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 .
Applicants' arguments, filed August 18, 2025, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application. The arguments regarding Broder are moot as this reference is no longer used to reject any claim.
Information Disclosure Statement
The information disclosure statement filed August 18, 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Comments and Notes
The response filed August 18, 2025 was not properly formatted. Amendments to the specification must begin on a separate page and the amendments to the specification commence on the cover sheet submitted with the response. The claim amendments are also not properly formatted as in claim 3, the addition of double brackets is indicated by the use of underlying, but the double brackets are being added not produce a clean version of the claim containing double brackets but to indicate the removal of the previously present word “about”. Double brackets were not necessary as the strikethrough could be easily perceived but “about” is five characters, the maximum character limit for the use of double brackets (see 37 CFR 1.121 (c)(2)), so the use of double brackets was proper but underlining them was not. Claim 17 was newly added in the claim set filed December 13, 2024 but is completely absent in the current claim set.
To promote compact prosecution, a Notice of Non-Responsive Amendment has not been prepared but failure to properly format future responses may result in mailing of such a notice.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 13, and arrow is missing between the 0 and ∞ immediate after “AUC”. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 5 – 8 were 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. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 19, 2025 and those set forth herein.
The amendments to the claim 1 have not resulted in a claim whose metes and bounds can be determined such that claim 1 and all the claims that depend from claim 1 remain indefinite.
In the amended paragraph at the end of claim 1 containing multiple wherein clauses, it is not clear what “the amount of paclitaxel” in relation to the first or second comparator formulations means. Nothing in the wording of that phrase with “the amount” makes explicit reference any linkage of such an amount to the amount of paclitaxel present in the prepared compressed tablet set forth previously in the claim. The only use of the “amount” previously in the claims is that the tablet comprises “an amount of greater than 10% by weight paclitaxel”. This renders it unclear if the amount of paclitaxel in each comparator formulation similarly must exceed 10% by weight of the formulation either to the same % as the compressed tablet dosage form being made or to any value that is at least 10% even if not identical to that of the compressed tablet dosage form. Alternatively, “the amount of paclitaxel” might be referring to the absolute amount of paclitaxel such as in milligrams present in the comparator formulation but the “an” not “the” should be used.
The wording of the final paragraph of claim 1 is quite convoluted so it is not clear what is administered and the required relative comparison of Tmax and AUC0[[Wingdings font/0xE0]]∞ should the conditions being set forth were to actually be carried out. The phrase “both the first comparator composition and the second comparator are co-administered with HM30181A on the schedule” could be taken to mean that both formulations and the HM30181A are administered at the same time, particularly as “or” separates the preceding descriptions of the composition of each comparator also includes “and”, or this could mean that just one of either (first comparator formulation + HM30181A) or (second comparator formulation + HM30181A) is administered. The last three lines of the claims that recite “upon oral administration of the compressed tablet, the first comparator formulation or the second comparator” appears in the overall construction of this section of the claim to be the basis for the comparison for Tmax and AUC0[[Wingdings font/0xE0]]∞ but no mention is made to the HM30181A. And when the comparisons are made for if an increase in Tmax and AUC0[[Wingdings font/0xE0]]∞, can that be in relation to compressed tablet in relation to either of the three options listed at the very end of claim 1? Unless the compressed tablet is compared with compressed tablet co-administered with HM30181A, a comparison with itself seems unlikely to result in any increase. But the administration of either comparator formulation only seems to be required when in combination with HM30181A, so then how is data for just the first or second comparator obtained as referenced at the very end of claim 1?
The dependent claims fall therewith.
Please clarify.
Applicants indicate the correction of a typographical error [Examiner note: this same error recurred in the amendments made to the last paragraph of claim 1] that has been corrected. Specific reference to paclitaxel as the taxane has been added. Applicants note the lack of specific guidance, the content and form of the claim with formulations limited by functional claim language to those that provide specified pharmacokinetic parameters relative to defined comparator formulations are present. Applicant believes that a person of ordinary skill in the art would find the claim sufficiently clear.
These arguments are unpersuasive. The required ingredients of the claimed formulation, the first and second comparator formulations are set forth clearly. The relative amounts of the various ingredients and the amount of paclitaxel in the compressed tablet is clear. The amount of paclitaxel in the comparator formulations is not clear as discussed above. But which formulations in combination with what are administered, and which conditions are compared with one another to assess changes in Tmax AUC0[[Wingdings font/0xE0]]∞ are not clear in claim 1 as currently amended as discussed in greater detail above. When alternative claim language that is both definite and fully supported by the disclosure is apparent to an Examiner, a suggestion as to such language may be made but it is not a requirement that an Examiner provide specific guidance as to how to amend a claim to overcome a rejection such as this.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3 and 5 – 8 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection that is MAINTAINED for the reasons of record set forth in the Office Action mailed March 19, 2025 and those set forth herein.
Amendments to the specification and claim 1 have been made in an attempt to overcome the new matter rejection set forth in the previous Office Action. These amendments do not result in claim 1 that is fully supported by the disclosure as originally filed for the reason
Claim 1 has been amended to recite that there is co-administration of “HM30181A on a schedule” but this limitation is not supported by the disclosure as filed. The only appearance of “schedule” is at ¶ [0049] of the PGPub of the instant application but that is in relation to the manufacturing processes and a generic “effective dosing schedule” which is not the context of the amended claim 1. Table 8 (¶ [0075] of the PGPub of the instant application) indicates a HM30181A dosing schedule of one 15 mg dose for various groups that is also set forth in Tables 9, 11 and 12 (¶¶ [0076], [0086] and [0088] respectively). These very specific dosing regimens do not provide sufficient support for the broad genus of “on a schedule” which encompasses any dosage and any timing as that constitutes a schedule as now present in claim 1.
Even with the amendment to the specification to cite to a U.S. Patent Application this is the national stage entry of the previously cited WO document for the composition of the comparative formulations, these specific examples are much narrower than the claim. Example 9 of WO 2015/152433 (table 3 on p 15) contains 30 units paclitaxel, 90 units of PVP-K30 (polyvinylpyrrolidone K30), 30 units of sodium lauryl sulfate (also known as sodium dodecyl sulfate, SDS) and 30 units of TWEEN® 80 (polysorbate 80). This does not provide support for either the first or second comparator formulations as the claims do not require the presence of SDS and both PVP K30 and polysorbate 80. Comparative example 12 (table 6 on p 16) contains 30 units of paclitaxel and 350 units of TWEEN® 80 (polysorbate). While these are the only two ingredients specified for the second comparator formulation, those two ingredients appear to be present in any amount in the claims as presently written although “the amount of paclitaxel” is indefinite as discussed above although again, only specific amounts with no units (e.g., milligrams” were given in the cited document) and are not limited to the specific formulation from the document incorporated by reference.
In addition to compositions of the comparator formulations not being supported, any co-administration with HM30108A is encompassed by the claims are currently presented but the disclosure of the instant application as originally filed does not support such breadth, with only the specific dosing regimen set forth in tables 8 (¶ [0075]), 9 (¶ [0076]), 11 (¶ [0086] and 12 (¶ [0088]) being supported.
While the idea of co-administration of the formulation with a P-glycoprotein (PGP) inhibitor is disclosed at ¶ [0070] of the PGPub of the instant application, that the co-administration alters pharmacokinetic parameters such as increasing the Tmax and/or increasing the AUC0∞ is not described in the disclosure as originally filed. Table 9 reports only pharmacokinetics with HM3018A, which is described at ¶ [0008] of the PGPub of the instant application as a PGP inhibitor, there no data in the absence of such an agent to provide support for relative to specific pharmacokinetic parameters even for the specific formulations that were tested as shown in Table 9.
The dependent claims fall therewith as no claim limits the claimed subject matter to that which was disclosed in the application as originally filed.
Applicants traverse this rejection on the grounds that at least table 9 supports the most recent claim amendments. Reference is made to the specific formulations incorporated by reference in the specification as to the particular recipes for comparator 1 and 2 of the instant claims. Comparison of specific pharmacokinetic parameters as function limitations with a quotation from MPEP 2173.05(g) stating that functional language in a claim not rendering a claim improper. The functional limitations directed to comparative pharmacokinetic parameters between formulations cited within the claim are supported, proper and should be considered.
These arguments are unpersuasive. The multiple possible interpretations of the claims as to what is administered, the timing of such administration and what set of conditions being compared to what is set forth above. As mentioned previously and reiterated again, the very specific examples of the disclosure as originally filed are insufficient to support broad limitations and comparisons as set forth in the claim 1 as currently presented as a representative number of species with the genus being claimed have not been disclosed (see MPEP 2163 (II)(A)(3)(a)(ii) that is also applicable to amended claims). Claim 1 is not being rejected because of the mere presence of functional language in the claims but that this claim language is not clear (see indefiniteness rejection above) and that the full scope of this claim language is not supported by the disclosure as originally filed (this specific rejection).
Claims 9, 11 – 14 and 16 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection that is MAINTAINED for the reasons of record set forth in the Office Action mailed March 19, 2025 and those set forth herein.
Claim 9 has been amended and the new matter relating to ratio of the components has been corrected and is now supported by the disclosure as originally filed.
However, the conditions for maintaining a supersaturated state are still not supported by the disclosure as originally filed. Figure 9 shows results with pH varied over time and with the y-axis showing the percent of paclitaxel release. ¶ [0063] of the PGPub of the instant application references a “supersaturated solubility of 80% of docetaxel released” being maintained for at least 3 hours but this formulation does not contain SDS, a required ingredient. ¶ [0074] of the PGPub of the instant application states that supersaturation of the paclitaxel was maintained for more than 3 hours, but this is a specific example with a different taxane. When supersaturation is mentioned elsewhere in the disclosure as filed, it is accompanied by percentages relating to the amount of taxane similar to that highlighted above and percentages are not present in amended claim 9. And even in those figures that show percent drug release, exposure to pH 4 takes place for 1 hour, and the new phrase in claim 9 of “following exposure to pH 4” encompasses any length of time at pH 4, ranging from very short time frames on the order of seconds to multiple hours. So even if the data presented in such figures did relate to degree of saturation of the released active agent, the conditions over which the supersaturation was obtained do not match those set forth on the x-axis.
Therefore, even as amended, claim 9 still contains new matter.
The dependent claims fall therewith as no claim limits the claimed subject matter to that which was disclosed in the application as originally filed.
Applicants traverse this rejection by directing attention to Figure 4A with data for the dissolution of ASD examples 13 – 17 showing similar dissolution profiles and indicate maintenance of docetaxel at supersaturating concentrations for an extended period of time. Supersaturated is a well-understood term by a person of ordinary skill in the art.
These arguments are unpersuasive. As indicated above, the amendments have resolved the new matter issue related to the amounts of each of the ingredients. But Figure 4A uses a 1 hour (60 minute) exposure to pH 4.0, which is narrower than the claims, and the y-axis of this figure is amount of docetaxel released, which does not provide any information as to the degree of saturation of the liquid in which the released docetaxel is present. As the saturation point, and thus if the solution is supersaturated at any given time, depends on factors including the solution volume, composition, pH and temperature, the data in Figure 4A provides no information as to the presence and/or maintenance of a supersaturated solution at any given time point. Figure 9 is similar in the data presented and was discussed on p 7 of the March 19, 2025 Office Action. ¶ [0063] of the PGPub of the instant application was mentioned in that same paragraph as actually mentioning supersaturation but that material does not match the claimed subject matter in claim 9 or any of the claims that depend from claim 9.
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.
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.
Claim(s) 1, 3, 5 – 9, 11 – 14 and 16 were rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. (US 2019/0105397). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 19, 2025.
Applicants note that Yoon is the parent application to which the instant application claims priority with an identical specification. As the availability of Yoon is predicated on the finding of new matter in claims 1 and 9, the effective priority date was assigned as the effective priority date. Claims 1 and 9 have been amended not to introduce new matter so Yoon et al. is not a proper reference under 35 USC § 103 and cannot render the claims obvious.
These arguments are unpersuasive. As detailed above, both independent claims 1 and 9 still contain new matter and as the claimed subject matter is not supported by the disclosure of the instant applications or those to which benefit is claimed, Yoon et al. remains available as prior art as description which renders the claimed subject matter obvious is not sufficient to satisfy the written description requirement.
Claim(s) 1, 3, 5 – 9, 11 – 14 and 16 were rejected under 35 U.S.C. 103 as being unpatentable over Yoon et al. as applied to claims 1, 3, 5 – 9, 11 – 14 and 16 above, and further in view of Lee et al. (Cancer Res Treat, 2014).
This rejection is made to promote compact prosecution by interpreting claim 1 as requiring administration of the taxane containing dosage form to a subject and also administering to the same subject a P-glycoprotein inhibitor even though the wherein clause of claim 1 does not require such steps.
Please see p 11 – 13 of the March 19, 2025 Office Action for the complete discussion of the teachings of Yoon et al.
The administration of both a taxane such as paclitaxel or docetaxel and a P-glycoprotein (PGP) inhibitor is not disclosed.
Lee et al. discloses that paclitaxel is useful against a wide range of solid cancers and while some oral forms have been developed, a major obstacle is poor oral bioavailability originating from high-affinity for P-glycoprotein (¶ bridging p 234 and 235). Oral co-administration of paclitaxel with P-gp inhibitors could increase paclitaxel bioavailability (p 235, col 1, ¶ 1). HM30181A displayed selective inhibition of P-gp and co-administration of oral paclitaxel with it increased the oral bioavailability of paclitaxel in rats (p 235, col 1, ¶ 2). The paper carried out studies in humans (e.g., title) showed that co-administration was feasible and therapeutic plasma levels of paclitaxel were achievable (p 241, col 1, ¶ 3).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer the taxane tablet dosage form of Yoon et al. to a subject who is also co-administered a PGP inhibitor. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that the bioavailability of the taxane paclitaxel can be improved by co-administration with the PGP inhibitor HM30181A. One of ordinary skill in the art would reasonably expect that such co-administration regardless of the exact formulation of the PGP inhibitor dosage form to result in increased bioavailability and enhanced pharmacokinetic parameters for the taxane such as paclitaxel or docetaxel.
Claim(s) 1, 3, 5 – 9, 11 – 14 and 16 were rejected under 35 U.S.C. 103 as being unpatentable over CN 103083240 (CN’240; all citations from machine translation that accompanied the December 14, 2023 Office Action) in view of Albano et al. (US 2013/0172375), Brouwers et al. (J Pharm Sci, 2009) and Shanmugan et al. (Drug Dev Ind Pharm, 2015). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed March 19, 2025 and those set forth herein.
Applicants traverse this rejection by briefly mentioning each applied reference and stating that prior art references must be considered in their entirety, including portions that would lead away from the claimed invention and the Examiner has cherry picked terms, took them out of context and combined them in a way that is a clear error. A lack of solubility is central to method of Fude that prepares hollow microspheres that are washed extensively before use. The only apparent use of SDS is in the aqueous solution in which paclitaxel and HPMCAS are not soluble, the formulations do not include SDS. Fude teaches against the use of SDS in formulations that improve solubility of paclitaxel and HPMCAS and teaches against such inclusion.
These arguments are unpersuasive. The rejection does not argue that the SDS taught in CN’240/Fude ends up in the final formulation as the rejection is made over the combination of the applied prior art. Even when more than one alternative is taught in a reference, that does not rise to level of teaching away unless there is criticism, discrediting or otherwise discouraging of the solution claimed (see MPEP 2123). That SDS is not present in the material prepared does not rise to the level of teaching away. All of the claimed features are rendered obvious when the explicit, implicit and inherent teachings of the prior art and the knowledge of one of ordinary skill in the art are considered.
Applicants also argue that Albano is cited as curing the deficiencies of Fude but neither compound in this reference is a taxane such as paclitaxel or docetaxel. The disclosed compounds share a close structural similarity but different polymer matrices are used. A review of this reference shows that it teaches addition of surfactants to only one of the formulations that does not use HPMCAS. Albano provides neither teaching or suggesting of polymer carriers and/or surfactants useful in improving paclitaxel or docetaxel formulations. The Office has failed to provide either a reference or convincing line of reasoning that effects of polymer carrier and/or surfactants of the two compounds disclosed have any bearing on the performance of taxanes. As very different formulations were required, the performance of a particular carrier formulation cannot be imputed even for a closely related compound. SDS inclusion is taught against by Fude.
These arguments are unpersuasive. A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton (MPEP 2141(II)(C). Albano et al. provides guidance as to solutions to optimize AUC and Cmax and how to determine the optimal formulation for a given drug through section of the matrix materials in a solid dispersion with ingredients including HPMCAS as taught by CN’240 for use in paclitaxel containing drug formulations. While the prior art may not provide explicit guidance as to the amounts of particular materials to use, the arguments and evidence do not establish the undue experimentation would be required and/or that one of ordinary skill in the art would not have a reasonable expectation of success in being able to produce a paclitaxel with optimized pharmacokinetic parameters such as AUC and Cmax. When the combined teachings of all of the applied prior art references, explicit, implicit and inherent, and the knowledge of one of ordinary skill in the art is taken into account, the subject matter of the instant claims is rendered obvious. That such compounds may have different pharmacokinetics and/or optimal formulations that are not the same as those for paclitaxel or docetaxel does not mean that the guidance and knowledge would not have led one of ordinary skill to reasonably expected that SDS can be included in the formulations of CN’240. The teachings of Albano indicate the types of experiments routinely undertaken by those of ordinary skill in the art when optimizing a particular drug formulation and that the presence or absence of SDS is one variable that can be investigated. This conclusion is bolstered by Brouwers that discloses that the inclusion of SDS may delay precipitation from supersaturated solutions.
Regarding Brouwers, Applicants state that this reference teaches that successful selection of drug excipient combinations for SDDS (supersaturating drug delivery systems) is mainly trial and error based with the available data on physicochemical properties governing drug-excipient interactions are insufficient to enable a more rational or predictive selection, citing to p 2565. The degree of unpredictability in the art can lead to a conclusion of non-obviousness, citing Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989 (Fed. Cir. 2009). Albano and Brouwers point to a high degree of unpredictability so there is no reasonable expectation of success. Brouwers fails to teach of suggest the utility of HPMCAS and SDS in paclitaxel or docetaxel containing formulations, particularly in view of Fude in regard to the lack of solubility of paclitaxel/HPMCAS in aqueous SDS.
These arguments are unpersuasive. That trial and error is required does not necessarily result in undue experimentation and/or there not being a reasonable expectation of success. For example, p 2550, col 1, ¶ 2 of Brouwers notes that the use of high throughput screening in drug development, so one of ordinary skill in the art could reasonably use high throughput screening to screen numerous possible formulations based on the art recognized functions such as inhibition of precipitation by SDS to carry out the screening of a large number of different formulations with a reasonable expectation of success even if a priori predictive selection of the optimal formulation using ingredients that are known for use in such formulation is not possible to arrive at an optimized formulation for a particular drug. Only a reasonable and not absolute expectation of success is required for a prima facie case of obviousness. The primary reference CN’240 teaches a combination of paclitaxel with HPMCAS that resulted in significantly increased bioavailability and therefore it is not unexpected that HPMCAS increases the bioavailability of paclitaxel. Albano et al. generally teaches the desirability of solid dispersions and that the inclusion of surfactants such as SDS allow for improved dissolution of the active ingredient along with ranges for the amounts of drug, polymer and surfactant. Brouwers discusses in the right hand column on p 2565 four different possible mechanism by which surfactants may alter precipitation kinetics. While the instant claims may not be rendered obvious based on the teachings of Brouwers or any of the applied references alone, the additional references provide additional guidance to one of ordinary skill in the art looking to optimize bioavailability by generating more bioavailable formulations of paclitaxel such as by favoring supersaturation, which is the focus on Brouwers. Brouwers taken as a whole provides guidance as to various strategies that can be used to generate and/or stabilize supersaturation. These strategies and the knowledge of one of ordinary skill would reinforce the teachings such as the inclusion of surfactants such as SDS in Albano as what can be applied when looking to further optimize the HPMCAS-paclitaxel formulations of CN’240. The pharmacokinetic parameters arise from the composition itself and the combination of applied prior art references renders obvious the claimed taxane containing pharmaceutical formulations.
Regarding Shanmugan, Applicants indicates that the paclitaxel formulations disclosed do not contain or suggest HPMCAS but rather PVP or an HPMC. SDS is only used in combination with PVP and given the lack of predictability cited in both Albane and Brouwers, this neither teaches nor suggests [the] utility of SDS in combination with HPMCAS and the inclusion of SDS is taught against by Fude.
These arguments are unpersuasive. "The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference .... Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 413,425 (CCPA 1981) MPEP 2145(III) Here Shanmugan is not being relied on the render obvious the combination of paclitaxel, HPMCAS and SDS but that spray drying is appropriate for use with these ingredients generally and that the ratio of these ingredients alters the properties of the final formulations when producing orally administrable tablets containing solid dispersion granules. The arguments and evidence of record have not established that one of ordinary skill would only use fluid bed granulation when SDS is present such that SDS would be considered incompatible with spray drying. The pharmacokinetic parameters arise from the composition itself and the combination of applied prior art references renders obvious the claimed taxane containing pharmaceutical formulations.
Claim(s) 1, 3, 5 – 9, 11 – 14 and 16 were rejected under 35 U.S.C. 103 as being unpatentable over CN 103083240, Albano et al., Brouwers et al. and Shanmugan as applied to claims 1, 3, 5 – 9, 11 – 14 and 16 above, and further in view of Lee et al. (Cancer Res Treat, 2014).
This rejection is made to promote compact prosecution by interpreting claim 1 as requiring administration of the taxane containing dosage form to a subject and also administering to the same subject a P-glycoprotein inhibitor even though the wherein clause of claim 1 does not require such steps.
Please see p 15 – 22 of the Office Action mailed March 19, 2025 for the complete discussion of the teachings of CN 103083240, Albano et al., Brouwers et al. and Shanmugan et al.
The administration of both a taxane such as paclitaxel or docetaxel and a P-glycoprotein inhibitor is not disclosed.
Lee et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer the taxane tablet dosage forms rendered obvious by the combined teachings of CN 103083240, Albano et al., Brouwers et al. and Shanmugan et al. to a subject who is also co-administered a PGP inhibitor. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Lee et al. discloses that the bioavailability of the taxane paclitaxel can be improved by co-administration with the PGP inhibitor HM30181A. One of ordinary skill in the art would reasonably expect that such co-administration regardless of the exact formulation of the PGP inhibitor dosage form to result in increased bioavailability and enhanced pharmacokinetic parameters for the taxane.
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618