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 1-16 are pending in the instant application and subject to examination herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/KR2022/020875, filed on 12/20/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/06/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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.
Claim 14 is 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 14 recites the limitation "with the powders" in further limiting the method of claim 12, regarding preparing a pharmaceutical preparation comprising the steps of preparing a first dissolved product comprising an excipient selected from a Markush group, and then preparing a second dissolved product comprising docetaxel or a pharmaceutically acceptable salt thereof, to wherein the method further comprises a step for physically mixing one or more mineral excipient(s) selected from a Markush group “with the powders”. There is insufficient antecedent basis for this limitation in the claim, because claim 12 does not disclose any powder(s), therefore it is unclear how the mineral excipient(s) are to be mixed with the composition prepared in claim 12.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-7, 10-13 and 16 are anticipated by Beijnen.
Claims 1-3, 6-7, 10-13 and 16 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Beijnen (U.S. PG Pub 2011/0207804 A1).
Claim 1 is drawn to a pharmaceutical composition comprising docetaxel or a pharmaceutically acceptable salt thereof, and one or more of a Markush group of excipients that includes polyvinylpyrrolidone (PVP), a cellulose-based compound, a poloxamer-based compound, a polyethylene glycol (PEG) based compound, and sodium dodecyl sulfate (SDS).
Beijnen solid pharmaceutical compositions comprising a taxane (e.g., docetaxel), a carrier, and a surfactant (Abstract). Beijnen discloses that the taxanes docetaxel and paclitaxel are typical examples of anticancer drugs that have low and variable bioavailability (paragraph [0003]) and that the invention discloses therein provides a solid pharmaceutical composition for oral administration comprising a substantially amorphous taxane, a hydrophilic carrier and a surfactant, wherein the amorphous taxane is prepared by a solvent evaporation method (paragraph [0006]). Beijnen specifically discloses “Example 2”, wherein oral formulations of docetaxel are described, including solid dispersion comprising a PVP polymer (as carrier) and SDS (as surfactant), in varying proportions (paragraphs [0149]-[0153], including Table 13, bridging pages 10-11), as well as formulations including PEG (as carrier) and SDS (as surfactant) with docetaxel (Table 19, page 16).
Thus, claim 1 is anticipated by the disclosure of Beijnen.
Claim 2 further limits claim 1 to wherein the composition further comprises an excipient selected from a Markush group of excipients identified by their functions: a crystallization inhibitor, a swellable polymer, an enteric coating, a foam generator, and a swellable excipient. Beijnen discloses that the composition can comprise an enteric coating, to enable targeted delivery of the taxane to the intestines where the taxane is absorbed, thus ensuring that the limited time during which the taxane is present in solution (before crystallisation takes place) is only spent at
sites where absorption is possible (paragraph [0030]).
Claim 3 further limits claim 1 to wherein the PVP-based compound is one or more selected from a Markush group of specific PVP-based compounds including PVP-K12, PVP-K25, PVP-K30 and PVP-K90. Beijnen discloses specific exemplary formulation including each of these PVP-based compounds in Beijnen’s Table 13, discussed above.
Claim 6 further limits claim 1 to wherein the PEG-based compound is one or more selected from a Markush group of specific PEG-based compounds including PEG 1500. Beijnen specifically discloses an exemplary docetaxel formulation including PEG 1500, as formulation number 8 in Table 19, discussed above (page 16).
Claim 7 further limits claim 1 to wherein the composition is selected from a Markush group of specific compositions, including the following:
a “1st combination comprising docetaxel or a pharmaceutically acceptable salt thereof and a polyvinyl pyrrolidone-based compound”,
a “4th combination comprising docetaxel or a pharmaceutically acceptable salt thereof and a polyethylene glycol-based compound”,
a “7th combination comprising docetaxel or a pharmaceutically acceptable salt thereof and sodium dodecyl sulfate”,
a “13th combination comprising docetaxel or a pharmaceutically acceptable salt thereof, a polyvinyl pyrrolidone-based compound, and sodium dodecyl sulfate”, and
a “a 25th combination comprising docetaxel or a pharmaceutically acceptable salt thereof, a polyethylene glycol-based compound”.
Each of these limitations are met by the disclosure of Beijnen, as discussed above.
Claim 10 further limits claim 1 to wherein the docetaxel or pharmaceutically acceptable salt thereof and the excipient(s) selected from the Markush group of claim 1 are present in a weight ratio in the range of 1:1 to 1:12 (drug:excipient(s)). Beijnen discloses that the solid dispersions comprising amorphous docetaxel, PVP, and SDS have these components present in a 1:9:1 ratio, respectively (Table 13, bridging pages 10-11), and the solid dispersions comprising docetaxel, PEG, and SDS have these components present in a 1:9:1 ratio, respectively (Table 19, page 16).
Claim 11 further limits claim 1 to wherein the composition has an intended purposes that is anti-inflammatory, antiviral, or anticancer. As discussed above, taxanes are anticancer drugs. Additionally, Beijnen provides the disclosed invention compositions for use in the treatment of neoplastic disease, including various cancers (paragraphs [0038]-[0040]) and provides a method of treatment of a neoplastic disease, the method comprising the administration, to a subject in need of such treatment, of an effective amount of the above composition, including preferably to treat a human subject (paragraphs [0041]-[0042]).
Claim 12 is drawn to a method for preparing a pharmaceutical composition, the method comprising preparing a first dissolved product by dissolving the excipient(s), selected from a Markush group that includes PVP, PEG, and SDS, in an organic solvent, and preparing a second dissolve product by adding or stirring docetaxel or a pharmaceutically acceptable salt thereof into the first dissolved product.
Claim 13 further limits claim 12 to wherein the method further comprises a step for forming powders by evaporating the solvent from the second dissolved product.
Beijnen discloses a method for preparing solid dispersions of docetaxel, wherein the carrier and surfactant are dissolved in water for injection, and this solution is added together with docetaxel in t-butanol, and the final mixture is transferred to a lyophilization box and the t-butanol and water are removed by lyophilization (paragraph [0153]).
Claim 16 is drawn to a method for providing an anti-inflammatory, antiviral or anticancer effect, comprising administering to a subject in need thereof the pharmaceutical composition of claim 1. As discussed above, Beijnen discloses a method of treatment of a neoplastic disease (e.g., cancer), the method comprising the administration, to a subject in need of such treatment, of an effective amount of the above composition, including preferably to treat a human subject (paragraphs [0041]-[0042]), and further discloses that the neoplastic disease is preferably a solid tumor, preferably selected from a Markush group of cancers (paragraph [0039]).
Thus, claims 2-3, 6-7, 10-13 and 16 are anticipated by the disclosure of Beijnen.
Claims 1, 4-5, 7, 11 and 16 are anticipated by Kim.
Claims 1, 4-5, 7, 11 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (Kim, J.K., et al.; Pharmaceutical Research, v29, pp525-534; 2012).
The limitations of claims 1, 7, 11 and 16 are discussed in the rejection above and hereby incorporated into the instant rejection.
Kim teaches a study in the development of a combination systems for local and sustained delivery of docetaxel, comprising a system of low-molecular-weight methylcellulose-based gel and Pluronic F127 micelle (Abstract, page 525). Kim teaches that stock solutions of methylcellulose, Pluronic F127, and ammonium sulfate are prepared in phosphate buffered saline (PBS), and that docetaxel is dissolved in ethanol and then added to the stock solution of Pluronic F127 and mixed until full dissolution is reached (page 526), after which the docetaxel/Pluronic F127 mixture was mixed with stock solutions of methylcellulose and ammonium sulfate to achieve a combination gel/micelle composition (page 527). While Kim does not discloses that Pluronic F127 is a poloxamer, a person of ordinary skill in the art would at once recognize that Pluronic F127 is another name for Poloxamer 407, as this is an inherent aspect of Pluronic F127 that was known in the art, as evidenced by Rowe (Rowe, R.C., et al.; Handbook of Pharmaceutical Excipients, Pharmaceutical Press, London, UK; 2009, pp535-538), who teaches a review on the properties and uses of Poloxamers, including that in the USA the trade name Pluronic is used by BASF Corp. for pharmaceutical-grade and industrial grade poloxamers, while in Europe the trade name Lutrol is used, and that Poloxamer 407 is identified in the commercial grade as F-127 (page 508, including Table V).
Thus, claim 1 is anticipated by the teaching of Kim.
Claim 4 further further limits claim 1 in regard to specific types of poloxamer to be included in the composition, including poloxamer 407. As discussed above, Kim teaches a composition comprising docetaxel and poloxamer 407.
Claim 5 further limits claim 1 in regard to specific types of cellulose-based based compound to be included in the composition, including methylcellulose. As discussed above, Kim teaches a composition comprising docetaxel and methylcellulose.
Regarding claim 7, as discussed above, Kim teaches a composition comprising docetaxel, a poloxamer, and a cellulose-based compound.
Regarding claims 11 and 16, Kim teaches that the combination gel/micelle composition of docetaxel is administered at varying dosages to mice bearing melanoma tumors, and the mice were studied for the anticancer effect of composition, in terms of tumor volume, body weight and survival rates (pages 527-528, bridging paragraph). Kim teaches that the docetaxel-loaded combination gel/micelle combination suppressed tumor growth better than free docetaxel or micelle-encapsulated docetaxel (i.e., docetaxel/Tween/buffer composition) at the same dosage strength, and that as dosage strength increases, the docetaxel-loaded gel/micelle composition’s tumor suppression improves (Figure 4a, page 531), and that the docetaxel-loaded gel/micelle composition similarly outperforms free docetaxel and micelle-encapsulated docetaxel in terms of overall survival (Table I, page 532).
Thus, claims 4-5, 7, 11 and 16 are anticipated by the teaching of Kim.
Allowable Subject Matter
Claims 8-9 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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