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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 4, 13, 15, 17-18, 22, 24, 29, 31, 33, 82-83, and 89) in the reply filed on 03/06/26 is acknowledged.
The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 38-39, 42-43, 50, 55, and 76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.
Claims 1, 4, 13, 15, 17-18, 22, 24, 29, 31, 33, 82-83, and 89 are included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/13/26 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement.
Please see the attached copy of PTO-1449.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13, 31, and 89 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 13 and 31, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 89 recites: “An emulsion produced by mixing the pharmaceutical composition of claim 17 with water or by administering the pharmaceutical composition of claim 17 to a mammal.” It is unclear how an emulsion is produced by administering the composition. Clarification and/or amendment are required.
Notice for all US Patent Applications filed on or after March 16, 2013
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 13, 15, 17-18, 22, 24, 29, 33, 82-83, and 89 are rejected under 35 U.S.C. 103 as being unpatentable over Sharp et al. (US 10,792,292 B2 – “Sharp”) in view of Torrejón et al. (EP 3 944 860 A1 – “Torrejon”).
Instant claim 1 is drawn to a pharmaceutical composition comprising: (a) abiraterone decanoate; and (b) a lipid-based drug delivery system, wherein the abiraterone decanoate has the following structure:
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wherein the pharmaceutical composition is formulated for oral delivery of the abiraterone decanoate, wherein the lipid-based drug delivery system comprises: (1) a triglyceride, monoglyceride, diglyceride, and/or a propylene glycol ester; and (2) a surfactant comprising a polyglyceryl ester and/or polyoxyglyceride.
Sharp teaches a pharmaceutical composition comprising abiraterone decanoate and a pharmaceutically acceptable carrier (claim 6), wherein the abiraterone decanoate has the following formula:
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The pharmaceutically acceptable carrier comprises a pharmaceutically acceptable oil and optionally a pharmaceutically acceptable solvent (claim 8), wherein the pharmaceutically acceptable oil comprises a triglyceride (claim 9).
Sharp does not expressly teach a surfactant.
Torrejon teaches formulations comprising abiraterone or pharmaceutically acceptable salts thereof (Abstract). Pharmaceutical compositions comprising the total daily amount of the active may further comprises one or more pharmaceutically acceptable excipients ([0042]), wherein the pharmaceutical excipients include surfactants ([0043]), the surfactants include non-ionic surfactants ([0044]), the non-ionic surfactants include macrogol 15 hydroxystearate, polyglyceryl-3-dioleate (Plurol oleique CC 497), and polyoxyl 40 hydrogenated castor oil (Kolliphor RH40) ([0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a pharmaceutical composition comprising abiraterone decanoate and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable oil comprises a triglyceride, as taught by Sharp, in view of the pharmaceutical compositions comprising abiraterone or pharmaceutically acceptable salts and non-ionic surfactants which include macrogol 15 hydroxystearate, polyglyceryl-3-dioleate (Plurol oleique CC 497), and polyoxyl 40 hydrogenated castor oil (Kolliphor RH40), as taught by Torrejon, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so because both references teach pharmaceutical compositions comprising abiraterone and pharmaceutically acceptable salts thereof and pharmaceutically acceptable excipients. One of ordinary skill in the art would have found it obvious to include the non-ionic surfactants of Torrejon in the composition of Sharp and have a reasonable expectation of success since these components are known to be used with abiraterone salts in a pharmaceutical composition. Moreover, it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claims 1, 17, and 82, the limitations of a pharmaceutical composition comprising: (a) abiraterone decanoate would have been obvious over the pharmaceutical composition comprising abiraterone decanoate and a pharmaceutically acceptable carrier (claim 6), as taught by Sharp.
Regarding instant claims 1, 17, and 82, the limitations of (b) a lipid-based drug delivery system comprising (1) a triglyceride, monoglyceride, diglyceride, and/or a propylene glycol ester would have been obvious over the pharmaceutically acceptable carrier which comprises a pharmaceutically acceptable oil and optionally a pharmaceutically acceptable solvent (claim 8), wherein the pharmaceutically acceptable oil comprises a triglyceride (claim 9), as taught by Sharp.
Regarding instant claims 1, 17, and 82, the limitations of (b) a lipid-based drug delivery system comprising (2) a surfactant comprising a polyglyceryl ester and/or polyoxyglyceride would have been obvious over the formulations comprising abiraterone or pharmaceutically acceptable salts thereof (Abstract) and pharmaceutically acceptable excipients ([0042]), wherein the pharmaceutical excipients include surfactants ([0043]), the surfactants include non-ionic surfactants ([0044]), the non-ionic surfactants include macrogol 15 hydroxystearate, polyglyceryl-3-dioleate (Plurol oleique CC 497), and polyoxyl 40 hydrogenated castor oil (Kolliphor RH40) ([0046]), as taught by Torrejon.
Regarding instant claim 4, the limitation of (i) the lipid-based drug delivery system comprising a medium-chain triglyceride, (ii) a glycerol/glyceryl linoleate, (iii) propylene glycol monocaprylate and/or propylene glycol monolaurate, (iv) polyglyceryl oleate, and/or (v) macrogolglycerol hydroxystearate or lauroyl polyoxyl-6-glycerides would have been obvious over the stearoyl macrogol-32 glyceride (Labrafac), the glyceryl monolinoleate (Maisine), the propylene glycol monocaprylate (Capryol 90), the propylene glycol monolaurate (Lauroglycol FCC or Lauroglycol 90) ([0046]), polyglyceryl-3 dioleate (Plurol oleique CC 497), macrogol 15 hydroxystearate (Solutol HS-15, Kolliphor HS-15), and lauroyl polyoxyl/macrogol 32 glycerides (Gelucire), respectively ([0046]), as taught by Torrejon.
Regarding instant claims 13 and 17, the limitations of the abiraterone decanoate dispersed or dissolved in the lipid-based drug delivery system would have been obvious over the abiraterone dissolved or dispersed in a pharmaceutically acceptable carrier (Col. 22, lines 34-38), the pharmaceutically acceptable oil (claim 8), and the pharmaceutically acceptable oil comprising a triglyceride (claim 9), as taught by Sharp in view of the surfactants ([0043]), the surfactants include non-ionic surfactants ([0044]), the non-ionic surfactants include macrogol 15 hydroxystearate, polyglyceryl-3-dioleate (Plurol oleique CC 497), and polyoxyl 40 hydrogenated castor oil (Kolliphor RH40) ([0046]), as taught by Torrejon.
Regarding instant claims 13, 17, and 24, the limitations of the abiraterone decanoate concentration ranging from about 1 mg/g to about 250 mg/g (instant claim 13), from about 10 mg/g to about 150 mg/g (instant claim 17), and about 20 mg/g to about 120 mg/g (instant claim 24) would have been obvious over the concentration of the abiraterone decanoate of about 25 mg/ml, about 50 mg/ml, about 100 mg/ml, about 150 mg/ml, about 200 mg/ml, about 250 mg/ml, or any range between the recited values (Col. 26, lines 11-17), as taught by Sharp, since 1 mg/ml = 1mg/g. Furthermore, according to MPEP 2144.05, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Regarding instant claims 15 and 29, the limitations of the characteristics (1)-(4) would have been obvious over the pharmaceutical composition comprising abiraterone decanoate and a pharmaceutically acceptable carrier (claim 6), the pharmaceutically acceptable carrier comprising a pharmaceutically acceptable oil and optionally a pharmaceutically acceptable solvent (claim 8), wherein the pharmaceutically acceptable oil comprises a triglyceride (claim 9), as taught by Sharp in view of the surfactants ([0043]), the surfactants include non-ionic surfactants ([0044]), the non-ionic surfactants include macrogol 15 hydroxystearate, polyglyceryl-3-dioleate (Plurol oleique CC 497), and polyoxyl 40 hydrogenated castor oil (Kolliphor RH40) ([0046]), as taught by Torrejon. The recited characteristics are properties associated with the pharmaceutical composition and are inseparable from it. Since the prior art teaches the same pharmaceutical composition, the same properties would have been expected.
Regarding instant claim 17, the limitation of (a) a lipid in an amount of about 10-80% by weight of the lipid-based drug delivery system would have been obvious over oil (e.g., castor oil, corn oil) used in an exemplary amount/concentration of 70% to 100% of solvent (Col. 28 - TABLE A), as taught by Sharp. Please see MPEP 2144.05.
Regarding instant claim 17, the limitation of (b) one or more non-ionic surfactants in an amount of about 20-90% by weight of the lipid-based drug delivery system would have been obvious over the pharmaceutical composition comprising surfactants between 20% to 90% by weight (w/w) in regard to the fill mixture weight composition ([0051]), as taught by Torrejon. Please see MPEP 2144.05.
Regarding instant claims 18, 24, and 83, the limitations of the lipid comprising medium-chain triglycerides of caprylic (C8) and capric (C10) acids in an amount of about 10% to about 50% (instant claim 18) and about 20-40% (instant claim 24) by weight of the lipid based drug delivery system would have been obvious over the stearoyl macrogol-32 glyceride (Labrafac) ([0046]) and the pharmaceutical composition comprising surfactants between 20% to 90% by weight (w/w) in regard to the fill mixture weight composition ([0051]), as taught by Torrejon. Please see MPEP 2144.05.
Regarding instant claim 22, the limitations of macrogolglycerol hydroxystearate and/or polyglyceryl oleate and/or the one or more non-ionic surfactants comprise oleoyl polyoxyl-6 glycerides and/or lauroyl polyoxyl-6 glycerides would have been obvious over the polyglyceryl-3-dioleate (Plurol oleique CC 497), lauroyl polyoxyl/macrogol 32 glycerides (Gelucire), and polyoxyl 40 hydrogenated castor oil (Kolliphor RH40) ([0046]), as taught by Torrejon.
Regarding instant claim 33, the limitation of the substantially pure abiraterone decanoate would have been obvious over the substantially pure form of abiraterone decanoate which has a purity of greater than 95%, greater than 97%, greater than 98%, greater than 99%, and greater than 99% (Col. 41, lines 51-57), as taught by Sharp.
Regarding instant claims 82, the limitation of an emulsion would have been obvious over the emulsions ([0055]), as taught by Torrejon.
Regarding instant claim 89, the limitation of an emulsion produced by mixing the pharmaceutical composition of claim 17 with water would have been obvious over the oil-in-water or water-in-oil liquid emulsions ([0055]), as taught by Torrejon. It is noted that instant claim 89 is set forth in the form of product-by-process claim, which is considered a product claim by the Office. Applicants are reminded that process limitations cannot impart patentability to a product that is not patentably distinguished over the prior art. In re Thorpe et al. (CAFC 1985), In re Brown et al. (CCPA 1972) 459 F2d 531, 173 USPQ 685. “’[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.’ Therefore when no structure is implied, the product-by-process recitation does not add any limitations that affect patentability. The steps in the recited method a do not add any clear structure to the final product not already required by the composition being in an emulsion form.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Sharp et al. (US 10,792,292 B2 – “Sharp”) in view of Torrejón et al. (EP 3 944 860 A1 – “Torrejon”), as applied to claims 1, 4, 13, 15, 17-18, 22, 24, 29, 33, 82-83, and 89 above, further in view of Legen et al. (WO 2014/009434 A1 – “Legen”).
Instant claim 31 is drawn to the pharmaceutical composition of claim 17, wherein (i) the lipid-based drug delivery system is a self-dispersing drug delivery system, such as a self-emulsifying drug delivery system or self-microemulsifying drug delivery system; and/or (ii) upon oral administration to a mammal, at least a portion of the abiraterone decanoate is absorbed through the lymphatic system.
The teachings of Sharp and Torrejon are discussed above.
Sharp and Torrejon do not expressly teach a self-dispersing, self-emulsifying, or self-microemulsifying drug delivery system.
Legen teaches a self-microemulsifying drug delivery system of abiraterone (Title and Abstract). Legen also teaches the advantages of a self-microemulsifying drug delivery system including “Compared with ready-to-use microemulsions self-microemulsifying drug delivery systems may provide advantages such as improved physical and/or chemical stability upon long-term storage, the possibility of filling them into unit dosage forms such as soft/hard gelatin or HPMC capsules which improves their commercial viability and patient compliance/acceptability, no palatability-related issues as self-microemulsifying drug delivery systems can be filled into capsules” (Page 7, 1st ¶).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a pharmaceutical composition comprising abiraterone decanoate and a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable oil comprises a triglyceride, as taught by Sharp, in view of the pharmaceutical compositions comprising abiraterone or pharmaceutically acceptable salts and non-ionic surfactants which include macrogol 15 hydroxystearate, polyglyceryl-3-dioleate (Plurol oleique CC 497), and polyoxyl 40 hydrogenated castor oil (Kolliphor RH40), as taught by Torrejon, further in view of the self-microemulsifying drug delivery system of abiraterone, as taught by Legen, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so because all the references teach pharmaceutical compositions comprising abiraterone, and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). One of ordinary skill in the art would have been motivated to use the self-microemulsifying drug delivery system of Legen in the composition of Sharp based on the advantages of improved physical and/or chemical stability upon long-term storage, the possibility of filling them into unit dosage forms such as soft/hard gelatin or HPMC capsules which improves their commercial viability and patient compliance/acceptability, no palatability-related issues as self-microemulsifying drug delivery systems can be filled into capsules (Page 7, 1st ¶), as taught by Legen.
Regarding instant claim 31, the limitation of a self-microemulsifying drug delivery system would have been obvious over the self-microemulsifying drug delivery system of abiraterone (Title, Abstract, Page 7, 1st ¶), as taught by Legen.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 pm.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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