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 Application
The Amendments and Remarks filed on 04/28/26 are acknowledged.
Claims 2-34 were previously cancelled. Claims 35 and 44 were cancelled on 04/28/26.
Claims 1, 36, 38-39, 45, and 50-51 were amended.
Claims 1, 36-43, and 45-51 are pending and included in the prosecution.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 04/28/26 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.
Response to Amendments/Arguments
Objection to the Abstract
In light of the amendment of the Abstract, the objection to the Abstract is withdrawn.
Applicant’s amendment of claim 38 to correct a typo is acknowledged.
Rejection of claims under 35 USC § 103
Applicant amended claim 1 to delete olaparib and only recite abiraterone acetate. In light of this amendment, Applicant’s arguments (Pages 5-7, filed 04/28/26) regarding the rejection of claims 1, 35, 38-39, and 41-48 under 35 U.S.C. 103 as being unpatentable over Mishra et al. (WO 2018/113890 A1 – “Mishra”) in view of Sheikh et al. (US 2017/0105937 A1 – “Sheikh”) have been fully considered and are persuasive.
Mishra and Sheikh do not expressly teach abiraterone acetate. Therefore, the rejection is withdrawn.
However, upon further consideration of the amended claims, a new ground(s) of rejection of claims 1, 35, 38-39, and 41-48 is made over Mishra in view of Sheikh and further in view of Chen et al. (US 2019/0330196 A1 – “Chen”). Since the new grounds of rejection were necessitated by Applicants’ amendment, this action is made FINAL.
New Rejections Necessitated by Amendment
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 50 and 51 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.
Claim 50 is dependent on claim 1 and recites the inclusion of olaparib. However, based on the amendment filed on 04/28/26, claim 1 does not recite olaparib any longer. It is unclear how dependent claim 50 can include olaparib when claim 1 does not recite this drug. Clarification and/or amendment are required.
Claim 51 is included in this rejection for not correcting the defects of the claim from which it depends.
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, 36, 38-43, and 45-51 are rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (WO 2018/113890 A1 – “Mishra”) in view of Sheikh et al. (US 2017/0105937 A1 – “Sheikh”) and Chen et al. (US 2019/0330196 A1 – “Chen”).
Instant claim 1 is drawn to a co-amorphous form of beta-lactoglobulin and a drug substance, wherein the drug substance is abiraterone acetate and wherein the concentration of the drug substance in the co-amorphous form is from 10% to 90% w/w based on the total weight of the co-amorphous form.
Mishra teaches a co-amorphous form of a substance and a protein, and pharmaceutical compositions comprising the co-amorphous form (Abstract and claims 1-12). The protein includes beta-lactoglobulin (Page 2, lines 13- 21; Page 14, lines 13-16; and claims 1-9). A co-amorphous form of a substance and a protein according to the invention may contain from 1-95% w/w of the substance and from 5 to 99% w/w of the protein, and suitable examples of co-amorphous forms contain from about 25 to about 75% w/w of a drug substance (Page 9, lines 26-32). Co-amorphous indomethacin-beta-lactoglobulin is obtained by spray drying (Page 16, lines 18-19 and Page 21, lines 5-9).
Mishra does not expressly teach abiraterone acetate.
Sheikh teaches co-precipitates of an anti-cancer agent (olaparib) and an ionic polymer and a pharmaceutical composition containing the co-precipitates (Abstract, claims 1-5 and 10-11). The anti-cancer agent olaparib is an FDA-approved targeted therapy for cancer ([0003]) and may be present in the co-precipitate in an amount of from about 10% to about 80% by weight of the co-precipitate ([0030]). The co-precipitates of olaparib and an ionic polymer are prepared by spray drying ([0032], [0037], claims 6 and 9).
Chen teaches compounds intended for pharmaceutical use which are obtained by spray drying ([0901]). Anti-cancer agents are used in conjunction with the compounds in pharmaceutical compositions ([0950]) and include olaparib, niraparib, and abiraterone acetate, and combinations thereof ([0951]).
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 co-amorphous form of about 25 to about 75% w/w of a drug substance and a beta-lactoglobulin protein which is obtained by spray drying, as taught by Mishra, in view of co-precipitates of the anti-cancer drug olaparib and an ionic polymer prepared by spray drying, as taught by Sheikh, use a combination of the anti-cancer drugs olaparib, abiraterone acetate, and niraparib, as taught by Chen, and produce the instant invention.
One of ordinary skill in the art would have been motivated to use the spray dried co-amorphous form containing a drug substance and beta-globulin taught by Mishra for the anti-cancer drug olaparib taught by Sheikh and the anti-cancer drugs olaparib, abiraterone acetate, and niraparib taught by Chen because Mishra teaches that “… when a protein or peptide, notably a native peptide or native protein, is used to produce a co-amorphous form of a poorly soluble substance such as a poorly soluble drug substance, the resulting co-amorphous form is a completely homogeneous, one-phase system in which the substance and the protein are combined at the molecular level. In this way, the aqueous solubility and the oral absorption is improved compared to an amorphous form of the substance itself without any protein excipient. Moreover, the physical stability of the co-amorphous form is also increased compared to the amorphous form of the drug itself and the physical mixture of the substance and the protein. Another advantage … is that it may utilize inexpensive proteins or protein mixtures, which are produced in abundance as byproducts during food production such as dairy production” (Page 1, line 27 to Page 2, line 2). Mishra teaches that commercially available whey protein isolates (WPIs) comprise about 55 to about 65% beta-lactoglobulin (Page 6, lines 5-6). Additional advantages of using the beta-lactoglobulin based co-amorphous forms include not only increasing the solubility and stability of the drug substance, but also increasing bioavailability (Page 13, lines 7-10).
Furthermore, both Mishra and Sheikh teach preparing co-amorphous forms or co-precipitates by the same spray drying method. 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 combine the teachings of Mishra and Sheikh with the teachings of Chen because Chen teaches a combination of cancer treatment drugs, including the olaparib taught by Sheikh, with abiraterone acetate and niraparib ([0951]). One of ordinary skill in the art would have had a reasonable expectation of success in preparing a functional co-amorphous form containing a combination of cancer treatment drugs since combinations of such drugs are taught by Chen.
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 claim 1, the limitation of a co-amorphous form of beta-lactoglobulin and a drug substance would have been obvious over a co-amorphous form of a substance and a protein (Abstract and claims 1-12), wherein the protein includes beta-lactoglobulin (Page 2, lines 13- 21; Page 14, lines 13-16; and claims 1-9), as taught by Mishra.
Regarding instant claim 1, the limitation of abiraterone acetate would have been obvious over the abiraterone acetate ([0951]), as taught by Chen.
Regarding instant claim 1, the limitation of the concentration of the drug substance in the co-amorphous form is from 10% to 90% w/w based on the total weight of the co-amorphous form would have been obvious over the co-amorphous forms that contain from about 25 to about 75% w/w of a drug substance (Page 9, lines 26-32), as taught by Mishra, the anticancer drug olaparib which may be present in the co-precipitate in an amount of from about 10% to about 80% by weight of the co-precipitate ([0030]), as taught by Sheikh, and the anti-cancer agents including olaparib, niraparib, and abiraterone acetate, and combinations thereof ([0950]-[0951]) as taught by Chen.
Regarding instant claim 36, the limitation of the concentration of abiraterone acetate in the co-amorphous form of from 10% to 70% w/w based on the total weight of the co-amorphous form would have been obvious over the co-amorphous forms that contain from about 25 to about 75% w/w of a drug substance (Page 9, lines 26-32), as taught by Mishra, the cancer treatment drug (olaparib) which may be present in the co-precipitate in an amount of from about 10% to about 80% by weight of the co-precipitate precipitate; or in an amount of from about 20% to about 60%, by weight, of the coprecipitate; or in an amount of about 30%, by weight, of the co-precipitate ([0030]), as taught by Sheikh, and the anti-cancer drug abiraterone acetate ([0951]), as taught by Chen.
Regarding instant claim 38, the limitation of the co-amorphous form admixed with a co-amorphous form of beta-lactoglobulin and a corticosteroid would have been obvious over the drug substance which includes the corticosteroid prednisone (Page 9, line 4), as taught by Mishra.
Regarding instant claim 39, the limitation of the co-amorphous form of beta-lactoglobulin, a corticosteroid, and olaparib would have been obvious over the co-amorphous form of beta-lactoglobulin (Page 2, lines 13- 21; Page 14, lines 13-16; and claims 1-9), as taught by Mishra, the drug substance which includes the corticosteroid prednisone (Page 9, line 4), as taught by Mishra, and the abiraterone acetate ([0951]), as taught by Chen.
Regarding instant claims 40 and 49, the limitations of niraparib would have been obvious over the cancer treatment drug olaparib in the co-precipitate in the tablet composition (Example 2 – [0054]), as taught by Sheikh, and the anti-cancer drugs olaparib and niraparib ([0951]), as taught by Chen. One of ordinary skill in the art would have found it obvious to substitute the olaparib with the niraparib since Chen teaches that both these drugs are used as anti-cancer agents ([0951]).
Regarding instant claim 41, the limitation of a composition comprising the co-amorphous form would have been obvious over the pharmaceutical compositions comprising the co-amorphous form (Abstract and claims 1-12), as taught by Mishra, and the pharmaceutical composition containing the co-precipitates (Abstract, claims 1-5 and 10-11), as taught by Sheikh.
Regarding instant claim 42, the limitation of a pharmaceutically acceptable excipient would have been obvious over the pharmaceutically acceptable excipients (Page 10, lines 4-7), as taught by Mishra, and the pharmaceutically acceptable excipients ([0014]), as taught by Sheikh.
Regarding instant claim 43, the limitation of the composition comprising from 5% to 100% w/w of the co-amorphous form, based on the total weight of the composition would have been obvious over the 50.0% w/w of the olaparib co-precipitate in the tablet composition (Example 2 – [0054]), as taught by Sheikh.
Regarding instant claim 45, the limitation of the concentration of abiraterone acetate in the co-amorphous form of from 40% to 85% w/w of the total weight of the composition would have been obvious over the abiraterone acetate ([0951]), as taught by Chen and the 50.0% w/w of the cancer treatment drug olaparib in the co-precipitate in the tablet composition (Example 2 – [0054]), as taught by Sheikh. One of ordinary skill in the art would have found it obvious to substitute the olaparib with the abiraterone acetate since Chen teaches that both these drugs are used for as anti-cancer agents ([0951]).
Regarding instant claim 46, the limitation of one or more corticosteroids would have been obvious over the corticosteroid prednisone (Page 9, line 4), as taught by Mishra.
Regarding instant claim 47, the limitation of the composition formulated for oral administration would have been obvious over the composition for oral administration (Page 10, lines 1-3 and Page 13, lines 7-10), the tablets (Page 22, lines 20-26), as taught by Mishra, and the tablet composition (Example 2 – [0054]), as taught by Sheikh.
Regarding instant claim 48, the limitation of a solid dosage form would have been obvious over the tablets (Page 22, lines 20-26), as taught by Mishra, and the tablet composition (Example 2 – [0054]), as taught by Sheikh.
Regarding instant claim 50, the limitation of the dosage regime would have been obvious over the cancer treatment drug olaparib in the co-precipitate in the tablet composition (Example 2 – [0054]), as taught by Sheikh, and the anti-cancer drugs olaparib, abiraterone acetate, and combinations thereof ([0951]), as taught by Chen. One of ordinary skill in the art would have found it obvious to combine the olaparib with the abiraterone acetate since Chen teaches combinations of these drugs and that these drugs are used as anti-cancer agents ([0951]). The dosage regime and the dosages of each drug would have been obvious over the overlapping dosage of 10 to 1000 mg of olaparib ([0049]), as taught by Sheikh. One of ordinary skill in the art would have found it obvious to use the same dosage of olaparib for the dosage of abiraterone acetate since both drugs are used for the treatment of cancer. One of ordinary skill in the art would have found it obvious to adjust the dosage and dosage regime based on the subject being treated, the particular cancer being treated, the severity of the cancer, and the optimal rate of administration. The recited dosage regime would have been obvious over the prior art unless there is evidence of criticality or unexpected results.
Regarding instant claim 51, the limitation of each tablet further comprising prednisone or prednisolone would have been obvious over the corticosteroid prednisone (Page 9, line 4), as taught by Mishra, and the prednisone and prednisolone in combination with anti-cancer agents olaparib and abiraterone acetate ([0951]), as taught by Chen.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Mishra et al. (WO 2018/113890 A1 – “Mishra”) in view of Sheikh et al. (US 2017/0105937 A1 – “Sheikh”) and Chen et al. (US 2019/0330196 A1 – “Chen”), as applied to claims 1, 36, 38-43, and 45-51 above, further in view of Bertelsen et al. (WO 2018/115520 A1 – “Bertelsen”).
Instant claim 37 is drawn to the co-amorphous form according to claim 1, wherein the purity of beta-lactoglobulin is 92% or more.
The teachings of Mishra, Sheikh, and Chen are discussed above.
Mishra, Sheikh, and Chen do not expressly teach that the purity of beta-lactoglobulin is 92% or more.
Bertelsen teaches beta-lactoglobulin (BLG) compositions (Abstract, claims 1-29). The BLG-containing composition may be a BLG isolate, e.g., contains BLG in an amount of more than 90% (w/w) relative to total protein (Page 36, lines 19-20).
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 co-amorphous form of about 25 to about 75% w/w of a drug substance and a beta-lactoglobulin protein which is obtained by spray drying, as taught by Mishra, in view of co-precipitates of the anti-cancer drug olaparib and an ionic polymer prepared by spray drying, as taught by Sheikh, use a combination of the anti-cancer drugs olaparib, abiraterone acetate, and niraparib, as taught by Chen, further in view of the BLG isolate which contains BLG in an amount of more than 90% (w/w) relative to the total protein, as taught by Bertelsen, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because, 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.” The range of more than 90% (w/) of BLG relative to the total protein (Page 36, lines 19-20) taught by Bertelsen overlaps the claimed range and is close to the claimed range, thereby rendering it obvious. One of ordinary skill in the art would have found it obvious to use the BLG taught by Bertelsen in the co-amorphous form of Mishra since the simple substitution of one known element for another to obtain predictable results is obvious. Please see MPEP 2141(III)(B).
Regarding instant claim 37, the limitation of the purity of beta-lactoglobulin is 92% or more would have been obvious over the BLG-containing composition or BLG isolate which contains BLG in an amount of more than 90% (w/w) relative to total protein (Page 36, lines 19-20), as taught by Bertelsen.
Response to Arguments
Applicant’s arguments (Pages 5-7, filed 04/28/26) with respect to the following rejections as they now apply to the amended claims and the updated rejections above have been fully considered but are not persuasive.
Rejection of claims 1, 35, 38-39, and 41-48 under 35 U.S.C. 103 as being unpatentable over Mishra in view of Sheikh
Rejection of claims 36, 40, 45, and 49-51 under 35 U.S.C. 103 as being unpatentable over Mishra in view of Sheikh and Chen
Rejection of claim 37 under 35 U.S.C. 103 as being unpatentable over Mishra in view of Sheikh and Bertelsen
Applicant argues that claim 1 recites that the drug substance is abiraterone acetate, and that within cited paragraph [0951] of Chen, abiraterone acetate is one of numerous antineoplastic agents mentioned. Applicant argues that Chen does not provide motivation to choose abiraterone acetate in particular over any of the other options, and certainly no teaching or suggestion that abiraterone acetate with beta-lactoglobulin would perform significantly better than existing abiraterone acetate drugs Yonsa and Zytiga.
This is not persuasive because one of ordinary skill in the art would have been motivated to choose from the numerous antineoplastic agents mentioned by Chen and have a reasonable expectation that they would all function efficaciously as antineoplastic agents. According to MPEP 2121, “When the reference relied on expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to provide facts rebutting the presumption of operability.”
Applicant points to Example 13 of the present specification and argues that this example demonstrates unexpected results of the claimed co-amorphous form of beta-lactoglobulin and a drug substance having an increased bioavailability relative to Yonsa and Zytiga. Applicant argues that: “Additionally, Example 13 demonstrates an unexpected result that the coefficient of variation (CV) of the claimed co-amorphous form of beta-lactoglobulin and a drug substance is reduced even further than for Yonsa. This finding evidences that the claimed co-amorphous form of beta-lactoglobulin and abiraterone acetate is an unexpected improvement over Yonsa, as the claimed co-amorphous form of beta-lactoglobulin and abiraterone acetate would be even less affected by food.”
Example 13 in the present Specification has been fully considered but Applicant’s arguments are not persuasive because the unexpected results are based on a specific dosage of abiraterone acetate along with the specific excipients and the corresponding concentrations.
However, instant claim 1 is silent regarding the specific dosage of abiraterone acetate along with the specific excipients and the corresponding concentrations. As such, the evidence is not commensurate in scope with the claimed invention. Please see MPEP 2145.
Furthermore, 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 nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.””
Regarding instant claim 37, the deficiency regarding the purity of BLG of 92% or more is cured by Bertelson. The combination of Mishra, Sheikh, Chen, and Bertelson is proper because 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.” The range of more than 90% (w/) of BLG relative to the total protein (Page 36, lines 19-20) taught by Bertelsen overlaps the claimed range and is close to the claimed range, thereby rendering it obvious. One of ordinary skill in the art would have found it obvious to use the BLG taught by Bertelsen in the co-amorphous form of Mishra since the simple substitution of one known element for another to obtain predictable results is obvious. Please see MPEP 2141(III)(B).
Therefore, the rejection of 11/04/25 based on Mishra, Sheikh, and Chen is applied to claims 1, 36, 38-43, and 45-51; and claim 37 is rejected based on Mishra, Sheikh, Chen, and Bertelson.
Double Patenting
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.
Updated Rejection
Claims 1, 36-43 and 45-51 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 of US Patent No. 12,564,554 B2 in view of Mishra et al. (WO 2018/113890 A1 – “Mishra”), Sheikh et al. (US 2017/0105937 A1 – “Sheikh”), and Chen et al. (US 2019/0330196 A1 – “Chen”).
Please note that the previous provisional rejection is updated to be a non-provisional rejection since Application No. 17/779,566 (“the ‘566 Application”) issued as Patent No. 12,564,554 B2 on March 3, 2026.
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a co-amorphous form of beta-lactoglobulin (BLG) and a drug substance, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claims of the ‘566 Application recite that the purity of the BLG is at least 92% w/w (claim 1), at least 94% w/w (claim 3), at least 96% w/w (claim 4), at least 97% w/w (claim 5), at least 98% w/w (claim 6) of the total amount of protein comprised in the co-amorphous form. However, instant claim 37 recites that the purity of BLG is overlapping at 92% or more, thereby rendering these limitations obvious.
Another difference is that claim 7 of the ‘566 Application recites bovine BLG whereas instant claims are silent regarding the source of the BLG. However, one of ordinary skill in the art would have found it obvious to use various sources of BLG including bovine BLG based on the desired attributes of the co-amorphous form.
Yet another difference is that instant claim 1 recites that the drug substance is abiraterone acetate, whereas claims of the ‘566 Application does not recite this drug. The teaching of Mishra with respect to a co-amorphous form of about 25 to about 75% w/w of a drug substance and a BLG protein which is obtained by spray drying; the teaching of Sheikh with respect to co-precipitates of olaparib and an ionic polymer prepared by spray drying; and the teaching of Chen with respect to anti-cancer including olaparib, niraparib, and abiraterone acetate, and combinations thereof are discussed above in detail.
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 co-amorphous form of an active pharmaceutical ingredient (API) and a BLG protein as recited in claims of the ‘566 Application, in view of the co-amorphous form of about 25 to about 75% w/w of a drug substance and a beta-lactoglobulin protein which is obtained by spray drying, as taught by Mishra, the co-precipitates of olaparib (which is used in the treatment of cancer) and an ionic polymer prepared by spray drying, as taught by Sheikh, the combination of anti-cancer agents olaparib, abiraterone acetate, and niraparib, as taught by Chen, and produce the instant invention.
One of ordinary skill in the art would have been motivated to use the spray dried co-amorphous form containing a drug substance and beta-globulin taught by Mishra for the anti-cancer drug olaparib taught by Sheikh and the anti-cancer drugs olaparib, abiraterone acetate, and niraparib taught by Chen because Mishra teaches that “… when a protein or peptide, notably a native peptide or native protein, is used to produce a co-amorphous form of a poorly soluble substance such as a poorly soluble drug substance, the resulting co-amorphous form is a completely homogeneous, one-phase system in which the substance and the protein are combined at the molecular level. In this way, the aqueous solubility and the oral absorption is improved compared to an amorphous form of the substance itself without any protein excipient. Moreover, the physical stability of the co-amorphous form is also increased compared to the amorphous form of the drug itself.
One of ordinary skill in the art would have had a reasonable expectation of success in preparing a functional co-amorphous form containing a combination of cancer treatment drugs and corticosteroids (recited in instant claims 38, 39, and 51) since combinations of such drugs are taught by Chen ([0951]).
Therefore, instant claims are obvious over claims of the ‘566 Application in view of Mishra, Sheikh, and Chen, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1, 36, 38-43, and 45-51 are again provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 26, and 33 of copending Application No. 18/166,339 (“the ‘339 Application”) in view of Mishra et al. (WO 2018/113890 A1 – “Mishra”), Sheikh et al. (US 2017/0105937 A1 – “Sheikh”), and Chen et al. (US 2019/0330196 A1 – “Chen”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a co-amorphous form of BLG and a drug substance, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘339 Application recites that therapeutically active substance is a member of Biopharmaceutics Classification System (BCS) Class II or IV, whereas instant claims do not recite this limitation. However, since instant claim 50 recites olaparib, which belongs to BCS Class 4 (instant specification Page 9, lines 24-25), this limitation is rendered obvious since olaparib is a species of the drugs in BCS Class 4.
Another difference is that claim 1 of the ‘339 Application recites that the co-amorphous form is a mixture of the therapeutically active substance and the protein at the molecular level in a single homogenous amorphous phase, whereas instant claims do not recite this limitation. However, since both sets of claims recite a co-amorphous form of a drug and the same BLG, the limitation of the single homogenous amorphous phase is intrinsically present in the instant claims.
Yet another difference is that instant claim 1 recites that the drug substance is abiraterone acetate, whereas claims of the ‘339 Application does not recite this drug. The teaching of Mishra with respect to a co-amorphous form of about 25 to about 75% w/w of a drug substance and a BLG protein which is obtained by spray drying; the teaching of Sheikh with respect to co-precipitates of olaparib and an ionic polymer prepared by spray drying; and the teaching of Chen with respect to anti-cancer including olaparib, niraparib, and abiraterone acetate, and combinations thereof are discussed above in detail.
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 co-amorphous form of a therapeutically active substance and a BLG protein as recited in claims of the ‘339 Application, in view of the co-amorphous form of about 25 to about 75% w/w of a drug substance and a beta-lactoglobulin protein which is obtained by spray drying, as taught by Mishra, the co-precipitates of olaparib (which is used in the treatment of cancer) and an ionic polymer prepared by spray drying, as taught by Sheikh, the combination of anti-cancer agents olaparib, abiraterone acetate, and niraparib, as taught by Chen, and produce the instant invention.
One of ordinary skill in the art would have been motivated to use the spray dried co-amorphous form containing a drug substance and beta-globulin taught by Mishra for the anti-cancer drug olaparib taught by Sheikh and the anti-cancer drugs olaparib, abiraterone acetate, and niraparib taught by Chen because Mishra teaches that “… when a protein or peptide, notably a native peptide or native protein, is used to produce a co-amorphous form of a poorly soluble substance such as a poorly soluble drug substance, the resulting co-amorphous form is a completely homogeneous, one-phase system in which the substance and the protein are combined at the molecular level. In this way, the aqueous solubility and the oral absorption is improved compared to an amorphous form of the substance itself without any protein excipient. Moreover, the physical stability of the co-amorphous form is also increased compared to the amorphous form of the drug itself.
One of ordinary skill in the art would have had a reasonable expectation of success in preparing a functional co-amorphous form containing a combination of cancer treatment drugs and corticosteroids (recited in instant claims 38, 39, and 51) since combinations of such drugs are taught by Chen ([0951]).
Therefore, instant claims are obvious over claims of the ‘339 Application in view of Mishra, Sheikh, and Chen, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 1, 36-43, and 45-51 are again provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 14, and 15, of copending Application No. 18/713,118 (“the ‘118 Application”) in view of Mishra et al. (WO 2018/113890 A1 – “Mishra”), Sheikh et al. (US 2017/0105937 A1 – “Sheikh”), and Chen et al. (US 2019/0330196 A1 – “Chen”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a co-amorphous form of BLG and a drug substance, and therefore, encompass overlapping or coextensive subject matter.
One difference is that claim 1 of the ‘118 Application recites a co-amorphous form of a drug, a nutraceutical, or a dietary supplement with a protein and a water-soluble polymer, whereas instant claims do not recite a water-soluble polymer. However, instant claims do not recite closed language, e.g., “consisting of,” and allow the inclusion of additional materials, such as the water-soluble polymer recited in claim 1 of the ‘118 Application.
Another difference is that instant claim 1 recites abiraterone acetate whereas claims of the ‘118 Application do not recite this drug. However, since claim 15 of the ‘118 Application recites that the drug compound is classified in BCS Class II or IV, this limitation is rendered obvious since instant claim 50 recites olaparib, which belongs to BCS Class 4 (instant specification Page 9, lines 24-25). This limitation is rendered obvious since olaparib is a species of the drugs in BCS Class 4.
Yet another difference is that instant claim 1 recites that the drug substance is abiraterone acetate, whereas claims of the ‘118 Application do not recite this drug. The teaching of Mishra with respect to a co-amorphous form of about 25 to about 75% w/w of a drug substance and a BLG protein which is obtained by spray drying; the teaching of Sheikh with respect to co-precipitates of olaparib and an ionic polymer prepared by spray drying; and the teaching of Chen with respect to anti-cancer including olaparib, niraparib, and abiraterone acetate, and combinations thereof are discussed above in detail.
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 co-amorphous form of a therapeutically active substance and a BLG protein as recited in claims of the ‘118 Application, in view of the co-amorphous form of about 25 to about 75% w/w of a drug substance and a beta-lactoglobulin protein which is obtained by spray drying, as taught by Mishra, the co-precipitates of olaparib (which is used in the treatment of cancer) and an ionic polymer prepared by spray drying, as taught by Sheikh, the combination of anti-cancer agents olaparib, abiraterone acetate, and niraparib, as taught by Chen, and produce the instant invention.
One of ordinary skill in the art would have been motivated to use the spray dried co-amorphous form containing a drug substance and beta-globulin taught by Mishra for the anti-cancer drug olaparib taught by Sheikh and the anti-cancer drugs olaparib, abiraterone acetate, and niraparib taught by Chen because Mishra teaches that “… when a protein or peptide, notably a native peptide or native protein, is used to produce a co-amorphous form of a poorly soluble substance such as a poorly soluble drug substance, the resulting co-amorphous form is a completely homogeneous, one-phase system in which the substance and the protein are combined at the molecular level. In this way, the aqueous solubility and the oral absorption is improved compared to an amorphous form of the substance itself without any protein excipient. Moreover, the physical stability of the co-amorphous form is also increased compared to the amorphous form of the drug itself.
One of ordinary skill in the art would have had a reasonable expectation of success in preparing a functional co-amorphous form containing a combination of cancer treatment drugs and corticosteroids (recited in instant claims 38, 39, and 51) since combinations of such drugs are taught by Chen ([0951]).
Therefore, instant claims are obvious over claims of the ‘118 Application in view of Mishra, Sheikh, and Chen, and they are not patentably distinct over each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant’s arguments (Page 7, filed 04/28/26) with respect to the double patenting rejections as they now apply to the amended claims and the updated rejections above have been fully considered but are not persuasive.
Applicant requests reconsideration of the double patenting rejection in view of the amendments.
This is not persuasive as the double patenting rejections are maintained for the reasons articulated above. Until such time that terminal disclaimers are filed the double patenting rejections will be maintained.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615
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