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
In the amendment filed April 23, 2025, claims 1-2, 5-6, 12, 20, 31, 45, 49, and 54-55 are amended. Cumulatively, claims 3-4, 8, 10-11, 13-19, 21-26, 28-30, 32-44, 46-48, and 50-53 have been canceled. Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are currently pending.
Response to Amendments and Arguments
Previous rejections for indefiniteness:
The rejections of claims 2, 5, 12, 20, 30, 31, and 46 for indefiniteness are obviated by the amendments to these claims. These rejections are accordingly withdrawn.
With respect to the rejection of claim 6 for indefiniteness based on the phrase, “no detectable amount of ethyl prasterone,” Applicant argues that this phrase is not indefinite because the specification states that the amount of ethyl prasterone can be readily determined by HPLC methods. Applicant contends that, in view of this, there is nothing unclear about the phrase. This argument has been fully considered, but is not found persuasive.
When one says that the presence of an impurity is less than 0.1% by mass or by molarity, for example, that is an objective standard that can be validated across a variety of detection methodologies. By contrast, when one says that an impurity is “undetectable,” without giving a fairly precise description of the methodology, that is a highly variable standard because different methods of detection will have different detection limits. For example, one could use NMR or elemental analysis (see, for example, the non-patent publication, Absolute Quantitative 1H NMR Spectroscopy for Compound Purity Determination, J. Med. Chem., 57, pg. 9219 (2014) by Cushman et al.). These various techniques would not have the same limits of detection as one another, and even within one technique, the limit of detection would vary depending on the instrument used. For example, an NMR instrument having a 14.1 T B0 magnetic field would have an appreciably higher S/N and therefore greater ability to detect trace amounts of impurity than would an NMR instrument having a 1.41 T B0 magnetic field (see, for example, the non-patent publication, NMR Basics, University of Wyoming Chemistry website, obtained at the time of this writing at the url www.uwyo.edu/chemistry/instrumentation/NMR/Introduction.html, available online at least by 2016, by Goroncy).
While the instant specification states that the amount of ethyl prasterone can be readily determined by HPLC methods (paragraphs [0118] and [0195]), it is improper to import claim limitations from the specification, and a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment. Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, (Fed. Cir. 2004). See also, MPEP 2111.01(II) and additional cases cited and discussed therein.
Furthermore, even if one did assume “HPLC methods” as the technique for detecting possible ethyl prasterone impurities, the limit of detection could still vary considerably on the basis of multiple factors, particularly the detection technique that is coupled with the HPLC. For example, abiraterone impurities can be detected by HPLC coupled to UV absorbance (see, for example, the non-patent publication, Identification, Characterization and High-Performance Liquid Chromatography Quantification for Process-Related Impurities in Abiraterone Acetate Bulk Drug, J. Chromatogr. Sci., 56, pgs. 802-811 (2018) by Hu et al.), although UV detection would likely have low ethyl prasterone sensitivity and fluorescence detection would likely be possible (see, for example, the non-patent publication, High Performance Liquid Chromatography (HPLC) with Fluorescence Detection for Quantification of Steroids in Clinical, Pharmaceutical, and Environmental Samples: A Review, Molecules, 27, art. 1807, 32 pgs. (2022) by Hameedat et al.), with a much higher sensitivity for ethyl prasterone (see, for example, the non-patent publication, Choosing the Best Detection Method: Absorbance vs. Fluorescence, Biocompare website, obtained at the time of this writing at the url www.biocompare.com/Bench-Tips/173963-Choosing-the-Best-Detection-Method-Absorbance-vs-Fluorescence/# (2015) by Geisler, noting that “[t]he sensitivity of fluorescence detection is approximately 1,000 times greater than absorption spectrophotometric methods. This leads to greater limits of detection”).
Perhaps most conventionally, one could use HPLC coupled with mass spectrometry detection (HPLC-MS) but, even here, the sensitivity and limit of detection could vary based on the nature of the MS instrument (see, for example, the non-patent publication, From routine analysis to drug discovery, there’s an LC/MS for the job, Agilent web site, obtained at the url www.agilent.com/en/product/liquid-chromatography-mass-spectrometry-lc-ms/lcms-fundamentals/lcms-instrument-types (undated, but currently bearing a 2025 copyright mark)), as well as on the details of the chromatographic regimen (see, for example, the non-patent publication, LC–MS Sensitivity: Practical Strategies to Boost Your Signal and Lower Your Noise, LCGC N. America, 36, pgs. 652-660 (2018) by Lupo, noting that MS optimization, sample pretreatment strategies, mobile-phase composition, and LC column characteristics are all integral to ionization efficiency and will improve analyte signal when optimized).
Thus, it is entirely feasible that a sample having 1 ppm ethyl prasterone would exhibit no detectable ethyl prasterone by one methodology and set of equipment, while the same sample would exhibit readily detectable ethyl prasterone by a different methodology and set of equipment. For all of these reasons, a limitation that ethyl prasterone is “undetectable,” absent a fairly precise description of the required method of detection, is intrinsically indefinite. The rejection is maintained.
Previous rejections for obviousness:
The previous rejections of claims 1-3, 7, 9, 12, 18-20, 27, 31, 45-46, and 49-50 are substantially obviated by the amendment to claim 1 and the cancelation of claims 3, 18-19, 46, and 50. With respect to the previous rejection of claim 4, now canceled but essentially identical in scope to currently amended claim 1, Applicant’s arguments have been fully considered and have been found partially persuasive – at least sufficiently persuasive to overcome the reasons for rejection.
The previous rejection of claim 4 (now claim 1, in effect) was under 35 U.S.C. § 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0337003 to Koziol et al (hereinafter, “Koziol”), in view of the non-patent publication, Ester Prodrugs of Zidovudine, J. Pharm. Sci., 79, pgs. 531-533 (1990) by Kawaguchi et al. (hereinafter, “Kawaguchi”).
Briefly, Koziol teaches, inter alia, ester prodrugs of abiraterone having C2-C7 acyl chains (i.e. compounds of the following formula:
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where R is C1-C6 alkyl). The previous rejection contended that it would have been obvious to modify Koziol by utilizing longer alkyl chain lengths (such as where R is C9 alkyl, to produce the decanoate ester of instant amended claim 1), because utilizing longer acyl chains on prodrug esters to extend the time of drug release was well-known in the art, such as demonstrated by Kawaguchi. Kawaguchi teaches ester prodrugs of AZT with C2-C18 acyl chains, and teaches that AZT prodrugs having longer acyl chains (e.g. C10 or C18) have longer-lasting drug concentration profiles in plasma than do the prodrugs with shorter acyl chains (e.g. C2, analogous to acetyl chain of acetyl abiraterone). Furthermore it was noted that Kawaguchi specifically shows that the decanoate ester of AZT has peak activity with mammalian esterases for conversion to the active drug, thus motivating investigation of similar medium-length acyl chains on the esterified abiraterone prodrugs of Koziol.
Applicant has argued that there is no evidence that one of skill in the art would want a sustained plasma level of abiraterone or, more generally, no indication what types of release profile are desired for abiraterone (pg. 13 of Applicant’s remarks, last full paragraph leading into the paragraph spanning the bottom of pg. 13 to the top of pg. 14). This is found persuasive.
While the Background of the instant specification suggests an understood need for sustained-release abiraterone (e.g. paragraphs [0008]-[0009], suggesting a disadvantage of acetyl abiraterone is rapid clearance, associated with loss of therapeutic effect (paragraph [0008]), and consequently an undesirable absence of sustained-release formulations (paragraph [0009])), the art in general does not appear to support a recognized need for sustained-release abiraterone that would motivate one apply the teachings of Kawaguchi to extend the release profile of the ester prodrugs of Koziol.
To the contrary, the non-patent publication, Rapid conversion of the ester prodrug abiraterone acetate results in intestinal supersaturation and enhanced absorption of abiraterone: In vitro, rat in situ and human in vivo studies, Eur. J. Pharmaceut. & Biopharmaceut., 90, pgs. 1-7 (2015) by Stappaerts et al. (hereinafter, “Stappaerts”) teaches, inter alia, a study of intestinal absorption of abiraterone resulting from intake of abiraterone or abiraterone acetate (Abstract). The results showed rapid hydrolysis of the prodrug producing intestinal concentrations exceeding the apparent solubility of free abiraterone, and higher flux values for the prodrug than for the free drug (Abstract). On this basis, the authors concluded that fast dissolution and subsequent immediate degradation of the prodrug is the underlying mechanism justifying the use of the prodrug over abiraterone (pg. 7, left column). On the basis of this view, one would not have been motivated to apply the teachings of Kawaguchi to the abiraterone esters of Koziol, as the potentially extended release and decreased solubility that one would have expected, would have reasonably been regarded as most likely detrimental in view of the teachings of Stappaerts.
The rejection previously applied to claim 4, which would otherwise be relevant to current claim 1, is withdrawn, or not applied to currently amended claim 1, for the reasons described above.
Claim Rejections - 35 USC § 112 – Maintained
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 6 is indefinite:
Claim 6 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 6 is indefinite for reciting that the substantially pure abiraterone decanoate is characterized as having no detectable amount of ethyl prasterone decanoate, because a person of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. In particular, whether is given compound is “detectable” depends on the method used to detect it, the sensitivity of the assay/equipment, etc. As such, while ethyl prasterone decanoate might not be detected in a given sample when examined by a given assay, there would be no way to determine if the species is in any objective, overriding sense, not detectable.
Claim Rejections - Double Patenting – Newly Added
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, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are rejected for nonstatutory double patenting over the ’292 patent:
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 12-22, and 26-30 of U.S. Patent No. 10,792,292 to Sharp et al. (hereinafter, “the ’292 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the 292 overlap in scope with the instant claims.
Claims 12-22 of the 292 recite methods of treating various disorders, and claims 26-27 of the 292 recite a method of treating prostate cancer, essentially overlapping with the methods of instant claims 1, 2, 5-7, 9, 12, 20, 27, 31, and 45. Claims 1-4 of the 292 recite a compound that is abiraterone decanoate, and substantially overlap with instant claim 54 directed to a composition of substantially pure abiraterone decanoate. Claims 28-30 of the 292 recite a method for preparing an abiraterone decanoate formulation, and substantially overlap with instant claim 55.
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are rejected for nonstatutory double patenting over the ’534 patent:
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 16-23 of U.S. Patent No. 11,559,534 to Sharp et al. (hereinafter, “the ’534 patent”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ’534 patent overlap in scope with the instant claims.
Claims 16-23 of the ’534 patent recite a method of treating prostate cancer, essentially overlapping with the methods of instant claims 1, 2, 5-7, 9, 12, 20, 27, 31, and 45. Claim 1 of the ’534 patent recites a compound that is abiraterone decanoate, and substantially overlap with instant claim 54 directed to a composition of substantially pure abiraterone decanoate. Claims 2-10 of the ’534 patent recite a pharmaceutical composition having abiraterone decanoate and a pharmaceutically acceptable carrier. It would have been obvious that a method of making such a composition would include mixing a substantially pure abiraterone decanoate with a pharmaceutically acceptable carrier, as recited in instant claim 55.
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are rejected for nonstatutory double patenting over the ’696 patent:
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,957,696 to Sharp et al. (hereinafter, “the ’696 patent”), in view of U.S. Patent No. 8,882,438 to Murphy et al. (hereinafter, “Murphy”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ’696 patent overlap in scope with the instant claims.
Claims 1-21 of the ’696 patent recite methods of treating cancer wherein the subject is characterized as having prostate cancer, and essentially overlap with the methods of instant claims 1, 2, 5-7, 9, 12, 20, 27, 31, and 45. The claimed methods of the ’696 patent involve administering a pharmaceutical composition having abiraterone decanoate. It would have been obvious that such a composition would be made by mixing abiraterone decanoate with the pharmaceutical carrier and that one would desire substantially pure abiraterone decanoate for such admixture. It would thus have been obvious to produce a substantially pure abiraterone decanoate as in instant claim 54, and to mix this compound with a pharmaceutically acceptable carrier as in instant claim 55.
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are provisionally rejected for nonstatutory double patenting over the ’358 application:
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2-18 of copending Application No. 18/920,358 (hereinafter, “the ’358 application”). The corresponding U.S. Patent Application Publication No. 2025/0099489 is cited in the attached form PTO-892. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ’358 application overlap in scope with the instant claims.
Claims 2-18 of the ’358 application recite methods of treating prostate cancer, essentially overlapping with the methods of instant claims 1, 2, 5-7, 9, 12, 20, 27, 31, and 45. Claim 9 of the ’358 application recites administering to the subject a pharmaceutical composition comprising abiraterone decanoate and a pharmaceutically acceptable oil (i.e. a pharmaceutically acceptable carrier). It would have been obvious that such a composition would be made by mixing abiraterone decanoate with the pharmaceutical carrier and that one would desire substantially pure abiraterone decanoate for such admixture. It would thus have been obvious to produce a substantially pure abiraterone decanoate as in instant claim 54, and to mix this compound with a pharmaceutically acceptable carrier as in instant claim 55.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are provisionally rejected for nonstatutory double patenting over the ’339 application:
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-14, 18, 21-22, 28, 38-39, 41-42, 48, 65, 69-70, 82-88, and 92-93 of copending Application No. 18/226,339 (hereinafter, “the ’339 application”). The corresponding U.S. Patent Application Publication No. 2024/0139212 is cited in the attached form PTO-892. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ’339 application overlap in scope with the instant claims.
Claims 1-2, 5-14, 18, 21-22, 28, 38-39, 41-42, 48, 65, and 69-70 of the ’339 application recite a method of treating a cancer, including prostate cancer (claim 21 of the ’339 application), essentially overlapping with the methods of instant claims 1, 2, 5-7, 9, 12, 20, 27, 31, and 45. Claims 82-87 of the ’339 application recite a compound that is abiraterone decanoate, and substantially overlap with instant claim 54 directed to a composition of substantially pure abiraterone decanoate. Claims 88 and 92-93 of the ’339 application recite a method for preparing an abiraterone decanoate formulation, and substantially overlap with instant claim 55.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are provisionally rejected for nonstatutory double patenting over the ’500 application:
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of copending Application No. 18/689,500 (hereinafter, “the ’500 application”). The corresponding U.S. Patent Application Publication No. 2025/0025417 is cited in the attached form PTO-892. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ’500 application overlap in scope with the instant claims.
Claims 38-81 of the ’500 application recite a method of treating a disease or disorder, including prostate cancer (claim 39 of the ’500 application), essentially overlapping with the methods of instant claims 1, 2, 5-7, 9, 12, 20, 27, 31, and 45. Claims 1-37 of the ’500 application recite a pharmaceutical composition having abiraterone decanoate and a lipid based drug delivery system (a pharmaceutically acceptable carrier). It would have been obvious that such a composition would be made by mixing abiraterone decanoate with the pharmaceutical carrier and that one would desire substantially pure abiraterone decanoate for such admixture. It would thus have been obvious to produce a substantially pure abiraterone decanoate as in instant claim 54, and to mix this compound with a pharmaceutically acceptable carrier as in instant claim 55.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are provisionally rejected for nonstatutory double patenting over the ’725 application:
Claims 1, 2, 5-7, 9, 12, 20, 27, 31, 45, 49, and 54-55 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-58 and 93-95 of copending Application No. 18/842,725 (hereinafter, “the ’725 application”). The corresponding U.S. Patent Application Publication No. 2025/0186463 is cited in the attached form PTO-892. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ’725 application overlap in scope with the instant claims.
Claims 1-58 of the ’725 application recite a method of treating a disease or disorder, including prostate cancer (claim 6 of the ’725 application), essentially overlapping with the methods of instant claims 1, 2, 5-7, 9, 12, 20, 27, 31, and 45. Claims 93-95 of the ’725 application recite a pharmaceutical composition having abiraterone decanoate and, inter alia, corn oil (a pharmaceutically acceptable carrier). It would have been obvious that such a composition would be made by mixing abiraterone decanoate with the pharmaceutical carrier and that one would desire substantially pure abiraterone decanoate for such admixture. It would thus have been obvious to produce a substantially pure abiraterone decanoate as in instant claim 54, and to mix this compound with a pharmaceutically acceptable carrier as in instant claim 55.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Because this Office Action includes rejections that could have been made in the previous Action, this Action is Non-Final.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629