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 .
This is a Non-Final Office Action.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 3, 2025 has been entered.
Election/Restrictions
Applicant's election with traverse of Group (I) in the reply filed on January 10, 2022 is acknowledged. Group (I), drawn to compounds of formula (I-A) and compositions thereof, embraced by claims 1-19 was elected by Applicant.
Applicant also elected, with traverse, the following species:
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and claims 1, 2, 7, 14, 17, 18 and 19 read upon the elected species.
In summary claims 3-17, 20, 21 and 24 are pending and claims 7, 14, 17 and 24 are under consideration. Claims 3-6, 8-13, 15, 16, 20 and 21 are withdrawn.
Priority
Applicant's claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) (PROVISIONAL) or 119(a) (FOREIGN) or under 35 U.S.C. 120 (CONT/CIP), 121(DIV), or 365(c) (WO) is acknowledged. Applicant still has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(a) as follows: The later-filed application must be an application for a patent application (the parent for an invention which is also disclosed in the prior application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed applications, Application No. 201821047939 and Application No. 201821019542, fail to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for claims 7, 14, 17 and 24 of this application. The present formula (VII) in claim 7, specifically R12 defined as acyl, is not found in either prior-filed applications nor are the subformulas
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from claims 14 and 17. The species in claim 24 is found in Application No. 201821047939. There may be other omissions as well. Thus, the effective filing date of the present claims 7, 14 and 17 is the international filing date of May 24, 2019 and December 18, 2018 for claims 24.
Applicant contends, “Prior-filed Indian Application No. 201821019542 explicitly discloses the following:
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See page 4, first paragraph.
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See page 5, third paragraph [emphasis added].
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See page 7, first paragraph.
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See pages 12, last paragraph to 13, first paragraph [emphasis added].
Applicants assert that this disclosure reasonably conveys to a person of ordinary skill in the art that the inventor had possession of the claimed species, including,
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. As clarified in MPEP § 2163, literal disclosure of every substituent is not required; representative and generic descriptions are sufficient.”
Indeed, “literal” disclosure of every substituent is not required and representative and generic descriptions are acceptable. However, to receive the benefit of a priority document, the priority document must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention, which is currently not the case. Therefore, the effective filing date of the present claims 7, 14 and 17 is the international filing date of May 24, 2019 and December 18, 2018 for claims 24 for the reasons provided above.
Claim Objections
The objection to claim 14 because the proviso at the end of claim 14, wherein R12 is aryl, no longer applies, is withdrawn based on the amendments.
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(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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(a) 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 under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 7, 14, 17 and 24 are rejected under AIA 35 U.S.C. 103(a) as being unpatentable over Jiao et al. (US 20160060288) in view of Dosa et al. (ChemMedChem, 2013, 8, 1002-1011), Ferriz et al. (Current Pharmaceutical Design, 2010, 16, pp. 2033-2052), , Rautio et al. (Nature Reviews, 2018, 17, 559-587) and Rautio et al. (2) (Nature Reviews, 2008, 7, 255-270).
The present application claims prodrugs of the drug fulvestrant as provided by formula (I-A):
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, wherein A= H and R= P(O)(OR12)2 and CH2OP(O)(OR12)2, wherein R12 is H or the Na salt.
The following is the structure of fulvestrant:
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, which is excluded by proviso.
The ‘288 reference teaches fulvestrant as an “estrogen receptor blocking agent in the treatment of postmenopausal advanced breast cancer which fails to respond to anti-estrogen therapy and which is estrogen receptor positive,” see page 1, paragraph 0002. The reference further teaches “Currently, many commercially available preparations of fulvestrant use oil as an excipient for the following two reasons. On the one hand, fulvestrant, which is of poor stability and easy to degrade, is generally stored at −20, and should not be stored at room temperature for too long, otherwise its purity would be affected. Although the mechanism of its degradation is not clear, it is generally believed that the main reason for affecting its stability lies in the presence of —OH at positions C-3 and C-17. Meanwhile, the presence of —OH at 3- and 17-positions increases the polarity of drugs and the stimulation of drugs on the gastrointestinal tract, thus it can only be prepared into injection. On the other hand, like other steroids, fulvestrant, which is difficult to be formulated due to certain physical properties, is a molecule with high lipophilicity and extremely low water solubility of about 10 ng/mL,” see page 1, paragraphs 0004-0005. The ‘344 reference teaches prodrugs of fulvestrant where either one or both OH groups are protected with an ester functionality, where the prodrugs are outside of the scope of the present claims.
The ‘288 reference does not teach phosphate ester prodrug at the 3-position of the phenyl ring of the steroid core.
Dosa et al. also teaches water-soluble prodrugs of ursodeoxycholic acid utilizing phosphate prodrugs, see abstract. The reference further states, “However, we were unable to test UDCA in these models because its limited aqueous solubility precluded the administration, preferably intravenously (iv) for these indications, of doses large enough to have an effect. This is unfortunate as UDCA is an FDA-approved drug in the U.S. with an excellent safety record in humans even when used for extended periods of time at high doses, making it a particularly attractive potential therapy. With this in mind, we set out to synthesize highly water-soluble prodrugs of UDCA. We chose to focus on synthesizing phosphate ester prodrugs as this modification often increases aqueous solubility by several orders of magnitude. There are several examples of this class of prodrugs already in clinical use, including prednisolone phosphate, fosphenytoin, and fosamprenavir,” see page 1002, right-hand column, see also page 1003, Scheme 1 for compound 3, and page 1004, Scheme 4 for compound 16.
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The fused steroid core in the Dosa reference differ from the presently claimed fused steroid core in that ring A is a fused cyclohexyl and in the present compound is a fused phenyl ring. However, the phosphate esters are at the 3-position of the steroid core and were utilized in an attempt to overcome the low water solubility property of the compound.
The Dosa reference does not teach fulvestrant with a phosphate ester prodrug at the 3-position of the phenyl ring of the steroid core but does teach a similar steroid compound with a phosphate ester prodrug at the 3-position of the steroid core.
Ferriz et al. teaches “The phenolic hydroxyl group is one of the most common functional groups found in drug molecules such as narcotic agonists and antagonists, estrogens, neurotransmitters, anticancer agents or antibacterial agents, among others. However, phenolic drugs usually present limited bioavailability and thus limited affectivity. Due to their poor delivery characteristics caused by their metabolic instability, they are often subjected to extensive first pass metabolism and in general, non-lipophilic character results in poor biomembrane passage. Solubility limitations have been also frequently encountered in the development of commercial phenolic drugs. Alternatively, the presence of phenolic groups brings the possibility of prodrug approach which can result in effective, safe and efficient delivery of the parent drug to the systemic circulation and to the desired site of action,” see page 2033, first paragraph.
The reference further teaches, “Phosphate ester prodrug approach has overcome numerous drug delivery problems of sparingly water soluble potential drugs. The phosphate moiety can be directly attached to the parent drug to form a phosphomonoester, which undergoes an alkaline phosphatase-catalyzed bioconversion in vivo to release the parent phenol drug and inorganic phosphate, or via a chemical linker such as oxymethyl spacer, usually used to increase the space around the enzymatically cleavable bond,” see page 2036, right-hand column, third full paragraph.
Ferriz goes on to state the addition of the following phosphate groups to propofol, a low aqueous solubility drug, see compounds 12 (propofol) and 22 below. The reference goes on to state, “Although the 22 hypnotic dose (HD50) was found to be around 10 times larger than the HD50 values reported for 12, the PP lethal dose (LD50) was as well bigger in mice, rats and pigs; this implies lower hypnotic activity and lower toxicity so it would be possible to apply larger doses of 22 to achieve the same level of sedation as with 12… Fig. (7),” see page 2036-2037, bridged paragraph.
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Another example in the Ferriz reference is compounds 31 and 32, shown below, see pages 2038-2040. Ferriz states, “DP-TAT-59 (31) Fig. (11) is a practically insoluble analogue of tamoxifen, an antagonist of the estrogen receptor in breast tissue, therefore used in the treatment of breast cancer. In order to increase the solubility of 31, a phosphate prodrug strategy was developed. Miproxifene phosphate (TAT-59) (32) Fig. (11) was synthesized [66,67] and actually is in phase II-III trials. Surprisingly 32 showed unusual low solubility comparing to most phosphate esters freely soluble in water [68,69]. Despite the relatively low solubility of 32, its solubility and dissolution rate were much higher than those of the parent drug, making succeed the prodrug approach. The dephosphorylation in vivo of 32 was rather quick as it was shown in pharmacokinetic studies. The bioavailability of 31 after oral 32 dosing was 28.8% in rats and 23.8% in dogs. Furthermore, no intact prodrug was detected in plasma of either species. However, no bioavailability data have been published for humans.”
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Ferriz further teaches a solubility increase of compound 33, 0.017 mg/mL at pH 1.2 and 1.75 mg/mL at pH 7.4 and 37C, to 30 mg/mL at both pHs for compound 34, shown below, see pages 2039 and 2040.
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These are just several examples of phosphate prodrugs taught in the Ferriz reference.
The Ferriz reference does not teach a phosphate ester prodrug at the 3-position of the phenyl ring of the steroid core but does teach a phenyl ring substituted with a phosphate ester prodrug.
Rautio et al. teach a plethora of prodrugs, including phosphate esters, see 560, Figure 1, upper left-hand side. The reference further teaches fospropofol, compound 3 in Table 1, page 562, and tedizolid phosphate, compound 17 in Table 1, page 564, provided increase water solubiity for the base compound, see Table 1 for each compound and page 561, last paragraph on bottom right-hand column and page 566, bottom left-hand column.
Rautio further teaches, “Prodrugs can be used to protect active drugs from this first-pass effect by masking a metabolically labile but pharmacologically essential functional group, such as a phenol, to avoid rapid metabolism. This strategy is effectively illustrated by bambuterol, which is a long-lasting prodrug of the bronchodilator and β2-adrenergic receptor agonist terbutaline. In bambuterol, two metabolically susceptible phenol moieties on terbutaline are protected by dimethylcarbamate promoieties designed to avoid rapid and extensive first-pass metabolism in the gut and liver,” see page 572, bottom right-hand column. The present compound has a hydroxy at the 3-position of the fused phenyl moiety, which may also be susceptible to rapid metabolism due to the first-pass effect.
Rautio further teaches, “Aqueous solubility is one of the most important proper-ties, regardless of the administration route of a drug. For oral drug delivery, a drug with low solubility may face low and variable oral bioavailability, which leads to an unpredictable clinical response. Prodrug strategies to improve solubility for oral administration are simi-lar to those used for solubilizing drugs in aqueous for-mulations for parenteral administration,” see page 567, first paragraph, right-hand column.
Rautio (2) teaches “Phosphate esters can increase the oral bioavailability of many poorly water-soluble drugs. They are especially useful for drug candidates that require a high dose and exhibit a dissolution-rate limited absorption28. Nearly all oral phosphate ester prodrugs are rapidly hydrolysed to the parent drug by endogenous alkaline phosphatases at the intestinal cell surface during absorption, leading to low prodrug concentrations in the systemic circulation. An example is a water-soluble phosphate ester miproxifene phosphate (TAT‑59; TABLE 2), the prodrug of DP‑TAT‑59 (Refs 28,66). The parent drug, DP‑TAT‑59, has low to moderate hepatic clearance (CLh) compared with the hepatic blood flow (Qh) in preclinical species66 and in humans67, and a low Eh in the rat (0.4) and dog (0.2). DP‑TAT‑59 is apparently not bioavailable in preclinical species owing to the ‘brickdust’ nature of this parent drug, with a solubility of less than 1 μg per ml68. After TAT‑59 prodrug dosing, DP‑TAT‑59 bioavailability was greatly enhanced to 28.8% in rats and 23.8% in the dog, and in human trials DP‑TAT‑59 showed dose-linear pharmacokinetics after TAT‑59 dosing,” see page 261, right-hand column, third full paragraph. See also page 258, Table 2, second row, where the aqueous solubility was increased by -1,000 fold by the addition of a phosphate ester.
Therefore, it would be obvious to add a phosphaste ester group as a prodrug to the phenolic group of fulvestrant because Ferriz teaches said addition improves water solubility of phenolic drugs and Jiao teaches fulvestrant is highly lipophilic and has extremely low water solubility. Dosa teaches a similar compound where a phosphate ester was added at the 3-position of a nonaromatic steroid A ring and Rautio and Rautio (2) teaches phosphate prodrugs increase water solubility and oral bioavailability of the base compound.
Thus, said claims are rendered obvious by Jiao et al., Ferriz et al., Dosa et al., Rautio et al. and Rautio et al. (2).
Applicant traverses by stating, “Thus, the claims are directed to novel compounds that share a key structural feature - a phosphate moiety at the 3-position of fulvestrant but also specific asymmetric R12 substitution pattern required by the claims. Applicants assert that the proviso which reads - that only one R12 may be alkyl or aryl while the other must be hydrogen - defines a narrow and distinct class of compounds. Thus, the claims require both the phosphate moiety at the 3-position and the asymmetric R12 substitution pattern.”
This is not persuasive. The proviso does not exclude compounds where both R12 variables are defined as H, which embraces the elected species.
Applicant further traverses by stating, “The Cited Art, Alone Or Combined, Does Not Teach Or Suggest Every Element Of The Claimed Invention… Hence, neither Jiao et al., Ferriz et. al., Dosa et al., nor Rautio et al. alone or in combination, teach or suggest a phosphate moiety at the 3-position and the specific asymmetric R12 substitution pattern required by the claims, which is critical to the claimed compound's properties. Thus, the Office's reliance on the phosphate moiety alone is insufficient to establish obviousness.”
This is unpersuasive. Applicant discusses each reference cited in the previous rejection and concludes that none of the references teach a phosphate moiety at the 3-position and the specific asymmetric R12 substitution pattern required by the claims. This is not correct since the Dosa reference teaches a similar compound with a 3-phosphate ester prodrug at the 3-position of a steroid core. Moreover, as mentioned above, the proviso does not exclude compounds where both R12 variables are defined as H, which embraces the elected species.
Applicant notes, “There Is No Motivation To Combine The Teachings Of The Cited Art With Any Reasonable Expectation Of Success… The Office has not established a prima facie case of obviousness because the references fail to provide any teaching, suggestion, motivation, or reasonable expectation of success in arriving at the claimed prodrugs.”
This is also not persuasive. The rejection outlines the motivation to make a phosphate ester prodrug to increase the solubility and the oral bioavailability of the drug as taught by at least Rautio (both references).
Applicant further notes, “Unexpected Results (Solubility & Oral Bioavailability)… Applicants assert that the route of administration depends on complex interplay of chemical structure, ionic properties, lipophilicity, enzymatic activation, and membrane permeability, all of which require extensive empirical optimization and cannot be inferred merely from phosphate prodrug chemistry in isolation... Consistent with this holding, and supported by pharmacokinetic data demonstrating superior oral bioavailability compared to fulvestrant, Applicants assert that although compounds (I-ak) and (I-s) show a dramatic 1000-fold increase in solubility relative to fulvestrant, this by itself is not determinative of improved oral bioavailability. See Declaration under 37 CFR 1.132 by Dr. Purohit (filed on June 17, 2024).”
Indeed, the route of administration depends on complex interplay of chemical structure, ionic properties, lipophilicity, enzymatic activation, and membrane permeability. However, the Rautio references teach regardless of the route of administration, an increase in solubility may increase the bioavailability, which is noted in the rejection.
Applicant notes additional pharmacokinetic data is found in the declaration submitted on June 17, 2024, which includes complete error calculations. Applicant further notes that “ "ND" in this context means "Not Detectable."
The Examiner appreciates the clarification for the “ND” term. Compound (I-t) being detectable over fulvestrant is not unexpected based on the fact that phosphate prodrugs increase water solubility of steroids which in turn increase bioavailability as explained in the response above.
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Applicant provides additional data of unexpected solubility and bioavailability of presently claimed compounds in a Declaration submitted by Dr. Parva Yogeshchandra Purohit.
Lastly to address the declaration, wherein the declaration provides data shown in Table 1 below that measures the thermodynamic solubility of compound (i-ak) and (i-s) compared to fulvestrant.
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Compound (i-ak) was not discussed in the obviousness rejection and the declaration states said compound is provided for additional data, see Table 1. Compound (i-s) is the elected species and used for the comparison to fulvestrant. Table 1 shows compounds (i-ak, 1.32 mg.mL) and (i-s, 1.22 mg.mL), the phosphate esters are more soluble, approximately 1000-1100 times than fulvestrant, (0.0012 mg.mL). This is not unexpected. As noted in the rejection above, making a phosphate ester of a low, water-soluble compound, will increase the water solubility, which in turn, will increase the bioavailability.
The declaration further contends, “Table-2 shown below shows bioavailability data of Fulvestrant after oral administration of Fulvestrant, compound (l-ak) and compound (I-s), where bioavailability of Fulvestrant was tested after compound (I-s), compound (l-ak), and Fulvestrant were given orally to beagle dogs (non-rodent), where Compound (I-s) and compound (I-z) tested are different compounds under different genus.”
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Again, this is not unexpected. As noted above, phosphate prodrugs increase the water solubility, which in turn, may increase the bioavailability.
Even if, arguendo, the results are considered unexpected, the claims are not commensurate in scope with the unexpected results.
MPEP 716.02(D) states, “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). The non-obviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range if one of ordinary skill in the art would be able to determine a trend in the exemplified data which would allow the artisan to reasonably extend the probative value thereof. In re Kollman, 595 F.2d 48, 201 USPQ 193 (CCPA 1979).
Applicant further traverses by contending, “The claimed invention demonstrates successful oral delivery. On the other hand, the prior art teaches away from oral administration of phosphate prodrugs. Jiao et al. focuses on parenteral administration (injectable) and emphasizes phosphate ester only as a way to improve solubility for injection, not oral delivery. Jiao et al. does not even contemplate oral administration and actually suggests phosphate prodrugs are unstable or unsuitable for oral administration. In light of this, a person skilled in the art would conclude that phosphate fulvestrant derivatives are unsuitable for oral administration. Rautio et al. discusses phosphate prodrugs but emphasizes instability and metabolic liability in oral administration. This is a direct dissuasion of oral phosphate prodrugs. Ferriz et al. and Dosa et al. focus on phosphate prodrugs but largely in parenteral contexts or with different substitution patterns. These references clearly caution against oral administration of phosphate prodrugs. Applicant's data directly contradicts this teaching, showing that the claimed compounds succeed where the art predicts failure.”
This is unpersuasive. The claims are drawn to a specific phosphaste ester prodrug of fulvestrant at the 3-position of the steroid core and the rejection provides motivation to make the specific phosphate ester phosphaste ester prodrug of fulvestrant at the 3-position of the steroid core. This is all that is required.
Applicant further contends that the claimed phosphate prodrugs solve a distinct and unmet need, as confirmed by supporting experimental data (Table 2 of Declaration under 37 CFR 1.132 by Dr. Purohit, filed on June 17, 2024). The prior art neither discloses nor suggests a prodrug approach that specifically solves fulvestrant's oral bioavailability problems and instead focuses on parenteral administration or general solubility improvements. Thus, obviousness cannot be found when prior art does not recognize the unmet need or provide motivation to overcome it, supporting the non-obviousness of the claimed invention.”
This is not persuasive. Regarding secondary considerations, Applicant has not provided any evidence that shows there is a distinct and unmet need based on the oral bioavailability of fulvestrant. The declaration is discussed above.
Applicant also notes, “The Office's position improperly applies hindsight by reading knowledge of the present invention back into the prior art, contrary to the Supreme Court's caution in KSR Int'l Co. V. Teleflex Inc., 550 U.S. 398 (2007), and Federal Circuit precedent requiring a specific motivation and reasonable expectation of success to support obviousness In re O'Farre, 853 F.2d 894, 903-04 (Fed. Cir. 1988); Amgen, Inc. V. Chugai Pharm. Co., 927 F.2d 1200, 1207-08 (Fed. Cir. 1991).”
This is not found to be persuasive. it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Therefore, the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached on Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624