability, however, the improvement in chemical stability of formulations of docetaxel appears to be expected based on the teachings of Machado et al, where the addition of an organic acid to solutions of docetaxel were known to inhibit its degradation, improve docetaxel stably, and improve the shelf-life.
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, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/325,311 (newly published, reference application), 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.
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). 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.
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.
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) and Machado et al (US 20090221688 A1). 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 and Machado et al 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.
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) and Machado et al (US 20090221688 A1) 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 and Machado et al, 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 and Machado et al, 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 and Machado et al, for the same reasons discussed above by Sun.
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 it would not have been obvious to obtain present claim 1 from the claims of the U.S. Patents above, for the same reasons discussed above, as Sun does not provide any motivation to add any organic acid to a composition of docetaxel.
Respectfully, this argument is not persuasive. In view of Applicants amendments to the independent claim, Machado et al is newly cited and provides motivation to further include an organic acid to the docetaxel formulations, as discussed above and for the same reasons. Accordingly, the claims stand rejected 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) and Machado et al (US 20090221688 A1). 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 and Machado et al 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.
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 it would not have been obvious to obtain present claim 1 from the claims above, for the same reasons discussed above, as Sun does not provide any motivation to add any organic acid to a composition of docetaxel.
Respectfully, this argument is not persuasive. In view of Applicants amendments to the independent claim, Machado et al is newly cited and provides motivation to further include an organic acid to the docetaxel formulations, as discussed above and for the same reasons. Accordingly, the claims stand rejected for the same reasons above and of record.
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 JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612